# FDA WARNING_LETTER - Derma Remedies - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/derma-remedies/14d6b5d5-8ac7-4a42-bf05-be8d4c37fedd

> FDA WARNING_LETTER for Derma Remedies on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Derma Remedies
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/evelyn-bonnin/3fdb9ef8-ea23-4a86-9176-cab37e5dea36)
- [Associate Director](https://www.keypedia.com/people/mary-k-engle/9426dfba-028c-4d3a-bb62-7bdea653e6bc)
- [Former FDA Deputy Commissioner](https://www.keypedia.com/people/deborah-m-autor/b16e4745-566a-4102-ae98-d314ad1b61f5)

Company: https://www.keypedia.com/companies/derma-remedies/49312ada-01f5-481d-be79-ee5d4a166082

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c