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This article applies to selling in: United States

Dietary Supplements

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.

Dietary Supplements covered by this policy

In the United States, the Food and Drug Administration (FDA) regulates the quality, safety, and labeling requirements 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 are safe 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.

Our policy for Dietary Supplements

Amazon requires that Dietary Supplements covered by this policy have been tested and meet the specific regulation or standard requirements listed below for each of the Dietary Supplements you list:

Product Regulation/Standard Requirements
Dietary Supplements

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.

Required information

For Dietary Supplements, you must submit:

  1. Certificate of Analysis (COA)from an ISO/IEC 17025 accredited laboratory for each dietary supplement you are applying to list.
    1. A CoA must contain the following information:
      1. Product name.
      2. Batch/lot number or date code of product.
      3. Name and address of the manufacturer or distributor.
      4. Quantitative analysis to support the active ingredient concentration as claimed on supplement facts panel.
      5. The active ingredient name on supplement facts panel should match the active ingredient name on the CoA.
      6. The concentration units on the supplement facts panel (i.e. mcg/mg) should match the unit of measure on CoA.
    2. Additional CoA requirements:
      1. CoA submitted to Amazon must have been issued within the past six months.
      2. Laboratory test results of expired product will not be accepted.
      3. CoA documents must be accompanied by legible product images as referenced below in Item 2 (“Product Images”).
  2. Product Images must meet the following requirements:
    1. Have all sides of the product label visible, including batch/lot number or date code.
    2. Have a clear image of the supplemental or nutritional fact panel, and ingredient list.
    3. Contain name and address of the company.
    4. Contain product name.
  3. Letter of Guarantee - A letter of guarantee from the manufacturer of the product that meets the following requirements:
    1. Is on official manufacturer letterhead.
    2. Contains complete product name as listed on label, and labeling.
    3. Assurance that the product is manufactured under current Good Manufacturing Practices as listed in 21 CFR Part 111.
    4. Assurance that only lawful and safe, as defined in section 402 (f) of the FD&C Act, ingredients are utilized.
    5. Assurance that concentration of active ingredient(s) as stated on the label and labeling is safe for consumption.

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.

Some labs provide special Amazon rates for testing. To find more information about these providers, visit the Seller Central Service Provider Network Page.

How to submit information

If you are contacted by Amazon for compliance documents, complete the following steps to submit the requested information:

  1. In Seller Central, select Inventory, and then click Add a Product.
  2. Search for the ASIN you want to sell.
  3. In the search results, click the Listing limitations apply link next to the ASIN.
  4. Click Request Approval to start the application process.

Policy violations

If you do not provide the required information by the applicable deadline, we may:

  • Remove the relevant product listings
  • Suspend your ability to add new products and/or listing privileges
  • Withhold any payments due to you
  • Pursue legal action

We reserve the right to take any further actions that may be necessary in our sole discretion.

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