“This company has had a long and troubled history with FDA,” said Marc Ullman, an attorney with the firm Ullman, Shapiro & Ullman. “The only surprise here is that it took so long.”
According to FDA, the action came “following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.”
“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.”
The injunction, if granted by a judge, would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements and all disease claims are removed from its websites, product labels, and all other products and websites under the company’s custody and control.
Injunction seen as foregone conclusion
And it’s almost certain the judge would grant the injunction. FDA doesn’t roll the dice, said Justin Prochnow, an attorney with the firm Greenberg Traurig.
“FDA doesn’t take the 51-49 type cases to court,” he said.
That certainty gives FDA leverage to drive a pre-trial consent decree, which is how many such cases are resolved, Prochnow said. In the case of Cole, the company has had problems with both disease claim and GMP compliance. Prochnow said an agreement in a case like this likely would include third party certification that the company had cleaned up its GMP issues at its manufacturing plant, followed by another inspection by FDA itself. And a labeling expert would likely be called in to review the company’s websites, labels and marketing materials to make sure they comply with the law. That whole process, which it goes without saying would be very costly, could last as much as 120 days before the company could resume operations, he said.
“For a lot of companies, being out of business for six months means you are out of business, period,” Prochnow said.
Even though the granting of an injunction might be seen as a foregone conclusion, that doesn’t prevent some companies from trying to mount a defense, Ullman said.
“I expect we might see a First Amendment defense in this case,” he said.
Warning letter history
Cole has received at least four warning letters, starting in 2004, with the latest coming in 2012. The company has been cited for numerous GMP violations and has been cited for noncompliant disease claims on a long list of products. According to FDA, the company has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia, and high cholesterol. Marketing supplements in this way and for these conditions causes them to be considered unapproved drugs, the agency said.
“I thought it was interesting that they mentioned the Facebook page,” Ullman said. It points out a developing in FDA’s thinking, namely that a company’s responsibility for the language used in connection with its products extends beyond its own brand website.
”Even if statements are on a Facebook page and were put up by customers, if the page is under the control of the company, they are responsible for it,” he said.