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Oct
27

AOAC ERP of the Year to Kombucha Alcohol Group

by NaturPro in Uncategorized Comments: 1

NaturPro Contributes to Expert Panel Receiving AOAC Award: “ERP of the Year” to Kombucha Alcohol Group

The AOAC Expert Review Panel (ERP) charged with reviewing methods of analysis for ethanol in kombucha initially met in September 2016 to review methods against AOAC SMPR 2016.001 (Determination of Ethanol in Kombucha). At this meeting, the ERP adopted an Official Method of Analysis for First Action status, AOAC 2016.12 (Determination of Ethanol in Kombucha) using gas chromatography with flame ionization detection (GC-FID). The selection and validation of this method was coordinated by NaturPro Scientific and performed by Covance Laboratories, Wisconsin.

kombucha tea testing alcohol ethanol

Method adopted for kombucha tea testing for alcohol in validated labs

AOAC states: “The ERP’s work directly impacts the resolution of urgent and key issues identified by industry, and serves as a forum where both the kombucha industry and government work together.

“The ERP was selected because its open and thorough scientific scrutiny of methods and its output clearly demonstrate the culmination of an industry-wide effort that facilitates regulatory and industry engagement for addressing urgent analytical disputes and facilitating trade. All ERP members receive the award, and publicly receiving the award on behalf of the group is the ERP chair, Sneh Bhandari.

“The Expert Review Panel (ERP) of the Year Award recognizes an ERP for achieving and completing signicant milestone(s) (e.g., Final report, First Action Method, Final Action Method), highlighted by some unique or particularly noteworthy aspect of a review panel report, such as innovative technology or application, breadth of applicability, critical need, difficult analysis, or timeliness.

“The report demonstrates significant merit as to the scope of the project, diversity of the panel, or an innovative approach to difficult analytical challenges. The report must have been submitted within the last 3 years.”

 

 

Oct
20

Cannabis Consultants

by NaturPro in Uncategorized Comments: 21

NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

There are a lot of things to consider when developing cannabis products or hiring a consultant.

  1. Whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.
  2. Scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.
  3. Inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.
  4. Experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

Cannabis Consultants and Experts in Innovation, Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in regulatory compliance, GMP and quality assurance on CBD, 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.

Audits for 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.

 

Standard operating procedures (SOP) for cultivation, processing and testing 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

CBD 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.

CBD 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)
Oct
20

CBD Quality Consultants and Experts 

by NaturPro in Uncategorized Comments: 5

In a world where everyone claims to be an expert, NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

Our experience: There are a lot of things to consider when developing cannabis products or hiring a consultant.

First, is whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.

Second, is scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.

Third, is inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.

Fourth — is experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

CBD Quality Consultants and Experts Specializing in Innovation and Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on CBD, 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 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.

 

Standard operating procedures (SOP) for CBD processing 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

CBD 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.

CBD 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)
Oct
20

CBD and Cannabis Audits, GMP and Quality

by NaturPro in Quality Comments: 11

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.

Aug
15

Food and Supplement Product Manufacturing Feasibility

by NaturPro in Product Development Comments: 11

Knowing whether a material will be able to be made into a product is a key step to product development. A lot of natural products are unstable, insoluble, non-flowable, terrible tasting, or otherwise challenging to mix into the desired product form.

In today’s ‘clean label’ demanding market, many of the additives used to make a high quality tablet or beverage are no longer salable.

Food and Supplement Product Manufacturing Feasibility

Related to the exercise of understanding manufacturing feasibility, we also offer a number of production-related services:

  • Source and qualify bulk raw materials
  • Raw material quality verification program
  • Supplier verification program
  • Facility design and GMP
  • Formula/recipe development
  • Project management
  • Manufacturing process design
  • Equipment qualification, sourcing, IQ/OQ/PQ
  • Contract manufacturer qualification
  • Materials selection & sourcing
  • Packaging & label development
  • Documentation & systems

NaturPro’s core experiences are in understanding how to make better products and better ingredients. Contact us to learn more.

Food and Supplement Product Manufacturing Feasibility

Food and supplement product manufacturing feasibility is the first step in understanding whether the product of your dreams can become a reality.

Jul
26

The Regulatory Patchwork of Dietary Supplements

by NaturPro in Quality Comments: 11

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. 

May
17

Dietary Supplement Ingredients and Raw Materials

by NaturPro in Product Development, Quality Comments: 6

NaturPro Scientific are experts in dietary supplement bulk raw materials and ingredients, especially botanicals and herbs.  We know how botanical and medicinal plants are grown, harvested, aggregated, processed, extracted and tested.

We are specialists in qualifying, testing and sourcing herbal dietary ingredients and botanical raw materials used in supplements, foods, pharmaceuticals and cosmetics.

Quick Facts on Bulk Supplement Ingredient Formats, Quality, Testing 

  1. Most raw materials are available as whole, cut, powdered or powdered extract. We recommend and specialize in fully standardized botanical extracts with full supply chain traceability and transparency, meeting the strictest global requirements.
  2. For non-botanicals, we suggest working directly with the manufacturer, and not with a distributor. All certificates of analysis should list the manufacturer’s name and the address of the manufacturing facility where the product was produced, or be accompanied by traceability documentation.
  3. Many raw materials are available as Certified Organic. Most products are naturally non-GMO.
  4. All materials may be tested at dedicated laboratories for the presence and amount of nutrients, potency, microbiology and pathogens, heavy metals, pathogens, 500+ pesticides, 100+ volatile organic compounds and solvents, food allergens and gluten, and mycotoxins.
  5. The testing plan is based on the material specification, which is typically based on the regulatory requirements of the country where the materials will be sold.
  6. We also recognize and actively seek out materials meeting various benchmarked quality standards, such as U.S. 21 CFR 111, USP <561> Articles of Botanical Origin and official pharmacopeial monographs, WHO Good Agricultural and Collection Practices (GACP), USDA Good Agricultural Practices, Fairtrade,  U.N. Forum on Sustainability Standards.

Dietary Supplement Ingredients and Raw Materials 

Here is a partial list of ingredients that we are able to qualify and develop for our clients:

Abies webbiana  (Talispatra)

Abrus precatorius (Rati Gunj)

Acacia arabica (Nilotica)

Acerola Cherry

Achyranthes aspera Seed (Apamarg)

Adhatoda vasica Leaf (Vasa, Adulsa)

Aegle marmelos Fruit (Bilva, Bel)

Aesculus hippocastanum L.

Aglaia roxburghiana Fruit (Priyangu)

Ajmud (Carum roxburgianum)

Allium sativum L.

Aloe ferox Miller

Aloe Gel (Ghrit Kumari)

Aloe vera

Alpha Lipoic Acid

Amalaki, Amla Fruit (Emblica officinalis)

Ambrette Seed (Latakasturi, Muskdana)

Amla Fruit Extract (Phyllanthus emblica)

Amorphophalms konjac

Andrographis Herb (Bhunimba, Kalmegh) Papda)

Andrographis paniculata

Angelica sinensis (Oliv.)Diels

Annatto (Shinduri)

Apple

Arctostaphylos uva-ursi L.

Argemone mexicana Herb (Swarnakshiri)

Argyreia nervosa Seed (Vriddhadaru)

Aristolochia indica Root (Pushkarmul)

Arjun Bark (Terminalia arjuna)

Arrowroot

Artemisia annua L.

Ascorbic Acid

Ascorbyl Palmitate

Ashok Bark (Saraca indica)

Ashwagandha Root (Withania somnifera)

Asparagus racemosus Root (Shatavari)

Astaxanthin

Asteracantha longifolia Seed (Talimakhana)

Astragalus membranaceus(Fisch.)Bge

Atibala Root (Abutilon indicum)

Azadiracta indica Bark (Neem)

Azadiracta indica Leaf (Neem)

B-3 Niacinamide USP

Bacopa monnieri Herb (Brahmi)

Bala Root (Sida cordifolia)

Baliospermum montanum (Danti)

Bamboo Manna (Vansrochan)

Barberry Stem Bark

Barley Grass (Yava)

Basil Leaf

Basil Seed (Sabja, Tukmaria)

Basil, Camphor (Karpur Tulsi)

Bauhinia tomentosa Bark (Kanchanar)

Beet Root

Berberis aristata Stem (Daru Haridra/Haldi)

Bergenia ligulata (Pashan Bheda)

Bhringraja Herb (Eclipta alba)

Bhumyamalaki Herb (Phyllanthus amarus)

Bhunimba Herb (Andrographis paniculata)

Bibhitaki, Baheda Fruit (Terminalia bellerica)

Bilberry (Vaccinium myrtillus L.) Fruit

Bilva, Bel Fruit (Aegle marmelos)

Biotin

Bishops Weed Seed (Ammi majus)

Bitter melon (Karvellak, Karela)

Black Cohosh

Blackberry

Blueberry

Boerhavia diffusa (Punarnava)

Bombax malabaricum (Mochras)

Borago officinalis L. (Borage)

Boswellia serrata (Frankincense, Shallaki)

Brahmi (Bacopa monnieri)

Bridelia retusa (Asana)

Broccoli (Brassica oleracea) Flower Powder

Broccoli Seed Ext BSPE-13-25

Bromelain

Bupleurum Root

Butea monosperma Bark (Palash)

Butea monosperma Flower (Palash)

Buxus sinica（Rehd.et Wils.)Cheng

Caesalpinia bonducella Seed (Lata Karanj)

Caesalpinia sappan (Patang, Sappan wood)

Calamus Root (Vacha, Bach)

Calendula Petals

Calotropis gigantea Root (Mandar, Aak)

Camellia sinensis (L.) O.Kuntze (Green Tea)

Camphor

Camptotheca acuminata

Cane Sugar

Capsicum annuum L.

Cassia absus (Chakshu)

Cassia angustifolia Vahi

Cassia fistula Fruit Pulp (Arghvadh, Bahava)

Cassia nomame(sibe.)L.Kitagawa

Cassia tora (Chakramard)

Catechu Bark (Khadir, Khair)

Cayenne Pepper Powder

Cedrus deodar Wood (Devdaru)

Celastrus paniculatus Fruit (Jyotismati)

Celery Seed (Apium graveolens, Ajmud)

Centella asiatica (Gotu kola) aerials

Chamomile Herb

Chamomilla recutita(L.)Rausch

Chaste Tree Berry

Chen Pi Extract

Chickweed (Stellaria Media Herb) Extract

Chlorophytum borivilium Root (Safed Musli)

Choline Bitartrate

Chrysin

Cimicifuga foetida L.

Cinnamomum zeylanicum (True or Ceylon cinnamon) bark

Cinnamon (Cinnamomum cassia) bark

Cinnamon Powder Low Oil

Cissampelos pareira (Patha)

Cissus quadrangularis Herb (Ashthisandhar)

Citric Acid Anhydrous USP/FCC

Citrullus colocynthis Fruit (Indravaruni) Citrus anrantium L.

Citrus aurantium L.

Citrus Bioflavonoids

Citrus Bioflavonoids Extract

Citrus paradisi Macfadyen

Clerodendron serratum Root (Bharangi)

Clitoria ternatea Herb (Aparajita)

Cnidium monnieri L.

Coenzyme Q10

Cola nitida(Vent.) Schott et Endl

Coleus barbatus Benth

Coleus forskohlii Root (Pashanbheda)

Commiphora mukul Resin (Guggul)

Commiphora myrrah Resin (Raktabol)

Convolvulus pluricaulis Herb (Shankhpushpi)

Coptis Chinensis Extract

Cordyceps sinensis Extract

Costus speciosus (Kustha)

Country Mallow, Indian Root (Atibala)

Cranberry Fruit Powder

Crataegus pinnatifida

Crataeva nurvala Wood (Vaiverna)

Croscarmellose Sodium

Curculigo orchioides Root (Musli)

Curcuma amada Root (Amra Haridra, Amba Haldi)

Curcuma aromatica (Van Haridra)

Curcuma zedoaria (Karchura)

Curcumin 95% Powder

Curry (Murraya koenigii) Leaf

Cyanocobalamin (Vitamin B12 1%)

Cyanocobalamin 0.1%, Vit B12

Cynara scolymus L

Cynodon dactylon (Durva)

Cyperus rotundus Root (Musta, Nagarmotha)

Datura metel Seed (Dhoorta, Dhatura)

Desmodium gangeticum Root (Shaliparni)

Dioscorea bulbifera Tuber (Varahi Kand)

D-Limonene

Dong Quai Extract

Echinacea purpurea Herb Extract

Eclipta alba Herb (Bhringraja)

Eleutherococcus Senticosus Root Extract

Embelia ribes Seed (Vidang)

Emblica officinalis Fruit (Amalaki, Amla)

Epimedium brevicorn

Equisetum arvense L.

Eucalyptus citridora Leaf (Nilgiri)

Euphorbia nerifolia Herb (Sudha)

Evodia rutaecarpa（Juss.）Benth

Evolvulus alsinoides Herb (Shankhpushpi)

Feronia limonia (Wood apple, Kapittha, Kaith)

Ficus benghalensis Bark (Banyan, Vata, Vad)

Ficus benghalensis Shoot (Vatankur)

Ficus racemosa Bark (Udumbara, Gular)

Ficus religiosa Bark (Ashwatha, Peepal)

Flax Seed Extract

Flaxseed Lignans Powder

Foeniculum vulgare Mill (Fennel)

Folic Acid 10%

Folium Artemisiae Argyi

Fructose DC

Fucus vesiculosus L.

Fumaria parviflora Seed (Yavan Parpat, Pitta Papda)

Galangal (Kulinjan)

Ganoderma lucidum (Leyss.ex Fr.)Karst

Garcinia cambogia Fruit Rind (Vrikshamla)

Garcinia mangostana L. (Mangosteen)

Gardenia gummifera (Nadihingu)

Gardenia jasminoides Ellis

Ginger Extract 5%

Ginger Root Powder

Ginkgo Biloba 24% Extract

Gloriosa superba Seed (Langli, Kalihari)

Glucosamine HCl (non-shellfish)

Glycine max(L.)Merr

Glycyrrhiza glabra L.

Gmelina arborea Root (Gambhari, Shivan)

Gokshur Fruit (Tribulus terrestris)

Gokshur Herb (Tribulus terrestris)

Gotu Kola Herb (Mandukparni, Brahmi) Pumpkin Seed

Grape (Citis vinifera) Seed

Green Coffee (Coffea arabica) Bean

Green Tea (Camellia sinensis) Leaf Ext

Green Tea 40% Decaffeinated Water Extracted

Green Tea PE Decaffeinated 40% EGCG

Griffonia Simplicifolia

Guar Gum

Guduchi, Amrita Herb (Tinospora cordifolia)

Guggul Resin (Commiphora mukul)

Gum arabic (Acacia arabica, A. nilotica)

Gymnema Leaf (Madhunashini, Shardunika, Gudmar)

Gymnema sylvestre

Gynostemma pentaphyllum (Thunb.) Makino

Hamamelis mollis Oliver

Haritaki, Harde (Terminalia chebula)

Harpagophytum procumbens DC

Hawthorn Leaf and Flower Ext 5.5 to 1

Hedychium spicatum Root (Sati, Kapur Kachri)

Helicteres isora Fruit (Avartini)

Hemidismus inducus (Anantmul)

Hemsleya amabilis Diels

Hemp Protein

Hemp Seed Oil

Hemp Extract (Cannabidiol, CBD)

Henna Leaf (Madayantika, Mehandi)

Herpestis moniera Herb (Brahmi)

Hesperidin

Hibiscus Flower (Japa, Jaswand) Sage

Hippophae rhamnoides L.

Holarrhena antidysenterica Bark (Kutaj)

Holy Basil Leaf (Tulsi)

Honey

Hops Extract Powder

Hops Powder

Horse Chestnut Extract  20%

Horsetail Shavegrass

Humulus lupulus L.

Huperzia serrata (Huperzine-A)

Hydrocotyle asiatica Herb (Mandukparni)

Hypericum perforatum L.

Indian Goosebery Fruit (Amalaki, Amla)

Indigo Leaf (Neelini, Neel)

Indole-3-Carbinol

Inositol

Ipomoea digitata Tuber (Kshri Vidari)

Japanese Knotweed Extract

Jasmine Flower (Mallika)

Jatamansi Root (Nardostachys jatamansi)

Jatropha curcas

Jujube Seed

Kanchanar Bark (Bauhinia tomentosa)

Korean Ginseng (Panax ginseng)

Kutki Root (Picrorhiza kurroa)

Lagerstroemia speciosa (L.) Pers

Laminaria japonica Arsch

L-Arginine

Lavandula pedunculata L.

L-Carnitine Fumarate

L-Citrulline

L-Cysteine

Lemon Bioflavonoid Complex

Lemon Peel

Lemongrass

Lentinus edodes (Berk.)sing

Lepidium sativum Seed

Leptadenia reticulata (Jivanti)

L-Glutamine

Licorice Extract, Deglycyrrhizinated (Glycyrrhiza Glabra)

Linum usitatissimum L.

Lllicium verum Hook.f

Lotus (Padam, Neel Kamal)

L-Selenomethionine

Lycium barbarum L. (Goji berry)

Maca root

Madder, Indian Root (Manjistha)

Madhuca india (Madhuka)

Magnesium Carbonate

Magnesium Gluconate

Magnesium Lactate

Magnolia Bark

Magnolia officinalis Rehd. et Wils

 

Manganese Gluconate

Marigold Flower (Zendu)

Marjoram

Marshmallow Root Ext 4:1

Melissa officinalis L. (Lemon Balm)

Mentha haplocalyx Briq

Mesua ferra Stamen (Nagkeshara)

Mexican Poppy Herb (Argemon mexicana)

Milk Thistle Seed Extract 80% silymarin

Momordica charantia (Bitter Melon)

Moringa oleifera (Shigru, Sahijan)

Motherwort Powder Extract  6.5:1

Mucuna pruriens

N-Acetyl L-Cysteine

Narcissus pseudonarcissus L.

Neem

Nettle Root

Niacin

Noni (Morinda citrifolia) Fruit

Nyctanthes arbortristis Leaf (Parijat, Harsingar)

Oenothera erythrosepala Borb

Olive Leaf Extract

Opuntia dillenii

Orange Peel

Orange Powder

Oregano

Oregon Grape Root Extract 4:1

Oroxylum indicum Root (Shyonak, Tetu)

Oroxylum indicum(L.)Vent

Orris, Indian Root (Pushkarmula)

Panax Ginseng Extract

Papaya Leaf

Parsley

Passion Flower Ext

Patchouli Leaf

Pepper, Long Fruit (Pippali)

Pepper, Long Root (Pippali)

Perilla frutescens(L.)Britt

Perilla Seed Extract

Periwinkle Herb (Sadaphuli)

Phellodendron amurense (Berberine HCl)

Phellodendron amurense Rup

Phosphatyl Serine 30%

Phyllanthus amarus Herb (Bhumyamalaki)

Phyllanthus emblica Fruit (Amalaki, Amla)

Picrorhiza kurroa Root (Katuka, Kutki)

Picrorhiza kurroa Root Extract

Pinus massoniana Lamb

Pinus massoniana Lamb

Piper betle Leaf (Nagvalli, Paan)

Piper Methysticum

Piper nigrum L.

Pistacia integerrima (Karkatshringi)

Plantain Flour

Pluchea lanceolata Root (Rasna)

Plumbago zeylanica Root (Chitrak)

Polygonum cuspidatum Root Extract 50%

Pomegranate Fruit Extract

Pomegranate Flower

Pongamia pinnata (Karanj)

Poppy Seed (Post Dana)

Potassium Sulfate

Potassium bicarbonate

Pregelatinized Starch

Premna integrifolia Root (Agnimantha)

Prune Skin Extract

Psoralea corylifolia Seed (Bakuchi, Bavchi)

Psyllium Husk (Isaphgula, Isabgol)

Pterocarpus marsupium Wood (Vijaysar)

Pueraria lobata (Willd.)

Pueraria Root Extract 40% Isoflavones

Pueraria tuberose Tuber (Vidari)

Pumpkin Seed Powder – Steam Treated

Punarnava Root (Boerhavia diffusa)

Punica granatum L.

Pyridoxine Hydrochloride

Quercetin Anhydrous Granular

Quercetin Anhydrous Powder GRAS

Quercetin Dihydrate

Quercetin Dihydrate Powder

Quercus infectoria (Mayaphal, Majuphal)

Randia dumetorum (Madanphal)

Raspberry Fruit Powder

Rauwolfia serpentine Root (Sarpagandha)

Red Clover Extract

Red Yeast Rice

Rhamnus purshiana

Rhodiola rosea

Rhus succedanea (Karkatshringi)

Riboflavin (Vitamin B2)

Rice Protein Hydrolysate

Rodiola Rosea 5%

Rose Petal (Shatpatri, Gulab)

Rosemary Ext 95%

Rosmarinus officinalis L.

Rublaceae.Corynant.Yohimbine

Rubus chingli Hu

Rue Herb (Ruta graveolens)

Ruscus aculeatus L.

Rutin

Safed Musli Root (Chlorophytum borivilium)

Safflower Seed

Salacia chinesis (Saptarangi)

Salix alba L.

Salvia Extract, 1% Dan Shen

Salvia Sclare L.

Sambucus williamsii Hance

Sappan Wood (Patang)

Saraca indica Bark (Ashok)

Sarperia (Rauwolfia serpentina)

Sarsaparilla, Indian (Anantmul)

Saw Palmetto Ext 45%

Schisandra chinensis(Turcz.)Baill

Scindapsus officinalis (Gajpippli)

Seabuckthorn (Hippophae rhamnoides)

Selenium

Semecarpus anacardinum Nut (Bhallatak)

Senna Leaf (Markandika, Sanai)

Serenoa repens (Saw palmetto)

Sesame Seed (Til)

Sesamum indicum L.

Shankhpushpi Herb (Convolvulus pluricaulis)

Shatavari Root (Asparagus racemosus)

Sheabutter officinalis

Shorea robusta (Raal)

Sida cordifolia Root (Bala)

Sida rhombifolia Root (Mahabala)

Silybum marianum(L.)gaertn

Sisymbrium officinale L.

Skullcap Root Extract

Soap Nut (Arishtak, Reetha)

Sodium Ascorbate Granular 99%

Sodium Copper Chlorophyllin

Solanum indicum Root (Brihati)

Solanum lycopersicum L

Solanum nigrum Root (Kakmachi)

Solanum xanthocarpum Fruit (Kantakari)

Sophora alopecuroides L.

Sophora japonica L.

Sophora subprostrata

Sorbus aucuparia L.

Soy Isoflavones

Spent Hops (Polyphenol Rich Hops Pellets)

Sphaeranthus indicus Herb (Mundi)

Spikenard, Indian Root (Jatamansi)

Spilanthes acmella Root (Akarkarbha)

Spirulina

St John’s Wort

Stereospermum suaveolens Root (Patala)

Stevia Leaf Extract (Rebaudioside A)

Strychnos potatorum (Nirmali)

Sunflower

Symplocos racemosus Stem (Lodhra)

Syzygium cumini Seed (Jambu, Jamun)

Tagetes erecta L. (Marigold)

Tamarind Fruit

Tamarindus indica L.

Tarragon (Artemisia dracunculus)

Taxus baccata L

Tea, Black

Terminalia arjuna Bark (Arjuna)

Terminalia bellerica Fruit (Bibhitaki, Baheda)

Terminalia chebula Fruit (Haritaki, Harde)

Thiamine Hydrochloride

Thyme

Thymus mongolicus Ronn

Tinospora cordifolia Stem (Guduchi, Amrita, Galo)

Trachycarpus fortunei(Hook.)H.Wendl)

Tribulus terrestris Fruit (Gokshur, Gokhru)

Trichosanthes cucumerina Root (Patol)

Trifolium pratense L.

Tulsi Leaf (Ocimum sanctum)

Turmeric (Curcuma longa) Root Extract

Turmeric Root Powder

Vaccinium myrtillus L.

Valerian Root ext 0.8%

Valeriana wallichi Root (Sugandha bala, Tagar)

Vanadium Citrate 0.5%

Vanilla Bean

Vasa, Adulsa Leaf (Adhatoda vasica)

Viola odorata Leaf (Banafsa)

Vitex negundo Herb (Nirgundi)

Vitex trifolia L.

Vitis vinifera L.

Voacango africana Stapf

Watercress Herb Ext. 4:1 Steam Treated (non irradiated)

Wheat Grass

White Willow Bark 15%

Withania somnifera (Ashwagandha)

Wormwood Plant Ext 5%, 8:1

Xylitol (Foods)

Zanthoxylum bungeanum Maxim

Zinc Chelate (Tasteless) 10%

Zinc Citrate 32%

Zingiber officinale Roscoe (Ginger) root

Ziziphus jujube

Here are ingredient of concern listed on FDA’s website:

May
17

Dietary Supplement Testing and Analysis: Quality Control

by NaturPro in Uncategorized Comments: 12

Dietary Supplement Testing and Analysis: Quality Control

Dietary supplements are subject to FDA requirements for good manufacturing practices (cGMP) and 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 partial list of 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
  9. 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
  10. 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
  11. USP Food Fraud Mitigation Guidance, http://www.usp.org/food/food-fraud-mitigation-guidance

 

May
17

Nootropic Supplement Product Development

by NaturPro in Product Development Comments: 1

Development of nootropic supplements as products supporting brain and cognitive health requires a focus on efficacy, quality and purity. Regulatory compliance and safety of ingredients for nootropics are key factors in developing formulas and products.

Facts on Nootropic Supplement Product Development:

  1. NaturPro Scientific assists in the development, sourcing, testing and production of nootropic ingredients and products.
  2. Focus, attention, memory and alertness are all clinical endpoints measured for nootropics.
  3. Nootropics may come in the form of capsules, powders, beverages, tea bags, tablets, liquids and even foods.
  4. Caffeine is one of the most widely consumed nootropics.
  5. Here’s an example of a proprietary Nootropic Tea Formula or NooTea.

What are Nootropics?

From Wikipedia:

Nootropics (pronunciation: /noʊ.əˈtrɒpᵻks/ noh-ə-trop-iks)—also called smart drugs or cognitive enhancers—are drugs, supplements, or other substances that improve cognitive function, particularly executive functions, memory, creativity, or motivation, in healthy individuals.[1][2] The use of cognition-enhancing drugs by healthy individuals in the absence of a medical indication is one of the most debated topics among neuroscientists, psychiatrists, and physicians which spans a number of issues, including the ethics and fairness of their use, concerns over adverse effects, and the diversion of prescription drugs for nonmedical uses, among others.[1][3][4] Nonetheless, the international sales of cognition-enhancing supplements exceeded US$1 billion in 2015 and the global demand for these compounds is still growing rapidly.[5]

The word nootropic was coined in 1972 by a Romanian psychologist and chemist, Corneliu E. Giurgea,[6][7] from the Greek words νους (nous), or “mind”, and τρέπειν (trepein), meaning to bend or turn.[8]

Nootropic Safety and Side Effects

Many ingredients used in nootropic supplements are synthetic substances not found in nature or our food supply. These may be considered unapproved drugs. Central nervous system stimulants and plant alkaloids are also areas of concern for safety, due to their impact on the brain. Many CNS stimulants are considered toxic to the liver and other organs. It is essential that nootropic ingredients are supported by safety studies and a long history of human use, in addition to GRAS (generally recognized as safe) or other suitable safety assessments as determined by regulations.

From Wikipedia: “The main concern with pharmaceutical drugs is adverse effects, and these concerns apply to cognitive-enhancing drugs as well. Long-term safety data is typically unavailable for some types of nootropics[9] (e.g., many non-pharmaceutical cognitive enhancers, newly developed pharmaceuticals and pharmaceuticals with short-term therapeutic use). Racetams—piracetam and other compounds that are structurally related to piracetam—have few serious adverse effects and low toxicity, but there is little evidence that they enhance cognition in individuals without cognitive impairments.[22][23] While addiction to stimulants is sometimes identified as a cause for concern,[24] a very large body of research on the therapeutic use of the “more addictive” psychostimulants indicate that addiction is fairly rare in therapeutic doses.[25][26][27] On their safety profile, a systematic review from June 2015 asserted, “evidence indicates that at low, clinically relevant doses, psychostimulants are devoid of the behavioral and neurochemical actions that define this class of drugs and instead act largely as cognitive enhancers.”[28]

In the United States dietary supplements may be marketed if the manufacturer can show that it can manufacture the supplement safely, that the supplement is indeed generally recognized as safe, and if the manufacturer does not make any claims about the supplement’s use to treat or prevent any disease or condition; supplements that contain drugs or for which treatment or prevention claims are made are illegal under US law.”

Types of Nootropics (From Wikipedia):

Stimulants

 In 2015, systematic medical reviews and meta-analyses of clinical research in humans established consensus that certain stimulants, only when used at low (therapeutic) concentrations, unambiguously enhance cognition in the general population;[28][30][31][32] in particular, the classes of stimulants that demonstrate cognition-enhancing effects in humans act as direct agonists or indirect agonists of dopamine receptor D1, adrenoceptor A2, or both receptors in the prefrontal cortex.[28][30][32][33] Relatively high doses of stimulants cause cognitive deficits.[32][33]

Miscellaneous

  • l-Theanine – A 2014 systematic review and meta-analysis found that concurrent caffeine and l-theanine use has synergistic psychoactive effects that promote alertness, attention, and task switching;[43] these effects are most pronounced during the first hour post-dose.[43]
  • Tolcapone – a systematic review noted that it improves verbal episodic memory and episodic memory encoding.[44]
  • Levodopa – a systematic review noted that it improves verbal episodic memory and episodic memory encoding.[44]
  • Atomoxetine – can improve working memory and aspects of attention when used at an optimal dose.[33]

Dietary supplements

  • Bacopa monnieri – A herb sold as a dietary supplement. There is some preliminary evidence for memory-enhancing effects.[45]
  • Panax ginseng – A review by the Cochrane Collaboration concluded that “there is a lack of convincing evidence to show a cognitive enhancing effect of Panax ginseng in healthy participants and no high quality evidence about its efficacy in patients with dementia.”[46] According to the National Center for Complementary and Integrative Health “Although Asian ginseng has been widely studied for a variety of uses, research results to date do not conclusively support health claims associated with the herb.”[47] According to a review published in the journal “Advances in Nutrition”, multiple RCTs in healthy volunteers have indicated increases in accuracy of memory, speed in performing attention tasks and improvement in performing difficult mental arithmetic tasks, as well as reduction in fatigue and improvement in mood.[48]
  • Ginkgo biloba – An extract of Ginkgo biloba leaf (GBE) is marketed in dietary supplement form with claims it can enhance cognitive function in people without known cognitive problems. Studies have failed to find such effects on memory or attention in healthy people.[49][50]

Racetams

Main article: Racetams

Racetams, such as piracetam, oxiracetam, and aniracetam, are structurally similar compounds, which are often marketed as cognitive enhancers and sold over-the-counter. Racetams are often referred to as nootropics, but this property of the drug class is not well established.[51] The racetams have poorly understood mechanisms of action; however, piracetam and aniracetam are known to act as positive allosteric modulators of AMPA receptors and appear to modulate cholinergic systems.[52]

According to the US Food and Drug Administration, “Piracetam is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, piracetam is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. […] Accordingly, these products are drugs, under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C), because they are not foods and they are intended to affect the structure or any function of the body. Moreover, these products are new drugs as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.”[53]

Null findings in systematic reviews

  • Omega-3 fatty acids: DHA and EPA – two Cochrane Collaboration reviews on the use of supplemental omega-3 fatty acids for ADHD and learning disorders conclude that there is limited evidence of treatment benefits for either disorder.[54][55] Two other systematic reviews noted no cognition-enhancing effects in the general population or middle-aged and older adults.[56][57]
  • B vitamins – no cognition-enhancing effects in middle-aged and older adults.[57]
  • Vitamin E – no cognition-enhancing effects in middle-aged and older adults.[57]
  • Pramipexole – no significant cognition-enhancing effects in healthy individuals.[44]
  • Guanfacine – no significant cognition-enhancing effects in healthy individuals.[44]
  • Clonidine – no significant cognition-enhancing effects in healthy individuals.[44]
  • Ampakines – no significant cognition-enhancing effects in healthy individuals.[44]
  • Fexofenadine – no significant cognition-enhancing effects in healthy individuals.[44]
  • Salvia officinalis – Although some evidence is suggestive of cognition benefits, the study quality is so poor that no conclusions can be drawn from it.[58]
May
17

Turmeric Supplement Testing — Curcumin Products

by NaturPro in Uncategorized Comments: 11

Laboratory testing of turmeric supplements and curcumin products is important for quality, safety, dosage and bioavailability. NaturPro Scientific offers testing and analysis consulting for turmeric, and works with expert research and quality control testing laboratories.

A number of analytical methods and monographs have been developed for turmeric to ensure bioavailability, consistency, potency and purity of curcumin products.

Turmeric Supplement Testing — Curcumin Products

We recommend all turmeric products have routine and/or periodic independent testing for the following parameters:

  1. Curcuminoids (curcumin) by HPLC
  2. Biological activity
  3. Bioavailability
  4. Heavy metals
  5. Microbiology and pathogens
  6. Residual solvents
  7. Pesticides
  8. Natural source by carbon radioisotope (if labeled as ‘turmeric’)
  9. Food allergens
  10. Sudan dyes

Traditional dosage forms listed by the EU Community Herbal Monograph include the following herbal preparations:

  1. Powdered herbal substance
  2. Comminuted herbal substance
  3. Tincture (Ratio of herbal substance to extraction solvent 1:10), extraction solvent ethanol 70% (v/v)
  4. Dry extract (DER 13-25:1), extraction solvent ethanol 96% (v/v)
  5. Dry extract (DER 5.5-6.5:1), extraction solvent ethanol 50% (v/v)
  6. Tincture (Ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 70% (v/v)
    Other solvents are commonly used to extract curcuminoids.

The JECFA has developed a monograph on turmeric oleoresin:

“Obtained by solvent extraction of turmeric (Curcuma longa L.). Only the following solvents may be used in the extraction: acetone, dichloromethane, 1,2-dichloroethane, methanol, ethanol, isopropanol and light petroleum (hexanes).

The selection of a turmeric oleoresin of a particular composition is based on the intended use in food. In general, all turmeric oleoresins contain colouring matter and most contain flavouring matter but some oleoresins are processed to remove aromatic compounds. Commercial products include oleoresins (per se) and formulations in which oleoresin is diluted in carrier solvents and which may contain emulsifiers and antioxidants. Purified extracts of turmeric containing more than 90% total colouring matter are subject to specifications for “Curcumin”.

Turmeric Oleoresins are sold on the basis of “colour value” or “curcumin content”, which generally means the total content of the curcuminoid substances: (I) curcumin, (II) demethoxycurcumin and (III) bis- demethoxycurcumin.

The principle colouring components are:
I. 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene- 3,5-dione
II. 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxyphenyl)-hepta-1,6-diene- 3,5-dione
III. 1,7-bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione

Turmeric Oleoresins, per se, are deep brownish-orange viscous oily fluids, pasty semisolids or hard amorphous solids containing 37-55% curcuminoids and up to 25% volatile oil. Diluted turmeric oleoresin formulations are, generally yellow solutions containing 6-15% curcuminoids and nil to 10% volatile oil.

Residual solvents limits:

Acetone : Not more than 30 mg/kg
Methanol: Not more than 50 mg/kg
Ethanol: Not more than 50 mg/kg
Isopropanol: Not more than 50 mg/kg
Dichloromethane and 1,2-dichloroethane: Not more than 30 mg/kg, singly or in combination

Light petroleum (hexanes): Not more than 25 mg/kg

The WHO monograph for medicinal plants for turmeric is excerpted below:

Rhizome (root) of Curcuma Longa L. (turmeric)

Definition

Rhizoma Curcumae Longae is the dried rhizome of Curcuma longa L. (Zingiberaceae) (1).

Dried rhizomes of Curcuma wenyujin Y.H. Lee et C. Ling, C. kwangsiensis S. Lee et C.F. Liang. and C. phaeocaulis Val. are also official sources of Radix Curcumae or Turmeric Root-Tuber in China (2).

Synonyms

Curcuma domestica Valeton., C. rotunda L., C. xanthorrhiza Naves, Amomum curcuma Jacq. (3–5).

Selected vernacular names

Acafrao, arqussofar, asabi-e-safr, avea, cago rerega, chiang-huang, common tumeric, curcum, curcuma, dilau, dilaw, Gelbwurzel, gezo, goeratji, haladi, haldi, haldu, haku halu, hardi, haridra, huang chiang, hsanwen, hurid, Indian saffron, jiânghuang, kaha, kakoenji, kalo haledo, khamin chan, khaminchan, kilunga kuku, kitambwe, kiko eea, koening, koenit, koenjet, kondin, kooneit, kunyit, kurcum, kurkum, Kurkumawurzelstock, luyang dilaw, mandano, manjano, manjal, nghe, nisha, oendre, pasupu, rajani, rame, renga, rhizome de curcuma, saffran vert, safran, safran des indes, skyer-rtsa, tumeric, tumeric root, tumeric rhizome, turmeric, ukon, ul gum, wong keong, wong keung, yellow root, yii-chin, zardchob (1–3, 6–14).

Description

Perennial herb up to 1.0 m in height; stout, fleshy, main rhizome nearly ovoid (about 3 cm in diameter and 4 cm long). Lateral rhizome, slightly bent (1cm × 2–6cm), flesh orange in colour; large leaves lanceolate, uniformly green, up to 50cm long and 7–25cm wide; apex acute and caudate with tapering base, petiole and sheath sparsely to densely pubescent. Spike, apical, cylindrical, 10– 15cm long and 5–7 cm in diameter. Bract white or white with light green upper half, 5–6 cm long, each subtending flowers, bracteoles up to 3.5 cm long. Pale yellow flowers about 5cm long; calyx tubular, unilaterally split, unequally toothed; corolla white, tube funnel shaped, limb 3-lobed. Stamens lateral, petaloid, widely elliptical, longer than the anther; filament united to anther about the middle of the pollen sac, spurred at base. Ovary trilocular; style glabrous. Capsule ellipsoid. Rhizomes orange within (1, 4, 6, 15).

Plant material of interest: dried rhizome

General appearance

The primary rhizome is ovate, oblong or pear-shaped round turmeric, while the secondary rhizome is often short-branched long turmeric; the round form is about half as broad as long; the long form is from 2–5cm long and 1–1.8cm thick; externally yellowish to yellowish brown, with root scars and annulations, the latter from the scars of leaf bases; fracture horny; internally orangeyellow to orange; waxy, showing a cortex separated from a central cylinder by a distinct endodermis (1, 9, 13).

Organoleptic properties

Odour, aromatic; taste, warmly aromatic and bitter (1, 9, 13). Drug when chewed colours the saliva yellow (9).

Microscopic characteristics

The transverse section of the rhizome is characterized by the presence of mostly thin-walled rounded parenchyma cells, scattered vascular bundles, defi- nite endodermis, a few layers of cork developed under the epidermis and scattered oleoresin cells with brownish contents. The cells of the ground tissue are also filled with many starch grains. Epidermis is thin walled, consisting of cubical cells of various dimensions. The cork cambium is developed from the subepidermal layers and even after the development of the cork, the epidermis is retained. Cork is generally composed of 4–6 layers of thin-walled brickshaped parenchymatous cells. The parenchyma of the pith and cortex contains curcumin and is filled with starch grains. Cortical vascular bundles are scattered and are of collateral type. The vascular bundles in the pith region are mostly scattered and they form discontinuous rings just under the endodermis. The vessels have mainly spiral thickening and only a few have reticulate and annular structure (1, 8, 9).

Powdered plant material

Coloured deep yellow. Fragments of parenchymatous cells contain numerous altered, pasty masses of starch grains coloured yellow by curcumin, fragments of vessels; cork fragments of cells in sectional view; scattered unicellular trichomes; abundant starch grains; fragments of epidermal and cork cells in surface view; and scattered oil droplets, rarely seen (1, 13).

Geographical distribution

Cambodia, China, India, Indonesia, Lao People’s Democratic Republic, Madagascar, Malaysia, the Philippines, and Viet Nam (1, 13, 16). It is exten- sively cultivated in China, India, Indonesia, Thailand and throughout the tropics, including tropical regions of Africa (1, 7, 13, 16).

General identity tests

Macroscopic and microscopic examinations; test for the presence of curcuminoids by colorimetric and thin-layer chromatographic methods (1).

Purity tests

Microbiology

The test for Salmonella spp. in Rhizoma Curcumae Longae products should be negative. The maximum acceptable limits of other microorganisms are as follows (17–19). For preparation of decoction: aerobic bacteria-not more than 107/g; fungi-not more than 105/g; Escherichia coli-not more than 102/g. Preparations for internal use: aerobic bacteria-not more than 105/g or ml; fungi-not more than 104/g or ml; enterobacteria and certain Gram-negative bacteria-not more than 103/g or ml; Escherichia coli-0/g or ml.

Foreign organic matter

Not more than 2% (1, 9).

Total ash

Not more than 8.0% (1, 15).

Acid-insoluble ash

Not more than 1% (1, 9, 15).

Water-soluble extractive

Not less than 9.0% (1).

Alcohol-soluble extractive

Not less than 10% (1).

Moisture

Not more than 10% (1).

Pesticide residues

To be established in accordance with national requirements. Normally, the maximum residue limit of aldrin and dieldrin in Rhizoma Curcumae Longae is not more than 0.05 mg/kg (19). For other pesticides, see WHO guidelines on quality control methods for medicinal plants (17) and guidelines for predicting dietary intake of pesticide residues (20).

Heavy metals

Recommended lead and cadmium levels are not more than 10 and 0.3mg/kg, respectively, in the final dosage form of the plant material (17).

Radioactive residues

For analysis of strontium-90, iodine-131, caesium-134, caesium-137, and plutonium-239, see WHO guidelines on quality control methods for medicinal plants (17).

Other purity tests

Chemical tests to be established in accordance with national requirements.

Chemical assays

Not less than 4.0% of volatile oil, and not less than 3.0% of curcuminoids (1). Qualitative analysis by thin-layer and high-performance liquid chromatography (1, 21) and quantitative assay for total curcuminoids by spectrophotometric (1, 22) or by high-performance liquid chromatographic methods (23, 24).

Major chemical constituents

Pale yellow to orange-yellow volatile oil (6%) composed of a number of monoterpenes and sesquiterpenes, including zingiberene, curcumene, α- and β- turmerone among others. The colouring principles (5%) are curcuminoids, 50–60% of which are a mixture of curcumin, monodesmethoxycurcumin and bisdesmethoxycurcumin (1, 6, 25). Representative structures of curcuminoids are presented below.

Dosage forms

Powdered crude plant material, rhizomes (1, 2), and corresponding preparations (25). Store in a dry environment protected from light. Air dry the crude drug every 2–3 months (1).

Medicinal uses

Uses supported by clinical data

The principal use of Rhizoma Curcumae Longae is for the treatment of acid, flatulent, or atonic dyspepsia (26–28).

Uses described in pharmacopoeias and in traditional systems of medicine

Treatment of peptic ulcers, and pain and inflammation due to rheumatoid arthritis (2, 11, 14, 29, 30) and of amenorrhoea, dysmenorrhoea, diarrhoea, epilepsy, pain, and skin diseases (2, 3, 16).

Uses described in folk medicine, not supported by experimental or clinical data

The treatment of asthma, boils, bruises, coughs, dizziness, epilepsy, haemorrhages, insect bites, jaundice, ringworm, urinary calculi, and slow lactation (3, 7, 8–10, 14).