[CHA]FDA and Ephedra

[Guest guest]

This was on MDConsult. The red text is my highlight. Nothing necessarily

new, but thought I'd pass it along.

Sean

 

Lawmakers want stronger law on diet supplements Story List

 

 

 

 

March 26, 2004

 

 

By Lisa Richwine

 

WASHINGTON (Reuters) - 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.

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.