FDA Backpedals on Supplements for Pregnancy Conditions 35017

FDA Backpedals on Supplements for Pregnancy Conditions

WASHINGTON--Birth defect experts confronted the Food and Drug Administration(FDA) concerning the agency's January ruling that pregnancy supplements would gounchecked. As a result, FDA issued a warning that companies cannot promote theirproducts as treatments for morning sickness, leg swelling or any other conditionrelating to pregnancy. "This statement is a response to a number ofletters, most of them from the healthcare sector, that raised concerns aboutsafety issues," said Margaret Dotzel, FDA's acting associate commissionerfor policy. "We are not changing our position, we are initiating aprocess."

The Dietary Supplement Health and Education Act (DSHEA) of 1994 prohibiteddietary supplements from claiming to treat or cure diseases without FDA'sapproval, but it did allow supplements to promote alleviation of non-diseasehealth conditions. Since DSHEA's inception, FDA has worked to distinguish whatwould constitute disease claims as opposed to structure/function, "passagesof life" claims. In its recent proposed regulations to implement DSHEA, FDAmaintained that morning sickness and leg swelling were not diseases, but normalconditions of pregnancy.

Therefore, a supplement targeting these conditions could claim healthbenefits without prior FDA testing as long as a disclaimer appeared on the labelinforming the consumer the product was not FDA-approved.

However, birth defect researchers maintain that FDA's regulations may provedetrimental to an unborn child. "Scientifically, everyone knows that theunborn fetus is extremely susceptible, and they [the FDA] should have knownthis," said Sidney Wolfe, director of Public Citizen's Health ResearchGroup in Washington, D.C.

In a Feb. 3 letter written to FDA commissioner Jane Henney, Wolfe wrote,"A government regulation that facilitates consumption by pregnant women ofsuch agents, which have not been tested for their adverse effects on the fetus,will unfortunately put embryos and fetuses at risk."

Critics argued that if a product claimed to help with pregnancy conditions,consumers would assume that the product had been tested safe for the unbornbaby. "There certainly are some plants that if people take, they couldresult in birth defects," FDA drug chief Dr. Janet Woodcock admitted.

FDA, in an effort to amend the pregnancy clause of the new regulations, willconvene a public meeting on March 30 to debate the matter. Woodcock said theagency will evaluate if action needs to be taken against companies that ignorethe warning. In the meantime, pregnant women are urged to consult with theirdoctors before taking any dietary supplements or medications.