A U.S. District Judge for the Middle District of Florida, James S. Moody, Jr. has entered a consent decree of permanent injunction between the United States and James R. Hill of Florida, doing business as Viruxo LLC, a distributor of dietary supplements, for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes a civil fraud charge, by promoting the product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to support the claims.
Hill was sent a warning letter in April 2011, stating that the therapeutic claims he is making are untrue. The FDA has not approved the product for any use. The product was marketed as a treatment for herpes. In addition, the product was misbranded because the label didn’t provide adequate directions for use. The product was “offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.”
The warning letter states that some of the claims on the website include “New Herpes Treatment and Cure for Herpes Outbreaks,” “America’s #1 Herpes Outbreak Eliminator,” and “VIRUXO helps to prevent the symptoms as well as the outbreak itself.” Other claims included “Viruxo gives your skin more strength to prevent herpes outbreaks,” along with disease claims in the form of Customer Stories.
The consent decree prohibits Hill from marketing misbranded or unapproved new drugs. He must hiring a labeling expert, remove all claims from his website and promotional material that his product can treat or cure disease, and receive written permission from the FDA to resume operations.
Melinda Plaisier, FDA associate commissioner for regulatory affaris, said in a statement, “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. When a company refuses to comply with regulations, we will take enforcement action to protect the public.”
If Hill intends to resume distributing dietary supplements or drugs, he must notify the FDA in writing at least 90 days before doing so. Hill claimed he was correcting violations noted in the warning letter, but continued to market his product as a treatment for herpes.