RoyceDerm LLC – FDA Warning Letter, Oct 1, 2026

RoyceDerm LLC received an FDA Warning Letter following a review of the company’s website in July 2026. The FDA identified significant violations regarding the marketing of "Herpes Relief Cream," which is classified as an unapproved new drug under the Federal Food, Drug, and Cosmetic Act. The agency noted that the product is promoted for the treatment of herpes and other sexually transmitted infections (STIs), claiming to relieve blisters, rashes, and pain while reducing recurrence. The FDA emphasized that there are no over-the-counter drug products approved to treat or prevent STIs. Marketing such products poses a serious public health risk, as consumers may forgo necessary medical diagnosis and treatment, potentially leading to severe health complications or the spread of infections. Because the product lacks an approved application and is not recognized as safe and effective for its stated uses, its sale violates federal regulations. RoyceDerm LLC is required to investigate the root cause of these violations and implement corrective actions to prevent recurrence. The company must submit a detailed written response within 15 business days outlining the steps taken to achieve compliance. Failure to address these issues promptly may result in legal action, including product seizures or injunctions.