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FDA Considers Sodium Picosulfate For OTC Laxatives Monograph Inclusion

This article was originally published in The Tan Sheet

Executive Summary

FDA has announced a call for data for safety and effectiveness information on sodium picosulfate up to 10 mg as a laxative single active ingredient

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In Brief

FDA seeks DMAA product seizure; skin tag remover study flawed – ERSP; Plan B One-Step approved fully OTC; FDA continues evaluating laxative TEA; FDA hosts supply chain public hearing; energy drink marketing to youths challenged; more news In Brief.

Aloe, Cascara Sagrada Safety In Laxatives Still Needs Supporting Data – FDA

Data on aloe and cascara sagrada from the German Commission E monographs, World Health Organization reviews and the National Toxicology Program are insufficient to support the safety and efficacy of the ingredients in OTC laxatives, FDA concludes in a July 3 letter to the American Herbal Products Association

Phenolphthalein Banned In OTC Laxatives Effective Jan. 28

FDA's final rule banning the use of phenolphthalein in OTC stimulant laxatives based on safety concerns was published in the Jan. 28 Federal Register. The rule is effective immediately.


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