The Fda's War Of The Rose HipsJohn Carey
If you believe what you read, your local health-food store has a remedy for most of the ills plaguing humanity. A concoction of vitamins called Ultra Hair claims to darken graying temples, render thinning pates hirsute, and fix annoying split ends. Manhood Plus promises confidence during that next big date. And products with names such as Ageless Beauty and Runner's Edge pledge everything from more youthful skin to a speedier jogging pace--even though they're all made from concentrated wheat sprouts.
Sound like bunk? If so, such nostrums are highly profitable bunk. The dietary-supplements industry pulls in more than $4 billion annually from the 70 million or so Americans who regularly down fistfuls of vitamins and supplements.
WIPEOUT? Now, the prospect of new regulations from the Food & Drug Administration has the industry reaching for its Ultra Mega Stress Formula (guaranteed "high performance nutrition for times of physical stress"). The agency has proposed rules that would stop almost all health claims made for such products. And the regulations may go into effect soon if the industry can't stop them.
That's why the vitamin companies and their supporters are waging all-out war to preserve their inalienable right to market whatever they like. "The FDA will wipe out our entire industry if we let them," says Stephen A. Levine, president of NutriCology, a California company now fighting the government over its product claims, which include the assertion that flaxseed oil can help cure alcoholism and that pine-bark extract can help alleviate varicose veins.
In this War of the Rose Hips, the industry has just fired the biggest shot so far. On Apr. 30, Senator Orrin G. Hatch (R-Utah), and Representative Bill Richardson (D-N.M.), in whose states many health-supplement companies are headquartered, announced a bill that would allow vitamin manufacturers to make any claim they consider legitimate.The bill has made the antivitamin camp hopping mad. Bruce Silverglade, legal director of the Center for Science in the Public Interest, gripes that the legislation is "nothing less than a snake-oil promotion act." But it's being taken seriously, because the nation's legions of vitamin buffs give the industry clout.
LOW PRIORITY. What's really at stake is the industry's freedom to make health claims for its products. Strictly read, federal law says any substance purporting to treat or cure disease is a drug and must therefore undergo extensive--and expensive--clinical trials. But the FDA has given supplements little enforcement priority. "We've only gone after the most serious toxicity and health-fraud problems," says Michael R. Taylor, deputy FDA commissioner for policy.
That laissez-faire attitude started to change in 1990, when Congress ordered up rules ending the proliferation of such often-misleading terms on food products as "lite" and "low-fat." If foodmakers can't say that carrots help ward off cancer, the FDA reasoned, supplements containing beta carotene (an "active ingredient" in carrots) shouldn't be marketed with such claims, either. Another bill now before Congress would beef up the FDA's ability to punish violators with huge fines and product seizures.
Hatch pushed through a one-year moratorium on the FDA's rules on food supplements last December. Now, Congress must decide. The choice is clear: trust the FDA to keep the supplement industry in check or allow the industry to regulate itself--and let the consumer beware.