If you list products on Amazon, you must comply with all federal, state, 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). All manufacturers and distributors of dietary supplements are responsible for ensuring that their products meet all regulatory standards before they go to market. The dietary supplements come in many forms such as powders, pills, liquid drops, and oral sprays. The FDA defines a dietary ingredient as a vitamin, mineral, herb or other botanical, amino acid, 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.
Amazon requires that Dietary Supplements meet applicable regulations or standard requirements, including but not limited to the below:
21 CFR 101.36 Nutritional Labeling of Dietary Supplements
21 CFR Part 111 Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements.
Please also see the Restricted Products help page on Dietary Supplement for additional product restrictions.
For Dietary Supplements, you must submit:
If you believe that your product is not a dietary supplement, please submit product images of all side of the product packaging and a brief explanation in the comments section.
If you would like to seek approval to sell the affected products, complete the following steps to start the application process:
We only require that the laboratory (in-house or third party) currently holds an ISO/IEC 17025 accreditation. Although we do not require accreditation specific to a certain test, the fact that the laboratory holds any ISO/IEC 17025 accreditation demonstrates general competence of preforming tests and calibrations.
Industry recognized laboratory assays of finished product should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, then you must provide either a CoA for the raw materials or additional information (such as ingredient identity testing) that can verify that the ingredients meet their specifications for identity, purity, strength, or composition as claimed on the label without testing, as permitted by 21 CFR 111.75(c).
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 all the ingredients listed in the proprietary blend; however, if this is not possible due to the unavailability of a scientifically valid test method for one or more ingredients, you may list the ingredient “by input” subject to the conditions set forth in question #2 above.
You must have a CoA with a laboratory assay(s) for each ingredient if the supplement facts panel declares:
Yes, Amazon accepts certifications for review from the following independent organizations: NSF International Sport, Banned Substances Control Group (BSCG), Informed-Choice/Informed-Sport, or active participants of USP Dietary Supplement Verification Program. These certifications are an acceptable alternative to a CoA and LoG. Images are still required.
If you do not provide the required information by the applicable deadline, we may:
We reserve the right to take any further actions that may be necessary in our sole discretion.