Dangers of Loose Regulation of Supplements

Critics of the relaxed standards for herbal supplements that took effect in 1994 point to a number of recent cases of illness and death connected to the use of supplements. According to FDA records, the agency has logged nearly 2,500 reports of side effects and 94 deaths associated with dietary supplements since 1993.

In the 1990s, supplement manufacturers began including ephedra (also known as ma huang) in many of their products. Ephedra is a plant that has been used for thousands of years in Chinese medicine to treat respiratory ailments. Its active ingredient, ephedrine, is used in many decongestants and bronchodilators in the U.S. Supplement makers caught on to ephedra's stimulant effect, and began promoting ephedra to boost energy or aid weight loss.

The FDA began receiving complaints about products containing ephedra in 1993. In the years since, ephedra has been associated with more than 800 reports of adverse reactions from consumers and at least 38 reported deaths. The FDA has linked supplements containing ephedra to complaints of chest pain, abnormal heart rhythms, strokes, heart attacks and seizures.

In June 1997, the FDA proposed that ephedra be limited to doses not exceeding eight milligrams and that packages contain a warning to consumers stating that taking more than the recommended dosage "may result in heart attack, stroke, seizure or death." Those proposals are pending while the FDA considers public input on them, however. A number of states have taken firmer action, banning the sale of certain products containing ephedra.

One of ephedra's most controversial incarnations is in "herbal ecstasy," a combination of herbs sold over the counter and through mail-order services that purports to mimic the effects of an illegal drug known as ecstasy. The supplement is sold under names such as "Cloud 9," "Rave Energy" and "Ultimate Xphoria," promising increased energy, "inner visions" and "cosmic consciousness." By May 1996, the makers of "Herbal Ecstacy" had sold more than 150 million pills.

In March 1996, while on spring break in Panama City, Fla., 20-year-old Peter Schledorf died suddenly after taking "Ultimate Xphoria." He had taken eight pills, twice the dosage recommended on the package. The cause of death was determined to be a combination of ephedrine, pseudoephedrine, caffeine and other chemical substances, all of which were found in the herbal ecstasy he had taken. A month later, the FDA issued a warning about herbal ecstasy, citing reports of heart attacks, seizures, strokes and deaths related to its use.

However, the FDA has limited regulatory powers over supplement manufacturers. Global World Media Corp. in Venice, Calif., makers of "Herbal Ecstacy," reported that its sales went up 25% after the FDA issued its April 1996 warning against herbal ecstasy. Shortly after the FDA warned consumers, the company introduced a similar product that substituted the herb kavakava, believed to relieve anxiety, for ephedra.

Another risk that stems from the lack of dietary supplement regulation is the possible contamination of products. Experts are particularly concerned about that danger because many botanical products are imported from countries with weak regulation of contaminants. In the late 1980s, 1,500 people who had taken dietary supplements containing L-tryptophan, an amino acid that is combined with many herbal remedies, developed a number of harmful symptoms. Many of the victims had taken supplements that came from a contaminated batch of L-tryptophan, but some had used other L-tryptophan products.

The victims, mostly young and middle-aged women, developed a rare blood disorder that caused severe muscle and joint pain, swelling and skin rashes. Some experienced nerve damage, and others had scarring in the lungs that prevented them from breathing. Nearly 40 people died and others were permanently disabled. The FDA banned the sale of L-tryptophan in the early 1990s.

Herbal supplement advocates maintain that the dangers of those products are exaggerated by a medical establishment and mainstream press that are resistant to unconventional healing. They maintain that problems such as those caused by ephedra and L-tryptophan are highly unusual, and that skeptical scientists have seized on a few exceptional cases to give all herbal supplements a bad name. Herbal remedies have been safely used across the world for centuries, they point out.

Skeptics insist, however, that a long history of safe use of an herbal product does not guarantee its safety. Because people had much shorter lifespans in centuries past, they say, long-term effects such as cancer were not an issue. Few studies have examined the long-term impacts of herbal supplement use.

Defenders of herbal supplements point out that FDA-approved prescription drugs result in many more deaths than do herbal products. According to the American Association of Poison Control Centers, pharmaceutical products that have been approved by the FDA kill approximately 500 people for every person killed by an herbal product. "The data just doesn't support the view that these products cause widespread harm," says Loren Israelsen, executive director of the Utah Natural Products Alliance.

Sources

Cowley, Geoffrey. "Herbal Warning." Newsweek (May 6, 1996): 60.

Daniels, Anthony. "To Heal the Hollow Soul." National Review (July 6, 1998): 46.

Hellmich, Nanci. "Many Doubt Supplements Can Live up to the Claims." USA Today (November 25, 1997): 1A.

Krantz, Michael. "The Self-Medication Generation." Time (May 12, 1997): 72.

Okie, Susan. "With Dietary Supplements, Health Claims Needn't Wait for Science." Washington Post (November 25, 1997): A1.

Ruppel Shell, Ellen. "The Hippocratic Wars." New York Times Magazine (June 28, 1998): 34.