Call us toll free: (317)727-9173
Top notch Multipurpose WordPress Theme!

CBD and Cannabis Audits, GMP and Quality

by NaturPro in Quality Comments: 0

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

CBD and Cannabis Auditors, GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence
cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

CBD SOP’s and Cannabis Procedures

by NaturPro in Quality Comments: 0

Standard operating procedures (SOP) for CBD and Cannabis operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.


  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)

———————

The following information is a partial excerpt from draft from U.S. Hemp Roundtable guidance for CBD products, which NaturPro was fortunate to contribute to.

CBD SOP’s and Cannabis Procedures

U.S. Hemp Guidance Program PHASE 2

1 GROWER
1.1 GENERAL TERMS & DEFINITIONS

The following Definitions and Interpretations apply to such terms when used in this U.S. Hemp Guidance Program.

Adulteration refers to a food that may be considered adulterated if it contains “any poisonous or deleterious substance which may render it injurious to health…..or if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is”.

Batch means a specific quantity of industrial hemp that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified period of time according to a single manufacturing record.

Batch number, or lot number means any distinctive group of letters, or numbers, or any combination of them, from which the complete history of the processing, packaging, labeling, and/or storage of a batch or lot of industrial hemp product can be determined.

Biomass means the amount of living matter in a given habitat, expressed either as the weight of organisms per unit area or as the volume of organisms per unit volume of habitat.

Component means any substance intended for use in the manufacture of industrial hemp, including those that may not appear in the finished batch of the industrial hemp.

Growth Medium means the solid, liquid or semi-solid substance used to support the growth of the plant.

Hemp refers to cannabis varieties and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.

Industrial Hemp is Hemp
Ingredient means any substance that is used in the manufacture of hemp and that is intended to

be present in the finished batch of the hemp product.

In-process material means any material that is compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any way for use in the manufacture of the hemp product.

Lot means a batch, or a specific identified portion of a batch, or, in the case of a hemp product produced by continuous process, a specific identified amount produced in a specified unit of time or

page4image1693296

1

U.S. Hemp Guidance Program PHASE 2

quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms means yeasts, molds, bacteria, viruses, toxins, and other similar microscopic organisms which may or may not have a health or sanitary concern.

Pest means any objectionable insect or other animal including but not limited to birds, rodents, flies, mites, and larvae.

Physical plant or facility means all or any part of a building or facility used for or in connection with manufacturing, processing packaging, labeling, or storage of industrial hemp products or ingredients.

Processor means making a transformative change to the hemp plant or product following harvest.

Product complaint means any communication that contains any allegation, written, electronic, or oral, expressing concern, which may or may not have be related to the quality of an industrial hemp product.

Quality means that the hemp product meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.

Quality Management Systems means a planned and systematic operation or procedure for ensuring the quality of a hemp product.

Quality Management Systems personnel means any person, persons, or group, within or outside the organization, designated to be responsible for quality control operations.

Representative sample means a sample with an adequate number of units that are intended to ensure that the sample accurately portrays the material being sampled.

Reserve sample means a representative sample of product that is held for a designated period of time.

Sanitize means to adequately treat cleaned equipment, containers, utensils, etc.by a process that is effective in destroying of microorganisms of public health concerns.

2

U.S. Hemp Guidance Program PHASE 2

1.2 REGISTRATION/APPLICATION/NOTIFICATION

Prior to the Industrial Hemp Grower planting any seed, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)

1.2.1 Registration/Application Guidance

  • Name of the person or corporation to whom the license or authorization is to be issued
  • Address of the farm or place including county and township or legal description
  • The number of acres
  • Global Positioning System coordinates
  • Intended purpos of industrial hemp
  • In the case of a plant breeder, the variety of industrial hemp that may be cultivated; and

o Any conditions that are necessary to minimize security, public health or safety hazards related to the licensed or authorized activities.

o Specify if the hemp is for food or non-food purposes

1.2.2 Notification of Changes to the licensor by the licensee

Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:

  • Corporate name or ownership, or officers, and the replacement of an officer, or director
  • Any change to the address of the licensee
  • The replacement of an individual referred to a licensee
  • Any change in the mailing address of the licensee
  • Any change in the ownership of the land used to cultivate industrial hemp
  • Any change to the approved cultivar being sown or, in the case of a plant breeder, to thevariety of industrial hemp being sown;
  • Any genetic modification.

page6image1687472

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

3

U.S. Hemp Guidance Program PHASE 2

1.3 PERSONNEL

Qualified employees who grow, manufacture, package, or label industrial hemp shall be qualified to do so, and those responsible for quality control or performing any quality control operations, must have the education, training, or experience to perform the assigned functions.

Supervisors shall be qualified by education, training, or experience to supervise.
Contamination Prevention and Hygienic measures shall be taken to exclude from any operations

any person who might be a source of microbial contamination.

Such measures shall include the following:

  • Exclude personnel from working in any operations that may have an illness, infection, open lesion, or any other abnormal source of contamination.
  • Instructing employees to notify their supervisor if there is a possibility that they have a health condition described above.
  • Wearing outer garments in a manner that protects against the contamination.
  • Maintaining adequate personal cleanliness.
  • Washing hands thoroughly, and sanitizing if necessary, in a hand-washing facility.
  • Removing or covering all unsecured jewelry and other objects that might fall into components, industrial hemp, equipment, or packaging.
  • Using gloves when appropriate.
  • Wearing, where appropriate, hair nets, caps, beard covers, shoes, PPE etc.Personnel and employee safety measures shall include the following:
  • Appropriate and Adequate First Aid Equipment
  • Adequate bathrooms and changing rooms
  • Appropriate OSHA warnings, labels, and training
  • Appropriate training and personal protective equipment for pesticide application

4

U.S. Hemp Guidance Program PHASE 2

1.3.1 U.S. HEMP GUIDANCE – GROWER – PERSONNEL CHECKLIST

√ ifApplicable

YES

NO

NOTES

Are the supervisors qualified for their responsibilities by training, education or experience?

Do the employees performing the growing, processing, packaging and labeling tasks, have the proper training necessary to perform the tasks?

page8image3012944page8image3672096 page8image3673136

Are contamination and hygienic measures in place to exclude personnel who might be a source of contamination?

Are personnel excluded from operations if they have, an illness, infection, open lesion, or any other abnormal source of contamination?

Do employees notify their supervisor if there is a possible health condition as described above?

page8image3011712page8image3682704 page8image3683744

Do personnel wear outer garments in a manner that protects against the contamination?

Do operating personnel maintain adequate personal cleanliness?

page8image4994288page8image3687904 page8image3688736

Are hand washing facilities available and used?

page8image3003648page8image3693312 page8image3694352

Do operating personnel remove or cover unsecured jewelry etc. to prevent them from falling into hemp products or causing harm?

Are gloves used when appropriate?

page8image2994912page8image3700384 page8image3701424

Are caps, shoes and head covering used when appropriate?

Is the appropriate Personal Protective Equipment (PPE) used as needed?

page8image3008240page8image3705584 page8image3706416

Are there adequate and appropriate first aid equipment available?

Is there adequate bathrooms and changing rooms?

Are the OSHA warnings and signs visible?

Has there been adequate training?

If applicable is the PPE and trains available for the pesticide applicators?

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

5

U.S. Hemp Guidance Program PHASE 2

1.3.2 U.S. HEMP GUIDANCE – GROWER – BEST MANAGEMENT PRACTICES CHECKLIST

NOTES

page9image3691232page9image2976880

YES

NO

Are you using the best soil available?

Have you Soil tested for macro and micro nutrients?

Have you used the appropriate Growth Medium for intended purposes?

page9image2939248

Has the licensee determined the concentration of THC in the hemp?

page9image2960528

Is seed planted listed on the license?

Is the entire hemp plant used as licensed?

page9image4990816

Do you properly use pre- plant weed control?

Do you have a Germination Certificate from the seed supplier

page9image5001680

Did you use the proper Certified Seed suitable for location?

Did you use the proper seed treatment?

Do you have a site history?

page9image3726592page9image2939472 page9image3728464

Do you have a water quality report or history?

page9image2934992

Did you use fertilizer to target desired yield per acre according to soil test?

Did you use animal manure for fertilizer or biomass purposes?

page9image2956160

Did you plant by optimum seeding date?

page9image3735328 page9image3736576

Did you plant at the optimum rate of seeds per acre?

page9image3738032page9image2968480 page9image3739904

Have samples of the industrial hemp been collected in accordance with the Guidance Procedures?

page9image2940480

Has the equipment used to sow, harvest and transport the hemp been thoroughly cleaned to prevent contamination?

Are you prepared to harvest when the plant is ready?

page9image3744480 page9image3745728

Have you complied with the drying procedures

page9image3747184page9image2948768 page9image3749056

Do you have sufficient and proper storage facilities or adequate transportation equipment available?

Is the biomass sold to a licensed person or entity according the Guidance Procedures?

page9image2966352page9image3752800 page9image3754256

Is the biomass packaged, labeled, and transported according to the Transportation Guidance Procedures?

Has any loss or theft been reported according to the license requirements?

page9image3756336 page9image3757376 page9image3758208 page9image3758832

Are the records being kept according to the Guidance Procedures for Record Retention?

page9image3760288 page9image3761328

page9image3763824

Grower Signature___________________________ Date _________________ Printed Name___________________ Farm location or identifier__________________

6

U.S. Hemp Guidance Program PHASE 2

1.3.3 U.S. HEMP GUIDANCE – GROWER – FACILITY & BIOSECURITY AWARENESS CHECKLISTA.

√ ifApplicable

page10image2919984page10image3704752page10image2919088

Facility Security (physical security of buildings and grounds)

Is the facility using:

YES

NO

NOTES

Security lighting

Perimeter fencing

Controlled gate access

page10image2946864 page10image2960976page10image3718272

Off-hours security guard

Electronic motion detectors

Door alarms

Video cameras

page10image2976096 page10image2976320page10image3729504

Adequate indoor lighting

Alarms linked to an off-site security system

page10image2947424page10image2961536 page10image2961648page10image3735328page10image2961760page10image3736368

Door hardware is of industrial design

Guards are installed on exterior ladders

page10image2928272page10image2928384 page10image2928496page10image3741152page10image2928608page10image3742192

Exit doors and gate are electronically/mechanically secured

Entry and discharge points of exterior tanks are padlocked when not in use

page10image2928944 page10image2971392page10image3746144

All vehicles parked outside are locked

Empty/loaded containers are parked inside

page10image2942720 page10image2956944page10image3753840

Law enforcement patrol over company premises on regular but unpredictable basis

Employees reporting any suspicious behaviors

Restricted access to computer process control and data systems

Safeguard of data systems using data security program

page10image2971952 page10image2972064page10image3763616

Backup of all data and processes at an off-site place

page10image2942944page10image2943056 page10image2943168page10image3767360page10image2943280page10image3768400

page10image3775264page10image3775472page10image3775680page10image3775888page10image3776096

B.

√ ifApplicable

Visitor Policy

page10image3776512page10image3776720page10image3776928page10image3777136page10image2957616page10image2957728page10image3778176page10image3778384page10image3778592page10image3778800page10image3779008page10image3779216page10image3779424

Is the facility using:

YES

NO

NOTES

page10image3779840page10image3780048page10image3780256page10image3780464page10image2972288page10image2972400page10image3781504page10image3781712page10image3781920page10image3782128page10image3782336page10image3782544page10image3782752

Company representative for visitor to check in with

page10image3783168page10image3783376page10image3783584page10image3783792page10image2972624page10image2943392page10image3784832page10image3785040page10image3785248page10image3785456page10image3785664page10image3785872page10image3786080

Signs informing visitors where to report

page10image3786496page10image3786704page10image3786912page10image3787120page10image2943616page10image2943728page10image3788160page10image3788368page10image3788576page10image3788784page10image3788992page10image3789200page10image3789408

Specific area for visitor parking

page10image3789824page10image3790032page10image3790240page10image3790448page10image2957952page10image2958064page10image3791488page10image3791696page10image3791904page10image3792112page10image3792320page10image3792528page10image3792736

Records of visitors (include name, company, arrival and departure, and purpose of visit)

page10image3793152page10image3793360page10image3793568page10image2929952page10image2930064page10image3794608page10image3794816page10image3795024page10image3795232page10image3795440page10image3795648page10image3795856

Visitor badges/identification cards

page10image3796272page10image3796480page10image3796688page10image2930288page10image2972736page10image3797728page10image3797936page10image3798352page10image3798560page10image3798768page10image3798976

Company representative to escort visitor all the time

page10image3799392page10image3799600page10image3799808page10image3800016page10image2972960page10image2973072page10image5767168page10image5767376page10image5767584page10image5767792page10image5768000page10image5768208page10image5768416

Restricted access to key manufacturing areas

page10image5768832page10image5769040page10image5769248page10image5769456page10image2943952page10image2944064page10image5770496page10image5770704page10image5770912page10image5771120page10image5771328page10image5771536page10image5771744page10image5772160page10image5772368page10image5772576page10image2944176page10image2958288page10image5773616page10image5773824page10image5774032page10image5774240

C.

√ ifApplicable

Distribution

page10image5774656page10image5774864page10image5775072page10image2958624page10image2930400page10image5776112page10image5776320page10image5776528page10image5776736page10image5776944page10image5777152page10image5777360

Is the facility implementing the following:

YES

NO

NOTES

page10image5777776page10image5777984page10image5778192page10image5778400page10image2973296page10image2973408page10image5779440page10image5779648page10image5779856page10image5780064page10image5780272page10image5780480page10image5780688

Bulk containers are inspected prior to loading for foreign and/or suspicious material

page10image2944288page10image5781520page10image5781728page10image5781936page10image2944400page10image2944512page10image5782976page10image5783184page10image2944624

7

U.S. Hemp Guidance Program PHASE 2

page11image2970272

Verify that all customer pick-up drivers are representatives of the customer

The product stream is inspected visually

Container access points are secured after loading

Seal numbers are documented on the shipping papers

page11image2915504 page11image2964672page11image5807312

Shipping documents are used to identify the contents of each compartment

Shipping log is maintained

Bio-sanitation program is implemented

page11image2965904 page11image2937120page11image5816048

Procedures exist to disinfect vehicles and drivers

page11image2951680 page11image2951456page11image5819376

page11image5822080page11image5822288page11image5822496page11image5822704page11image5822912

D.

√ if Applicable

E.

√ ifApplicable

Housekeeping

page11image5823328page11image5823536page11image5823744page11image2982704page11image2982816page11image5824784page11image5824992page11image5825200page11image5825408page11image5825616page11image5825824page11image5826032

Is the facility implementing the following:

YES

NO

NOTES

page11image5826448page11image5826656page11image5826864page11image2963888page11image2917072page11image5827904page11image5828112page11image5828320page11image5828528page11image5828736page11image5828944page11image5829152

Written housekeeping program for all areas of the facility

page11image5829568page11image5829776page11image5829984page11image2963552page11image2917520page11image5831024page11image5831232page11image5831440page11image5831648page11image5831856page11image5832064page11image5832272

Written pesticide and rodenticide program

page11image5832688page11image5832896page11image5833104page11image2966240page11image2966128page11image5834144page11image5834352page11image5834560page11image5834976page11image5835184page11image5835392page11image5835600page11image5835808

Emergency Response

page11image5836224page11image5836432page11image5836640page11image2966688page11image2966576page11image5837680page11image5837888page11image5838096page11image5838304page11image5838512page11image5838720page11image5838928

Is the facility implementing the following:

YES

NO

NOTES

page11image5839344page11image5839552page11image5839760page11image2945632page11image2983264page11image5840800page11image5841008page11image5841216page11image5841424page11image5841632page11image5841840page11image5842048

Employees are adequately trained to respond to a crisis as calmly and safely as possible

page11image5842464page11image5842672page11image5842880page11image2983488page11image2983600page11image5843920page11image5844128page11image5844336page11image5844544page11image5844752page11image5844960page11image5845168

Current inventory of all hazardous and flammable products

page11image5845584page11image5845792page11image5846000page11image2933984page11image2917744page11image5847040page11image5847248page11image5847456page11image5847664page11image5847872page11image5848080page11image5848288

A plan to provided MSDS to emergency response teams etc.

page11image5848704page11image5848912page11image5849120page11image5849328page11image2918304page11image2962208page11image5850368page11image5850576page11image5850784page11image5850992page11image5851200page11image5851408page11image5851616

A list of emergency contacts is posted

page11image5852032page11image5852240page11image5852448page11image2966464page11image2922112page11image5853488page11image5853696page11image5853904page11image5854112page11image5854320page11image5854528page11image5854736

An action plan to deal with suspicious devices or substances

page11image5855152page11image5855360page11image5855568page11image2966912page11image2922560page11image5856608page11image5856816page11image5857024page11image5857232page11image5857440page11image5857648page11image5857856

Evacuation plan in case of fire and explosions is published

page11image5858272page11image5858480page11image5858688page11image2974416page11image2973856page11image5859728page11image5859936page11image5860144page11image5860352page11image5860560page11image5860768page11image5860976

Establish and maintain an up-to-date employee roster and visitor log to facilitate personnel head count at any time

page11image5861392page11image5861600page11image5861808page11image5862016page11image2925696page11image2925136page11image5863056page11image5863264page11image5863472page11image5863680page11image5863888page11image5864096page11image5864304

Disaster Preparedness Plan

page11image5864720page11image5864928page11image5865136page11image2983936page11image2984048page11image5866176page11image5866384page11image5866592page11image5866800page11image5867008page11image5867216page11image5867424

A weapons security program

page11image5867840page11image5868048page11image5868256page11image5868464page11image2984272page11image2960528page11image5869504page11image5869712page11image5869920page11image5870128page11image5870336page11image5870544page11image5870752

Conduct evacuation and respond drill periodically

page11image5871168page11image5871376page11image5871584page11image5871792page11image2945968page11image2974640page11image5872832page11image5873040page11image5873248page11image2945408page11image2974080page11image2922336page11image2952352page11image2967472

Post a site plan depicting escape routes, fire-fighting and rescue equipment

page11image5876160page11image5876368page11image5876576

Signature: _____________________________
Printed Name: __________________________ Company: ________________________________

Date: ________________________________ Facility Location: ________________________________8

U.S. Hemp Guidance Program PHASE 2

1.4 SAMPLING AND HANDLING HEMP FOR THC & CBD1.4.1 Definitions

delta-9-THC means delta-9-tetrahydrocannabinol concentration.
Authority having jurisdiction usually means the state, but it could be FDA, USDA,

county or city.

Certified seed means seed for which a certificate or any other instrument has been issued, by an agency authorized under the laws of a state, territory, or possession to certify seed and which has standards and procedures approved by the United States Secretary of Agriculture to ensure the genetic purity and identity of the seed certified.

Plot means a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of hemp throughout the area.

ppm means parts per million.ppb means parts per billion.

Post-Harvest Sample means a sample taken from the harvested hemp materialfrom a particular plot’s harvest. The entire plot’s harvest must be in the same form(e.g., intact-plant, flowers, ground materials, etc.), homogenous, and not mixed with non-hemp materials or hemp materials from another plot.

Pre-Harvest Sample means a composite, representative portion from plants in a hemp plot collected in accordance with the procedures as defined by the state providing authority.

Processing means converting an agricultural commodity into a marketable form.Prohibited Variety means a variety or strain of cannabis excluded from the state

providing authority.

Sample means a sufficient amount of material that is representative of the population from which it is taken. A sample may be a particular plant part, including inflorescence (flower), leaf, stalk or seed, or it may be a processed product (oil, extract, powder. Samples must be dried to a sufficiently low moisture content so as not to harbor growth of microorganisms.

Seed source means the origin of the seed or propagules as determined by the state providing authority.

9

U.S. Hemp Guidance Program PHASE 2

  1. 1.4.2  Sampling Timeline and Grower Responsibilities
    1. The grower shall refer to the jurisdiction having authority to determine a timeline.
    2. During the sampling, the grower or an authorized representative shall be present at the growing site.
    3. Floral materials harvested for phytocannabinoid extraction shall not be moved beyond the processor, nor commingled, nor extracted, until test results are complete
  2. 1.4.3  Pre-Harvest Sampling Procedure
    1. Adequate personal protective equipment shall be used.
    2. Proper equipment shall be used to prevent cross contamination.
    3. The material selected for Pre-Harvest Sampling will be determined by the grower. Cuttings will be collected to make one representative sample.
    4. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
      1. Clip the top 12 inches of hemp plant’s primary stem, including female floralmaterial.
      2. Take cuttings from at least five (5) hemp plants within the plot.
      3. Place the complete sample in a paper bag.
      4. Seal the bag by folding over the top once and staple the bag shut.
      5. A separate sample must be taken from each non-contiguous plot of a given variety.
      6. A separate sample must be taken for each variety.
      7. Samples shall be secured in a paper bag (to allow for air-drying during transport).
      8. Label the sample container with a sample ID.
  3. 1.4.4  Handling Procedures of Pre-Harvest Samples
    1. Samples will be taken for drying and storage.
    2. Samples should be arranged in a single layer for drying.
    3. Drying oven will be used when possible.
    4. Samples in the oven will be left in the labeled sample bag.
    5. If selected for testing, the entire sample will be sent to a testing lab for analysis.
  4. 1.4.5  Post-Harvest Sampling Procedures for Floral Material
    1. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
    2. Adequate personal protective equipment shall be used.
    3. Proper equipment shall be used to prevent cross contamination
    4. The plot selected for sampling shall be designated by the Pre-Harvest Sampleresults. The material selected for Post-Harvest Sampling from this plot will be

10

U.S. Hemp Guidance Program PHASE 2

determined by the grower. All Post-Harvest Samples of floral material shall be taken from the designated harvested plot materials in the form (intact-plant, flowers, ground materials, etc.) in which the material will be sent to the processor

e. Grower must inventory the entire harvest to determine the form in which it exists and follow the protocol as appropriate in part a), b), or c) below.

  1. If, upon inventory, the grower determines that the entire harvest is not in a homogenous form (intact-plant, flowers, ground materials, etc.), it must be determined to take additional samples or other course of action or take the pre-harvest results.
  2. For intact-plant post-harvest samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., intact-plants).
    2. Clip the top 12 inches) of hemp plant, primary stem, includingfemale floral material.
    3. Take cuttings from at least five (5) non-adjacent hemp plantswithin the harvest’s storage/drying area.
    4. Place the complete sample in a paper bag.
    5. Seal the paper bag by folding over top once and stapling to keep closed.
    6. Complete sampling procedures in part (d) –(f).
  3. For ground plant or ground floral material Post-Harvest Samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., all harvested material whether whole plant or floral material only must be ground with no intact plants or whole flowers remaining from that harvest).
    2. Sample material from bag or container.
    3. Sample from a minimum of four locations within the containers from a given harvest.
    4. Place the complete sample in a plastic sample container.
    5. Seal the plastic sample container.
    6. Complete sampling procedures in part (d) –(f).
  4. For Post-Harvest Samples in other forms (e.g., trimmed floral material, or floral material and stems, etc.):
    1. Ensure that the entire harvest is accounted for and in the same form (i.e., all harvested material must be uniform).
    2. Randomly collect at least one cup of material by volume.
    3. Place the complete sample in a paper bag or plastic containerand seal the container, as appropriate.
    4. Complete sampling procedures in part (d) –(f).
  5. A separate sample must be taken for each plot designated for Post-Harvest Sampling.
  6. Samples shall be labeled and prepared for transport to the lab.
  7. Label the sample container with a sample ID.

11

U.S. Hemp Guidance Program PHASE 2

1.4.6 Handling Procedures of Post-Harvest Samples

  1. The entire sample will be sent to the testing lab for analysis.
  2. Industrial hemp crops generated from Certified seed will incur pre-harvest testing of at least five percent (5%) of growing plots per variety, per seed source.
  3. Industrial hemp crops from planting materials other than Certified seed will incur pre- harvest testing of at least fifty percent (50%) of growing plots per variety, per seed source.
  4. 100% of post-harvest samples will be tested.

Tainted Supplements Perspective & A Master List of Offenders

by NaturPro in Quality Comments: 0

On Tainted Supplements: A Perspective and Recommendation, with a Working List
 of Recent FDA Actions on Drugs Labeled as Dietary Supplements.

Dietary supplement adulteration from 2007-2016 was relatively infrequent compared to instances of food adulteration, and issues of adulteration were from drugs labeled as supplements, according to October 2018 article in JAMA.

According to one estimate based on the JAMA study and industry volume data from Nutrition Business Journal, approximately one bottle of dietary supplements may be adulterated for every 9,000 sold in the U.S.

Supplements as a subset of food comprises less than 5% of all adulterated food imports. When combined with cases of domestic adulteration and confirmed food poisoning caused by adulteration of fruits, vegetables and meat with pathogens like Salmonella, supplements comprise far less than 1% of documented adulteration.

The most interesting part of the JAMA study, is that about 98% of supplement adulteration are for drug spiking of products sold in only 3 sub-markets:  weight loss, men’s sexual health and bodybuilding products. Only 13 adulterated products were noted for the rest of the industry, suggesting that the issue is not as far-reaching as many assume.

The issue of ‘drugs masquerading as supplements’ is a global one affecting many countries, and not just the U.S. Spiking of dietary supplements or foods with drugs is not only unsafe, but it’s also illegal and can (and should) lead to jail time.

While we have compiled a partial list of product names of mislabeled drugs (below),  the offenders in the U.S. often remain anonymous, and don’t have their name, address or company name listed for industry and consumers to be aware of.

If you disagree with the policy of covering up the identity of ‘bad actors’, or you suspect possible drug-spiking in weight loss, bodybuilding or sexual health products, you should report to FDA by email to TaintedProducts@fda.hhs.gov.  Please ask FDA to publish the names and addresses of all owners of all listed products.

If you have a symptom or health issue that you think may be caused by a drug, food or  supplement, contact your physician immediately. 

The information on this page is not intended to include every instance of adulterated or mislabeled products.  Source: www.KeepSupplementsClean.org accessed October 2018

 

UNITED STATES

Product Name
Company
Date
Action Taken
Nuvitra Company Unknown 08/13/18 Public Notification
Asunsa Company Unknown 07/09/18 Public Notification
Lyn DTOX FS3 Company Unknown 07/09/18 Public Notification
Platinum Maximum Strength Blue Pill Version, Slimming Plus Advanced Weight Loss, Lean Extreme Max, X-treme Beauty Slim, Meizitang Strong Version capsules, Magic Slim capsules, Slim Xtreme capsules, Meizi Evolution capsules, SlimEasy Herbs capsules, Super Fat Burning Bomb capsules, FRUTA Bio, JIANFEIJINDAN Activity Girl, Reduce Weight FRUTA PLANTA, Fat Loss Slimming Beauty, Fruta Planta, Botanical Slimming, Slim Body MyNicNaxs LLC 07/06/18 Voluntary Nationwide Recall
Adipotrim XT Company Unknown 07/03/18 Public Notification
Body Shape Weight Loss System Company Unknown 07/03/18 Public Notification
Row of Antibody Pil Company Unknown 07/03/18 Public Notification
Adriana Balance S Company Unknown 06/20/18 Public Notification
AB Slim Company Unknown 06/20/18 Public Notification
PAYA Dietary Supplement Product Company Unknown 06/07/18 Public Notification
Asia Slim Capsules Company Unknown 11/22/17 Public Notification
Fruta Planta Life (Garcinia Cambogia Premium) Company Unknown 11/20/17 Public Notification
Adipessum Miracle Slimming Capsules Company Unknown 11/20/17 Public Notification
A1 Slim Kiriko LLC 10/05/17 Voluntary Nationwide Recall
Atomic and Xplode Capsules EZ Weight Loss TX LLC 07/24/17 Voluntary Nationwide Recall
LaBri’s Body Health Atomic 60 Capsules Envy Me 03/28/17 Urgent Recall
Slimming Plus Advanced This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/03/17 Public Notification
Platinum Max Strength Blue Pill Version This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/03/17 Public Notification
Platinum Weight Loss Solution – Fat Loss Metabolizer This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/03/17 Public Notification
Lean Extreme Max This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/02/17 Public Notification
X-treme Beauty Slim This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/02/17 Public Notification
Queen Slimming Soft Gel This product is promoted and sold for weight loss on the Web site, www.zxtbeepollenpills.com, and possibly in some retail stores. 12/22/16 Public Notification
Ultimate Body Tox PRO This product is promoted and sold for weight loss on the Web site, www.zxtbeepollenpills.com, and possibly in some retail stores. 11/30/16 Nationwide Voluntary Recall
DMAA Net Weight 500g This product is purchased through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and wholesale. 11/23/16 Voluntary Recall
ABX Weight Loss This product is promoted and sold for weight loss on the Web site, www.zxtbeepollenpills.com, and possibly in some retail stores. 11/16/16 Public Notification
Supreme Slim 5.7 This product is promoted and sold for weight loss on various websites including www.absolutenaturalweightloss.net, and possibly in some retail stores. 11/09/16 Public Notification
Skinny Bee Diet The product is used as a weight loss dietary supplement and is packaged in white silver bottle with red capsules. The affected Skinny Bee Diet product includes bottles MFD: 03.07.2016 EXP: 03.06.2018 Love My Tru Body distributed Skinny Bee Diet capsules nationwide March 23 – April 28, 2016 to consumers via the internet www.lovemytrubody.com 11/08/16 Voluntary Nationwide Recall
Ultimate Body Tox This product is promoted and sold for weight loss on various websites including www.ultimatebodytox.com, and possibly in some retail stores. 11/07/16 Public Notification
Zi Su Body Fat Health II (紫苏瘦身营养素 II – Zi Su Shou Shen Ying Yang Su II) This product is promoted and sold for weight loss on various websites and in stores. 10/25/16 Public Notification
Results This product is promoted and sold for weight loss on various websites, including distributors via www.facebook.com, and possibly in some retail stores. 10/19/16 Public Notification
Accelerator Boost This product is promoted and sold for weight loss on various websites and in stores. 10/19/16 Public Notification
Skinny Bee Diet This product is promoted and sold for weight loss on various websites and in stores. 10/19/16 Public Notification
Adelganzantes R-II This product is promoted and sold for weight loss on various websites and in stores. 08/09/16 Public Notification
Ultimate Lean This product was promoted and sold for weight loss on various websites and possibly in some retail stores. 07/28/16 Public Notification
Zi Xiu Tang Beauty Face and Figure Capsule This product was promoted and sold for weight loss on various websites and possibly in some retail stores. 07/28/16 Public Notification
Slim Fit X This product was promoted and sold for energy weight loss on various websites. 07/27/16 Public Notification
Mang Luk Power Slim Detox Promoted and sold for weight loss on various websites. 07/27/16 Public Notification
Xcelerated Weight Loss Charged Up Promoted and sold for weight loss on various websites, including www.xceleratedweightloss.com, and possibly in some retail stores. 07/22/16 Public Notification
Xcelerated Weight Loss Turbo Charge Promoted and sold for weight loss on various websites, including www.xceleratedweightloss.com, and possibly in some retail stores 07/22/16 Public Notification
Xcelerated Weight Loss Ultra Max Promoted and sold for weight loss on various websites, including www.xceleratedweightloss.com, and possibly in some retail stores 07/22/16 Public Notification
Dream Body, Dream Body Extreme Gold and Dream Body Advanced Dream Body Weight Loss 07/01/16 Voluntary Nationwide Recall
Step 2 The Body Shot Bar 06/07/16 Voluntary Nationwide Recall
3rd Degree, Black Gold X Advanced, and Black Label X Making It A Lifestyle LLC 04/29/16 Voluntary Nationwide Recall
SUPER HERBS The affected Super Herbs product includes all bottles which have been distributed nationwide to consumers via internet www.mysuperherbs.comdisclaimer icon. 04/11/16 Voluntary Recall
Propell Platinum This product was promoted and sold for weight loss and energy on various websites and possibly in some retail stores. 03/29/16 Public Notification
ENVY BP This product was promoted and sold for weight loss on various websites, including www.purelysimpleweightloss.com, and possibly in some retail stores. 03/28/16 Public Notification
ZlimXter Capsules This product was promoted and sold for weight loss and energy on various websites and possibly in some retail stores. 03/17/16 Public Notification
Dynamizm Capsules This product was promoted and sold for weight loss on various websites and possibly in some retail stores. 03/17/16 Public Notification
Eradicate Capsules This product was promoted and sold for weight loss on various websites, including www.x2zero.com, and possibly in some retail stores. 03/17/16 Public Notification
Xerophagy Capsules This product is promoted and sold for weight loss on various websites and possibly in some retail stores. 03/17/16 Public Notification
Pink Bikini and Shorts on the Beach Capsules These products were distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store. 01/28/16 Voluntary Nationwide Recall
Thirty Plus Product promoted for weight loss on various websites, including www.getskinny.bigcartel.com, and in some retail stores. 12/17/15 Public Notification
Pink Bikini Lucy’s Weight Loss System. Product promoted for weight loss on the website and in some retail stores. 12/09/15 Voluntary Nationwide Recall
Lipo Escultura Product promoted and sold for weight loss on www.lipoesculturatreatment.com by JAT Productos Naturales Corp., but may also be distributed under the following aliases: Lipo Escultura Corporation and JAT Natural Products Corp. This product is also heavily promoted on the firm’s Facebook and Instagram accounts.Image of Lipo Escultura 12/02/15 Public Notification
Zero Fat Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
SPCARET Princess Diet Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
Slyn Both Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
Perfect Slim Fast Track Slim Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
Super Herbs Product promoted for weight loss on the website, www.mysuperherbs.com, and in some retail stores. 11/19/15 Public Notification
Xtreme Fat Burner Capsules Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Tip-Top Shape Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Lishou Slimming Coffee Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Basha Nut 100% Fruit Soft Gel Capsules Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Ultimate Herbal Slimcap Product promoted and sold for weight loss on various websites, including www.fitfirmandfabulous.com< 10/01/15 Public Notification
NATUREAL Product promoted and sold for weight loss on various websites, and possibly in some retail stores.< 10/01/15 Public Notification
Pink Bikini and Shorts on The Beach Lucy’s Weight Loss System 09/23/15 Voluntary Nationwide Recall
MIRACLE DIET 30 and MIRACLE ROCK 48 http://www.fda.gov/Safety/Recalls/ucm462131.htm< 09/11/15 Voluntary Nationwide Recall
Meizi Super Power Fruits Herbal Slimming Formula Product promoted and sold for weight loss on various websites, and possibly in some retail stores.< 09/03/15 Public Notification
Methyldrene Original 25 Methyldrene 08/24/15 Voluntary Recall
Black Widow 25 Black Widow 08/24/15 Voluntary Recall
Asia Black Asia Black 08/24/15 Voluntary Recall
Xcellerator Xcellerator 08/24/15 Voluntary Recall
Thin and Slim Naturally AM Thin and Slim Naturally 08/24/15 Voluntary Recall
Tru Trim Tru Trim 08/24/15 Voluntary Recall
Metabolic Accelerator Metabolic Accelerator 08/24/15 Voluntary Recall
ThermoFX ThermoFX 08/24/15 Voluntary Recall
Fataway Ultimate Stack, MaxOut Body, Burn Fat Now, Thermogenic Fat Burner, Extreme Stack Thin & Slim 08/24/15 Voluntary Recall
Kaboom Action Strips and Lida Daidaihua Blue Square Market 08/17/15 Nationwide Recall
Achieving Zero Blue Square Market 08/06/15 Public Notification
Akttive High Performance Fat Burner Gold Capsules Life & More LLC 07/23/15 Nationwide Recall
Smart Lipo (800, 900, 950 mg) capsules Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800mg, 77 bottles of 900mg, and 23 bottles of 950mg.The affected Smart Lipo products include the following expiration dates: 800mg capsules – 9/15/2017, 900mg capsules – 7/30/2017, 950mg capsules – 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.comdisclaimer icon 06/03/15 Nationwide Recall
Li Da Dai Dai Hua Slimming Capsule Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/30/15 Public Notification
Slim Forte Slimming Capsule Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/30/15 Public Notification
Superior Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/29/15 Public Notification
Fatloss Slimming Beauty Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/29/15 Public Notification
Slim Trim U, ZXT Slim Bee Pollen, Magic Slim, ZXT Bee Pollen, ZXT Gold Infinity, Lean Body Extreme, Bnew Beauty and Body and Natural Body Solutions Floyd Nutrition LLC 04/15/15 Consumer Warning
Ultimate Boost Product promoted and sold for weight loss on various websites, including www.sportnutrition1.com, and possibly in some retail stores. 03/18/15 Public Notification
Xcel Product promoted and sold on various websites including www.zixiutangforyourfigure.com and in some retail stores. 03/18/15 Public Notification
Xcel Advanced Product promoted and sold on various websites including www.beenaturalnutrition.com, and possibly in some retail stores. 03/18/15 Public Notification
Ultra ZX Product promoted and sold on various websites and in some retail stores. 03/10/15 Recall
L-Carnitine Sob Strengthening Version Slimming Miracle Capsule Product promoted and sold on various websites and in some retail stores. 03/05/15 Public Notification
Natural Max Slimming Product promoted and sold on various websites and in some retail stores. 03/03/15 Public Notification
Diablos Eca Fire Caps Product promoted and sold on various websites and in some retail stores. 03/03/15 Public Notification
Black Mamba Hyperrush Product promoted and sold on various websites and in some retail stores. 03/03/15 Public Notification
Elimulating Weight & Toxin Keeping Beauty Product promoted and sold on various websites and in some retail stores. 03/02/15 Public Notification
Nine Slim Product promoted for weight loss and sold on various websites and in some retail stores. 02/28/15 Public Notification
Oxy ELITE Pro Super Thermogenic Product promoted and sold on various websites and in some retail stores. 02/28/15 Public Notification
Seven Slim Product promoted and sold on various websites and in some retail stores. 02/28/15 Public Notification
Botanical Slimming (Red) Product promoted for weight loss and sold on various websites and in some retail stores. 02/27/15 Public Notification
Lean Body Extreme Product promoted for weight loss and sold on various websites and in some retail stores. 02/25/15 Public Notification
Yanhee Slim Product promoted for weight loss and sold on various websites and in some retail stores. 02/03/15 Public Notification
Slim-K Promoted and sold for weight loss on various websites including www.bethel30.com and possibly in some retail stores. 12/23/14 Public Notification
B-Lipo Capsules Promoted and sold for weight loss on various websites including www.bethel30.com and possibly in some retail stores. 12/23/14 Public Notification
SLIM-K Capsules Promoted and sold for weight loss on various websites and possibly in some retail stores. 12/19/14 Voluntary Recall
B-Lipo Capsules Promoted and sold for weight loss on various websites and possibly in some retail stores. 12/19/14 Voluntary Recall
Slim-Vie Promoted and sold for weight loss on various websites and possibly in some retail stores. 11/25/14 Public Notification
Bee Thin Promoted and sold for weight loss on various websites, including www.beethinzxt.com, and possibly in some retail stores. 11/24/14 Public Notification
Bee Slim Promoted and sold for weight loss on various websites, including www.alphaomegaherbs.com, and possibly in some retail stores. 11/24/14 Public Notification
Super Extreme Accelerator Promoted and sold for weight loss on various websites and in some retail stores. 11/24/14 Public Notification
V26 Slimming Coffee Promoted and sold for weight loss on various websites and in some retail stores 11/04/14 Public Notification
Sit and Slim II Promoted and sold for weight loss on various websites and in some retail stores 10/10/14 Public Notification
LX1 Promoted and sold for weight loss on various websites, including Dr. Skin Secrets, and possibly in some retail stores 09/23/14 Public Notification
Best Line Suplemento Alimenticio Capsules Product promoted for weight loss and sold on various websites and in some retail stores. 09/15/14 Public Notification
Mezo Product promoted for weight loss and sold on various websites and in some retail stores. 09/15/14 Public Notification
RegeneSlim Appetite Control Capsules Purchased by and distributed through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and retail sales. 08/07/14 Recall
24 Ince Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Trim-Fast Slimming Softgel Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Lingzhi Cleansed Slim Tea Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Lipo 8 Burn Slim Capsules Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Mix Fruit Slimming Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Sliming (sic) Diet By Pretty White Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Toxin Discharged Tea Product promoted and sold on various websites and in some retail stores. 06/17/14 Public Notification
Sport Burner Product promoted and sold on various websites and in some retail stores. 06/17/14 Public Notification
Sliming Diet Product promoted and sold on various websites and in some retail stores. 06/17/14 Public Notification
La Jiao Shou Shen Product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com and in some retail stores. 06/10/14 Public Notification
Bangkok Pills Product promoted and sold on various websites and in some retail stores. 06/08/14 Consumer Warning
B-Perfect Product promoted and sold for weight loss on www.icanb-perfect.com and possibly sold in some retail stores. 06/05/14 Public Notification
Asset Bold Product promoted and sold on various websites and in some retail stores. 05/16/14 Public Notification
Asset Bee Pollen Product promoted and sold for weight loss on various websites, including www.assetcapsules4u.com, and in some retail stores. 05/12/14 Public Notification
African Black Ant, Black Ant, and Mojo Risen Eugene Oregon Inc. 05/05/14 Voluntary Recall
Slim Trim U Product promoted and sold for weight loss and sold on various websites and in some retail stores. 05/05/14 Public Notification
Natural Body Solution Product promoted and sold for weight loss and sold on various websites and in some retail stores. 05/05/14 Public Notification
LiteFit USA Bacai Inc. 04/29/14 Voluntary Recall
Zi Xiu Tang Bee Pollen Manufactured by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd. It is offered for sale on the Internet, and it can be found in various retail stores, spas and fitness centers. In addition, licensed health care professionals have promoted the product. 04/17/14 Consumer Warning
Lite Fit USA Product promoted and sold for weight loss on various websites, including www.herbsultimate.com, and in some retail stores. 04/10/14 Public Notification
Infinity Product promoted and sold for weight loss on various websites, and in some retail stores. 04/10/14 Public Notification
Thinogenics Products Nature’s Universe 04/09/14 Worldwide Recall
New You Product promoted and sold for weight loss and sold on various websites and in some retail stores. 04/02/14 Public Notification
Bella Vi Brand Pure Edge Nutrition LLC 03/26/14 Voluntary Nationwide Recall
Super Fat Burner, Maxi Gold and Esmeralda New Life Nutritional Center 03/25/14 Voluntary Nationwide Recall
Vitaccino Coffee Product promoted and sold on various websites and in some retail stores 03/19/14 Public Notification
Fat Burner HCA America Bysilver Pharmaceutical Co. 02/06/14 Consumer Warning
Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction MyNicKnaxs LLC 02/04/14 Voluntary Nationwide and International Recall
Reduce Weight Fruta Planta MyNicKnaxs LLC 02/04/14 Voluntary Nationwide and International Recall
Dr. Ming’s Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule Slim Beauty USA 01/31/14 Warning Letter
Mega Slim Herbal Appetite Management YoungYou International 01/30/14 Voluntary Recall
Citrus Fit Gold Product promoted and sold for weight loss on various websites, including www.citrusfit.com, and in some retail stores. 01/28/14 Public Notification
Tonic Life BP Product promoted and sold for weight loss and sold on various websites, including www.tonic-life-products.com, and in some retail stores 01/28/14 Public Notification
Thinogenics Product promoted and sold for weight loss and sold on various websites, including www.easy2loseweight.com, and in some retail stores 01/28/14 Public Notification
Hot Detox Promoted and sold for weight loss and sold on various websites, including www.hotdetoxllc.com, and in some retail stores 01/28/14 Public Notification
Dream Body Slimming Capsule Product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com, and in some retail stores. 01/21/14 Public Notification
Magic Slim Product promoted and sold for weight loss and sold on various websites, including www.slimbeautyusa.com, and in some retail stores. 01/21/14 Public Notification
Asset Extreme Plus Product promoted and sold for weight loss on various websites, including www.allnaturalbeelievers.com, and in some retail stores. 12/19/13 Public Notification
Meizitang Citrus Product is promoted and sold for weight loss on various websites and in some retail stores. 12/19/13 Public Notification
Sliming Diet Berry Plus Product is promoted and sold for weight loss on various websites and in some retail stores. 12/19/13 Public Notification
Asset Extreme product promoted and sold for weight loss on various websites, including www.assetcapsules4u.com, and in some retail stores. 12/19/13 Public Notification
SlimEasy Herbs Capsule Product is promoted and sold for weight loss on various websites and in some retail stores. 12/19/13 Public Notification
7 Days Herbal Slim Product promoted and sold for weight loss on various websites, including www.suncoastspaequipment.com, and in some retail stores. 12/19/13 Public Notification
Dr. Ming’s Chinese Capsule Product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com, and in some retail stores. 12/19/13 Public Notification
Zanocap Capsules Stone Independent Reseach Inc. 12/13/13 Recall
Burn 7 Capsules Deseo Rebajar Inc. 12/23/13 Voluntary Recall
Adipotrim XT Deseo Rebajar Inc. 11/19/13 Voluntary Puerto Rico Recall
SlimExtra Herbal Capsules Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Diet Master Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Super Slim Promoted and sold for weight loss on various websites, including www.bonanza.com, and in some retail stores. 11/21/13 Public Notification
“1 Day Diet” Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Body Beauty 5 Days Slimming Coffee Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Slim Max Product is promoted and sold for weight loss on various websites and in some retail stores. 11/20/13 Public Notification
Jimpness Beauty Fat Loss Capsules Promoted and sold for weight loss on various websites, including www.jimpness.net. 11/07/13 Public Notification
Goodliness Fat-Reducing Product is promoted and sold for weight loss on various websites and in some retail stores. 11/05/13 Public Notification
Perfect Body Solutions and Burn 7 Product is promoted and sold for weight loss on various websites and in some retail stores. 10/10/13 Public Notification
Bella Vi Insane Amp’d and Bella Vi Amp’d Up These products are promoted for weight loss and sold on various websites, including www.pureedgenutrition.com and www.newedgenutrition.com, as well as in retail stores. 10/10/13 Public Notification
Slim Fortune, Lidiy, and Slim Expert B@B Trade Inc. 10/07/13 Voluntary Recall
Dr. Mao Slimming Capsules Product is promoted and sold for weight loss on various websites and in some retail stores. 10/10/13 Public Notification
Be Inspired Product is promoted and sold for weight loss on various websites, including www.beinspirednaturally.com, and in some retail stores. 10/10/13 Public Notification
Oxy Elite Pro and VERSA-1 USP Labs 10/11/13 Warning Letter
“收腹提臀果香型减肥胶囊 ”or “Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang” (translates – Abdomen Hips Fruit Flavored Slimming Capsules) also known as “Сокращать живот и повышать 3ад” (translates – Reducing Belly and Lifting the Buttocks) Product is promoted and sold for weight loss on various websites, including www.instantslim.org, and in some retail stores. 09/17/13 Public Notification
Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 GE Pharma LLC 09/12/13 Recall
Ortiga sold on multiple websites, including www.ebay.com, and in some retail stores 08/22/13 Public Notification
Esbelder Man Capsules, Esbelder Fem Capsules, and Esbelder Siloutte Capsules Herbal Give Care LLC 08/16/13 Voluntary Recall
Best Slim CTV Best Group Inc. 08/03/13 Voliuntary Recall
Quick Thin and Bethel Advance Bethel Nutritional Consulting, Inc. 08/05/13 Expanded Voluntary Recall
Healthy Life Chemistry Purity First B-50 07/26/13 Consumer Warning
Esbelin siloutte te
Esbelin siloutte Herbal Blend with L-Carnitine (30 capsules)
Herbal Give Care LLC 07/19/13 Recall
JaDera
Xiyouji Qingzhi
Dolphin Intertrade Corp. 05/21/13 Recall
Meizi Evolution sold online on various websites including www.ebay.com and in some retail stores 06/27/13 Public Notification
Strawberry Balance sold online on various websites and in some retail stores 06/27/13 Public Notification
Paiyouji Plus sold online on various websites and in some retail stores 06/17/13 Public Notification
Fruit & Plant Slimming sold online on various websites and in some retail stores 06/17/13 Public Notification
Fat Zero sold online on various websites and in some retail stores 06/17/13 Public Notification
Extreme Body Slim sold online on various websites and in some retail stores 06/17/13 Public Notification
Bethel 30 sold online on various websites including www.bethel30.com and in some retail stores 06/10/13 Public Notification
XIYOUJI QUNGZHI CAPSULE sold online on various websites including www.jadera.net. 06/10/13 Public Notification
Zi Xiu Tang Bee Pollen Capsules
Ultimate Formula Bee Pollen Capsules
Zi Xiu Tang Success 05/14/13 Warning Letter
MAXILOSS Weight Advanced Blue Promoted and sold on various websites including www.extremevitaminworld.com and www.dreamlifeweightloss.com 04/04/13 Public Notification
Maxiloss Weight Advanced Softgels Olaax Corp. 02/21/13 Recall
SlimXtreme
SlimXtreme Gold
SlimPlus
SlimLee
GelSlim
SlimDrops
Colonew
Globe All Wellness, LLC 02/14/13 News Release
MAXILOSS Weight Advanced Promoted and sold on various websites including www.dreamlifeweightloss.com and retail stores 01/08/13 Public Notification
SLIMDIA Revolution Promoted and sold on various websites including www.pinkfatty.com and in some retail stores 12/20/2012 Public Notification
Japan Hokkaido Slimming Weight Loss Pills Promoted and sold on various websites including www.ebay.com 11/08/12 Public Notification
Beautiful Slim Body Promoted and sold on various websites including www.houseofmonet.com 11/08/2012 Public Notification
Japan Hokkaido Slimming Weight Loss Pills Promoted and sold on various websites including www.ebay.com 11/08/2012 Public Notification
Brazilian Slimming Coffee Best Share Green Coffee 11/08/2012 Public Notification
Tianji True Slim AmericaQualityHerbs.com 10/4/2012 Public Notification
Classic Zi Xiu Tang Bee Pollen Capsules
Ultimate Formula Capsules
Zi Xui Tang Success, LLC 10/24/2012 Voluntary Recall
ACTRA-Sx 500 Capsules Body Basics 9/18/2012 Recall
Mojo Nights
Mojo Nights for Her
Evol Nutrition Associates Inc. 8/23/2012 Recall
Japan Rapid Weight Loss Diet Pills Green www.amazon.com
distributed by Xiushentang
4/03/2012 News Release
Japan Weight Loss Blue Distributed by: Vitaminbestbuy.com 2/18/2012 News Release
SlimXtreme
ViaXtreme
Global All Wellness, LLC 2/6/2012 Warning Letter

Mince Belle Dietary Supplement
PERFECT Men Dietary Supplement
EVERLAX Dietary Supplement
EVER Slim Dietary Supplement
Herbal Drink Acai-man Mangosteen Dietary Supplement
EVER SLIM Shake Mix Dietary Supplement Strawberry
EVER SLIM Shake Mix Dietary Supplement Chocolate

Healthy People Co. 2/3/2012 Recall
Slimforte Slimming Capsules
Slimforte Slimming Coffee
Botanical Slimming Soft Gel
Intercharm Inc. 07/25/11 Recall
Celerite Slimming Capsules
Celerite Slimming Tea
Shaping Beauty, Inc.
H & S GMP Factory
07/14/11 Warning Letter
Counterfeit Alli
2 Day Diet
Superslim
Meitzitang
Shengyang Zhou 06/03/11 Court Order
Slim Xtreme Herbal Slimming Capsule Globe All Wellness 05/10/11 News Release
Quick Action Slim Tea God’s Garden Pharmacy 05/04/11 Warning Letter
CELERITE Slimming Tea Shaping Beauty, Inc. 03/15/11 Recall
Svelte 30 Svelte 30 Nutritional Consultants 02/09/11 Recall
CELERITE Slimming Capsules Shaping Beauty, Inc. 01/24/11 Recall
Fruta Planta
Reduce Weight Fruta Planta
Reduce Wieght
PRock Marketing, LLC
Godi International, Corp.
12/30/10
01/31/11
Recall
Recall
Leptin Green Coffee 800
Leptin Slimming Coffee
MyLeptin Weight Loss Jelly
Lose Weight Coffee
Bruce Imports 12/09/10 Recall
Weight and Blood Fat Reducing Coffee
Coffee Fast
Tek Shing Trading Pty Limited 11/30/10 Recall
Moti Angel Coffee Moti Group Australia 11/11/10 Recall
Meridia Abbott Laboratories 10/08/10 Recall
AcaiPure Central Coast Nutraceuticals, Inc.
iLife Health and Wellness LLC
Simply Naturals LLC
Health Beauty Solutions LLC
Fit for Life LLC
08/16/10 Court Order
Que She Distributed via:
Online: Bouncing Bear Botanicals
Retail outlets, including: Sacred Journey in Lawrence, Kansas
08/08/10 News Release
Solo Slim® and Solo Slim® Extra Strength EZVille, Ltd. 08/06/10 Recall
Joyful Slim J & H Besta Corp. 07/22/10 Recall
Slim-30 Herb Supplement J & H Besta Corp. 07/16/10 Recall
Accelis
nanoSLIM
Iovate Health Sciences U.S.A. 07/14/10 Court Order
Xenical
Alli
05/26/10 News Release
Lipodissolve (aka mesotherapy, lipozap, lipotherapy, or injection lipolysis)
phosphatidylcholine and deoxycholate
Monarch Medspa, King of Prussia, PA; Spa 35, Boise, ID; Medical Cosmetic Enhancements, Chevy Chase, MD.; Innovative Directions in Health, Edina, MN.; PURE Med Spa, Boca Raton, FLl.; and All About You Med Spa, Madison, IN.
zipmed.net and mesoone.com
04/07/10 New Release
YI SHOU Ultimate Fat Burner 400mg capsules and YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules Healthy Body Forero, Inc. 03/15/10 Warning Letter
Lipoban SlimAmerica, Frank Sarcona et. al.
Lipoban Clinic
03/01/10 Court Order
Chinese Diet Tea
Bio-Slim Patch
Bronson Partners, LLC 01/11/10 Court Order
2 Day Diet
2 Day Diet Slim Advance
2x Powerful Slimming
3 Day Diet
3 Days Fit
3x Slimming Power
5x Imelda Perfect Slimming
7 Day Herbal Slim
7 Days Diet
7 Diet
7 Diet Day/Night Formula
8 Factor Diet
Eight Factor Diet
21 Double Slim
24 Hours Diet
999 Fitness Essence
BioEmagrecim
Body Creator
Body Shaping
Body Slimming
Cosmo Slim
Extrim Plus
Extrim Plus 24 Hour Reburn
Fasting Diet
Fatloss Slimming
GMP
Herbal Xenicol
Imelda Fat Reducer
Imelda Perfect Slim
JM Fat Reducer
Lida DaiDaihua
Meili
Meizitang
Miaozi MeiMiaoQianZiJiaoNang
Miaozi Slim Capsules
Natural Model
Perfect Slim
Perfect Slim 5x
Perfect Slim Up
Phyto Shape
Powerful Slim
ProSlim Plus
Reduce Weihgt
Royal Slimming Formula
Sana Plus
Slim 3 in 1
Slim 3 in 1 Extra Slim Formula
Slim 3 in 1 Extra Slim Waist Formula
Slim 3 in 1 M18 Royal Diet
Slim 3 in 1 Slim Formula
Slim Burn
Slim Express 4 in 1
Slim Express 360
Slim Fast (different from Slim-Fast®)
Slim Tech
Slim Up
Slim Waist Formula
Slim Waistline
Slimbionic
Sliminate
Slimming Formula
Somotrim
Starcaps
Super Fat Burner
Superslim
Super Slimming
Trim 2 Plus
Triple Slim
Venom Hyperdrive 3.0
Waist Strength Formula
Xsvelten
Zhen de Shou
Consumer Info
Counterfeit “Alli” Sold online auction sites Warning
Pai You Guo GMP Herbal Products 11/30/09 Recall
Relacore
Akävar 20/50
Basic Research LLC
Carter-Reed LLC
Dynakor Pharmacal LLC
11/02/09 Court Order
Pineapple Fat Reducing Slimming Capsule
Tomato Slimming (Lose Weight)
Slim Up
Fresh Lemon Slimming (Xian Ning Meng Shou Shen)
Slim Quick Result 3 in 1
Perfect Combination Balishou Capsule
Apple Slim
Shoufsy Activity Girl
Platinum Strategies, Inc. 09/23/09 Warning Letter
Supreme Greens Direct Marketing Concepts, Inc.
ITV Direct, Inc.
King Media, Inc.
Triad ML Marketing, Inc.
08/27/09 Court Order
Slimbionic
One Weight Loss Pill
SlimDemand
Botanical Weight Loss
Young You Corporation 07/15/09 Recall
Counterfeit Hoodia gordonii Nutraceuticals International LLC
Stella Labs LLC
04/27/09 Court Action
ProSlim Plus
3 DAYS fit
EIGHT FACTOR DIET
24hours Diet
Slim 3in1 M-18 ROYAL DIET
3X SLIMMING POWER
Extrim Plus 24 Hours RE-BURN Formula
Slim 3in1 EXTRA SLIM FORMULA
Slim 3in1 EXTRA SLIM WAIST FORMULA
SLIM EXPRESS 360º C
SLIM EXPRESS 4in1
ROYAL SLIMMING FORMULA
BODY CREATOR
Slim Waistline (labeling written in Chinese)
BODY SHAPING
Perfect Slim 100% Natural Herbal Essence
IMELDA Perfect Slim
Slim Waist Formula
Super Slimming
2 DAY DIET
Powerful Slim
BODY SHAPING
SUPER FAT BURNER
SLIMMING FORMULA
SLIM FAST 2
SLIM FAST
Slim up
7 DAYS DIET
Perfect Slim U
JM Fat Reducer
SlimBurn
21 Double SLIM
TRIM PLUS 2
Universal ABC Beauty Supply Iternational, Inc. 04/20/09 Recall
For Women Only weight-loss pills
Lite Bites weight-loss food bars and shakes
Bee-Alive Royal Jelly energy supplements
QVC, Inc. Court Order
Venom HYPERDRIVE 3.0 Applied Lifescience Research Industries Inc. 01/27/09 Warning
ThermaLean
Lipodrene
National Urological Group dbaWarner Laboratories
National Institute for Clinical Weight Loss, Inc.,
Hi-Tech Pharmaceuticals, Inc., dba Planet Pharmacy, Global Pharmacy
01/15/09 Court Order
Ab Force Telebrands Corporation
TV Savings LLC
01/14/09 Court Order
Zhen De Shou Fat Loss Capsules Fashion Sanctuary 11/25/08 Recall
Counterfeit Hoodia gordonii Spear Systems, Inc.
Quebec, Inc., dba Q Web
HBE, Inc.
07/15/08 Court Order

BODYBUILDING

Sten Z and M1 Alpha Andropharm 07/11/17 Voluntary Nationwide Recall
GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall – Presence of Anabolic Steroids GEC Laxoplex is marketed as a dietary supplement and sold as a muscle enhancing agent. The product is packaged in a white plastic bottle containing 60 capsules with UPC code 0058049984 and can be identified by GEC Laxoplex. The recall affects all lots of GEC Laxoplex. GEC Laxoplex was distributed Nationwide in the USA through various nutritional supplement retail outlets. 05/08/17 Recall
Tri-Methyl Xtreme Sold and promoted on websites including Ebay 04/13/15 Public Warning
Ortiga Sold and promoted on websites including Ebay 8/22/13 Public Notification
Healthy Life Chemistry B-50 (100 capsules) Healthly Life Chemistry Multi-Meneral (200 capsules) Healthy Life Chemistry Vitamin C (200 capsules) Purity First Health Products Inc. 07/31/13 Recall
Reumofan Plus USA, LLC and Reumofan USA, LLC Reumofan Plus 02/15/13 Recall
Anabolic Xtreme Hyperdrol
Anabolic Xtreme Slim Xtreme
Nutrition Distribution, Inc (previously dba. Anabolic Xtreme) 11/09/11 Plead Guilty
Dienedrone
Liquidrone
Orafinadrol 50
Methyldrostanolone
Advanced Muscle Science (DCD)
R & D Holdings, LLC dba Culver Products
11/10/11 Plead Guilty
Uprizing 2.0 Superior Metabolic Technologies, Inc. 10/05/11 Recall
Novedex XT Gaspari Nutrition Incorproated 10/07/10 Recall
Reversitol Tribravus Enterprises, LLC
iForce Nutrition, LLC
09/16/10 Recall
Arom-X
Arom-X UTT
Arom-XL
4-AD
Decavol
Advanced Muscle Science 09/16/10 Recall
Off Cycle II Hardcore Fizogen Precision Technologies 09/15/10 Recall
Clomed KiloSports Inc. 09/14/10 Recall
ArimaDex Genetic Edge Technologies, Inc 09/13/10 Recall
Smart Powders Piracetam
Primaforce Piracetam
Advanced Muscle Science Arom-X
Advanced Muscle Science 4-AD UTT
G.E.T ArimaDex
iForce Nutrition Reversitol
Fizogen Off Cycle II Hardcore
Unlimited Nutrition 08/30/10 Warning Letter
On Cycle II Hardcore Atlas Operations, Inc. 06/04/10 Warning Letter
MasXtreme Natural Wellness 03/30/10 Recall
Advanced Muscle Science Dienedrone
Advanced Muscle Science Liquidrone
Anabolic Formulation M1, 4AD
Anabolic Formulations 1, 4 AD
Anabolic Xtreme Hyperdrol X2
Anabolic Xtreme 3-AD
BCS Labs Testra-Flex
Competitive Edge Labs M-Drol
Competitive Edge Labs P-Plex
Competitive Edge Labs X-Tren
4Ever Fit D-Drol
Gaspari Novedex XT
Gaspari Halodrol Liquigels
iForce 1,4 AD BOLD 200
iForce MethaDROL
iForce Dymethazine
Monster Caps
MuscleMaster.com, Inc. 01/15/10 Recall
TREN-Xtreme
MASS Xtreme
ESTRO Xtreme
AH-89-Xtreme
HMG Xtreme
MMA-3 Xtreme
VNS-9 Xtreme
TT-40-Xtreme
American Cellular Laboratories, Inc. 07/27/09 Warning Letter
Bromodrol
Dual Action Grow Tabs
Grow Tabs
Ripped Tabs TR
Sold by: IDS Sports 11/12/09 Recall
4Ever Fit D-Drol, Advanced Muscle Science Dienedrone, Advanced Muscle Science Liquidrone UTT, Anabolic Xtreme Hyperdrol X2, APS (aka Advanced Muscle Science) Mastavol, APS (aka Advanced Muscle Science) Revamp, APS (aka Advanced Muscle Science) Ultra Mass Stack, APS (aka Advanced Muscle Science) Ripped Stack, Better Body Sports Finadex, Black China Labs Straight Drol, Black China Labs Straight Phlexed, Body Conditioning Solutions TestraFLEX, Bjorklund Methyldrostanolone, BOSC Enterprises Epi-Tren, BOSC Enterprises Magna Drol, Chaparral Labs Epivol, Chaparral Labs Pheravol-V, Competitive Edge Labs M-Drol, Competitive Edge Labs P-Plex, Competitive Edge Labs X-tren, Diabolic Labs Epio-Plex, Diabolic Labs Finabolic 50, Diabolic Labs Revenge, Ergopharm 6-OXO, Ergopharm 6-OXO Extreme, EST (aka Engineered Sports Technology) MethAnstance , Extreme Labs Susto-Test Depot, Fizogen ON Cycle II Hardcore, G.E.T/ (Genetic Edge Technologies) SUS-500, G.E.T/ (Genetic Edge Technologies) Tren-250, Hardcore Formulations T-Roid, I Force Nutrition 1,4 AD Bold 200, I Force Dymethazine/Reversitol Combo Pack, I Force Reversitol , I Force Nutrition 17a PheraFLEX, I Force Nutrition Dymethazine, I Force Nutrition Methadrol , IDS (aka Innovative Delivery Systems) Bromodrol, IDS (aka Innovative Delivery Systems) Grow Tabs TR, IDS (aka Innovative Delivery Systems) Mass Tabs, IDS (aka Innovative Delivery Systems) Oxodrol Pro, IDS (aka Innovative Delivery Systems) Ripped Tabs TR, IDS (aka Innovative Delivery Systems) Rapid Release, Ripped Tabs, Kilo Sports Massdrol, Kilo Sports Phera-Mass, Kilo Sports Trenadrol, Monster Caps Monster Caps, Myogenix Spawn, Nutra Coastal D-Stianozol, Nutra Coastal H-Drol, Nutra Coastal MDIT, Nutra Coastal S-Drol, Nutra Coastal Trena, Performance Anabolics Methastadrol, Performance Anabolics Tri-Methyl X, Purus Labs E-pol Inslinsified, Purus Labs Nasty Mass, Rage RV2, Rage RV3, Rage RV4, Rage RV5, Redefine Nutrition Finaflex 550-XD, Redefine Nutrition Finaflex Ripped, Transform Supplements Forged Extreme Mass, Transform Supplements Forged Lean Mass Sold by: Bodybuilding.com 11/03/09 Recall
S-DROL (Lot 810481) Nutracoastal Trading LLC 07/28/09 Recall
Methyl 1-D
Methyl 1-D XL
Formadrol Extreme XL
LG Sciences LLC 05/11/09 Forfeiture
Venom HYPERDRIVE 3.0 Applied Lifescience Research Industries Inc. 01/27/09 News Release

 

SEXUAL HEALTH

 

Various unnamed products Just Enhance and R Thomas Marketing LLC 08/31/2018 District Court Enters Permanent Injunction to Stop New Jersey and New York Companies and Executives From Distributing Unapproved and Misbranded Drugs
XXXPlosion Ultra Company unknown-sold on various websites and possibly in some retail stores. 08/13/2018 Public Notification
Panther Power Platinum 11000 Company unknown-sold on various websites and possibly in some retail stores. 08/13/2018 Public Notification
Ding Ji Wei Ge Company unknown-sold on various websites and possibly in some retail stores. 08/10/2018 Public Notification
5K Company unknown-sold on various websites and possibly in some retail stores. 08/10/2018 Public Notification
Platinum Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Krazzy Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Gold Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Boss Rhino 15000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Black Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Dale Mas Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
C.U. Plus Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
Grakcu Capsule Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
Maximum Powerful Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
African Viagra, GINSENG, African Superman, Hokkaiodo, MyNicNaxs LLC 07/06/2018 Voluntary Nationwide Recall
Chong Cao Qiang Shen Wang Company unknown-sold on various websites and possibly in some retail stores. 07/03/2018 Public Notification
Maxidus Company unknown-sold on various websites and possibly in some retail stores. 07/03/2018 Public Notification
Black Stallion 35000 Company unknown-sold on various websites and possibly in some retail stores. 07/03/2018 Public Notification
Gold Viagra Company unknown-sold on various websites and possibly in some retail stores. 06/20/2018 Public Notification
XXXPlosion Company unknown-sold on various websites and possibly in some retail stores. 06/20/2018 Public Notification
Euphoric Capsules Epic Products LLC 04/16/2018 Voluntary Nationwide Recall
Best Candy Company unknown-sold on various websites and possibly in some retail stores. 05/14/2018 Public Notification
Rhino 69 Extreme 50000 AMA Wholesale Inc. 04/12/2018 Voluntary Recall
Black Lion Pill Company unknown-sold on various websites, including www.rakuten.com, and possibly in some retail stores. 03/28/2018 Public Notification
Red Zone Xtreme 3000 Company unknown-sold on various websites, including www.ebay.com, and possibly in some retail stores. 03/28/2018 Public Notification
Rhino 69 Extreme 50000 Company unknown-AMA Wholesale Inc. (Distributor/Re-seller) issued recall. Product sold on various websites, including www.bonanza.com, and possibly in some retail stores. 03/28/2018 Public Notification
All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg Marmex Corp 12/13/17 Voluntary National Recall
Chao Jimengnan Company unknown-sold on various websites, including www.spanishfly.com, and possibly in some retail stores. 11/30/17 Public Notification
Bull and Chao Jimengnan Tablets Nutra Labs Inc. 11/30/17 Voluntary National Recall
Tyrannosaurus Company unknown 11/20/17 Public Notification
V9 Male Sexual Stimulant Company unknown 11/20/17 Public Notification
S.W.A.G. II Platinum 33K Company unknown. 11/20/17 Public Notification
Rhino 69 Premium 8000 Company unknown 11/20/17 Public Notification
Rhino 25K 15000 Company unknown 11/20/17 Public Notification
Rhino 12 Titanium 6000 Company unknown 11/20/17 Public Notification
Rhino 11 Platinum 11000 Company unknown 11/20/17 Public Notification
Qibianli Company unknown 11/20/17 Public Notification
Pro Solution Company unknown 11/20/17 Public Notification
New Stiff Nights Platinum 10K Company unknown 11/20/17 Public Notification
MenXtrong Company unknown 11/20/17 Public Notification
Blue Diamond Pill Company unknown 11/20/17 Public Notification
Control Capsules Company unknown 11/20/17 Public Notificaion
Blue Pearl All Natural Male Enhancement Company unknown-product promoted and sold on various websites, including www.bluepearlformen.com (redirects to www.bluefusions.com), and possibly in some retail stores. 11/20/17 Public Notification
Hard Times for Men Company unknown-product promoted and sold on various websites, including www.blankterrmall.com, and possibly in some retail stores. 11/20/17 Public Notification
Tiger 5000 Company unknown-product promoted and sold on websites and possibly retail stores. 09/20/17 Public Notification
Vegetable Vigra Nature Supplement Inc. 09/20/17 Voluntary Florida Recall
Man of Steel 1 and Man of Steel 2 Man of Steel 08/04/17 Voluntary National Recall
Super Panther 7K Ultra Shop Supplement 07/21/17 Voluntary National Recall
RHINO 7 Platinum 5000 Company unknown 07/17/17 Public Notification
Royal Honey VIP Company unknown 07/17/17 Public Notification
Kingdom Honey for Him Company unknown 07/17/17 Public Notification
Kingdom Honey for Her Company unknown 07/17/17 Public Notification
Kopi Jantan Tradisional Natural Herbs Coffee Bestherbs Coffee LLC 07/17/17 Voluntary National Recall
Triple X 2000 SHH Trading 06/23/17 Public Notification
Triple Premium Zen Gold 1300mg SHH Trading 06/23/17 Public Notification
XXX Zone Platinum SHH Trading 06/23/17 Public Notificaion
Triple Miracle Zen Plus 1200mg SHH Trading 06/22/17 Public Notification
Macho Man 3000 SHH Trading 06/22/17 Public Notification
Monster X 1350 SHH Trading 06/22/17 Public Notification
Own the Knight 1750 SHH Trading 06/22/17 Public Notification
Royal Master 1500 SHH Trading 06/22/17 Public Notification
Xzone Gold SHH Trading 06/22/17 Public Notification
Love Zen 3000 SHH Trading 06/22/17 Public Notification
Super Panther 7K Company unknown-product promoted and sold on various Web sites, including www.ultraxshop.comdisclaimer icon, and possibly in some retail stores. 06/22/17 Public Notification
Man of Steel 2 Company unknown-product promoted and sold on various Web sites, including www.manofsteelpills.comdisclaimer icon, and possibly in some retail stores. 06/22/17 Public Notification
Man of Steel Company unknown-product promoted and sold on various Web sites, including www.manofsteelpills.comdisclaimer icon, and possibly in some retail stores. 06/22/17 Public Notification
Caverflo Natural Herbal Coffee Caverflo.com 05/25/17 Voluntary National Recall
Megajex MS Bionic 05/03/17 Warning Letter
Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX capsules Organic Herbal Supply Products 04/18/17 Voluntary National Recall
Black Ant (4600 mg), Indian God Lotion, Evil Root (1200 mg), Germany Black Gold (2800 mg), Germany Niubian (3000 mg), Hard Ten Days (4500 mg), Lang Yi Hao (Chaonogsuopian) (500 mg), Gold Vigra, Clalis, Ye Lang Shen (5000 mg), Zhansheng Weige Chaoyue Xilishi (2000 mg), Zhonghua Niubian (2000 mg), Stree Overlord (3800 mg), Max Man (3000 mg), Hu Hu Sheng Wei, Tiger King, Viagra 100 (2000 mg), Power V8 Viagra (200 mg), Dadiyongshi Xiangganglongshengwu, Lien Chan for Seven Days, Maca Gold (6800 mg) A&H Focal Inc. 03/07/17 National Recall
Arouse-Plus Company unknown 03/03/17 Public Notification
Bazook Bullet Company unknown 03/03/17 Public Notification
XtraHRD Natural Male Enhancement Capsules Organic Herbal Supply 02/22/17 Recall
Goldreallas Original Company unknown 02/03/17 Public Notification
Ginseng for Reinforcing Kidney Company unknown 02/03/17 Public Notification
Old Chinese Company unknown 02/02/17 Public Notification
Shenjingpian Company unknown 02/02/17 Public Notification
Goldreallas XXX Company unknown 02/02/17 Public Notification
XtraHRD Company unknown 01/26/17 Public Notification
Duramaxx Company unknown 12/22/16 Public Notification
African Viagra Company unknown 12/22/16 Public Notification
Triple Green Capsules Company unknown 12/22/16 Public Notification
Power Male Sexual Stimulant Company unknown 12/22/16 Public Notification
Rhino 8 Platinum 8000 Company unknown 12/22/16 Public Notification
Black 3K Plus Male Sexual Enhancement Capsules Company unknown 12/22/16 Public Notification
Rhino 5 1500 Capsules Company unknown 12/22/16 Public Notification
Black Mamba 2 Premium Company unknown 12/22/16 Public Notification
Bl4ck 4K Capsules Company unknown 12/22/16 Public Notification
Rhino 7K 9000 Male Performance Booster Company unknown 12/22/16 Public Notification
Lang Yi Hao Company unknown 12/22/16 Public Notification
Rhino 9 Premium 3500 Company unknown 12/22/16 Public Notification
90° Jiushidu Capsules Company unknown 12/22/16 Public Notification
Big Penis Male Sexual Stimulant Company unknown 12/22/16 Public Notification
Megajex Natural Male Sex Enhancer MS Bionic, Inc. 11/29/16 Voluntary Nationwide Recall
Ready Man! Company unknown 11/09/16 Public Notification
Stiff Bull Herbal Coffee Company unknown 09/16/16 Public Notification
Kopi Jantan Tradisional Natural Herbs Coffee Company unknown 08/30/16 Public Notification
One More Night Company unknown 08/16/16 Public Notification
Love4Long Company unknown 08/16/16 Public Notification
Master Zone 1500 Company unknown 08/16/16 Public Notification
Boss-Rhino Gold X-tra Strength Company unknown 08/09/16 Public Notification
Anaconda Strong Formula Company unknown 08/09/16 Public Notification
De Guo Hei Bei Company unknown 08/09/16 Public Notification
Ziyinzhuangyang Company unknown 07/29/16 Public Notification
Weili (Yi Pao Dao Tian Liang) Company unknown 07/28/16 Public Notification
Super Shangai Company unknown 07/27/16 Public Notification
The Golden Root Company unknown 07/27/16 Public Notification
Shangai Ultra X Company unknown 07/27/16 Public Notification
Super Bull 6000 Company unknown 07/27/16 Public Notification
Power Spring (XXX) Oral Liquid Company unknown 07/27/16 Public Notification
Libigirl Company unknown 07/27/16 Public Notification
My Steel Woody Company unknown 06/30/16 Public Notification
DR’s Secret Bio Herbs Coffee Company unknown 06/01/16 Public Notification
Black Label X Company unknown 04/26/16 Public Notification
Salute Capsules Company unknown 03/17/16 Public Notification
ZlimXter Capsules Company unknown 03/17/16 Public Notification
Sextra Company unknown-Product promoted and sold on various websites, including www.iShopLSTV.com. 03/03/16 Public Notification
Bull’s Genital Company unknown-Product promoted and sold on various websites, including www.bullsgenital.com. 02/11/16 Public Notification
Zhong Hua Niu Bian Company unknown-Promoted and sold on various websites, including www.zhonghuaniubian.com. 02/11/16 Public Notification
Weekend Prince Company unknown 02/11/16 Public Notificaton
Bull Company unknown-Promoted and sold on various websites, including www.bullsexpills.com. 02/11/16 Public Notification
Mamba is Hero Company unknown 02/05/16 Public Notification
Ninja-X Company unknown 02/05/16 Public Notification
Ginseng Power-X Company unknown 02/05/16 Public Notificaton
Boss Number #6 Company unknown 02/05/16 Public Notification
Golden Night Company unknown 02/05/16 Public Notification
Wonder-Erect Male Pills Company unknown 01/21/16 Public Notification
Wonder-Erect Male Gum Company unknown 01/21/16 Public Notification
Black Ant, Herb Viagra, Real Skill, Weekend Prince, African Black Ant And Stree Overlord Along With Multiple Other Products R Thomas Marketing LLC 01/09/16 Nationwide Recall
Xtra Zone 2400 Company unknown 12/28/15 Public Notification
OrgaZen 3000 Company unknown 12/28/15 Public Notification
Rhino 7 Blue 9000 Company unknown 12/28/15 Public Notification
Rhino Big Horn 3000 Company unknown 12/28/15 Public Notification
Diamond 3500 Company unknown 12/28/15 Public Notification
Triple MiracleZen Extreme 1750 mg Company unknown 12/28/15 Public Notification
Eros Power Zone 1900 Company unknown 12/28/15 Public Notification
OrgaZen 3500 Company unknown 12/28/15 Public Notification
Xtra Zone 2200 Company unknown 12/28/15 Public Notification
Xtra Zone 2600 Company unknown 12/28/15 Public Notification
Triple Power Zen Gold 2000 Company unknown 12/28/15 Public Notification
Triple Power Zen Plus 2000 Company unknown 12/28/15 Public Notification
Triple MiracleZen Gold 1750mg Company unknown 12/28/15 Public Notification
APEXXX Nuway Distributors 12/23/15 Nationwide Recall
Power Tiger-X Company unknown-Promoted and sold on various websites, including www.everestwholesales.com, and in some retail stores. 12/17/15 Public Notification
Fuel Up Plus Reesna Inc. 12/11/15 Nationwide Recall
Fuel Up High Octane Reesna Inc. 12/11/15 Nationwide Recall
Australia Kangaroo Essence Company unknown 11/19/15 Public Notification
Effective Viagra Tablets Company unknown 11/19/15 Public Notification
Sex Drive Capsules Company unknown 11/19/15 Public Notification
XForMan Plus Company unknown 11/19/15 Public Notification
Rhino X Company unknown 11/19/15 Public Notification
Power Khan Company unknown 11/05/15 Public Notification
Wild Sexx Capsules Company unknown 10/23/15 Public Notification
Ultra SX Capsules Company unknown 10/23/15 Public Notification
Super Dragon 6000 Capsules Company unknown 10/23/15 Public Notification
Sex-Love Secret Code Capsules Company unknown 10/23/15 Public Notification
Paradise Suplemento Natural Ultra Plus Capsules Company unknown 10/23/15 Public Notification
Fuel Up Plus Company unknown 10/23/15 Public Notification
Fuel Up High Octane Company unknown 10/23/15 Public Notification
APEXXX Nuway Distributors 10/23/15 Public Notification
S.W.A.G.G.E.R Extreme Capsules Company unknown 10/23/15 Public Notification
Rhino 7 3000 and Rhino 7 Platinum 3000 Capsules TF Supplements 10/09/15 Voluntary Nationwide Recall
Kaboom Action Strips Company unknown 09/21/15 Public Notification
Extreme Diamond 3000 Company unknown 04/30/15 Public Notification
King of Romance Company unknown 04/30/15 Public Notification
Viagra 700 Company unknown 04/30/15 Public Notification
Black Panther Company unknown 04/30/15 Public Notification
Herb Viagra Male Sexual Stimulant Company unknown 03/11/15 Public Notification
Bigger Longer More Time More Sperms (sic) Company unknown 03/05/15 Public Notification
Black Ant King Company unknown 03/05/15 Public Notification
Black Mamba Premium Company unknown 03/05/15 Public Notification
African Superman Company unknown 03/05/15 Public Notification
La Pepa Negra Company unknown 03/03/15 Public Notification
Stiff Nights Company unknown 03/03/15 Public Notification
Stiff Nights Company unknown 03/03/15 Public Notification
Herb Viagra Company unknown 03/03/15 Public Notification
Rhino Blitz Gold 3000 Company unknown 03/03/15 Public Notification
Vim-25 Company unknown 03/03/15 Public Notification
Baolong Company unknown 03/03/15 Public Notification
Male Silkworm Moth Nourishing Oral Liquid Company unknown 03/03/15 Public Notification
Sex Men Company unknown 03/02/15 Public Notification
Santi Scalper Company unknown 03/02/15 Public Notification
Vigra Company unknown 03/02/15 Public Notification
Plant Vigra Company unknown 03/02/15 Public Notification
Super Hard Company unknown 03/02/15 Public Notification
Vigour 300 Company unknown 03/02/15 Public Notification
MME MAXMAN Company unknown 03/02/15 Public Notification
Hard Wang Company unknown 03/02/15 Public Notification
FX3000 Company unknown 03/02/15 Public Notification
Libigrow XXX Treme Company unknown 02/28/15 Public Notification
Night Man Company unknown 02/28/15 Public Notification
Black King Kong Company unknown 02/28/15 Public Notification
72HP Company unknown 02/27/15 Public Notification
Tibet Babao Company unknown 02/27/15 Public Notification
Germany Niubian Company unknown 02/27/15 Public Notification
Happy Passengers Company unknown 01/21/15 Public Notification
Samurai-X Company unknown 12/23/14 Public Notification
Zhansheng Weige Chaoyue Xilishi Company unknown 12/23/14 Public Notification
Triple PowerZEN Gold Company unknown 12/23/14 Public Notification
Black Storm Company unknown 11/24/14 Public Notification
Mayhem Company unknown 11/13/14 Public Notification
Herbal Vigor Quick Fix Company unknown-Promoted and sold for sexual enhancement on various websites, including www.calcompnutrition.com, and in some retail stores. 08/11/14 Public Notification
Arize Company unknown-Promoted and soldon various websites, including www.calcompnutrition.com, and in some retail stores. 08/11/14 Public Notification
O.M.G. Company unknown 07/22/14 Public Notification
Gold Vigra Company unknown 06/17/14 Public Notification
Miraculous Evil Root Company unknown 06/17/14 Public Notification
Zhen Gong Fu Company unknown 06/05/14 Public Notification
Liu Bian Li Company unknown 06/02/14 Public Notification
Dick’s Hard Up Company unknown 06/02/14 Public Notification
Eyeful Company unknown 06/02/14 Public Notification
3 Hard Knights Company unknown 06/02/14 Public Notification
Full Throttle on Demand Company unknown 06/02/14 Public Notification
GoldReallas Company unknown 06/02/14 Public Notification
African Black Ant, Black Ant, Mojo Risen Eugene Oregon 05/28/14 Voluntary Recall
MV5 Days Company unknown 05/16/14 Public Notification
S.W.A.G. Company unknown-Promoted and sold on various websites, including www.SexWithAGrudge.com, and in some retail stores. 04/16/14 Public Notification
African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), XZone 1200 (Lot# 13071012) and Mojo Risen (Lot# 10081359) Nova Products Inc. 04/01/14 Voluntary Nationwide Recall
Weekend Warrior Company unknown-Product promoted and sold on various websites, including www.onlinecoralcalcium.com, and in some retail stores. 03/07/14 Public Notification
Bali Mojo Company unknown 01/28/14 Public Notification
Tiger King Company unknown 01/28/14 Public Notification
Vimax Company unknown 01/28/14 Public Notification
JINQIANGBUDOR Red Dragon Company unknown 01/28/14 Public Notification
SexRx Company unknown-Product promoted and sold on various websites, including www.alternative-health-supplements.com, and in some retail stores. 01/28/14 Public Notification
Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men, “New” Extenze, and New XZen Platinum Midwest Wholesale 01/09/14 Voluntary Recall
CONTROL All Natural Sexual Enhancement Company unknown 12/19/13 Public Notification
Best Whips Company unknown 12/19/13 Public Notification
P-Boost AKA NatuRECT Tendex 11/19/13 Voluntary Recall
RezzRX Fossil Fuel Products LLC 11/18/13 Voluntary Recall
Rhino 5 Plus, Maxtremezen and Extenzone Jobbers Wholesale 11/16/13 Voluntary Recall
Alpha Male Company unknown 11/21/13 Public Notification
ExtenZe Maximum Strength lot number 0512058 Company unknown 11/12/13 Consumer Warning
Vitalikor Fast Acting Company unknown-Promoted and soldon various websites and in retail stores, such as www.vitalityresearchlabs.com, www.vitalikor.com, and in GNC stores (including on www.gnc.com). 11/08/13 Public Notification
Wood-E Company unknown 09/24/13 Public Notification
XZone Premium Company unknown 09/24/13 Public Notification
Xzen 1200, Xzen Gold or Xzen XPress Company unknown 09/24/13 Public Notification
Virilis Pro, PHUK and Prolifta Haute Health LCC 09/24/13 Voluntary Recall
72HP, Evil Root and Pro Power Max Hardmenstore.com 08/27/13 Voluntary Recall
Jack Rabbit Jack Rabbit Inc. 08/12/13 Voluntary Recall
Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules Volcano Company 07/18/13 Voluntary Worldwide Recall
Silver Sword and Clalis Hardmenstore.com 07/05/13 Voluntary Recall
Silver sword Company unknown-promoted and sold on various websites including www.hardmenstore.com and in some retail stores 06/28/13 Public Notification
Exten 1300 Company unknown 06/28/13 Public Notification
MVP Mega Company unknown 06/28/13 Public Notification
MaxTreme Zen Company unknown 06/28/13 Public Notification
Clalis Company unknown 06/28/13 Public Notification
Royal Dragon Herbal Tonic Balls Company unknown 06/17/13 Public Notification
Mojo Risen Company unknown 6/10/13 Public Notification
Reload Company unknown-sold on various websites including www.reloadpill.com and in some retail stores 6/10/13 Public Notification
Cave Diver Company unknown-sold on various websites including www.bonanza.com and in some retail stores 6/10/13 Public Notification
X Zen Platinum Company unknown 6/10/13 Public Notification
Super Cheetah Company unknown-sold online on various websites including www.bonanza.com and in some retail stores 06/10/13 Public Notification
Nights to Remember Company unknown 06/10/13 Public Notification
Get It Up Company unknown 06/10/13 Public Notification
SexVoltz
Velextra
Amerect
Beamonstar Products 05/07/13 Recall
Bullet Proof Company unknown 05/07/13 Public Notification
Lightning Rod Capsules Chang Kwung 05/07/13 Recall
Vicerex Capsules
Black Ant Capsules
American Lifesyle 05/01/13 Recall
Sex Plus sold online and some retail stores 04/25/13 Public Notification
Zoom-Zooma-Zoom Company unknown 04/25/13 Public Notification
Affirm XL Affirm XL, Inc. 04/10/13 Recall
Love Rider Company unknown 04/03/13 Public Notification
AFFIRM XL Company unknown 04/03/13 Public Notification
Nina Mojo Company unknown 04/03/13 Public Notification
ROCK-IT MAN Consumer Concepts, Inc. 04/01/13 Recall
Rock-It Man sold online 03/21/2013 Public Notification
Libido Sexual Enhancer sold online 03/21/13 Public Notification
Stiff Days Company unknown 03/21/13 Public Notification
X-ROCK All Natural for Men
Z-ROCK All Natural
X-ROCK All Natural 3 Day Pill For Men
X-ROCK for ERECTILE REFUNCTION, The 3 Day Pill
Coral Rock Man Inc. dba CRM Laboratories 03/13/2013 Warning Letter
Night Bullet Green Planet, Inc. 03/12/13 Recall
Super Power D&S Herbals, LLC 01/24/13 Recall
Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® Performance Plus Marketing Inc. 12/17/12 Recall
Evol Nutrition Associates, Inc./ Red Dawn Issues Voluntary Nationwide Recall of Dietary
Supplements
Mojo Nights and Mojo Nights for Her 9/21/12 Recall
ACTRA-Sx 500 Capsules Body Basics, Inc. 9/18/12 Recall
X-ROCK 3 Day Pill for Men & Z ROCK sold online 07/24/2012 Public Notification
IBU-RELIEF 12
Idebenone
Sexual Virility Max
ABCO Laboratories, Inc. 06/19/2012 Warning Letter
Kaboom Action Strips www.kaboomformen.com and in some retail stores 05/25/2012 Public Notification
Mojo Nights Sold online, and various retail stores 05/25/2012 Warning
V Maxx Rx www.themensclub.net www.vmaxxrx.com 05/25/2012 Recall-Firm Press Release
EreXite Sold online, including www.amazon.com 05/22/2012 Public Notification
Firminite
Extra Strength Instant Hot Rod
Libidron
West Coast Nutritionals, Ltd. 05/18/2012 Recall-Firm Press Release
Firminite Sold online, www.firminit.com 05/16/2012 Public Notification
Boost-Ultra Sexial Enhancement Formula Sold online, www.bosstultra.biz 05/16/2012 Public Notification
VMaxx Rx Sold online, www.vmaxxrx.com 05/16/2012 Public Notification
X-Rock CRM Laboratories, sold online 4/18/2012 Recall

Public Notification

Stree Overlord Sold online 4/05/2012 Public Notification
African Black Ant Sold online, ebay.com 4/05/2012 Public Notification
France T253 Sold online, ebay.com 4/03/2012 Public Notification
Man King Sold online 2/18/2012 Public Notification
Hard Ten Days Sold online 2/18/2012 Public Notification
RegenErect Regeneca, Inc. 2/27/2012

Recall

Press Release

RegenArouse Regeneca, Inc. 2/10/2012 Recall
Virility Max Keime Inc dba Barry’s Vitamins 11/10/11 Recall
ViaXtreme Global Wellness, LLC 06/06/11 Recall
Regenerect Ethos Environmental, Inc.
d.b.a. Regeneca International, Inc.
05/25/11 Warning Letter
Regenerect Ethos Environmental, Inc.
d.b.a. Regeneca International, Inc.
04/28/11 Recall
Duro Extend Intelli Health Products, LLC 04/27/11 Warning Letter
X-Hero
Male Enhancer
USA Far Ocean Group, Inc. 03/29/11 Recall
THE BEST Enhancer AVNS, Inc. 03/28/11 Recall
Black Ant Sold online 03/16/11 News Release
EXTENZE Biotab Nutraceuticals, Inc. 02/22/11 Recall
Nite Rider Maximum Sexual Enhancer For Men
STUD Capsule for Men
Kanec USA, Inc. 01/18/11 Recall
Rock Hard Extreme
Passion Coffee
Drive Total Energy 12/30/10 Recall
RockHard Weekend
Pandora
RockHard Laboratories 12/22/10 Recall
Man Up Now Synergy Distribution LLC 12/15/10 News Release
Duro Extend Capsules For Men Intelli Health Products 12/2/10 Recall
Vigor-25 Piston Corp. 11/19/10 News Release
MasXtreme
Passion Power for Men
Passion Power for Women
Natural Wellness, LLC 10/05/10 Warning Letter
Magic Power Coffee INZ Distributors, Inc. 08/23/10 Warning Letter
TimeOut Capsules Sold online 08/25/10 News Release
Mr. Magic Male Enhancer Glow Industries, Inc. 08/18/10 Recall
Stiff Nights
Aziffa
Size Matters
Erex
Mojo
Hard Drive
Eyeful
Red Magic
Straight Up
Zotrex
Monster Excyte
WOW
Xaitrex
Verec
Prolatis
Xytamax
Maxyte
Libidinal
OMG
OMG45
Zilex (with Golden Spear)
Novacare LLC 08/10/10 Recall
Prolatis’ Prolatis’ 08/09/10 Recall
Revivexxx Extra Strength EZVille, Ltd. 08/06/10 Recall
Ejaculoid XXTREME
Stimuloid II
Nutraloid Labs, Inc. 07/28/10 Recall
Vialipro Good Health, Inc. 07/16/10 Recall
Natural Progesterone Cream USP with Adrenal Support
Testosterone Cream Formula FOR WOMEN
Testosterone Cream Formula FOR MEN
Total HGH Cream
LibidoEdge Capsules NATURAL SEXUAL ENHANCEMENT
Libido Edge Labs, LLC 06/10/10 Warning Letter
Rock Hard Weekend
72 Hours
Stamin I
Finally On Demand
Stamini
Vierect
Atlas Operations, Inc. 06/04/10 Warning Letter
Vitalex Vitapro 04/20/10 Prison Sentence
Super Shangai
Strong Testis
Shangai Ultra
Shangai Ultra X
Lady Shangai
Shangai Regular
Shangai Chaojimengnan
Naturalë Super Plus
Shangai Distributors Inc. 04/08/10 News Release
Stud Capsule For Men Kanec USA, Inc. 04/02/10 Recall
Stiff Nights Impulsaria LLC 11/05/09 News Release
Enzyte Berkeley Premium Nutraceuticals, Inc. 07/22/09 Court Order
LibieXtreme
Y-4ever
Libimax X Liquid
Powermania Liquid
Capsule
Herbal Disiac
Opteron 1 Inc. dba Nature & Health Co. 07/15/09 Recall
Stamina-Rx Hi-Tech Pharmaceuticals, Inc. 07/15/09 Recall
Libipower Plus Haloteco 07/13/09 Recall
Actra-Rx
Actra-Sx
Libidus
Nasutra
Neophase
Vigor-25
Yilishen
Zimaxx
4EVERON
Liviro3
Lycium Barbarum L.
Adam Free
Rhino V Max
V.Max
True Man
Energy Max
HS Joy of Love
NaturalUp
Blue Steel
Erextra
Hero
Xiadafil VIP tablets (Lots 6K029 and 6K209-SEI only)
Sold online Consumer Update
Zencore Plus Bodee LLC 03/11/09 Recall
Spontane-ES National Urological Group dbaWarner Laboratories
National Institute for Clinical Weight Loss, Inc.,
Hi-Tech Pharmaceuticals, Inc., dba Planet Pharmacy, Global Pharmacy
01/15/09 Court Order
Rize 2 The Occasion
Rose 4 Her
Jack Distribution, LLC
G & N works, Inc.
Devine Distribution, Inc.
07/28/08 Recall
Xiadafil VIP SEI Pharmaceuticals, Inc. 07/28/08 Seizing
Xiadafil VIP SEI Pharmaceuticals, Inc. 05/27/08 Recall
Viapro (in 375mg capsules) EG Labs, LLC 07/23/08 Recall
Viril-Ity-Power (VIP) Tabs International Pharmaceuticals, Ltd. 05/29/08 Recall
Blue Steel
Hero
Active Nutraceuticals
Marion Group
05/25/08 News Release
BOOM! Yoi Jin Sei LLC 04/23/08 Court Order
Shangai Regular
Shangai Ultra
Super Shangai
Naturalë Super Plus
Lady Shangai
Shangai Distributors Inc. 04/9/08 Seizing
Maxidus pills KG Enterprises LLC 03/31/08 Recall
Aspire36
Aspire Lite
Palo Alto Labs 02/28/08 Recall
Encore Tabs Bodee LLC 11/21/07 Recall
True Man’s Sexual Energy Nutriment Men’s Formula
Energy Max
Energy Supplement Men’s Formula
America True Man Health Incorporated 11/16/07 Recall
Nasutra Nasutra, LLC 09/20/06 Recall
SIGRA
STAMINA Rx
STAMINA Rx for Women
Y-Y
Spontane ES
Uroprine
NVE Inc., distributed by Hi-Tech 06/20/03 News Release

AUSTRALIA

09/23/18:NET Remedies homeopathic products
08/22/18:Liangzern Dietary Supplements
08/22/18:Germany Niubian tablets
08/22/18:Rhino 8 Platinum 8000 capsules
08/15/18:G Female Oral Tablets
08/02/18:Fairy capsules
06/28/18:Need for Seal tablets
06/28/18:Gold Maka tablets
06/28/18:One Night Lover tablets
06/19/18:Platinum-Male Enhancer tablets
06/19/18:Bulbao Male Enhancer tablets
06/19/18:Meltz-Instant Energy for Male tablets
06/05/18:Camellia sinensis (green tea) extract
06/02/18:Solve Botanical Slimming capsules
05/23/18:Hypnotic poisom capsules
05/17/18: Jaguar 30000 capsules
05/14/18:Lishou Strong Slimming capsule
03/07/18:Ja Dera Max+ capsules
02/28/18:Help 100% & Pure Natural & Body Slim capsules
02/06/18:Perfect slim capsules by Peenuch
01/16/18:Yunnan Feng Shi Ling capsules – counterfeit
12/19/17:Counterfeit: SLAM Natural Formula 29000 mg capsules
12/11/17:Semenax capsules (counterfeit version)
11/13/17:Super Soniic Capsules
11/13/17:Hard Rod Plus Capsules
11/09/17:LISHOU Fuling Jiaonang Capsules
11/07/17:Red Ant Tablets
11/07/17:Maximum Powerful (Baiwei USA) tablets
11/02/17:Lose Weight 30 Capsules
11/02/17:Beautiful Lose Weight Gold 30 Capsules
10/18/17:Jimpness Beauty Fat Loss capsules
09/18/17:Body Con Plus Capsules
09/18/17:7 Day Slim Extreme capsules
08/28/17:Rhino 9 Capsules
08/25/17:Recall – Oh Baby!, JO LMax Extra and RUFF Natural Formula
08/04/17:Maxidus capsules
08/04/17:Majestic African Mango capsules
08/04/17:Herbal Max Real Slim Capsules
08/02/17:Germany Black Gorilla tablets
07/27/17:Bittermelon Slimming Capsules
07/25/17:RUFF Natural Formula capsules
07/24/17:V8 Tablets
07/24/17:Jing Pin Heijin Gang Tablets
06/13/17: Slimming Capsule-Reduce Fat
05/30/17: Jinqiangbudor Red Dragon Tablets
05/30/17: Dragon Power (Yong Gang Tablets)
05/12/17: Man XXX Herbal capsules
05/04/17: Black Gorilla tablets
05/04/17: France T253 capsules
05/04/17: Gold Reallas XXX capsules
05/04/17: Dragon Power Capsules
05/04/17: Real Skill Male Sexual Stimulant capsules
05/04/17: V9 Male Sexual Stimulant tablets
05/04/17: Rize N Shine tablets
05/04/17: XXXL Penis Enlarging Ointment
05/04/17: MME Maxman IX capsules
05/04/17: 100% Healthy Food For Men tablets
05/02/17: Maxman IV capsules
05/02/17: Dragon Max capsules
05/02/17: Maxman Premium capsules
05/02/17: Maxman V capsules
05/02/17: MMC Maxman XI tablets
05/02/17: New Advanced Technological tablets
04/20/17: Slim-Vie Slimming Capsules
04/11/17: Lose Weight Capsules
04/08/17: Nangen Zengzhangsu capsules
03/15/17: Change Me Herbal Slimming capsules
03/09/17: Africa Black Ant capsules

New FDA Requirements for Imported Ingredients

by NaturPro in Quality Comments: 0

Importing any food or supplement products? Do you have training, procedures and records according to FDA’s FSVP guidance? 

Many firms in the food and dietary supplement industry are quietly putting significant investment into meeting the Food Safety Modernization Act (FSMA). FSMA was signed by President Obama in 2011 as the first major legislation to update food safety regulations in more than 50 years. FSMA and FSVP represent the best approach to ensuring a safe global food chain.

supplement food verification

For supplements and health foods, its more reliable to verify than it is to trust.

FDA Requires You To Do these Things:

  1. Your FSVP includes all written procedures and records that demonstrate compliance with FSMA, especially the requirements for Supply Chain Preventive Controls (PC). If you purchase any ingredients directly from foreign sources outside the U.S., then you must have a written FSVP. And if your U.S. based supplier imports ingredients, you are responsible for verifying their FSVP is effective.
  2. Warehouses, marketers and distributors, and supplement manufacturers are subject to “modified” FSVP requirements. Even if you don’t receive product, or open any containers, you must still verify those you designate to handle, order, process or store your product.  If your name is on the  label of any product or package, then you must be able to show (with written documentation) that your supplier, warehouse, processor, and customer ensures the safety of the product within 24 hours of the FDA visiting you or requesting this information by phone.
  3. If you import, own and/or have a financial stake in the imported goods, then you are probably responsible for the goods as the designated “FSVP Importer”. For imports involving multiple U.S. parties, there must be a written agreement specifying who is responsible for what. Foreign firms who send goods to the U.S. without a designated buyer must have a U.S.-based agent to act as importer, and take responsibility for the shipment once it arrives to the U.S.
  4. You need to have a Qualified Individual or QI to write your FSVP. No standard training is required to be a QI, but it will greatly help your QI to be trained on PCQI and/or FSVP. Because the final FSVP rule includes more than 300 mentions of the word ‘flexibility’, you still gotta know what you’re doing.
  5. With few exceptions, importers must perform a hazard analysis on all imported products. This requires you to know how your ingredients are grown and made, where they came from, and what biological, chemical or physical hazards may be present that could make them unsafe. A hazard requiring a preventive control is defined as one that is “known or reasonably foreseeable to cause significant injury or illness”. It’s up to your QI to determine these hazards.  You can agree in writing with your supplier or customer to ensure that they are responsible for a preventive control – otherwise, the responsibility probably falls on you.
  6. The most common hazards are:
    1. Undeclared allergens
    2. Salmonella
    3. Listeria
    4. These three are the source of 88% of all product recalls! 
  7. Economically Motivated Adulteration (EMA) and radiological contamination are often overlooked as hazards, and often require PC in the FSVP guidance.
  8. Much of the available information on hazards is provided by FDA for free. Some examples:
    1. FDA Import Alerts
    2. FDA Warning Letters
    3. FDA Product Recalls
    4. FDA Guidance on Potential Hazards for Foods and Processes
    5. FDA Bad Bug Book
    6. FDA Guidance on Chemical Hazards
    7. FDA Reportable Food Registry
    8. Product specifications that control for hazards like salmonella and allergens. These are often not publicly available, but many are found on industry databases like UL Prospector.
  9. The easiest and most impactful thing you can do to start evaluating your foreign supplier is to request their hazard analysis!
  10. Third party experts are the most popular way to develop FSVP programs. A couple days of staff training is not the same as experience and expertise, especially with today’s global supply. Remember that suppliers are not allowed to verify themselves – this duty is left to customers, third party auditors, or other qualified individuals sent on behalf of the customer.

If you don’t have the time or expertise on staff to handle your supplier verification according to FSMA, make sure you talk to someone trained in FSVP with experience in qualifying your type of products and suppliers.

For more information on FSVP, visit the FDA page “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

NaturPro Scientific LLC is a leading natural products consultancy specializing in evaluating and maximizing the value of foods and dietary supplements. Contact us for more information at http://naturproscientific.com/contact-us

 

Workshop on Product Testing at Supplyside

by NaturPro in Quality Comments: 0

2018 SUPPLYSIDE WORKSHOP — Effectively Partnering with a Contract Laboratory

Location: Lower Level, North Convention Center

Wednesday, November 7 | 1:30-4:30pm

  • NaturPro Scientific will be discussing common pain points (and reliable cures) to forging long-lasting client-lab partnerships. For example, many companies responsible for testing their product pay little attention to how the material is being tested, and whether the lab is using a scientifically valid method.
  • Miscommunication, lack of transparency, and insufficient lab QC practices can hamper the reliability and consistency of lab test results. Ultimately, product quality suffers.
  • Open communication, verification, and investment in testing of ingredients and finished products are critical factors of successful partnerships in many ways — the main being to prove the validity of test methods required by GMP, and ensure accurate and reliable results.
  • The business benefits of positive client-lab relationships are often reflected in key performance metrics such as fewer production delays and product recalls, and reduced testing expenses.

——————

About the Workshop:

The extensive range of requirements for testing—of ingredients and finished products—places a great burden on manufacturers to invest in their own laboratory facilities, or to select an appropriate contracted partner. Many companies do both, using internal resources for day-to-day operations and outsourcing higher cost tests or seeking independent validation of results. Understanding the steps involved in selecting the right laboratory partner to meet your needs, and managing that partnership over the long term, can lead to greater peace of mind and, ultimately, ensure you’re delivering the highest quality products to consumers.

  • Top considerations and questions for a contract laboratory partner
  • Ensuring your laboratory is compliant with all regulations—and that you’re covered
  • Determining the type of testing that can be accommodated in-house and what is best served by an outside partner.

Speakers:

  • Tara Couch, EAS Consulting
  • Blake Ebersole, NaturPro Scientific
  • Michael Hoard, Arizona Nutritional Supplements
  • Holly Johnson, AHPA
  • Aaron Secrist, NOW Foods

Underwritten By:

American Testing Lab

Eurofins

Micro Quality Labs

Good Manufacturing Practices (GMP) for Natural Products

by NaturPro in Quality Comments: 0

Scientific Publications on Natural Products, including Food, Medicine and Dietary Supplements: With a focus on Good Manufacturing Practices (GMP) for Natural Products, Quality Management Systems, and Good Agricultural and Collection Practices (GACP)

(Have a suggestion to add? Contact us!)

    1. A Field Guide to Herbal Dietary Supplements, AHPA-ERB Foundation, http://www.ahpafoundation.org/fieldguide.pdf
    2. A Harvester’s Handbook to Wild Medicinal Plant Collection in Kosovo (2003). Lonner J. and Thomas M. Source: http://www.gowildconsulting.com/wp-content/uploads/2011/02/harvesters_handbook.pdf
    3. AHPA-AHP Good Agricultural and Collection Practice for Herbal Raw Materials, December 2006. (Updated draft 2016)
    4. AHPA Botanical Identity References Compendium, http://www.botanicalauthentication.org/index.php/Main_Page
    5. AHPA Guidance Policies, http://www.ahpa.org/Portals/0/PDFs/Policies/AHPA_Guidance_Policies.pdf
    6. Aspects of sustainable wild plant collection (2012) Rodina K, WWF Hungary/TRAFFIC
    7. Biological Diversity Act 2002 (India)
    8. BRC’s Global Standard for Food Safety
    9. Canadian Herb, Spice and Natural Health Product Coalition (CHSNC) Good Agriculture and Collection Practices (GACP). Kehler C. Source: https://www.cotr.bc.ca/webs_media/Creston/_docManager/docs/Good%20Agricultural%20and%20Collection%20Practices(1).pdf
    10. Canadian Horticultural Council OFFS (CanadaGAP)
    11. Code of Good Agricultural Practices of Georgia (2007). Ministry of Agriculture of Georgia. Source: http://iwlearn.net/iw-projects/633/reports/aret-code-of-good-agriculture-practices-of-georgia
    12. Code of hygienic practices for spices and dried aromatic herbs. (2014) Codex Alimentarius Commission, CAC/RCP 42-1995
    13. Codex Alimentarius Commission Recommended International Code of Practice – General Principles of Food Hygiene CAC/RCP1-1969, Rev. 4 -2003
    14. Current good manufacturing practice in manufacturing, packaging, labeling or holding operations for dietary supplements (21 CFR 111)
    15. Current good manufacturing practice, hazard analysis and risk-based preventive controls for human food (21 CFR 117)
    16. Development of a Good Agricultural Practice Approach. November 5, 2003. Source: http://www.fao.org/prods/GAP/archive/GAPCONCEPT12_en.pdf.
    17. Development of Good Wildcrafting Practices and Wildcrafter Certification for Medicinal Plants. (2006) Howe A. Source:  http://www.bestlibrary.org/best_teachers/files/Wildcraftingfinalreport.pdf
    18. Dietary Supplement Ingredient Database, https://dietarysupplementdatabase.usda.nih.gov/
    19. Dietary Supplement Label Database, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
    20. Dietary supplement laboratory quality assurance program: the first five exercises. Phillips MM, Rimmer CA, Wood LJ, Lippa KA, Sharpless KE, Duewer DL, Sander LC, Betz JM.  J AOAC Int 2011;94:803-14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3173719/
    21. Dietary Supplement Online Wellness Library (OWL), Council for Responsible Nutrition (CRN), http://www.supplementowl.org/
    22. EFSIS Safe & Legal: https://www.saiglobal.com/assurance/food-safety/SafeandLegal.htm
    23. Ensuring the Compliance of Raw Herbal Materials stemmed from China with European Good Agricultural and Collection Practice. Philippe A. et al. Chinese Herbal Medicine, (2011) 3(4): 251-256
    24. FairWild Standard, Version 2.0 (2010).
    25. FairWild Standards Map. Source: http://search.standardsmap.org/assets/media/FairWild/English/AtAGlance_EN.pdf
    26. FDA Food Safety Modernization Act http://www.fda.gov/Food/GuidanceRegulation/FSMA/
    27. FDA Dietary Supplement Labeling Guide, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm
    28. Field Techniques Used by Missouri Botanical Garden. Compiled by R. Liesner with suggestions from MO staff and others. Source: http://www.mobot.org/MOBOT/molib/fieldtechbook/pdf/handbook.pdf
    29. GAP Production of TCM Herbs in China (2010) Zhang B. et al. Planta Med 2010 76:1948-1955
    30. General guidelines for good agricultural practices: spices. International Organisation of Spice Trade Associations (IOSTA) (2013). Source: http://www.esa-spices.org/download/iosta-gap-final.pdf
    31. Global GAP, http://www.globalgap.org/uk_en/
    32. Good Agricultural and Collection Practices – Guidelines for the cultivation and collection of herbal medicines. (2012) Republic of Kenya.
    33. Good agricultural and collection practices for medicinal plants: Illustrated booklet for farmers and collectors. Source: http://www.dmapr.org.in/Downloads/Illustratedbooklet.pdf
    34. Good Agricultural and Wild Collection Practice (GACP) of Medicinal Plants in Europe, EUROPAM,( EHGA), c/o Veterinaerplatz, Vienna.
    35. Good Agricultural Practice (GAP) – Does It Ensure a Perfect Supply of Medicinal Herbs for Research and Drug Development? (2008) Leung PC and Cheng KF. Int J. App. Res. Nat. Prod. 1(2);1-8.
    36. Good Agricultural Practices and Good Handling Practices: Audit Verification Program. (2011) USDA Source: https://www.ams.usda.gov/sites/default/files/media/GAPGHP_Audit_Program_User%27s_Guide%5B1%5D.pdf
    37. Good Agricultural Practices and Good Handling Practices: Risk Mitigation in Edible Horticultural Production Systems (2015) Urbanowitz S and Bishop C. Source: https://www.unce.unr.edu/publications/files/ag/2015/cm1501.pdf
    38. Good agricultural practices for Artemisia (2014) ICAR Directorate of Medicinal and Aromatic Plants Research, Anand, Gujarat, India. Source: http://www.dmapr.org.in/publications/bulletine/artemisia%2016-1-15.pdf
    39. Good Agricultural Practices for Chinese Crude Drugs (Interim) (2002). Source: http://eng.sfda.gov.cn/WS03/CL0768/61642.html
    40. Good Agricultural Practices for Medicinal Plants (2009) National Medicinal Plant Board (NMPB), Department of AYUSH, India and World Health Organization Source: http://nmpb.nic.in/WriteReadData/links/8527013542Good%20Agricultural%20Practicies%20(GAPs)%20Booklet%20-%20Part%20-%20I.pdf
    41. Good Agricultural Practices for Plantago ovate Forsk. National Medicinal Plant Board (NMPB), Department of AYUSH, India and World Health Organization Source:
    42. Good agricultural practices for senna (2015) ICAR Directorate of Medicinal and Aromatic Plants Research, Anand, Gujarat, India. Source: http://www.dmapr.org.in/publications/bulletine/Good%20Agricultural%20Practices%20for%20Senna.pdf
    43. Good agricultural practices for small diversified farms, Carolina Farm Stewardship Association. Source: http://www.carolinafarmstewards.org/wp-content/uploads/2013/07/CFSA_GAPS-web.pdf
    44. Good agricultural practices for sustainable cocoa production: a guide for farmer training. Asare R and Sonii D. (2010) University of Copenhagen
    45. Good Practices for Plant Identification for the Herbal Industry (2004), Saskatchewan Herb and Spice Association, National Herb and Spice Coalition (Canada)
    46. Grocery Manufacturers Association (GMA-SAFE)
    47. Guidance for Implementing the International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP). (2008) Leaman and Cunningham.
    48. Guidance for Industry: Botanical Drug Products (2004) FDA.Source: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070491.pdf
    49. Guidance Manual for Organic Collection of Wild Plants (2005) Swiss Import Promotion Programme (SIPPO).
    50. Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin. London, 20 February 2006. Doc. Ref. EMEA/HMPC/246816/2005 Source: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003362.pd
    51. Guidelines for good agricultural and hygiene practices for raw materials used for herbal and fruit infusions (GAHP). [Former EHIA Document], Version 6, 2014 Source: http://www.thie-online.eu/fileadmin/inhalte/Publications/HFI/2_2014-06_PU_GAHP_Version_6.pdf
    52. Guidelines for good agricultural and wild collection practices for medicinal and aromatic plants (2010). EUROPAM the European Herb Growers Association Brussels, November, 2010; EUROPAM GACP‐MAP 8.0
    53. Guidelines for identification and collection of medicinal plants in Bhutan. 2008.
    54. Guidelines for the Sustainable Harvesting of Traditional Medicinal Plants in Zimbabwe ( ). Khumalo SG, Frode A, Sola P. Research and Development Section Southern Alliance for Indigenous Resources (SAFIRE). Source: http://projects.nri.org/adappt/docs/HarvestingGuidelines.pdf
    55. Hand book of domestic medicine and common Ayurvedic remedies. Source: http://niimh.nic.in/ebooks/ayuhandbook/index.php
    56. Heavy metals: analysis and limits in herbal dietary supplements, http://www.naturalhealthresearch.org/wp-content/uploads/2013/02/09_1214_AHPA_Heavy-Metals-White-Paper-Revised.pdf
    57. Herbs of Commerce, American Herbal Products Association, Second Ed. (First Ed., 1992 available here: https://law.resource.org/pub/us/cfr/ibr/001/ahpa.herbs.1992.pdf )
    58. In search of comprehensive standards for nontimber forest products in the botanicals trade. PIERCE, A.R. and S.A. LAIRD. (2003). International Forestry Review 5(2):138-147.
    59. International Labour Organization: Labour Principles of the United Nations Global Compact
    60. International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP) (2007) Version 1.0 Source: http://www.floraweb.de/map-pro/Standard_Version1_0.pdf
    61. ISO /TS 22003:2007 Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems
    62. ISO 22000:2005 Food safety management systems – Requirements for any organization in the food chain
    63. ISO 9000:2005 Quality management systems – Fundamentals and vocabulary
    64. ISO 9001:2008 Quality management systems – Requirements
    65. ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles
    66. ISO/IEC 17011:2004 Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies
    67. ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems
    68. ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems
    69. Legal and regulatory frameworks governing the growing, packing and handling of fresh produce in countries exporting to the U.S. (2010) Produce Safety Project, Pew Charitable Trust, Georgetown University. Source: http://www.pewtrusts.org/~/media/legacy/uploadedfiles/phg/content_level_pages/reports/psprptlegalregexportspdf.pdf
    70. National Advisory Committee on Microbiological Criteria for Foods Hazard Analysis and Critical Control Point Principles and Application Guidelines, August 1997.
    71. Office of Dietary Supplements, Background Information on Dietary Supplements, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
    72. Pesticide Analytical Manual, Vol I, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113702.pdf
    73. Pesticide Analytical Manual, Vol II, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113721.pdf
    74. Pesticide chemicals in processed foods (21 CFR 170.19)
    75. Phytomedicine 101: plant taxonomy for preclinical and clinical medicinal plant researchers. Bennett, BC, Balick MJ.  J Soc Integr Oncol 2008;6:150-157.  https://www.ncbi.nlm.nih.gov/pubmed/19134447
    76. Quality assurance of cultivated and gathered medicinal plants. Mathe and Mathe, Source: http://www.mtk.nyme.hu/fileadmin/user_upload/kornyezet/Mathe/Quality_assurance.pdf
    77. Quality control methods for medicinal plant materials (1998) World Health Organization
    78. Recommendations for microbial limits in herbal products, American Herbal Products Association, http://www.ahpa.org/Portals/0/PDFs/Policies/14_0206_AHPA_micro_limits_comparisons.pdf
    79. Research and implementation of good agricultural practice for traditional Chinese medicinal materials in Jilin Province, China. (2014) Li C, Yan Z, Zhang L, Li Y. Ginseng Res. 38;227-232 Source: http://www.ginsengres.com/article/S1226-8453(14)00062-1/pdf
    80. Safe Quality Food, Edition 7.0. (SQF 2000 Levels 1, 2 & 3)
    81. Selection and authentication of botanical materials for the development of analytical methods. Applequist WL, Miller JS.  Anal Bioanal Chem 2013;405):4419-28. https://www.ncbi.nlm.nih.gov/pubmed/23224664
    82. Standard operating procedure for the collection and preparation of voucher plant specimens for use in the nutraceutical industry. Hildreth J, Hrabeta-Robinson E, Applequist W, Betz J, Miller J. Anal Bioanal Chem. 2007 Sep;389(1):13-7. Epub 2007 Jun 16.
    83. Standardization of herbal medicines – A review. Kunle O.F. et al, (2012) Int. J Biodiv and Conserv. 4(3) 101-112. Source: http://www.academicjournals.org/article/article1380017716_Kunle%20et%20al.pdf
    84. Suggested Good Agricultural and Collection Practices for North Carolina Medicinal Herbs (2016) Davis J. Source: http://content.ces.ncsu.edu/suggested-good-agricultural-and-collection-practices-for-north-carolina-medicinal-herbs
    85. Suggested guidelines for articles about botanical dietary supplements. Swanson CA. Am J Clin Nutr 2002;75:8-10, https://www.ncbi.nlm.nih.gov/pubmed/11756054
    86. The Ayurvedic Pharmacopoeia of India, 5 Volumes, Ministry of Health and Family Welfare, Govt. of India, New Delhi, 1989-2005
    87. The Chinese Approach to Medicinal Plants – Their Utilization and Conservation. Pen-Gen X. (1991) In: Akerle, O., V. Heywood, and H. Synge (eds.). Conservation of Medicinal Plants. Cambridge University Press, Cambridge, UK.
    88. The Drugs and Cosmetics Act and Rules (as amended up through 30 June 2005. New Delhi: Department of Health. 2005.Schedule T: Good Manufacturing Practices (GMPs) for Ayurveda, Siddha and Unani Medicines.
    89. The Global Food Safety Initiative: GFSI Guidance Document, 6th Version 6.3
    90. The Indian Forest Act, India, 1927
    91. The NIH analytical methods and reference materials program for dietary supplements. Betz JM., Fisher KD., Saldanha LG, Coates PM.  Anal Bioanal Chem 2007; 389:19-25.  https://www.ncbi.nlm.nih.gov/pubmed/17541565
    92. The Siddha Pharmacopoeia of India, Part I(1), Ministry of Health and Family Welfare, 
 of India, New Delhi, 2007
    93. The Unani Pharmacopoeia of India, Part-I, Ministry of Health and Family Welfare, Govt. of India, New Delhi
    94. Trainer’s manual on good agricultural and collection practices for medicinal plants: Source: http://www.dmapr.org.in/Downloads/Trainersmanual.pdf
    95. U.S. Customs & Border Protection, (C-TPAT)
    96. USDA (National Organic Program), https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program
    97. USP Food Fraud Mitigation Guidance, http://www.usp.org/food/food-fraud-mitigation-guidance
    98. USP <2750> Manufacturing Practices for Dietary Supplements.
    1. USP <467> Residual Solvents
    2. USP <561> Articles of Botanical Origin
    3. Voluntary Sustainability Standards (Draft), United Nations Forum on Sustainability Standards Source: https://unfss.org/documentation/general-documentation/
    4. WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants (2003). Source: http://apps.who.int/iris/bitstream/10665/42783/1/9241546271.pdf
    5. WHO Traditional Medicine Strategy 2002-2005. World Health Organization, Geneva.
    6. Wild Life (Protection) Act, India, 1972

 

Article: Dietary Supplements: Regulatory Challenges


Dietary Supplements: Regulatory Challenges and Research Resources

Johanna T. Dwyer, Paul M. Coates, and Michael J. Smith

Nutrients 2018, 10, 41; doi:10.3390/nu10010041 (Open Access)

Abstract: Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

Keywords: dietary supplements; food supplements; supplement science; scientific challenges; regulatory challenges; natural health product; complementary medicine; traditional medicines; National Institutes of Health; Office of Dietary Supplements

1. Introduction

The fundamental challenge in any discussion about the regulation of dietary supplements is that there is no global consensus on how the category of products known variously as dietary supplements, natural health products (NHPs), complementary medicines or food supplements in different countries is defined. For example, a product considered to be a dietary supplement and regulated as a food in the USA, in another jurisdiction may be considered a food supplement or a therapeutic good (complementary medicine) or a therapeutic good (prescription medicine) or potentially even a controlled substance. The situation is even more complicated when countries like China or India that have an existing regulatory framework for traditional medicine or phytomedicine that includes crude botanicals are considered. To add further to the confusion, many regulatory frameworks are changing.

Another challenge is that while all regulatory scientists want to protect consumers from harm, ensure that consumers have the ability to make informed choices about the products they use, and do the right thing, the scientific challenges and regulatory systems that have arisen to deal with them vary greatly from country to country. Even in countries with similar cultures, legal systems, and levels of economic development, regulations applying to dietary supplements vary considerably. Some of these differences are explored below, using examples from Australia, Canada and the USA, all English-speaking countries with largely similar cultures and legal systems to illustrate this point. The discussion of other countries with similar legal systems such as the United Kingdom, New Zealand and South Africa or other nations in the Americas, Europe, Africa and Asia, often with different cultures, legal systems, and levels of economic development is left for others with greater expertise and experience.

A final challenge is that “dietary supplement” health products are often very emotive and polarizing topics, evoking a diverse range of opinions and viewpoints. While some observers may contend that these products should be considered in a similar fashion to conventional drugs and foods, others believe that a more tailored approach is necessary since there is often a traditional or historical evidence base and products often contain multiple ingredients. Increasingly, this situation has become even more complex because of the lucrative nature of the global dietary supplement sector, increased involvement of a growing industry sector producing them, and the introduction of many new and innovative products onto the market. A detailed discussion of the politics of the subject is outside the scope of this paper. However, it must be recognized that politics may play both a positive and negative role in shaping both regulatory frameworks and research agendas. Irrespective of the reader’s point of view, this context is important in any discussion of dietary supplement products.

1.1. Importance of Research on Dietary Supplements

Until relatively recently, there was limited scientific research on dietary supplements and so little was known about them [1]. However, the prevalence of supplement use has increased dramatically over the past 20 years [2], and they have become a matter of consumer interest [3,4]. At the same time, the application of state-of-the art scientific methods to explore issues involving dietary supplements has advanced rapidly. The other invited articles in this special issue illustrate progress in our understanding of supplement science as it applies to several nutrients, including vitamin D, iron, omega-3 fatty acids, and iodine. Progress on botanicals and other non-nutrient ingredients (e.g., glucosamine, methylsulfonylmethane (MSM), coenzyme Q10) has been more challenging [5]. There is no global consensus in terminology for the category of products known variously as dietary supplements, NHPs, and food supplements in different countries and while we recognize this limitation, for the purpose of this article the term dietary supplement will be used to refer to such products as nutritional supplements, herbal medicines and traditional medicines. This article summarizes some of the scientific challenges in supplement research and some resources that may be useful in studying them. Most of the scientific challenges in supplement science are ubiquitous and global, so it is vital for scientists to collaborate across nations to help meet them without duplicating effort. A case study is provided by the work of the NIH Office of Dietary Supplements (ODS) which has been pursuing this goal since 2000. Some freely available resources and tools that ODS has developed for advancing health-related scientific knowledge on supplements are presented. The supplement marketplace is increasingly international, making collaboration between regulators essential since national decisions have international implications. Since products are consumed world-wide, calls for global quality standards are emerging. The remainder of the article focuses on regulatory challenges involving dietary supplements, and perspectives on how the regulatory systems in a number of different countries deal with them. Key resources for learning more about these approaches are provided.

1.2. Areas of Scientific Consensus about Supplement Science

Although there is broad consensus on the need for advances in science to make progress, opinions vary on the best paths to take and on priority areas for consideration.

1.2.1. Quality

The supply of ingredients used in supplements has outpaced the availability of methods and trained personnel to analyze them [6]. For example, in 1994, when the Dietary Supplement Health and Education Act (DSHEA) first became law in the USA, about 600 U.S. manufacturers of supplements were producing an estimated 4000 products. By 2000, more than 29,000 supplement products were on the US market but few documented analytical methods or reference materials (RM) were available for these products. This growth in the market has also been evident internationally. For example, there are anecdotal reports that over 100,000 product license applications have been approved in Canada since the Natural Health Products Regulations came into force in 2005. The need for improving quality continues today, since now there are estimated to be more than 85,000 supplement products in the US marketplace and concerns about ingredient misidentification, safety concerns, and quality assurance/control problems continue to be important for the industry and the public [7,8].

The first step in characterizing supplement products is generally identifying the ingredients [9]. Plant identification is a particular challenge. Even when easily identified whole plants or plant parts are used, unless the chain of custody is tight, and the exact manufacturing process is known and well characterized, the quality of extracts and blends such as those found in many botanical products is difficult to ascertain. Reliable analytical methods to characterize the bioactive components in supplements are helpful, but even for the nutrients in supplements, specific analytical chemistry methods must be often developed [10]. The bioactives in supplements differ from those in foods in their matrices in that the forms, combinations, and doses in which they are consumed, and the circumstances under which they are used are likely to differ. Analytical techniques for other bioactives in supplements are further complicated because the active compound(s) are often unknown, and even when they are known, validated analytical methods may not exist for determining their content. Reference materials are often unavailable to compare results between different laboratories for research purposes and to monitor data and supplement quality.

1.2.2. Safety

Manufacturers are prohibited from marketing supplement products that are unsafe or contain unsafe ingredients. This includes assuring that safe upper levels of intake for nutrients or maximum dosages for other constituents are not exceeded and ensuring that toxic contaminants are absent. Improved accuracy and precision of the nutrient measurements, bioactive marker compounds for other ingredients, natural toxins, toxic elements and/or pesticides in dietary supplement ingredients and finished products will be helpful to regulatory agencies.

1.2.3. Efficacy

Demonstration of efficacy typically depends on a number of research approaches ranging from basic in-vitro research on the mechanisms of action to animal and human studies. For example, in the past, large and expensive clinical trials using poorly characterized herbal supplement products for which the mechanisms of action were not understood were performed, leading to results that were inconclusive and irreproducible [11–13]. These experiences led publishers and funders to demand better product characterization and funders to demand more mechanistic evidence of bioactivity. Once mechanistic plausibility is established, animal and small phase 1 and phase 2 trials should precede the launch of large phase 3 studies of efficacy. More and better clinical studies of the safety and efficacy of dietary supplements on “hard” health outcomes are also sorely needed. Health outcomes such as changes in validated surrogate markers for performance, functions, morbidity, and mortality from diseases or conditions are required rather than changes in biochemical measures in blood with unvalidated surrogate markers. The question of the use of evidence from traditional forms of health and healing such as Traditional Chinese Medicine (TCM) makes the question of efficacy often more complex. This is briefly explored in the regulatory section below.

1.2.4. Translation of the Science

Widespread consensus exists on the need to translate the scientific evidence on supplements into appropriate recommendations, regulations, and policies that ensure the public health. Population-based prevalence estimates of supplement use are needed to estimate total exposures to nutrients or other bioactives that can be related to health outcomes [14]. Monitoring is especially important when supplementation is used as a public health strategy to fill nutrient gaps in deficient populations. It is also needed in other countries such as the USA where use of certain supplements is high, and where substantial proportions of total intakes of nutrients such as vitamin D and calcium come from supplements, especially among older adults [15].

2. Challenges and Resources: Regulatory Perspectives

As with other categories of regulated goods such as foods and drugs, the development of regulations is a balancing act where many different factors need to be taken into account. Notable among these are ensuring that products are of high quality and safe, that any claims made are truthful and not misleading, and that there is reasonable and appropriate access to the marketplace. All regulatory scientists want to both protect consumers from harm and support them in making informed choices about the products they include—or as importantly do not include—in their healthcare options. Appropriate regulatory oversight of this category is very challenging, and requires that scientists and regulators work together, as the former director general of the World Health Organization, Margaret Chan, MD urged [16]. This section provides a concise overview of how these regulations have been developed, and common themes as well as challenges faced in a global market.

2.1. Definition of “Dietary Supplements”

Although the definition of dietary supplement within a specific jurisdiction such as the USA is quite precise [17,18], a fundamental challenge to any discussion on regulation is that there is no global consensus on either what falls within this category or even what the category is called. Intuitively many equate a dietary supplement in the USA with a NHP in Canada or a traditional herbal medicine in the European Union or a complementary medicine in Australia, but this is not the case. For example, while melatonin is regulated in the USA as a dietary supplement and in Canada as a NHP, in Australia it is considered as a prescription medicine [19–21]. Dehydroepiandrosterone (DHEA) is readily available as a dietary supplement in the US, while in many other jurisdictions it is regulated as a controlled substance and is subject to significant regulatory oversight [22].

This situation is even more complicated when one considers that in addition to dietary supplements such as vitamins and minerals, many of these products come from traditional systems of health and healing such as TCM in China and Ayurvedic/Unani/Siddha medicine in India. For this reason, we must differentiate between the manner in which nations regulate the practice of medicine and the manner in which they regulate marketed products used in medical practice or as foods. In the U.S., the practice of medicine is regulated by the states, while marketed food and drug products in interstate commerce are regulated by the Federal government. Approaches and regulatory frameworks in many parts of the world, notably in Asia, reflect this fact with terminology and categories developed accordingly [23].

To assist in development of its Traditional Medicine Strategy 2014–2023, the World Health Organization refers to this category as Traditional and Complementary Medicines (T & CM) [16]. Although this classification does have significant limitations, it recognizes the fact that definitions for this category vary significantly globally. Descriptions of specific national/regional definitions and categories can be found through the list of resources in Table 1.

Health Canada
EU Parliament and Council
European Food Safety Authority (EFSA)
China Food and Drugs Administration (CFDA)
Health Ministry—Chinese Medicine Division
Food Safety and Standards Authority of India (FSSAI)
Ministry of Ayurveda, Yoga, Unani, Siddha and Homeopathy (AYUSH)
WHO World Health Organization
World Self Medication Industry
International Alliance of Dietary/Food Supplement Associations (IADSA)

While it would be easy just to consider that the substance itself is the defining factor in determining whether or not a product is a dietary supplement, this is not the case. Two other important factors considered are the claim that the product is making and how the product is supplied or recommended (intended use). In many jurisdictions such as the USA, Canada and Australia, dietary supplements are considered suitable for self-selection without the need for the intervention of a practitioner or prescription. Here the claims that can be made are limited to minor conditions and to the support of health and wellness depending on the jurisdiction [24,25]. In other jurisdictions, notably those where a traditional form of health and healing is recognized, traditional and complementary medicine products are often prescribed, and in some cases supply is limited only to trained practitioners.

2.2. Regulatory Models

As with the definition of the products themselves, there is no consistent global approach to regulation, with many different frameworks developed that largely reflecting national and regional priorities and needs. That being said, there are a number of common themes and approaches that have been taken internationally.

2.2.1. Where Does the Category Fall within Existing Legislation?

With a few exceptions, notably where traditional forms of health and healing exist, most countries do not regulate dietary supplements as a stand-alone category. Rather, they include them as a subset of existing legislation [17,18]. That is, they “hang from the hook” that is set in existing legislation. In the past, this was largely a question of whether these products should be considered a subset of drugs or foods; increasingly though, a third option is to capture them under existing regulations for biologics. It is important to note that overarching legislation is often one of the most important factors impacting the type of claim that can be made and what level of scrutiny and oversight will exist. For example, countries that regulate these products as a subset of drugs or therapeutic goods such as Australia, Canada and the European Union (EU) for traditional herbal medicines allow far more specific clinical claims to be made than in a jurisdiction such as the USA, where dietary supplements are captured in regulations under the existing food legislation, with their advertising regulated by trade regulations [20,25,26].

2.2.2. Should They Be Regulated as a Group?

As noted above in many jurisdictions dietary supplements are simply captured under the existing food or drug regulations and legislation with no specific consideration for these products, in some cases specific regulations have developed to reflect the category. In these cases, two different regulatory models have typically been adopted that reflect their domestic use, national priorities and public health needs. In many jurisdictions, the first model applies. Dietary supplements are simply captured under the existing food or drug regulations and legislation. In that model, a wide range of products (typically herbal medicines, traditional medicines and dietary or nutritional supplements) reside under an umbrella term such as dietary supplements in the USA, complementary medicines in Australia or NHP in Canada [20,24,25]. In the second model, specific regulations are developed to deal with these products. In this case, specific categories are developed with very structured regulatory frameworks for specific types of T&CMs. This is particularly the case in countries with a strong traditional form of health and healing such as Chinese proprietary medicines in China (TCM), Ayurvedic medicines in India and Kampo medicines in Japan [23].

Irrespective of the approach taken, it is rare that one set of regulations will encompass all products commonly considered to be dietary supplement-like. Typical examples of this are guidelines and legislation related to advertising that apply irrespective of whether or not a product is considered to be a dietary supplement.

2.2.3. Common Elements of Regulatory Frameworks

As with other forms of regulations, independent and irrespective of the approach taken, frameworks that deal with dietary supplements may contain a number of common elements, in this case often specifically developed to reflect the challenges and nature of the products. These common elements include: process for approval of a product to be sold; provisions related to manufacture and Good Manufacturing Practices (GMPs); reporting of adverse events; controls on labeling related to indications, contraindications and warnings; and, where claims are permitted, the type and quality of supporting evidence required. Again, the number and nature of these elements applied are determined by the specific regulations in place.

2.2.4. Risk-Based Approach

Operationally, the regulation of dietary supplements faces a number of issues and challenges not shared with conventional drugs or even food products. Notable amongst these are the sheer number of individual dietary supplements on the domestic markets, often numbering in the tens of thousands, and the fact that the sector contains many different types of products often posing very different risks that are grouped together often by the fact that they do not fit under any other regulatory regime. In particular, considerable challenges are posed especially by herbal and traditional medicine products that contain crude botanicals and a complex milieu of potentially active moieties, unlike conventional allopathic pharmaceuticals.

While a completely pre-market approach, where all products and manufacturing sites are ‘approved’ before the dietary supplement is marketed would be the optimal situation, given the challenges mentioned above, this is often impractical. This has led to the development of regulatory frameworks that increasingly blend elements looking at products and sites both before they come to market as well as once they are available to consumers, or post-market. This regulatory oversight is sometimes referred to as a “life-cycle” approach. Examples of post-market regulatory approaches (i.e., once the dietary supplement is on the market) include target audits where dietary supplements already on the market are analyzed for quality or manufacturers are requested to submit evidence they may hold that supports a specific claim. The determining factor on which approach is applied is largely determined by risk posed to the consumer. Since most dietary supplements when appropriately manufactured are considered to be inherently low risk, increasingly regulatory frameworks are increasingly focused more on post-market review than pre-market licensure.

Even in countries that are in many ways socially, economically and legally similar, different approaches to the definition and regulation of dietary supplement health products are evident although they contain some common elements. Illustrative examples of this are evident in the different regulatory frameworks in place in the United States, Australia and Canada.

In the United States, dietary supplements are regulated under the Dietary Supplements Health Education Act of 1994 (DSHEA) as a subset of foods and limited to those taken orally. This approach is primarily post-market in nature. However, it does contain pre-market elements. For example, manufacturers must hold evidence to support their claims and they cannot make specific disease treatment claims but only claims related to nutritional support (which includes physiological structure and function) [20]. All products must carry a disclaimer on the label stating that claims have not been reviewed by the US Food and Drug Administration (FDA). Provisions also include a post-market site audit process for manufacturing sites for Good Manufacturing Practice compliance and mandatory reporting of serious adverse effects by manufacturers. Companies must notify the Food and Drug Administration before marketing products with new dietary ingredients (NDI) [27]. There is at present no indication that DSHEA will be substantially changed or modified by Congress, in recent years the regulatory authority has given more attention to the notification and classification of NDIs as well as the importance of Good Manufacturing Practices (GMP) [20].

In Australia, although a small number of these products are captured by a food standard, most are regulated as therapeutic goods under the Australian Therapeutic Goods Act. Products are referred to as complementary medicines and are legally defined as being a listed therapeutic good or a registered therapeutic good. The legislation itself does not define these terms, but a comprehensive set of guidelines describes how they are considered. Most complementary medicines are listed medicines and are managed through an online portal called the Electronic Listing Facility (ELF). Permitted claims are limited to minor, self-limited considerations and those traditional forms of health and healing such as traditional Chinese medicine. Evidence for efficacy is assured through a random and targeted post-market audit system and new listable substances are evaluated pre-market. As with all registered therapeutic goods, registered complementary medicines are evaluated pre-market for safety, quality and efficacy. Manufacturers of either finished listed or registered complementary medicines must undergo an on-site audit to ensure GMP [28].

In 2014, complementary medicines were included within a comprehensive review of regulations for all therapeutic goods and medical devices to be conducted by an external expert panel [29]. The Commonwealth government accepted the majority of the recommendations from the panel and preliminary draft legislation was made public in September 2017. Although one of the recommendations was to keep complementary medicines as a distinct category, some significant changes are proposed, allowing mid-level claims through a new third regulatory route between the listed and registered therapeutic goods process as well as changes to how advertising is approved and compliance management [25,30].

In Canada, the majority of these dietary supplement products are referred to as natural health products (NHPs) and are considered a subset of drugs under a specific set of regulations—the Natural Health Products Regulations. Products must undergo a premarket assessment for safety, quality and efficacy. This is done in part through an online submission process with permissible claims supported by Health Canada monographs. Producers of NHPs who wish to make novel claims not supported through the monograph process must submit a full dossier of evidence for review. The products can make therapeutic claims, but their use is limited to self-care situations. While manufacturers are required to have a valid site license following approved GMP guidelines, no pre-market site audit is needed; the process being primarily paper based [24]. To address the growing number of NHPs sold in a food-like format, Health Canada has created a new category of food currently defined through regulatory policy called “supplemented foods”. The category does allow for some health claims, but they are limited reflecting the nature of the products [31].

Unlike Australia, Canada is proposing to take different approach and rather than keeping NHPs as a distinct category, will include them in a self-care health product category together with non-prescription medicines and cosmetics. The intent of this initiative is to support informed consumer choice through a more consistent regulatory approach to these product categories that is based on risk. Key questions being explored deal with topics including evidence needed to support claims, provisions ensuring safety and quality and introduction of cost recovery framework [32].

2.2.5. Competing Types of Evidence

While it is clear that high quality scientific evidence is always required to support the quality of a dietary supplement, from a regulatory perspective the same may not always be true with regard the type and nature of the evidence required to support a product claim. Given the nature of the dietary supplement sector and the fact that it often encompasses traditional medicines with a long history of use, the question faced by regulators is how to balance the need for robust scientific evidence with a respect for diverse forms of health and healing.

Globally, no consistent approach has been taken in answering this question. In some jurisdictions such as Canada and Australia, the approach has been to link the form of evidence, whether it be traditional or evidence based from scientific research, to the level and type of claim that can be made. In these cases, typically products based on traditional evidence making traditional health care claims are ‘approved’ according to pre-cleared and approved sources of information such as monographs or labeling standards. For products making higher level, clinical claims, in a way similar to that for conventional pharmaceuticals, companies must supply a full dossier with appropriate supporting evidence such as that from randomized controlled trials (RCTs) [24,28]. In many countries such as the United States with no pre-market approval framework system, claims that can be made are more limited [17,18]. In countries with long-established traditional forms of medicines such as in China, India, and Japan, specific regulatory frameworks have been developed for these types of products with the type of claim that can be made and the evidence required to reflect this approach [23].

As the dietary supplement sector matures and develops and the market for raw ingredients becomes more global, establishing a balance between evidence generated by scientific research and that coming from traditional forms of health and healing is becoming increasingly demanding. This will be discussed later.

2.3. Evolving Regulatory Landscape—Challenging Issues

International regulatory frameworks are still considered by many to be a new and novel sector, although many of them are now more than two decades old. They were developed to reflect a time when the sector and nature of the market, not to mention the needs and demands of the consumer, were very different. This has meant that some decisions made in the past around policies and regulatory decisions may need to be revisited. These include the need to evaluate evidence of the “grandfathering” of dietary supplements already on the market when new regulations were implemented, the need to ensure that approaches are sustainable through cost-recovery mechanisms and the more global nature of the market place. Table 1 provides links to some of the regulatory frameworks of different countries that provide insights into the ways issues are dealt with in them.

2.3.1. Evaluating Evidence for Product Claims

As the market for dietary supplements has increased, so has the amount and diversity of scientific evidence and research to support, or not support, their use. This market is made more complex when there are conflicting evidence bases and conflicting ways for evaluating them. For example, how, or should, traditional evidence be evaluated within the framework of traditional healing theories or those of allopathic evidence based medicine; what should be done when evidence from traditional forms of health and healing are not supported by more conventional evaluation mechanisms such as randomized clinical trials; and how can consumers, often wanting to explore both conventional and traditional medicine, be supported in making informed choices about including, or not including, these products in their health care options.

The original concept of Evidence Based Medicine is based on three basic premises—individual clinical expertise, the best external evidence and patients’ values and expectations [33]. The challenge faced by the regulator is to ensure that these are in play and to support consumers in making informed choices that are often made in a self-care setting.

2.3.2. Questions at the Regulatory Interface

It has never been easy to distinguish between a dietary supplement and other categories such as conventional foods, drugs and biologics. As all these sectors have evolved, this question of product classification has become even more complex. Two of the main questions at the regulatory interface are: what are the boundaries are between dietary supplements and conventional foods and between dietary supplements and over-the-counter drugs?.

As the popularity of dietary supplements available in a food-like format such as a pre-prepared drink or bar has increased, the line between what a consumer would understand to be a food as compared to a dietary supplement has become increasingly blurred. In essence, how does the regulator provide for appropriate regulatory oversight? This has been particularly challenging for those jurisdictions that consider these products as a sub-set of drugs with regulation and often legislation governing them that is very different from that for foods. In these cases, the regulatory frameworks are more specific to such dosage forms as capsules, tablets and tinctures. The challenge is one primarily of balance in providing a regulatory approach that is appropriate and not unnecessarily restrictive with the need to ensure that consumers are aware that these food-like dietary supplements that they are considering are not typical foods. This lack of clarity is also challenging for the private sector in determining what regulatory framework applies to a product, either food or drug, that they wish to develop and bring to market. In Canada, this concern required the government to create a new category called “supplemented foods” distinct from NHPs where products in a food like format are considered as a subset of foods and not as natural health products [31]. In other jurisdictions such as Australia, authority has been given to the respective regulators to deem something to be either a therapeutic good or a food based a specific set of criteria [34].

The challenge at the over-the-counter (OTC)/dietary supplement interface is even more pronounced. A number of herbal medicines with a long history of use within the conventional health care model, such as senna and cascara, are regulated in most countries as OTC drugs rather than dietary supplements. As described above, Health Canada is proposing to address this issue in part by considering both NHPs and OTC drugs within a single regulatory approach for self-care products [32].

2.3.3. Working on the Global Stage

Although science and research may be global, regulations are still made primarily to reflect domestic needs and pressures. This poses a challenge regarding dietary supplements and dietary supplement ingredients that are now often sourced and/or manufactured outside of the country where they are sold. In spite of calls for regulatory harmonization, examples of true harmonization are limited to regions such as countries in the Association of South East Asian Nations (ASEAN) with the lack of a coherent and consistent regulatory approach prohibiting this globally [35]. Even if regulatory harmonization is not possible, regulatory cooperation is often a viable option, taking into account inputs from stakeholder groups such as industry and not just governments. For example, to support cooperation between regulators, in 2005 in Ottawa, the World Health Organization supported the creation of the International Cooperation on Herbal Medicine (IRCH). IRCH now has over twenty members and provides a forum and mechanism for regulators to share information on safety issues and common challenges they all face [36]. Increasingly governments are working together as well as with other stakeholders such as industry and consumers to address common problems and in some cases to provide regulatory decisions in one jurisdiction that can be used as a basis for action in another.

2.3.4. Strengthening Product Quality

As the dietary supplement market has become more global and lucrative, so have the importance of ensuring product quality and the challenges in doing so. There are increasing numbers of cases of adverse reactions and some fatalities due to contaminants or adulterants in the product rather than in the dietary supplement ingredients themselves. In some cases this has been due to intentional fraud by producers of these poor quality products who have developed sophisticated methods for overcoming existing regulations and oversight. This situation is explored in greater depth elsewhere in this paper.

2.4. Need for Continued Science in Support of Regulation

Irrespective of whether the goal is to support production of high quality products or to develop, apply or modify methods for evaluation of evidence in support of claims, the need for robust and relevant science and research on dietary supplements has never been more necessary. As regulatory frameworks evolve, many of the questions posed above will need to be addressed, balancing the need for robust science with a respect for traditional forms of health and healing.

3. Challenges: Scientific Perspectives

3.1. Issues Involving Human Requirements

Scientists often disagree about definitions of human requirements for bioactives and the implications for supplements. They differ on whether some non-nutrient bioactives are required for certain population subgroups and also on the health effects associated with the use of non-nutrient bioactives. It has been known for over 100 years that inborn errors of nutrient metabolism exist that can be remediated by supplying the lacking nutrient that has become conditionally essential. However, it is not clear that such a model based on single gene defects is useful for the amelioration of multigenic complex diseases. It is unclear that there are large numbers of individuals with common diseases and conditions such as type 2 diabetes or depression whose unique genetic characteristics cause them to have special nutritional requirements requiring supplements or medical foods [37].

Discoveries of genetic polymorphisms and the advent of inexpensive genetic tests that are widely available to consumers have nutritional implications. They have led to the rise of personalized or “precision nutrition” [38] and to the proliferation of boutique “personalized” eating plans and “precision” dietary supplements supposedly tailored to an individual’s genetic profile. The extent to which such supplements are efficacious in reducing chronic degenerative disease remains to be determined.

3.2. Supplement Quality, Safety and Efficacy

Challenges remain on the appropriate means for assuring supplement quality, safety and efficacy.

3.2.1. Quality

Regulators, health professionals and manufacturers often disagree on how much quality testing is necessary for supplements. This is echoed by the World Health Organization’s Strategy on Traditional Medicines 2014–2023 [39] where quality is seen as a cornerstone of the sector. Botanical extracts and blends present particular challenges for detecting misidentification and contamination. The presence of adulterants and contaminants of both a biological and chemical nature in supplements is also challenging. Certain categories of supplements, such as athletic performance, sexual performance, and weight loss products, are particularly prone to the deliberate “spiking” with unlabeled extraneous or synthetic substances to confuse analytical techniques and even occasionally the addition of active synthetic drugs. Purity is a special problem for individuals with inborn errors of metabolism for specific nutrients such as vitamin B-6 or choline who require reliable, high quality sources of the nutrient. In countries that do not require that added nutrients be pharmaceutical grade or provide nutrients free to such patients, afflicted individuals must buy products that vary greatly in their quality on the open market.

The scientific challenges involved in all of the problems cited above depend in part on the adequacy and application of analytical methods. Analytical methods and reference standards are lacking for many of the thousands of different bioactive ingredients in dietary supplements. There is still disagreement about whether only a single officially endorsed method of analysis is acceptable. Any analytical method that is appropriately calibrated to a recognized reference standard should suffice but the onus is on the user of the method to demonstrate that affirmative requirements are met and that the method is suitable for its intended use and yields results that are accurate and precise. Methods that are suitable for foods may not be so for dietary supplements. Opinions also differ on whether government or the private sector is responsible for developing reference standards and analytical methods, and, if the private sector develops them, how they can be both kept independent and objective and made publicly available to avoid duplication of effort while preserving the marketing advantage of the developer. Tension also exists between researchers who desire ever more precise analytical methods for ingredients in dietary supplements and manufacturers who are concerned about the expertise and monetary costs required to apply some of the methods. A balance needs to be struck between the two.

3.2.2. Safety

Apart from concerns related to product quality, the safety of dietary supplements depends largely on dose. High doses of some nutrients are more likely to pose problems than others, although there is disagreement about the levels at which problems arise. For example, some dialysis patients who are receiving very large doses of calcium and the active form of vitamin D on a chronic basis may exceed the Tolerable Upper Level (UL) and incur adverse effects on health, including calcification of the soft tissues [40]. Very high doses of vitamin D may also cause adverse effects in people with normal kidney function [41]. There is little evidence that usual doses and forms of these nutrients give rise to health problems [42]. The possibilities of excessive intakes of nutrients from dietary supplements are greater in countries with programs to fortify their food supplies than in others, and therefore they must also be evaluated [43–46].

Dose-response data for establishing safe levels of intakes of non-nutrient bioactives in supplements is frequently lacking [47,48]. Some dietary supplements containing non-target herbs added intentionally (like germander as an adulterant for skullcap), or others such as black cohosh, kava extract, green tea and others have been associated with liver injures of various types even after taking into account concomitant use with acetaminophen and alcohol and consumption while fasting [49]. Extracts that are used in bodybuilding and weight loss have also been linked to liver injury. This has led to studies of the composition of different supplements [50,51]. Causes of liver toxicity from supplements appear to be due to insufficient regulatory authority, inaccurate product labeling, adulterants and inconsistent sourcing of ingredients [52]. There is controversy about whether evidence of causality is sufficient for regulators to take action against supplements that seem to pose a hepatotoxic risk [53]. Some possible actions include requirements for warning labels with usage instructions as is done for drugs, or/and removal of products from the market. Adulterated or fraudulent tainted products sold as dietary supplements are already illegal and subject to recall [54].

Interactions of some ingredients in supplements with other dietary supplements, nutrients, prescription or over-the-counter drugs are well documented. Of particular concern are adverse reactions occurring with commonly used medications, such as anti-hypertensive and cardiovascular preparations [55]. In addition, much interest focuses around concomitant use of herbal medicines such as St. John’s Wort which has been shown to alter drug metabolism of a number of drugs notably those used in the treatment of HIV/AIDS, warfarin, insulin, aspirin and digoxin [56].

3.2.3. Efficacy

Among the most hotly debated issues in supplement research is the type and amount of evidence needed to demonstrate the efficacy of dietary supplements. Many of the issues involving efficacy include those common in testing of all medications such as study designs, significance testing, appropriate outcomes, effect sizes, acceptable biomarkers of effect, and the differences between statistical and clinical significance. In order to be efficacious, dietary supplements must be bioavailable, and yet in some countries regulations do not require testing of supplements for disintegration and dissolution and some products on the market fail such tests. This is a matter of concern both to researchers and regulators since such results have a negative impact on studies of dietary supplement efficacy. In-vitro methods are available for testing disintegration and dissolution of drugs, and these are adaptable for use with dietary supplement products. Regulators in some countries insist on changes in health outcomes or in validated surrogate biochemical markers of effect on the causal pathway to a health or performance outcome. Others accept changes in intermediary biochemical markers that may or may not be surrogates of health outcomes. These considerations have come to the fore because supplements on the market in some countries apparently have little or no demonstrated efficacy. For example, one recent review of 63 randomized, placebo-controlled clinical trials of dietary supplements in Western adults found that in 45 of them no benefits were found, 10 showed a trend toward harm and 2 showed a trend toward benefit, while 4 reported actual harm, and 2 both harms and benefits; only vitamin D and omega 3 fatty acids had strong enough benefits and lack of harm to suggest possible efficacy [3]. This is an area of controversy that is highly polarized with questions being raised that depend on the type of dietary supplement being used, notably herbal medicines, the quality of the studies included in the review, and additional factors such as product quality of the supplement being evaluated that need to be taken into account [57].

3.2.4. Standards of Efficacy for Traditional Natural Products

The traditional use of Chinese medicines, Ayurvedic medicines and other remedies is embedded in larger healing systems and cultural or metaphysical beliefs that are part of users’ larger and more holistic world views. Should usual standards for efficacy should apply to them when they are used in the traditional manner? Clearly such uses are quite different than the use of a single product or ingredient at much higher traditional doses and without such a cultural context.

3.3. Policy

Although policy issues arise with all types of dietary supplements, the examples below will focus on nutrient-containing dietary supplements since these are particularly germane to discussions of nutritional status.

3.3.1. Nutrient Supplements Are Only One of Many Strategies for Improving Nutrient Intakes

There are many strategies for filling nutrient gaps in dietary intakes. They include nutrition education on appropriate food choices, fortification and enrichment that add nutrients to staple foods, genetic engineering that increases the nutrient content of a commodity itself either by genetic engineering/biotechnology, biofortification involving conventional breeding, and the use of nutrient containing dietary supplements. Dietary supplements provide concentrated sources of bioactives that are low or lacking in some individuals’ ordinary dietary intakes. The supplements can be used selectively by those whose diets have gaps in them. However, supplements have disadvantages. Their use depends upon individual motivations. Because they provide concentrated sources of bioactives at relatively high levels, they may increase the risks that some individuals will ingest excessive quantities and suffer health risks. Moreover, since dietary supplements can contain ingredients that lack a history of safe use, their long-term health effects may be unknown. The advantages and disadvantages of dietary supplements as a strategy to improve dietary intakes therefore must be carefully considered.

3.3.2. Supplementation as a Strategy to Achieve Nutritional Adequacy

The cost-effectiveness of using supplements to fill gaps in nutrient intakes as opposed to other means such as fortification or nutrition education varies from one nutrient to another and by country, and so each situation is unique and must be evaluated independently. There are also questions about what the supplement should be, if supplementation is chosen. In countries where nutrient containing dietary supplements are common, the use of multivitamin-multi-mineral (MVM) supplements is often associated with a greater proportion of the population reaching the estimated average requirement (EAR) for nutrients [58]. However, for some of these nutrients, intakes are already adequate, so that the increased intakes may do little good, and in some cases supplements may increase the risk of exceeding the upper safe level (UL) of intakes.

3.3.3. Monitoring of Supplement Use

Monitoring of supplement use is particularly important in countries where premarket approval is not required to detect potential adverse reactions. Dietary indicators are known to be imprecise and estimates of usual intake are lacking for many nutrients [59]. Biochemical indicators of deficiency are often not well linked with adverse health outcomes, underscoring the need for more attention to be paid to the development of agreed on measures of deficiency and excess [60]. Recent work on key nutrient biomarkers is now available, facilitating the monitoring of high risk groups, such as pregnant women for folate status [61,62].

3.3.4. Authoritative Recommendations for Dietary Supplements

Health and nutrition experts differ on whether it is appropriate to include recommendations for nutrient containing dietary supplements in national health promotion and disease prevention recommendations. Many countries opt to recommend that adequate nutrient intake for the general public be achieved solely from foods, and reserve recommendations of specific nutrient supplements for specific subgroups in the population. Others recommend only food alone with no recommendations for special populations.

3.3.5. Inclusion of Dietary Supplements in Food Programs to Reduce Malnutrition

There is pressure by industry to include MVM or other dietary supplements in food programs. However, there is little evidence that the target groups are deficient in the ingredients in the supplements, nor has it been demonstrated that provision of a supplement leads to better health outcomes.

3.3.6. Stimulating Innovation

The development of new and more highly bioavailable forms of the nutrients, timed release, dosage forms, novel bioactive constituents and the appropriate application of new technologies such as nanotechnology are all important, but some pose new scientific and regulatory challenges.

4. Case Study: Office of Dietary Supplements (ODS), National Institutes of Health (NIH), USA

This case study highlights some examples of dietary supplement research supported by or conducted at the ODS, and provides some research tools it has developed that may be useful resources for scientists both there and abroad.

4.1. Background

Since its establishment in 1995 as part of the implementation of the Dietary Supplement and Health Education Act [17,18] of 1994, the ODS is the lead federal agency devoted to the scientific exploration of dietary supplements. Its mission is to support, conduct and coordinate scientific research and provide intellectual leadership to strengthen the knowledge and understanding of dietary supplements in order to enhance the US population’s health and quality of life. ODS’s four goals are to: expand the scientific knowledge base on dietary supplements by stimulating and supporting a full range of biomedical research and by developing and contributing to collaborative initiatives, workshops, meetings and conferences; enhance the dietary supplement research workforce through training and career development; foster development and dissemination of research resources and tools to enhance the quality of dietary supplement research; and translate dietary supplement research findings into useful information for consumers, health professionals, researchers, and policymakers.

Several of its major initiatives that have expanded the scientific knowledge base on dietary supplements are described elsewhere in this special issue of NUTRIENTS. They include studies to clarify the implications for public health of omega-3 fatty acids [63], iodine [64], vitamin D [65], and iron [66].

4.2. Research Resources and Tools

This section provides the details on freely available research resources developed by ODS that are available for scientists to use to enhance the quality of dietary supplement research and meet public health priorities, with a focus on those that may be useful to scientists in other countries.

4.3. Analytical Methods for Dietary Supplements

The rigorous assessment of dietary supplement ingredients requires accurate, precise and reliable analytical methods and matching reference materials. The ODS Analytical Methods and Reference Materials program accelerates the creation and dissemination of validated methods and reference materials. It provides resources for characterization and verification of supplement product content that enhance the reliability and reproducibility of research using these products and supports product quality [67].

The genesis of the program was the paucity of publicly available methods for the analysis of supplement ingredients [68,69]. In 2000, the US dietary supplement community tended to use proprietary or compendial methods for quality control operations, and scientists and laboratories often kept their proprietary methods to themselves. Negative publicity about discrepancies between label claims and the results of product testing performed by third parties led to some unsuccessful efforts on the part of the industry to pay a laboratory to develop and validate methods through the Association of Official Analytical Chemists International (AOACI). The program was not successful for several reasons, including lack of expert technical guidance and conflicting sponsor priorities. However, this early effort led to a collaboration between trade associations, ODS, the AOACI, the United States Pharmacopoeia (USP), NSF International, and others in an attempt to establish standard methods for dietary supplement analysis. The ODS became involved because explicit wording in DSHEA required the Government to use “publicly available” analytical methods for enforcement actions involving dietary supplements. In response to the need for such publicly available methods and to support efforts to validate methods used in biomedical research on dietary supplement ingredients, ODS established the Analytical Methods and Reference Materials (AMRM) program in 2002.

ODS has been involved in sponsoring the creation of AOAC Official Methods of Analysis for dietary supplements and in the development and dissemination of numerous analytical methods and reference materials for 15 ingredients in dietary supplements in the USA, 32 botanical identification and documentation projects, and 45 studies determining contamination and adulterants. It has also helped to develop guidance on the validation of identity methods for botanical ingredients [70] and the conduct of single-laboratory validation studies for dietary supplements, Appendix K, AOAC Official Methods of Analysis, and provided guidance to evaluation of the literature on botanical supplements [71,72]. The portion of the ODS website includes a searchable database of analytical methods; these can be accessed at: https://ods.od.nih.gov/Research/AMRMProgramWebsite.aspx.

ODS also supports the Dietary Supplement Laboratory Quality Assurance Program in which participants measure concentrations of active and/or marker compounds and nutritional and toxic elements in practice and test materials. Exercises have included water and fat-soluble vitamins, nutritional and toxic elements, fatty acids, contaminants (e.g., aflatoxins, polyaromatic hydrocarbons (PAH’s)) and botanical markers (e.g., phytosterols and flavonoids).

4.4. Reference Materials

ODS supports the development of certified reference materials for dietary supplement ingredients with assigned values for concentrations of active and/or marker compounds, pesticides, and toxic metals to assist in the verification of product label claims and in quality control during the manufacturing process. A reference material is a material that is sufficiently homogeneous and stable with respect to one or more specified properties, which have been established to be fit for its intended use in a measurement process. A certified reference material (CRM) is a reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability. Certified reference materials can be used for laboratory proficiency studies, methods development, method verification, and method validation studies. Calibration standards are the single chemical entities necessary for construction of calibration curves for quantitative analysis and for confirming analyte identity. Several processes are used to produce calibration standards. ODS provided funding to the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) for the development and distribution of calibration standard solutions and matrix standard reference materials (SRM®; a NIST-trademarked type of CRM). The materials fall into one of the following categories: (1) pure chemical entities or their mixtures, including many nutrients and other ingredients in dietary supplements for use in establishing analyte identity and for calibrating instruments; (2) natural matrix materials that represent the supply chain of a particular dietary supplement, e.g., biomass (ginkgo leaves and powder), processed botanical ingredient (ginkgo extract), finished product; (3) natural matrix materials that cover a range of analytes including nutritional compounds, botanical marker compounds, and compounds with known health concerns (heavy metals, pesticides, plant toxins); and (4) Clinical materials that can be used to assist clinical laboratories assess nutrient status or exposure, such as the measure of measure of vitamin D status commonly used around the world, serum 25-hydroxyvitamin D [73–75]. ODS is now expanding efforts to develop biomarkers of nutrient exposure and status in blood and other biological specimens in relation to chronic disease risk in individuals and populations. ODS has worked with NIST to produce and make available reference materials for calibration of various laboratory methods. Supplementary Table S1 shows NIST Standard Reference Materials (SRM®) now available. Supplementary Table S2 shows dietary supplement and nutritional assessment SRMs that are currently in progress.

4.5. Dietary Supplement Databases

Two databases have been developed by ODS that are described elsewhere in detail [76–80]. The goal of the Dietary Supplement Label Database (DSLD) is to include labels for virtually all dietary supplements sold in the USA. This provides all the information on the product label including composition, claims, and manufacturer contact information. It now contains over 72,000 dietary supplement labels, with new labels added at the rate of 1000 per month. Used together with food composition databases it is possible to estimate total daily intakes of nutrients and other bioactive ingredients from both foods and dietary supplements. A mobile version of DSLD is now available for use on smartphones to enhance consumer access to it [78,80]. It is primarily aimed at researchers and so contains information about products that are currently on the market, as well as those that have been removed from the market.

The Dietary Supplement Ingredient Database (DSID) provides analytically derived information on the amount of labeled ingredients of a representative sample of commonly used categories of supplement products sold in the USA, including adult, child and prenatal MVM supplements and omega-3 fatty acids. DSID is now being expanded to examine botanicals and other ingredients in supplements that are of public health interest, such as green tea products. Calculators included with the DSID permit a consumer to examine how closely the labeled contents of a nutrient in a product compare to chemical analyses of all products in the category [79].

4.6. Nutrition Research Methods and Review Methodology

Systematic reviews of dietary supplements require special techniques. ODS has sponsored a series of technical reports on the application of review methodology to the field of nutrition and dietary supplements [81–86]. Staff have also collaborated in performing systematic reviews with other groups [87,88].

4.7. Population-Based Monitoring of Dietary Supplement Use

In collaboration with the National Health and Nutrition Examination Survey (NHANES) of the National Center for Health Statistics, ODS investigates patterns of dietary supplement use using national and other large cohorts, and assesses supplements’ effects on total nutrient intakes. Several studies have focused on adults [89], children [90,91], and others in the population and their supplement use. Other studies have focused on the contributions to total intakes of nutrients made by dietary supplements. Investigators at ODS have been active in funding monitoring efforts on the links between intakes of folic acid and health [92]. They have devoted particular attention to blood levels of folic acid and dietary intake patterns that are associated with very low and very high intakes of the nutrient [93–95]. The survey methods used are well documented and they may be useful for those in other countries planning similar population-based surveys to consult [96].

The motivations for use of dietary supplements are also documented; they often differ from those specified in regulations. NHANES contains several items that are consumer tested and available for use in other surveys on motivations. Knowledge of motivations can improve understanding of how people use these products and may provide clues for encouraging appropriate supplement use.

4.8. Translation of Supplement Science for Health Professionals and the Public

ODS has produced and periodically updates a library of more than two dozen fact sheets on the ingredients in supplements such as vitamin D, magnesium, and special products such as MVM supplements and products marketed for weight loss. There is a detailed version for professionals that is complete with detailed references, as well as easy-to-read versions for consumers in both English and Spanish. ODS also works with the National Library of Medicine (NLM) to produce and update a Dietary Supplement Subset of NLM’s PubMed. The National Center for Complementary and Integrative Health (NCCIH) at NIH produces a series of fact sheets on many botanicals and other non-nutrient bioactives in supplements that are also useful. They can be accessed at https:

//www.nccih.nih.gov. ODS also hosts an intensive, free 3-day course on issues in dietary supplement research annually for researchers. Further information about these and other projects is accessible at:https://www.ods.od.nih.gov.

4.9. Other Resources

In order to foster the development of appropriate study methods for dietary supplement research, ODS sponsors workshops on the latest knowledge and emerging approaches to the study of dietary supplements. It also supports the development of cutting–edge approaches to elucidate the mechanisms of action of complex botanical dietary supplements. It co-funds the Centers for Advancing Research on Natural Products (CARBON) with the NCCIM, including its program to develop high content high throughput methods to rapidly generate hypotheses on active compounds and the cellular targets. These and other resources are announced as they become available on the ODS website.

4.10. Fostering Use of Systematic Evidence Reviews in Policy Making and Clinical Practice

ODS has strengthened the scientific framework for developing dietary recommendations by encouraging the incorporation of systematic reviews into the development of the DRI. It has sponsored 18 systematic reviews on topics related to dietary supplements. These include ephedra, B vitamins, MVM supplements, omega-3 fatty acids, soy, probiotics, and vitamin D. The ephedra systematic review was helpful to the US government in banning ephedra products from the US market. The systematic reviews of omega-3 fatty acids funded over a decade ago and more recent updates on their associations with cardiovascular disease and infant health outcomes have been useful for planning intervention programs as well as for regulatory purposes. Current AHRQ reviews are available on the AHRQ website (https://www.ahrq.gov).

5. Future Needs

Attitudes toward safety, efficacy, and values about what is important in food and life will be important in determining future needs involving supplement science in the countries we have discussed and perhaps elsewhere in the world. Safety is critical, and requires better chains of custody and product characterization that exists at present for these products, particularly those involving global markets. Efficacy, that is that the health promotion claims for the product are true and not misleading is also critical. Demonstrating efficacy requires clinical studies with well defined products and rigorous experimental designs, and the studies must be replicable. To that end, many publishers now require that submitted manuscripts comply with established guidelines for the reporting of clinical trial results (e.g., CONSORT guidelines), while funders require demonstration of product integrity by applicants [97,98]. Finally there are issues of personal choice and values, sometimes involving the efficacy of supplements as complementary and alternative therapies that are part of a larger philosophical or religious world views and systems. These must be accommodated without abandoning safety.

Both basic and more applied challenges will continue well into the future. Much remains to be learned about the effects of bioactive constituents such as flavonoids in foods and dietary supplements on health outcomes, as many recent papers in Nutrients and elsewhere indicate [99–101]. More and better biomarkers need to be developed and their associations with health outcomes clarified [102]. Supplements intended to enhance sports performance [103] botanicals used for disease treatment [104] and those ingredients thought to slow aging [105] all require identification of valid biomarkers of efficacy as well as of exposure. The role of supplements and the gut microbiome also must be explored for its associations with common diseases and conditions [106]. The associations between supplement ingredients and health outcomes in chronic degenerative disease must be clarified [47,105,107–109]. High risk groups need more attention Certain subgroups within the population such as athletes consume very high amounts of some supplements and it is important to monitor them to prevent adverse outcomes and study the effects, if any, on athletic performance [110]. Others use supplements in the hope that they will improve cognitive performance [103]. Those who practice polypharmacy with prescription, non-prescription drugs and dietary supplements represent another high-risk group, and interventions to limit the potential for adverse events are needed [111,112]. Collaborations among scientists in many countries are needed to drive supplement science forward.

Irrespective of the type of health product, high quality science is fundamental to the success of any regulatory framework. Assessments of the safety, quality and efficacy of nutrients and other bioactives are needed to provide the scientific information that regulators need [113]. As mentioned earlier, the nature and diversity of the sector means that regulators face a number of very specific challenges for these low risk products. These include evaluating traditional evidence, dealing with products that contain multiple bio-actives and addressing the growing challenges of ensuring product quality. It is critical that scientists and regulators work together and learn from each other in both identifying issues and developing ways in which they can be addressed. Although regulatory challenges must be met at the national level, there must be due regard paid to the fact that national regulatory decisions about supplements have global implications.

6. Conclusions

Science is vital in regulatory settings, and there is no reason that science and regulation should be incompatible [114]. The challenges in supplement science and its regulation provide new opportunities for scientists and regulators to work together both nationally and internationally, to learn from each other, and to cooperate and when appropriate harmonize approaches to improve the public health.

Supplementary Materials: The following are available online at www.mdpi.com/2072-6643/10/1/41/s1, Tables S1 and S2 Table S1 Standard Reference Materials (SRM®) available from the National Institute of Science and Technology, US Department of Commerce. Table S2 Dietary supplement and nutritional assessment Standard Reference Materials (SRM®) currently under development at the National Institute of Science and Technology, US Department of Commerce (as of December 2016).

Acknowledgments: Funded by the National Institutes of Health, Bethesda, MD, USA. We thank Joseph M. Betz, Leila Saldanha, Cara Welsh, for their thoughtful and critical reviews of the manuscript, and Joyce Merkel, for technical editing and support.

Author Contributions: J.T.D. and P.M.C. developed the concept for the manuscript. J.T.D., P.M.C. and M.J.S. wrote the manuscript.

Conflicts of Interest: Johanna T. Dwyer holds stock in several food and drug companies, and serves on the scientific advisory boards of Conagra Foods, McCormick Spices, and as a consultant for Gerber/Nestle. She accepted partial travel and per diem expenses to speak at a symposium on dietary supplements sponsored by the International Association of Dietary/Food Supplement Associations at the International Congress of Nutrition in Buenos Aires, Argentina in October 2017. Michael J. Smith holds stock in several food and drug companies as well as acting as a consultant with clients in both the private and public sector including companies in dietary supplement and natural health products sector. He sits on the scientific advisory board of ISURA and the advisory board of the American Botanical Council. Paul M. Coates reports no conflicts of interest.

References

1. White, A. Growth-inhibition produced in rats by the oral administration of sodium benzoate: Effects of various dietary supplements. Yale J. Biol. Med. 1941, 13, 759–768. [PubMed]

  1. Kantor, E.D.; Rehm, C.D.; Du, M.; White, E.; Giovannucci, E.L. Trends in dietary supplement use among US adults from 1999–2012. JAMA Intern. Med. 2016, 316, 1464–1474. [CrossRef] [PubMed]
  2. Marik, P.E.; Flemmer, M. Do dietary supplements have beneficial health effects in industrialized nations: What is the evidence? JPEN J. Parenter. Enter. Nutr. 2012, 36, 159–168. [CrossRef] [PubMed]
  3. Manson, J.E.; Brannon, P.M.; Rosen, C.J.; Taylor, C.L. Vitamin D deficiency—Is there really a pandemic?N. Engl. J. Med. 2016, 375, 1817–1820. [CrossRef] [PubMed]
  4. Balentine, D.A.; Dwyer, J.T.; Erdman, J.W., Jr.; Ferruzzi, M.G.; Gaine, P.C.; Harnly, J.M.; Kwik-Uribe, C.L. Recommendations on reporting requirements for flavonoids in research. Am. J. Clin. Nutr. 2015, 101, 1113–1125. [CrossRef] [PubMed]
  5. Betz, J.M.; (NIH Office of Dietary Supplements, Bethesda, MD, USA). Personal communication, 2017.
  6. Mudge, E.M.; Betz, J.M.; Brown, P.N. The importance of method selection in determining product integrityfor nutrition research. Adv. Nutr. 2016, 7, 390–398. [CrossRef] [PubMed]
  7. Orhan, I.E.; Senol, F.S.; Skalicka-Wozniak, K.; Georgiev, M.; Sener, B. Adulteration and safety issues in nutraceuticals and dietary supplements: Innocent or risky? In Nutraceuticals, Nanotechnology in the Agri-Food Industry; Grumezescu, A.M., Ed.; Academic Press: Amsterdam, The Netherlands, 2016; Volume 4, pp. 153–182.
  8. AOAC International. AOAC International guidelines for validation of botanical identification methods.J. AOAC Int. 2012, 95, 268–272.
  9. Dwyer, J.T.; Holden, J.; Andrews, K.; Roseland, J.; Zhao, C.; Schweitzer, A.; Perry, C.R.; Harnly, J.; Wolf, W.R.; Picciano, M.F.; et al. Measuring vitamins and minerals in dietary supplements for nutrition studies in the USA. Anal. Bioanal. Chem. 2007, 389, 37–46. [CrossRef] [PubMed]
  10. Swanson, C.A. Suggested guidelines for articles about botanical dietary supplements. Am. J. Clin. Nutr.2002, 75, 8–10. [PubMed]
  11. Wolsko, P.M.; Solondz, D.K.; Phillips, R.S.; Schachter, S.C.; Eisenberg, D.M. Lack of herbal supplement characterization in published randomized controlled trials. Am. J. Med. 2005, 118, 1087–1093. [CrossRef] [PubMed]
  12. Gagnier, J.J.; DeMelo, J.; Boon, H.; Rochon, P.; Bombardier, C. Quality of reporting of randomized controlled trials of herbal medicine interventions. Am. J. Med. 2006, 119, 800.e1–800.e11. [CrossRef] [PubMed]
  13. Dwyer, J.; Costello, R.B.; Merkel, J. Assessment of dietary supplements. In Nutrition in the Prevention and Treatment of Disease, 4th ed.; Coulston, A.M., Boushey, C.J., Rerruzai, M.G., Delahaty, L.M., Eds.; Academic Press: London, UK, 2017; pp. 49–70.
  14. Ahluwalia, N.; Dwyer, J.; Terry, A.; Moshfegh, A.; Johnson, C. Update on NHANES dietary data: Focus on collection, release, analytical considerations, and uses to inform public policy. Adv. Nutr. 2016, 7, 121–134. [CrossRef] [PubMed]
  15. Chan, M. Forward. In WHO Traditional Medicine Strategy: 2014–2023; WHO: Hong Kong, China, 2013; pp. 7–8.
  16. Dickinson, A. History and overview of DSHEA. Fitoterapia 2011, 82, 5–10. [CrossRef] [PubMed]
  17. Taylor, C.L. Regulatory frameworks for functional foods and dietary supplements. Nutr. Rev. 2004, 62, 55–59.
  18. Australian Government Department of Health Therapeutic Goods Administration. The Poisons Standard(the SUSMP). Available online: https://www.tga.gov.au/publication/poisons-standard-susmp (accessed on17 September 2017).
  19. U.S. Food and Drug Administration. Dietary Supplements. Available online: https://www.fda.gov/food/dietarysupplements/ (accessed on 17 September 2017).
  20. Health Canada. Monograph: Melatonin—Oral. Available online: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=136 (accessed on 17 September 2017).
  21. Ventola, C.L. Current issues regarding complementary and alternative medicine (CAM) in the United States:Part 2: Regulatory and safety concerns and proposed governmental policy changes with respect to dietarysupplements. P T 2010, 35, 514–522. [PubMed]
  22. World Health Organization. National Policy on Traditional Medicine and Regulation of Herbal Medicines—Reportof a WHO Global Survey. Available online: http://apps.who.int/medicinedocs/en/d/Js7916e/ (accessed on 6 November 2017).
  1. Health Canada Natural and Non-prescription Health Products Directorate (NNHPD) About Natural Health Product Regulation in Canada. Available online: https://www.canada.ca/en/health-canada/services/ drugs-health-products/natural-non-prescription/regulation.html (accessed on 5 September 2017).
  2. Australian Government Department of Health Therapeutic Goods Administration. Exposure Drafts: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017. Available online: https://www.tga.gov.au/consultation/consultation-exposure-drafts-2017 (accessed on 17 September 2017).
  3. European Commission Directorate-General for Health and Food Safety. Herbal Medicinal Products. Available online: https://ec.europa.eu/health/human-use/herbal-medicines_en (accessed on 17 September 2017).
  4. U.S. Food and Drug Administration. New Dietary Ingredients (NDI) Notification Process. Available online: https://www.fda.gov/food/dietarysupplements/newdietaryingredientsnotificationprocess/default.htm (accessed on 17 September 2017).
  5. Australian Government Department of Health Therapeutic Goods Administration. Australian Regulatory Guidelines for Complementary Medicines (ARGCM). Available online: https://www.tga.gov.au/publication/australian-regulatory-guidelines-complementary-medicines-argcm (accessed on 17 September 2017).
  6. Australian Government Department of Health Therapeutic Goods Administration. Medicines and Medical Devices Regulation Review. Available online: https://www.tga.gov.au/mmdr (accessed on 17 September 2017).
  7. Australian Government Department of Health Therapeutic Goods Administration. Australian Government Response to the Review of Medicines and Medical Devices Regulation. Available online: https://www.tga. gov.au/australian-government-response-review-medicines-and-medical-devices-regulation (accessed on 17 September 2017).
  8. Government of Canada. Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food. Available online: https://www.canada.ca/en/health-canada/services/food-nutrition/legislation- guidelines/guidance-documents/category-specific-guidance-temporary-marketing-authorization- supplemented-food.html (accessed on 17 September 2017).
  9. Government of Canada Health Canada. Consulting Canadians on the Regulation of Self-Care Products in Canada. Available online: https://www.canada.ca/en/health-canada/programs/consultation-regulation-self- care-products/consulting-canadians-regulation-self-care-products-canada.html (accessed on 17 September 2017).
  10. Physiopedia. Evidence Based Practice (EBP). Available online: https://www.physio-pedia.com/Evidence_ Based_Practice_(EBP) (accessed on 17 September 2017).
  11. Australian Government Department of Health Therapeutic Goods Administration. Complementary Medicine Interface Issues. Available online: https://www.tga.gov.au/complementary-medicine-interface- issues (accessed on 17 September 2017).
  12. Singapore Government Health Science Authority. ASEAN Harmonization of Traditional Medicines and Health Supplements. Available online: http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/ Complementary_Health_Products/Overview/ASEAN_Harmonization_of_Traditional_Medicines_and_ Health_Supplements.html (accessed on 17 September 2017).
  13. World Health Organization. International Regulatory Cooperation for Herbal Medicines (IRCH). Available online: http://www.who.int/medicines/areas/traditional/irch/en/ (accessed on 17 September 2017).
  14. Gorman, U.; Mathers, J.C.; Grimaldi, K.A.; Ahlgren, J.; Nordstrom, K. Do we know enough? A scientific and ethical analysis of the basis for genetic-based personalized nutrition. Genes Nutr. 2013, 8, 373–381. [CrossRef] [PubMed]
  15. De Toro-Martin, J.; Arsenault, B.J.; Despres, J.P.; Vohl, M.C. Precision nutrition: A review of personalized nutritional approaches for the prevention and management of metabolic syndrome. Nutrients 2017, 9, 913. [CrossRef] [PubMed]
  16. World Health Organization. WHO Traditional Medicine Strategy: 2014–2023. Available online: http://www. who.int/medicines/publications/traditional/trm_strategy14_23/en/ (accessed on 17 September 2017).
  17. Drueke, T.B.; Massy, Z.A. Role of vitamin D in vascular calcification: Bad guy or good guy? Nephrol. Dial. Transplant.2012, 27, 1704–1707. [CrossRef] [PubMed]
  18. Rooney, M.R.; Harnack, L.; Michos, E.D.; Ogilvie, R.P.; Sempos, C.T.; Lutsey, P.L. Trends in use of high-dose vitamin D supplements exceeding 1000 or 4000 international units daily, 1999–2014. JAMA Intern. Med. 2017, 317, 2448–2450. [CrossRef] [PubMed]
  1. Prentice, R.L.; Pettinger, M.B.; Jackson, R.D.; Wactawski-Wende, J.; Lacroix, A.Z.; Anderson, G.L.; Chlebowski, R.T.; Manson, J.E.; Van Horn, L.; Vitolins, M.Z.; et al. Health risks and benefits from calcium and vitamin D supplementation: Women’s Health Initiative clinical trial and cohort study. Osteoporos. Int.2013, 24, 567–580. [CrossRef] [PubMed]
  2. Fulgoni, V.L., 3rd; Keast, D.R.; Bailey, R.L.; Dwyer, J. Foods, fortificants, and supplements: Where do Americans get their nutrients? J. Nutr. 2011, 141, 1847–1854. [CrossRef] [PubMed]
  3. Boyles, A.L.; Yetley, E.A.; Thayer, K.A.; Coates, P.M. Safe use of high intakes of folic acid: Research challenges and paths forward. Nutr. Rev. 2016, 74, 469–474. [CrossRef] [PubMed]
  4. Dwyer, J.T.; Wiemer, K.L.; Dary, O.; Keen, C.L.; King, J.C.; Miller, K.B.; Philbert, M.A.; Tarasuk, V.; Taylor, C.L.; Gaine, P.C.; et al. Fortification and health: Challenges and opportunities. Adv. Nutr. 2015, 6, 124–131. [CrossRef] [PubMed]
  5. Dwyer, J.T.; Woteki, C.; Bailey, R.; Britten, P.; Carriquiry, A.; Gaine, P.C.; Miller, D.; Moshfegh, A.; Murphy, M.M.; Smith Edge, M. Fortification: New findings and implications. Nutr. Rev. 2014, 72, 127–141. [CrossRef] [PubMed]
  6. Yetley, E.A.; MacFarlane, A.J.; Greene-Finestone, L.S.; Garza, C.; Ard, J.D.; Atkinson, S.A.; Bier, D.M.; Carriquiry, A.L.; Harlan, W.R.; Hattis, D.; et al. Options for basing Dietary Reference Intakes (DRIs) on chronic disease endpoints: Report from a joint US-/Canadian-sponsored working group. Am. J. Clin. Nutr. 2017, 105, 249s–285s. [CrossRef] [PubMed]
  7. Gaine, P.C.; Balentine, D.A.; Erdman, J.W., Jr.; Dwyer, J.T.; Ellwood, K.C.; Hu, F.B.; Russell, R.M. Are dietary bioactives ready for recommended intakes? Adv. Nutr. 2013, 4, 539–541. [CrossRef] [PubMed]
  8. Brown, A.C. Liver toxicity related to herbs and dietary supplements: Online table of case reports. Part 2 of 5 series. Food Chem. Toxicol. 2017, 107, 472–501. [CrossRef] [PubMed]
  9. Saldanha, L.; Dwyer, J.; Andrews, K.; Betz, J.; Harnly, J.; Pehrsson, P.; Rimmer, C.; Savarala, S. Feasibility of including green tea products for an analytically verified dietary supplement database. J. Food Sci. 2015, 80, H883–H888. [CrossRef] [PubMed]
  10. Sander, L.C.; Bedner, M.; Tims, M.C.; Yen, J.H.; Duewer, D.L.; Porter, B.; Christopher, S.J.; Day, R.D.; Long, S.E.; Molloy, J.L.; et al. Development and certification of green tea-containing standard reference materials. Anal. Bioanal. Chem. 2012, 402, 473–487. [CrossRef] [PubMed]
  11. De Boer, Y.S.; Sherker, A.H. Herbal and dietary supplement-induced liver injury. Clin. Liver Dis. 2017, 21, 135–149. [CrossRef] [PubMed]
  12. Avigan, M.I.; Mozersky, R.P.; Seeff, L.B. Scientific and regulatory perspectives in herbal and dietary supplement associated hepatotoxicity in the United States. Int. J. Mol. Sci. 2016, 17, 331. [CrossRef] [PubMed]
  13. Brown, A.C. An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series. Food Chem. Toxicol. 2017, 107, 449–471.
  14. Gardiner, P.; Phillips, R.; Shaughnessy, A.F. Herbal and dietary supplement-drug interactions in patients with chronic illnesses. Am. Fam. Physician 2008, 77, 73–78. [PubMed]
  15. Tsai, H.H.; Lin, H.W.; Simon Pickard, A.; Tsai, H.Y.; Mahady, G.B. Evaluation of documented drug interactions and contraindications associated with herbs and dietary supplements: A systematic literature review. Int. J. Clin. Pract. 2012, 66, 1056–1078.
  16. Gagnier, J.J.; Boon, H.; Rochon, P.; Moher, D.; Barnes, J.; Bombardier, C.; Group, C. Reporting randomized, controlled trials of herbal interventions: An elaborated CONSORT statement. Ann. Intern. Med. 2006, 144, 364–367.
  17. Blumberg, J.B.; Frei, B.B.; Fulgoni, V.L.; Weaver, C.M.; Zeisel, S.H. Impact of frequency of multi-vitamin/ multi-mineral supplement intake on nutritional adequacy and nutrient deficiencies in U.S. adults. Nutrients 2017, 9, 849. [CrossRef] [PubMed]
  18. Raghavan, R.; Ashour, F.S.; Bailey, R. A review of cutoffs for nutritional biomarkers. Adv. Nutr. 2016, 7, 112–120. [CrossRef] [PubMed]
  19. Centers for Disease Control and Prevention National Center for Environmental Health Division of Laboratory Sciences. Second National Report on Biochemical Indicators of Diet and Nutrition in the U.S. Population; Centers for Disease Control and Prevention: Atlanta, GA, USA, 2012.
  20. Bailey, L.B.; Stover, P.J.; McNulty, H.; Fenech, M.F.; Gregory, J.F., 3rd; Mills, J.L.; Pfeiffer, C.M.; Fazili, Z.; Zhang, M.; Ueland, P.M.; et al. Biomarkers of nutrition for development-folate review. J. Nutr. 2015, 145, 1636s–1680s. [CrossRef] [PubMed]
  1. Branum, A.M.; Bailey, R.; Singer, B.J. Dietary supplement use and folate status during pregnancy in the United States. J. Nutr. 2013, 143, 486–492. [CrossRef] [PubMed]
  2. Balk, E.M.; Lichtenstein, A.H. Omega-3 fatty acids and cardiovascular disease: Summary of the 2016 Agency of Healthcare Research and Quality evidence review. Nutrients 2017, 9, 865. [CrossRef] [PubMed]
  3. Ershow, A.G.; Skaeff, S.; Merkel, J.; Pehrsson, P. Development of databases on iodine in foods and dietary supplements. Nutrients 2018, in press.
  4. Taylor, C.L.; Sempos, C.T.; Davis, C.D.; Brannon, P.M. Vitamin D: Moving forward to address emerging science. Nutrients 2017, 9, 1308. [CrossRef] [PubMed]
  5. Brannon, P.M.; Taylor, C.L. Iron supplementation during pregnancy and infancy: Uncertainties and implications for research and policy. Nutrients 2017, 9, 1327. [CrossRef] [PubMed]
  6. Kuszak, A.J.; Hopp, D.C.; Williamson, J.S.; Betz, J.M.; Sorkin, B.C. Approaches by the U.S. National Institutes of Health to support rigorous scientific research on dietary supplements and natural products. Drug Test. Anal.2016, 8, 413–417. [CrossRef] [PubMed]
  7. Betz, J.M.; Fisher, K.D.; Saldanha, L.G.; Coates, P.M. The NIH analytical methods and reference materials program for dietary supplements. Anal. Bioanal. Chem. 2007, 389, 19–25. [CrossRef] [PubMed]
  8. Betz, J.M.; Brown, P.N.; Roman, M.C. Accuracy, precision, and reliability of chemical measurements in natural products research. Fitoterapia 2011, 82, 44–52. [CrossRef] [PubMed]
  9. LaBudde, R.A.; Harnly, J.M. Probability of identification: A statistical model for the validation of qualitative botanical identification methods. J. AOAC Int. 2012, 95, 273–285. [CrossRef] [PubMed]
  10. Betz, J.M.; Hardy, M.L. Evaluating the botanic dietary supplement literature. In The HERBAL Guide: Dietary Supplement Resources for the Clinician; Bonakdar, R.A., Ed.; Lippincott Williams and Wilkins: Philadelphia, PA, USA, 2010; pp. 175–184.
  11. Betz, J.M.; Hardy, M.L. Evaluating the botanical dietary supplement literature: How healthcare providers can better understand the scientific and clinical literature on herbs and phytomedicines. HerbalGram 2014, 101, 58–67.
  12. Brooks, S.P.J.; Sempos, C.T. The importance of 25-hydroxyvitamin D assay standardization and the Vitamin D Standardization Program. J. AOAC Int. 2017, 100, 1223–1224. [CrossRef] [PubMed]
  13. Phinney, K.W.; Tai, S.S.; Bedner, M.; Camara, J.E.; Chia, R.R.C.; Sander, L.C.; Sharpless, K.E.; Wise, S.A.; Yen, J.H.; Schleicher, R.L.; et al. Development of an improved standard reference material for vitamin D metabolites in human serum. Anal. Chem. 2017, 89, 4907–4913. [CrossRef] [PubMed]
  14. Phinney, K.W.; Bedner, M.; Tai, S.S.; Vamathevan, V.V.; Sander, L.C.; Sharpless, K.E.; Wise, S.A.; Yen, J.H.; Schleicher, R.L.; Chaudhary-Webb, M.; et al. Development and certification of a standard reference material for vitamin D metabolites in human serum. Anal. Chem. 2012, 84, 956–962. [CrossRef] [PubMed]
  15. Dwyer, J.T.; Picciano, M.F.; Betz, J.M.; Fisher, K.D.; Saldanha, L.G.; Yetley, E.A.; Coates, P.M.; Milner, J.A.; Whitted, J.; Burt, V.; et al. Progress in developing analytical and label-based dietary supplement databases at the NIH Office of Dietary Supplements. J. Food Compost. Anal. 2008, 21, S83–S93. [CrossRef] [PubMed]
  16. Dwyer, J.T.; Saldanha, L.G.; Bailen, R.A.; Bailey, R.L.; Costello, R.B.; Betz, J.M.; Chang, F.F.; Goshorn, J.; Andrews, K.W.; Pehrsson, P.R.; et al. A free new dietary supplement label database for registered dietitian nutritionists. J. Acad. Nutr. Diet. 2014, 114, 1512–1517. [CrossRef] [PubMed]
  17. Dwyer, J.T.; (NIH Office of Dietary Supplements, Bethesda, MD, USA). Personal communication, 2017.
  18. Andrews, K.W.; (USDA-ARS Beltsville Human Nutrition Research Center, Beltsville, MD, USA). Personal communication, 2017.
  19. Saldanha, L.G.; (NIH Office of Dietary Supplements, Bethesda, MD, USA). Personal communication, 2017.
  20. Lichtenstein, A.H.; Yetley, E.A.; Lau, J. Application of Systematic Review Methodology to the Field of Nutrition: Nutritional Research Series; Agency for Healthcare Research and Quality: Rockville, MD, USA, 2009; Volume 1.
  21. Helfand, M.; Balshem, H. AHRQ series paper 2: Principles for developing guidance: AHRQ and the effective health-care program. J. Clin. Epidemiol. 2010, 63, 484–490. [CrossRef] [PubMed]
  22. Trikalinos, T.A.; Lee, J.; Moorthy, D.; Yu, W.W.; Lau, J.; Lichtenstein, A.H.; Chung, M. Effects of Eicosapentanoic Acid and Docosahexanoic Acid on Mortality across Diverse Settings: Systematic Review and Meta-Analysis of Randomized Trials and Prospective Cohorts: Nutritional Research Series; Agency for Healthcare Research and Quality: Rockville, MD, USA, 2012; Volume 4.
  1. Trikalinos, T.A.; Moorthy, D.; Chung, M.; Yu, W.W.; Lee, J.H.; Lichtenstein, A.H.; Lau, J. Comparison of Translational Patterns in Two Nutrient-Disease Associations; Agency for Healthcare Research and Quality: Rockville, MD, USA, 2011.
  2. Moorthy, D.; Chung, M.; Lee, J.; Yu, W.W.; Lau, J.; Trikalinos, T.A. Concordance between the Findings of Epidemiological Studies and Randomized Trials in Nutrition: An Empirical Evaluation and Citation Analysis; Agency for Healthcare Research and Quality: Rockville, MD, USA, 2013.
  3. Brannon, P.M.; Taylor, C.L.; Coates, P.M. Use and applications of systematic reviews in public health nutrition.Annu. Rev. Nutr. 2014, 34, 401–419. [CrossRef] [PubMed]
  4. Ko, R.; Low Dog, T.; Gorecki, D.K.; Cantilena, L.R.; Costello, R.B.; Evans, W.J.; Hardy, M.L.; Jordan, S.A.; Maughan, R.J.; Rankin, J.W.; et al. Evidence-based evaluation of potential benefits and safety of beta-alanine supplementation for military personnel. Nutr. Rev. 2014, 72, 217–225. [CrossRef] [PubMed]
  5. Brooks, J.R.; Oketch-Rabah, H.; Low Dog, T.; Gorecki, D.K.; Barrett, M.L.; Cantilena, L.; Chung, M.; Costello, R.B.; Dwyer, J.; Hardy, M.L.; et al. Safety and performance benefits of arginine supplements for military personnel: A systematic review. Nutr. Rev. 2016, 74, 708–721. [CrossRef] [PubMed]
  6. Bailey, R.L.; Gahche, J.J.; Miller, P.E.; Thomas, P.R.; Dwyer, J.T. Why US adults use dietary supplements.JAMA Intern. Med. 2013, 173, 355–361. [CrossRef] [PubMed]
  7. Bailey, R.L.; Gahche, J.J.; Thomas, P.R.; Dwyer, J.T. Why US children use dietary supplements. Pediatr. Res.2013, 74, 737–741. [CrossRef] [PubMed]
  8. Berner, L.A.; Keast, D.R.; Bailey, R.L.; Dwyer, J.T. Fortified foods are major contributors to nutrient intakes in diets of US children and adolescents. J. Acad. Nutr. Diet. 2014, 114, 1009–1022.e8. [CrossRef] [PubMed]
  9. Taylor, C.L.; Bailey, R.L.; Carriquiry, A.L. Use of folate-based and other fortification scenarios illustrates different shifts for tails of the distribution of serum 25-hydroxyvitamin D concentrations. J. Nutr. 2015, 145, 1623–1629. [CrossRef] [PubMed]
  10. Pfeiffer, C.M.; Hughes, J.P.; Lacher, D.A.; Bailey, R.L.; Berry, R.J.; Zhang, M.; Yetley, E.A.; Rader, J.I.; Sempos, C.T.; Johnson, C.L. Estimation of trends in serum and RBC folate in the U.S. population from pre- to postfortification using assay-adjusted data from the NHANES 1988–2010. J. Nutr. 2012, 142, 886–893. [CrossRef] [PubMed]
  11. Pfeiffer, C.M.; Sternberg, M.R.; Hamner, H.C.; Crider, K.S.; Lacher, D.A.; Rogers, L.M.; Bailey, R.L.; Yetley, E.A. Applying inappropriate cutoffs leads to misinterpretation of folate status in the US population. Am. J. Clin. Nutr.2016, 104, 1607–1615. [CrossRef] [PubMed]
  12. Pfeiffer, C.M.; Lacher, D.A.; Schleicher, R.L.; Johnson, C.L.; Yetley, E.A. Challenges and lessons learned in generating and interpreting NHANES nutritional biomarker data. Adv. Nutr. 2017, 8, 290–307. [CrossRef] [PubMed]
  13. Gahche, J.J.; (NIH Office of Dietary Supplements, Bethesda, MD, USA). Personal communication, 2017.
  14. NIH National Center for Complementary and Integrative Health. NCCIH Policy: Natural Product Integrity. Available online: https://nccih.nih.gov/research/policies/naturalproduct.htm (accessed on 7 November 2017).
  15. NIH Office of Extramural Research. Grants & Funcing—Rigor and Reproducibility. Available online: https://grants.nih.gov/reproducibility/index.htm#guidance (accessed on 7 November 2017).
  16. Sebastian, R.S.; Wilkinson Enns, C.; Goldman, J.D.; Moshfegh, A.J. Dietary flavonoid intake is inversely associated with cardiovascular disease risk as assessed by body mass index and waist circumference among adults in the United States. Nutrients 2017, 9, 827. [CrossRef] [PubMed]© 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).

Dietary Supplement Facts and Label Review


There’s a lot of detail required for dietary supplement labels. Between supplement facts, structure-function health claims, and required formatting, it’s easy to overlook some of the FDA requirements for labeling.

 

Supplement Label Review Nutrition Facts

Supplement Label Review for Supplement Facts, Nutrition Labeling and Claims

Dietary Supplement Facts and Label Review

As part of our Label Review services, NaturPro helps clients develop, review and suggest improvements to dietary supplement labels, to ensure compliance with FDA regulatory requirements

Our clients enjoy the following benefits:

  1. Reliability: 100% accuracy and FDA compliance
  2. Experience: 15+ years of experience reviewing supplement labels
  3. Science-driven: Our reviews are based on the most current, reliable information, techniques and evidence
  4. Perspective: We have experience on the business side of the industry, so we know what the law is, whether it’s followed, and what is likely to happen if you don’t.

Updated 2018 Pricing:

Label Review: $400-600 ea. (Volume discounts may apply for similarly labeled products.)

Marketing Review: Contact for Pricing

Contact Us for a Free Estimate


FDA Dietary Supplement Labeling Guidelines

See our Dietary Supplement Label Review Checklist.

The following outlines some of the most frequently asked questions (FAQ) for dietary supplement labels:

  1. How are dietary supplements defined?Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:
    1. A vitamin;
    2. A mineral;
    3. An herb or other botanical;
    4. An amino acid;
    5. A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
    6. A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
  2.  What label statements are required on the containers and packages of dietary supplements?Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
  3.  Where do I place the required label statements?You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).
  4.  What label statements must I place on the principal display panel?You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.
  5.  How do I locate the principal display panel?The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.
  6.  What label statements must I place on the information panel?You must place the “Supplement Facts” panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the “Supplement Facts” panel in 21 CFR 101.36(i)(2)(iii) and (i)(5). See questions 46 and 56 in Chapter IV for more details.
  7.  Where is the information panel?The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.
  8.  What name and address must I list on the label of my product?You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.
  9.  May I place intervening material on the information panel?No. You may not place intervening material, which is defined as label information that is not required (e.g., UPC bar code), between label information that is required on the information panel.
  10.  What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?You are required to use a print or type size that is prominent, conspicuous and easy to read. The letters must be at least one-sixteenth (1/16) inch in height based on the lower case letter “o,” and not be more than three times as high as they are wide, unless you petition for an exemption in accordance with 21 CFR 101.2(f). The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. See Chapter IV for the type size requirements for the nutrition label.
  11.  Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.
  12. What is the nutrition label for a dietary supplement called?The nutrition label for a dietary supplement is called a “Supplement Facts” panel.
    1. You must list dietary ingredients without RDIs or DRVs in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
    2. You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
    3. You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
    4. You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
    5. You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.How does “Supplement Facts” differ from “nutrition facts?”The major differences between “Supplement Facts” panel and “Nutrition Facts” panel are as follows:
  13. What information must I list in the “Supplement Facts” panel?You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement. For example, when the net quantity of contents statement is 100 tablets and the “Serving Size” is one tablet, the “Serving Per Container” also would be 100 tablets and would not need to be listed.
  14. How must I display the “Supplement Facts” panel?The “Supplement Facts” nutrition information (referred to as a panel) must be enclosed in a box by using hairlines. The title, “Supplement Facts,” must be larger than all other print in the panel and, unless impractical, must be set full width of the panel. The title and all headings must be bolded to distinguish them from other information.
  15. How must I present the information in the “Supplement Facts” panel?You must present all information using the following:
    1. A single easy-to-read type style;
    2. All black or one color type, printed on a white or neutral contrasting background, whenever practical;
    3. Upper- and lowercase letters, except that you may use all uppercase lettering on small packages (i.e., packages having a total surface area available to bear labeling of less than 12 square inches);
    4. At least one point leading (i.e., space between lines of text); and
    5. Letters that do not touch.

  16. What are the type size requirements for the “Supplement Facts” panel?Except as provided for small and intermediate-sized packages, you must set information other than the title, headings, and footnotes in uniform type size no smaller than 8 point. You also must use a type size larger than all other print size in the nutrition label for the title “Supplement Facts.” You may set the column headings and footnotes in type no smaller than 6 point type. See the section on “Special Labeling Provisions” for the exceptions for small and intermediate-sized packages.
    For more information, visit FDA Dietary Supplement Labeling Guide

Food & Supplement Testing for Natural Products


Testing Foods, Supplements and Ingredients

NaturPro offers independent laboratory support for food & supplement testing for natural products.

Have natural product analysis questions? Contact Us..

Why Testing is Important: Supplement and natural product testing with a compliant laboratory is required by FDA for foods, dietary supplements and ingredients to ensure they meet standards for safety, quality and effectiveness. For example, identity, potency and purity are quality control parameters needed to legally sell a natural product as an ingredient, food or dietary supplement.

NaturPro Scientific is driven to achieve the right answers for our clients.  Some have even called us the UnLab. Why?

Being independent means that we do not own or have interest in any laboratory, which means we are free to pick from the top scientific experts for each type of test or analysis. As a result, we are truly able to work on behalf of our clients, to ensure that correct methods are used and results are obtained.


Natural Product and Supplement Testing Consultants

Natural Product and Supplement Testing Consultants

We know which labs are experienced with ginseng, but not with ginkgo — and this can mean a world of difference in test results.


11 reasons to use a supplement testing consultant for natural products:

  1. To ensure analytical methods used are valid and fit for purpose
  2. To make sure laboratories don’t take shortcuts with your sample
  3. To determine if results are precise and accurate
  4. To replicate the results of another lab
  5. To resolve out-of-specification test results
  6. To resolve disputes in data reports
  7. To determine if “dry-labbing” may be occurring
  8. To have an independent expert to review methods and results
  9. To perform due diligence on a supplier or partner
  10. To eliminate the potential for perceived conflict of interest when testing own products
  11. To qualify a lab as a good partnership choice.

3 main benefits of food and natural products testing consultants:

  1. Better analysis and testing validity  for reliable, replicable and defensible results.
  2. Fast turnaround and lower testing costs.
  3. Reduced retesting, rejections, production delays and product recalls.

Bottom Line – NaturPro knows the right methods and labs to use, and the right questions to ask. We know the shortcuts that testing labs can take, and how to prevent that from happening to you, to ensure testing gives the most scientific, accurate and defensible results possible.

 

 

 


Contact Us with your Testing Questions

The Regulatory Patchwork of Dietary Supplements

by NaturPro in Quality Comments: 0

In the United States, dietary supplements and their ingredients are subject to a patchwork of regulations, industry guidance, voluntary certifications and audit programs. With some exceptions, few standards for dietary supplements have been developed with expert consensus and  broadly implemented by the dietary supplement industry.

FDA’s dietary supplement GMPs (good manufacturing practices) are part of the exception and have made today’s supplement products generally a higher level of quality than at any time before.

Dietary Supplement Deming Opinion

In Dietary Supplements, Data is Needed to Support Compliance

Making A Quilt from the Regulatory Patchwork: What Successful, Resourceful Firms Do

Yet few industry standards are clearly understood, consistently applied and sufficiently comprehensive to cover all the ground.

One primary example is the gap between compliance requirements for dietary ingredients (under food GMPs) and dietary supplements, whose GMP framework is derived from that for pharmaceuticals. The underlying litmus test for the level of safety demanded for supplements and foods are different—that of “non-adulteration” versus “safe for human consumption,” Respectively. Maybe due to the differences, supplement GMP audit programs can overlook the food GMPs that govern ingredients. It is not uncommon for a manufacturer and a supplier to speak completely different quality languages. Audits for supplement GMPs are frequently unable to determine to a reasonable degree of certainty whether a particular ingredient, based on its certificate of analysis (CoA), should be expected to meet supplement requirements once it is placed inside a capsule or tablet.

As could be expected, an unintended consequence of this major gap is the common practice of a raw material CoA being duplicated as the manufacturer’s raw material specification.

In this scenario, an ingredient specification has been developed according to food requirements and, often without further analysis or verification, it is assumed to meet the requirements of the finished supplement. The result is a supplement that is essentially of no better quality than the “food-grade” ingredients put into it.

Especially for botanicals and animal-derived raw materials: cultivation, harvesting and processing before the final ‘transformation’ adds another dimension..

Confirming identity and purity is a complicated problem, particularly for a global supply chain of agricultural materials susceptible to contaminants during farming, harvesting, processing, storage or transportation to the ingredient processing facility.

In many poorer countries, the supply chain, and contaminants are not as well regulated as in advanced nations, and are freely shipped with no knowledge of their destination. Likewise, the final manufacturer or end user may have no information on the source of the material beyond the previous dock. In an uncomfortable way, the U.S., with its more lax regulations, often receives the materials rejected by Europe. Thus, potential contaminants may not be necessarily listed on the specification or controlled by the food GMPs, yet they can cause the products to which they are added to be adulterated.

Dozens of standards have been written for agricultural products, many of which don’t (or can’t) apply to the small family farmers who are a predominant source of botanical raw materials. In addition to recent requirements for fresh produce established by the Food Safety Modernization Act (FSMA), which don’t really apply to dried agricultural materials, we also have: USDA good agricultural practices (GAPs), which are intended for large farms and seldom fully practiced in the United States; certified organic, which requires no testing for contaminants like pesticides that may cause a product to be adulterated; independent farm standards like Global GAP, which arealso intended for large, modernized industrial farms; and, dozens of good agricultural and collection practices (GACPs) for medicinal plants that have been independently written by various nations and trade groups.


Some experts say the mess of standards, the dynamics of the industry and the law of entropy do not support the possibility of a clear and unified regulatory structure.


Others recognize the limitations, yet remain busy sewing the patches together into a quilt that is greater than the sum of its parts.


Fortunately,

initiatives are in process or recently completed that contribute to the integrity of our industry quilt and have provided free information. Just in the past couple years:

•             The U.S. Pharmacopoeia (USP) and American Herbal Pharmacopoeia (AHP) developed monographs and methods for testing dietary supplement ingredients.

•             USP also developed a Food Fraud Mitigation Database that lists adulterants common for food ingredients.

•             AOAC International developed analytical methods for dietary supplement ingredient potency and contaminants.

•             The National Institutes of Health’s (NIH) Office of Dietary Supplements (ODS) website became a valuable source of information and resources.

•             Trade groups such as the American Herbal Products Association (AHPA) and American Botanical Council (ABC) made enormous efforts to educate and guide the industry on issues around botanical dietary ingredients and adulteration, including a recently updated draft GACP from AHPA, and the ABC-AHP-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program.

•             The Supplement Online Wellness Library (OWL) was established by the Council for Responsible Nutrition (CRN), to allow labels for supplement products on the U.S. market to be put into in one place.

•             The Supplement Safety and Compliance Initiative (SSCI) was formed as a broad industry initiative, with wide support from trade associations, to address some of the gaps for supplements that aren’t sufficiently covered under other standards. SSCI is led by experienced players in retail, manufacturing and supply, and includes a focus on identity, risk assessment and quality for raw materials.

•             In response to consumer demand, leading retailers, manufacturers and ingredient suppliers invested significant resources into traceability and quality, and are now able to make meaningful claims to these effects that are not only important to consumers, but also serve as a reliable way to differentiate from the competition.

Today’s movement toward a greater level of education and transparency includes a firming of the gaps, especially where raw material traceability and quality are concerned. Successful companies across the entire supply chain are actively improving and adopting new standards, building a level of quality and integrity that provides lasting value to their business. Those who are upping their game are piecing together a quilt of their own, leveraging their quality advantages into claims that deliver marketing value. On the other side, those who continue to rely on ignorance or a lack of regulatory clarity as reason to take no action are increasingly left behind.

In an industry where faceless online product marketers are more common than they should be, and where a list of the tens of thousands of products available on the market is just getting online, our combined efforts to fill in the gaps of the collective regulatory patchwork benefits everyone.

This article was previously published in Natural Products Insider, July 2017.