Supplement Manufacturer Ordered to Cease Operations Due to False Advertising
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Supplement Manufacturer Ordered to Cease Operations Due to False Advertising

March 3, 2016

A federal court has ordered a Florida company to stop selling a dubious herpes treatment.

Senior U.S. District Judge James S. Moody, Jr. issued a consent decree of permanent injunction against James R. Hill, doing business as Viruxo, a distributor of dietary supplements.

According to the Food and Drug Administration (FDA), Hill is guilty of unlawfully distributing an unapproved and misbranded drug.

The complaint includes a fraud charge, citing 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.

"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," Melinda Plaisier, FDA associate commissioner for regulatory affairs, said in a written statement. "When a company refuses to comply with regulations, we will take enforcement action to protect the public."

In April 2011, Hill received a warning letter from the FDA, triggered by false claims made on the Viruxo website. Despite assurances that Hill was correcting violations noted in the warning letter, he continued to market his product on the internet to consumers as a treatment for herpes.

The judgement prohibits Hill from marketing misbranded or unapproved new drugs. Before resuming operations, Hill must hire a labeling expert, remove all representations from his website that his product can cure, mitigate, treat, or prevent disease, and receive written permission from the FDA to resume operations. In addition, the decree requires Hill to notify the FDA at least 14 days before the creation of a new website.