Overview

Amazon enforces strict compliance requirements for sellers listing dietary supplements on its marketplace. These rules align with FDA regulations and cover everything from product testing and labeling to prohibited marketing claims. Sellers who fail to meet these standards risk listing suppression, ASIN removal, or account-level enforcement actions.

Key Points / What Sellers Need to Know

• Third-Party Testing Is Mandatory — Amazon now requires sellers to work with accredited third-party testing, inspection, and certification (TIC) providers to validate product compliance. Submitting testing documentation directly to Amazon is no longer accepted.
• FDA Regulations Apply — Dietary supplements sold in the U.S. must comply with FDA rules under the Dietary Supplement Health and Education Act (DSHEA) and related federal regulations, including 21 CFR 111 (cGMP for supplements) and 21 CFR 101 (labeling).
• cGMP Certification Required — Products must be manufactured in facilities that hold current, valid cGMP certifications from accredited third-party auditors. Self-audits, first-party audits, consulting audits, and FDA inspections alone are not sufficient.
• Strict Labeling and Image Standards — Product detail pages and images must accurately reflect label information, including supplement facts panels, ingredient lists, and quantity counts.
• Prohibited Claims Can Get You Suspended — Disease claims, drug comparison claims, and misleading potency statements are explicitly banned unless pre-approved by the FDA.
• Ongoing Surveillance — Even after approval, Amazon may require periodic retesting or additional evaluation at any time as part of quality control efforts.

Compliance Requirements and Testing

Amazon requires that all dietary supplements have been tested against applicable federal regulations and recognized standards. Key standards include 21 CFR 111 for current Good Manufacturing Practices specific to dietary supplements, 21 CFR 117 as an equivalent standard, and NSF/ANSI 173-2024 for dietary supplement compliance. Sellers must engage an accredited TIC service provider either to test their products directly or to validate existing testing documentation. Accepted cGMP certification programs include those administered by NSF, UL, USP, SAI Global, and similar accredited bodies. Certifications must be current and in good standing — expired certificates will not be accepted.