FDA Issues Warning On Triax
The government is warning consumers not to purchase a diet supplement called Triax Metabolic Accelerator because it contains a potent thyroid hormone and can cause severe health problems, reports CBS News Correspondent Dan Raviv.
The product contains the ingredient tiratricol, another name for the thyroid hormone TRIAC. It is promoted in health food stores and over the Internet as a way to lose weight by increasing metabolism.
The agency urged Triax users to see a doctor if they have symptoms of thyroid disease, including fatigue, profound weight loss, diarrhea, anxiety, nervousness or insomnia.
The product's distributor insisted Triax is safe and threatened to sue the FDA.
But people who take the recommended dose of Triax could be getting up to 10 times more per day of a potent thyroid hormone than is normal, said Dr. David Orloff, an FDA medical officer.
That can cause not just uncomfortable thyroid-related symptoms, but can increase the risk of heart attack, stroke and high blood pressure, particularly in people with underlying heart disease, he said.
While the FDA's published warning mentioned only Triax, a quick Internet search uncovered numerous other tiratricol-containing products. When told, FDA officials responded that they would investigate further.
"I think that's wise," Orloff said when asked if consumers should avoid any tiratricol.
Missouri-based Syntrax Innovations Inc. said it would challenge FDA's charges in court.
"They are saying it's a drug. It's totally legal" under a 1994 dietary supplements law, said Syntrax owner Derek Cornelius.
That law released dietary supplements from most federal regulation, unless the FDA can prove a product poses a health risk. The last time a supplement manufacturer sued the FDA for declaring its product a drug-in-disguise, the government lost.
"We've sold 100,000 bottles, with not one complaint," Cornelius added. "I don't have a cease-and-desist (order), and we are going to continue to distribute it."
But the FDA cited a 38-year-old Los Angeles Triax user, who saw a doctor for severe diarrhea and other thyroid-related symptoms. Laboratory tests uncovered severe hyperthyroidism that the woman's doctor linked to Triax. Her husband, a fellow Triax user, was then tested and also found to have the ailment, Orloff said.