Viruxo may sound great to herpes sufferers but the Food and Drug Administration says it has not been studied or approved and can’t be legally sold, and now a federal court has ordered the company to stop selling its product, which it allegedly claimed could treat herpes.
“Products being sold as treatments for which they have not been studied or approved defrauds consumers and can cause harm if proper treatment is delayed,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “When a company refuses to comply with regulations, we will take enforcement action to protect the public.”
U.S. District Judge James S. Moody, Jr., entered a consent decree that establishes a permanent injunction against James R. Hill of Florida, doing business as Viruxo LLC. The U.S. Department of Justice had sued Hill on behalf of the U.S. Food and Drug Administration, charging Hill with unlawfully distributing an unapproved new drug and misbranded drug.
The complaint also includes a civil fraud charge for Hill’s intent to defraud consumers by promoting his product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to substantiate his claims.
The action follows a warning letter the FDA sent Hill back in April 2011. The letter warned Hill against making therapeutic claims for his product.
Despite assurances that Hill was correcting violations noted in the warning letter, he continued to market his product on the internet as a treatment for herpes.