If you list products on Amazon, you must comply with all federal, state, and local laws and Amazon policies applicable to those products and product listings.
In the United States, the Food and Drug Administration (FDA) regulates the manufacturing, packaging, holding and labeling of dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and its subsequent amending statutes, including the Dietary Supplement Health and Education Act (DSHEA). The FDA defines a dietary ingredient as a vitamin, mineral, herb or other botanical, amino acid, or dietary substance for use to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Dietary supplements come in different forms such as powders, pills, liquid drops, and oral sprays, and include categories such as vitamins and minerals, herbs and botanicals, sexual enhancements, weight management, and body building and sports nutrition. Dietary supplements may not contain articles that are approved as new drugs, other undeclared drug ingredients, or make disease claims.
Amazon requires selling partners to submit documentation that reflects compliance with applicable regulations or standard requirements, including but not limited to the following:
21 CFR 101.36 - Nutritional Labeling of Dietary Supplements
21 CFR 111 - Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements
21 CFR 117 - Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk Based Preventative Controls (HARPC) for Human Food
Effective December 6, 2021, sexual enhancement and weight loss dietary supplement products cannot be sold in single or double pill packs. Single and double pill pack offerings are prohibited on Amazon.
For additional product requirements related to dietary supplements, go to the Restricted Products Help page on Dietary supplements.
I. All dietary supplements
For each dietary supplement product or ASIN, you must submit the following documents:
Evidence of product enrollment or participation in one of the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, or UL Brand Certification Program.
II. Supplements intended for sexual enhancement or weight loss and weight management
In addition to the above requirements, each dietary supplement product that is intended for sexual enhancement or weight loss and weight management must also submit the following documentation:
You must submit a finished product Certificate of Analysis (COA) to support the amount per unit or per serving of each dietary ingredient claimed on the applicable facts panel. The COA submitted to Amazon must have been issued within the past 12 months; must be in Portable Document Format (.pdf); and must contain the following information:
Testing requirements for sexual enhancement and weight loss and weight management supplements
For sexual enhancement and weight loss supplements, the COA must include testing results for the specific compounds outlined below. The general COA requirements above still apply.
|Category||Test for||Frequency of submission|
|Weight loss and weight management||
We reserve the right to test for additional substances and increase the frequency of testing at any time.
Product images must meet the following requirements:
If we contact you to submit compliance documents, complete the following steps to start the application process:
Go to the Approval Required view within the Fix Your Products in Seller Central, and select Request Approval.
Alternatively, use the following steps to request approval:
Established laboratory assays of finished product should be accomplished whenever possible. If that is not possible due to unavailability of a scientifically valid test method, then you must provide a COA (or additional documentation) from the manufacturing facility for the ingredients used in the manufacture of the finished product. The COA must verify that the ingredients used in the manufacture of the finished product meet specifications for identity, purity, strength, or composition without testing, as per 21 CFR 111.75 (d). As stated above, a valid GMP certificate for the manufacturing facility must also be submitted.
The proprietary blend must be listed on the product label in accordance with 21 CFR 101.36 (c). The COA may contain the quantitative amount for the total of the dietary ingredients listed in the proprietary blend; however, if this is not possible due to the unavailability of a scientifically valid test method for the proprietary blend, you may list the proprietary blend “by input.” If you list the proprietary blend "by input," you must also submit the additional documentation set forth in question 2 above.
No, only the testing for the specific compounds listed above for sexual enhancement and weight loss supplements must be conducted by an external ISO/IEC 17025 accredited laboratory. (For additional details about Certificate of Analysis specifications, go to Requirements for the Certificate of Analysis.)
You must have a COA with a laboratory assay or assays for each dietary ingredient if the Supplement Facts panel declares:
If you have been contacted but believe that your product is not a dietary supplement, please submit product images of all sides of the product packaging and a brief explanation in the comments section.
If you do not provide the required information by the applicable deadline, we may take the following actions:
We reserve the right to take any further actions that may be necessary in our sole discretion.
Updated on February 17, 2022.