FDA WARNING_LETTER - Thrasio, LLC D/B/A ZymaDerm - May 11, 2023

On August 18, 2023, the FDA issued a Warning Letter to Naturopathix, Inc. regarding their product "ZymaDerm for Molluscum," sold via their website naturopathix.com and promoted on facebook.com/ZymaDerm. The FDA determined that "ZymaDerm for Molluscum" is an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a).

The product is deemed a drug because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the body's structure or function, as evidenced by claims on their websites such as "effective in reducing or eliminating molluscum lesions," "effective and safe for molluscum contagiosum treatment," and "safe proven treatment to painlessly eliminate molluscum contagiosum."

Molluscum contagiosum is not amenable to self-diagnosis and treatment, and no legally marketed OTC drugs exist for it. The FDA is particularly concerned as the product is marketed for children, potentially delaying proper diagnosis and treatment of serious conditions. The product is not generally recognized as safe and effective (GRASE) for its intended uses and lacks an FDA-approved application.

The letter requires Naturopathix, Inc. to respond within fifteen working days, detailing corrective actions taken to address these