Court Rules to Keep Folic Acid Disclaimer

WASHINGTON--A judge has decided to keep the Food and Drug Administration's (FDA) disclaimer for the Pearson v. Shalala folic acid health claim after FDA filed for a reconsideration.

The saga began last October when FDA denied health claims for fiber and folic acid and the plaintiffs brought the matter to court. On Feb. 1, U.S. District Judge Gladys Kessler found FDA unconstitutional for denying a health claim that stated folic acid in supplement form is more effective in preventing neural tube defects (NTDs) than that in food. As part of the court order, Kessler made FDA draft disclaimers that could accompany the claim.

The claim, as it stands, reads: "0.8 mg folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form." However, FDA's disclaimer was a double-edged sword for the industry: "FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects." On the coattails of this decision, the FDA filed a motion for reconsideration of the District Court decision.

The grounds for reconsideration, according to FDA, was that a disclaimer cannot make a statement suggesting that "800 mcg is more effective than 400 mcg" of folic acid less misleading. However, Kessler found that the health claim was not inherently misleading, which she said tilted the balance in favor of disclaimers rather than suppression of the claim itself. "In its motion for reconsideration, FDA has again refused to accept the reality and finality of that conclusion by the court of appeals," Kessler concluded.

For more details, visit www.emord.com or www.cfsan.fda.gov.