WASHINGTON, D.C. — The FDA is warning three companies for selling unapproved new drugs across state lines.
The warnings come after Amazon, Ariella Naturals and Justified Laboratories sold mole and skin tag removal products. The FDA says there are no FDA-approved prescription or over-the-counter drug products for treating moles, wart-like growths, or skin tags.
In a consumer warning, the FDA said products that are being sold claiming to help remove these lesions are potentially dangerous. They may contain high concentrations of salicylic acid or other harmful ingredients.
The FDA said these products often don’t remove the lesion, or remove all of it. Even if the lesion falls off, using these products may lead to potentially harmful side effects or other serious risks.
These risks include skin injuries, infection requiring antibiotics, scarring, and delayed skin cancer diagnosis and treatment. The FDA said it has received reports about people who developed permanent skin injuries and infections after using products marketed as mole or skin tag removers.
“It is the FDA’s duty to protect public health from harmful products not approved for the U.S. marketplace” 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.”Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research
The FDA said most moles, wart-like growths, and skin tags are not cancerous. However, sometimes skin cancer can look harmless. This includes melanoma, a type of skin cancer that is particularly dangerous and can spread if not caught early.
The agency said if a mole or skin tag is growing, changing, bleeding, or painful, people should seek medical attention. They urge people not to treat the skin issue themselves. By doing so, health care providers may have a harder time determining if it is skin cancer and coming up with an effective treatment plan.
The warning letters alert the companies that the failure to adequately address the violations may result in legal action. This could include seizure or injunction. The FDA said the companies have 15 days to respond telling them how they have addressed any violations.
Amazon released a statement after getting the warning letter saying the products have been removed.
“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and removed.”Amazon Spokesperson
Anyone who experienced an adverse event involving any mole, seborrheic keratosis, or skin tag remover by using the FDA’s MedWatch Safety Information and Adverse Event Reporting Program
- Complete and submit the report online.
- Download the form or call 1-800-332-1088 to request a reporting form in the mail, then complete and return to the address on the form, or submit it by fax to 1-800-FDA-0178.
If anyone has a question about a medication, the FDA encourages them to call their health care professional or the FDA. The FDA’s Division of Drug Information (DDI) will answer almost any drug question. DDI pharmacists are available by email, firstname.lastname@example.org, and by phone, 1-855-543-DRUG (3784) and 301-796-3400.