FDA issues final rule for OTC laxative drug products

April 2, 2007

FDA is issuing a final rule establishing that over the counter laxative drug products in granular dosage form containing the bulk-forming ingredients psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed are not generally recognized as safe and effective and are misbranded.

FDA is issuing a final rule establishing that OTC laxative drug products in granular dosage form containing the bulk-forming ingredients psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed are not generally recognized as safe and effective and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. This final rule, which takes effect on Oct. 1, does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers.

To see more Hot off the Press news articles, click here.

To go to the Drug Topics homepage, click here.