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PRESS RELEASE: District Court Enters Permanent Injunction to Prevent Florida Man from Distributing Unapproved Herpes Cure

Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Friday, February 26, 2016

District Court Enters Permanent Injunction to Prevent Florida Man from Distributing Unapproved Herpes Cure

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.

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Most of the information you will see comes from some Federal/state Government documents or Federal/State Governm Agency. -----------------------------------------------The fellow that can only see a week ahead is always the popular fellow, for he is looking with the crowd. But the one that can see years ahead, he has a telescope but he can't make anybody believe that he has it. ~~~~Will Rogers __The woman who follows the crowd will usually go no further than the crowd. The woman who walks alone is likely to find herself in places no one has ever been before.~ Albert Einstein ~"I never work better than when I am inspired by anger; for when I am angry, I can write, pray, and preach well, for then my whole temperament is quickened, my understandingsharpen​ed, and all mundane vexations and temptations depart.” ~Dr. Martin Luther King Jr. _________________________________________________________________________________________ ~"The bosom of America is open to receive not only the Opulent and respectable Stranger, but the oppressed and persecuted of all Nations and Religions; whom we shall welcome to a participation of all our rights and privileges, if by decency and propriety of conduct they appear to merit the enjoyment".~___________________________________ George Washington, Address to the Members of the Volunteer Association of Ireland, December 2, 1783 Fredericacade@gmail.com

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