FDA: Dietary Supplements Caused 'Adverse Events'

Sept. 23, 2008— -- Serious side effects from the use of food supplements resulted in 604 "adverse-event" reports — a list that includes at least five deaths — through the first six months that such accounts have been required by law.

The Office of Nutritional Products, Labeling and Dietary Supplements in the Food and Drug Administration's Center for Food Safety and Applied Nutrition acknowledged receiving 368 mandatory reports from supplement manufacturers and 236 reports from consumers or health care professionals.

An adverse event can be anything from a concern that a supplement isn't working to a serious illness that follows consumption. FDA spokesman Michael Herndon said five deaths and 85 hospitalizations were reported through April 15, the most current numbers available. "Some of these deaths were likely due to underlying medical conditions," he says.

The FDA did not identify the supplements linked to the adverse events. The agency defines dietary supplements as including vitamins, minerals, amino acids, herbs or botanicals, and enzyme supplements.

Dietary supplements have long been a controversial topic, with consumer advocates critical of the fact that, unlike with drugs, supplement makers don't have to prove their products are safe or effective before they reach the market.

Sen. Richard Durbin, D-Ill., sponsored legislation in 2006 to require supplement manufacturers to inform the FDA when there are adverse events. The bill took effect Jan. 1.

"Five years ago, the dietary supplement industry claimed that they had no reports of health problems — zero — related to their products," Durbin said in an e-mail.

"Thanks in part to our legislation, we today know there are hundreds of serious problems each year, many involving hospitalization and death," he says.

If the trend continues, there will be fewer than the 960 adverse-event reports the FDA had estimated it would receive each year.

"These numbers don't alarm us," says Steve Mister, president and chief executive of the supplement trade group Council for Responsible Nutrition. "We thought they would be much less than the FDA estimate."

The legislation pushed by Durbin came in the wake of several deaths related to the now-banned supplement ephedra. The weight-loss and energy enhancer was implicated in the deaths of Minnesota Vikings offensive lineman Korey Stringer in 2001 and Baltimore Orioles pitcher Steve Bechler in 2003.

"There's still no assurance that supplements are safe," says Peter Lurie, deputy director of Public Citizen's Health Research Group. "Many people are under the impression that the FDA has approved supplements, but that's not the case. There's really no assurance that what manufacturers say is in the product is really in there."

Adverse-event reporting has been required for prescription and some non-prescription drugs for years. The FDA took in 482,154 adverse-event reports for prescription drugs last year.