A Florida resident has been permanently enjoined from distributing unapproved drugs billed as a cure for the herpes virus. Although Viruxo Immune Support (Viruxo) was labeled as a dietary supplement, the seller made claims that were not supported by FDA approval, causing the drug to be qualified as unapproved and misbranded. The consent decree followed a complaint filed by the Department of Justice (DOJ) in Florida district court.
The FDA issued a warning in April 2011 regarding Viruxo and the claims surrounding it, which stated that it could not be sold without FDA approval. The consent decree found that despite the warning, the seller and his company, Viruxo LLC, violated the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq) by: (1) delivering an unapproved drug into interstate commerce; (2) delivering a misbranded drug into interstate commerce; and (3) selling products promoted to cure, mitigate, treat, or prevent a disease despite a lack of scientific substantiation.
The seller stated that he was not currently engaged in distributing any supplements or drugs, but the injunction requires him to obtain FDA approval or avoid making certain representations in his labeling and marketing if he decides to engage in selling any food or drug product, including dietary supplements. He must also notify the FDA of his intent to market and sell products and receive a written notice that he is in compliance with all requirements found in the decree before he resumes activities. Any violations of the consent decree, the FDC Act, or implementing regulations will result in hefty penalties per day per violation, as well as liquidated damages of twice the retail value of products distributed.