Three Steps to Selling FDA Regulated Products on Amazon
“Is it FDA approved?” This is the most frequent question received by phone and e-mail. It’s also the most commonly asked question by Amazon. The online retailer’s popularity with start-up companies is surging. It allows a quick and convenient means to sell and distribute products across the U.S. Browsing Amazon one will find a range of FDA regulated products – cosmetics products, cosmetic devices, herbal remedies, and dietary supplements of all types (muscle building, weight loss, etc.).
Amazon works with start-ups to ensure products are FDA approved, but it cannot do the work of the Agency. Amazon listings are a familiar subject for FDA Warning Letters.
Here are three steps to consider before selling your product on Amazon:
1) Are My Ingredients FDA Approved?
Certain ingredients are classified as over-the-counter (OTC) drugs others may be new food or color additives. It is important to evaluate a product’s ingredients before selling it on Amazon. Certain categories of products are also only considered drugs or devices, no matter the ingredients or labeling.
2) Are My Claims Approved?
Classification of a product hinges on claims. Claims provide evidence for the FDA about the intended use, e.g. what the consumer should expect the product to do. It is not enough to add a disclaimer, if your product’s claims qualify as drug or device claims then evidence of pre-market approval will be required.
3) Avoid Comparing to Similar Products Listed on Amazon
Some products slip through the system others may be already engaged in an FDA enforcement action. In any case, the FDA will not accept as a defense comparison a product marketed and sold without the approvals or revisions the Agency is requesting for your product.
What matters are the regulations and any statutory defenses? Assess the risks based on your own review of the regulations, not on the risks another company did or did not evaluate.
These three steps cover the big areas of compliance. There are other considerations, especially with imported products. It is important to gain a full sense of the regulatory requirements and the risks of FDA enforcement before selling on Amazon.
Feel free to contact us for a complimentary assessment of your products.
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.