More Labeling for Dietary Supplements

A pair of bills introduced in the U.S. House of Representatives would add extra labeling mandates to the Dietary Supplement Health and Education Act of 1994 (DSHEA), as well as give FDA greater scrutiny over dietary supplement manufacturing and packaging.

On October 10, Representative Susan Davis (D–CA) introduced the Dietary Supplement Information Act and the Ephedrine Alkaloid Consumer Protection Act. The former would require all U.S. manufacturers, packagers, and distributors of dietary supplements to register with FDA and report serious adverse effects to the agency within 15 days of being alerted by consumers. It also would enable FDA to require post-marketing surveillance studies if it determined that a product had serious health consequences and require the FDA MedWatch phone number and Web site to be included on all labels.

The latter act would ban the sale of supplements containing ephedrine to those under 18 years of age and require retail sales to be made from behind the counter. It also calls for a standardized warning, as well as the FDA MedWatch phone number and Web site, to be printed on the label of any such product.

"The goal of these bills is to facilitate the flow of information between consumers and the industry," Davis says. "Consumers have a right to know what they are putting into their bodies. People are getting sick, and some are dying. Congress must act."

The Consumer Health Products Association (CHPA; Washington, DC), which represents some dietary supplement makers, opposes the bills because it believes they are unnecessary.

"We feel that DSHEA is all we need," says Donna L. Edenhart, CHPA's deputy director of public affairs. "The full implementation of DSHEA would be the best course of action. The system is there—it's just a matter of putting it to good use. That is a matter of resources, finding the proper people, and funding."

Other organizations, such as the American Heart Association, the American Cancer Society, and the National Consumers League, have endorsed the legislation. The bills have been assigned to the House Committee on Energy and Commerce; however, no hearings had been scheduled as of press time.

Erik Swain

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