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Just the facts

The FDA doesn't want any more lies on dietary supplement labels.

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This story appears in the March 2005 issue of Entrepreneur. Subscribe »

Because home-run hitters Barry Bonds and Mark McGwire knocked dietary supplements (and steroids) into the headlines over the past year, the has taken a swing at the product category.

In November 2004, the agency published a draft guidance document, which, for the first time, defined a standard--"competent and reliable scientific evidence"--that a company would have to meet before putting a "structure/function" claim on a dietary supplement. Structure/function claims state relationships such as "calcium builds strong bones." The FDA has said that about 70 percent of the nearly 30,000 supplement products sold in the United States make claims on their , the majority of them structure/function claims. Ninety-five percent of the 1,050 companies in the industry are small, with annual revenues below $20 million, according to the FDA.

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