Feb. 9, 2000

Statement of Sidney M. Wolfe, M.D.
Public Citizen?s Health Research Group,
Concerning the Food and Drug Administration?s Announcement on
Herbals/Dietary Supplements for Pregnancy

We are pleased that the Food and Drug Administration (FDA) has acted, just one week after our letter urging the agency to stop the use of dietary supplements for pregnant women and two days after its regulation became final on Feb. 7.

The FDA realizes it made a serious mistake in yielding to pressure from the herbal/diet supplement industry and allowing promotion of the industry?s largely untested products for pregnancy-related conditions such as morning sickness or edema (leg swelling). The well-known dangers of many herbal products for pregnant women should have been sufficient for the FDA not to have issued the reckless Jan. 6, 2000, regulation.

The larger issue is the crippling effect of DSHEA (the Dietary Supplement Health and Education Act of 1994), under which these regulations were issued, on FDA?s regulatory authority. Hundreds of people in this country have had life-threatening heart arrhythmias including many deaths from weight-reduction products containing the herb ephedra. Until DSHEA is repealed or significantly amended, these preventable disasters will continue.