These Skincare Products Can Cause "Permanent Injury," FDA Says in New Warning

The agency calls the over-the-counter remedies "potentially dangerous."

For many people, taking care of their skin is essential to their daily routine. And for everything from spot treating blemishes to moisturizing head to toe, it can take a wide range of products to ensure all steps are covered. Finding the right items for your skin can sometimes take trial and error, with the worst outcome usually being that it's ineffective or causes slight irritation. But now, the Food & Drug Administration (FDA) is warning the public about specific skincare products that could lead to "permanent injury." Read on to see which items you should avoid from now on.

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The FDA has a process for ensuring the safety of skincare products.

woman shopping for skincare
GaudiLab / Shutterstock

Just like any dietary supplements you see for sale in the U.S., skincare products are subject to scrutiny from federal agencies like the FDA to ensure they're safe to use. However, this also means the items you see on the shelf aren't required to get any "premarket preapproval" before they go on sale and can only be regulated for violating a list of rules set by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Products run afoul of this law when they commit "adulteration"—which refers to using potentially dangerous ingredients or contaminants—or "misbranding," referring to when a product is "false or misleading" about its benefits or doesn't include all of the necessary information on its label.

"Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products," the FDA writes on its website. "Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients."

Now, certain products have come under fire from the agency and could face legal action.

The FDA is warning about certain skincare products on the market.

Woman looking at the red inflamed skin on her arm

On Aug. 10, the FDA issued an alert to the public that it had sent warning letters to, Ariella Naturals, and Justified Laboratories for introducing and selling mole and skin tag removers that were "not evaluated by the FDA for safety, effectiveness or quality, and require FDA approval." In addition, the agency says the products also violated the FD&C Act when the companies introduced them for interstate commerce without getting the appropriate approval.

"It is the FDA's duty to protect public health from harmful products not approved for the U.S. marketplace," Donald D. Ashley, JD, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a press release. "The agency's rigorous surveillance works to identify threats to public health and stop these products from reaching our communities. This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law."

The agency says the companies will now have 15 days to respond with the actions they've taken to address the violations, stating that "warning letters are not meant to be final agency solution."

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The agency cautions that the items could cause "permanent damage."

Skin tags

The agency says it's advising against the use of mole and skin tag removers because of the potentially "harmful side effects and serious risks" they pose, including "skin injuries, infection requiring antibiotics, scarring, and delayed skin cancer diagnosis and treatment." The FDA says it has also received reports from consumers who "developed permanent skin injuries and infections" as a result of using the over-the-counter (OTC) remedies.

"Products marketed for the cosmetic removal of moles, skin tags, or other skin lesions usually contain high concentrations of salicylic acid or other potentially dangerous substances," the agency wrote in its notice. "These products often don't remove the lesion or don't remove all of it. Worse, even if the lesion falls off, the product may cause permanent injury to the surrounding skin, such as scarring or discoloration. In some cases, the end result may be more distressing and noticeable than the original lesion, especially if you apply the product to your face."

The FDA advises seeing your doctor to check any suspicious mole or skin tag and says customers should "avoid" the OTC removers.

Woman showing doctor her arm

The FDA advises the public to "avoid these products" due to the potential danger they pose. Instead, the agency says a doctor should always check moles or skin tags to ensure that the spots aren't cancerous and that any potentially necessary treatment isn't delayed. While most moles and skin growths aren't a cause for concern, the FDA warns there are a few signs that they could be something more serious.

"If a mole or skin tag is growing, changing, bleeding, or is painful, you should seek medical attention," the agency warns. "Do not treat the skin issue yourself. If you remove it or change how it looks, health care providers may have a harder time determining if it is skin cancer and coming up with an effective treatment plan."

Anyone who has suffered an adverse event as a result of using mole or skin tag removers can also report it to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing the online form. You can also call 1-800-332-1088 to have a copy of the form sent to you or download it before completing it and sending it to the address listed or faxing it to 1-800-FDA-0178.

Zachary Mack
Zach is a freelance writer specializing in beer, wine, food, spirits, and travel. He is based in Manhattan. Read more
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