United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2007_register executive 2010-09-22 article Rules and Regulations D09002ee1c80b3260 D09002ee1c80b3301 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 72 FR 14669 https://www.govinfo.gov/app/details/FR-2007-03-29/E7-5740 E7-5740 fr29mr07-8 RIN 0910-AF38 4160-01-S Docket No. 1978N-0036L https://www.govinfo.gov/app/details/FR-2007-03-29/E7-5740 https://www.govinfo.gov/content/pkg/FR-2007-03-29/html/E7-5740.htm https://www.govinfo.gov/content/pkg/FR-2007-03-29/pdf/E7-5740.pdf 6 p. 14669 14674 72 FR 14669 Title 21 Part 201 21 CFR Part 201 Title 21 Part 310 21 CFR Part 310 RIN 0910-AF38 Laxative Drug Products for Over-the-Counter Human Use; Psyllium Ingredients in Granular Dosage Forms; Federal Register Vol. 72, Issue RULE E7-5740 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2007-10-01 Docket No. 1978N-0036L 4160-01-S E7-5740 Final rule.

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.

Effective Date: This rule is effective October 1, 2007. Reynold Tan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993-0002, 301- 796-2090. http://www.fda.gov/ohrms/dockets/default.htm Vol. 72, no. 60 Office of the Federal Register, National Archives and Records Administration 2007-03-29 continuing daily deposited born digital 372 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-03-29 P0b002ee180965bdb 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29mr07 https://www.govinfo.gov/app/details/FR-2007-03-29 https://www.govinfo.gov/content/pkg/FR-2007-03-29/pdf/FR-2007-03-29.pdf https://www.govinfo.gov/content/pkg/FR-2007-03-29/xml/FR-2007-03-29.xml fdlp 14649 15008 DGPO 2010-09-22 2024-06-05 FR-2007-03-29 machine generated eng FR FR-2007-03-29 72 60