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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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44 rows where docket_id = "FDA-2006-P-0033" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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 Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);