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As one of the largest channels facilitating the purchase and sale of dietary supplements, Amazon has often faced criticism for its lack of oversight and failure to take action to restrict the sale of supplements on its platform which are illegal, misbranded, adulterated, or otherwise dangerous for consumers. In response, Amazon recently updated its dietary supplement policy to impose additional obligations on dietary supplement sellers to ensure that products marketed on its platform are safe for consumers and are manufactured and labeled in compliance with Food & Drug Administration (“FDA”) regulations.
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To summarize, the key aspects required by Amazon are:
1. A Certificate of Analysis (CoA) from an ISO/IEC 17025 accredited laboratory (in-house or third party) for each dietary supplement you are applying to list OR product enrollment in an Independent Quality Certification Program, such as NSF International Sport, BSCG, Informed-Choice/Informed-Sport, or active participants of USP Dietary Supplement Verification Program
2. A Letter of Guarantee from the brand owner of the product that guarantees compliance with current Good Manufacturing Practices (21 CFR Part 111); assurances that the products only contains lawful and safe ingredients (as defined in section 402 (f) of the FD&C Act); and that labels are accurate.