Originally created 02/11/00

FDA backs off rule allowing morning sickness supplements



WASHINGTON -- Under fire from birth defects experts, the government is backing off a new regulation that would have let dietary supplements treat morning sickness without proof the products are safe for unborn babies.

The Food and Drug Administration told dietary supplement manufacturers Wednesday not to claim that their products can treat morning sickness or pregnancy-related leg swelling until the issue is settled.

Last month, the FDA eased restrictions on the claims dietary supplement companies can make about how their products affect people's health. Birth defects experts were stunned to see those two pregnancy-related conditions on the list of claims that otherwise unregulated dietary supplements could now sport.

That rule reversed current medical policy and "has the potential to put pregnant women and their offspring at serious risk," one prominent pregnancy expert told the FDA, as doctors and consumer advocates began a string of protests to the agency last week.

Thanks to a 1994 law, dietary supplements do not undergo government scrutiny -- and in most cases undergo little if any scientific study -- to ensure they're safe and effective before they are sold to millions of Americans.

That 1994 law does prohibit dietary supplements from claiming to treat or cure diseases, but it says they can advertise help for non-disease health conditions. The FDA's new rule attempted to draw the line between what was an acceptable and illegal claim for these products.

FDA officials have maintained that morning sickness and leg swelling are not a disease but are normal pregnancy conditions and thus dietary supplements, under the 1994 law, could claim to treat them.

But because so many chemicals -- natural or synthetic -- can hurt a fetus, the government until now had always required safety studies before letting any medical substance target pregnant women.

If a product claims to treat sickness, consumers would assume it's been proven safe for the unborn baby -- when in fact that's not the case, critics said.

"There certainly are some plants that if people take, they could result in birth defects," FDA drug chief Dr. Janet Woodcock acknowledged Wednesday.

So the FDA has put the pregnancy part of the new rule on hold, and will convene a public meeting within a few months to debate what to do.

"FDA realizes it made a serious mistake," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, who spearheaded the protests. "The well-known dangers of many herbal products for pregnant women ... should have been sufficient for FDA not to have issued the reckless Jan. 6 regulation."

Meanwhile, all pregnant women should consult a doctor before taking any dietary supplement -- or any medication, Woodcock cautioned.