FDA WARNING_LETTER - JB Exchange Inc./Justified Laboratories - August 09, 2022

On August 4, 2022, the FDA issued a Warning Letter to Justified Laboratories regarding their website, www.justifiedlaboratories.com. The FDA's review in August 2022 found that the company was taking orders for "Skincell Advanced Mole Skin Tag Corrector Serum" and "Skincell Mole Skin Tag Corrector Serum."

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 products are considered 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 to affect body structure or function.

The FDA highlighted that there are no legally sold over-the-counter (OTC) drugs for mole or skin tag removal, citing safety concerns about self-diagnosis and treatment potentially delaying cancer diagnosis. The products are not generally recognized as safe and effective for their stated uses, making them "new drugs" under section 201(p) of the FD&C Act,