Supplement makers need stricter FDA oversight
When I read about the founder of Berkeley Premium Nutraceuticals being sentenced last week to 25 years in prison for defrauding customers with dubious herbal remedies, I asked myself yet again: Why doesn't the government regulate this stuff?
Unlike conventional drugs, which must be approved by the Food and Drug Administration before hitting store shelves, dietary supplements are basically sold under the honor system. These products now constitute a $22-billion industry.
Supplement makers are required by a 1994 federal law to ensure that their products are safe before being marketed, although no one checks on the companies' research, if any. The FDA steps in only after a product is marketed, usually if questions arise over whether a product is safe or effective.
By then, of course, it can be too late.
The most prominent supplement gone bad was ephedra, which tens of thousands of people ingested to try to lose weight. By the time it was finally banned by the FDA in 2004 -- after seven years of dithering by officials -- ephedra was linked to more than 100 deaths.
Last week, the Journal of the American Medical Assn. reported that about one-fifth of so-called ayurvedic herbal medicines used by thousands of Americans may contain dangerously high levels of lead, mercury and other toxic substances.
"It's a real crapshoot for consumers," said David Schardt, senior nutritionist at the Center for Science in the Public Interest. "There's no authoritative body you can trust before a dietary supplement is sold."
Take Airborne, for instance. For more than a decade, people have been plopping those fizzy tablets into water to help prevent colds. "Created by a school teacher!" Airborne's packaging declared. "Helps support your immune system."
Last month, Airborne Inc. agreed to pay $30 million to settle charges brought by the Federal Trade Commission that the company was making unsubstantiated claims about the product's effectiveness.
"It's like we're back in the 19th century," Schardt said. "Companies make these concoctions and sell them with all these wild claims."
Berkeley Premium Nutraceuticals has sold a variety of herbal supplements, including Enzyte, which the Ohio company's website says provides a "firmer, stronger, fuller-feeling" sensation to the anatomy of millions of men.
Perhaps you've seen Berkeley's ads featuring a wide-mouthed fellow named Smiling Bob, who apparently enjoys the benefits of a steady regimen of Enzyte.
