Welcome back to our latest series of learning about compliance requirements for products. As a reminder, here are our previous articles in the series:
💭Thinking About Selling... Pest Control Products and Pesticides
💭Thinking About Selling...Products With Batteries
💭Thinking About Selling...Jewelry💍
💭Thinking About Selling...Magnetic Toys
Today we’re going to over the compliance requirements and checklist for selling dietary supplements. In the United States, the Food and Drug Administration (FDA) regulates the manufacturing, packaging, storing, and labeling of dietary supplements under the Federal Food, Drug, and Cosmetic Act, and its subsequent amending statutes, including the Dietary Supplement Health and Education Act.
The FDA defines a dietary ingredient as a vitamin, mineral, herb, or other botanical, amino acid, or dietary substance used to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances intended for human consumption. Dietary supplements come in different forms such as powders, pills, capsules, liquid drops, and oral sprays. They include, but are not limited to, categories such as vitamins and minerals and herbs and botanicals; and they can be marketed for functions such as sexual enhancement, weight management, bodybuilding, sports nutrition, and joint health. Dietary supplements must not make disease claims or contain undeclared drug ingredients or articles that are approved as new drugs.
The policy for dietary supplements is available in the dietary supplement page. It is required to verify that dietary supplement products meet the policy via third-party testing on an annual basis to ensure products meet this criteria. This includes:
* Products are manufactured in a facility compliant with the FDA's Current Good Manufacturing Practice regulations (cGMPs, 21 CFR 111/117 or equivalent)
* Products do not contain contaminants that may pose a human health or regulatory concern
* Products contain the ingredients claimed on the product label
* Products do not contain undeclared active pharmaceutical ingredients
* Products are labeled according to guidelines set forth by the FDA and do not contain illegal or disease claims
As of April 8, 2024, the following are approved third-party testing, inspection, and certification verifiers:
* Eurofins
* UL
* NSF International
The full compliance checklist for how your dietary supplement product should be packaged & labeled is available on this page. This page also includes a list of known prohibited dietary supplement products.
If you have any dietary supplements that are impacted by the above requirements, you will find them in your Manage Your Compliance dashboard.
Please note: If you were not already approved to sell in the supplements category, as part of our ongoing efforts to provide the best possible customer experience, Amazon has implemented additional restrictions for ingestible supplement products. Unfortunately, we are not accepting applications for supplements at this time. You are welcome to check back later to see if the category is accepting applications in the future. If you believe your products have been misclassified within a certain category or sub-category that requires approval, please contact Selling Partner Support with evidence, such as product pictures, to support this claim. Amazon will review your claim and make a final determination that will ensure the best shopping experience for our customers.
Should you encounter any difficulties or have questions regarding the review process for dietary supplements, please create a new thread, choose the “Product Safety and Compliance” category, and include your Compliance case ID.
How did your process for reviewing dietary supplements go? Is there any feedback or questions that you have that we can address? Let us know in the comments below.
Regards,
- Manny