The U.S. law enacted 10 years ago to regulate vitamins, herbs and other dietary supplements needs strengthening to better protect Americans from dangerous products, lawmakers said on Wednesday.
Critics cited the example of ephedra, a stimulant linked to heart attacks, strokes and deaths, on which Food and Drug Administration spent years compiling evidence to ban the product, while reports of serious side effects mounted.
Several lawmakers told a House Government Reform subcommittee the FDA needs new tools to act quickly against dangerous dietary supplements, while acknowledging the health benefits of many others.
“Without changes, we could see more and more dietary supplements follow in (ephedra’s) wake,” Rep. Susan Davis, a California Democrat, told the panel.
Dietary supplements do not have to undergo the same strict safety and effectiveness testing needed for prescription drugs before they can be sold. Supplements are widely available at grocery and drug stores and are used by millions.
Revamping the system
The FDA currently can stop misleading or unsupported claims about supplements, ban a product if officials prove an unreasonable risk. But the ephedra ban, set to take effect April 12, is the first time the agency has moved to outlaw a supplement.
Davis and other lawmakers said manufacturers should be required to turn over to the FDA any reports of serious side effects that may be linked to their products. Under current law, such reporting is voluntary, which can hamper investigations of risky supplements.
Industry groups contend that the 1994 law, the Dietary Supplement Health and Education Act, gives the FDA adequate power to force risky supplements off the market, but the law has not been fully implemented and enforced.
FDA officials “have the authority, clearly, to take action on products if they so choose,” argued David Seckman, executive director of the National Nutritional Foods Association.
Robert Brackett, director of the FDA’s Center for Food Safety and Applied Nutrition, said the agency is revamping its system for reports on side effects, which should improve detection of potential problems.
He said the FDA believes it has adequate power to act against dangerous supplements and is not advocating strengthening the 1994 law. “I think we should use the existing law to its fullest extent,” said Brackett.
