Navigating Amazon Dietary Supplements Requirements: A 2025 Compliance Guide
Selling dietary supplements on Amazon USA can be highly profitable, but it also involves strict compliance with both Amazon’s internal policies and U.S. federal regulations. In recent years, Amazon has significantly tightened its oversight on supplement listings, making it critical for sellers—both domestic and international—to understand and fulfill all Amazon dietary supplements requirements. This guide offers a comprehensive overview of what’s needed to remain compliant and succeed in this competitive marketplace in 2025.
1. Understanding the Regulatory Landscape
The U.S. Food and Drug Administration (FDA) governs the dietary supplement industry under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Although supplements are regulated as foods rather than drugs, manufacturers must still meet stringent legal and quality control expectations:
- Follow Good Manufacturing Practices (GMPs) under 21 CFR Part 111
- Ensure product labels meet FDA criteria, including proper Supplement Facts and ingredient disclosures
- Use only ingredients that are considered safe and lawful
The Federal Trade Commission (FTC) also monitors product marketing for false or misleading claims.
2. Amazon’s Dietary Supplement Rules
Amazon has established its own dietary supplement compliance policy that complements FDA regulations. These requirements are mandatory for listing and selling nutritional supplements on its platform:
a. Certificate of Analysis (COA)
Each product must have a COA issued within the last six months by an ISO 17025-accredited laboratory. The certificate must verify:
- Ingredient identity and concentration
- Absence of contaminants (e.g., heavy metals, microbiological agents)
- Matching batch or lot number to the product listing
b. Third-Party GMP Certification
While not required by the FDA, Amazon mandates GMP certification from an approved third-party certifier such as:
- NSF International
- UL Solutions
- SGS
- Eurofins
This certificate must include the name and address of the manufacturer and be issued by a recognized, accredited body.
c. Product Label Requirements
To meet Amazon dietary supplements requirements, product labels must:
- Be in English
- Display a complete Supplement Facts panel
- Include the name and contact information of the responsible company
- Avoid unapproved disease treatment claims
If you make structure/function claims (e.g., “supports immune health”), you must include the FDA disclaimer.
d. Manufacturer Letter of Guarantee (LoG)
Although optional, Amazon may request a Letter of Guarantee stating:
- The product is produced following cGMP standards
- All ingredients are safe and permitted for use
- Labeling is accurate and non-deceptive
3. Documentation Checklist for Amazon
To ensure your product is approved for listing on Amazon USA, prepare and submit:
- Recent COA (from ISO 17025-certified lab)
- GMP Certificate (from Amazon-approved certifier)
- Clear product label images
- Letter of Guarantee (recommended)
- Packaging photos
- Any relevant marketing claims and documentation
All uploads should be submitted through Amazon Seller Central’s Manage Your Compliance portal.
4. Common Compliance Mistakes
a. Improper Health Claims
Statements implying the supplement can treat or cure a disease are illegal and prohibited by both FDA and Amazon.
Incorrect: “Lowers cholesterol and prevents heart disease”
Compliant: “Supports heart health”
b. COA Mismatches
Certificates that are outdated, missing key data, or not linked to the actual batch for sale are a major red flag and result in listing removal.
c. Missing U.S. Import Oversight
Foreign manufacturers must register with the FDA and may be required to appoint an FSVP (Foreign Supplier Verification Program) agent if there is no U.S.-based consignee.
5. FSVP and Importer Obligations
The FSVP rule under the FDA requires U.S. importers to verify that foreign-made supplements meet U.S. safety and labeling requirements. If your U.S. distributor is your importer of record, they must:
- Conduct GMP compliance checks
- Maintain up-to-date COAs
- Provide documents to the FDA upon request
If you don’t have a U.S. importer, you’ll need to designate an FSVP agent.
6. Amazon Compliance Monitoring
Amazon uses automated tools to continuously monitor seller listings for regulatory violations. Your product may be flagged or deactivated for:
- Expired or missing COAs
- Non-compliant labels
- Consumer complaints or safety incidents
To maintain listing eligibility, you should:
- Renew documentation every 6–12 months
- Respond quickly to compliance inquiries
- Monitor reviews for adverse event reports
7. Tips to Navigate Amazon Supplement Rules
- Hire a qualified regulatory consultant to ensure all documents and labels meet current standards
- Use certified labs and auditing firms to streamline approvals
- Perform quarterly reviews of your listings and documentation
- Steer clear of risky claims and restricted ingredients in high-risk categories like sexual health and weight loss
Note: Cosmereg can assist with FDA registration, FSVP compliance, supplement labeling, and document preparation for Amazon listing. However, Cosmereg does not provide laboratory testing or GMP certification. These services must be arranged through accredited third parties.
If you need expert support with Amazon dietary supplements requirements, reach out to Cosmereg here or visit www.cosmereg.com.
Conclusion
Successfully selling dietary supplements on Amazon USA in 2025 requires full adherence to both regulatory laws and Amazon dietary supplements requirements. By preparing compliant documents, securing third-party certifications, and avoiding high-risk claims, sellers can reduce the risk of suspension and build consumer trust.
With the right guidance and consistent attention to regulatory detail, you can navigate Amazon’s strict supplement standards and establish a strong, compliant brand in the U.S. market.
