The Internet created access to more products and services than ever imaginable. You can literally buy anything on Amazon. The site has made getting things or selling things easier. Unfortunately, loose regulation has caused a rise in adulterated or tainted supplements being readily available for consumer purchase. These products are meant for the purpose of promoting health, so consumers want to know the certainty of the product. Plus, health is a major topic of discussion in today’s Covid world. Amazon took notice and changed their policy for selling these dietary supplements earlier in 2021.
To start, what is the definition of a dietary supplement? The US Food and Drug Administration (FDA) describes a dietary ingredient as “a vitamin, mineral, herb or other botanical, amino acid, or dietary substance for use to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of the preceding substances”. These come in the form of pills, powders, liquid drops, and oral sprays. Dietary supplements are categorized as vitamins and minerals, herbs and botanicals, sexual enhancements, weight management, and body building and sports nutrition. Anything from Flintstones vitamins to Viagra is considered a supplement by the FDA.
The updated policy about selling dietary supplements on Amazon requires documentation proving that the dietary ingredients listed are compliant with specific regulations found in chapter 21 of the Code of Federal Regulations (21 CFR):
- Nutritional Labeling of Dietary Supplements (part 101.36)
- Current Good Manufacturing Practices (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements (part 111), and
- cGMP, Hazard Analysis, and Risk Based Preventative Controls (HARPC) for Human Food (part 117)
For each dietary supplement sold on Amazon, the following documents need to be submitted as evidence that the ingredients meet the requirements of 21 CFR:
- A valid GMP certificate issued by an accredited third-party certification body
- A finished product Certificate of Analysis (COA) of the declared dietary ingredients issued by an ISO/IEC 17025-accredited laboratory, with the accredited laboratory’s certificate number listed, or by an in-house laboratory that is compliant with 21 CFR Part 111 or 21 CFR Part 117*
- Evidence of product enrollment or participation in a recognized third-party quality certification program
*Note: for supplements intended for sexual enhancement or weight loss/management, the finished product COA must come from an ISO/IEC 17025-accredited laboratory.
Amazon prefers that the laboratories issuing these COAs use official AOAC test methods, but there are allowances for labs that use novel, modified, or in-house methods.
The onus is on the seller, not the laboratory issuing the COA, to comply with these requirements. You, as the seller, are responsible for ensuring your product meets this regulatory compliance and can be held liable if not. Part of any business is making sure your customers are satisfied and delighted with your product. A bad review or failure of compliance sullies a good reputation. Please note that you may need to have your product(s) tested by more than one ISO/IEC 17025-accredited laboratory to cover all the ingredients in your product(s).
As the only independent, non-profit accrediting body in the United States, A2LA accredits more than 75 dietary supplement testing laboratories to ISO/IEC 17025. Many of these labs are also accredited to the 2018 AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, which provide additional confidence that the documentation for your product will meet or exceed the Amazon seller requirements. Fulfilling these standards means your product is easily sold throughout the world, as A2LA accreditation is internationally recognized. This means you can expand your market outreach, just by complying to ISO/IEC 17025.
If you are a laboratory that performs testing on dietary supplements, you can help ensure sellers are able to meet the Amazon requirements by becoming accredited to ISO/IEC 17025 (and the optional 2018 AOAC guidelines) by applying on our website. The accreditation process is straightforward, and it can take as little as 4 months to become accredited; sometimes less, depending on how ready your lab is. Contact A2LA to discover why straight ISO/IEC 17025 accreditation and accreditation to the optional AOAC guidelines will set your organization up for success.
Please refer to Amazon’s Dietary Supplement Policy for further information.