- 21 CFR: Refers to Title 21 of the Code of Federal Regulations, which governs food and drug law in the U.S., including dietary supplement labeling (e.g., 21 CFR 101.36) and manufacturing practices (21 CFR 111 and 117). These rules form the foundation of Amazon’s compliance requirements.
- Active Pharmaceutical Ingredient (API): A substance with pharmacological activity – in supplements this refers to undeclared drug ingredients that Amazon expressly prohibits. Supplements must be tested to verify they do not contain APIs.
- API Adulterants Panel: A lab screening test that checks for undeclared drug ingredients (APIs) that may be illegally added to dietary supplements.
- Certificate of Analysis (COA): Also called a test report. A formal laboratory-prepared document that details test results for a product sample, confirming identity, potency, purity, and absence of contaminants. Amazon requires COAs from an ISO/IEC 17025 accredited lab for dietary supplements as proof of lab testing.
- Contaminant Screen: Substances like heavy metals, microbes, pesticides, or THC that must be tested for and shown to be below safe or allowable limits. Amazon requires contaminant screening to ensure safety.
- cGMP (Current Good Manufacturing Practices): A set of quality and safety standards for dietary supplement production enforced by the FDA (e.g., 21 CFR 111/117). Amazon mandates that supplements be made in cGMP-compliant facilities, verified by third-party certification.
- Dietary Supplement: Per FDA’s Dietary Supplement Health and Education Act (DSHEA), this is a product taken orally intended to supplement the diet, including vitamins, minerals, herbs, amino acids, and related compounds. Amazon’s policy aligns with this definition.
- GFSI: Global Food Safety Initiative provides global, harmonized food safety standards, benchmarking recognized certification programs to ensure safe food supply chains.
- ISO/IEC 17025: International standard for testing and calibration laboratories demonstrating technical competence and quality. Amazon requires COAs to come from ISO/IEC 17025-accredited labs and be verified by an approved third-party TIC. Certified Laboratories is ISO/IEC 17025 accredited and is an Amazon-approved TIC for supplements.
- Label Claim Verification: Testing that confirms that the amount and identity of dietary ingredients match what’s declared on the product label (e.g., “Supplement Facts”). This helps ensure the product isn’t misbranded.
- Manage Your Compliance Dashboard: The Seller Central interface where sellers can submit COAs to Amazon-approved TIC verifiers for supplements, request lab services, and manage compliance documentation.
- NSF/ANSI 455-2 and 229 GMP: Facility certification standards that verify a dietary supplement manufacturer follows Good Manufacturing Practices (GMP) for consistent quality, safety, and compliance.
- Prohibited Ingredients: Ingredients Amazon will not allow in dietary supplements, including certain drugs, prohibited substances under DEA schedules, and materials from protected species. Products must be tested to confirm absence of these prohibited ingredients.
- Specifications: Pre-defined criteria for product attributes (e.g., identity, strength, purity, composition) that certified lab methods must confirm through testing. Specifications are part of both FDA and Amazon requirements. We explain dietary supplement component specifications and testing here.
- SQF Dietary Supplements Food Safety Code: A globally recognized certification program that confirms a facility follows food safety and quality management requirements for manufacturing dietary supplements, including strong controls for safety, traceability, and compliance.
- Supplement Facts Panel: The label section required by FDA regulations showing serving size, ingredients, and quantities. Amazon requires compliant Supplement Facts panels and tests that support the claims in that panel. Learn more about Supplement Facts panels here.
- TIC (Testing, Inspection, and Certification) Verifier: An Amazon-approved third-party service, such as Certified Laboratories, that reviews COAs and validates compliance with Amazon’s dietary supplement policy. Sellers submit COAs via a TIC verifier as part of compliance.
- Unauthorized Claims (Disease Claims): Any label statement suggesting a product diagnoses, treats, cures, or prevents disease. These are prohibited on supplements unless approved by FDA. Amazon enforces this rule as part of labeling compliance.
- USP GMP for Dietary Supplements: Good Manufacturing Practices (GMP) standards used to help ensure dietary supplements are consistently produced for quality, safety, and label accuracy, following USP and FDA expectations.
Ready for more? Our Cosmetics, OTC, & Supplements Resource Library contains more resources on Amazon dietary supplements testing:
- Amazon Dietary Supplement Testing | 101 Guide
- Amazon Dietary Supplements Testing | 201 Guide
- Amazon Dietary Supplement Testing | 301 Guide
