The U.S. Food Drug and Administration (FDA) has warned six companies — including Amazon and Walmart — over selling unapproved products marketed as treatments for a skin condition affecting children.
The FDA’s Center for Drug Evaluation and Research sent the six companies — Amazon, Walmart, Nature’s Innovation, MolluscumRx, Thrasio and Molluscumaway — warning letters dated Aug. 18 over unapproved products that are marketed to treat molluscum contagiosum.
The letters, which were published online Tuesday, said that the skin condition cannot be treated through self-diagnosis and treatment, noting that there is not any over-the-counter product that is approved to treat the condition.
The letters warn the companies over products including Naturasil Molluscum Treatment Kit, Conzerol 2 Step Treatment for Molluscum Contagiosum, ZymaDerm for Molluscum and HealthyDerm Molluscum Contagiosum Treatment. The FDA said that the selling of such unapproved products violates the Federal Food, Drug, and Cosmetic Act.
The FDA gave the companies 15 days to respond with proof that they are no longer selling the products or with evidence saying that the sale does not violate FDA rules. If they do not comply, the companies could face further discipline.
A Walmart spokesperson confirmed to The Hill that the company removed the unapproved products from its website.
“We were informed by FDA that a product, Naturasil Molluscum Treatment Kit, being sold on our Marketplace by a third party seller did not meet FDA requirements,” the spokesperson said in a statement. “We promptly removed the product from our site and will continue to work closely with FDA to help ensure products on our site comply with FDA’s laws and regulations and our policies.”
As of Wednesday, it appeared that Nature’s Innovation, MolluscumRx and Molluscumaway have not taken down the products from their respective websites.
The FDA wrote that the products “are especially concerning from a public health perspective because they are marketed for use in children.”
“In addition, 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,” the letter stated.
Molluscum is a “common, benign, viral infection that can cause white, pink, or flesh-colored bumps,” according to the FDA. It is spread by skin-to-skin contact and is most common in children under the age of 10.
Without treatment, the skin condition will likely go away on its own within six to 12 months, but in some cases could take up to five years. Last month, the FDA approved the first prescription treatment for the condition, “Ycanth,” for children 2 years old and older.
“Do not purchase or use nonprescription (over-the-counter, or OTC) products that claim to treat molluscum, even if the companies make statements that suggest their product may have been reviewed or is endorsed by the FDA,” the FDA warned.
The Hill has reached out to the companies for comment.
