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Related links Public Citizen's Health Research Group Association of Women's Health, Obstetric, and Neonatal Nurses |
FDA recants ruling on dietary supplements for pregnant
women
Posted
2-21-2000 Washington. Bowing to pressure from consumer advocates, the Food and Drug Administration recently revised its Jan. 6 labeling rule for dietary supplements directed toward pregnant women. The FDA ruling allowed companies to claim that their products can "affect structure or function of the body." But the ruling did not take into consideration the effects untested dietary supplements, such as those claiming to treat leg edema or morning sickness, would have on an unborn fetus. Numerous letters written by Public Citizen’s Health Research Group alerted the FDA to the ruling’s potential risks to pregnant women and their fetuses, said Larry Sasich, spokesman for the group. These actions led the FDA to put a hold on the ruling and extend the comment period. The date for a public meeting to discuss these concerns will be posted this week, according to Brad Stone, press spokesperson for the FDA. Melinda Mercer Ray, MSN, RN, director of health policy and legislative affairs for the Association of Women’s Health, Obstetric, and Neonatal Nurses, was pleased by the FDA’s speedy action. "We applaud them for acting promptly, and are looking forward to working with them to ensure that adequate research is done [on the effects of dietary supplements on pregnant women and fetuses]." The FDA’s Jan. 6 ruling narrowed a previous ruling, the Dietary Supplement Health and Education Act of 1994, on what can be claimed on labels without prior approval by the FDA. The pregnancy part of the ruling will be put on hold until further notice. In the meantime, the FDA cautions pregnant women to consult their physicians before taking any dietary supplements.
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