A Bucks County company may have violated federal rules designed to limit marketing and health claims on dietary supplements.
The Tatra Herb Company sells products listed as “medicinal teas” as well as loose herbs.
The U.S. Food and Drug Administration sent the Morrisville company a warning letter in June. It says the firm’s website and product promotions included prohibited “therapeutic claims.”
“You cross the line if a company starts to make claims about the prevention, treatment or curing of a disease,” said Steve Mister, president of the Council for Responsible Nutrition, a trade and advocacy group. “That becomes a disease claim and those are absolutely off limits for dietary supplements.”
The letter says Tatra promoted its products for conditions including acne, gum disease, HIV and diabetes. In the correspondence, an FDA director said Tatra’s unlawful claims were too numerous to list.
Calls to the company were not returned by deadline.
The FDA began regulating dietary supplements in 1994. Mister says the federal rules do allow supplement makers to promote a product’s effects on a healthy functioning body.
“A structure-function claim might be ‘to help to build healthy bones,’ ‘help maintain a healthy immune system,’ things like that,” he said.