Aloe, Cascara Sagrada Safety In Laxatives Still Needs Supporting Data – FDA
This article was originally published in The Tan Sheet
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
You may also be interested in...
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
FDA will not defer enforcement action against manufacturers of OTC laxatives containing cascara sagrada, agency states in Sept. 2 letter to Atlanta law firm Arnall Golden Gregory denying citizen petition. Decision barring laxatives containing ingredient from initial entry into interstate commerce as of Nov. 5, 2002 stands, FDA says. Agency reply follows recent letter to AHPA denying association's request to move cascara sagrada from Category III to Category I (1"The Tan Sheet" Aug. 4, 2003, p. 11)...
FDA's final rule on aloe and cascara sagrada does not properly distinguish between aloe used in OTC drug laxatives and aloe vera gel used in foods and dietary supplements, AHPA and the International Aloe Science Council say in a 1citizen petition