Amazon and Walmart Cited For Distributing Homeopathic “Drug” Products

Amazon, Walmart, and four other companies were issued warning letters for distributing homeopathic products used to treat molluscum contagiosum, a viral skin condition most commonly occurring in children. This is the second warning letter Amazon and Walmart have received in the past year. The other letters were for distributing drug-spiked products with disease claims.

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🔷 Why did FDA choose to select products marketed for the skin ailment molluscum contagiosum? It seems FDA is concerned about the self-diagnosis of this skin infection when it could potentially be skin cancer. They also are concerned about products marketed as being “child safe.”
👉From warning letter. “A healthcare professional is needed to rule out the possibility of a more serious condition, such as, skin cancer…… FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.”

🔷We all know that Amazon dislikes this type of attention, and I wonder if this means the end of homeopathic sales on their platform.

🔷I am always interested when distributors actually get in trouble for selling products on their marketplace. We recently saw delta 8 distributors cited for this as well. According to regulations, companies are responsible for the products they distribute.

🔷The footnotes in the warning letter are worth reading and show that both Walmart and Amazon touched the products. If they did not physically handle the products, would they have been cited?
👉 From warning letter. “Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows businesses to outsource order fulfillment to Amazon. .....when a customer makes a purchase, we pick, pack, and ship the order.”

🔷The warning letter footnotes also include FDA’s position on homeopathics. Several recent FDA letters have cited homeopathic claims, and I expect more in the future.

Here is the Homeopathic Drug Products: Guidance. Reading this guidance and the warning letter footnotes shed light on where FDA’s thinking lies when it comes to homeopathic enforcement priorities and “discretion.”

👉Read the full Walmart letter

👉Amazon 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.