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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Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.
Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.
