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withdrawn,object_id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-0102-0063,FDA,FDA-2000-P-0102,"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,,2020-05-26T18:15:54Z,,0,0,09000064846aeba0
FDA-2000-P-0102-0065,FDA,FDA-2000-P-0102,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,,2020-05-26T18:33:32Z,,0,0,09000064846af68d
FDA-2000-P-0102-0062,FDA,FDA-2000-P-0102,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,,2020-05-26T18:08:59Z,,0,0,09000064846aef27
FDA-2000-P-0102-0064,FDA,FDA-2000-P-0102,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,,2020-05-26T18:20:39Z,,0,0,09000064846aebf8
FDA-2000-P-0102-0061,FDA,FDA-2000-P-0102,"Letter from FDA CFSAN to Forbes Medi-Tech, Inc.",Other,Letter(s),2019-03-25T04:00:00Z,2019,3,2019-03-25T04:00:00Z,,2019-03-25T15:25:17Z,,0,0,09000064804c22f2
FDA-2000-P-0102-0059,FDA,FDA-2000-P-0102,Health Claims: Phytosterols and Risk of Coronary Heart Disease,Notice,General Notice,2012-02-21T05:00:00Z,2012,2,2012-02-21T05:00:00Z,2012-04-24T03:59:59Z,2012-02-23T12:39:12Z,2012-03940,0,0,0900006480fbbd36
FDA-2000-P-0102-0055,FDA,FDA-2000-P-0102,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,2011-08-11T14:38:52Z,2011-20406,0,0,0900006480eddf11
FDA-2000-P-0102-0052,FDA,FDA-2000-P-0102,"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,,2013-08-11T04:44:50Z,,0,0,0900006480c1056a
FDA-2000-P-0102-0053,FDA,FDA-2000-P-0102,"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,,2013-07-27T23:48:04Z,,0,0,0900006480c0cf51
FDA-2000-P-0102-0048,FDA,FDA-2000-P-0102,"Exhibit A - ""Container and Carton Label for Nature Made® Cholestoff®"" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0102-0047",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T22:21:22Z,,0,0,0900006480bfadf4
FDA-2000-P-0102-0049,FDA,FDA-2000-P-0102,"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-0102-0047",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T22:21:23Z,,0,0,0900006480bfadf9
FDA-2000-P-0102-0051,FDA,FDA-2000-P-0102,"Acknowlegement 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,,2013-07-27T23:46:12Z,,0,0,0900006480bfad7a
FDA-2000-P-0102-0050,FDA,FDA-2000-P-0102,"Exhibit D - ""Kevin C. Maki, Ph.D. - Curriculum Vitae"" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2000-P-0102-0047",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T22:21:25Z,,0,0,0900006480c00f65
FDA-2000-P-0102-0044,FDA,FDA-2000-P-0102,"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-0102-0042",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T17:37:26Z,,0,0,0900006480bfa3eb
FDA-2000-P-0102-0046,FDA,FDA-2000-P-0102,"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,,2013-08-11T01:40:08Z,,0,0,0900006480bfa380
FDA-2000-P-0102-0047,FDA,FDA-2000-P-0102,"Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition",Other,CP-Citizen Petition,2011-03-02T05:00:00Z,2011,3,2011-03-02T05:00:00Z,,2013-07-27T23:46:12Z,,0,0,0900006480bfad77
FDA-2000-P-0102-0045,FDA,FDA-2000-P-0102,"Exhibit D - ""Kevin C. Maki, Ph.D. - Curriculum Vitae"" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0102-0042",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T17:37:28Z,,0,0,0900006480bfd1d5
FDA-2000-P-0102-0043,FDA,FDA-2000-P-0102,"Exhibit A - ""Container and Carton Label for Nature Made® Cholestoff®"" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2000-P-0102-0042",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T17:37:24Z,,0,0,0900006480bfa3c6
FDA-2000-P-0102-0042,FDA,FDA-2000-P-0102,"Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Petition for Stay of Action",Other,PSA-Petition for Stay,2011-03-01T05:00:00Z,2011,3,2011-03-01T05:00:00Z,,2024-11-12T04:59:22Z,,1,0,0900006480bfa304
FDA-2000-P-0102-0040,FDA,FDA-2000-P-0102,"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-0102-0030",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:23:48Z,,0,0,0900006480bf628c
FDA-2000-P-0102-0041,FDA,FDA-2000-P-0102,"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-0102-0030",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:24:14Z,,0,0,0900006480bf6292
FDA-2000-P-0102-0039,FDA,FDA-2000-P-0102,"Attachment 4 - ""On Nutrition and Health Claims Made on Food"" - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-2000-P-0102-0030",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:22:13Z,,0,0,0900006480bf6162
FDA-2000-P-0102-0038,FDA,FDA-2000-P-0102,"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-0102-0028",Supporting & Related Material,,2011-02-28T00:00:00Z,2011,2,,,2011-02-28T21:36:22Z,,0,1,0900006480bf138c
FDA-2000-P-0102-0028,FDA,FDA-2000-P-0102,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,2011-02-18T23:12:37Z,2011-3678,0,0,0900006480bf2393
FDA-2000-P-0102-0029,FDA,FDA-2000-P-0102,"Reference - ""Letter of Enforcement Discretion From FDA to Cargill Health & Food Technologies, February 13, 2003"" - [Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG-Background Material,2011-02-18T05:00:00Z,2011,2,,,2011-02-18T23:09:33Z,,0,0,0900006480bf1cb3
FDA-2000-P-0102-0027,FDA,FDA-2000-P-0102,List of References 31-69 - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease],Supporting & Related Material,BKG- Background Material (internal references),2011-02-15T05:00:00Z,2011,2,,,2011-02-15T22:28:41Z,,0,0,0900006480bade7c
FDA-2000-P-0102-0024,FDA,FDA-2000-P-0102,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,,2013-07-27T23:45:03Z,,0,0,0900006480bed177
FDA-2000-P-0102-0020,FDA,FDA-2000-P-0102,"Pharmachem Laboratories, Inc., (Fommer Lawrence & Haug LLP) - Petition for Stay of Action",Other,PSA-Petition for Stay,2011-02-08T05:00:00Z,2011,2,2011-02-08T05:00:00Z,,2013-07-27T23:43:59Z,,0,0,0900006480bd6ebf
FDA-2000-P-0102-0021,FDA,FDA-2000-P-0102,"Acknowledgement Letter to Pharmachem Laboratories, Inc., (Fommer Lawrence & Haug LLP)",Other,ACK-Acknowledgement Letter,2011-02-08T05:00:00Z,2011,2,2011-02-08T05:00:00Z,,2011-03-24T21:11:48Z,,0,0,0900006480bd6ec1
FDA-2000-P-0102-0018,FDA,FDA-2000-P-0102,Cargill Inc. (Covington & Burling) - Petition for Stay of Action,Other,PSA-Petition for Stay,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2024-11-07T22:28:12Z,,1,0,0900006480bc80d3
FDA-2000-P-0102-0017,FDA,FDA-2000-P-0102,Council for Responsible Nutrition - Letter,Other,LET-Letter,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2013-07-27T23:42:01Z,,0,0,0900006480bc80d0
FDA-2000-P-0102-0019,FDA,FDA-2000-P-0102,"Acknowledgement Letter to Cargill Inc., (Covington & Burling)",Other,ACK-Acknowledgement Letter,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2013-08-11T04:43:43Z,,0,0,0900006480bc80d8
FDA-2000-P-0102-0016,FDA,FDA-2000-P-0102,"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,,,2010-12-15T23:40:40Z,,0,0,0900006480bad93f
FDA-2000-P-0102-0015,FDA,FDA-2000-P-0102,"Tab 19 - ""FDA/CFSAN, New Dietary Ingredient Report 54 & 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,,,2010-12-15T23:49:01Z,,0,0,0900006480bad93e
FDA-2000-P-0102-0011,FDA,FDA-2000-P-0102,"Tab 1 - CFSAN, FDA-Letter of Enforcement Discretion from FDA to Cargill Health & Food Technologies. Docket No. FDA-2000-P-0102, Document ID DRAFT-0059 (Formerly 2000P-1275/LET3) & Docket No. FDA-2000-P-0133, Document ID DRAFT-0127 (Formerly 2000P-1276/LET4). February 14, 2003 - [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,,,2010-12-14T02:28:46Z,,0,0,0900006480bad901
FDA-2000-P-0102-0012,FDA,FDA-2000-P-0102,"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] - Background Material",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2010-12-14T02:28:47Z,,0,0,0900006480bad902
FDA-2000-P-0102-0010,FDA,FDA-2000-P-0102,"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] - Background Material",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2010-12-14T02:28:44Z,,0,0,0900006480baccd0
FDA-2000-P-0102-0013,FDA,FDA-2000-P-0102,"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,,,2010-12-14T02:28:49Z,,0,0,0900006480bad903
FDA-2000-P-0102-0014,FDA,FDA-2000-P-0102,"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,,,2010-12-14T02:41:43Z,,0,0,0900006480bad904
FDA-2000-P-0102-0008,FDA,FDA-2000-P-0102,"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] - Background Material",Supporting & Related Material,BKG- Background Material (internal references),2010-12-08T05:00:00Z,2010,12,,,2010-12-08T20:41:19Z,,0,0,0900006480baccce
FDA-2000-P-0102-0006,FDA,FDA-2000-P-0102,Food Labeling; Health Claims: 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,2011-02-23T04:59:59Z,2010-12-08T16:52:51Z,2010-30386,0,0,0900006480bb1f0b
FDA-2000-P-0102-0007,FDA,FDA-2000-P-0102,List of References - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease],Supporting & Related Material,BKG- Background Material (internal references),2010-12-08T05:00:00Z,2010,12,,,2011-02-15T22:30:41Z,,0,0,0900006480bad5e6
FDA-2000-P-0102-0009,FDA,FDA-2000-P-0102,"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] - Background Material",Supporting & Related Material,BKG- Background Material (internal references),2010-12-08T05:00:00Z,2010,12,,,2010-12-08T20:42:41Z,,0,0,0900006480bacccf
FDA-2000-P-0102-0026,FDA,FDA-2000-P-0102,"Tab 30 - ""Pelletier, et al., A Diet Moderately Enriched In Phytosterols Lowers Plasma Cholesterol Concentrations In Normocholesterolemic Humans - [Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-01T05:00:00Z,2010,12,,,2011-02-15T22:24:25Z,,0,0,0900006480badbbf
FDA-2000-P-0102-0005,FDA,FDA-2000-P-0102,Meeting on Smart Balance and Coronary Heart Disease,Other,MM-Memorandum of Meeting,2003-11-12T05:00:00Z,2003,11,,,2008-04-25T01:47:39Z,,0,0,09000064804c22ff
FDA-2000-P-0102-0004,FDA,FDA-2000-P-0102,FDA,Notice,NEC-Notice of Extension,2001-10-12T04:00:00Z,2001,10,2001-10-12T04:00:00Z,2001-11-20T04:59:59Z,2008-04-25T01:47:38Z,,0,0,09000064804c22da
FDA-2000-P-0102-0002,FDA,FDA-2000-P-0102,FDA,Notice,NIR-Notice of Interim Rule,2000-09-14T04:00:00Z,2000,9,2000-09-14T04:00:00Z,2000-11-23T04:59:59Z,2008-04-25T01:47:38Z,,0,0,09000064804c22b6
FDA-2000-P-0102-0003,FDA,FDA-2000-P-0102,FDA,Notice,NIR-Notice of Interim Rule,2000-09-14T04:00:00Z,2000,9,2000-09-14T04:00:00Z,2000-11-23T04:59:59Z,2008-04-25T01:47:39Z,,0,0,09000064804c22b7
FDA-2000-P-0102-0001,FDA,FDA-2000-P-0102,FDA,Notice,NIR-Notice of Interim Rule,2000-09-14T04:00:00Z,2000,9,2000-09-14T04:00:00Z,2000-11-23T04:59:59Z,2008-04-25T01:47:38Z,,0,0,09000064804c22ac