Gulping The Profit The Unusual, Lucrative Life Of The Supplement Business.

Back in 1993, the dietary supplement business—the nonprescription herbs, vitamins and minerals sold at places like GNC stores and CVS pharmacies—was a category worth $8.4 billion. Today, sales are estimated to top $22 billion. Sales are not the only figures heading through the roof. Last year, supplement makers dropped $981 million dollars on advertising, a surge of 25% from the $787 million spent in 2005.

What spurred such radical growth in less than 15 years? Observers point to the Dietary Supplement Health and Education Act of 1994 as a major launching pad. The law contained a number of key provisions:

• It allowed marketers to sell pills without approval from the FDA, so long as those marketers don't use any "new" chemicals or ingredients.

• It allowed marketers to make "structure and function" claims. For example, while a company cannot claim that a pill "prevents" or "cures" heart disease, it can say that the pill "supports" heart function.

• It allowed the FDA to step in only if the agency could prove that a pill "presents a significant or unreasonable risk of illness or injury."

Another consequence of the law is that the Federal Trade Commission now has more power over the dietary-supplement marketers than the FDA does—as the Berkeley case amply demonstrates. "Dietary supplements don't go through an approval process," FTC chairman Deborah Platt Majoras said. "Instead, those who market them . . . have to have scientific support for those claims. So our role is to monitor this marketplace" for false science claims.

Critics of this arrangement complain that not only have supplement makers shifted the onus off their shoulders, but that the FDA—burdened with proving that a supplement is not safe—is at a disadvantage because the agency lacks the resources to clinically test all products.

As a result, only the supplements that are truly harmful (such as the heart rate-accelerating ephedra, banned in 2004 after killing 155 people) are likely to be pulled from store shelves. The larger fallout, say critics, is that pharmacies and health shops are packed with useless (but, fortunately, mostly harmless) bottles of pills that have been pitched to a gullible public as "supporting" their health.

The FTC will step in when marketing claims have crossed the line, as it did in January, when it extracted a $25 million settlement from the marketers of One-A-Day WeightSmart, among other pills. The action was especially significant because One-A-Day is owned by Bayer HealthCare, hardly a company anyone would call a fly-by-night pill pusher.

The industry is aware that companies like Berkeley cast a cloud over its reputation, and has responded by stepping up self-regulatory efforts. The Council for Responsible Nutrition has successfully pushed for a new federal law requiring marketers to report "adverse events" associated with their pills to the FDA.

According to CRN CEO Steven Mister, the trade group is next hoping to persuade Congress to allow food stamps and healthcare flexible-spending accounts to be spent on vitamins. —J.E.