Selling Dietary Supplements on Amazon? As an ISO/IEC 17025:2017 accredited laboratory, Vivariant can help you comply with Amazon’s Certificate of Analysis (COA) requirements.

Why did Amazon introduce lab testing requirements for dietary supplements?

The FDA has issued warning letters to Amazon regarding certain dietary supplements sold on its platform. These warning letters typically cite issues such as the presence of undeclared, potentially harmful ingredients or false or misleading claims made on the product’s label.

For example, In January 2020, FDA sent warning letters to Amazon and other retailers for illegally selling dietary supplements containing the controlled substance sibutramine. In August 2020, FDA sent warning letters to Amazon and other retailers for selling dietary supplements containing picamilon, a drug that is not legally marketed as a dietary supplement in the United States.

The US FDA already has has testing requirements for dietary supplements. Are Amazon’s testing requirements identical? Not exactly. See the venn diagram below:

Note that although safety/contaminant testing is not explicitly called for in Amazon’s current seller’s requirements, they are still required by the FDA.

The test report, also known as a certificate of analysis (COA), must include the following information:

• The name and address of the testing laboratory
• The name and batch number of the product tested
• The date of testing
• A list of all tests conducted, including the test method and reference standard used
• The test results and a statement of compliance with the specifications
• The name and signature of the person responsible for the report

Amazon also has special testing for dietary supplements falling in the sexual enhancement, weight loss and sports nutrition categories to ensure that certain undeclared ingredients are not present.

The COA should also include a statement that the product was tested in accordance with the appropriate monograph or compendial method, such as USP, FCC, or AOAC, or any other established industry standards.

To read Amazon’s requirements for selling Dietary Supplements in the USA, click here.

To read Amazon’s requirements for selling Natural Health Products in Canada, click here.

How can Vivariant help?

• Testing for active ingredients
• Testing for chemical and microbial contaminants
• Testing for undeclared ingredients for supplements in the sexual enhancement, weight loss and sports nutrition categories
• Identity testing for raw materials “quantified by input”

Contact us to learn how to keep your Dietary Supplement and/or NHP listing in good standing on Amazon.