documents

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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

149,259 rows where agency_id = "FDA" and document_type = "Other" sorted by posted_date descending

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  • Other · 149,259 ✖

agency_id 1

  • FDA · 149,259 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-H-12248-0001 FDA DAB Civil Money Penalty; Wawa Florida, LLC d/b/a Wawa 5497 FDA-2026-H-12248 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T20:07:35Z   0 0 09000064b9671b11
FDA-2026-S-0024-0712 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000789 - LifeSeasons - LifeSeasons, Children's Calm + Focus Chewables - Behavior Support Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:39Z   0 0 09000064b966ae8e
FDA-2026-S-0024-0715 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000793 - Imana Health Inc - Muna oral probiotic - oral probiotic that supports vaginal health and immune function Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:00Z   0 0 09000064b966e2e8
FDA-2026-H-12245-0001 FDA DAB Civil Money Penalty; Dolgencorp, LLC d/b/a Dollar General 30967 FDA-2026-H-12245 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T21:43:36Z   0 0 09000064b9671d17
FDA-2026-H-12251-0001 FDA DAB Civil Money Penalty; Papo Mini Market LLC d/b/a Papo Mini Market LLC. FDA-2026-H-12251 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T22:09:38Z   0 0 09000064b9671d4b
FDA-2026-S-0024-0736 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000790 - Nestle Health Science - Multiple Claims (6) Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:47:25Z   0 0 09000064b966cb2c
FDA-2026-S-0024-0730 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000810 - Maharishi Ayurveda Products USA Inc - Multiple Claims (2) Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:29Z   0 0 09000064b966cfbd
FDA-2026-S-0024-0723 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000801 - TSI USA LLC - Tailored Script, Gymnema sylvestre - supports glucose metabolism Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:51Z   0 0 09000064b966d88c
FDA-2026-S-0024-0716 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000794 - Pharmavite LLC - Nature Made IRON + C & Bs capsules - C supports immune health & Bs support cellular energy Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:10Z   0 0 09000064b966e2ea
FDA-2026-S-0024-0720 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000798 - TSI USA LLC - Tailored Script, Ginkgo Biloba - supports healthy circulation and blood flow Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:31Z   0 0 09000064b966e2f2
FDA-2026-S-0024-0726 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000804 - TSI USA LLC - Tailored Script, Calcium hydroxyapatite - Supports bone health Supports dental health Supports calcium supplementation Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:08Z   0 0 09000064b966ea3d
FDA-2026-V-11784-0002 FDA Laser Light Show FDA-2026-V-11784 Acknowledgment Letter from FDA DMB to Connor Younge Other Acknowledgement Letter/Receipt 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T18:17:28Z   0 0 09000064b961e3b5
FDA-2026-V-11784-0003 FDA Laser Light Show FDA-2026-V-11784 Variance Approval Letter to Connor Younge Other Approval for Variance (VRA) 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T18:17:32Z   0 0 09000064b96692ab
FDA-2026-P-12447-0001 FDA Request that the FDA order manufacturers of all approved systemic fluroquinolone antibiotics (including ciprofloxacin, lavofloxacin, moxifloxacin, delafloxacin, and ofloxacin) to update their professional physician labeling and patient Medication Guides to achieve the following FDA-2026-P-12447 Citizen Petition from Charles Bennett Other Citizen Petition 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T19:31:41Z   1 0 09000064b966d233
FDA-2026-S-0024-0729 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000809 - CanPrev Natural Health Products Ltd - B9 Folate (5-MTHF + B12) - helps to maintain healthy metabolism Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:24Z   0 0 09000064b966cfbb
FDA-2026-S-0024-0724 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000802 - TSI USA LLC - Tailored Script, Chaste tree (Vitex agnus-castus) - supports female reproductive health Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:56Z   0 0 09000064b966d88e
FDA-2026-S-0024-0727 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000805 - Infirst Healthcare Inc - Mylicon, Children's Mylicon Nighttime Tummy Relief + Sleep - Helps with occasional upset stomach Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:14Z   0 0 09000064b966ea3f
FDA-2026-P-12607-0002 FDA Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C. Other Acknowledgement Letter/Receipt 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-16T00:48:03Z   0 0 09000064b9672ff0
FDA-2026-S-0024-0711 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000788 - LifeSeasons - LifeSeasons, Anxie-Teen Focus and Stress Chewables - Support occaisonal stress Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:34Z   0 0 09000064b966ae8c
FDA-2026-H-12253-0001 FDA DAB Civil Money Penalty; Yafa Services Inc. d/b/a Dale Road Drive Thru FDA-2026-H-12253 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T21:09:54Z   0 0 09000064b9671b21
FDA-2026-H-12246-0001 FDA DAB Civil Money Penalty; Mama Enterprise LLC d/b/a Exxon / Food Mart FDA-2026-H-12246 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T21:41:24Z   0 0 09000064b966e2f8
FDA-2026-H-12252-0001 FDA DAB Civil Money Penalty; Catherine Store Ventures LLC, d/b/a Catherine Store / Shell FDA-2026-H-12252 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T22:14:12Z   0 0 09000064b9671d5c
FDA-2026-P-12447-0002 FDA Request that the FDA order manufacturers of all approved systemic fluroquinolone antibiotics (including ciprofloxacin, lavofloxacin, moxifloxacin, delafloxacin, and ofloxacin) to update their professional physician labeling and patient Medication Guides to achieve the following FDA-2026-P-12447 Acknowledgment Letter from FDA DOD to Charles Bennett Other Acknowledgement Letter/Receipt 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T19:31:45Z   0 0 09000064b966d24a
FDA-2011-D-0611-0105 FDA Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry Other Guidance 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T19:50:39Z   1 0 09000064b9670307
FDA-2026-V-11618-0001 FDA Laser Light Show FDA-2026-V-11618 Variance Application from Ultimate Rush Floyd LLC Other Application for Variance (VAR) 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T18:20:20Z   0 0 09000064b95fcba4
FDA-2026-V-11784-0001 FDA Laser Light Show FDA-2026-V-11784 Variance Application from Connor Younge Other Application for Variance (VAR) 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T18:17:25Z   0 0 09000064b961e3b2
FDA-2026-S-0024-0706 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000782 - Haleon - Benefober Daily Prebiotic Fiber Gummies Berry Citrus Splash - support an environment for good digestive health Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:11Z   0 0 09000064b9658198
FDA-2026-S-0024-0713 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000791 - Iovate Health Sciences International Inc - Multiple Claims (7) Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:48Z   0 0 09000064b966cb2e
FDA-2026-S-0024-0719 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000797 - TSI USA LLC - Tailored Script, Tart Cherry - supports a healthy immune system Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:26Z   0 0 09000064b966e2f0
FDA-2026-S-0024-0734 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000814 - DOVITA NUTRITION HEALTH LLC - AIDEVI AKKERMANSIA 34 BILLION - METABOLIC BALANCE FORMULA Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:49Z   0 0 09000064b966e671
FDA-2026-S-0024-0728 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000808 - The Waterstreet Collective - Multiple Claims (4) Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:19Z   0 0 09000064b966ea41
FDA-2026-P-12607-0001 FDA Requests that the FDA declare that the drug product Diclofenac Sodium Topical Solution, 1.95%, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12607 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-16T00:47:59Z   1 0 09000064b9672fea
FDA-2022-V-2880-0004 FDA Laser Light Show FDA-2022-V-2880 Variance Renewal from California Pro Sound and Light Other Application for Variance (VAR) 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T19:38:24Z   0 0 09000064b9671aa1
FDA-2022-V-2880-0005 FDA Laser Light Show FDA-2022-V-2880 Variance Approval Letter from FDA CDRH to California Pro Sound And Light Other Acknowledgement Letter/Receipt 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T19:38:29Z   0 0 09000064b9671aaa
FDA-2026-H-12250-0001 FDA DAB Civil Money Penalty; Vallabh Krupa Inc. d/b/a Pilgrim Liquors FDA-2026-H-12250 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T22:33:11Z   0 0 09000064b9671c1c
FDA-2026-S-0024-0714 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000792 - Iovate Health Sciences International Inc - Multiple Claims (3) Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:55Z   0 0 09000064b966e2e6
FDA-2026-S-0024-0718 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000796 - Wella - Nioxin Pro Clinical Age Defense Supplement - promotes hair fullness and maintains hair color Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:19Z   0 0 09000064b966e2ee
FDA-2026-S-0024-0731 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000811 - DOVITA NUTRITION HEALTH LLC - AIDEVI WHITE TOMATO WHITENING PRO - enhances skin elasticity Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:34Z   0 0 09000064b966e66b
FDA-2026-P-12444-0002 FDA Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 Acknowledgment Letter from FDA DOD to John Kelser Other Acknowledgement Letter/Receipt 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T19:16:51Z   0 0 09000064b966d1a8
FDA-2026-V-11618-0002 FDA Laser Light Show FDA-2026-V-11618 Acknowledgment Letter from FDA DMB to Ultimate Rush Floyd LLC Other Acknowledgement Letter/Receipt 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T18:20:24Z   0 0 09000064b95fcba6
FDA-2026-S-0024-0705 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000781 - Herb Pharm - Herb Pharm, Oil of Oregano - supports the immune system Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:06Z   0 0 09000064b9653ed1
FDA-2026-S-0024-0708 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000784 - Transformative Learning Pte Ltd - HERBUS, Shilajit - Support healthy Menopause Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:19Z   0 0 09000064b96642a5
FDA-2026-S-0024-0709 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000786 - Soi Health LLC - Soi Health, SO I DON'T BARF- fast- acting support for occasional stomach discomfort Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:23Z   0 0 09000064b96642bc
FDA-2026-S-0024-0710 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000787 - LifeSeasons - LifeSeasons, Children's Eye + Brain Chewables - Learning Support Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:28Z   0 0 09000064b9668ede
FDA-2026-S-0024-0722 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000800 - TSI US LLC - Tailored Script, St. John's Wort - supports mood Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:47Z   0 0 09000064b966d88a
FDA-2026-S-0024-0725 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000803 - TSI USA LLC - Tailored Script, NMN (Nicotinamide mononucleotide) - Supports NAD+ metabolism Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:02Z   0 0 09000064b966d890
FDA-2026-S-0024-0717 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000795 - Pharmavite LLC - Nature Made NAD+ Booster capsules - increased NAD+ in blood cells vs placebo Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:15Z   0 0 09000064b966e2ec
FDA-2026-S-0024-0732 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000812 - DOVITA NUTRITION HEALTH LLC - AIDEVI LIVER HEALTH ULTRA - DETOX & REPAIR Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:39Z   0 0 09000064b966e66d
FDA-2026-S-0024-0733 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000813 - DOVITA NUTRITION HEALTH LLC - AIDEVI NAD+ SUSTAIN - boosts NAD+ levels Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:43Z   0 0 09000064b966e66f
FDA-2026-V-11618-0003 FDA Laser Light Show FDA-2026-V-11618 Variance Approval Letter to Ultimate Rush Floyd, LLC Other Approval for Variance (VRA) 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T18:20:27Z   0 0 09000064b9664350
FDA-2026-P-12444-0001 FDA Request that the FDA Establish an Independent Heath Safety Investigation Board with Replay-Analysis Authority for Systemic Review of Regulatory Failures in the Oversight of Foods, Drugs, Biological Products, and Medical Devices FDA-2026-P-12444 Citizen Petition from John Kelser Other Citizen Petition 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T19:16:47Z   1 0 09000064b966d19e
FDA-2026-H-12247-0001 FDA DAB Civil Money Penalty; Winn-Dixie Stores, LLC d/b/a Winn-Dixie 191 FDA-2026-H-12247 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T21:52:47Z   0 0 09000064b9671b34
FDA-2026-H-12249-0001 FDA DAB Civil Money Penalty; BJ and George Inc. d/b/a Northside Food Store FDA-2026-H-12249 Complaint Other Complaint 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T22:26:28Z   0 0 09000064b9673209
FDA-2026-S-0024-0707 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000783 - M D PH NATURAL HEALTH LTD - Made Organics Fluid Balance - Supports healthy fluid balance and gentle water balance regulation in the body Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:44:16Z   0 0 09000064b96642a3
FDA-2026-S-0024-0721 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000799 - TSI USA LLC - Olive Leaf Extract - provides antioxidant support Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:45:39Z   0 0 09000064b966e2f4
FDA-2026-S-0024-0735 FDA 30-Day Structure Function Claim Letters, Dietary Supplements_2026 FDA-2026-S-0024 2026-000815 - DOVITA NUTRITION HEALTH LLC - AIDEVI MENOPAUSE SUPPORT - Hormone-Balancing Other 30 Day Structured Function Claim 2026-10-15T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T23:46:56Z   0 0 09000064b966e673
FDA-2026-H-12018-0001 FDA DAB Civil Money Penalty; Cleopatra L. Dixon d/b/a Hwy 188 Quick Stop FDA-2026-H-12018 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T18:12:00Z   0 0 09000064b966ae92
FDA-2026-P-12386-0001 FDA Requests that the FDA to determine whether the Reference Listed Drug (RLD) URSO 250 and URSO FORTE (Ursodiol) Tablets, 250 mg and 500 mg under New Drug Application (NDA) 020675 held by ABBVIE INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons FDA-2026-P-12386 Citizen Petition from Strides Pharma, Inc. Other Citizen Petition 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T15:21:56Z   1 0 09000064b9668ef0
FDA-2026-P-12446-0002 FDA Requests that the FDA declare that Diclofenac Sodium Topical Solution, 1.6%, is suitable for submission as an ANDA FDA-2026-P-12446 Acknowledgement Letter from FDA DOD to Hyman, Phelps & McNamara, P.C. Other Acknowledgement Letter/Receipt 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-15T00:13:52Z   0 0 09000064b9663ed7
FDA-2026-P-11249-0007 FDA Request that the FDA declare that the drug products Furosemide Capsules, 20 mg, 40 mg, and 80 mg, are suitable for consideration in an Abbreviated New Drug Application (ANDA) FDA-2026-P-11249 Completeness Assessment Correspondence to Hyman, Phelps & McNamara, P.C. Other Assessment Document or Analysis 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-15T01:37:06Z   0 0 09000064b96643f3
FDA-2026-P-5994-0007 FDA Requests that FDA declare that Rosuvastatin Calcium Tablets, 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg, are suitable for submission as an ANDA. FDA-2026-P-5994 Final Response Other Letter(s) 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-15T00:44:10Z   0 0 09000064b966a3fa
FDA-2026-H-12122-0001 FDA DAB Civil Money Penalty; Malahee Gas Inc. d/b/a Mobil FDA-2026-H-12122 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T20:27:43Z   0 0 09000064b966ccad
FDA-2026-H-11929-0001 FDA DAB Civil Money Penalty; Smoke Kings Inc. d/b/a Smoke Kings FDA-2026-H-11929 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T20:16:42Z   0 0 09000064b966fcf8
FDA-2026-H-12014-0001 FDA DAB Civil Money Penalty; The Empire Stores, LLC d/b/a Empire Smoke Shop FDA-2026-H-12014 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-15T04:00:00Z   2026-10-15T20:18:15Z   0 0 09000064b96718f0
FDA-2026-F-2048-0006 FDA Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use) FDA-2026-F-2048 Finding of No Significant Impact (FONSI) in support of a Food Additive Petition (FAP) for chromium propionate in layer and breeding chickens as a supplemental source of chromium Kemin Industries, Inc. Other Additional Information 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T19:07:53Z   0 0 09000064b966d950
FDA-2026-P-12386-0002 FDA Requests that the FDA to determine whether the Reference Listed Drug (RLD) URSO 250 and URSO FORTE (Ursodiol) Tablets, 250 mg and 500 mg under New Drug Application (NDA) 020675 held by ABBVIE INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons FDA-2026-P-12386 Acknowledgment Letter from FDA DOD to Strides Pharma, Inc. Other Acknowledgement Letter/Receipt 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T15:22:01Z   0 0 09000064b9668ef2
FDA-2026-P-12446-0001 FDA Requests that the FDA declare that Diclofenac Sodium Topical Solution, 1.6%, is suitable for submission as an ANDA FDA-2026-P-12446 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-15T00:06:00Z   1 0 09000064b9663ed6
FDA-2026-H-12121-0001 FDA DAB Civil Money Penalty; Pekin Liquor & Food LLC d/b/a Ace Liquors FDA-2026-H-12121 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T20:14:59Z   0 0 09000064b966cc63
FDA-2026-H-11922-0001 FDA DAB Civil Money Penalty; The Smoking Club LLC d/b/a Smoking Club Smoke Shop FDA-2026-H-11922 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T18:03:00Z   0 0 09000064b9657071
FDA-2026-H-12016-0001 FDA DAB Civil Money Penalty; Tulsi Enterprises LLC d/b/a Midway Truck Stop FDA-2026-H-12016 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T18:03:54Z   0 0 09000064b966cb32
FDA-2026-H-12021-0001 FDA DAB Civil Money Penalty; Sami Eskandar, d/b/a Blend Smoke Shop FDA-2026-H-12021 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-15T00:00:19Z   0 0 09000064b966d25d
FDA-2026-H-12181-0001 FDA DAB Civil Money Penalty; Kaizen Food and Gas LLC d/b/a Food Center / Marathon FDA-2026-H-12181 Complaint Other Complaint 2026-10-14T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T21:39:18Z   0 0 09000064b966d1fa
FDA-2026-H-12113-0001 FDA DAB Civil Money Penalty; Hudson Food Stores, Inc. d/b/a 4 Corners Package Store FDA-2026-H-12113 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T16:41:40Z   0 0 09000064b966c7e3
FDA-2026-H-12117-0001 FDA DAB Civil Money Penalty; MB Palm Beach Inc. d/b/a Orion Fuels FDA-2026-H-12117 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T18:00:26Z   0 0 09000064b966c863
FDA-2026-H-12118-0001 FDA DAB Civil Money Penalty; Casey's Retail Company d/b/a Casey's General Store 2158 FDA-2026-H-12118 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T18:03:07Z   0 0 09000064b966c875
FDA-2026-H-11947-0001 FDA DAB Civil Money Penalty; Midway Market LLC, d/b/a Tillmans Corner Chevron FDA-2026-H-11947 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-14T00:23:32Z   0 0 09000064b9668ea5
FDA-2026-P-12350-0002 FDA Request the FDA determine whether the Reference Listed Drug (RLD) BROMFED-DM (BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE) Oral Syrup, 2 mg/5 mL, 10 mg/5 mL, 30 mg/5 mL; under Abbreviated New Drug Application (ANDA) 088811 held by PHARMOBEDIENT CONSULTING LLC, was voluntarily withdrawn from commercial FDA-2026-P-12350 Acknowledgment Letter from FDA DOD to Strides Pharma, Inc. Other Acknowledgement Letter/Receipt 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-13T23:19:40Z   0 0 09000064b966410a
FDA-2026-H-12017-0001 FDA DAB Civil Money Penalty; Millennium Petroleum II, LLC d/b/a 76 FDA-2026-H-12017 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T18:05:49Z   0 0 09000064b9664400
FDA-2026-H-11665-0001 FDA DAB Civil Money Penalty; Rollin Cloudz Vape, LLC d/b/a Cloudz Vape FDA-2026-H-11665 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T21:48:47Z   0 0 09000064b966dcb2
FDA-2026-H-11585-0001 FDA DAB Civil Money Penalty; Michael Mattern and Jeremy Olds d/b/a Twenty Past 4 FDA-2026-H-11585 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T20:54:37Z   0 0 09000064b966d5eb
FDA-2026-P-12383-0001 FDA Requests that the FDA use one or more lawful mechanisms to require or secure a postmarketing evidence-generation program that includes the following components: Postmarketing studies and a National Patient Registry. FDA-2026-P-12383 Citizen Petition from Antidepressant Coalition for Education Other Citizen Petition 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-14T04:03:21Z   1 0 09000064b9668e76
FDA-2026-P-12383-0002 FDA Requests that the FDA use one or more lawful mechanisms to require or secure a postmarketing evidence-generation program that includes the following components: Postmarketing studies and a National Patient Registry. FDA-2026-P-12383 Acknowledgement Letter from FDA DMB to Antidepressant Coalition for Education Other Acknowledgement Letter/Receipt 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-14T04:03:27Z   0 0 09000064b9668e78
FDA-2024-V-5106-0004 FDA Laser Light Show FDA-2024-V-5106 Variance Renewal Application from Izakaya LLC Other Application for Variance (VAR) 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-13T23:15:09Z   0 0 09000064b964f969
FDA-2026-P-12080-0001 FDA Requests that the FDA declare that the drug product Metformin HCL Oral Solution, 1,000 mg/15 mL, is suitable for consideration in an Abbreviated New Drug Application. FDA-2026-P-12080 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-13T16:26:56Z   1 0 09000064b964de38
FDA-2026-H-12112-0001 FDA DAB Civil Money Penalty; Sarsak Star Inc. d/b/a Palm Beach Vapors FDA-2026-H-12112 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T16:35:19Z   0 0 09000064b966caaa
FDA-2026-H-11923-0001 FDA DAB Civil Money Penalty; 7-Eleven, Inc. d/b/a 7-Eleven 40373A / Sunoco FDA-2026-H-11923 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-14T00:23:13Z   0 0 09000064b9658251
FDA-2026-H-11949-0001 FDA DAB Civil Money Penalty; Sama, Inc., d/b/a Prime Wine & Spirits FDA-2026-H-11949 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T16:33:31Z   0 0 09000064b9664349
FDA-2026-H-11950-0001 FDA DAB Civil Money Penalty; M & M 7 LLC d/b/a M & M Mart FDA-2026-H-11950 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T16:34:25Z   0 0 09000064b9668de5
FDA-2024-D-2581-0011 FDA Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability FDA-2024-D-2581 Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers; Guidance for Industry Other Guidance 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-13T20:17:10Z   1 0 09000064b9664250
FDA-2026-P-12379-0001 FDA Requests that the FDA issue an order exempting from premarket notification, subject to conditions, a defined subgroup of sunlamp products classified under 21 CFR 878.4635. FDA-2026-P-12379 Citizen Petition from Eternal Vitality Ventures, LLC Other Citizen Petition 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-13T22:58:45Z   1 0 09000064b9664279
FDA-2026-H-12022-0001 FDA DAB Civil Money Penalty; Holiday Stationstores, LLC, d/b/a Holiday Station 141 / Circle K FDA-2026-H-12022 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-14T00:24:03Z   0 0 09000064b966432d
FDA-2026-H-11948-0001 FDA DAB Civil Money Penalty; Fayette Express Mart Inc, d/b/a Tobacco & Vape Shop FDA-2026-H-11948 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-14T00:23:40Z   0 0 09000064b9668eab
FDA-2026-H-12124-0001 FDA DAB Civil Money Penalty;Kroger Limited Partnership I d/b/a Kroger Fuel Center 923 FDA-2026-H-12124 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-13T04:00:00Z   2026-10-14T00:24:36Z   0 0 09000064b9668eda
FDA-2026-H-11592-0001 FDA DAB Civil Money Penalty; Two Sons Flint Inc. d/b/a Liquor Plus Mini Mart FDA-2026-H-11592 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T18:15:49Z   0 0 09000064b966c7e9
FDA-2026-H-12182-0001 FDA DAB Civil Money Penalty; 2000 Springfield Rd Quickstop Inc. d/b/a Phillips 66 FDA-2026-H-12182 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T21:40:22Z   0 0 09000064b966ae9d
FDA-2026-H-12023-0001 FDA DAB Civil Money Penalty; First Street Gas & Convenience LLC, d/b/a Phillips 66 FDA-2026-H-12023 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T21:36:51Z   0 0 09000064b966cc49
FDA-2026-H-12183-0001 FDA DAB Civil Money Penalty; Pekin Liquor & Food, LLC d/b/a Ace Liquors FDA-2026-H-12183 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T21:43:30Z   0 0 09000064b966ccf3
FDA-2026-H-12180-0001 FDA DAB Civil Money Penalty; Blazing Ape & Vape / Delta 8 Inc. d/b/a Blazing Ape Vape & Smoke Shop FDA-2026-H-12180 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T21:35:18Z   0 0 09000064b966d1f2
FDA-2026-H-12119-0001 FDA DAB Civil Money Penalty; Washington Smoke & Vape Inc. d/b/a Smoke Zone Vape and Tobacco FDA-2026-H-12119 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T21:45:10Z   0 0 09000064b966cc5f
FDA-2026-H-12114-0001 FDA DAB Civil Money Penalty; J & A Vape Shop 6 Inc. d/b/a JA Convenience Exotics / Cigar Tobacco Shop FDA-2026-H-12114 Complaint Other Complaint 2026-10-13T04:00:00Z 2026 10 2026-10-14T04:00:00Z   2026-10-14T16:43:32Z   0 0 09000064b966cab0

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;