Amazon updates dietary supplement compliance program

Amazon updates dietary supplement compliance program

November 2021: Sets new requirements for 3rd-party certification and for sexual enhancement and weight loss / weight management products

Published: Wednesday, November 10, 2021

Early this month, Amazon updated its policy for vendors of dietary supplements on the Amazon platform. Amazon has maintained such a policy since at least late 2018, and has amended the policy on several occasions in the interim.

In revisions to that policy posted on November 1 and November 3 and of significance to dietary supplements generally, Amazon is changing a policy that to date has allowed dietary supplement marketers to meet the policy requirements by providing certificates of analysis to confirm identify of their products. Under the new policy, Amazon will now also require each vendor to submit a “valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body.” The policy identifies several such bodies as acceptable to meet this new requirement, including: NSF/ANSI 455-2, NSF/ANSI 173 Section 8, GRMA 455-2, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

In another significant revision to the policy, Amazon has now directed particular attention to any listed product “that is intended for sexual enhancement or weight loss and weight management.” Under the revised policy, Amazon will now require vendors of these products to submit documentation, in the form of a finished product certificate of analysis issued at least annually by an independent ISO/IEC 17025 accredited laboratory, “for the compounds listed” in an accompanying table.

The identified compounds for sexual enhancement products are sildenafil and several of its analogues, including tadalafil, vardenafil, sulfoaildenafil and desmethyl carbodenafil. For weight loss and weight management products, the compounds identified include sibutramine, desmethylsibutramine, phenolphthalein and fluoxetine. None of the identified compounds are lawful dietary ingredients, though each has been identified by the Food and Drug Administration in product recalls or consumer advisories related to illegal drugs that have been flagged by FDA as masquerading as dietary supplements and marketed either for male sexual enhancement or for weight loss (but not for weight management).

AHPA will continue to maintain attention to Amazon’s policy for dietary supplements and the effect of that policy on our members. Please contact Robert Marriott, AHPA’s Director of Regulatory Affairs, if you would like to contribute to and participate in future discussions relevant to this matter.

The current Amazon policy for dietary supplements is here.

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