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)