Laxative record open
This article was originally published in The Tan Sheet
Executive Summary
FDA is reopening the administrative record for OTC laxative products until Jan. 20, 2004, agency announces in Oct. 22 1Federal Register. Agency explains it "has received new data and information submitted to the rulemaking for OTC laxative drug products after the administrative record closed on the various dates" since the 1985 tentative final monograph. Separately, comments on the agency's proposal to reclassify granular psyllium as Category II (not generally recognized as safe and effective) from Category I (generally recognized as safe and effective) are due Nov. 3, FDA says (2"The Tan Sheet" Aug. 11, 2003, p. 10)...
You may also be interested in...
Laxatives monograph clarification
CHPA asks FDA to accept the statement of identity "fiber laxative" as well as "the indication 'Fiber therapy for relief of occasional constipation' [which may be followed by '(irregularity)']" in a Jan. 20 letter. The trade group also requests clarification on whether "'fiber laxative' may be used as an alternative to 'bulk-forming laxative.'" CHPA's request comes after the October 2003 reopening of the administrative record for OTC laxatives (1"The Tan Sheet" Oct. 27, 2003, In Brief)...
Granular Psyllium Laxatives Category II Classification Advised – FDA
FDA is proposing to declare that bulk-forming psyllium ingredients in granular form are not safe for use in OTC laxatives
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.