FDA WARNING_LETTER - Ariella Naturals - August 09, 2022

The FDA issued a Warning Letter on August 4, 2022, to the entity operating tryariella.com, following a website review in August 2022. The letter addresses the sale of "Ariella Skin Tag Remover & Mole Corrector and Repair Lotion Set" and "Ariella Skin Tag Remover and Mole Remover 2 pcs" (collectively, "Ariella products").

The FDA determined that claims on the website establish these products as unapproved new drugs, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The FDA states there are no legally sold over-the-counter (OTC) drugs for mole or skin tag removal and expresses safety concerns, noting that self-treatment could delay cancer diagnosis and cause injuries or scarring.

The "Ariella products" are classified as drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to their intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or affecting body structure or function. As they are not generally recognized as safe and effective for their stated uses, they are considered "new drugs" under section