Quality and safety of dietary supplements are of utmost importance to the consumer. These supplements are regulated by the United States Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), with additional oversight through the Dietary Supplement Health and Education Act (DSHEA). These acts were put into place to protect consumers by regulating the ingredients and forms of dietary supplements.
Requirements for Selling Dietary Supplements on Amazon
Many dietary supplement suppliers use Amazon as a means for selling and distributing their products. Amazon has implemented requirements for all sellers of dietary supplements, including those for weight management, body building, and sports nutrition. Sellers must, at a minimum, demonstrate compliance with three Good Manufacturing Practice (GMP) regulations:
21 CFR 101.36 – Nutritional Labeling of Dietary Supplements
21 CFR 111 – Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations of Dietary Supplements
21 CFR 117 – Current Good Manufacturing Practices (cGMP), Hazard Analysis, and Risk Based Preventive Controls (HARPC) for Human Food
Additionally, dietary supplement products must either be tested by a laboratory accredited to ISO/IEC 17025:2017 or be enrolled in a third-party certification program. Accredited testing ensures validity of results through validated methods, competent personnel, and documented processes. Product certification provides the same assurance.
ANAB Accreditation for Labs Testing Dietary Supplements
ANAB accredits numerous laboratories that test dietary supplements under an ISO/IEC 17025:2017 management system. Oftentimes, the laboratory accreditation is enhanced with additional requirements from AOAC using the AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals.
ANAB also accredits two of the product certification programs approved by Amazon, NSF/ANSI 173 and the UL National Brand Certification Program (NBCP). NSF/ANSI 173 establishes requirements for the ingredients in dietary supplements via three components: labeling, toxicology review, and contaminant review. The UL National Brand Certification program assesses the extent to which an organization conforms to the applicable regulations and/or standards regarding their products being manufactured, packaged, shipped, and/or stored.
Amazon has recognized that accreditation and certification are critical to product quality and consumer safety. Implementing these requirements on sellers of dietary supplements will ensure that the products sold on the Amazon platform not only comply with FDA requirements, but also meet the high-quality standards that accreditation and certification bring.
Refer to Amazon’s Dietary Supplements Policy for additional information.