Court Orders FDA to Draft Disclaimers and Allow Folic Acid Health Claim

Court Orders FDA to Draft Disclaimers and Allow Folic AcidHealth Claim

WASHINGTON--A U.S. District Court has found unconstitutionalthe Food and Drug Administration's (FDA) denial of a health claim holding thatfolic acid in supplement form is more effective in preventing neural tubedefects (NTDs) than that in food. In her order issued Feb. 1, Judge GladysKessler ordered FDA to draft disclaimers that can accompany the claim. Therequest for injunction was filed by Pearson, et. Al., after FDA denied the claimlast year.

The claim stated that "0.8 mg of folic acid in a dietary supplement ismore effective in reducing the risk of neural tube defects than a lower amountin foods in common form." "The court finds that the FDA's decision toclassify Plaintiffs' folic acid claim as 'inherently misleading' was arbitrary,capricious and an abuse of discretion," Kessler wrote in her opinion."Accordingly, the Court concludes that the FDA acted unconstitutionally,and particularly in violation of the Court of Appeals decision in Pearson v.Shalala, in suppressing Plaintiffs' claim rather than proposing a clarifyingdisclaimer to accompany the claim." The court remanded the case back toFDA, which must draft one or more "short, succinct and accuratedisclaimers" to be used with the folic acid claim, and suggested the agencyconsider the disclaimers suggested by the Pearson court or that put forth by thePlaintiffs.

"The really wonderful thing in reversing this act by FDA that had theeffect of keeping women at a higher risk of neural tube defects is that it willhelp ensure that women understand they can't rely on foods in common form toprovide the level of folate needed to reduce NTDs," said Jonathan Emord,counsel for the plaintiffs. "It also means that the victory of Pearson v.Shalala holds the promise that the First Amendment will now have firm footing atFDA." For a copy of the decision, visit www.dcd.uscourts.gov/district-court-recent.html.