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Amazon Receives 3rd Warning Letter This Year

Distributors are responsible for products they sell

Amazon Receives 3rd Warning Letter This Year

Amazon just received its third warning letter this year and the fifth in the last 15 months! All of these letters are for selling adulterated or unallowable products. What makes this warning letter interesting is that it’s for a sexual enhancement product that was adulterated with sildenafil (Viagra). Amazon requires some mandatory third-party tests for products in this high-risk category, but I wonder why the drug-spiked ingredients were not found here. Perhaps after the initial batch tests, a subsequent non-tested batch contained the drug-spiked ingredients?

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🔷When we look at other Amazon warning letters, FDA seems to “follow the breadcrumbs” from other warning letters, recalls, or issues to Amazon. For example, this warning letter references products that were part of a drug-spiked recall in August. I would think that Amazon has the technological capability to find and remove recalled products from its platform. These types of warning letters come in groups so if companies were selling any of the adulterated brands cited in this warning letter, removing them from commerce now can help to avoid a letter.

🔷Amazon warning letters state that Amazon handles the products as opposed to them being dropped-shipped by the vendors. In my opinion, this “handling” is important to designate Amazon’s responsibility. I wonder if this means that marketplace sites that don’t actually touch the products have a lower risk of distributor scrutiny.
👉From warning letter. “Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows you to outsource order fulfillment to Amazon. Sign up for Amazon FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.”

🔷Other recent Amazon warning letters were for ophthalmic (eye), homeopathic products for molluscum contagiosum, Diclofenac spiked products and disease claims, and skin tag removal products.

Read the full warning letter.

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

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