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withdrawn,object_id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-2006-P-0033-0069,FDA,FDA-2006-P-0033,Petition Response Letter from FDA CDER to Mr Raubicheck  on behalf of Pharmachem Laboratories Inc.,Other,Letter(s),2022-05-31T04:00:00Z,2022,5,2022-05-31T04:00:00Z,,2022-05-31T14:50:00Z,,0,0,09000064846af6a2
FDA-2006-P-0033-0067,FDA,FDA-2006-P-0033,"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,,2020-05-26T18:17:10Z,,0,0,09000064846aeba2
FDA-2006-P-0033-0066,FDA,FDA-2006-P-0033,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,,2020-05-26T18:16:55Z,,0,0,09000064846aeb9d
FDA-2006-P-0033-0068,FDA,FDA-2006-P-0033,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,,2020-05-26T18:22:20Z,,0,0,09000064846af529
FDA-2006-P-0033-0064,FDA,FDA-2006-P-0033,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,2012-02-23T13:16:18Z,2012-03940,0,0,0900006480fbedec
FDA-2006-P-0033-0055,FDA,FDA-2006-P-0033,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,2011-08-11T14:47:58Z,2011-20406,0,0,0900006480eddb34
FDA-2006-P-0033-0051,FDA,FDA-2006-P-0033,"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,,0,0,0900006480c0df47
FDA-2006-P-0033-0050,FDA,FDA-2006-P-0033,"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,,2013-08-11T01:40:39Z,,0,0,0900006480c1056b
FDA-2006-P-0033-0049,FDA,FDA-2006-P-0033,"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,,0,0,0900006480bfae2d
FDA-2006-P-0033-0048,FDA,FDA-2006-P-0033,"Exhibit D - ""Kevin C. Maki, Ph.D. - Curriculum Vitae""  [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2006-P-0033-0045",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T22:58:44Z,,0,0,0900006480c0084e
FDA-2006-P-0033-0047,FDA,FDA-2006-P-0033,"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-2006-P-0033-0045",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T22:59:53Z,,0,0,0900006480c0084c
FDA-2006-P-0033-0045,FDA,FDA-2006-P-0033,"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,,1,0,0900006480bfae2a
FDA-2006-P-0033-0046,FDA,FDA-2006-P-0033,"Exhibit A - ""Container and Carton Label for Nature Made® Cholestoff®"" - [Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition] re FDA-2006-P-0033-0045",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2011-03-04T05:00:00Z,2011,3,,,2011-03-04T22:58:40Z,,0,0,0900006480c0084a
FDA-2006-P-0033-0038,FDA,FDA-2006-P-0033,"Exhibit D - ""Kevin C. Maki, Ph.D. - Curriculum Vitae"" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2006-P-0033-0035",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T20:22:32Z,,0,0,0900006480bfd1d8
FDA-2006-P-0033-0035,FDA,FDA-2006-P-0033,"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,,2024-11-07T22:28:44Z,,1,0,0900006480bfa44c
FDA-2006-P-0033-0037,FDA,FDA-2006-P-0033,"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-2006-P-0033-0035",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T20:22:30Z,,0,0,0900006480bfa463
FDA-2006-P-0033-0036,FDA,FDA-2006-P-0033,"Exhibit A - ""Container and Carton Label for Nature Made® Cholestoff®"" - [Pharmavite LLC - Petition for Stay of Action] re FDA-2006-P-0033-0035",Supporting & Related Material,PSA- Petition for Stay (Supporting and Related Material),2011-03-02T05:00:00Z,2011,3,,,2011-03-02T20:22:28Z,,0,0,0900006480bfa45f
FDA-2006-P-0033-0039,FDA,FDA-2006-P-0033,"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,,2013-07-27T23:46:08Z,,0,0,0900006480bfa45b
FDA-2006-P-0033-0031,FDA,FDA-2006-P-0033,"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-2006-P-0033-0029",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:12:13Z,,0,0,0900006480bfadfd
FDA-2006-P-0033-0030,FDA,FDA-2006-P-0033,"Attachment 4 - ""On Nutrition and Health Claims Made on Food"" - [Innoceutics bvba-llC University of Ghent - Comment] re FDA-2006-P-0033-0029",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:12:12Z,,0,0,0900006480bfadfc
FDA-2006-P-0033-0032,FDA,FDA-2006-P-0033,"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-2006-P-0033-0029",Supporting & Related Material,C-Comment (Supporting and Related Material),2011-02-28T05:00:00Z,2011,2,,,2011-02-28T22:12:15Z,,0,0,0900006480bfadfe
FDA-2006-P-0033-0033,FDA,FDA-2006-P-0033,"Unilever United States, Inc - Supplement",Other,SUP-Supplement,2011-02-28T05:00:00Z,2011,2,2011-02-28T05:00:00Z,,2011-02-28T22:19:20Z,,0,0,090000648044211c
FDA-2006-P-0033-0028,FDA,FDA-2006-P-0033,"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] re FDA-2006-P-0033-0027",Supporting & Related Material,BKG-Background Material,2011-02-18T05:00:00Z,2011,2,,,2011-02-28T20:53:35Z,,0,0,0900006480bf1444
FDA-2006-P-0033-0027,FDA,FDA-2006-P-0033,"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,2011-02-28T21:08:27Z,2011-3678,0,0,0900006480bf2522
FDA-2006-P-0033-0025,FDA,FDA-2006-P-0033,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,,0,0,0900006480befd95
FDA-2006-P-0033-0022,FDA,FDA-2006-P-0033,"Acknowledgement Letter to Fommer Lawrence & Haug LLP (Pharmachem Laboratories, Inc.)",Other,ACK-Acknowledgement Letter,2011-02-08T05:00:00Z,2011,2,2011-02-08T05:00:00Z,,2011-02-08T12:58:21Z,,0,0,0900006480bd7030
FDA-2006-P-0033-0021,FDA,FDA-2006-P-0033,"Fommer Lawrence & Haug LLP (Pharmachem Laboratories, Inc.) - Petition for Stay of Action",Other,PSA-Petition for Stay,2011-02-08T05:00:00Z,2011,2,2011-02-08T05:00:00Z,,2011-02-08T12:58:02Z,,0,0,0900006480bd702d
FDA-2006-P-0033-0018,FDA,FDA-2006-P-0033,Acknowledgement Letter to Covington & Burling (Cargill Inc.),Other,ACK-Acknowledgement Letter,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2011-01-10T22:37:53Z,,0,0,0900006480bc861f
FDA-2006-P-0033-0017,FDA,FDA-2006-P-0033,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,,2024-11-12T04:58:58Z,,1,0,0900006480bc861d
FDA-2006-P-0033-0016,FDA,FDA-2006-P-0033,Council for Responsible Nutrition - Letter,Other,LET-Letter,2011-01-10T05:00:00Z,2011,1,2011-01-10T05:00:00Z,,2013-07-27T23:42:03Z,,0,0,0900006480bc861a
FDA-2006-P-0033-0015,FDA,FDA-2006-P-0033,"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,,,2010-12-15T23:42:56Z,,0,0,0900006480bb7ecc
FDA-2006-P-0033-0014,FDA,FDA-2006-P-0033,"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,,,2010-12-15T23:47:24Z,,0,0,0900006480bb7ea6
FDA-2006-P-0033-0008,FDA,FDA-2006-P-0033,"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),2010-12-13T05:00:00Z,2010,12,,,2010-12-14T02:56:46Z,,0,0,0900006480bb2421
FDA-2006-P-0033-0013,FDA,FDA-2006-P-0033,"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,,,2010-12-14T02:56:54Z,,0,0,0900006480bb54e7
FDA-2006-P-0033-0011,FDA,FDA-2006-P-0033,"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,,,2010-12-14T02:56:51Z,,0,0,0900006480bb54e3
FDA-2006-P-0033-0010,FDA,FDA-2006-P-0033,"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,,,2010-12-14T02:56:49Z,,0,0,0900006480bb246a
FDA-2006-P-0033-0012,FDA,FDA-2006-P-0033,"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,,,2010-12-14T02:56:52Z,,0,0,0900006480bb54e5
FDA-2006-P-0033-0009,FDA,FDA-2006-P-0033,"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, Notice of Proposed Rule-BKG]",Supporting & Related Material,BKG- Background Material (internal references),2010-12-13T05:00:00Z,2010,12,,,2010-12-14T02:56:47Z,,0,0,0900006480bb2455
FDA-2006-P-0033-0007,FDA,FDA-2006-P-0033,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,,,2010-12-14T02:56:44Z,,0,0,0900006480bb241f
FDA-2006-P-0033-0006,FDA,FDA-2006-P-0033,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,2011-02-23T04:59:59Z,2010-12-08T19:55:40Z,,0,0,0900006480bb1ba2
FDA-2006-P-0033-0004,FDA,FDA-2006-P-0033,"Unilever United States, Inc - Citizen Petition",Other,CP-Citizen Petition,2009-03-16T04:00:00Z,2009,3,2009-03-16T04:00:00Z,,2009-03-16T19:54:56Z,,0,0,090000648044210a
FDA-2006-P-0033-0003,FDA,FDA-2006-P-0033,"Unilever United States, Inc. - Letter",Other,LET-Letter,2008-11-18T05:00:00Z,2008,11,2008-11-18T05:00:00Z,,2008-11-18T16:16:44Z,,0,0,09000064807a9e74
FDA-2006-P-0033-0001,FDA,FDA-2006-P-0033,"FDA/CFSAN to Unilever United States, Inc",Other,ACK-Acknowledgement Letter,2006-08-21T04:00:00Z,2006,8,,,2008-04-11T23:17:26Z,,0,0,09000064804420e3
FDA-2006-P-0033-0002,FDA,FDA-2006-P-0033,"FDA/CFSAN to Unilever United States, Inc",Other,LET-Letter,2006-08-21T04:00:00Z,2006,8,,,2008-04-11T23:17:26Z,,0,0,090000648044211f