February 14, 2000
WASHINGTON--Birth defect experts confronted FDA concerning the agency's January ruling that pregnancy supplements would go unchecked. As a result, FDA issued a warning that companies cannot promote their products as treatments for morning sickness, leg swelling or any other condition relating to pregnancy.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 prohibits dietary supplements from claiming to treat or cure diseases without FDA's approval, but it does allow supplements to promote alleviation of non-disease health conditions. Since DSHEA's inception, FDA has worked to distinguish what would constitute disease claims as opposed to structure/function, "passages of life" claims. In its recent proposed regulations to implement DSHEA, FDA maintained that morning sickness and leg swelling were not diseases, but normal conditions of pregnancy. Therefore, a supplement targeting these conditions could claim health benefits without prior FDA testing insofar as a disclaimer appeared on the label informing the consumer the product was not FDA-approved.
However, birth defect researchers maintain that FDA's regulations may prove detrimental to an unborn child. "Scientifically, everyone knows that the unborn fetus is extremely susceptible, and they [the FDA] should have known this," said Sidney Wolfe, director of Public Citizen's Health Research Group in Wash.
Critics argued that if a product claimed to help with pregnancy conditions, consumers would assume that the product had been tested safe for the unborn baby. "There certainly are some plants that if people take, they could result in birth defects," FDA drug chief Dr. Janet Woodcock admitted. FDA, in efforts to amend the pregnancy clause of the new regulations, will convene a public meeting within a few months to debate the matter. Woodcock said the agency will evaluate if action needs to be taken against companies who ignore the warning. In the meantime, pregnant women are urged to consult with their doctors before taking any dietary supplements or medications.
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