FDA issued warning letters to 3 companies for selling unapproved new drugs

FDA issued warning letters to 3 companies for selling unapproved new drugs

The U.S. Food and Drug Administration announced it issued three warning letters to three companies for introducing mole and skin tag removal products (Products: 1. Skincell Advanced, 2. Skincell, 3. Deisana, 4. Ariella Set and 5. Ariella) into interstate commerce that are unapproved new drugs, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags. 

Moles should be evaluated by a health care practitioner. Self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and treatment, and even cancer progression. The FDA has issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring. The sale of these products risks public health and may jeopardize consumers’ health when used without consulting a health care professional. 

On August 04, 2022, the FDA issued warning letters to:

Amazon.com (Products: “Deisana” and “Skincell”) 

Ariella Naturals (Products: “Ariella Set” and “Ariella”)

Justified Laboratories (Products: “Skincell Advanced” and “Skincell”)

The mole and skin tag removal products sold by these firms have not been evaluated by the FDA for safety, effectiveness or quality and require FDA approval. The introduction or delivery for introduction of these products into interstate commerce without an approved application is an additional violation of the FD&C Act.

Today’s warning letters alert the companies that failure to adequately address the violations cited by the FDA may result in legal action including seizure and/or injunction. The companies have 15 days from receipt of the warning letter to respond to the agency with actions they have taken to address any violations. The FDA will continue to use all tools available to protect public health and remove fraudulent or unproven drug products from the U.S. marketplace. Warning letters are not meant to be final agency action.

These products are not generally recognized as safe and effective for their above referenced uses and therefore are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for your products. The introduction or delivery for introduction into interstate commerce of these products without an approved application violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

“It is the FDA’s duty to protect public health from harmful products not approved for the U.S. marketplace” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “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.” 

*Source from FDA website.

FDA issued warning letters to 3 companies for selling unapproved new drugs: