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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 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.

Our policy for Dietary Supplements

Amazon requires that Dietary Supplements meet applicable regulations or standard requirements, including but not limited to the below:

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 (in-house or third party) for each dietary supplement you are applying to list OR product enrollment in an Independent Quality Certification Program (See FAQ #5).
    1. A CoA must contain the following information:
      1. Product name.
      2. Batch/lot number or date code of the finished product sample tested.
      3. Name and address of the accredited laboratory.
      4. Results from laboratory assay to support the dietary ingredient concentration as claimed on supplement facts panel.
      5. The laboratory method used must accompany each reported result.
      6. The ingredient name(s) on supplement facts panel should match the ingredient name(s) on the CoA.
      7. The unit of measure for each ingredient 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 nine months.
      2. Laboratory test results of expired product will not be accepted.
      3. CoA documents must be in Portable Document Format (.pdf).
      4. 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.
    2. Have a clear image of the supplemental fact panel, and ingredient list.
    3. Contain name and address of the brand owner.
    4. Contain product name.
  3. Letter of Guarantee - A letter of guarantee from the brand owner of the product that meets the following requirements:
    1. Is on official brand owner letterhead.
    2. Contains complete product name as listed on label, or list of products manufactured under the brand or by facility.
    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.

How to submit information

If you would like to seek approval to sell the affected products, complete the following steps to start the application process:

  1. In Seller Central, click the Inventory menu, and then select 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.

FAQ

1. Does the scope of the laboratory’s ISO/IEC 17025 accreditation need to include each test method listed on the CoA?

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.

2. May I use “by input” method on a CoA (also knowns as a quantitative amount by weight)?

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).

3. Do I have to provide a test that ensures that the total amount of active ingredients in a proprietary blend is accurately represented on the label, or do I need to show a test for each individual ingredient?

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.

4. My product is an herbal supplement, does it need to have a CoA?

You must have a CoA with a laboratory assay(s) for each ingredient if the supplement facts panel declares:

  1. A primary plant constituent (such as common sugars, amino acid, or proteins).
  2. A secondary plant constituent (such as alkaloids, terpenoids, saponins, phenolic compounds, flavonoids, or tannins).
  3. A whole plant ingredient, plant part(s) such as roots or leaves, in a dried state (such as a powder), must have a CoA containing confirmation of plant identity.

5. My product is part of a quality certification program. Can I submit the certificate instead of a CoA?

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.

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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