U.S. seeks standards for diet supplements

Proposal spurred by rise in ties to deaths, illnesses

March 08, 2003|By Bruce Japsen and Amanda K. Vogt | Bruce Japsen and Amanda K. Vogt,SPECIAL TO THE SUN

Consumers looking to improve their health with dietary supplements like St. John's wort and kava may soon know whether they're getting what they pay for.

Following a drastic increase in the number of reported deaths and illnesses linked to dietary supplements, the federal government proposed yesterday the first manufacturing standards for such products. The FDA does not require supplement-makers to prove that their products are safe or effective, as it does for prescription drugs, and the new rules will not change that.

But supplement-makers will have to list their ingredients, ensuring they are not adulterated with contaminants or impurities and that the dosages promised on the label are indeed correct. They also must be labeled accurately to reflect active and other ingredients.

The proposed regulations come just one week after the FDA said it wants more restrictions on the controversial dietary supplement ephedra, which has been linked to the recent death of Baltimore Orioles pitcher Steve Bechler.

Other consumer complaints to the FDA are on the rise: The number of adverse events tied to supplements, from headaches to heart attacks, more than doubled to 1,214 last year from 553 in 2001.

"It's too much of a `buyer, beware' market," FDA Commissioner Mark McClellan said. "Too often, consumers purchase dietary supplements based on inaccurate or incomplete information on what they are getting. Consumers should have access to dietary supplements that are accurately labeled and free of contaminants."

The industry, with annual U.S. sales of $19 billion, is growing at a rate of 15 percent a year.

Until the FDA's proposal, the supplement industry has been protected from most regulation. A law enacted in 1994, the Dietary Supplement Health and Education Act, largely hamstrung the agency in its effort to regulate dietary supplements unless it can see dangers.

Consumer advocates and medical professionals have long argued the 1994 law provides supplement makers with too much protection. They have been pressing Congress to require supplement makers be held to at least some of the same tough quality standards as drug- and device-makers.

"The FDA's proposed rule establishing quality standards for dietary supplement manufacturers is a step in the right direction, but falls short of what is needed to protect the public," said Bruce Silverglade, legal affairs director for the Center for Science in the Public Interest, a national consumer group.

"Congress has required the FDA to base manufacturing standards for supplements on those in place for processed foods, instead of over-the-counter drugs," Silverglade added. "Many dietary supplements, however, are more akin to drugs than to frozen green beans and should be manufactured to pharmaceutical standards."

The FDA said the new standards should prevent problems by requiring manufacturers to perform certain quality-control steps that include testing ingredients and finished products for contamination.

Bruce Japsen and Amanda K. Vogt write for the Chicago Tribune.

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