On February 26, 2016, the FDA announced that a Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes. The complaint, filed by the U.S. Department of Justice on behalf of the FDA, sought a permanent injunction against the Florida resident, 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 for his 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.
As part of the decree, the defendant represented to the court that he is not directly or indirectly engaged in distributing dietary supplements or drugs. However, if he intends to resume distributing dietary supplements or drugs, he must notify the FDA in writing at least 90 days before doing so and comply with additional requirements specified in the decree.
“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.”
In April 2011, the FDA and the U.S. Federal Trade Commission sent the defendant a warning letter for making therapeutic claims on his website establishing that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The FDA has not approved this product for any use. In addition, the warning letter stated that the product is also a misbranded drug because its labeling failed to provide adequate directions for use.
On the main webpage was a headline banner statement: “New Herpes Treatment! Cure for Herpes Outbreaks” and “Viruxo is currently available without a prescription consisting of 14 synergistic ingredients providing your body the ultimate defense against herpes outbreaks.” Despite assurances that he 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 consent decree prohibits him from marketing misbranded or unapproved new drugs. Before the defendant can resume operations, he must, among other things, hire a labeling expert, remove all representations from his website and other promotional materials 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 him to notify the FDA at least fourteen days before the creation of a new website, or link or reference to another website, which conveys information about his products.
See the FDA Announcement
See also Medical Law Perspectives, September 2014 Report: Hepatitis: Provider Malpractice and Patient Injury
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability