GSK pushes FDA to require approval for weight-loss supplements

WASHINGTON GlaxoSmithKline, which markets the only over-the-counter diet pill approved by the Food and Drug Administration, is pressing the agency to require supplement companies making weight-loss claims to conduct clinical studies to prove their products work, then win government approval before they can be marketed, according to The Star-Ledger. Under current regulations, the makers of diet pills face no such requirements.

If the FDA agrees with GSK, it essentially could eliminate competition for the company’s diet pill Alli and potentially open up challenges to numerous health-related claims made for a variety of dietary supplements.

Reclassifying the way dietary supplements are regulated and requiring more rigorous FDA oversight would advance public health, GSK argued, “since millions of Americans are currently relying on these unproven and ineffective dietary supplements to lose weight and reduce the risk of disease.”

The petition by GSK, filed jointly with the American Dietetic Association and two other health groups that receive financial support from the company, has provoked a strong backlash from the supplement industry.

“The effect of this would be to make it illegal to market dietary supplements for weight loss. The only products marketed for weight loss would be drugs,” said Michael McGuffin, president of the American Herbal Products Association, a group representing supplement companies.