Amazon has become the largest online retailer in the world, and now, more than half of all Amazon sales come from third-party sellers. Operations of this reach and magnitude require regulations to ensure products meet the quality and safety standards consumers deserve and need. These regulations go beyond the reviews and product evaluations made by buyers.

In order to grant permission to honest and legitimate sellers only, Amazon requires CoA’s issued from ISO 17025 certified laboratories. Specifically, products in the health, beauty, and pet food industry need to be manufactured under a recognized Quality Management System (QMS).

As stated on the Amazon website, a QMS is a “process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management within an organization.”

If you’re ready to get started with a test submission, click the button below to fill out the required forms. If you still have questions, keep scrolling for our most frequently asked questions.

What dietary supplements are covered by Amazon’s new certification 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.

What do I need to submit to Amazon for the new requirements?

Follow the checklist below to ensure you submit all of the proper paperwork to Amazon.

 

Certificate of Analysis Document must meet the following requirements:

[ ] Must contain lot number and manufacture date

[ ] Expiration date must not be in the past (documents with dates in the past will not be reviewed)

[ ] Includes the name and address of the manufacturer or distributor

[ ] Must be issued by an ISO 17025 certified laboratory

[ ] CoA issued within the last six months

[ ] CoA must contain quantitative analysis to support the active ingredient concentration as claimed on supplement facts panel

[ ] Must include product name

Product Packaging Picture (PPP) Document must meet the following requirements:

[ ] Clearly display all sides of the product or its packaging

[ ] A clear image of (1) supplemental or nutritional fact panel, and (2) ingredient list

[ ] Must contain name and address of the manufacturer.

[ ] Must include product name

Letter of Guarantee from Manufacturer (LoG) Document must meet the following requirements:

[ ] Must be printed on your company letterhead

[ ] LoG must contain complete product name as listed on label

[ ] LoG must contain an assurance that the product is manufactured under current Good Manufacturing Practices

[ ] LoG must contain an assurance that only lawful and safe, as defined in section 402 (f) of the FD&C Act, ingredients are utilized

[ ] LoG must contain an 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.

 

What does a supplement seller need to prove with documentation?

Amazon is mandating that supplement sellers submit documentation to prove:

  • That the product meets the potency claims specified on the label
  • That the product is manufactured under current Good Manufacturing Practices as listed in 21 CFR Part 111
  • That only lawful and safe (defined in section 402 (f) of the FD&C Act) ingredients are utilized
  • That concentration of active ingredients as stated on the label is safe for consumption

How do I submit certification information on Amazon?

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.

When will Amazon start enforcing these new regulations?

Indications are that Amazon will require full compliance with the new requirements for all dietary supplements sold on its platform by February 2021.

What happens if my product doesn’t meet these new certifications?

If you do not provide the required information by the applicable deadline, Amazon 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

What is your Lab’s pricing for these tests?

$100 per active for 5 business day turnaround time (standard)

  • Rush services: Requires Dyad Labs approval
  • 3 business day rush – 100% surcharge
  • 2 business day rush – 200% surcharge
  • 1 business day rush – 300% surcharge

What do you require for a submission?

Please provide copies of the below items:

  • Dyad Labs Customer Information Request Form (if new client)
  • Finished Product Specification
  • Batch Records (Blending Discharge, Blending Discharge Table and Blending Yields)
  • Input weights of each ingredient + run total weight must be clearly visible.
  • Picture of product (Lot # and Supplement Table)
  • Deviation documentation (if applicable)
  • Manufacture + Expiration date (if applicable)
  • Submission form, “Dyad Amazon Project Submission Form”  filled out to completion.
    • Please enter information to appear EXACTLY as it should on COA.