Vitamin Supplements: Are They Really Safe?

Advocates of strict regulations on herbal products contend that the FDA is powerless to regulate supplements that may be dangerous. Even in the case of ephedra, which has been fingered as the cause of death of dozens of supplement consumers, most of whom were under 40 years old, the FDA did not ban the supplement or propose making it a prescription drug.

Yet many observers say the FDA has underused the control it does have over the supplement industry. The FDA can ban products that create "significant or unreasonable risk of illness or injury," and has the power to mandate warning labels for supplements with dangerous side effects. Some have accused FDA officials of failing to act because they were unhappy about the 1994 DSHEA mandates. "They felt like [the new law] was shoved down their throat and they didn't like it, so it looks like they're just sitting on their hands," says John Cordaro, president of the Council for Responsible Nutrition, an association of supplement manufacturers.

Scientists say that it is often difficult for the FDA to establish the cause of supplement-related illnesses or deaths. Supplement manufacturers have a financial incentive to look for and suggest alternative causes of death, such as medical problems or overdoses. "You may have 10 people already dead. That may not be enough to prove in court that the product is hazardous," says Silverglade.

The FDA encourages people who experience adverse effects from supplements to report symptoms to its MEDWatch program. However, the FDA's surveillance system for herbal supplements is "very much underused," according to Elizabeth Yetley, director of the FDA Office of Special Nutritionals. Whereas manufacturers of prescription and over-the-counter drugs are required to report complaints of adverse reactions to their products to the FDA, supplement manufacturers face no such obligation.

In addition, experts say the MEDWatch system for supplements is unlikely to detect long-term effects, especially if the supplements are related to common ailments, such as heart disease. Meir Stampfer, professor of epidemiology at the Harvard School of Public Health in Cambridge, Mass., says the dangers of L-tryptophan were detected because the supplement caused unusual symptoms. "If it was causing run-of-the-mill asthma or heart attacks--any common outcome--you wouldn't give it a second thought," Stamfer says. "So it's a little scary."

Sources

Sharpe, Rochelle. "FDA Aims to Clarify the Distinction Between Drugs, Dietary Supplements." Wall Street Journal (April 27, 1998): B6.

Stabiner, Karen. "With Alternative Medicine, Profits are Big, Rules are Few." New York Times (June 21, 1998): Sect. 15, p. 25.

Stolberg, Sheryl Gay. "Drug Regulators Make Push to Rein in Herbal Remedies." New York Times (June 10, 1998): A1.