If you sell your dietary supplements on Amazon, you are most likely aware of Amazon’s strict policies and restrictions that surround dietary supplements. In 2021, Amazon is actively rolling out a new set of specific requirements surrounding dietary supplements. Here is a quick guide on how to stay in compliance with the new Amazon requirements.
Certificate of Analysis Issued by an ISO 17025 Accredited Laboratory
An ISO 17025 Certificate of Analysis (CoA) is a document issued by an ISO 17025 Certified Laboratory that confirms your dietary supplement meets its product descriptions and specifications. Because most contract manufacturers are not yet ISO 17025 certified, your contract manufacturer can recommend contract laboratories that are ISO 17025 certified.
A CoA from the ISO 17025 certified lab must include the following:
- Product name, batch/lot number or date code of the finished product sample tested
- Name and address of the ISO-17025 accredited laboratory
- Results from the ISO-17025 accredited laboratory to support the ingredient concentrations as claimed on the supplement facts panel
- Each reported result must be accompanied by the laboratory method that was used
- Quantitative analysis (Ingredient names AND units of measure for each ingredient on the supplement facts panel must match those of the CoA)
Additionally, for a product to be accepted by the Amazon Marketplace, its submitted CoA must have been provided within the past nine months and be submitted in PDF form. Laboratory tests of an expired item will not be accepted.
Letter of Guarantee
A Letter of Guarantee (LoG) is a document released by a brand owner that certifies that your dietary supplement was created in good faith, and in accordance with the regulations implemented by the FDA.
An LoG must include the following:
- The brand owner’s company letterhead
- Complete product name as listed on the label, or list of products manufactured under the brand or facility
- Assurances that:
- The dietary supplement is manufactured under current Good Manufacturing Practices as mentioned in 21 CFR Part 111
- All components and ingredients used are authorized and safe as established in section 402 (f) of the FD&C Act
- The concentration of active ingredient(s) as stated on the label is safe for consumption
For a dietary supplement to be accepted by Amazon, it must contain:
- Legible and clean product images that show all sides of the product label
- The product name, and the name and address of the brand owner
- A clear image of the supplement fact panel and ingredient list
Keep in mind that all dietary supplements must fully comply with these new requirements in order for your product to stay on the Amazon Marketplace. If your products do not meet these requirements, Amazon has the authority to pull your products from their marketplace, suspend you as a seller, withhold payments, and, possibly, take legal action.
How Paragon Can Help
Although Paragon is not an ISO 17025 Certified Laboratory, we leverage our industry expertise to provide you with third-party lab recommendations that clients can consult to get their CoA. Our account representatives can assist you in locating an ISO 17025 lab near you. Please reach out to your account representative for some laboratories that may be able to assist you with an Amazon compliant CoA.
Given these new regulations from Amazon, you may have to reevaluate your supplement brand. Although we are not an ISO 17025 lab, Paragon Laboratories is an Amazon-friendly contract manufacturer that will work closely with you to help you adhere to these changes. If you need assistance with finding a trusted ISO 17025 lab, contact us today.