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

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

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


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

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 Readiness, Supplier Qualification
5. GMP’s, Specifications, and Analytical Testing
6. Manufacturing Feasibility
7. Contract Manufacturer Qualification and Negotiation 

Contact Us

• Email: blake@npscientific.com
• Website: www.npscientific.com
• Twitter: @NaturalBlake
• Instagram: @NaturPro

As Dietary Supplement Consultants we often are asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of product, and whether its finished product, or an ingredient or raw material.

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

The 4 Initial Steps to Dietary Supplement Product Development

There are four basic elements to developing a groundbreaking product:

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.

The Secret of Getting Ahead is Getting Started.

Product developing plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A great 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