The U.S. Food and Drug Administration (FDA) has issued warnings to several companies, including Amazon and Walmart, for selling unapproved products that claim to treat a skin condition in children. The FDA’s Center for Drug Evaluation and Research sent warning letters dated Aug. 18 to Amazon, Walmart, Nature’s Innovation, MolluscumRx, Thrasio, and Molluscumaway regarding their unapproved products marketed for molluscum contagiosum. The FDA clarified that self-diagnosis and treatment are ineffective for this condition and that there are no over-the-counter products approved for treatment. The FDA identified specific products, such as Naturasil Molluscum Treatment Kit and Conzerol 2 Step Treatment for Molluscum Contagiosum, that violate the Federal Food, Drug, and Cosmetic Act. The companies have been given 15 days to respond and provide evidence that they are no longer selling the products or prove that their sales comply with FDA regulations. Failure to comply may result in further disciplinary action. Walmart has confirmed the removal of these products from its website, while Nature’s Innovation, MolluscumRx, and Molluscumaway have not taken action. The FDA emphasized the public health concern due to the marketing of these products for children. Additionally, the FDA expressed concern that people may delay or forgo proper diagnosis and treatment while relying on unapproved products. Molluscum contagiosum is a viral infection characterized by flesh-colored bumps that primarily affects children under the age of 10. Although the condition typically resolves within six to 12 months without treatment, the FDA recently approved the first prescription treatment, “Ycanth,” for children aged 2 and above. The FDA strongly advised against purchasing or using nonprescription products claiming to treat molluscum and emphasized that companies making statements suggesting FDA endorsement should not be trusted. The Hill has sought comments from the companies involved.
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