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Dietary Supplement Public Meeting May 2019

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Dietary Supplement Public Meeting May 2019 Meeting May 16, 2019 Page 1 1 DA/CFSAN PUBLIC MEETING 2 3 RESPONSIBLE INNOVATION IN DIETARY SUPPLEMENTS 4 5 6 Thursday, May 16, 2019 7 8:30 a.m. 8 9 10 11 12 13 14 US Food and Drug Administration 15 5001 Campus Drive 16 Wiley Auditorium 17 College Park, MD 20740 18 19 20 Court Reporter: KeVon Congo 21 JOB No.: 3391044 22 www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 2 1 A P P E A R A N C E S 2 ANDREW SHAO 3 ASHISH TALATI 4 BERIT DOCKTER 5 BONNIE PATTEN 6 CARA WELCH 7 CHARLES JOLLY 8 DANIEL FABRICANT 9 DANIEL WANG 10 DAVE SCHONEKER 11 FREDERICK BLAKE 12 GABRIEL GIANCASPARO 13 GEORGE PARASKEVAKOS 14 HARRY RICE 15 JAY SIROIS 16 KEVIN BELL 17 LARISA PAVLICK 18 LAURA MacCLEERY 19 MACK MITCHELL 20 MARK BLUMENTHAL 21 MARK LeDOUX 22 MARK MILLER www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 3 1 A P P E A R A N C E S - Continued 2 MICHAEL McGUFFIN 3 NANA BAFI-YEBOA 4 NORMAN SHARPLESS 5 PIETER COHEN 6 SANDRA ESKIN 7 SCOTT BASS 8 STEVE MISTER 9 STEVE TAVE 10 WES SIEGNER 11 12 13 14 15 16 17 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 4 1 I N D E X 2 SPEAKER: PAGE 3 CARA WELCH 6, 32 4 NORMAN SHARPLESS 10 5 STEVE TAVE 18, 144, 179 245 6 SCOTT BASS 38 7 LARISA PAVLICK 46, 287 8 GEORGE PARASKEVAKOS 60 9 MICHAEL McGUFFIN 99 10 PIETER COHEN 70 11 ASHISH TALATI 111 12 LAURA MacCLEERY 114 13 MANON BOMBARDIER 149 14 DAN FABRICANT 188, 271 15 ANDREW SHAO 195 16 WES SIEGNER 203 17 JAY SIROIS 211 18 SANDRA ESKIN 221 19 FREDERICK BLAKE 246 20 BERIT DOCKTER 250 21 22 www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 5 1 I N D E X - Continued 2 SPEAKER: PAGE 3 HARRY RICE 253 4 MARK LEDOUX 256 5 GEORGE PARASKEVAKOS 260 6 LAURA MACCLEERY 263 7 BONNIE PATTEN 267 8 CHARLES JOLLY 271 9 MARK BLUMENTHAL 278 10 DANIEL WANG 284 11 FRANK JAKSCH 290 12 JACK MITCHELL 293 13 STEVE MISTER 298 14 ROBIN MORLES 302 15 KAREN HOWELL 305 16 KEVIN BELL 309 17 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 6 1 P R O C E E D I N G S 2 DR. WELCH: Good morning. Good morning, 3 everyone. Thank you for sticking with us while we get 4 started. Welcome to FDA's public meeting on 5 Responsible Innovation in Dietary Supplements. My 6 name is Cara Welch from the Office of Policy, 7 Legislation, and International Affairs in the Office 8 of the Commissioner. And I'm so pleased to be working 9 on today's meeting with ODSP. I have some 10 housekeeping notes to get us started and then I'll 11 turn it over to Dr. Sharpless. 12 This public meeting is being webcast and 13 transcribed. The transcription and slide decks will 14 be added to FDA's website once they're prepared for 15 posting. I'm not sure on the timeline for this. It 16 could be as much as a few weeks before they get 17 posted. If you're interested in the transcription, I 18 would suggest you monitor FDA's meeting page specific 19 to today's meeting. 20 Wi-Fi is not available today. I'm 21 sorry. Also please take a moment to confirm your cell 22 phones and other devices are silenced as I do so www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 7 1 myself. 2 To ensure our webcast participants can 3 hear, please be sure to speak your remarks or 4 questions into the microphones. There are two mics 5 about part way down the, the stairs and we would 6 suggest that you use those. Also please introduce or 7 start your comments or questions with your name and 8 organization because of the transcription. 9 If, for the webcast participants, your 10 phones sound be automatically muted. If you have a 11 question to ask of our panelists during the Q&A 12 sessions, please type it into the chat function. We 13 have a few people monitoring that chat box and they 14 can ask the questions on your behalf. 15 Restrooms, as you exit the auditorium at 16 the top of the stairs, both the men's and women's 17 restrooms are located down the corridor back towards 18 security on your right. 19 Breaks and lunch. We have a couple 20 short breaks and a lunch break scheduled. Snacks and 21 beverages are available in the Wiley Building Cafe, 22 which is outside of the building outside of security www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 8 1 to the left. Additionally, there will be food trucks 2 available in the parking area for lunchtime. Seating 3 is available in the café or in the courtyard area 4 between the building and the parking lot if the 5 weather is nice. I think it's supposed to clear. 6 Please use the front door to exit and 7 enter. There is a door at the top of the auditorium. 8 Please don’t use that. We would get in trouble. And 9 always wear your nametag because you will need to go 10 back through security and that just indicates that you 11 can go directly to Donna's corridor to the public 12 meeting. 13 There are also two breakrooms available 14 for our use. They are 1A001 and 1A002 and people at 15 the registration desk can show you where those are. 16 There are no food or drinks allowed in this room. 17 Again, I'm sorry. 18 For any media or press questions, we 19 should have Mariana Nam and Julie Manga (ph) attending 20 the meeting. If they're in the room right now, they 21 will indicate. I don’t see either of them in the room 22 right now. You can also find them at the registration www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 9 1 table. And then we will also have Lindsay Haik from 2 our Office of Media Affairs available for other media 3 questions. 4 The folders you were all provided when 5 you checked in at the registration desk have some 6 documents for the day. The agenda for today, bios for 7 our presenters, both FDA and the panelists, and the 8 photo register notice. July 15 is the deadline for 9 submission of comments to the docket. 10 You were also able to pick up a list of 11 persons making public comments at the end of the day. 12 And speaking of which, the public comment session, we 13 are having a public comment session at the end of our 14 panels this afternoon. The list of persons who have 15 requested an opportunity are on that sheet. We ask 16 our commenters to target three minutes for their 17 comments. If we have time at the end of the day, we 18 could allow some extra unregistered people to give 19 comments. 20 If you would like to have that 21 opportunity, if we have time, please check in with 22 Juanita Yates at the registration desk. Juanita, can www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 10 1 you step forward and make sure people know who you 2 are? Very important for the meeting, Juanita Yates 3 helps us keep moving smoothly. For questions and 4 assistance, she is also probably your best source of 5 information. 6 And with that, I am very please to 7 welcome to the podium Dr. Ned Sharpless, Acting 8 Commissioner of FDA. Thank you. 9 (APPLAUSE.) 10 DR. SHARPLESS: Good morning. Thank 11 you, Cara, for that introduction. And thanks to 12 everyone here for participating in today's meeting. 13 Also for those of you online. The topic of today's 14 session is of particular importance to protecting the 15 public health and the work of the Food and Drug 16 Administration. Although I'm relatively new to the 17 FDA, I've been in the job about five weeks, protecting 18 and promoting the public health has been central to my 19 professional work and throughout my career. 20 As some of you may know, before coming 21 to FDA I ran the National Cancer Institute at NIH, and 22 before that I was a cancer researcher and a cancer www.CapitalReportingCompany.com 202-857-3376 Meeting May 16, 2019 Page 11 1 doctor treating patients with hematologic malignances 2 for 20 years in academia. During that time I ran an 3 NHI-funded lab studying the molecular mechanisms of 4 cancer and aging and I was a director of a large 5 comprehensive cancer center. 6 I'm thrilled to be at the FDA, to be a 7 part of the team that uses science to develop policies 8 and regulations that help make Americans more 9 knowledgeable and safer. A few of FDA's 10 responsibilities affect as many Americans on a daily 11 basis as our work in the foods arena, which includes 12 issues of food safety and labeling, but also issues of 13 nutrition and diet.
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