United States of America. In the context of its review of over-the-counter laxative ingredients, the Food and Drug Administration has proposed to reclassify the stimulant laxative ingredients aloe, bisacodyl, cascara sagrada and senna (including sennosides) from Category I (generally recognized as safe and effective) to Category III (more data needed).

The agency reviewed available data concerning these products, and concluded that carcinogenicity data are insufficient.

The full text is available on request.

[See also Pharmaceuticals Newsletter Nos. 5&6, May & June, 1&2, January & February 1998, Nos 11&12, November & December 1997, DRS Information Exchange Alert No. 65 of 7 October 1997]

Reference: Federal Register 63(118): 33592-33595 (1998).