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). 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. Dietary supplements come in different forms such as powders, pills, liquid drops, and oral sprays.
If your product has a Supplement Facts panel, you will be required to submit compliance documentation. If your product has a Nutrition Facts panel, this policy does not apply to you. Amazon requires sellers to provide documentation that Dietary Supplements sold on our store meet and comply with applicable regulations or standard requirements, including but not limited to the below:
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
Please also see the Restricted Products help page on Dietary Supplement for additional product restrictions.
For each dietary supplement product/ASIN, you must submit the following documents:
A finished product Certificate of Analysis (COA) issued by an ISO/IEC 17025 accredited lab (in-house or third-party). The valid ISO certificate showing name of accreditation body and accreditation number must also be submitted.
A finished product Certificate of Analysis (COA) issued by an in-house laboratory that is compliant with current good manufacturing practices (cGMP) per 21 CFR 111 and 117. A valid GMP certificate of the manufacturing facility must also be submitted. Amazon accepts GMP certificates from the following third-party programs: NSF (NSF/ANSI 173 section 8), GRMA (GRMA 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.
Evidence of Product/ASIN 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, UL Brand Certification Program.
A finished product Certificate of Analysis to support the amount per unit or per serving of each dietary ingredient(s) claimed on the Supplement Facts panel must be submitted. The COA submitted to Amazon must have been issued within the past twelve (12) months; must be in Portable Document Format (.pdf); and must contain the following information:
Product Images must meet the following requirements:
If you are contacted by us to submit compliance documents, complete the following
steps to start the application process:
Although we only require that the laboratory (in-house or third party) hold an active ISO/IEC 17025 accreditation as demonstration of general competence for preforming tests and calibrations, testing should be conducted by a laboratory that is fitted to do so.
COAs issued by a non-ISO/IEC accredited in-house laboratory that is located within a facility that is compliant with current good manufacturing practices (cGMP) as per 21 CFR 111 and 117 may be submitted. To demonstrate GMP compliance, a valid GMP audit certificate/verification for the manufacturing facility must be submitted from one of the following third-party programs: NSF (NSF/ANSI 173 section 8), GRMA (GRMA 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.
Industry recognized laboratory assays of finished product should be accomplished whenever possible, unless a company has testing technology to accurately quantify the amounts of dietary ingredients declared on label. If that is not possible, then you must provide a COA by input from the manufacturing facility of the product that meets specifications for identity, purity, strength, or composition as claimed on the label, as permitted by 21 CFR 111.75 (d), as well as evidence of GMP compliance for such facility. This includes, but not limited to products labeled to contain quantified amounts of herbs, herbal extracts, glands, or other dietary ingredients that are complex chemical mixtures; products labeled to contain mixtures of probiotics or mixtures of enzymes; and products labeled to contain quantified amounts of one or more proprietary blend of dietary ingredients.
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” but must also submit additional documentation set forth in question #3 above.
You must have a COA with a laboratory assay(s) 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 your application was previously denied due to a defective letter of guarantee, you have the opportunity to resubmit the required documentation, and your materials will be evaluated in relation to the current policy.
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.
Updated on 6 April 2021