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December 1, 2000
FDA Sued Over Folic Acid Claim
WASHINGTON--The Pearson v. Shalala plaintiffs filed suit Nov. 13 against theFood and Drug Administration (FDA), arguing that the agency's rejection of aproposed dietary supplement claim for folic acid/neural tube defects (NTD) isunconstitutional and disregards the current state of scientific evidence.
The claim would have stated that 0.8 mg of folic acid in supplement form maybe more effective than that found in food in reducing the risk for neural tubedefects in pregnant women. FDA said there was no significant scientificagreement for that claim, but noted that dietary supplements can carry qualifiedhealth claims regarding the amount and sources of folic acid effective inreducing the risk of NTDs. In the lawsuit, filed by Emord & Associates, theplaintiffs argue that denial of the claim means "fertile women unaware ofthe superior bioavailability of folic acid in supplements are likely toexperience a heightened risk of an NTD."
NTDs, specifically spina bifida and anecephaly, affect approximately 4,000live births and pregnancies each year in the United States. These spinal cordmalformations are associated with serious developmental disabilities, whileinfants with anecephaly usually die shortly after birth. The Institute ofMedicine of the National Academy of Sciences concluded that the current FDAfolic acid fortification has not reduced the prevalence of NTDs in the UnitedStates and that there is strong evidence for the protective effect of folate insupplements.
The plaintiffs are asking the U.S. District Court for the District ofColumbia to enjoin FDA from enforcing the prohibition against the claim untilreview of the complaint. It further asks that the court declare the denial ofthe claim unconstitutional and in violation of the health claim provision of theNutrition Labeling and Education Act (NLEA). For more information, contact Emordat (202) 466-6937.
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