Deltona Company Barred From Selling Unapproved Sex & Weight Loss Drugs

By on March 30, 2018 in WNDB News

Deltona, FL – A Deltona company has been permanently barred by a federal court from selling unapproved and misbranded sexual-enhancement and weight-loss drugs.

According to a press release from the United States Department of Justice, the company, MyNicNaxs LLC, Chevonne Torres, and Michael Banner claimed that the unapproved and misbranded drugs could treat several serious medical conditions and diseases. A complaint against the company was filed on March 14 at the request of the U.S. Food and Drug Administration (FDA). That complaint alleges that the company made those claims without FDA approval or proof of safety and efficacy.

“The presence of misbranded drugs represents a threat to the people of our district and the United States,” U.S. Attorney Maria Chapa Lopez announced on Wednesday. “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.”

The Department of Justice says that some products from MyNicNaxs contained undisclosed ingredients like 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the active pharmaceutical ingredient in Viagra; sibutramine, the active pharmaceutical ingredient in a drug that was withdrawn from the market after clinical data indicated that it posed an increased risk of heart attack and stroke; and phenolphthalein, an ingredient that FDA deemed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 cancer risk.

“When a company fails to disclose pharmaceutical ingredients in its products, consumer safety can be put at risk,” Acting Assistant Attorney General Chad Readler, of the Justice Department’s Civil Division, says. “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.”

The complaint against the company states that there is no credible scientific evidence to support the claims that the drugs cured or prevented certain serious diseases. The products also allegedly had no adequate directions for use, such as dosages, warnings, and side effects.

The defendants agreed to a consent decree of a permanent injunction filed in U.S. District Court for the Middle District of Florida. The decree requires the company and the defendants to take measures to comply with the law and to get written approval from the FDA before selling these types of drugs in the future.

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website here. You can also learn more about the U.S. Attorney’s Office for the Middle District of Florida at its website.

Photo courtesy David Smart and Shutterstock.com.

Copyright Southern Stone Communications 2018.

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