Graceful Touch, LLC – FDA Warning Letter, Jul 1, 2026

On October 1, 2026, the FDA issued a warning letter to Graceful Touch, LLC, following a July 2026 review of the company"s website. The agency identified significant legal violations concerning the marketing and distribution of the product "Herpes B Gone." The FDA determined that this product is being marketed as an unapproved new drug, which is a violation of the Federal Food, Drug, and Cosmetic Act. Specifically, the company’s website claimed the product could treat, soothe, and prevent herpes outbreaks on the mouth and genitals. Because the FDA has not approved any over-the-counter drug for the treatment or prevention of sexually transmitted infections (STIs), and because the product is not generally recognized as safe and effective for these uses, its sale is prohibited. The FDA highlighted that such products pose a serious public health risk by potentially causing consumers to delay professional medical treatment for STIs. Graceful Touch, LLC is required to investigate the root causes of these violations and implement corrective measures to ensure compliance. The company must provide a written response to the FDA within 15 business days detailing the specific actions taken to address the violations and prevent their recurrence. Failure to rectify these issues may result in legal action, such as product seizure or a court injunction.