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.

While Amazon’s existing policy requires that any dietary supplements listed on its platform conform to certain parameters (for example, no products may be listed which have been identified in an FDA Warning Letter as adulterated or misbranded), the new policy places affirmative reporting obligations on sellers.  Specifically, the new policy requires that for each dietary supplement product, manufacturers must submit for Amazon’s approval: (i) either a Certificate of Analysis (COA) from an ISO/EIC 17025 accredited laboratory, a COA from an in-house laboratory that is compliant with current good manufacturing practices (“cGMPs”), or evidence of product enrollment in an Independent Quality Certification Program such as NSF Certified for Sport®, BSCG Certified Drug Free®, or the USP Dietary Supplement Verification Program; and (ii) product images which clearly show the entirety of the product label and contain the name and contact information of the brand owner or manufacturer.  The COA requirement applies to finished dietary supplement products, with additional obligations for herbal supplements.  For example, for herbal supplements which declare quantified plant constituents on their Supplement Facts panel, COAs must be submitted for each dietary ingredient.

The new policy also requires dietary supplement sellers to provide Amazon with a Letter of Guarantee issued on official brand letterhead providing assurances that (i) the product was manufactured under cGMPs, (ii) only lawful and safe ingredients are utilized in the product, and (iii) the concentration of active ingredients as stated on the label is safe for consumption.  These new obligations apply to both new product listings as well as existing products which have already been listed for sale on Amazon, with a compliance deadline of May 31, 2021 for existing product listings.  Accordingly, any sellers with existing dietary supplement product listings must submit the required documentation and obtain approval of their listings by May 31, 2021.  The stated penalties for failure to provide the newly required information include removal of product listings, suspension of the seller’s ability to add new products or list products, a withholding of payments due to the seller, and/or potential additional legal action.

It is therefore especially critical that dietary supplement brands selling on Amazon are promptly taking steps to comply with the new policy and properly managing their quality obligations to ensure that their products are being manufactured in accordance with cGMPs, and are strongly advised to have detailed agreements in place with manufacturers which clearly spell out their respective quality and compliance responsibilities.

This alert does not purport to be a substitute for advice of counsel on specific matters.

Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Long Island, New York City, Rochester, Saratoga Springs, Syracuse and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.