ORLANDO – The Florida distributor of a dietary supplement that claimed to cure herpes has stopped distributing the product after agreeing to a consent decree, both the Justice Department and the Food and Drug Administration announced recently.
The original complaint against James R. Hill of Florida, whose company sold Viruxo Immune Support on the internet as a natural medicine that prevents herpes outbreaks, was brought by the U.S. Department of Justice on behalf of the FDA. In turn, a permanent injunction is in place against Hill for marketing and distributing what was essentially a misbranded new drug that lacked FDA approval.
“Misbranding is a charge we use frequently,” FDA spokeswoman Lyndsay Meyer told the Florida Record. “It can incorporate inadequate directions for use or not putting something required on the label.”
Signed by U.S. District Judge James Moody Jr. for the Middle District of Florida, the consent decree was sought after the FDA sent a warning letter to Hill pointing out that his company’s website made claims establishing the product as a drug, which had not been approved by the regulatory agency. Even so, the FDA indicated that Hill continued to market Viruxo on the web as a herpes treatment.
The warning letter notes that the statements on the website marketing Viruxo included headlines such as “New Herpes Treatment! Cure for Herpes Outbreaks” and “Viruxo Anti-Viral Support … Never have a Herpes Outbreak Again!” Such statements are illegal, according to the original Justice Department complaint, because they claim that a product can treat or prevent a disease despite a lack of clinical trials or significant scientific substantiation.
“In some instances, consumers might be choosing supplements over other proven therapies for serious conditions under the mistaken belief that these products can help,” Benjamin Mizer, the head of the Justice Department’s Civil Division, said in a prepared statement. “The Department of Justice will continue to work aggressively with FDA to prevent distribution of unapproved drugs.”
Meyer said that the FDA sees these types of false medical claims frequently and that the agency takes violations seriously, following through with warning letters or court injunctions. She noted that supplements in the United States represent a $30 billion to $40 billion industry, while the FDA staff that monitors supplement-related issues numbers fewer than two dozen.
“Anyone can go to market with a supplement, and they don’t necessarily have to ask the FDA first,” Meyer said. “The regulatory system is always in a catch-up mode.”
According to the FDA, if Hill wants to again start distributing products such as supplements or drugs, he must let the FDA know in writing at least three months before doing so and also follow additional requirements outlined in the consent decree, such as hiring a labeling expert and receiving written FDA permission.
Fines for not complying with the decree include thousands of dollars per day per violation plus charges that amount to twice the retail value of any product sold that violates the provisions of the decree.
Meyer said it’s sometimes difficult to determine how effective the FDA warning letters are in getting supplement distributors to cease illegal actions.
“If we send a warning letter, they could change the name of the product, and we’re back to square one,” she said.