Dietary supplements

If you list products on Amazon, you must comply with all federal, state, and 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). The FDA defines a dietary ingredient as a vitamin, mineral, herb or other botanical, amino acid, or 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, and include categories such as vitamins and minerals, herbs and botanicals, sexual enhancements, weight management, and body building and sports nutrition. Dietary supplements may not contain articles that are approved as new drugs, other undeclared drug ingredients, or make disease claims.

Our policy for dietary supplements

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

Effective December 6, 2021, sexual enhancement and weight loss dietary supplement products cannot be sold in single or double pill packs. Single and double pill pack offerings are prohibited on Amazon.

For additional product requirements related to dietary supplements, go to the Restricted Products Help page on Dietary supplements.

Required documentation

I. All dietary supplements

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

1. A valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111 (for products that are a dietary supplement as defined at 21 U.S.C. 321(ff)), or 21 CFR Part 117 (for any other human food product as defined at 21 U.S.C. 321(f)), or both. Amazon accepts GMP certificates from accredited third-party certification bodies, including NSF/ANSI 455-2, NSF/ANSI 173 Section 8, GRMA 455-2, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

   AND

2. A finished product Certificate of Analysis (COA) of declared dietary ingredients issued by an ISO/IEC 17025 accredited laboratory or in-house laboratory located in the above facility that is compliant with current GMPs (21 CFR Part 111 (for products that are a dietary supplement as defined at 21 U.S.C. 321(ff)), or 21 CFR Part 117 (for any other human food product as defined at 21 U.S.C. 321(f)), or both). (For additional details about Certificate of Analysis specifications, go to Requirements for the Certificate of Analysis or Frequently asked questions below.)

   or

   Evidence of product 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, or UL Brand Certification Program.

   AND

3. Product images (Go to Requirements for product images below for more details)

II. Supplements intended for sexual enhancement or weight loss and weight management

In addition to the above requirements, each dietary supplement product that is intended for sexual enhancement or weight loss and weight management must also submit the following documentation:

1. A finished product Certificate of Analysis (COA) for the compounds listed in Appendix 1, issued by an ISO/IEC 17025 accredited laboratory. We will not accept COAs from in-house labs for the compounds listed in Appendix 1. A valid COA must include the ISO accreditation number for the issuing lab or the ISO/IEC 17025 accreditation certificate. Please note that not all labs have the capabilities to test for these specific compounds. Depending on whether you sell sexual enhancement or weight loss and weight management supplements or both, you may need to use more than one lab. We understand the following labs have broad capabilities: Covance; Eurofins; Silliker; BSCG; NSF; LGC; USP; and UL. For additional details regarding Certificate of Analysis specifications, go to the Requirements for the Certificate of Analysis section below.

Requirements for the Certificate of Analysis

You must submit a finished product Certificate of Analysis (COA) to support the amount per unit or per serving of each dietary ingredient claimed on the applicable facts panel. The COA submitted to Amazon must have been issued within the past 12 months; must be in Portable Document Format (.pdf); and must contain the following information:

• Complete product name
• Batch number, lot number, or date code of the unexpired finished product sample that was tested
• Name and address, and ISO accreditation number of the laboratory issuing the COA
  • The laboratory’s authorized representative’s signature, printed name, and title on the COA
• Results from a laboratory assay performed to support the amount per unit or per serving of each dietary ingredient claimed on the applicable facts panel
• 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 (such as HPLC or GC). Actual data and observations should be recorded rather than non-specific “passes” or “conforms” statements. For testing “by input,” go to Frequently asked questions below for information about additional supporting documents.
• The dietary ingredient name or names on the applicable facts panel must match the ingredient name or names on the COA.
• The unit of measure for each dietary ingredient on the applicable facts panel (such as g, mg, or mcg) must match the unit of measure on the COA.

Testing requirements for sexual enhancement and weight loss and weight management supplements

For sexual enhancement and weight loss supplements, the COA must include testing results for the specific compounds outlined below. The general COA requirements above still apply.

We reserve the right to test for additional substances and increase the frequency of testing at any time.

Requirements for product images

Product images must meet the following requirements:

• Must be legible
• Must clearly show the entire product label (all sides), including the applicable facts panel, ingredients list, certification logos, identity statement, instructions for use, 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.
• These images must appear on the detail page of your product.

How to submit information

If we contact you to submit compliance documents, complete the following steps to start the application process:

Go to the Approval Required view within the Fix Your Products in Seller Central, and select Request Approval.

Alternatively, use the following steps to request approval:

1. In Seller Central, click the Inventory menu, and then select Add a Product.
2. Search for the item you want to sell.
3. In the search results, click the Apply to Sell link next to the item.
4. Click Request Approval to start the application process.
5. To upload images, go to Bulk image upload. Alternatively, go to the Inventory menu and select Upload images.

Frequently asked questions

1. Does the test method need to be listed on the COA?

   Yes.

2. May I use “by input” method on a COA (also known 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. The COA must verify that the ingredients used in the manufacture of the finished product meet specifications for identity, purity, strength, or composition without testing, as per 21 CFR 111.75 (d). As stated above, a valid GMP certificate for the manufacturing facility must also be submitted.

3. 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.” If you list the proprietary blend "by input," you must also submit the additional documentation set forth in question 2 above.

4. If my COA is issued from an in-house facility that is compliant with 21 CFR 111 or 21 CFR 111 & 117 to provide evidence of declared active ingredients, does it have to be ISO accredited?

   No, only the testing for the specific compounds listed above for sexual enhancement and weight loss supplements must be conducted by an external ISO/IEC 17025 accredited laboratory. (For additional details about Certificate of Analysis specifications, go to Requirements for the Certificate of Analysis.)

5. My product is an herbal supplement. Does it need to have a COA?

   You must have a COA with a laboratory assay or assays 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 constituents in the finished product is not possible, in which case report the quantities 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 constituents in the finished product is not possible, in which case report the quantities based on input.
   • A whole plant ingredient, plant parts such as roots or leaves, in a dried state (such as a powder), or any extract thereof, which does not declare any individual constituents, 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 take the following actions:

• Remove the relevant product listings
• Suspend your ability to add new products, listing privileges, or both
• Withhold any payments due to you

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
• Dietary supplements
• Food and Drug Administration: Dietary Supplements
• Global Food Safety Initiative
• Accredited certifying body

Updated on February 17, 2022.