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Cannabis, Hemp & CBD | SOP and Procedures



Standard Operating Procedures (SOP) for Cannabis, CBD and Hemp operations are required for every type of business — even if you are only a distributor or marketer. 

Our experts have decades of experience with all types of document requirements, for all types of firms — especially SOP supporting the following:

  1. Good Manufacturing Practices (GMP’s)
  2. Good Agricultural and Collection Practices (GACP)
  3. Good Distribution and Storage Practices

     


Need help with your SOP’s and GMP’s?  Contact us!

 

Our goal is to help you meet Cannabis, CBD and Hemp regulatory requirements as efficiently as possible.

 

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging, marketing, distribution, or testing business.

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

Cannabis SOP and procedures

Cannabis SOP and procedures are required in every state or jurisdiction.

All cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of regulations and standards 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.

Startups who invest in solid standard operating procedures (SOP) accelerate their growth from the start.

 

The worst thing a start-up can do is go in blind to what their processes and procedures — their Good Manufacturing Practices — should be.

But within a patchwork of regulations, processes and procedures depend on the type of product you are making. 

So what GMP guidelines should you follow?

Here’s some free advice, that’s common sense: Follow the most applicable regulatory guidelines, that are closest to your type of product.

The following types of products are generally considered dietary supplements, which are products intended to supplement the diet, but not replace food. Supplements in the U.S. are governed by 21 CFR 111, Good Manufacturing Practices (GMP) for Dietary Supplements:

  • Tinctures
  • Oils
  • Capsules and Softgels
  • Tablets
  • Powders
  • Food products with structure-function claims nutrients without recommended daily values

 

The following types of products are generally considered foods, governed under 21 CFR 117, that are FDA GMP’s for Food:

  • Protein powders
  • Ready to drink beverages
  • Snacks
  • Infused coffee and tea

Need help with your SOP’s and GMP’s?  Contact us!

 

When it comes to other types of products, standards or test methods, we generally recommend to pick the most relevant standards for your type of product.

Here is a basic set of quality management SOP’s for a Food facility: 

  1. 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)

       

We recommend to follow the standards and requirements set by FDA and other standards-setting organizations:

Need help with your SOP’s and GMP’s?  Contact us anytime!

 


Farmers are at the root of high quality product, so here’s some free SOP’s for farmers, followed by a sample guidance proposed for cannabis, hemp and CBD agricultural materials (i.e. “Farm SOP’s”)

CANNABIS, HEMP AND CBD FARM SOP LIST

  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

———————

A BASIC EXAMPLE for FARM OPERATIONS

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

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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.

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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.

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

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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?

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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?

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

     
 

Do operating personnel maintain adequate personal cleanliness?

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Are hand washing facilities available and used?

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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?

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Are caps, shoes and head covering used when appropriate?

     
 

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

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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

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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?

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

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Is seed planted listed on the license?

   

Is the entire hemp plant used as licensed?

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Do you properly use pre- plant weed control?

   

Do you have a Germination Certificate from the seed supplier

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Did you use the proper Certified Seed suitable for location?

   

Did you use the proper seed treatment?

   

Do you have a site history?

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Do you have a water quality report or history?

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

   

Did you use animal manure for fertilizer or biomass purposes?

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Did you plant by optimum seeding date?

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

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

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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?

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Have you complied with the drying procedures

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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?

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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?

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

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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

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Facility Security (physical security of buildings and grounds)

Is the facility using:

YES

NO

NOTES

Security lighting

     

Perimeter fencing

     

Controlled gate access

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Off-hours security guard

     

Electronic motion detectors

     

Door alarms

     

Video cameras

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Adequate indoor lighting

     

Alarms linked to an off-site security system

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Door hardware is of industrial design

     

Guards are installed on exterior ladders

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Exit doors and gate are electronically/mechanically secured

     

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

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All vehicles parked outside are locked

     

Empty/loaded containers are parked inside

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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

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

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B.

√ ifApplicable

Visitor Policy

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Is the facility using:

YES

NO

NOTES

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Company representative for visitor to check in with

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Signs informing visitors where to report

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Specific area for visitor parking

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

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Visitor badges/identification cards

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Company representative to escort visitor all the time

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Restricted access to key manufacturing areas

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C.

√ ifApplicable

Distribution

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Is the facility implementing the following:

YES

NO

NOTES

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

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7

U.S. Hemp Guidance Program PHASE 2

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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

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Shipping documents are used to identify the contents of each compartment

     

Shipping log is maintained

     

Bio-sanitation program is implemented

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Procedures exist to disinfect vehicles and drivers

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D.

√ if Applicable

E.

√ ifApplicable

Housekeeping

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Is the facility implementing the following:

YES

NO

NOTES

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Written housekeeping program for all areas of the facility

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Written pesticide and rodenticide program

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Emergency Response

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Is the facility implementing the following:

YES

NO

NOTES

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

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Current inventory of all hazardous and flammable products

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A plan to provided MSDS to emergency response teams etc.

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A list of emergency contacts is posted

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An action plan to deal with suspicious devices or substances

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Evacuation plan in case of fire and explosions is published

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

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Disaster Preparedness Plan

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A weapons security program

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Conduct evacuation and respond drill periodically

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

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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.

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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.

Private Label Drink and Beverage Powder Supplement Formulation

by Morgan Settle in Uncategorized Comments: 0

Creating a successful customized drink and beverage powder is a lot more than creating a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in production of drinks and beverage powder development, spanning from pilots to private labels.

We guide our clients in the right direction, by helping to manage all or parts of the process for private label drink and beverage powder formulation and development all for dietary supplement and health products.

Let’s dip into our product development toolbox!

Drink and Beverage Supplement Formula Development

Our client list includes folks of all shapes and sizes, from startup to large corporation.

No two clients or projects are the same, but there are some common approaches found in our Product Development Toolbox:

Product Development Toolbox: Top 10 Development Tools:

Powder development requires a ‘toolbox’ of analysis including the following

  1. Market Analysis, Competitive Analysis and Positioning
  2. Supplier and Copacker Relationships
  3. Understanding of Regulatory Status / Safety Assessment
  4. Claims Development and Substantiation
  5. Costing and Financials
  6. Ingredient Readiness, Supplier Qualification
  7. GMP’s, Specifications, and Analytical Testing
  8. Intellectual Property Development
  9. Manufacturing Feasibility
  10. Contract Manufacturer Qualification and Negotiation 

Contact Us

Dietary Supplement Label Review Checklist

by NaturPro in Uncategorized Comments: 0

The Food & Drug Administration (FDA) has specific rules for labeling and claims related to dietary supplements on packaging, marketing, websites, inserts and other promotional materials. If a label states a false or misleading claim, FDA, other regulatory agencies or class-action attorneys may file warning letters or lawsuits.

Dietary Supplement Label Review Checklist

⊗ PACKAGING REQUIREMENTS

Five general requirements for labels include: 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 (Supplement Facts Panel), 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.

⊗ 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 theconsumer when facing the product), unless otherwise specified by regulation(i.e., exemptions).

⊗ SUPPLEMENT FACTS PANEL

Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, totalcarbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, andiron must be listed when they are present in measurable amounts. Calories from saturated fat and the amount of polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they must be declared when a claim is made about them.

⊗ INGREDIENT LIST

When present, you must place the ingredient list on dietary supplementsimmediately below the nutrition label, or if there is insufficient space belowthe nutrition label, immediately contiguous and to the right of the
nutrition label.

⊗ WARNING STATEMENT

FDA requires warning statements related to safety and special precautions that, if not followed, could make the product unsafe.

⊗ UNITS OF MEASUREMENT

Proper units of measurement must be used, for example milligrams (mg), micrograms (mcg) or other appropriate units

⊗ PERCENTAGE DAILY VALUE (DV)

The % DV must be declared for all dietary ingredients for which FDA has established Daily Values, except that 1) the percent for protein may be omitted, and 2) on the labels of dietary supplements to be used by infants, children less than 4 years of age, or pregnant or lactating women, you must not list any percent for total fat, saturated fat, cholesterol, total carbohydrate,dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum,chloride, sodium, or potassium.

⊗ DOMESTIC ADDRESS OR PHONE NUMBER

The label of a dietary supplement being marketed in the United States must include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. If the label does not include the required domestic address or phone number, the dietary supplement is misbranded.

⊗ UPC BAR CODE

The UPC bar code may be obtained from the Uniform Code Council (www.uc-council.org)

⊗ NATURAL AND ARTIFICIAL FLAVORS

You must declare these ingredients in ingredient lists by using either specific common or usual names or by using the declarations  “natural flavor” or “artificial flavor,” or any combination thereof.

⊗ CHEMICAL PRESERVATIVES

You must list the common or usual name of the preservative, which may be followed by a description that explains its function e.g., “preservative,” “to retard spoilage,”“a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”

⊗ OTHER DIETARY INGREDIENTS

You must list “other dietary ingredients” by common or usual name in acolumn or linear display. FDA has not specified an order that you must follow. You must list the quantitative amount by weight per serving immediately following the name of the dietary ingredient or in a separate column. You must place a symbol in the column for “% Daily Value” that refers to the footnote “Daily Value Not Established,” except that the symbol must follow the weight when you do not use the column format.

⊗ LIQUID EXTRACTS

You must list liquid extracts using the volume or weight of the total extract and the condition of the starting material prior to extraction when it was fresh. You may include information on the concentration of the dietary ingredient and the solvent used. The solvent must be identified in either the nutrition label or ingredient list.

⊗ DRIED EXTRACTS

For dietary ingredients that are extracts from which the solvent has been removed, you must list the weights of the dried extracts.

⊗ CONSTITUENTS

You may list constituents of a dietary ingredient indented under the dietary ingredient and followed by their quantitative amounts by weight per serving. You may declare the constituents in a column or in a linear display.

⊗ PROPRIETARY BLENDS

You must identify proprietary blends by use of the term “Proprietary Blend” or an appropriately descriptive term or fanciful name. On the same line, you must list the total weight of all “other dietary ingredients” contained in the blend. Indented underneath the name of the blend, you must list the “other dietary ingredients” in the blend, either in a column or linear fashion, in descending order of predominance by weight. These ingredients should be followed by a symbol referring to the footnote “Daily Value Not Established.”Dietary ingredients having RDIs or DRVs must be listed separately and the individual weights declared.

⊗ PRODUCT CLAIMS

Claims come in four basic varieties:

  • structure/function claims
  • disease claims
  • health claims and qualified health claims
  • content claims

Basically, dietary supplements cannot make “disease” claims (for example: “treats cancer”). Dietary supplements that make disease claims are considered by FDA as drugs.

Dietary supplements can make “structure/function” claims (for example, “calcium builds strong bones”). A structure/function claim describes the product’s role in maintaining the “structure or function of the body,” or “general well-being.”

The Federal Trade Commission (“FTC”) has overlapping jurisdiction with the federal Food and Drug Administration (“FDA”), and focuses more on whether advertising is truthful, or false and misleading. Thus, it is important to respect nuanced labeling rules, including those regarding the statement of the identity.

⊗HIGH POTENCY CLAIMS

The regulation states that the term “high potency” may be used in a claim on the label or in labeling to describe individual vitamins or minerals thatare present at 100 percent or more of the Reference Daily Intakes (RDI) per reference amount customarily consumed (21 CFR 101.54(f)(1)(i)). This means a supplement may be labeled as “high potency” for each nutrient(s) that is present at 100% of the RDI per serving.

⊗ ANTIOXIDANT NUTRIENT CONTENT CLAIMS

A claim that describes the level of antioxidant nutrients present in a food is a nutrient content claim and may be used on the label or in the labeling of a food when the conditions of use in the regulation are met (21 CFR 101.54(g)).

The antioxidant nutrient must meet the requirements for nutrient content claims in 21 CFR 101.54.

⊗SUGAR-FREE CLAIMS

A dietary supplement may include claims in labeling such as “sugar free,” “no sugar,” or other claims provided it meets all of the eligibility criteria set forth in the regulation.

Among other requirements, a food must be labeled as “low calorie” or “reduced calorie” or bear a relative claim of special dietary usefulness. However, a dietary supplement that is prohibited from bearing a “low calorie”or “reduced calorie” claim can still use a sugar-free claim provided it meets the “low calorie” requirement in 21 CFR 101.60.

⊗HIGH OR GOOD SOURCE CLAIMS

You may make a “high” claim when your dietary supplement contains atleast 20% of the Daily Value (DV) (i.e. the Reference Daily Intake (RDI) or Daily Reference Value (DRV)) of the nutrient that is the subject of the claim perreference amount customarily consumed. You may make a “good source”claim when your dietary supplement contains 10 to 19% of DV.

⊗ LOW OR FREE-FROM CLAIMS

If a similar dietary supplement is normally expected to contain a nutrient and your dietary supplement is specially processed, altered, formulated, or reformulated as to lower the amount of the nutrient in the food, remove the nutrient in the food, or not include the nutrient, then you are permitted to make a “low” or “free” claim as applicable.

⊗ LOW CALORIE CLAIMS

A “low calorie” claim may not be made on dietary supplements, except when an equivalent amount of a dietary supplement that the labeled dietary supplement resembles and for which it substitutes (e.g., another protein supplement), normally exceeds the definition for “low calorie.”

⊗ QUALIFIED HEALTH CLAIMS

FDA will permit the use of a qualified health claim provided that 1) FDA hasissued a letter stating the conditions under which we will consider exercisingenforcement discretion for the specific health claim, 2) the qualified claim is accompanied by an agency-approved disclaimer, and 3) the claim meets all the general requirements for health claims in 21 CFR 101.14, except forthe requirement that the evidence for the claim meet the validity standard for authorizing a claim, and the requirement that the claim be made in accordance with an authorizing regulation.

This guidance was prepared by the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) in the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.

Further reading:

Article: Food and Supplement Claims with Confidence

Food and Supplement Testing for Natural Products

Dietary Supplement Facts and Label Review FAQ

Dietary Supplement and Food Label Review

 

 

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

Dietary Supplement Quality Control QA QC

by Morgan Settle in Uncategorized Comments: 0

Dietary Supplement Testing: Quality Control

Dietary supplements are subject to FDA requirements for quality control in the United States. cGMP require specifications for each ingredient and finished dietary supplement. The specifications list parameters for identity, purity, potency and other requirements for regulatory compliance. Each parameter on the specification must be tested with a scientifically valid method.

NaturPro Scientific, as an UnLab, partners with expert analytical laboratories to conduct specific testing on dietary supplements. Testing typically includes:

  • Physical characteristics (visual, color, odor, taste, density, mesh size)
  • Identity (matching an ingredient in a pass/fail fashion to a particular species of botanical or herb, or a chemical purity test)
  • Potency (concentration of active or marker compounds)
  • Purity (absence of impurities such as moisture, microbiology, pathogens, heavy metals, residual solvents, pesticides, mycotoxins)

The following are analytical principles or instruments that may be used for dietary supplement testing:

  • Karl Fischer
  • Ro-tap and particle size analysis
  • Titration
  • Gravimetry
  • Thin Layer Chromatography (TLC or HP-TLC)
  • High Performance Liquid Chromatography (HPLC)
  • Gas Chromatography with Flame Ionization Detection (GC-FID)
  • Gas Chromatography with Mass Spectrometry (GC-MS of GC-MS-MS)
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • Total Aerobic Plate Count
  • Pathogens (Salmonella, E. Coli, Staph)

The following is a list of documentation and regulations requiring testing under cGMPs:

  • Documentation of the specifications established (21 CFR 111.95(b)(1))
  • Documentation of your qualification of a supplier for the purpose of relying on the supplier’s certificate of analysis (21 CFR 111.95(b)(2))
  • Documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement (21 CFR 111.95(b)(3))
  • Documentation for why the results of appropriate tests or examinations for the product specifications that you selected for testing ensure that the dietary supplement meets all product specifications (21 CFR 111.95(b)(4))
  • Documentation for why any component and in-process testing, examination, or monitoring, and any other information, will ensure that a product specification that is exempted under 21 CFR 111.75(d) is met without verification through periodic testing of the finished batch, including documentation that the selected specifications tested or examined under 21 CFR 111.75 (c)(1) are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage (21 CFR 111.95(b)(5))

There are a number of sources of information for developing specifications and test methods for analysis of dietary supplements. The below is a list of eight references and resources:

  1. Dietary Supplement Ingredient Database, https://dietarysupplementdatabase.usda.nih.gov/
  2. Dietary Supplement Label Database, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
  3. 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/
  4. 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
  5. Pesticide Analytical Manual, Vol I, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113702.pdf
  6. Pesticide Analytical Manual, Vol II, FDA. Source: http://www.fda.gov/downloads/Food/FoodScienceResearch/ucm113721.pdf
  7. 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
  8. Quality control methods for medicinal plant materials (1998) World Health Organization

Customized Private Label Dietary Supplements

by Morgan Settle in Uncategorized Comments: 0

As Private Label Formulators we often get asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of dietary supplement, and whether its finished product, or an ingredient or raw material.

A number of considerations go into formulating successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the supplement or food do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • Who will benefit from the product?
  • How is the ingredient dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?


The 4 Steps to Private Label Dietary Supplement Formulation

There are 4 basic elements to formulating a groundbreaking private label dietary supplement:

  1. Begin with the finished product in mind. Determine in full detail how the product will be marketed, what the desired product claims will be, and how the product will address an unmet market need.
  2. Intimately understand the product value and market positioning compared to the competition. How will the product address an unmet need, or be different than what is already found on the market?  How will the product be priced compared to the competition? A full competitive analysis is important to determine positioning.
  3. What language will be used to describe the product? (This language, found on product labels and on webpages, is considered to be part of product claims.)
  4. In what country(s) will the product be marketed?  Regulations in different countries vary, and it is important to understand the unique requirements of each location.

It is the result of preparation, hard work, and learning from failure. -Colin Powell


Private label formulating plans often coordinate the knowledge of dietary supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good formulating plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on our Dietary Supplement Formulation and Development

Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

Nutraceutical Formulators

by Morgan Settle in Uncategorized Comments: 0

NaturPro are nutraceutical formulators with a broad range of experience in development and production of nutraceuticals, supplements, healthy foods and natural products — spanning from raw material to finished consumer product.

We talk through your goals with you and clarify the kind of nutraceutical formulators you’re looking to hire.

A number of considerations go into formulating successful, effective, safe and compliant nutracetical products.  These include:

  • What does the product or food do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • How is the ingredient dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?


The 4 Steps to Nutracetical Product Formulation

There are four main points when formulating nutraceutical products:

  •  Taste, Color, Delivery systems, and Dosage. We focus on the consumer market and how to help sell your product.
  • Market Analysis, Competitive Analysis and Positioning. Making your product stand out from others.
  • Supplement Testing and Analysis. NaturPro Scientific, as an UnLab, partners with expert analytical laboratories to conduct specific testing.
  • Product Manufacturing Feasibility. We check early on to make sure your product and ingredients are feasible and available to make.

“Only move forward with creating a product that will be ‘above the bar.’”


Nutraceutical formulators coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good development plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on our Nutraceutical Formulator Services



Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property


Nutrition Product Development

by Morgan Settle in Uncategorized Comments: 0


Development of nutrition products focus on efficacy, quality and purity. NaturPro has a broad base of knowledge in nutrition product development and production of nutrition supplements, healthy foods and natural products, spanning from raw material to finished consumer product.

We take the time to talk through your goals with you and clarify the kind of nutrition product you’re looking to develop and sell. A number of considerations go into developing successful, effective, safe and compliant nutritional supplements.  These include:

  • What does the product or food do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • Who will benefit from the product?
  • How is the ingredient dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?


Four Steps to Nutrition Product Development

There are four main points when developing nutritional products:

  • Dosage & Delivery We focus on the details that make your product and claims stand out from the rest.
  • Market Analysis, Competitive Analysis and Positioning. Making your product stand out from others.
  • Supplement Testing and Analysis. NaturPro Scientific, as an UnLab, partners with expert analytical laboratories to conduct specific testing.
  • Contract Manufacturing Advocacy – Qualifying and negotiating with contract manufacturers

Sufficient time spent in the planning phase is the difference between success and failure.


Product formulating plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good development plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on our Nutrition Product Development Services



Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

Nutrition Formulation Consultants

by Morgan Settle in Uncategorized Comments: 0

NaturPro Scientific stands out as consultants who work for our clients. Creating a successful product is a lot more than creating a list of ingredients that mix well together.

Our history: We have more than 30 years experience in developing the scientific aspects of nutrition products to support human health.

NaturPro has a broad base of knowledge in consulting services and nutritional product development, healthy foods and natural products, spanning from raw material to ingredient, to finished nutrition product.

A number of considerations go into developing successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the nutrition formula do?
  • How safe is the product?
  • How is the ingredient dosage determined?
  • What can be claimed about the nutrition product?
  • Is the evidence supporting the claims sufficient

Nutritional Product Formulation Consultants

Top 7 Nutrition Product Development Tools

Nutritional Formulation Consulting Services requires a ‘toolbox’ of analysis including the following

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Ingredient ReadinessSupplier Qualification
  5. GMP’s, Specifications, and Analytical Testing
  6. Manufacturing Feasibility
  7. Contract Manufacturer Qualification and Negotiation 

Contact Us

Nutritional Supplement Formulation Services

by Morgan Settle in Uncategorized Comments: 0

We lead our clients in the right direction, by helping to manage all (or parts) of the process for nutritional supplement formulation for dietary supplement and health food products.

Creating a successful product is a lot more than creating a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in nutritional supplement formulation services, from seed to shelf, from a unique idea, to the finished consumer product.

Nutritional Supplement Formulation Services

Our client list includes companies of all shapes and sizes, from startup to large corporation.

No two clients or projects are the same, but there are some common approaches found in our Product Formulation Toolbox:

Nutrition Supplement Toolbox: Top 7 Formulation Tools:

Nutritional Formulation requires a ‘toolbox’ of analysis that includes the following:

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Ingredient ReadinessSupplier Qualification
  5. GMP’s, Specifications, and Analytical Testing
  6. Manufacturing Feasibility
  7. Contract Manufacturer Qualification and Negotiation 

Contact Us