FDA WARNING_LETTER - Derma Remedies

The FDA and FTC issued a Warning Letter to Derma Remedies, specifically Mr. John Fields, regarding the marketing of H-Stop Dx, H-Guard Dx, Molluscum Dx, and Wart Dx on www.dermaremedies.com.

The FDA determined these products are unapproved new drugs and misbranded. Violations include: - **Unapproved New Drugs:** Products are marketed for conditions like herpes, molluscum contagiosum, and warts, which are not covered by any OTC monograph or ongoing rulemaking. They are considered "new drugs" lacking FDA-approved New Drug Applications (NDAs), violating sections 301(d) and 505(a) of the Act. - **Misbranding (Lack of Adequate Directions for Use):** Conditions like genital herpes, molluscum contagiosum, and genital warts are not amenable to self-diagnosis and treatment by laypersons. Therefore, adequate directions for safe use by a layman cannot be provided, violating section 502(f)(1) of the Act. - **Misbranding (Dangerous to Health):** H-Stop Dx and H-Guard Dx are deemed dangerous to health under section 502(j) because claims for herpes prevention, treatment, and cure may cause consumers to forgo or delay appropriate medical treatment. - **Inconsistent with OTC Drug Review:** The active ingredients in H-Stop Dx, H-Guard Dx, and Wart Dx