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, including this policy.

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). 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 may not contain articles that are approved as new drugs, other undeclared drug ingredients, or make disease claims. 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.

Our policy for Dietary Supplements

Amazon requires sellers to submit documentation that reflects compliance with applicable regulations or standard requirements, including but not limited to the below:

Please also see the Restricted Products help page on Dietary Supplements for additional product restrictions.

Required Documentation

For each dietary supplement product or ASIN, you must submit the following documents:

1. 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.

   or

   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: GRMA 455-2, NSF (NSF/ANSI 173 Section 8 of NSF/ANSI 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

   or

   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.

   AND

2. Product Images

Requirements for the Certificate of Analysis (COA)

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:

• Complete product name.
• Batch/lot number and/or date code of the unexpired finished product sample that was tested.
• Name and address of the laboratory issuing the COA.
• Results from a laboratory assay performed to support the amount per unit or per serving of each dietary ingredient(s) claimed on the Supplement Facts panel.
• Must include a reference to the test method used for each dietary ingredient listed. If the test method is novel, not an Association of Official Analytical Chemists (AOAC) Official Method of Analysis or is a modified version of these, or is in-house, the principle of the method should be stated (e.g., HPLC, GC, etc.). Actual data and observations should be recorded rather than non-specific “passes” or “conforms” statements. For testing “by input”, see FAQ section below for additional supporting documents.
• The dietary ingredient name(s) on the Supplement Facts panel should match the ingredient name(s) on the COA.
• The unit of measure for each dietary ingredient on the Supplement Facts panel (i.e. g, mg, mcg, etc.) should match the unit of measure on the COA.

Requirements for Product images

Product Images must meet the following requirements:

• All images must be legible.
• Images must clearly show the entire product label (all sides), including the Supplement Facts panel, ingredients list, certification logos, and any product warnings.
• Must contain the product name.
• Must contain the name and contact information of the brand owner or manufacturer.
• Must be a direct image of the product or its packaging. A computer-generated image or mock-up will not be accepted.

How to submit information

If you are contacted by us to submit compliance documents, complete the following steps to start the application process:

1. In Seller Central, select Performance tab, and choose Account Health.
2. Under Product Compliance Requests in the bottom right corner of the page, click Documentation Requests.
3. Click Provide Documentation or Appeal next to the product.
4. Select No to upload documents.
5. Follow the steps in the Submit required documents section.

FAQ

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

Testing should be conducted by a laboratory that is equipped to do so, although we do not require accreditation to a specific test. We will accept the fact that a laboratory holds an active ISO/IEC 17025 accreditation as demonstration of general competence for preforming tests and calibrations.

2. May I provide a COA from an In-house laboratory that is non-ISO/IEC 17025 accredited?

COAs issued by an in-house laboratory that is located within a GMP compliant manufacturing facility as per 21 CFR 111 and 117 are acceptable for review. A valid GMP certificate for the manufacturing facility must also be submitted. Amazon accepts GMP certificates from the following third-party programs: GRMA 455-2, NSF (NSF/ANSI 173 section 8 or NSF/ANSI 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

3. May I use “by input” method on a COA (also knowns as a quantitative amount by input weight or by input volume)?

Established laboratory assays of finished product should be accomplished whenever possible. If that is not possible due to unavailability of a scientifically valid test method, then you must provide a COA (or additional documentation) from the manufacturing facility for the ingredients used in the manufacture of the finished product that can verify that they meet specifications for identity, purity, strength, or composition without testing, as per 21 CFR 111.75 (d). A valid GMP certificate for the manufacturing facility must also be submitted.

4. Do I have to provide a test that ensures that the total amount of dietary 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 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.

5. 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 dietary ingredient if the Supplement Facts panel declares:

• A quantified primary plant constituent or class of constituents (such as common sugars, amino acid, or proteins), except where quantitation of the constituent(s) in the finished product is not possible, in which case report the quantity(s) based on input.
• A quantified secondary plant constituent or class of constituents (such as alkaloids, terpenoids, saponins, phenolic compounds, flavonoids, or tannins), except where quantitation of the constituent(s) in the finished product is not possible, in which case report the quantity(s) based on input.
• A whole plant ingredient, plant part(s) such as roots or leaves, in a dried state (such as a powder), or any extract thereof, which does not declare any individual constituent(s), must have a COA containing confirmation of plant identity.

6. What if my product is not a dietary supplement?

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.

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.

Additional Resources

• Amazon Services Business Solutions Agreement
• Remove inventory overview
• Fix stranded inventory
• Global Food Safety Initiative
• Accredited certifying body

Updated on 29 July 2021