WASHINGTON — A new government rule threatens pregnant women and their babies by allowing dietary supplements to treat morning sickness without evidence the products are safe, says a petition filed Thursday.
The Food and Drug Administration "seems to have thrown caution to the wind and appears willing to endanger unborn babies," said the consumer advocacy group Public Citizen and well-known birth defects expert Dr. Godfrey Oakley of Emory University.
The petition urges the FDA to rescind its ruling last month allowing dietary supplements to sell as treatments for "ordinary" morning sickness and pregnancy-related leg swelling.
The FDA rule "runs counter to medical understanding and practice," Dr. Philip Landrigan of New York's Mount Sinai Hospital wrote to the FDA separately. "This decision has the potential to put pregnant women and their offspring at serious risk."
Dietary supplements do not undergo government scrutiny for safety or effectiveness before selling.
Federal law does prohibit supplements from claiming to treat diseases. The FDA, however, ruled that morning sickness and leg swelling are not diseases.
Pregnant women are told to avoid chemicals in which fetal safety has not been proved, and these supplements contain untested ingredients, said Public Citizen's Dr. Sidney Wolfe. Some supplement ingredients, such as ephedrine, actually are considered risky in pregnancy, he added.
Plus, leg swelling sometimes signals a life-threatening condition, he warned.
FDA officials declined comment on the petition. When asked if such products are safe, FDA spokesman Brad Stone said pregnant women should consult a doctor.
The controversy should not be confused with prenatal vitamins and folic acid, dietary supplements that are important in pregnancy, cautioned Annette Dickinson of the industry's Council for Responsible Nutrition.