FDA, Justice Shut Down Sexual Enhancement, Weight Loss Business

By William Vogeler, Esq. on March 29, 2018 | Last updated on March 21, 2019

'Bulls genital male pills are ALL NATURAL,' said the sexual enhancement advertisement, but not anymore.

MyNicNaxs, a Florida company, nixed its ads because a federal court permanently enjoined it from selling unapproved and misbranded drugs. The U.S. Justice Department announced the court order after a receiving a request from the U.S. Food and Drug Administration.

"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. But what about the bull?

Sexual Enhancement

In a complaint filed earlier this month, the government alleged MyNicNaxs falsely marketed products that claimed to treat or prevent a host of serious conditions or diseases. The justice department said the products were not approved by the FDA.

The Department of Health and Human Services had warned the company three years ago about unapproved products. It identified nearly a dozen that had traces of pharmaceuticals that were not disclosed.

"Despite previous warnings, MyNicNaxs continued violating the law," said Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. Along with the other drugs, Sildenafil -- the active ingredient in Viagra -- showed up.

Dietary Supplements

The FDA said MyNicNax also distributed undisclosed pharmaceuticals such as Sibutramine -- which had links to heart attack and stroke -- and Phenolphthalein -- which poses a "potential carcinogenic risk."

The permanent injunction requires the defendant to "cease directly or indirectly distributing any unapproved new drugs or misbranded drugs." The company may not receive, manufacture, hold, or distribute any drugs or dietary supplements without written notification of compliance from the FDA.

The company has disabled its website from processing orders for supplements, but continues to sell waist trainers and butt lifters. Not a word about the bull.

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