FDA WARNING_LETTER - Aviralex Int.

On March 3, 2008, the FDA issued a Warning Letter to Aviralex Int. regarding their product "Aviralex," marketed by Registrant Caroline Buckley. The letter states that Aviralex is promoted on www.aviralex.com with claims indicating it prevents, treats, or cures disease conditions in humans and affects body structure and function, specifically for herpes. Examples of these claims include "Stop the painful, ugly outbreaks of ALL Herpes," "Proven to provide immediate relief and cessation of ALL herpes outbreaks," and "Aviralex works by killing the herpes virus it comes in contact with." Metatags like "herpes treatment" also contribute to these intended uses.

The FDA determined Aviralex is an unapproved new drug under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 321(g)(1) and 321(p). Its sale without an FDA-approved application violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a). Furthermore, the product is misbranded under section 502(f)(1) of the Act, 21 U.S.C.