Amazon Dietary Supplement Testing | 101 Guide

Basic FAQ Guide

1. Why does Amazon require lab testing for dietary supplements?
   Amazon mandates third-party testing to ensure product safety, label accuracy, ingredient authenticity, and absence of unsafe contaminants for supplements sold on its marketplace. This helps protect consumers and maintain compliance with applicable regulatory standards.
2. Is GMP certificate verification required for low-risk supplements?
   Yes. Amazon’s updated supplements policy applies to all dietary supplements, including low-risk products. Sellers may be required to submit a current third-party GMP certificate verified by an Amazon-approved TIC for supplements, even if additional lab testing is not requested.
3. What products fall under Amazon’s dietary supplement testing requirements?
   Previously Amazon focused on high-risk categories like weight loss, sexual enhancement, and sports nutrition, but its expanded policy now covers ALL dietary supplements sold on the marketplace. Sellers must verify compliance to maintain active listings.
4. What type of laboratory must perform the testing?
   Amazon accepts results from labs accredited to ISO/IEC 17025, demonstrating technical competence and valid analytical methods. Third-party Testing, Inspection, and Certification (TIC) organizations then verify those results for Amazon’s compliance program. ISO/IEC 17025 accreditation means the lab follows internationally recognized standards for testing quality and accuracy. Certified Laboratories is ISO/IEC 17025-accredited and an Amazon-approved TIC.
5. Do I need to use an Amazon-approved lab?
   Not necessarily – testing can be done at any ISO/IEC 17025-accredited lab (like Certified Laboratories). However, the results must be submitted through an Amazon-approved TIC verifier for compliance confirmation.
6. What tests does Amazon typically require?
   The exact tests vary by product type, but commonly include:
   • Identity testing – confirms ingredients are what you claim.
   • Potency/content testing – verifies amounts of dietary ingredients.
   • Purity & contaminant screening – heavy metals, microbes, pesticides, etc.
   • Label conformity – test results must align with the Supplement Facts panel.
   • Adulterant screening – especially for high-risk formulations like weight loss or sexual enhancement products.
7. What documentation must I submit to Amazon?
   To satisfy the policy you will need:
   • Certificate of Analysis (COA) (also called a Test Report) – from an ISO 17025-accredited lab showing key test results.
   • Third-party verification – submitted to Amazon via an approved TIC service.
   • GMP compliance documentation – proof the product was manufactured under current good manufacturing practice (cGMP) standards. This means that the facility/facilities manufacturing and/or packaging the final products must have an independent, third-party audit and certification to show compliance with FDA’s GMP requirements for dietary supplements (21 CFR 111 and 117).
8. How often do I need to test?
   Testing is typically required annually to maintain compliance. Amazon may also request additional testing if product changes or random sampling occur.
9. What are common reasons Amazon rejects supplement listings?
   • Missing or incomplete COA.
   • Lab results not submitted through an approved TIC.
   • Tests not performed by an ISO/IEC 17025-accredited lab.
   • Labels that contain disease claims or unapproved language.
   • Undeclared substances or contaminants above allowable limits.
   • Out-of-date third-party facility GMP certification.
10. Can I use results from an in-house lab?
    Yes, if the in-house lab is ISO/IEC 17025 accredited. However, Amazon will not accept results until they are verified by a third-party TIC provider. This often means submitting your COA to them for review.
11. Do foreign lab results count?
    Lab results from accredited ISO/IEC 17025 labs outside the U.S. can be accepted only if they meet Amazon’s policy requirements and are submitted to an approved TIC verifier. Always check Amazon’s current approved provider list in your Seller Central.
12. What happens if my product fails testing?
    Amazon’s focus is on consumer safety, so comprehensive, accurate supplement lab testing, and documentation are essential. Failing to provide compliant documentation can lead to:
    • Listing removal.
    • Account warnings or restrictions.
    • Delays in product approval.
    • Inability to sell affected SKUs (ASINs) until compliance is confirmed.
13. How do I start testing with Certified Laboratories?
    Certified Laboratories provides:
    • ISO/IEC 17025-accredited analytical and microbiology testing.
    • Support for Amazon testing requirements (heavy metals, contaminants, ingredient potency and/or identity, pesticides, and drug adulterants).
    • Assistance with COA preparation for submission through Amazon’s compliance dashboard.

Ready for more? Our Cosmetics, OTC, & Supplements Resource Library contains more resources on Amazon dietary supplements testing:

• Amazon Dietary Supplements Testing | Glossary
• Amazon Dietary Supplements Testing | 201 Guide
• Amazon Dietary Supplement Testing | 301 Guide