Five years ago, the Food and Drug Administration first warned a Florida man to stop peddling a supposed cure for herpes until he proved it worked and was safe. He subsequently tweaked the marketing to make it less cure-like, but federal prosecutors say he still went too far in promising his supplement could treat the sexually transmitted disease.
Back in 2011, the maker of a product called Viruxo was selling it as a “New Herpes Treatment! Cure for Herpes Outbreaks,” telling people that they could “Never Have A Herpes Outbreak Again” if they took “America’s #1 Herpes Outbreak Eliminator!”
Statements like these didn’t go over to well with the FDA, which sent out a warning letter, saying that any product making claims to cure or treat a disease must be considered a “drug” under the letter of the law.
More precisely, because Viruxo is not just a variation on an existing product that is generally recognized as safe, it’s considered a “new drug,” meaning its safety and efficacy must be demonstrated to the FDA before it can be sold for treating anything.
And so Viruxo backed off on the more obvious “cure” claims, and even added some fine print disclaimers to its website about how there is no known cure for herpes.
However, last fall the U.S. Department of Justice sued Viruxo in federal court, alleging that the product was still using drug-like claims to sell what was now labeled an “immune support” supplement instead of an “anti-viral.”
In the complaint [PDF], prosecutors took issue with Viruxo’s continued pronouncements that it could be used to “stop outbreaks” or references to the product as an “Over the Counter Herpes Medicine.”
In his response [PDF], the defendant denied maintained he was only selling a supplement made from “all natural ingredients all which available over the counter an in no way controlled.” [Typos in original.]
Regarding the non-disclaimer statement cited by the prosecutors, Viruxo contends that “It is…widely published through university and clinically proven research, that a strong healthy immune system, can keep the herpes virus in a dormant inactive state. Most all of the ingredients are widely recognizes to help boost the immune system.” [Again, typos in original.]
But today, the DOJ announced that it has entered into a consent decree [PDF] permanently barring Viruxo or its owner from selling any food, drug, or supplement without permission from the FDA.
“Unfortunately, many dietary supplements cannot do what their sellers claim they can do,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “In some instances, consumers might be choosing supplements over other proven therapies for serious conditions under the mistaken belief that these products can help.”