Mounting evidence suggests that increasing numbers of Americans are falling seriously ill or even dying after taking dietary supplements that promise everything from extra energy to sounder sleep.
The victims include men and women of all ages as well as children whose parents are feeding them snacks, drinks and nostrums made with herbal supplements that are neither regulated by the federal government nor tested for their effects on the young.
While the Food and Drug Administration issues periodic warnings about the dangers of individual supplements, no organization or agency has made a comprehensive analysis of the sickness and death associated with them.
But in attempting the first national survey, the Washington Post collected statistical snapshots from health officials, researchers and advocates reaching almost every state in the country. Among the findings:
Abuse of the bodybuilding supplement gamma-hydroxybutyrate (GHB) and similar substances has skyrocketed in recent years. In 1997-98, Texas recorded 86 hospital visits involving GHB. In 1999, three Florida poison centers logged 549 GHB incidents and two deaths. Last December, Phoenix Suns forward Tom Gugliotta took a GHB-related supplement, collapsed on the team bus and nearly died at a Portland, Ore., hospital.
Tests continue to reveal dangerous contaminants and poor quality control in supplement ingredients. California investigators in 1998 found that nearly one-third of 260 imported Asian herbals were either spiked with drugs not listed on the label or contained lead, arsenic or mercury. Last month, state officials discovered five Chinese herbals that contained powerful diabetes drugs. Health professionals across the country complain they cannot be sure how powerful a supplement is because the actual potency of the pill often doesn't match the legend on the label.
The weight-loss and energy supplement ephedra, also known as ma huang, and its derivatives are producing a stream of complaints from many states, including Georgia, Kentucky, Minnesota, Nebraska, Ohio, Pennsylvania and Texas. Previously unreleased FDA data implicate about two dozen ephedra products in 134 cases involving everything from jitteriness, chest pains and insomnia to addiction, stroke and death.
Poison control centers in various states are reporting adverse reactions to a broad range of supplements. Pittsburgh documented 198 incidents involving herbal supplements in the 15 months ending last March, with ginseng and St. John's wort, an antidepressant, the most frequently mentioned substances. In Georgia, ephedra and melatonin, a sleep aid, led the list in 1999.
In New Mexico, St. John's wort ranked first in 1998, followed by a compound that eases teething pain in infants.
Children are increasingly becoming the victims of supplement abuse. Last year, pediatrician Hillary Perr reported on children from wealthy California families who were malnourished from eating snack food spiked with supplements. In Long Island, a mother gave her 18-month-old baby a teaspoon of eucalyptus oil last year because a store clerk told her it was good for a fever. The child suffered permanent neurological damage and almost died.
While health care providers concede that diet supplements are not as dangerous as automobiles, which killed 41,826 people nationally in 1998, or diseases such as kidney disease, which killed 26,295, most experts consulted by the Post suspect their data vastly understate the incidents that actually occur.
Unlike pharmaceuticals or food additives, supplements do not have to be pre-screened by the FDA.This is because a 1994 federal law, fiercely pushed by the industry through an acquiescent Congress, exempts supplement companies from almost all federal regulation, including any requirement that they file reports when the use of one of their products goes wrong.
Unlike pharmaceuticals or food additives, supplements do not have to be pre-screened by the FDA, nor do they have to demonstrate through peer-reviewed science that they are safe before they can be sold. And once they are on sale, the burden of proof is on the FDA to show that a supplement is dangerous before it can be taken off the market.
The only tool federal officials have are the sketchy, patchwork reports voluntarily called in to them.
The industry is expanding rapidly, with hundreds of herbal products and product blends. Since 1994, supplement sales have grown by nearly 80 percent, from $8.8-billion to a projected $15.7-billion for 2000, according to the Nutrition Business Journal. Ephedra, for example, is sold as a "natural" way to increase human metabolism. St. John's wort is fast becoming a Prozac competitor.
Melatonin is touted as an elite cure for jet lag. Ginseng is a purported key to sexual stamina and eternal youth. Ginkgo biloba allegedly sharpens the mind and wards off Alzheimer's disease. Senna is a natural purgative to aid in weight-loss and exercise regimes.
Faced with the federal government's inability to regulate supplements, many states have passed restrictive laws. They also are collecting data on an industry that experts such as Lee C. Vermeulen, director of the University of Wisconsin Poison Control Center, expect will keep growing, along with its attendant problems, until "the economy goes south."
In this environment, the experts say they are catching only glimpses of supplements' potential dangers: "Ninety percent of the time we get called (only) when people are using these things from abuse," said Greene Shepherd, director of the North Texas Poison Control Center in Dallas, voicing a frequently heard complaint. "There's a huge portion that we're missing."
Also, added Prosy Abarquez-Delacruz, regional administrator for the California Health Services Department's Food and Drug Branch, companies have hastened to take advantage of the dearth of regulation.
"It's the John Wayne industry, like the wild, wild West, and the practices of the few have tainted the many," said Abarquez-Delacruz. In the past year her office temporarily halted sales of $1.5-million in exotic teas and beverages because of misleading label claims.
Many health professionals, including strong critics of supplements, acknowledge that they can be useful and safe, if taken in reasonable doses.
But many consumers become victims because they "believe that if a product wasn't safe, the government wouldn't allow it to be sold," said consumer advocate Bruce Silverglade, legal affairs director of the Center for Science in the Public Interest. "In this case, that's just a false assumption."
In fact, cautioned New York City Poison Center director Robert Hoffman, many supplements "are drugs. There's no doubt about it."
And in essence, added pediatrician Howard Mofenson, director of the Long Island Poison Center in Mineola, N.Y., public consumption of supplements has become the clinical trial: "Nothing will be done unless a tremendous outbreak occurs," Mofenson said. "This law is the greatest uncontrolled experiment that the United States has ever undergone."
