FDA warns Amazon, Walmart and others for selling unapproved drugs for viral skin infection

The US Food and Drug Administration (FDA) warned retail giants Amazon and Walmart, as well as four other companies, for marketing or distributing unapproved over-the-counter (OTC) products to treat a skin condition called molluscum contagiosum. FDA said an OTC drug for this disease has not been approved and advised these companies to remove the drugs from the market.

Other companies cited by FDA include Nature’s Innovation Inc, MolluscumRx, Inc., Thrasio LLC (d.b.a. ZymaDerm) and Molluscumaway, LLC. FDA sent all six warning letters on 18 August and posted them to its website on 22 August.

These warning follows on the heels of a June advisory warning consumers against using over-the-counter drugs to treat molluscum contagiosum, as the agency has not approved any drugs to treat the condition for OTC use. The agency approved the first prescription drug to treat molluscum contagiosum, Verrica Pharmaceuticals’ Ycanth (cantharidin) last month.

It’s uncommon for FDA to take action against online retailers such as Amazon and Walmart, as they often distribute the drugs on behalf of other sellers who list products on their platforms, yet in this case, Amazon and Walmart were labeled the responsible parties in introducing the drugs into interstate commerce.

The letters to both retail giants state that “your firm is responsible for introducing or delivering for introduction into interstate commerce of these products, which are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a).” It further notes that “introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).”

All six companies were taken to task for marketing unapproved new drugs under section 505(a) of the Federal Food, Drug and Cosmetic Act, and all contained the same boilerplate language stating that “Molluscum contagiosum is not a condition amenable to self-diagnosis and treatment, and there are no legally marketed over-the-counter (OTC) drug products to treat this condition.”

The warning letters gave companies 15 days to describe the steps they are taking to remove these products from the market. The agency further warned that failure to respond “may result in legal action including, seizure and/or injunction.”

The warning letter to Amazon’s CEO, Andrew Jassy, concerns four products the agency purchased through the company’s website, including Naturasil Molluscum Treatment Kit, Conzerol 2 Step Treatment for Molluscum Contagiosum, ZymaDerm for Molluscum and HealthyDerm Molluscum Contagiosum Treatment. FDA stated that all four products are “especially concerning” because they are marketed for use in children. The warning letter to Walmart’s also cited the company for selling Naturasil Molluscum Treatment Kit on its website.

The remaining warning letters addressed products sold by each company, some of which overlapped with the ones offered by Amazon and Walmart.

Molluscumway was cited for offering its MolluscumAway Hydrating Patches, Little Skins Smoothing Skin Ointment and Little Skins Gentle Body Wash products, while MolluscumRX was cited for promoting its MolluscumRx and MolluscumRx Soap products on its website and social media. One claim made by MolluscumRx stated that “My doctor said it was the best molluscum contagiosum medicine available. And he was right.”

FDA’s warning letter to Nature’s Innovation also took issue with the company’s promotion of an unapproved shingles treatment, Naturasil Shingles. “Shingles is a serious condition that is not amenable to either diagnosis or treatment by a lay person, and there are no legally marketed OTC drug products to treat this condition … Furthermore, FDA is concerned that people who use an unapproved drug product claiming to treat shingles are putting themselves at risk for developing serious complications, e.g., postherpetic neuralgia (long-term nerve pain), herpes zoster ophthalmicus (which can lead to vision loss), and skin infections.”

Warning letters: Amazon, Walmart, Nature’s Innovation, Thrasio, MolluscumRx, Molluscumaway

FDA warns Amazon, Walmart and others for selling unapproved drugs for viral skin infection

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