`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 1 of 8 Page|D# 10733
`
`
`
`
`
`EXHIBIT 9
`
`EXHIBIT 9
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 2 of 8 PageID# 10734
`
`UNITED STATES
`INTERNATIONAL TRADE COMMISSION
`
`------------------------------x
`
`In the Matter of Investigation No.
`
`
`
`CERTAIN TOBACCO HEATING ARTICLES 337-TA-1199
`
`AND COMPONENTS THEREOF
`
`------------------------------x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pages:
`
`Place:
`
`Date:
`
`1 through 284 (with excerpts)
`Washington, D.C.
`January 25, 2021
`
`
`
`OPEN SESSIONS
`
`
`
`
`
`
`HERITAGE REPORTING CORPORATION
`Official Reporters
`1220 L Street, N.W., Suite 206
`Washington, D.C. 20005
`(202) 628-4888
`contracts@hrccourtreporters.com
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 3 of 8 PageID# 10735
`
`
`
` 114
`
`
` 1 O P E N S E S S I O N
`
` 2 BY MR. NAPLES:
`
` 3 Q. Now, Dr. Figlar, though, you believe that the
`
` 4 public is not currently easily getting accurate information
`
` 5 on risk, correct?
`
` 6 A. They -- correct. Again, I don't believe that
`
` 7 public health authorities have made it very clear about the
`
` 8 vast difference between smokeless products and smoking
`
` 9 cigarettes.
`
` 10 So for a large amount of people, a significant
`
` 11 portion of people don't understand the differential of risk
`
` 12 between cigarette smoking and the use of smokeless tobacco
`
` 13 products.
`
` 14 Q. Okay. And the Camel Snus MRTPA, that has been
`
` 15 pending since 2017, correct?
`
` 16 A. 2017 is accurate. That's when we filed our
`
` 17 MRTPA.
`
` 18 Q. And that has not been granted, correct?
`
` 19 A. Not at this point in time.
`
` 20 Q. All right. Let's talk briefly about the Eclipse
`
` 21 product you mentioned during your direct examination.
`
` 22 Now, Reynolds calls the Eclipse a heat-not-burn
`
` 23 product, correct?
`
` 24 A. It is a heat-not-burn product, yes.
`
` 25 Q. Okay. And in the 20 years, over 20 years that
`
`
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 4 of 8 PageID# 10736
`
`
`
` 115
`
`
` 1 Eclipse has been on the market, it is actually never been a
`
` 2 big seller for Reynolds, right?
`
` 3 A. It has not been a large seller sadly, but, you
`
` 4 know, we continue to market and sell the product.
`
` 5 Q. Right. In fact, the sales of Eclipse,
`
` 6 Dr. Figlar, those have been pretty steadily declining since
`
` 7 2004, right?
`
` 8 A. That may be accurate. I have to look back at
`
` 9 the numbers again but, yeah, it's not -- it has declined
`
` 10 over the years.
`
` 11 Q. Okay. And Eclipse also has some pretty
`
` 12 well-known problems with consumers, doesn't it?
`
` 13 A. In what way? I am not sure I understand what
`
` 14 you mean by that.
`
` 15 Q. Well, it's not easy to light, right?
`
` 16 A. Oh, you know, most of these, almost all these
`
` 17 heat-not-burn products come with baggage associated, and my
`
` 18 costs as well, but, yeah, Eclipse has functional issues as
`
` 19 well, that's correct.
`
` 20 Q. Right. And one of those functional issues is it
`
` 21 is not easy to light, right?
`
` 22 A. It's -- it -- I mean, it's hard to say. I mean,
`
` 23 you have got to puff at it pretty hard to get the -- the
`
` 24 carbon heat strokes lit but, once it's lit, it's fine.
`
` 25 But, yeah, it's a little harder than, say, lighting a
`
`
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 5 of 8 PageID# 10737
`
`
`
` 116
`
`
` 1 regular cigarette. You have to kind of puff the first few
`
` 2 times like a cigar and then, once it gets going, it's good.
`
` 3 Q. Another problem with it from the consumer's
`
` 4 perspective is it doesn't really burn down like a
`
` 5 combustible cigarette does, correct?
`
` 6 A. Well, that is correct. No heat-not-burn product
`
` 7 burns down at all because they don't burn, period.
`
` 8 Q. But that's a problem with the Eclipse, correct?
`
` 9 A. It's -- I mean, if it's a consumer issue, it's a
`
` 10 problem with all heat-not-burn products, Eclipse, Glo,
`
` 11 IQOS, et cetera.
`
` 12 Q. Taste, people have also complained about the
`
` 13 taste of the Eclipse as well, right?
`
` 14 A. To some degree, yes, it doesn't taste like a
`
` 15 normal combustible cigarette. But it is certainly a lot
`
` 16 closer than, say, an e-cigarette is to a combustible, than
`
` 17 an e-cigarette.
`
` 18 Q. Okay. So it's fair to say, Dr. Figlar, in the
`
` 19 past 24 years that Eclipse really hasn't been much of a
`
` 20 home-run for Reynolds; is that right?
`
` 21 A. Sadly, it has not performed as well as we had
`
` 22 hoped it would.
`
` 23 Q. Okay. Now, Reynolds actually submitted an MRTPA
`
` 24 for Eclipse, right?
`
` 25 A. Years ago we did just enough to -- the Tobacco
`
`
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 6 of 8 PageID# 10738
`
`
`
` 138
`
`
` 1 tobacco consumers. Also, how is it going to affect people
`
` 2 who aren't using tobacco products? How are the
`
` 3 advertisements going to affect it? Is somebody who quit
`
` 4 using tobacco products going to come back into the category
`
` 5 because of this new product?
`
` 6 All of these considerations have to be done,
`
` 7 which, of course, takes a lot of work and a lot of science
`
` 8 to go around providing that information for the FDA to
`
` 9 render its decision. So it's a very complex road to go
`
` 10 down.
`
` 11 I hope I have explained at least -- I can go
`
` 12 into much more detail if you like, but obviously I have
`
` 13 spent a good deal of time with this, but I hope that helps
`
` 14 frame what a PMTA entails.
`
` 15 JUDGE CHENEY: That's very useful. Thank you.
`
` 16 Has a PMTA been approved for any product at issue in this
`
` 17 investigation, and I mean on either side?
`
` 18 THE WITNESS: The IQOS has been approved from a
`
` 19 PMTA perspective. The -- the heat-not-burn products that
`
` 20 Reynolds had didn't need a PMTA. Eclipse doesn't need a
`
` 21 PMTA because it's a grandfathered product so it's already
`
` 22 lawfully on the market.
`
` 23 And then the -- the decisions around the vapor
`
` 24 products that have been discussed, they are in FDA's hands
`
` 25 right now. So we're awaiting those decisions.
`
`
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 7 of 8 PageID# 10739
`
`
`
` 139
`
`
` 1 JUDGE CHENEY: Okay. Thank you.
`
` 2 THE WITNESS: If that's helpful.
`
` 3 JUDGE CHENEY: Very helpful. Thank you. We now
`
` 4 need to go on the confidential record.
`
` 5 (Whereupon, the trial proceeded in confidential
`
` 6 session.)
`
` 7
`
` 8
`
` 9
`
` 10
`
` 11
`
` 12
`
` 13
`
` 14
`
` 15
`
` 16
`
` 17
`
` 18
`
` 19
`
` 20
`
` 21
`
` 22
`
` 23
`
` 24
`
` 25
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`
`
`Case 1:20-cv-00393-LO-TCB Document 477-8 Filed 03/11/21 Page 8 of 8 PageID# 10740
`
`
`
` 284
`
`
` 1 CERTIFICATE OF REPORTER
`
` 2 TITLE: Certain Tobacco Heating Articles
`
` 3 INVESTIGATION NO: 337-TA-1199
`
` 4 HEARING DATE: January 25, 2021
`
` 5 LOCATION: Washington, D.C. - Remote
`
` 6 NATURE OF HEARING: Evidentiary Hearing
`
` 7 I hereby certify that the foregoing/attached
` transcript is a true, correct and complete record of the
` 8 above-referenced proceedings of the U.S. International
` Trade Commission.
` 9 Date: January 25, 2021
`
` 10 SIGNED:
`
` 11 Signature of the Contractor of the
` Authorized Contractor's Representative
` 12 1220 L Street, N.W, Suite 206
` Washington, D.C. 20005
` 13
` I hereby certify that I am not the Court Reporter
` 14 and that I have proofread the above-referenced transcript
` of the proceedings of the U.S. International Trade
` 15 Commission, against the aforementioned Court Reporter's
` notes and recordings, for accuracy in transcription in the
` 16 spelling, hyphenation, punctuation and speaker
` identification and did not make any changes of a
` 17 substantive nature. The foregoing/attached transcript is a
` true, correct and complete transcription of the
` 18 proceedings.
`
` 19 SIGNED:
` Signature of Proofreader
` 20
` I hereby certify that I reported the above-referenced
` 21 proceedings of the U.S. International Trade Commission and
` caused to be prepared from my tapes and notes of the
` 22 proceedings a true, correct and complete verbatim recording
` of the proceedings.
` 23
` SIGNED:
` 24 Signature of the Court Reporter
`
` 25
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`