FDA Releases Folic Acid Claim Disclaimer

WASHINGTON--As it was required to do by U.S. District Court, the Food and Drug Administration (FDA) has informed the Pearson v. Shalala plaintiffs of its recommended disclaimer to run with their health claim. (For details on the court's decision, see www.naturalproductsinsider.com/hotnews/12h210042.html.)

The claim 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." The Court asked FDA to consider a short, succinct and accurate disclaimer to allow the plaintiffs to use the claim. FDA's response: "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."

Plaintiff's counsel Emord & Associates was informed of the decision in a letter from Christine Lewis, Ph.D., director of the Office of Nutritional Products, Labeling and Dietary Supplements. Lewis' letter outlined the agency's reasoning behind the selection of the disclaimer language, including their concerns about correcting the implications of the claim. She also reiterated that FDA has filed a motion for reconsideration of the District Court decision. "As explained in our briefs in support of that motion, FDA believes that no disclaimer can remedy the deceptiveness of your claim because the claim is contrary to the weight of the scientific evidence," she wrote.

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