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Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule.
Fed Regist. 2007 Mar 29; 72(60):14669-74.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (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. 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. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

CatharticsConsumer Product SafetyDrug LabelingHumansNonprescription DrugsPsylliumUnited States

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17450664

Citation

Food and Drug Administration, HHS. "Laxative Drug Products for Over-the-counter Human Use; Psyllium Ingredients in Granular Dosage Forms. Final Rule." Federal Register, vol. 72, no. 60, 2007, pp. 14669-74.
Food and Drug Administration, HHS. Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule. Fed Regist. 2007;72(60):14669-74.
Food and Drug Administration, HHS. (2007). Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule. Federal Register, 72(60), 14669-74.
Food and Drug Administration, HHS. Laxative Drug Products for Over-the-counter Human Use; Psyllium Ingredients in Granular Dosage Forms. Final Rule. Fed Regist. 2007 Mar 29;72(60):14669-74. PubMed PMID: 17450664.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule. A1 - ,, PY - 2007/4/25/pubmed PY - 2007/5/2/medline PY - 2007/4/25/entrez SP - 14669 EP - 74 JF - Federal register JO - Fed Regist VL - 72 IS - 60 N2 - The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (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. 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. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/17450664/Laxative_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -