FDA WARNING_LETTER - MolluscumRx, Inc. - August 18, 2023

The FDA issued a Warning Letter to MolluscumRx after reviewing their website and social media in June 2023, identifying that their "MolluscumRx" and "MolluscumRx Soap" products are unapproved new drugs. Molluscum contagiosum is not amenable to self-diagnosis or treatment, and no legally marketed OTC drugs exist for it. The FDA is particularly concerned as these products are marketed for children, potentially delaying proper medical diagnosis and treatment for a serious condition.

The products are deemed "drugs" under section 201(g)(1) of the FD&C Act due to claims of treating, curing, or mitigating molluscum contagiosum, including statements like "MolluscumRx Works," "Organic Molluscum Treatment," and "Antiviral ingredients." Claims of being "proven safe for use across the body, face and genital areas" and "highly effective in the treatment for curing molluscum contagiosum" were also cited.

These products are not generally recognized as safe and effective (GRASE) and are therefore "new drugs" under section 201(p) of the FD&C Act. Since no FDA-approved application exists for them, their introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. The company must respond within fifteen working days, outlining corrective actions and preventative measures,