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Granular Laxative Products Not GRASE

03/29/2007

Federal Register Final rule: FDA is issuing a final rule establishing that OTC laxative drug products in granular dosage form containing the bulk-forming psyllium 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 (GRASE) and are misbranded. To view this final rule, click here.

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