Stricter Documentation Now Required for Supplements Sold on Amazon

Stricter Documentation Now Required for Supplements Sold on Amazon

December 18, 2020 By

Dietary supplement marketers selling on Amazon are now being asked to provide testing results and other manufacturing information on their supplement products in order to remain on Amazon’s site for sale.1,2 This request began just a couple of weeks ago, and marketers should be aware of having current documentation for their supplement products. Sellers of dietary supplements have until February 2021 (no specific date as of yet) to provide Amazon documented proof that their products adhere to the FDA’s regulatory requirements, including truthful labelling and compliance with current Good Manufacturing Practices (cGMP).

Documentation to be submitted as proof includes the following:  
  • Potency claims for the label required to be met and verified
  • cGMP are met as per 21 CFR Part 111 in the manufacturing of supplements 3
  • Ingredients used are safe and lawful under the FD&C Act Section 402 (f) [presents a significant or unreasonable risk of illness or injury under]
  • The label quantities of ingredients and labeling of the supplement is safe for consumption.

As part of the compliance checklist by Amazon, online retailers are now required to provide updated / current Certificates of Analysis (C of A) for each supplement product, as well as clear pictures of their product labels for all sides of the package, including the ingredient list and the Supplement Facts panels. The C of As should be from an ISO/IEC 17025 accredited laboratory as well.   However, the requirement does not appear to apply to food products containing Nutrition Facts panels, even though in some cases, the products may appear to be comparable to supplements in their marketing and packaging and labels.

NOW foods, a manufacturer based in Illinois, had recently expressed support for Amazon’s new policy for requesting documentation for dietary supplement compliance,4 which had expressed concern in the past to Amazon about adulterated or non-compliant supplement products. In some cases, NOW had even conducted their own independent testing which demonstrated evidence of label claims not matching the contents of the product and other quality-related problems.  In their assessment, NOW foods had tested several products for potency, and compared to their own products containing comparable ingredients, and found that the products did not meet the label claims for the potency of the stated ingredients. The findings were then provided to Amazon to demonstrate the concern in the quality of some products

Over the coming weeks, Amazon will continue to request documentation from sellers of dietary supplements, which is slated to continue until February 2021, so companies have until that time to provide documentation of compliance for products in order to continue selling on Amazon’s platform.

Contact dicentra for assistance in assessing your products for label compliance, testing, and cGMP, to ensure your Amazon products stay on the shelf.

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