Federal judge approves consent decree with Florida dietary supplement distributor, Viruxo.

A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes. Senior U.S. District Judge James S. Moody, Jr. for the Middle District of Florida entered a consent decree of permanent injunction between the United States and James R. Hill of Florida, doing business as Viruxo LLC, a distributor of dietary supplements.

The complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration, sought a permanent injunction against Hill for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes a civil fraud charge for Hill’s 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, Hill represented to the court that he is not directly or indirectly engaged in distributing dietary supplements or drugs.

However, if Hill 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 Hill 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 Hill’s product for any use.

In addition, the warning letter stated that Hill’s product is also a misbranded drug because its labeling failed to provide adequate directions for use. Despite assurances that Hill 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 Hill from marketing misbranded or unapproved new drugs.

Before Hill 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 Hill to notify the FDA at least 14 days before the creation of a new website, or link or reference to another website, which conveys information about his products. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA approves Opdivo to treat advanced form of kidney cancer.

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. “Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.” Torisel (temsirolimus), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer.


Renal cell carcinoma is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine. The National Cancer Institute estimates 61,560 new cases and 14,080 deaths from kidney and renal pelvis cancer in the United States this year.

“Additionally, Opdivo’s extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors,” continued Dr. Pazdur.

Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight cancer cells. Opdivo is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy (treatments that interfere with the blood vessels that contribute to the growth of cancerous cells).

The safety and efficacy of Opdivo for this use were demonstrated in an open-label, randomized study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent. Patients were treated with Opdivo or another type of kidney cancer treatment called everolimus (marketed as Afinitor). Those treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with Afinitor. This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors. Additionally, 21.5 percent of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9 percent of those taking Afinitor, lasting an average of 13.7 months.

The most common side effects of Opdivo for this use are conditions relating to abnormal weakness or lack of energy (asthenic conditions), cough, nausea, rash, difficulty breathing (dyspnea), diarrhea, constipation, decreased appetite, back pain and joint pain (arthralgia).

Opdivo also has the potential to cause serious side effects that result from the immune system effect of Opdivo (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.

The FDA granted the Opdivo application a breakthrough therapy designation, fast track designation, and priority review status. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.

Opdivo is marketed by Bristol-Myers Squibb based in Princeton, New Jersey. Torisel is marketed by Pfizer, based in New York, New York. Afinitor is marketed by Novartis Pharmaceuticals of East Hanover, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.