`Case 1:20-cv-00393-LO-TCB Document 1017-9 Filed 02/11/22 Page 1 of 4 PagelD# 28815
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`EXHIBIT I
`EXHIBIT I
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`Case 1:20-cv-00393-LO-TCB Document 1017-9 Filed 02/11/22 Page 2 of 4 PageID# 28816
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` 1
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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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` 12
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` 13
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` 14
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` 15
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` 16 Monday, January 25, 2021
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` 17
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` 18 EVIDENTIARY HEARING - VOLUME I - 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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`Heritage Reporting Corporation
`(202) 628-4888
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`Case 1:20-cv-00393-LO-TCB Document 1017-9 Filed 02/11/22 Page 3 of 4 PageID# 28817
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` 99
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` 1 correct?
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` 2 A. They are. They're called e-cigarettes, vape
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` 3 products, or ENDS.
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` 4 Q. Okay. And you talked a little bit about PMTAs
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` 5 during your direct examination. And Reynolds has put in a
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` 6 PMTA for its Solo product and its Vibe product, correct?
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` 7 A. We have, yes.
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` 8 Q. All right. It has also put in PMTAs for its
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` 9 other e-cigarette devices, the Ciro and the Alto, correct?
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` 10 A. Among other products, yes, that's correct.
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` 11 Q. Okay. And you agree, Dr. Figlar, that if the
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` 12 FDA denies Reynolds' PMTA applications for its Vuse
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` 13 products, then Reynolds has to pull those products from the
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` 14 market, correct?
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` 15 A. If -- if that were the case, that would be true,
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` 16 yes.
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` 17 Q. All right.
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` 18 A. We don't feel that that's likely, but that would
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` 19 be the case.
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` 20 Q. I understand. But, Dr. Figlar, you don't know
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` 21 if the FDA is going to authorize Reynolds' PMTAs for its
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` 22 Vuse products, correct?
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` 23 A. No, I don't know it but we're very, very
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` 24 confident, obviously, in our applications. But, you know,
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` 25 we don't -- we don't know until the FDA makes a judgment.
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`Heritage Reporting Corporation
`(202) 628-4888
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 1017-9 Filed 02/11/22 Page 4 of 4 PageID# 28818
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` 100
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` 1 Q. Right. So, Dr. Figlar, it's possible that the
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` 2 Vibe and the Solo domestic industry products will have to
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` 3 be removed from the market this year, right?
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` 4 A. This year, I'm not sure. It depends on when the
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` 5 FDA is going to make a decision before one would have to,
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` 6 you know, remove products from the market. But, you know,
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` 7 we will see.
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` 8 Q. Well, if the FDA denies the applications,
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` 9 Reynolds is going to pull the products, correct?
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` 10 A. Well, obviously I think Reynolds would -- would
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` 11 run the course of -- of administrative review, but -- but,
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` 12 yes, if ultimately the FDA makes that decision, then we
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` 13 would have to remove those products from the market.
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` 14 Q. Okay. Now, there's another FDA term that's been
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` 15 discussed in this case called an MRTPA, correct?
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` 16 A. I suppose, yes, I know what an MRTPA is, yes.
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` 17 Q. Right. An MRTPA stands for Modified Risk
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` 18 Tobacco Product Application, correct?
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` 19 A. That is correct.
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` 20 Q. Right. And if an MRT application is granted, a
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` 21 company can advertise a tobacco product as, for instance, a
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` 22 reduced risk or a reduced exposure product, correct?
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` 23 A. It depends on what the FDA decides with regard
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` 24 to those advertising claims, but, yes, there's a G-1 and
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` 25 G-2 path, exposure or risk.
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`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`
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