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 conveient 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 familar subject for FDA Warning Letters.
Here are three steps to consider before selling your product on Amazon:
1) Are My Ingredients 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 on Amazon. Certain categories of products are also only considered drugs or devices, not 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 enought 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 throught the system others may be already engaged in a FDA enforcement action. In any case the FDA will not accept as a defense comparison to 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 complientary assessment of your products.
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