FDA-Drafted Folic Acid Health Claim Disclaimers Ordered By Federal Judge
This article was originally published in The Tan Sheet
Executive Summary
FDA must draft "one or more appropriately short, succinct and accurate disclaimers" to accompany the Pearson plaintiffs' proposed dietary supplement health claim for folic acid/neural tube defects, a Washington, D.C. judge ruled Feb. 1 in a firmly worded opinion.
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Pearson
Dietary supplement firms may use proposed health claim relating .8 mg folic acid with neural tube defect reduction when accompanied by disclaimer: "FDA does not endorse this claim. Public health authorities recommend that women consume .4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects." Agency's April 3 announcement comes in response to D.C. federal court order requiring it to draft "short, succinct and accurate disclaimers" to accompany Pearson claim (1"The Tan Sheet" Feb. 5, p. 6). FDA is seeking reconsideration of that order and says it may disallow use of claim and disclaimer in future if court rules in its favor. Agency's decision on antioxidant vitamins/cancer health claim has been delayed until April 20