Pearson
This article was originally published in The Tan Sheet
Executive Summary
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
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Pearson
FDA request for reconsideration of court order requiring disclaimers for folic acid/NTD supplement health claim is baseless and demonstrates agency's "reluctance to fully comply with Pearson I," D.C. federal court Judge Gladys Kessler says in May 7 order upholding her prior ruling. Agency had argued Kessler committed "clear error" by "assigning undue weight" to 1992 human clinical study conducted in Hungary and creating legal standard inconsistent with D.C. appeals court's original decision requiring FDA to consider disclaimers for four Pearson claims. In April, FDA released disclaimer language for .8 mg folic acid/NTD reduction health claim (1"The Tan Sheet" April 9, In Brief)
Pearson
FDA request for reconsideration of court order requiring disclaimers for folic acid/NTD supplement health claim is baseless and demonstrates agency's "reluctance to fully comply with Pearson I," D.C. federal court Judge Gladys Kessler says in May 7 order upholding her prior ruling. Agency had argued Kessler committed "clear error" by "assigning undue weight" to 1992 human clinical study conducted in Hungary and creating legal standard inconsistent with D.C. appeals court's original decision requiring FDA to consider disclaimers for four Pearson claims. In April, FDA released disclaimer language for .8 mg folic acid/NTD reduction health claim (1"The Tan Sheet" April 9, In Brief)
Pearson
FDA request for reconsideration of court order requiring disclaimers for folic acid/NTD supplement health claim is baseless and demonstrates agency's "reluctance to fully comply with Pearson I," D.C. federal court Judge Gladys Kessler says in May 7 order upholding her prior ruling. Agency had argued Kessler committed "clear error" by "assigning undue weight" to 1992 human clinical study conducted in Hungary and creating legal standard inconsistent with D.C. appeals court's original decision requiring FDA to consider disclaimers for four Pearson claims. In April, FDA released disclaimer language for .8 mg folic acid/NTD reduction health claim (1"The Tan Sheet" April 9, In Brief)