FLORIDA–(ENEWSPF)–February 26, 2016. The U.S. District Court for the Middle District of Florida entered a consent decree of permanent injunction against James R. Hill, of Ocala, Florida, to prevent the distribution of unapproved drugs masquerading as a cure for the herpes virus, the Department of Justice announced today.
The department filed a complaint in the U.S. District Court for the Middle District of Florida alleging that Hill sold a product, Viruxo Immune Support (Viruxo), that he marketed as a “natural herpes medicine” that can “Stop Herpes Outbreaks.” Although labeled as a dietary supplement, Viruxo qualifies as an unapproved and misbranded drug, according to the complaint, because of Hill’s claims that it could treat the herpes virus despite the absence of approval from the Food and Drug Administration (FDA) that it was safe and effective for such a use.
The complaint further alleged that Hill defrauded consumers by promoting Viruxo to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or other credible scientific substantiation to support those claims. Hill made his misleading claims about Viruxo despite having received a warning letter from FDA and the Federal Trade Commission advising him that his product is an unapproved drug and was misbranded.
“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. The Department of Justice will continue to work aggressively with FDA to prevent the distribution of unapproved drugs.”
“Consumers should exercise extreme caution when purchasing supplements online,” warned U.S. Attorney A. Lee Bentley, III for the Middle District of Florida. “Viruxo was marketed to consumers as a ‘medicine’ for herpes, even though this product was not approved by the FDA and there were no well-controlled clinical studies to support the therapeutic 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,” said Associate Commissioner Melinda Plaisier for FDA regulatory affairs. “When a company refuses to comply with regulations, we will take enforcement action to protect the public.”
Hill agreed to settle the case and be bound by a consent decree of permanent injunction. Although he has ceased selling Viruxo, the consent decree requires him to notify FDA and receive its permission before resuming sale of Viruxo or distribution of any food, including a dietary supplement, or drug. To obtain permission from FDA, FDA must first determine that Hill’s practices comply with the Federal Food, Drug and Cosmetic Act.
The government is represented by Trial Attorney Daniel E. Zytnick of the Civil Division’s Consumer Protection Branch and Lacy R. Harwell Jr. of the U.S. Attorney’s Office for the Middle District of Florida, with the assistance of Senior Counsel Claudia J. Zuckerman of the Department of Health and Human Services’ Office of General Counsel – Food and Drug Division.
For more information about the Consumer Protection Branch, visit its website at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Middle District of Florida, visit its website at http://www.justice.gov/usao-mdfl.