The U.S. Department of Justice (DOJ) announced a permanent injunction against a Deltona, Florida company for the sale and distribution of unapproved and misbranded new drugs. According to the complaint filed with the consent decree, MyNicNaxs marketed dietary supplements to consumers on websites such as www.mynicnaxs.com and www.ruglamourous.com that U.S. Food and Drug Administration (FDA) testing showed to contain undisclosed pharmaceutical ingredients such as:
- Sildenafil, the active pharmaceutical ingredient in Viagra
- Sibutramine, a drug was withdrawn from the market at the FDA raised concerns over its safety in 2010; and
- Phenolphthalein, an ingredient that the FDA reclassified as “not generally recognized as safe and effective” in 1999 after indications of possible carcinogenic risk.
MyNicNaxs received a second warning letter from the FDA in 2015 after failing to comply with a 2013 warning to discontinue selling unapproved new drugs and misbranded drugs. Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research warned about the dangers that drugs containing undeclared active pharmaceutical ingredients post to consumers, stating: “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. 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.”
The permanent injunction requires MyNicNaxs to stop directly or indirectly distributing unapproved new drugs or misbranded drugs. The company is also prohibited from receiving, manufacturing, holding, and distributing any drugs or dietary supplements until they have received written notification from the FDA that they are in compliance with the decree and with the Food, Drug, and Cosmetics Act. This case was handled by Trial Attorney Joshua D. Rothman of the DOJ’s Civil Division Consumer Protection Branch, Assistant U.S. Attorney Jeremy R. Bloor from the U.S. Attorney’s Office for the Middle District, and Associate Chief Counsel for Enforcement Anna K. Thompson of the U.S. Department of Health and Human Services’ Office of General Counsel.