A federal court permanently enjoined a Deltona, Florida, company from selling and distributing unapproved and misbranded new drugs, the Justice Department announced.
In a complaint filed March 14 at the request of the U.S. Food and Drug Administration (FDA), the United States alleged that MyNicNaxs LLC, Chevonne Torres, and Michael Banner sold sexual-enhancement and weight-loss products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The complaint alleged that the defendants marketed products as drugs that could help treat or prevent a host of serious conditions or diseases. According to the complaint, the defendants made such claims without FDA approval and without proof of safety and efficacy.
The complaint further alleged that FDA tests showed some of the defendants’ products contained undisclosed pharmaceutical ingredients such as sildenafil, the active pharmaceutical ingredient in Viagra; sibutramine, the active pharmaceutical ingredient in a drug that was withdrawn from the market after clinical data indicated that it posed an increased risk of heart attack and stroke; and phenolphthalein, an ingredient that FDA deemed “not generally recognized as safe and effective” after studies indicated that it was a potential carcinogenic risk. The defendants agreed to be bound by a consent decree of permanent injunction filed in U.S. District Court for the Middle District of Florida.
“When a company fails to disclose pharmaceutical ingredients in its products, consumer safety can be put at risk,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure dietary supplement distributors provide accurate information about what is in their products.”
According to the complaint, no credible scientific evidence supported claims the defendants made that their products cured, mitigated, treated, or prevented a number of serious diseases. In addition, the complaint alleged that the defendants’ products failed to include adequate directions for use, such as dosages, warnings, and side effects. The consent decree, as entered by the court, requires the defendants to implement specific remedial measures to comply with the law and obtain written approval from the FDA before distributing such drugs in the future.
“The presence of misbranded drugs represents a threat to the people of our district and the United States,” said U.S. Attorney Maria Chapa Lopez. “This lawsuit and today’s decree demonstrates our office’s ongoing efforts to safeguard the public from the effects of this type of unlawful conduct.”
This matter was handled by Trial Attorney Joshua D. Rothman of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney Jeremy R. Bloor of the U.S. Attorney’s Office for the Middle District of Florida and Associate Chief Counsel for Enforcement Anna K. Thompson of the U.S. Department of Health and Human Services’ Office of General Counsel.