The companies in question are S Hackett Marketing LLC (doing business as Just Enhance) and R Thomas Marketing LLC. The injunction extended to individuals Shawn Hackett, president and owner of Just Enhance, and Roger Thomas, president and founder of R Thomas Marketing LLC.
According to a statement issued by the FDA yesterday, the defendants violated the Federal Food, Drug, and Cosmetic Act by selling unapproved and misbranded drugs to US consumers using more than 100 websites, which included the now inactive blackant.us and herbsviagra.com.
A lab analysis conducted by the FDA found the presence of sildenafil, a drug that requires a prescription and was sold under the brand name Viagra, in products marketed by the companies as dietary supplements. Viagra's labels warn against using the drug for patients who are already on blood pressure medication, as combining the two could lead to a dangerous drop in blood pressure.
In addition to undeclared drugs, the label on the defendants' products claimed—without FDA approval or clinical studies demonstrating safety and effectiveness—that the products “could treat or prevent a variety of serious conditions, including erectile dysfunction, impotence and prostatitis (swelling and inflammation of the prostate gland),” according to the FDA.
The complaint also stated the products were misbranded because they did not include adequate directions for use and their labels omitted material information.
The defendants first received a warning from the FDA in 2015. "Despite our warning, the defendants refused to comply with the law, and they put consumers at serious risk," said Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.
"Particularly egregious is the undisclosed presence of sildenafil, a potentially dangerous active pharmaceutical ingredient that requires a doctor's prescription. We will continue to take aggressive action when we learn of unsafe products and dishonest marketing."
The permanent injunction requires the defendants to cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act, among other things.
Earlier this year, the FDA shut down another company in the sexual performance space, MyNicNaxs, LLC, for marketing products as dietary supplements but containing sildenafil, sibutramine, and phenolphthalein.
FDA ramps up crack-down on package screenings
In April, FDA Commissioner Scott Gottlieb said in a blog post that the agency will be ramping up its monitor of illegal products, especially those entering the country.
“According to a January 2018 report by the US Senate Permanent Subcommittee on Investigations, in just three years from 2013 to 2015, the number of packages processed by the nation’s nine IMFs nearly doubled. Today, these combined facilities receive more than 275 million packages a year,” Gottlieb wrote.
Since many of these packages come with no identifying information, Gottlieb said there is no way to know how many of these contain products regulated by FDA.
“What we do know is that every year thousands of packages are found to contain FDA-regulated products and a surprising percentage of those products are illegal...They include unapproved products; counterfeit or substandard drugs; and purported dietary supplements being sold for weight loss, sexual enhancement, bodybuilding or pain relief,” he wrote.
The Council for Responsible Nutrition, a trade group representing the dietary supplements industry, welcomed Gottlieb's announcement for increased vigilance.
“The responsible industry has voiced innumerable times its suspicion of tainted products being manufactured overseas and entering the US via our ports. Thus, we are pleased FDA has heard our concerns, and we are committed to support the agency’s efforts to increase consumer safety through the prevention of illegal products from entering the marketplace,” CRN president Steve Mister told us in April.