FDA issues warning letters to Walmart and Amazon regarding the sale of an unapproved skin drug

The Food and Drug Administration (FDA) recently issued warning letters to Amazon and Walmart, addressing their sale of an unapproved medical product.

On August 18, the FDA directed these retail giants’ attention to their marketing and sales of the “Naturasil Molluscum Treatment Kit.” This particular product is designed for molluscum contagiosum treatment, yet it has not received approval as a new drug from the FDA. Molluscum contagiosum is an infection that frequently affects children, resulting in skin lesions due to a poxvirus.

One crucial concern stems from the fact that molluscum does not possess over-the-counter (OTC) treatments, given that it’s a condition that requires proper diagnosis and professional medical attention rather than self-diagnosis and individual treatment. The added concern arises from the product’s marketing for children.

The FDA’s warning letters highlight the agency’s worry that individuals might choose to avoid or delay appropriate diagnosis and treatment by resorting to an unapproved drug like the Naturasil treatment, specifically promoted for molluscum contagiosum.

In Amazon’s case, the company had also offered three other molluscum treatment options: “Conzerol 2 Step Treatment for Molluscum Contagiosum,” “ZymaDerm for Molluscum,” and “HealthyDerm Molluscum Contagiosum Treatment.”

To address this issue, both Amazon and Walmart were required to

provide explanations to the FDA detailing the actions they were taking to prevent the sale of these unapproved treatments. Presently, as of Tuesday, these products are no longer available on their respective online retail platforms. Neither company has yet responded to requests for comments.

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