A judge on Wednesday blocked a Florida-based company from selling dietary supplements until it complies with the Federal Food, Drug & Cosmetic Act (FDCA) and other requirements in a court order, FDA announced.
MyNicNaxs marketed weight loss and sexual enhancement products as dietary supplements directly to consumers through certain websites, including www.mynicnaxs.com, but some of the products tested positive for active pharmaceutical ingredients (APIs), according to an FDA news release.
The consent decree of permanent injunction was entered in the U.S. District Court for the Middle District of Florida between the United States and MyNicNaxs, LLC of Deltona, Florida, its owner Chevonne Torres and Michael Banner, an officer with MyNicNaxs.
The news release said FDA tests showed some of the MyNicNaxs products contained undisclosed pharmaceutical ingredients, such as:
- sildenafil, the API in Viagra;
- sibutramine, an API in a drug (Meridia) that was withdrawn from the market in 2010 after clinical data suggested the ingredient posed an increased risk of heart attack and stroke; and
- phenolphthalein, an ingredient FDA deemed “not generally recognized as safe and effective” after studies indicated it posed a potential carcinogenic risk.
In 2015, FDA warned Torres that he was continuing to distribute unapproved new and misbranded drugs in violation of the FDCA. Among other observations, the letter noted laboratory analysis of 10 products collected during an FDA inspection of a distribution facility in November 2013 verified the presence of undeclared sibutramine, analogues of sibutramine and/or phenolphthalein.
“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,” said Donald D. Ashley, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in a statement. “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.”
Under the injunction, the defendants must immediately stop distribution of unapproved new or misbranded drugs. The company also is barred from distributing, holding, manufacturing and receiving any drugs or dietary supplements until it receives permission from FDA to resume operations based on a finding of compliance with the consent decree, FDCA and FDA regulations.
MyNicNaxs did not immediately respond to an emailed request for comment.