id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2000-P-0133-0060,FDA,FDA-2000-P-0133,Petition Response Letter from FDA CDER to Mr Raubicheck  on behalf of Pharmachem Laboratories Inc.,Other,Letter(s),2020-05-26T04:00:00Z,2020,5,2020-05-26T04:00:00Z,,2020-05-26T18:32:39Z,,0,0,09000064846af5d2
FDA-2000-P-0133-0058,FDA,FDA-2000-P-0133,Petition Response Letter from FDA CDER to Anthony L. Young on behalf of Pharmavite,Other,Letter(s),2020-05-26T04:00:00Z,2020,5,2020-05-26T04:00:00Z,,2020-05-26T18:13:31Z,,0,0,09000064846af0c3
FDA-2000-P-0133-0059,FDA,FDA-2000-P-0133,Petition Response Letter from FDA CDER to Ms. Guggenheim on behalf of Cargill,Other,Letter(s),2020-05-26T04:00:00Z,2020,5,2020-05-26T04:00:00Z,,2020-05-26T18:21:35Z,,0,0,09000064846aecb6
FDA-2000-P-0133-0057,FDA,FDA-2000-P-0133,"Petition Response Letter from FDA CDER to Anthony L. Young on behalf of Botanical Laboratories, Inc.",Other,Letter(s),2020-05-26T04:00:00Z,2020,5,2020-05-26T04:00:00Z,,2020-05-26T17:53:27Z,,0,0,09000064846aeace
FDA-2000-P-0133-0054,FDA,FDA-2000-P-0133,Health Claims: Phytosterols and Risk of Coronary Heart Disease,Notice,General Notice,2012-02-23T05:00:00Z,2012,2,2012-02-23T05:00:00Z,2012-04-24T03:59:59Z,2012-04-24T12:01:32Z,2012-03940,0,0,0900006480fbdb92
FDA-2000-P-0133-0050,FDA,FDA-2000-P-0133,Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the Comment Period,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-11T04:00:00Z,2011,8,2011-08-11T04:00:00Z,2011-10-26T03:59:59Z,2011-08-11T14:44:41Z,2011-20406,0,0,0900006480eddb33
FDA-2000-P-0133-0047,FDA,FDA-2000-P-0133,List of References 31-69 - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease],Supporting & Related Material,BKG- Background Material (internal references),2011-03-25T04:00:00Z,2011,3,,,2011-03-25T21:03:47Z,,0,0,0900006480befe54
FDA-2000-P-0133-0046,FDA,FDA-2000-P-0133,"Acknowledgement Letter to Botanical Laboratories, Inc. (Kleinfeld Kaplan and Becker, LLP)",Other,ACK-Acknowledgement Letter,2011-03-24T04:00:00Z,2011,3,2011-03-24T04:00:00Z,,2013-07-27T23:48:11Z,,0,0,0900006480c0df46
FDA-2000-P-0133-0045,FDA,FDA-2000-P-0133,"Botanical Laboratories, Inc. (Kleinfeld Kaplan and Becker, LLP) - Petition for Stay",Other,PSA-Petition for Stay,2011-03-24T04:00:00Z,2011,3,2011-03-24T04:00:00Z,,2013-08-11T03:13:44Z,,0,0,0900006480c0ba3b
FDA-2000-P-0133-0043,FDA,FDA-2000-P-0133,"Exhibit D - ""Kevin C. Maki, Ph.D. - Curriculum Vitae"" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0133-0040",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T23:33:59Z,,0,0,0900006480c0111d
FDA-2000-P-0133-0040,FDA,FDA-2000-P-0133,"Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition",Other,CP-Citizen Petition,2011-03-04T05:00:00Z,2011,3,2011-03-04T05:00:00Z,,2024-11-07T22:28:35Z,,1,0,0900006480bfae26
FDA-2000-P-0133-0044,FDA,FDA-2000-P-0133,"Acknowledgement Letter to Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP)",Other,ACK-Acknowledgement Letter,2011-03-04T05:00:00Z,2011,3,2011-03-04T05:00:00Z,,2013-07-27T23:46:13Z,,0,0,0900006480bfae28
FDA-2000-P-0133-0041,FDA,FDA-2000-P-0133,"Exhibit A - ""Container and Carton Label for Nature Made® Cholestoff®"" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0133-0040",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T23:33:56Z,,0,0,0900006480c0084b
FDA-2000-P-0133-0042,FDA,FDA-2000-P-0133,"Exhibit C - ""Maki, et al., A Plant Sterol/Stanol Supplement in Tablet Form Lowers LDL and Non-HDL Cholesterol in Men and Woman with Primary Hypercholesterolemia (Poster)"" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0133-0040",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T23:33:57Z,,0,0,0900006480c0084d
FDA-2000-P-0133-0038,FDA,FDA-2000-P-0133,"Exhibit D - ""Kevin C. Maki, Ph.D. - Curriculum Vitae"" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0133-0035",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T20:23:58Z,,0,0,0900006480bfd1d7
FDA-2000-P-0133-0035,FDA,FDA-2000-P-0133,"Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Petition for Stay of Action",Other,PSA-Petition for Stay,2011-03-02T05:00:00Z,2011,3,2011-03-02T05:00:00Z,,2013-08-11T01:40:09Z,,0,0,0900006480bfa3f2
FDA-2000-P-0133-0037,FDA,FDA-2000-P-0133,"Exhibit C - ""Maki, et al., A Plant Sterol/Stanol Supplement in Tablet Form Lowers LDL and Non-HDL Cholesterol in Men and Woman with Primary Hypercholesterolemia (Poster)"" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0133-0035",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T20:24:25Z,,0,0,0900006480bfa43b
FDA-2000-P-0133-0039,FDA,FDA-2000-P-0133,"Acknowledgement Letter to Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP)",Other,ACK-Acknowledgement Letter,2011-03-02T05:00:00Z,2011,3,2011-03-02T05:00:00Z,,2013-08-11T01:40:09Z,,0,0,0900006480bfa423
FDA-2000-P-0133-0036,FDA,FDA-2000-P-0133,"Exhibit A - ""Container and Carton Label for Nature Made® Cholestoff®"" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0133-0035",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T20:24:48Z,,0,0,0900006480bfa428
FDA-2000-P-0133-0028,FDA,FDA-2000-P-0133,"Reference - ""Letter of Enforcement Discretion From FDA to Cargill Health & Food Technologies"" - [Health Claim; Phytosterols and Risk of Coronary Heart Disease] re FDA-2000-P-0133-0025",Supporting & Related Material,REF-Reference (internal unless indicated),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T21:01:53Z,,0,0,0900006480bf13be
FDA-2000-P-0133-0029,FDA,FDA-2000-P-0133,"Attachment 4 - ""On Nutrition and Health Claims Made on Food"" - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-FDA-2000-P-0133-0027",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:02:59Z,,0,0,0900006480bfad82
FDA-2000-P-0133-0030,FDA,FDA-2000-P-0133,"Attachment 5 - ""On the Authorisation of Certain Health Claims Made on Food and Referring to the Reduction of Disease Risk an to Children's Development and Health "" - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-2000-P-0133-0027",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:04:12Z,,0,0,0900006480bfad83
FDA-2000-P-0133-0031,FDA,FDA-2000-P-0133,"Attachment 6 - ""Amending Regulation (EC) No. 983/2009 on the Authorisation and Refusal of Authorisation of Certain Health Claims Made on Food and Referring to the Reduction of Disease Risk and to Children's Development and Health"" - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-2000-P-0133-0027",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:05:12Z,,0,0,0900006480bfad84
FDA-2000-P-0133-0026,FDA,FDA-2000-P-0133,"Reference - ""Letter of Enforcement Discretion From FDA to Cargill Health & Food Technologies, February 14, 2003"" - [Extension of Enforcement Discretion: Health Claim, Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG-Background Material,2011-02-18T05:00:00Z,2011,2,,,2011-02-18T23:19:29Z,,0,0,0900006480bf251f
FDA-2000-P-0133-0025,FDA,FDA-2000-P-0133,Health Claim; Phytosterols and Risk of Coronary Heart Disease,Proposed Rule,NEC-Notice of Extension,2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,2011-04-20T03:59:59Z,2011-02-28T20:59:23Z,2011-3678,0,0,0900006480bf251c
FDA-2000-P-0133-0023,FDA,FDA-2000-P-0133,Venable LLP - Request for Extension Comment Due Date,Other,EXT-Request for Extension Comment Due Date,2011-02-15T05:00:00Z,2011,2,2011-02-15T05:00:00Z,,2013-07-27T23:45:23Z,,0,0,0900006480befd94
FDA-2000-P-0133-0022,FDA,FDA-2000-P-0133,"Venable, LLP - Request for Extension of Comment Due Date",Other,EXT-Request for Extension Comment Due Date,2011-02-14T05:00:00Z,2011,2,2010-12-08T05:00:00Z,2011-02-12T04:59:59Z,2013-07-27T23:44:52Z,,0,0,0900006480bec04f
FDA-2000-P-0133-0019,FDA,FDA-2000-P-0133,"Fommer Lawrence & Haug LLP (Pharmachem Laboratories, Inc.) - Petition for Stay",Other,PSA-Petition for Stay,2011-02-01T05:00:00Z,2011,2,2011-02-01T05:00:00Z,,2013-08-11T01:39:31Z,,0,0,0900006480bd6ec6
FDA-2000-P-0133-0020,FDA,FDA-2000-P-0133,"Acknowledgement Letter to Fommer Lawrence & Haug LLP (Pharmachem Laboratories, Inc.)",Other,ACK-Acknowledgement Letter,2011-02-01T05:00:00Z,2011,2,2011-02-01T05:00:00Z,,2013-07-27T23:43:59Z,,0,0,0900006480bd6f6b
FDA-2000-P-0133-0018,FDA,FDA-2000-P-0133,Acknowledgement Letter to Covington & Burling (Cargill Inc.),Other,ACK-Acknowledgement Letter,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2013-07-27T23:42:02Z,,0,0,0900006480bc81d6
FDA-2000-P-0133-0017,FDA,FDA-2000-P-0133,Covington & Burling (Cargill Inc.) - Petition for Stay of Action,Other,PSA-Petition for Stay,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2024-11-12T04:58:05Z,,1,0,0900006480bc81d4
FDA-2000-P-0133-0016,FDA,FDA-2000-P-0133,Council for Responsible Nutrition - Letter,Other,LET-Letter,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2013-07-27T23:42:02Z,,0,0,0900006480bc81d2
FDA-2000-P-0133-0015,FDA,FDA-2000-P-0133,"Tab 20 - ""FDA/CFSAN, New Dietary Ingredient Report 77 & Tall Oil Phytosterols (Ingredient of Reducol)"" - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-15T05:00:00Z,2010,12,,,2010-12-15T23:41:58Z,,0,0,0900006480bb7ea7
FDA-2000-P-0133-0014,FDA,FDA-2000-P-0133,"Tab 19 - ""FDA/CFSAN, New Dietary Ingredient Report 77 & Plant Stanol Fatty Acid Esters"" - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-15T05:00:00Z,2010,12,,,2010-12-15T23:32:15Z,,0,0,0900006480bb7ea5
FDA-2000-P-0133-0009,FDA,FDA-2000-P-0133,"EXT2 - Extension Letter Sent from Nancy L. Schnell, Deputy General Counsel, Marketing & Regulatory for Unilever United States, Inc. to Dr. Kathleen Ellwood Granting An Extension of the Health Claim Petition to Amend 21CFR101.83 Phytosterols & Risk of Heart Disease To December 16, 2009 - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2011-02-15T22:05:05Z,,0,0,0900006480bb2453
FDA-2000-P-0133-0007,FDA,FDA-2000-P-0133,List of References - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease] - Background Material,Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2010-12-14T02:58:04Z,,0,0,0900006480bb241a
FDA-2000-P-0133-0008,FDA,FDA-2000-P-0133,"EXT1 - Extension Letter Sent From Nancy L. Schnell, Deputy General Counsel, Marketing & Regulatory for Unilever United States, Inc. to Dr. Kathleen Ellwood Granting An Extension of the Health Claim Petition To Amend 21CFR101.83 Phytosterols & Risk of Heart Disease to September 16, 2009 - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2011-02-15T22:04:36Z,,0,0,0900006480bb2420
FDA-2000-P-0133-0010,FDA,FDA-2000-P-0133,"EXT3 - Extension Letter Sent From Nancy L. Schnell, Deputy General Counsel, Marketing & Regulatory for Unilever United States, Inc. to Ms. Blakeley Denkinger Granting An Extension for the Health Claim Petition to Amend 21CFR101.83 Phytosterols & Risk of Heart Disease to December 14, 2010 - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2011-02-15T22:05:42Z,,0,0,0900006480bb2469
FDA-2000-P-0133-0013,FDA,FDA-2000-P-0133,"Tab 4 - ""Hallikainen, et al., - Short-Term LDL Cholesterol-Lowering Efficacy on Plants Sterol Esters"" - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2010-12-14T02:58:13Z,,0,0,0900006480bb54e6
FDA-2000-P-0133-0011,FDA,FDA-2000-P-0133,"Tab 2 - FDA/CFSAN -""Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims"". January, 2009"" - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2011-02-15T22:06:58Z,,0,0,0900006480bb54e2
FDA-2000-P-0133-0012,FDA,FDA-2000-P-0133,"Tab 3 - NIH - ""3rd Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation & Treatment of High Blood Pressure in Adults (Adult Treatment Panel III), Executive Summary, may 2001"" - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2010-12-14T02:58:12Z,,0,0,0900006480bb54e4
FDA-2000-P-0133-0006,FDA,FDA-2000-P-0133,Food Labeling: Health Claim; Phytosterols and Risk of Coronary Heart Disease,Proposed Rule,NPR-Notice of Proposed Rule-Making,2010-12-08T05:00:00Z,2010,12,2010-12-08T05:00:00Z,2011-02-12T04:59:59Z,2010-12-08T19:18:27Z,,0,0,0900006480bb1ba0
FDA-2000-P-0133-0005,FDA,FDA-2000-P-0133,Meeting on Smart Balance and Coronary Heart Disease,Other,MM-Memorandum of Meeting,2003-11-12T05:00:00Z,2003,11,,,2008-04-25T01:16:04Z,,0,0,09000064804cfda1
FDA-2000-P-0133-0004,FDA,FDA-2000-P-0133,FDA,Notice,NEC-Notice of Extension,2001-10-12T04:00:00Z,2001,10,2001-10-12T04:00:00Z,2001-11-20T04:59:59Z,2008-04-25T01:16:05Z,,0,0,09000064804cfd51
FDA-2000-P-0133-0003,FDA,FDA-2000-P-0133,FDA,Notice,NIR-Notice of Interim Rule,2000-09-14T04:00:00Z,2000,9,2000-09-14T04:00:00Z,2000-11-23T04:59:59Z,2008-04-25T01:16:05Z,,0,0,09000064804cfd10
FDA-2000-P-0133-0002,FDA,FDA-2000-P-0133,FDA,Notice,NIR-Notice of Interim Rule,2000-09-14T04:00:00Z,2000,9,2000-09-14T04:00:00Z,2000-11-23T04:59:59Z,2008-04-25T01:16:04Z,,0,0,09000064804cfd0b
FDA-2000-P-0133-0001,FDA,FDA-2000-P-0133,FDA,Notice,NIR-Notice of Interim Rule,2000-09-14T04:00:00Z,2000,9,2000-09-14T04:00:00Z,2000-11-23T04:59:59Z,2008-04-25T01:16:04Z,,0,0,09000064804cfc48