Amazon cGMP Mandate (2026)

Amazon requires dietary supplement sellers to show that their products are made in a facility with a current cGMP audit or certification from an accredited third party (FDA's 21 CFR 111 or 117 cGMP regulations); private, first-party and consulting audits and FDA inspections are not accepted, and a current GFSI food safety certification at the facility may satisfy the requirement. An Amazon-authorized TIC provider reviews the documents and submits them to Amazon (third-party verification requirement effective April 2, 2024). Amazon updates its authorized-provider list monthly, so confirm the current list under Select a Provider in Seller Central rather than relying on a fixed count. Response deadlines are listing-specific; read the 'Address issue by' date Amazon shows for that listing in Account Health rather than assuming a fixed number of days. Amazon also offers a Fast-Track Compliance Program: brands already certified by an accepted Fast-Track partner (current partner list in Seller Central) may have compliance auto-validated using existing certification data. For 3PL evaluation, this mandate creates a new quality signal: a 3PL that can demonstrate its holding operations support or do not interfere with a brand's cGMP compliance becomes more valuable for Amazon sellers.