Amazon Certification for Your Brands

In the United States, the Food and Drug Administration (FDA) regulates the quality, safety, and labeling requirements of dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its subsequent amending statutes, including the Dietary Supplement Health and Education Act (DSHEA).

All manufacturers and distributors of dietary supplements are responsible for ensuring their products are safe before they go to market. Dietary supplements come in many forms, such as powders, pills, liquid drops, and oral sprays. The FDA defines a dietary ingredient as a vitamin, mineral, herb, or other botanical, amino acid, or dietary substance to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.

Amazon is mandating that supplement sellers submit documentation to prove:

• That the product meets the potency claims specified on the label
• That the product is manufactured under current Good Manufacturing Practices as listed in 21 CFR Part 111
• That only lawful and safe (defined in section 402 (f) of the FD&C Act) ingredients are utilized
• That concentration of active ingredients as stated on the label is safe for consumption

If you are contacted by Amazon for compliance documents, complete the following steps to submit the requested information:

1. In Seller Central, select Inventory, and then click Add a Product.
2. Search for the ASIN you want to sell.
3. In the search results, click the Listing limitations apply link next to the ASIN.
4. Click Request Approval to start the application process.

Indications are that Amazon will require full compliance with the new requirements for all dietary supplements sold on its platform by February 2021.

If you do not provide the required information by the applicable deadline, Amazon may:

• Remove the relevant product listings
  
• Suspend your ability to add new products and/or listing privileges
  
• Withhold any payments due to you
  
• Pursue legal action

Please provide copies of the below items:

• Finished Product Specification
• Batch Records (Blending Discharge, Blending Discharge Table and Blending Yields)
• Input weights of each ingredient + run total weight must be clearly visible
• Picture of product (Lot # and Supplement Table)
• Deviation documentation (if applicable)
• Manufacture + Expiration date (if applicable)
• Submission form, information needs appear exactly as it should on COA.