FDA WARNING_LETTER - Viruxo.com - April 28, 2011

On April 28, 2011, the FDA and FTC issued a Warning Letter to Viruxo LLC, following a review of their website, www.viruxo.com. The product "Viruxo Anti-Viral Support" was found to be promoted with therapeutic claims, classifying it as an unapproved new drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

Violations included claims such as "New Herpes Treatment! Cure for Herpes Outbreaks," "Never Have A Herpes Outbreak Again!", and "America’s #1 Herpes Outbreak Eliminator!" These claims, along with others on the FAQ page and in customer testimonials, establish the product's intent for disease treatment or prevention. The product is also deemed misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because it lacks adequate directions for use by a layperson for conditions not amenable to self-diagnosis. The introduction of this misbranded drug into interstate commerce violates § 301(a) of the Act [21 U.S.C. § 331(a)].

The FTC also cited violations of the FTC Act, 15 U.S