There are new listing requirements for Dietary Supplements on Amazon.  You must comply with all federal, state, local laws, and Amazon policies applicable to those products and product listings.  All documentation must be submitted by May 3, 2021.  

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.

Amazon 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:

ProductRegulation/Standard Requirements
Dietary Supplements21 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.

 

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 the product.
      3. Name and address of the manufacturer or distributor.
      4. Quantitative analysis to support the active ingredient concentration as claimed on the supplement facts panel.
      5. The active ingredient name on the 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 products 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 the 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 the 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.

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

Per Amazon, if you do not submit this documentation by May 3rd 2021, you will only be able to update the Price and Qty. ANY OTHER CHANGES WILL MAKE YOUR LISTING UNAVAILABLE, AND YOU WILL BE REQUIRED TO SUBMIT COMPLIANCE DOCUMENTS TO REINSTATE YOUR OFFER.

Don't forget to share this post!

Recommended Articles