Senior U.S. District Judge James Moody Jr., representing the Middle District of Florida, has ruled that a Florida company must stop selling a dietary supplement the company told consumers could be used as a therapy for herpes.
Viruxo LLC and its owner, James Hill of Florida, were given a permanent injunction after a complaint was filed by the U.S. Department of Justice, acting for the U.S. Food and Drug Administration (FDA).
The complaint alleged that Viruxo had deliberately misbranded the drug, which was never approved by the FDA and was therefore not able to be distributed legally in the U.S.
A civil fraud charge has also been leveled at Hill; the DOJ said his company’s claims that the supplement could be used to treat herpes was an act of intentional fraud as the drug had never been the subject of any scientific or clinical studies. Additionally, Viruxo’s products had no labeling to outline directions for use, which is a requirement for all FDA-approved drugs.
“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. “When a company refuses to comply with regulations, we will take enforcement action to protect the public.”
Hill argued that, because he was not in any way involved with the actual distribution of any of Viruxo’s supplements or drugs, he could not be held liable.
Viruxo is now prohibited from distributing any dietary supplements or other drugs without notifying the FDA in writing at least 90 days in advance.
This is not the first time Hill has tangled with the federal government. He received a warning in April 2011 from the FDA and the U.S. Federal Trade Commission when they discovered he was claiming on a website he owned that his company’s products were drugs that had been approved to treat diseases.
“The FDA has not approved Hill’s product for any use,” FDA officials said.
The latest warning also requires Hill to hire a labeling expert and remove all therapeutic claims from his website and promotional material before he can sell any more supplements. He must also notify the FDA 14 days ahead of establishing any new websites, links or references to other websites that contain information about the supplements his company markets.
