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withdrawn,object_id FDA-2021-V-1357-0002,FDA,FDA-2021-V-1357,Acknowledgment Letter from FDA DMS to Sober Sound,Other,Acknowledgement Letter/Receipt,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T13:49:09Z,,0,0,0900006484f009ff FDA-2021-V-1293-0003,FDA,FDA-2021-V-1293,Variance Approval Letter from FDA CDRH to Supercalibrations,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:38:29Z,,0,0,0900006484f013f6 FDA-2021-V-1359-0002,FDA,FDA-2021-V-1359,Acknowledgment Letter from FDA DMS to Washington University,Other,Acknowledgement Letter/Receipt,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:47:06Z,,0,0,0900006484f0126d FDA-2021-V-1278-0003,FDA,FDA-2021-V-1278,Variance Approval Letter from FDA CDRH to Tranquility Zone LLP,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:22:59Z,,0,0,0900006484f01397 FDA-2021-V-1267-0003,FDA,FDA-2021-V-1267,Variance Approval Letter from FDA CDRH to Garrett Mcgrath,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:16:17Z,,0,0,0900006484f01300 FDA-2021-V-1276-0003,FDA,FDA-2021-V-1276,Variance Approval Letter from FDA CDRH to Custom Audio and Lighting,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:17:33Z,,0,0,0900006484f01341 FDA-2021-V-1282-0003,FDA,FDA-2021-V-1282,Variance Approval Letter from FDA CDRH to Systems Design and Integration Inc,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:26:45Z,,0,0,0900006484f0139e FDA-2021-V-1359-0001,FDA,FDA-2021-V-1359,Variance Application from Washington University,Other,Application for Variance (VAR),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:45:51Z,,0,0,0900006484f0126b FDA-2021-V-1264-0003,FDA,FDA-2021-V-1264,Variance Approval Letter from FDA CDRH to Hendo Studios,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:34:29Z,,0,0,0900006484f0133d FDA-2021-V-1303-0003,FDA,FDA-2021-V-1303,Variance Approval Letter from FDA CDRH to DTX Digital Theater Experts,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:41:38Z,,0,0,0900006484f013fb FDA-2021-V-1304-0003,FDA,FDA-2021-V-1304,Variance Approval Letter from FDA CDRH to Lunarhive LLC,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:31:10Z,,0,0,0900006484f013b5 FDA-2021-V-1307-0003,FDA,FDA-2021-V-1307,Variance Approval Letter from FDA CDRH to The Experts,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:44:30Z,,0,0,0900006484f013fe FDA-2021-V-1291-0003,FDA,FDA-2021-V-1291,Variance Approval Letter from FDA CDRH to Automated Living Inc,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:34:23Z,,0,0,0900006484f013da FDA-2021-V-1270-0003,FDA,FDA-2021-V-1270,Variance Approval Letter from FDA CDRH to Executive Electronics,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:42:43Z,,0,0,0900006484f013fa FDA-2021-V-1360-0001,FDA,FDA-2021-V-1360,Variance Application from William Potter,Other,Application for Variance (VAR),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:47:19Z,,0,0,0900006484f012f7 FDA-2021-V-1357-0001,FDA,FDA-2021-V-1357,Variance Application from Sober Sound,Other,Application for Variance (VAR),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T13:39:38Z,,0,0,0900006484f009f9 FDA-2021-V-1295-0003,FDA,FDA-2021-V-1295,Variance Approval Letter from FDA CDRH to Travel Marquette,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T18:12:01Z,,0,0,0900006484f019ce FDA-2021-V-1360-0002,FDA,FDA-2021-V-1360,Acknowledgment Letter from FDA DMS to William Potter,Other,Acknowledgement Letter/Receipt,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:49:47Z,,0,0,0900006484f012f9 FDA-2021-V-1257-0003,FDA,FDA-2021-V-1257,Variance Approval Letter from FDA CDRH to Nick Glover,Other,Approval for Variance (VRA),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T20:54:12Z,,0,0,0900006484f009a5 FDA-2021-N-0874-0052,FDA,FDA-2021-N-0874,Intarcia Letter to Office of the Commissioner,Other,Letter(s),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T13:57:57Z,,0,0,0900006484f0006f FDA-2021-V-1355-0001,FDA,FDA-2021-V-1355,Variance Application from Sean Chaney,Other,Application for Variance (VAR),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T14:41:36Z,,0,0,0900006484f00033 FDA-2021-V-1256-0003,FDA,FDA-2021-V-1256,Variance Approval Letter from FDA CDRH to Jonathan Bixler,Other,Approval for Variance (VRA),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T20:59:18Z,,0,0,0900006484f009fb FDA-2021-V-1355-0002,FDA,FDA-2021-V-1355,Acknowledgment Letter from FDA DMS to Sean Chaney,Other,Acknowledgement Letter/Receipt,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T14:38:33Z,,0,0,0900006484f00069 FDA-2021-P-0895-0003,FDA,FDA-2021-P-0895,Petition Response from FDA CDER to Eagle Pharmaceuticals,Other,Agency Response,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T13:27:34Z,,0,0,0900006484f0002f FDA-2021-V-1187-0003,FDA,FDA-2021-V-1187,Variance Approval Letter from FDA CDRH to RK Lighting LLC,Other,Approval for Variance (VRA),2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:21:26Z,,0,0,0900006484efec8f FDA-2021-V-1290-0003,FDA,FDA-2021-V-1290,Variance Approval Letter from FDA CDRH to Sergio Rangel,Other,Approval for Variance (VRA),2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:35:41Z,,0,0,0900006484eff191 FDA-2015-N-3534-0302,FDA,FDA-2015-N-3534,Nomination from College Pharmacy,Other,Nomination,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T15:34:37Z,,0,0,0900006484ed3d53 FDA-2021-D-0367-0002,FDA,FDA-2021-D-0367,Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) Draft Compliance Policy Guide Guidance for FDA Staff,Other,Guidance,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,2022-04-15T03:59:59Z,2025-07-16T09:00:27Z,,1,0,0900006484efdb70 FDA-2021-V-1220-0003,FDA,FDA-2021-V-1220,Variance Approval from FDA CDRH to Na’cho Production and Design LLC,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:04:08Z,,0,0,0900006484efd942 FDA-2021-V-1315-0003,FDA,FDA-2021-V-1315,Variance Approval from FDA CDRH to Tobin Tanner Designs,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:55:49Z,,0,0,0900006484efd980 FDA-2021-V-1235-0003,FDA,FDA-2021-V-1235,Variance Approval from FDA CDRH to Christopher Kent,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:32:03Z,,0,0,0900006484efd947 FDA-2019-D-2330-0035,FDA,FDA-2019-D-2330,Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry,Other,Guidance,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2024-11-12T23:35:32Z,,1,0,0900006484efda35 FDA-2021-P-1354-0001,FDA,FDA-2021-P-1354,Citizen Petition from Cardinal Health Regulatory Sciences,Other,Citizen Petition,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2022-04-13T14:35:43Z,,0,0,0900006484efd9a0 FDA-2021-V-1259-0003,FDA,FDA-2021-V-1259,Variance Approval from FDA CDRH to A Bright Idea,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:52:03Z,,0,0,0900006484efd97e FDA-2021-V-1237-0003,FDA,FDA-2021-V-1237,Variance Approval from FDA CDRH to Chris Andrews,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:37:14Z,,0,0,0900006484efd21a FDA-2021-V-0905-0003,FDA,FDA-2021-V-0905,"Variance Approval from FDA CDRH to Orange Coast College Planetarium, Orange Coast College",Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T18:44:38Z,,0,0,0900006484efe147 FDA-2021-P-1354-0002,FDA,FDA-2021-P-1354,Acknowledgment Letter from FDA DMS to Cardinal Health Regulatory Sciences,Other,Acknowledgement Letter/Receipt,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T18:24:22Z,,0,0,0900006484efdb74 FDA-2020-D-1118-0007,FDA,FDA-2020-D-1118,"Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2024-11-12T23:35:29Z,,1,0,0900006484efdb6c FDA-2021-V-1242-0003,FDA,FDA-2021-V-1242,Variance Approval from FDA CDRH to BIOPTIMIZERS USA INC,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:42:09Z,,0,0,0900006484efd21c FDA-2015-N-3469-0352,FDA,FDA-2015-N-3469,Nomination from OUTSOURCING FACILITIES ASSOCIATION,Other,Nomination,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T14:59:56Z,,0,0,0900006484ee8292 FDA-2021-V-1324-0003,FDA,FDA-2021-V-1324,Variance Approval from FDA CDRH to AVIO Inc,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:46:01Z,,0,0,0900006484efd949 FDA-2021-H-1342-0001,FDA,FDA-2021-H-1342,Complaint,Other,Complaint,2021-12-27T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T12:46:41Z,,0,0,0900006484efe26d FDA-2021-V-1218-0003,FDA,FDA-2021-V-1218,Variance Approval from FDA CDRH to NPI Audio Visual Solutions,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:23:37Z,,0,0,0900006484efd945 FDA-2021-D-1128-0002,FDA,FDA-2021-D-1128,"Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; DRAFT GUIDANCE",Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-24T03:59:59Z,2023-12-22T15:31:03Z,,0,0,0900006484ee7ccb FDA-2018-P-4664-0004,FDA,FDA-2018-P-4664,Withdrawal from Fresenius Kabi USA LLC,Other,Withdrawal,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:38:00Z,,0,0,0900006484ed3736 FDA-2021-V-1345-0002,FDA,FDA-2021-V-1345,Acknowledgement Letter from FDA DMS to Vincent Lighting Systems Company,Other,Acknowledgement Letter/Receipt,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:48:58Z,,0,0,0900006484ee28af FDA-2021-V-1344-0002,FDA,FDA-2021-V-1344,Acknowledgement Letter from FDA DMS to Rockstar Production Events LLC,Other,Acknowledgement Letter/Receipt,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:44:36Z,,0,0,0900006484ee3970 FDA-2021-P-1347-0002,FDA,FDA-2021-P-1347,Acknowledgment Letter from FDA DMS to Americans for Responsible Technology,Other,Acknowledgement Letter/Receipt,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-27T14:00:51Z,,0,0,0900006484ee57bc FDA-2021-D-1031-0007,FDA,FDA-2021-D-1031,Request for Extension from International Society for Pharmaceutical Engineering (ISPE),Other,Request for Extension,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T18:01:27Z,,0,0,0900006484ed0634 FDA-2019-P-2687-0004,FDA,FDA-2019-P-2687,Withdrawal from AuroMedics Pharma LLC on behalf of Aurobindo Pharma Ltd.,Other,Withdrawal,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:45:27Z,,0,0,0900006484ec86ae FDA-2020-D-1118-0005,FDA,FDA-2020-D-1118,Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH); Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-27T16:53:22Z,,0,0,0900006484ee91b6 FDA-2019-D-5606-0005,FDA,FDA-2019-D-5606,Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2024-11-07T00:35:31Z,,1,0,0900006484ee7ccd FDA-2021-P-1347-0001,FDA,FDA-2021-P-1347,Citizen Petition from Americans for Responsible Technology,Other,Citizen Petition,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2025-03-12T01:00:53Z,,1,0,0900006484ee5772 FDA-2021-D-1118-0002,FDA,FDA-2021-D-1118,Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-24T03:59:59Z,2023-03-24T19:22:26Z,,0,0,0900006484ee7cc8 FDA-2021-V-1345-0001,FDA,FDA-2021-V-1345,Variance Application from Vincent Lighting Systems Company,Other,Application for Variance (VAR),2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:48:48Z,,0,0,0900006484ee243a FDA-2021-V-1344-0001,FDA,FDA-2021-V-1344,Variance Application from Rockstar Production Events LLC,Other,Application for Variance (VAR),2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:44:20Z,,0,0,0900006484ee396e FDA-2021-D-1149-0002,FDA,FDA-2021-D-1149,Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-24T03:59:59Z,2023-03-24T17:56:10Z,,0,0,0900006484ee7574 FDA-2018-D-1774-0039,FDA,FDA-2018-D-1774,Request for Hearing from Prime Policy Group,Other,Request for Hearing,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:32:59Z,,0,0,0900006484ed7724 FDA-2014-P-1038-0006,FDA,FDA-2014-P-1038,Withdrawal From Lachman Consultant Services Inc,Other,Withdrawal,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:23:30Z,,0,0,0900006484ed71ed FDA-2020-P-2003-0458,FDA,FDA-2020-P-2003,Memorandum from FDA CFSAN on Health and Chemicals Coalition Meeting,Other,Memorandum,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T18:54:31Z,,0,0,0900006484ee98a9 FDA-1997-S-0006-1735,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Market America,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:52Z,,0,0,0900006484eaf935 FDA-1997-S-0006-1789,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to VIVRI USA LLC,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:54Z,,0,0,0900006484eaf9f4 FDA-1997-S-0006-1740,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to USANA Health Sciences Inc,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:57Z,,0,0,0900006484eaf946 FDA-1997-S-0006-1797,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to BioSchwartz,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:21:03Z,,0,0,0900006484ece601 FDA-1997-S-0006-1752,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Nutrallion,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:11Z,,0,0,0900006484eaf99d FDA-1997-S-0006-1790,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Corporation Genacol Canada Inc.,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:55Z,,0,0,0900006484eaf9f6 FDA-1997-S-0006-1731,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Greeniche Natural Health Inc.,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:47Z,,0,0,0900006484eaf926 FDA-1997-S-0006-1738,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Greeniche Natural Health Inc.,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:55Z,,0,0,0900006484eaf942 FDA-1997-S-0006-1720,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to BODYBIO,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:34Z,,0,0,0900006484eaf84c FDA-1997-S-0006-1803,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Market America,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:21:09Z,,0,0,0900006484ece60f FDA-1997-S-0006-1706,FDA,FDA-1997-S-0006,"Courtesy letter and related material from CFSAN to Beijing Kingbird Pharmaceutical Technology Development Co.,Ltd.",Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:18Z,,0,0,0900006484eaf7af FDA-1997-S-0006-1736,FDA,FDA-1997-S-0006,"Courtesy letter and related material from CFSAN to HealthyUp,Inc.",Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:53Z,,0,0,0900006484eaf937 FDA-1997-S-0006-1733,FDA,FDA-1997-S-0006,"Courtesy letter and related material from CFSAN to R&L CO., LTD",Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:49Z,,0,0,0900006484eaf931 FDA-1997-S-0006-1727,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Hang Obi Inc. (dba hangobi),Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:43Z,,0,0,0900006484eaf91e FDA-1997-S-0006-1745,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to BODYBIO,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:03Z,,0,0,0900006484eaf98f FDA-1997-S-0006-1774,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to BODYBIO,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:36Z,,0,0,0900006484eaf9cd FDA-1997-S-0006-1795,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Nordic Sunn Inc.,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:21:00Z,,0,0,0900006484ece5fd FDA-2021-S-0024-1044,FDA,FDA-2021-S-0024,"2021-001336 - Santa Cruz Nutritionals - GummiShot Energy Gummies Orange 3ct - Provides Powerful, long lasting, plant-based energy",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:47Z,,0,0,0900006484ea4675 FDA-2021-S-0024-1006,FDA,FDA-2021-S-0024,2021-001280 - ChildLife Essentials- Sleep Essential- Supports a healthy night's sleep,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:19:58Z,,0,0,0900006484ea4595 FDA-2021-S-0024-1029,FDA,FDA-2021-S-0024,2021-001328 - Santa Cruz Nutritionals- GummiShot Energy Gummies Tropical 3ct- PROMOTES ENERGY,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:27Z,,0,0,0900006484ea4651 FDA-2021-S-0024-1035,FDA,FDA-2021-S-0024,"2021-001343 - Swanson Health Products 11658148874 - Swanson Health Products, Prenatal Multi - Support for Mom and Baby during pregnancy",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:35Z,,0,0,0900006484ea465f FDA-2021-S-0024-1047,FDA,FDA-2021-S-0024,"2021-001332 - Santa Cruz Nutritionals - GummiShot Energy Gummies Elderberry 10 - 3ct - Provides Powerful, long lasting, plant-based energy",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:51Z,,0,0,0900006484ea467b FDA-2021-S-0024-1008,FDA,FDA-2021-S-0024,2021-001298- EVOLU RESEARCH- SCurma Fizzy New- SUPPORTS JOINT HEALTH,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:01Z,,0,0,0900006484ea459b FDA-2021-S-0024-1058,FDA,FDA-2021-S-0024,2021-001348 - Arbonne International LLC - Arbonne SkinElixir Collagen Builder - Helps to improve overall appearance of skin radiance,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:21:05Z,,0,0,0900006484ea46be FDA-2021-S-0024-1056,FDA,FDA-2021-S-0024,"2021-001355 - Vital Proteins - Vital Proteins Collagen Peptides - Vanilla - Support Skin, Hair, Nail and Joint for Youthful Appearance",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:21:03Z,,0,0,0900006484ea46ba FDA-2021-S-0024-1000,FDA,FDA-2021-S-0024,"2021-001289 - Schwabe North America Inc- Nature's Way Sambucus HoneyBerry Cough Syrup for coughs associated with hoarseness, dry throat, & irritants- Soothes coughs associated with hoarseness, dry throat, and irritants",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:19:50Z,,0,0,0900006484ea4588 FDA-2021-S-0024-1010,FDA,FDA-2021-S-0024,2021-001300 - RB Health US LLC- Airborne Immune Support with Zinc- SUPPORT IMMUNE HEALTH,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:03Z,,0,0,0900006484ea460d FDA-2021-S-0024-1023,FDA,FDA-2021-S-0024,2021-001316 - i-Health Inc.- Culturelle Women's Wellness Probiotic- maintain feminine health,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:18Z,,0,0,0900006484ea462a FDA-2021-S-0024-1060,FDA,FDA-2021-S-0024,2021-001354 - Rae Wellness PBC - 1 - Immunity Drops - Promote sense of calm and support mental cognition,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:21:08Z,,0,0,0900006484ea46c3 FDA-2021-S-0024-1040,FDA,FDA-2021-S-0024,2021-001342 - Pharmavite LLC- Nature Made Multi for Him Gummies - Provides key nutrients to help support men's health.,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:42Z,,0,0,0900006484ea466b FDA-2021-S-0024-1002,FDA,FDA-2021-S-0024,2021-001294 - Schwabe North America Inc- MULTIPLE CLAIMS (8),Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:19:53Z,,0,0,0900006484ea458c FDA-2021-S-0024-1049,FDA,FDA-2021-S-0024,2021-001357 - Nestle - Gerber Grow Mighty Organic - help support healthy growth and development [in little ones ages 2 and up],Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:54Z,,0,0,0900006484ea46ab FDA-2021-S-0024-1027,FDA,FDA-2021-S-0024,"2021-001311 - Greeniche Natural Health Inc.- Greeniche Natural Health, Fiberight- maintenance of good digestive health",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:24Z,,0,0,0900006484ea4634 FDA-2021-S-0024-0973,FDA,FDA-2021-S-0024,"2021-001246 Twinings North America, Inc.- MULTIPLE CLAIMS (2)",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:19:15Z,,0,0,0900006484ea3b46 FDA-2021-S-0024-0980,FDA,FDA-2021-S-0024,2021-001264 - Natals Inc.- MULTIPLE CLAIMS (3),Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:19:25Z,,0,0,0900006484ea3b55 FDA-2021-S-0024-0978,FDA,FDA-2021-S-0024,"2021-001265 - NOW Foods- NOW Foods, Collagen Jelly Beauty Complex- Promotes healthy, radiant skin while reducing fine lines and wrinkles within 4 weeks",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:19:22Z,,0,0,0900006484ea3b51 FDA-2021-S-0024-0969,FDA,FDA-2021-S-0024,2021-001270 - Beijing Kingbird Pharmaceutical Technology Development Co.Ltd. - RenshenNiuhuang Capsules -,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:19:10Z,,0,0,0900006484ea3b3e FDA-2021-S-0024-1037,FDA,FDA-2021-S-0024,2021-001327 - Pharmavite LLC - Nature Made Wellblends Stress Relief Gummies - helps reduce stress,Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:20:38Z,,0,0,0900006484ea4663 FDA-2021-S-0024-1063,FDA,FDA-2021-S-0024,"2021-001365 - MindBodyGreen LLC - chocolate beauty & gut collagen - support for glowing skin, strong hair and nails, and a healthy gut",Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:21:12Z,,0,0,0900006484ea46c9 FDA-2021-S-0024-0905,FDA,FDA-2021-S-0024,2021-001175 - Sensible - MULTIPLE CLAIMS (4),Other,30 Day Structured Function Claim,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T18:17:45Z,,0,0,0900006484ea3a9f