“This just demonstrates that FDA is taking these cases seriously,” said attorney Marc Ullman, of counsel with the firm Rivkin, Radler LLP. “Do you need any more proof that supplements are regulated and that spiking products with an undisclosed ingredient is a crime?”
Sex product spiking
In the Puerto Rico case, a Federal grand jury returned an indictment against Jorge L. Pagán Kortright and his companies AWD Group Inc. doing business as El Torito USA, Inc., Allied Worldwide Distributors Inc., and All Wheel Drive Corp., for introduction of misbranded drugs into interstate commerce, conspiracy to commit wire fraud, wire fraud, and mail fraud.
The products Kortright and his companies allegedly were selling included brand names such as “El Torito Plus 1000 mg,” ‘El Torito Xtreme 500 mg,” and “El Torito Black Bull Power 500 mg.” The capsules and pills sold over the counter and on the Internet on amazon.com were labeled and marketed as “100% natural” dietary supplements and performance enhancers. The capsules and pills were marketed as “natural supplements for men and women” to help “achieve a pleasant and lasting sexual experience with all natural ingredients.” In fact, El Torito’s products contained sildenafil and tadalafil (the active ingredients in Viagra and Cialis respectively), and their synthetic analogs, including desmethyl-carbodenafil and dithiodesmethyl-carbodenafil.
The defendants engaged in a conspiracy to hide these products from the probing eyes of authorities, hence the mail fraud claim. In one exchange detailed in the indictment, one of the defendants said that if a product was flagged, “all he has to do is send me a new brand name box and just change the style of the packaging the capsule in the blister pack and we can do this for ten years. So the authorities will be fooled all the time.”
Jail term in weight loss case
In the Pennsylvania case, this week Cheryl Floyd, age 52, Harrisburg, owner of Floyd Nutrition LLC, was sentenced to 30 months in federal prison by United States District Court Judge Sylvia H. Rambo today in Harrisburg for introducing misbranded drugs into interstate commerce and money laundering. Judge Rambo also ordered Floyd to pay $10,000 in fines and $7,530 in restitution.
According to summaries presented to the court by Assistant U.S. Attorney Christy H. Fawcett in connection with the guilty plea and the sentencing hearing, Floyd, also known as Cheryl Floyd Brown, was the owner and operator of an internet-based business known as Floyd Nutrition LLC, based at her Harrisburg residence and with warehouse facilities in the Harrisburg area.
The items offered for sale between 2010 and 2014 were purported all-natural dietary supplements sold as weight loss products. They contained the drugs sibutramine and phenolphthalein which are not listed as ingredients in the product labels.
Downplayed on website
Ullman said that industry should be enthusiastic about these actions. In its enforcement approach, FDA seems to be buying into the message that these products are not dietary supplements at all but are in fact misbranded drugs. Ullman said he only wishes the agency itself seemed as enthusiastic as he thinks industry itself ought to be.
“I do find it disturbing that neither of these enforcement actions are mentioned on the FDA home page because I submit that if these were cases brought against big pharma companies FDA would be trumpeting it everywhere. Secret enforcement is no deterrent,” he said.