Haloderm, Inc. – FDA Warning Letter, Oct 13, 2020

The FDA issued a Warning Letter to Mr. Putris concerning the marketing of "HaloDerm Regular Homeopathic Mole & Skin Tag Remover" and "HaloDerm Advanced Homeopathic Mole & Skin Tag Remover" on www.haloderm.com. The FDA determined these products are unapproved new drugs, and their introduction into interstate commerce violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 355(a) and 331(d)). The products are classified as drugs under section 201(g) due to their intended use claims and as "new drugs" under section 201(p) because they are not generally recognized as safe and effective. No FDA-approved applications exist for these products, and their homeopathic labeling does not exempt them from drug approval requirements. The FDA highlighted public health concerns, noting the products contain corrosive ingredients like bloodroot and zinc chloride, which can cause tissue damage. Additionally, marketing products for mole removal directly to consumers may lead to delayed cancer diagnosis or discontinuation of effective medical treatments. The company must take prompt corrective action and respond to the FDA within fifteen working days, detailing steps taken to correct violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction.