FDA WARNING_LETTER - Medavir Medical Advances, Inc.

The FDA and FTC issued a Warning Letter to Medavir Medical Advances, Inc. regarding their products Medavir, ViraBalm, and Vyristic Immune Support, sold on www.medavir.com, www.medavir.net, and www.taghealth.com. The FDA determined these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

Violations include marketing products with claims like "prevents 98% of all outbreaks" and "stop herpes simplex outbreaks forever!" for Medavir, "inactivate the herpes virus" for ViraBalm, and "prevent future outbreaks" for Vyristic. These claims, along with metatags like "herpes cure," classify them as drugs intended to treat or prevent disease. As "new drugs," they require FDA-approved New Drug Applications (NDAs), which are absent.

The products are also misbranded because genital herpes is not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. Furthermore, the products are deemed dangerous to health under Section 502(j) of the Act, as consumers might delay appropriate medical treatment. The letter notes that genital herpes is not covered by any OTC Drug Review monograph, and Medavir's active ingredient (Stannous Fluoride) is not evaluated for cold sore treatment. Oral products like Vyristic for cold sores are also unapproved new drugs.