Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

SILVER SPRING, Md., March 28, 2018 /PRNewswire-USNewswire/ -- A federal court ordered a Florida-based company to stop selling drugs and dietary supplements until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.

The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction between the United States and MyNicNaxs, LLC of Deltona, Florida; Chevonne Torres, the company's owner; and Michael Banner, an officer at the company. MyNicNaxs distributed weight loss and sexual enhancement products, which the company marketed as dietary supplements, directly to consumers online through the websites www.mynicnaxs.com and www.ruglamourous.com. Some of these products tested positive for undeclared active pharmaceutical ingredients.

"Marketing products with undeclared active pharmaceutical ingredients poses serious safety risks to consumers. These types of products are particularly concerning because consumers do not know what the products actually contain, and the undeclared ingredients may cause serious, even life threatening, adverse reactions," said Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "Despite previous warnings, MyNicNaxs continued violating the law. The FDA will continue to take action to protect the American public when companies knowingly violate the law and put consumers at risk."

According to the complaint filed with the consent decree, FDA tests showed some of the MyNicNaxs products contained undisclosed pharmaceutical ingredients such as:

• Sildenafil, the active pharmaceutical ingredient in Viagra;
• Sibutramine, the active pharmaceutical ingredient in Meridia, a drug that was withdrawn from the market after clinical data indicated that it poses an increased risk of heart attack and stroke; and
• Phenolphthalein, an ingredient that the FDA deemed "not generally recognized as safe and effective" after studies indicated that it was a potential carcinogenic risk.

The complaint alleges that certain MyNicNaxs products are drugs under the FD&C Act because they are intended to cure, mitigate, treat or prevent disease. Further, the drugs are misbranded because their labeling is false and misleading in that it does not declare certain active pharmaceutical ingredients, their labeling fails to bear adequate directions for use, and/or the drugs are dangerous to health when used as recommended in the labeling.

The permanent injunction requires the defendants to cease directly or indirectly distributing any unapproved new drugs or misbranded drugs. MyNicNaxs is prohibited from receiving, manufacturing, holding and distributing any drugs or dietary supplements until they receive a written notification from the FDA stating that they appear to be in compliance with the decree, the FD&C Act, and its regulations, and that they may resume operations.

In 2015, the FDA issued a warning letter to MyNicNaxs after it was discovered that the company continued to sell unapproved new drugs and misbranded drugs.

The U.S. Department of Justice filed the complaint on behalf of the FDA.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also 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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SOURCE U.S. Food and Drug Administration