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FDA offers standards to cut fraud in supplements

Saturday, March 8, 2003

WASHINGTON -- Millions of users of St. John's wort, calcium and other dietary supplements may soon know for sure they're getting what they pay for: The government proposed the first manufacturing standards for the $19 billion supplement industry Friday in an attempt to cut fraud and contamination.

There still will be no guarantee that the pills and powders deliver the health benefits advertised or are even safe to swallow. Unlike drugs, supplements can be sold without any scientific proof of safety or effectiveness.

But the Food and Drug Administration's long-awaited factory rules aim to ensure that the ingredients and dosages promised on a supplement's bottle really are contained inside -- without dangerous contaminants like bacteria and brain-damaging lead that have been found in some.

Today, this is "a buyer-beware market," said FDA commissioner Mark McClellan. "Millions of Americans use dietary supplements every day, and we need to make sure they're getting the products they pay for ... that are accurately labeled and free from contaminants."

There are more than 1,000 makers of dietary supplements, products that range from mainstream vitamins to herbs to controversial hormones and stimulants. Ephedra -- an herbal stimulant blamed for dozens of heart attacks, strokes and deaths -- is the most notorious, drawing an FDA warning last week.

Supplement makers are exempt from most safety oversight, thanks to a 1994 law. Nor has there even been federal quality control: Over and over in recent years, scientists and consumer groups have uncovered fraud when testing various types and brands.

The new manufacturing standards aim to prevent such problems with, among other things, certain quality-control steps that require company testing of ingredients and finished products to verify purity and dose. Also required are improvements in labeling and ways to handle consumer complaints.

The FDA characterized the rules as a mix of standards now required for foods and for over-the-counter drugs such as aspirin.

The rules are open for public comment for three months. Final regulations are expected next year, and manufacturers then would have time to start complying -- up to three years for the smallest companies. McClellan promised inspections of supplement factories, with special focus on "potential bad actors," to ensure compliance.

Until now, only a small portion of the supplement industry has followed voluntary quality standards. Some companies paid for programs, run by such organizations as the U.S. Pharmacopeia, that did spot-testing to certify a product contained the ingredients advertised.

Some supplement makers have long lobbied for the standards, required under the 1994 supplement law, by arguing that less reputable competitors were harming the whole industry.

"The responsible manufacturers are happy to comply" with FDA's standards, said John Hathcock of the Council for Responsible Nutrition, which represents 80 companies that follow voluntary quality standards.

The rules will force bad manufacturers to "get in line or get out of business," he said.

Consumer groups also welcomed the standards.

The proposal is "a step in the right direction," said Bruce Silverglade of the Center for Science in the Public Interest, which has pushed FDA to crack down on fraudulent and dangerous supplements.

But the rules won't ensure a supplement is completely safe, just that it has no impurities, Silverglade cautioned.

Consumers "can know it has the strength per dose of whatever ingredient it is they're ingesting, but it could still be harmful to them," agreed Janelle Mayo Duncan of Consumers Union, which wants more stringent regulation to bar risky supplements.

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