Dietary supplements
If you list products on Amazon, you must comply with all applicable laws, regulations, standards, and our policies related to those products and product listings.
To learn more about our policy relating to dietary supplements, watch our webinar or the following video:
Dietary supplements covered by this policy
In the United States, the Food and Drug Administration (FDA) regulates the manufacturing, packaging, storing, and labeling of dietary supplements under the Federal Food, Drug, and Cosmetic Act, and its subsequent amending statutes, including the Dietary Supplement Health and Education Act.
The FDA defines a dietary ingredient as a vitamin, mineral, herb, or other botanical, amino acid, or dietary substance used to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances intended for human consumption. Dietary supplements come in different forms such as powders, pills, capsules, liquid drops, and oral sprays. They include, but are not limited to, categories such as vitamins and minerals and herbs and botanicals; and they can be marketed for functions such as sexual enhancement, weight management, bodybuilding, sports nutrition, and joint health.
Dietary supplements must not make disease claims or contain undeclared drug ingredients or articles that are approved as new drugs.
Our policy for dietary supplements
We require you to verify that dietary supplement products meet our policy via third-party testing on an annual basis to ensure products offered in our store meet the following criteria:
- Products are manufactured in a facility compliant with the FDA's Current Good Manufacturing Practice regulations (cGMPs, 21 CFR 111/117 or equivalent)
- Products do not contain contaminants that may pose a human health or regulatory concern
- Products contain the ingredients claimed on the product label
- Products do not contain undeclared active pharmaceutical ingredients
- Products are labeled according to guidelines set forth by the FDA and do not contain illegal or disease claims
Dietary supplements products identified as being affected by this initiative can be found within the Manage Your Compliance dashboard.
| Parameter | Requirement |
|---|---|
| Product was manufactured in a facility compliant with cGMPs in accordance with requirements outlined in 21 CFR 111/117 or equivalent |
Accepted GMP programs include but are not limited to the following: Eurofins GMP, NSF/ANSI 455-2, 229 GMP, UL GMP, USP GMP, SAI Global, SGS, Intertek, TGA, SQF Dietary Supplements Food Safety Code, GFSI, and SSCI. GMP must be performed by an accredited third-party. Private audits, first-party audits, consulting audits, FDA inspections, and ISO standards will not be accepted. The GMP certificate must be in good standing and cannot be expired. |
| Contaminant screen* | Products must be tested for the presence of heavy metal and microbial contaminants, and based on a review of the finished product components may also be tested for pesticides and THC in accordance with requirements outlined in NSF/ANSI 173-2024 or according to USP <2021>, <2022>, <62>, <561> |
| Content claims verification* | Products must contain dietary ingredients according to tolerances listed in 21 CFR 101.36 and 101.9(g)(3) & (g)(4). |
| Active pharmaceutical ingredient screen* | Products classified as sexual enhancement, weight management, sports nutrition, bodybuilding, or joint health must undergo testing for known adulterants outlined in NSF/ANSI 173-2024 5.3.5.1- 4 |
| Product labeling and claims | Products must clearly show facts panel, ingredient list, identity statement, appropriate FDA disclaimers, and relevant product warnings. Products must not contain illegal or disease claims that are not authorized by the FDA. |
* For products where testing has already been conducted by an ISO 17025 accredited lab (including in-house labs), you can submit a test request form for the affected products to an approved verification service provider of your choice by following the steps below. You can provide this information directly to the third-party verification provider if it meets our policy.
Effective December 6, 2021, sexual enhancement and weight loss dietary supplement products cannot be sold in single- or double-pill packs.
For more details about prohibited dietary supplements go to the Dietary supplements help page.
Third-party testing, inspection, and certification verifiers
As of April 8, 2024, the following third-party testing, inspection, and certification verifiers have been approved to verify that products meet our dietary supplements policy:
- Eurofins
- UL
- NSF International: For products certified to NSF/ANSI 173 or NSF 229 and that meet our policy requirements. For affected products, follow the steps regarding testing verification below and select NSF International as your third-party provider to complete the compliance process.
Service providers are subject to change. Go to the Manage Your Compliance dashboard for the most up-to-date list of service providers.
Compliance services
Dietary supplements products that are identified as part of this initiative and require action can be found within your Manage Your Compliance dashboard.
To comply with our policy for testing verification, follow these steps:
- Go to the Manage Your Compliance dashboard.
- Click Add or appeal compliance next to the product.
- Select Request lab service.
If you believe that your products don't require testing verification, follow these steps:
- Go to the Manage Your Compliance dashboard.
- Click Appeal request and choose an appeal reason. You may also add comments.
- Click Submit.
Policy violations
If you don’t provide the required information (listed above) upon request, we reserve the right to take any further actions in accordance with the Amazon Services Business Solutions Agreement, including, but not limited to, removing the relevant product listings.
For reports where parameters have been identified as out of specification or fail, the third-party verifier chosen to conduct testing will provide failure resolution options, if applicable. You can initiate a corrective-action process with the third-party verifier that issued the failing report.
Additional resources
- Amazon Services Business Solutions Agreement
- Remove inventory overview
- Fix stranded inventory
- Food and Drug Administration: Dietary Supplements
- Global Food Safety Initiative
- Accredited certifying body
Disclaimer: The information provided on this page does not and is not intended to constitute legal advice. All information, content, and materials available on this site are for general informational purposes only.
