Like pharmaceuticals: supplement regulation pushed by advocates

OB/GYN News, May 15, 2004 by Steve Perlstein

The lack of federal regulation requiring safety and efficacy testing means that millions of Americans are unwittingly spending billions of dollars every year on dietary supplements that are at least dangerous and at worst deadly, Consumers Union officials said at a news conference.

A decade after Congress passed the Dietary Supplement Health and Education Act (DSHEA), which allows supplements to be marketed without any of the testing required of pharmaceuticals, the public is woefully uninformed about the lack of safety and efficacy information available for products on which it spends $19.4 billion a year, said Nancy Metcalf, author of a report on supplements published in the organization's magazine, Consumer Reports.

Under DSHEA, the burden of proof is on the Food and Drug Administration to prove a supplement is unsafe before it can be pulled from the market, and manufacturers are not required to pass on any data regarding adverse events.

"Most consumers have no clue that their products have not been tested for safety," Ms. Metcalf said. "We found one supplement (Thermorexin, marketed as a fat-burning supplement) containing 30 mg of theophylline. This stuff you can now buy completely unregulated in a pill."

Consumers Union has named its "Dirty Dozen," 12 dietary supplements deemed either "Definitely Hazardous" (documented organ failure or known carcinogenic properties), "Very Likely Hazardous" (banned in other countries, FDA warning, or adverse effects in studies), or "Likely Hazardous" (adverse event reports or theoretical risks). A Consumers Union researcher was able to buy all 12 substances either online or at retail outlets.

The only supplement listed as "Definitely Hazardous," aristolochic acid, often is marketed as a premenstrual syndrome remedy or a heart disease treatment under such names as PMS-Ease and Cardioflex. It is banned in at least 10 countries, and the FDA issued a warning in 2001 that the product was associated with permanent kidney damage and cancers of the urinary tract.

Annette Dickinson, Ph.D., president of the Council for Responsible Nutrition, a supplement industry trade group, disagrees with the premise of the report.

"They basically are not correct in their assumption that the current situation requires that DSHEA be changed," Dr. Dickinson told this newspaper.

While supplement manufacturers are not required to test their products before marketing, the burden of proof of safety still falls on the manufacturers to assure the product is safe, she said. "In general, these products, like all foods, are considered safe based on a long history of use."

She said some of the products in the report "certainly raise concerns." but that current laws should guard against the sale of them. For example, she said, aristolochic acid is not produced in the United States and the federal government has an import ban on it, so if the law were being enforced it would not be available for sale here.

Chuck Bell, Consumers Union programs director, dismissed the industry's claims and said his organization is fighting for legislation currently pending on Capitol Hill that would supplant DSHEA and require the supplement industry to follow at least some of the rules pharmaceutical manufacturers must live by.

For more information, go to www.consumerreports.org/co/supplements.> BY STEVE PERLSTEIN

Midwest Bureau

COPYRIGHT 2004 International Medical News Group

COPYRIGHT 2008 Gale, Cengage Learning