As one of the largest channels making it easy to buy and sell dietary supplements, Amazon has often been criticized for its lack of oversight and failure to take action to restrict the sale of supplements on its platform which are illegal, mislabeled, falsified or otherwise dangerous. for consumers. In response, Amazon recently updated its Dietary Supplement Policy to impose additional obligations on sellers of dietary supplements to ensure that products marketed on its platform are safe for consumers and are manufactured and labeled in accordance with the requirements. the regulations of the Food & Drug Administration (“FDA”).
While Amazon’s existing policy requires that all dietary supplements listed on its platform comply with certain parameters (for example, no product can be listed that has been identified in an FDA warning letter as being falsified or mislabeled), the new policy imposes affirmative reporting obligations on sellers. . Specifically, the new policy requires that for each dietary supplement product, manufacturers submit for Amazon approval: (i) either a Certificate of Analysis (COA) from an ISO / EIC 17025 accredited laboratory, a COA from an in-house laboratory that complies with current Good Manufacturing Practices (“cGMP”), or proof of product enrollment in an independent quality certification program, such as NSF Certified for Sport®, BSCG Certified Drug Free ® or USP Dietary Supplement Verification Program; and (ii) product images that clearly show the entire product label and contain the name and contact details of the brand owner or manufacturer. The COA requirement applies to finished dietary supplement products, with additional requirements for herbal supplements. For example, for herbal supplements that declare quantified plant constituents on their supplement information panel, certificates of authenticity must be submitted for each food ingredient.
The new policy also requires that sellers of dietary supplements provide Amazon with a letter of guarantee issued on official brand letterhead guaranteeing that (i) the product has been manufactured in accordance with GMP, (ii) only ingredients legal and safe are used in the product, and (iii) the strength of the active ingredients stated on the label is safe for consumption. These new obligations apply to both new product listings as well as existing products that have already been offered for sale on Amazon, with a compliance deadline of May 31, 2021 for existing product listings. Accordingly, all vendors with existing dietary supplement product listings must submit the required documentation and obtain approval of their listings by May 31, 2021. Penalties for failure to provide the newly requested information include deletion product listings, the suspension of the seller’s ability to add new products or list products, withholding of payment due to the seller and / or possible additional legal action.
It is therefore particularly essential that dietary supplement brands selling on Amazon take swift action to comply with the new policy and properly manage their quality obligations to ensure that their products are manufactured in accordance with cGMP, and it is highly advised to have detailed agreements in place with manufacturers that clearly state their respective responsibilities for quality and compliance.