Flexcin claims draw FDA warning
By Carol Gentry
6/16/2010 © Health News Florida
A Florida company that claims its joint-pain remedy "helps relieve bursitis, rheumatoid arthritis, gout, fibromyalgia, and any other other form of arthritis" is violating the law, the Food and Drug Administration warns.
Flexcin International, based in Fort Myers, received a warning letter for claims on three of its products: "Flexin with CM8™,'' "Cal-Flex Calcium Pure" and a supplement for animals, "Flexpet."
“The therapeutic claims on your website establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals,” says a May 25 letter from the FDA’s Florida office that was posted on the FDA site late Tuesday.
Because the company claims the products can treat illness those products fall into the category of a drug, and thus can't be sold without going through the FDA drug-application process, says the letter from Emma Singleton, director of the Maitland FDA office.
In such cases, FDA typically gives a company an opportunity to correct its mistakes. If it does not, the agency has the power to seize its products, though that seldom happens.
Flexcin International acknowledged receiving the letter and said it was preparing a response for FDA officials. "We are going to be working with them to make the necessary changes to our marketing so we do remain in compliance," said spokesman Tate Dugan.
"We do feel this is a little unfair of FDA," he said, since vitamin and supplement makers were removed from the agency's regulation under an act of Congress in the mid-1990s. "We do stand by the claims we make."
Among the claims that got the company in trouble, according to the FDA letter, is this one "Flexcin has been shown to ...decrease joint pain dramatically."
The company doesn't release data on its sales volume, but its joint-pain supplements are the top seller in their category, he said. According to the company's Web site, its products are sold over the Internet as well as in 500 stores nationwide.
The company has been manufacturing Flexcin products for about 10 years, he said, and they are sold in many countries.
--Carol Gentry, Editor, can be reached at 727-410-3266 or by e-mail.