July 21, 2018

Consent Decree Issued Against MyNicNaxs, Maker of Dietary Supplements

A federal court ordered a Florida-based company called MyNicNaxs to stop selling drugs and dietary supplements until it complies with the Federal Food, Drug, and Cosmetic Act and other requirements. The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction against MyNicNaxs of Deltona Florida.

Consent Decree of Permanent Injunction

The company distributed weight loss and sexual enhancement products, marketed as dietary supplements, directly to consumers online through their websites. Some of these products tested positive for undeclared active pharmaceutical ingredients.

Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a statement, “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. 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.”

Some of the products contained Sildenafil, the active ingredient in Viagra,, as well as Sibutramine, the active ingredient in Merdia, a drug that was withdrawn from the market after clinical data showed it posed an increased risk of heart attacks and stroke. Some of the products also contained phenolphthalein, an ingredient deemed by the FDA as “not generally regarded as safe and effective,” after studies found it is a potential carcinogen.

That makes these products drugs until the FD&C Act because they are “intended to cure, mitigate, treat, or prevent disease.” The drugs are also 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 company received a warning letter from the FDA in 2015. The company cannot sell or indirectly distributed any unapproved new drugs or misbranded drugs. The U.S. Justice Department filed the complaint on behalf of the FDA.

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