UNITED STATES
`INTERNATIONAL TRADE COMMISSION
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`In the Matter of Investigation No.
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`CERTAIN TOBACCO HEATING ARTICLES 337-TA-1199
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`AND COMPONENTS THEREOF
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`Pages:
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`January 28, 2021
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`OPEN SESSIONS
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`HERITAGE REPORTING CORPORATION
`Official Reporters
`1220 L Street, N.W., Suite 206
`Washington, D.C. 20005
`(202) 628-4888
`contracts@hrccourtreporters.com
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`INTERNATIONAL TRADE COMMISSION
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`In the Matter of Investigation No.
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`CERTAIN TOBACCO HEATING ARTICLES 337-TA-1199
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`AND COMPONENTS THEREOF
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`Pages:
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`Washington, D.C.
`January 28, 2021
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`OPEN SESSIONS
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`HERITAGE REPORTING CORPORATION
`Official Reporters
`1220 L Street, N.W., Suite 206
`Washington, D.C. 20005
`(202) 628-4888
`contracts@hrccourtreporters.com
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` 1 UNITED STATES INTERNATIONAL TRADE COMMISSION
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` 2 Washington, D.C.
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` 3 Before the Honorable Clark S. Cheney
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` 4 Administrative Law Judge
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` 5
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` 6 ------------------------------x
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` 7 In the Matter of Investigation No.
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` 8
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` 9 CERTAIN TOBACCO HEATING ARTICLES 337-TA-1199
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` 10 AND COMPONENTS THEREOF
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` 11 ------------------------------x
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` 16 Thursday, January 28, 2021
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` 17
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` 18 EVIDENTIARY HEARING - VOLUME IV - REMOTE
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` 19
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` 20
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` 21 The parties met, via remote videoconferencing, pursuant to
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` 22 notice of the Administrative Law Judge, at 9:00 a.m.
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` 23 Eastern.
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` 24
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` 25 Reported by: Karen Brynteson, RMR, CRR, FAPR
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` 1 APPEARANCES:
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` 2 (all parties appeared remotely)
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` 3
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` 4 For Complainants RAI Strategic Holdings, Inc.; R.J.
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` 5 Reynolds Vapor Company; and R.J. Reynolds Tobacco Company:
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` 6 DAVID M. MAIORANA, ESQ.
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` 7 KENNETH LUCHESI, ESQ.
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` 8 RYAN B. MCCRUM, ESQ.
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` 9 Jones Day
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` 10 901 Lakeside Avenue
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` 11 Cleveland, Ohio 44114
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` 12 216-586-3939
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` 14 STEPHANIE E. PARKER, ESQ.
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` 15 FRANK T. BAYUK, ESQ.
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` 16 Jones Day
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` 17 1420 Peachtree Street, N.W., Suite 800
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` 18 Atlanta, Georgia 30309
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` 19 404-521-3939
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` 20
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` 21 ANTHONY M. INSOGNA, ESQ.
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` 22 Jones Day
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` 23 4655 Executive Drive, Suite 1500
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` 24 San Diego, CA 92121
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` 25 858-314-1200
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` 1
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` 2 APPEARANCES (Continued):
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` 3 For Complainants:
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` 4 JOHN J. NORMILE, ESQ.
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` 5 Jones Day
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` 6 250 Vesey Street
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` 7 New York, New York 10281
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` 8 212-326-3939
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` 9
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` 10 NICOLE M. SMITH, ESQ.
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` 11 Jones Day
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` 12 555 S. Flower Street, Fiftieth Floor
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` 13 Los Angeles, CA 90071
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` 14 213-489-3939
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` 1 APPEARANCES (Continued:)
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` 2 For Respondents Altria Client Services LLC; Altria Group,
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` 3 Inc.; Philip Morris USA, Inc.; Philip Morris International
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` 4 Inc.; and Philip Morris Products S.A.:
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` 5 MAXIMILIAN A. GRANT,
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` 6 BERT C. REISER, ESQ.
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` 7 MATTHEW J. MOORE, ESQ.
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` 8 JAMIE D. UNDERWOOD, ESQ.
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` 9 Latham & Watkins LLP
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` 10 555 Eleventh Street, NW
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` 11 Washington, DC 20004
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` 12 202-637-2200
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` 14 BRENDA L. DANEK, ESQ.
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` 15 DALE CHANG, ESQ.
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` 16 Latham & Watkins LLP
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` 17 330 North Wabash Avenue, Suite 2800
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` 18 Chicago, IL 60611
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` 19 312-876-7700
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` 20
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` 21 CLEMENT NAPLES, ESQ.
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` 22 Latham & Watkins LLP
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` 23 885 Third Avenue
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` 24 New York, New York 10022-4834
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` 25 212-906-1331
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` 1 APPEARANCES (continued):
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` 2 For Resondents (Continued);
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` 3 GREGORY K. SOBOLSKI, ESQ.
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` 4 Latham & Watkins LLP
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` 5 505 Montgomery Street, Suite 2000
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` 6 San Francisco, CA 94111
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` 7 415-395-8035
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` 8
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` 9 For the Office of Unfair Import Investigations:
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` 10 SARAH J. SLADIC, ESQ.
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` 11 ANNE GOALWIN, ESQ.
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` 12 U.S. International Trade Commission
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` 13 500 E Street, SW
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` 14 Washington, DC 20436
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` 16
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` 17 Attorney Advisor:
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` 18 PATRICIA CHOW, ESQ.
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` 19 Attorney-Advisor
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` 20 U.S. International Trade Commission
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` 21 500 E Street, SW
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` 22 Washington, D.C. 20436
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` 1 P R O C E E D I N G S (9:02 a.m.)
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` 2 JUDGE CHENEY: We're on the record now in
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` 3 Investigation No. 1199. When we left off yesterday in the
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` 4 evidentiary hearing, we were listening to the Respondents'
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` 5 case-in-chief. And I understand from the parties that
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` 6 there is a witness in Switzerland that is ready to testify
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` 7 this morning, and the parties are in agreement that we can
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` 8 take that witness now, although we were in the middle of
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` 9 hearing testimony from another witness.
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` 10 So, Mr. Grant, why don't you call the foreign
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` 11 witness.
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` 12 MR. GRANT: Thank you, Your Honor. I'll let
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` 13 Mr. Reiser do that.
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` 14 MR. REISER: Good morning, Your Honor.
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` 15 JUDGE CHENEY: Good morning, Mr. Reiser.
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` 16 MR. REISER: Your Honor, Respondents call our
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` 17 next witness, Dr. Moira Gilchrist.
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` 18 Good afternoon, Dr. Gilchrist. Can you hear me
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` 19 okay?
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` 20 THE WITNESS: I can perfectly.
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` 21 MR. REISER: Okay. And can you see His Honor
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` 22 and everything is working at your end?
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` 23 THE WITNESS: It is. Thank you.
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` 24 MR. REISER: Wonderful. Thank you.
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` 25 JUDGE CHENEY: Great. Dr. Gilchrist, I'm going
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` 1 to ask you to please raise your right hand and I will
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` 2 administer the oath.
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` 3 Whereupon--
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` 4 MOIRA GILCHRIST,
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` 5 having been first duly sworn, was examined and testified as
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` 6 follows:
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` 7 JUDGE CHENEY: Thank you.
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` 8 Please proceed, Mr. Reiser.
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` 9 MR. REISER: Thank you, Your Honor.
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` 10 DIRECT EXAMINATION
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` 11 BY MR. REISER:
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` 12 Q. Dr. Gilchrist, could you please introduce
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` 13 yourself to the Judge formally and tell him where you're
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` 14 working currently?
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` 15 A. Yes. Good morning, Judge Cheney. My name is
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` 16 Moira Gilchrist. I'm the vice president of strategic and
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` 17 scientific communications here at Philip Morris
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` 18 International in -- based in Switzerland.
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` 19 Q. And what are your primary responsibilities in
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` 20 that role?
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` 21 A. So my role is really to communicate to a broad
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` 22 range of different stakeholders about our science, the
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` 23 science, the facts of our smoke-free alternatives, and our
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` 24 general transformation away from cigarettes.
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` 25 Q. And what kinds of information do you share with
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` 1 these stakeholders?
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` 2 A. So it can be in-depth scientific information.
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` 3 It can be the -- the facts about our investment in
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` 4 smoke-free products. It can be our progress in
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` 5 transitioning smokers away from cigarettes, a whole range
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` 6 of different topics, also challenges in the regulatory
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` 7 environment as well.
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` 8 Q. How do you do this kind of communication?
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` 9 A. There's a whole range of tools that -- that I
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` 10 use and that we use in my team, so whether it be attending
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` 11 conferences, presenting at conferences, whether it be
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` 12 talking to journalists, writing articles, social media,
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` 13 one-on-one meetings, a whole range of different ways.
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` 14 Q. Does PMI sometimes host these kinds of events?
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` 15 A. Yes, we do. We host site meetings sometimes at
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` 16 conferences or other events. We also invite people to our
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` 17 R&D facility called the Cube in Switzerland. We have
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` 18 hundreds of visitors there every year.
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` 19 Q. How long have you served as vice president of
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` 20 strategic and scientific communication at the company?
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` 21 A. My job title changed a little bit over the last
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` 22 couple of years, but really I've had the same
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` 23 responsibilities since January 2018.
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` 24 Q. Sort of stepping back for a moment, could you
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` 25 please tell us a little bit about your professional
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` 1 background?
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` 2 A. Sure. So I qualified as a pharmacist with a
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` 3 Ph.D. in pharmaceutical sciences. I worked in the
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` 4 pharmaceutical industry for many years on inhalation drug
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` 5 delivery and also cancer research. I became a consultant,
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` 6 consulting with a wide -- wide range of different
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` 7 pharmaceutical companies before I joined Philip Morris
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` 8 International in 2006 to work on the transformation of
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` 9 research and development to be ready to develop and assess
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` 10 smoke-free products. I worked in R&D for quite some years
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` 11 before I then transitioned into my current role.
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` 12 Q. Just a few moments ago, you used this phrase
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` 13 "general transformation of the company" and discussing that
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` 14 with stakeholders. What did you mean by general
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` 15 transformation of the company?
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` 16 A. So before I joined the company, we were already
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` 17 developing -- looking at developing and assessing
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` 18 smoke-free alternatives. After I joined, that effort
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` 19 really ramped up, and when we started to see the scientific
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` 20 results, when we started to get consumer feedback about the
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` 21 products, we decided really that we have to plan to go, if
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` 22 you like, all in, so to completely transition our business
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` 23 away from combustible cigarettes to this range of
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` 24 smoke-free alternatives.
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` 25 And we did quite some planning for that, but in
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` 1 2016, we announced that publicly. And to date, we're --
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` 2 we're the only multinational tobacco company that has made
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` 3 that commitment.
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` 4 Q. And what are the reasons behind why PM -- PMI
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` 5 decided to transition away from combustible cigarettes?
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` 6 A. Well, it -- it really made perfect business
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` 7 sense, if you like, because we know that adult smokers are
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` 8 demanding better alternatives. We knew that we had the
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` 9 technology and the scientific capability to produce the
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` 10 products and the scientific evidence to back them up.
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` 11 So, overall, we -- we thought that this is, you
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` 12 know, a really good opportunity for us as a business, but
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` 13 then also a massive opportunity for public health if we can
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` 14 encourage each and every adult smoker who doesn't quit to
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` 15 -- to switch instead to a smoke-free alternative such as
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` 16 IQOS.
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` 17 Q. Now, what would you say to critics who might
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` 18 suggest that that's more of a marketing campaign, a kind of
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` 19 a gimmick, than a genuine corporate transformation?
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` 20 A. Well, I -- I get that question a lot, and I -- I
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` 21 understand the skepticism that people have, but we also
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` 22 anticipated that. So we made a decision very early on to
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` 23 make everything transparently available, so not just our
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` 24 scientific research but we also publish metrics about our
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` 25 transformation, so the amount of dollar spend on R&D.
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` 1 For example, there have been billions of dollars
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` 2 spent on the development and assessment of IQOS, but then
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` 3 our progress commercially as well in terms of the number of
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` 4 -- of smokers who have switched. Currently it's 11
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` 5 million, more than 11 million, adult smokers worldwide have
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` 6 switched completely and abandoned cigarettes.
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` 7 So all that's publicly available. I just ask
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` 8 people to look at the -- look at the facts.
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` 9 Q. And what do you perceive as the benefits of
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` 10 IQOS?
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` 11 A. So there's really two aspects to the benefits.
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` 12 I mean, we know scientifically that it's the burning of
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` 13 tobacco that causes the production of the vast majority of
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` 14 the harmful chemicals that cause smoking-related diseases.
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` 15 So IQOS doesn't burn tobacco. So it produces much, much
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` 16 lower levels of harmful chemicals, significant reductions.
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` 17 And -- but we also know that people need -- need
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` 18 a sensory experience, if you like, that replaces what
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` 19 they're used to with cigarettes. And the benefit of -- of
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` 20 IQOS is that it comes very, very close to that sensory
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` 21 experience that people are used to from oftentimes many
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` 22 years of smoking cigarettes.
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` 23 So that really helps them to -- to switch away
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` 24 and -- and not go back to cigarettes. And that's really
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` 25 unique in terms of IQOS.
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` 1 Q. Are you familiar with the term "potentially
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` 2 reduced risk products"?
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` 3 A. Yes, I am.
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` 4 Q. And if I sometimes use acronym PRRP, will you
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` 5 understand that to refer to potentially reduced risk
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` 6 products?
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` 7 A. Of course, yes.
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` 8 Q. And do you consider IQOS a PRRP?
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` 9 A. Yes.
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` 10 Q. Are there other PRRPs available to combustible
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` 11 cigarette smokers in the United States?
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` 12 A. Yes. Yes, there are. I mean, obviously, I
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` 13 explained the -- the fact that combustion is the problem,
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` 14 so there are many non-combusted alternatives available on
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` 15 the market in the United States that -- that offer an
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` 16 alternative to current adult smokers.
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` 17 Q. And what role, in your view, do other
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` 18 potentially reduced risk products play in the effort to
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` 19 reduce combustible cigarette smoking?
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` 20 A. So really it's about choice. And the -- the
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` 21 decision and -- and the effort to switch away from
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` 22 combustible cigarettes is not an easy one. And it's really
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` 23 important adult smokers are offered a range of different
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` 24 alternatives so that they can find the one that really fits
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` 25 their needs, their sensory desires, their -- their desire
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` 1 for the ritual that suits them, because all of them are
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` 2 different to cigarettes, all of them require some kind of
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` 3 compromise, so offering choice means that people can find
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` 4 something that -- that suits them and help them to move
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` 5 away from combustible cigarettes.
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` 6 Q. How many markets is IQOS available in currently?
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` 7 A. So it's currently available in, I think, 61
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` 8 different markets around the world, so ranging from Asia,
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` 9 Europe, the Americas, all over the place, and has been, you
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` 10 know, growing on -- in number since really 2015.
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` 11 Q. And how is IQOS performing in those markets?
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` 12 A. Extremely well. It has exceeded all of our
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` 13 expectations.
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` 14 Q. Now, has PMI ever had to pull IQOS from any of
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` 15 its markets due to poor performance?
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` 16 A. No, we have never done that.
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` 17 Q. Do you expect positive results in term of sales
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` 18 in the United States?
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` 19 A. Of course, yes.
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` 20 Q. Why?
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` 21 A. There's no reason for it not to be successful.
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` 22 I think we have sufficient experience from a range of
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` 23 different countries now with all sorts of different adult
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` 24 smokers being able to adopt the product and abandon
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` 25 cigarettes. I see absolutely no reason why the United
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` 1 States would be an exception to what we've seen in 61
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` 2 different places around the world.
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` 3 Q. And is there anything about the U.S. market, in
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` 4 particular, that the company expects will encourage the
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` 5 success of IQOS?
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` 6 A. So I think what's unique about the United States
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` 7 compared to any of those other countries is the oversight
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` 8 of FDA. And, particularly -- not just the -- the
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` 9 pre-market tobacco product authorization, which we went
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` 10 through for IQOS, but also the modified risk tobacco
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` 11 product authorization.
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` 12 So now in the United States we're able to
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` 13 communicate to adult smokers some health information which
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` 14 can really help to gather choices. And I think overall
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` 15 this -- this oversight of a well-respected regulatory
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` 16 agency gives consumers confidence in the categories of
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` 17 alternative products that go through the authorization.
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` 18 Q. Now, you just mentioned the IQOS PMTA and MRTP
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` 19 authorizations. Did you play a role in preparing the
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` 20 materials for those applications?
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` 21 A. Yes, I did. For the initial applications, I was
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` 22 involved in reviewing documents and helping with the -- the
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` 23 finalization of the submission. And I was also Philip
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` 24 Morris International's lead presenter at the public Tobacco
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` 25 Product Scientific Advisory Committee meeting, which is a
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` 1 two-day public hearing that took place in 2018 in January.
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` 2 Q. And is that sometimes referred to as TPSAC?
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` 3 A. That's correct, yes.
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` 4 Q. Can you describe generally the kinds of
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` 5 materials that were included in the submissions to FDA?
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` 6 A. So really it was a huge breadth of science
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` 7 ranging from design and manufacturing information through
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` 8 to aerosol chemistry, toxicology, clinical studies,
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` 9 perception and behavior. A whole range from right across
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` 10 our scientific assessment process went into the -- the
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` 11 applications.
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` 12 Q. And just so we have an understanding about the
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` 13 size of these applications, if you were to print out the
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` 14 MRTPA, for example, about how many pages would that be?
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` 15 A. So the MRTP was more than a million pages in
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` 16 length in total.
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` 17 Q. And for the PMTA, about how many pages would
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` 18 that be?
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` 19 A. So that -- if anything, that was slightly larger
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` 20 because it cross-referenced the MRTP but also had some
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` 21 studies that were specific to -- to that application as
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` 22 well, so slightly larger, I would say.
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` 23 Q. And how did PMI go about gathering all the
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` 24 information needed, the scientific information, for those
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` 25 applications?
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` 1 A. Well, it -- it took more than a decade. We
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` 2 hired lots of people like me from the pharmaceutical
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` 3 industry to augment the skills that were already in place
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` 4 in PMI. We designed the assessment process. We engaged
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` 5 with third-party contract research organizations to help us
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` 6 run studies.
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` 7 We -- we executed clinical studies, for example,
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` 8 with contract research organizations, and ultimately all of
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` 9 that information was assembled into the -- the dossier that
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` 10 was -- dossiers that were submitted to FDA.
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` 11 Q. How many clinical studies did PMI submit for its
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` 12 FDA application?
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` 13 A. So the original application had -- I think it
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` 14 was eight core studies. We submitted ones after that, but
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` 15 the main core of it was eight studies.
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` 16 Q. And -- and for those of us who don't do this for
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` 17 a living, can -- can you please describe what exactly a
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` 18 clinical study is?
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` 19 A. Sure. Well, it's -- it's, you know, obviously
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` 20 something that's done in human subjects, so that means that
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` 21 it's subject to the most high standard of -- of rigor of
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` 22 any type of scientific study to ensure the safety and
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` 23 reproducibility of -- of the studies.
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` 24 So, first of all, you have to plan the study.
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` 25 You have to discuss with the regulatory agency like FDA,
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` 1 for example. You have to register the study on a public
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` 2 web site so people can be made aware that it's taking place
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` 3 and they can follow for the -- for the results. You have
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` 4 to register everything in your quality management system
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` 5 according to something called good clinical practice, which
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` 6 means that you have contemporaneous records of anything
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` 7 that occurred during the studies. And, ultimately, you
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` 8 have to report out on then and make public the -- the
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` 9 findings.
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` 10 Q. Now, once PMI submitted its first PMTA and the
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` 11 MRTPA, what happens next in the process?
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` 12 A. So after the FDA accepted the applications for
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` 13 what's called substantive scientific review, there's a lot
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` 14 of back and forth with the agency. So they have questions
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` 15 that they want clarification on, so there would be
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` 16 questions -- answers provided to the agency.
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` 17 There was also a public comment period, where
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` 18 anybody could -- could review the materials that would get
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` 19 submitted to the agency and provide their own opinion on
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` 20 them. And then there was the TPSAC meeting, which was
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` 21 obviously a public meeting as well where people could
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` 22 comment.
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` 23 Q. And when did FDA grant the PMTA authorization
`
` 24 for IQOS?
`
` 25 A. So the first PMTA was authorized in April 2019.
`
`
`
`
`
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`Heritage Reporting Corporation
`(202) 628-4888
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` 847
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` 1 Q. And was there a second?
`
` 2 A. There was. So we submitted a second,
`
` 3 supplemental PMTA application for an update -- updated
`
` 4 version of the -- the IQOS device, for the IQOS 3. That, I
`
` 5 believe, was granted in December of 2020, yes.
`
` 6 Q. Could we please put up Exhibit JX-0018.
`
` 7 Dr. Gilchrist, do you recognize this document?
`
` 8 A. I do, yes. That's the FDA's press release for
`
` 9 the original PMTA authorization for the IQOS 2.4 device.
`
` 10 Q. And when did FDA grant MRTP authorization for
`
` 11 IQOS?
`
` 12 A. So the MRTP authorization came in July -- I
`
` 13 think it was July 7th of 2020.
`
` 14 Q. And why did PMI seek MRTP authorization for --
`
` 15 for the product?
`
` 16 A. So one of the fundamental thoughts that we have
`
` 17 or had at the beginning of the development and assessment
`
` 18 of IQOS was there's no use in having all this scientific
`
` 19 information if we can't tell consumers about it to help
`
` 20 guide their choices. So two things have to go hand in
`
` 21 hand.
`
` 22 And so in the United States, that means you have
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` 23 to submit through the modified risk tobacco product pathway
`
` 24 in order that you can make communications about relative
`
` 25 health risks or exposure risks. You have to submit through
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`Heritage Reporting Corporation
`(202) 628-4888
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` 848
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` 1 that pathway to get FDA's authorization to make those
`
` 2 communications to adult smokers.
`
` 3 Q. Can we look, please, at RX-0316.
`
` 4 Dr. Gilchrist, can you identify this document
`
` 5 for us?
`
` 6 A. Yes. This is the FDA's press release in
`
` 7 relation to the authorization of IQOS's modified risk
`
` 8 tobacco products in July 7th, 2020.
`
` 9 Q. Now, what type of MRTP authorization did IQOS
`
` 10 receive?
`
` 11 A. So there are two standards within the MRTP
`
` 12 pathway, which is already a huge bar to pass. The -- the
`
` 13 higher standard is one for what's called reduced risk, and
`
` 14 the second standard is something called reduced exposure.
`
` 15 So at the time that FDA made their announcement, they said
`
` 16 at this time t
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