Beyond Ephedra

Ephedra was only beginning. Following its ban on this controversial supplement, the U.S. Food and Drug Administration announced it will subject other such questionable products to closer scrutiny -- an effort that will involve new FDA-mandated manufacturing and labeling regulations for dietary supplements that will be announced later this year.

Some of the products already garnering closer attention include bitter orange, aristolochic acid and usnic acid.

Under these new regulations, FDA Administrator Mark McClellan said, supplements no longer will be sold on the basis of “buyer beware.”

Currently, supplements, unlike drugs, do not have to be proved safe before they are released on the market.

“Granted, there are some loosely written rules about quality and what should go into the product,” said Dr. Robert Keith, an Alabama Cooperative Extension System nutritionist and Auburn University professor of nutrition and food science. “But no one has set a standard for the industry. Certainly no one is closely overseeing them from a regulatory standpoint, though some companies do a better job policing themselves than others.”

The Bush administration's decision late last year to prohibit the sale of ephedra marks the first federal ban of an over-the-counter nutritional supplement.

Posted by Jim Langcuster at January 26, 2004 09:17 AM