Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 1 of 7 PageID# 10710
`Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 1 of 7 Page|D# 10710
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`EXHIBIT 6
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`EXHIBIT 6
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`Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 2 of 7 PageID# 10711
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`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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`Place:
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`Date:
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`556 through 829 (with excerpts)
`Washington, D.C.
`January 27, 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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`Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 3 of 7 PageID# 10712
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` 536
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` 1 you -- let me ask you about the final category, because
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` 2 that's what the last couple of questions relate to.
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` 3 A. Sure.
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` 4 Q. This -- this final category of products that
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` 5 have their applications pending before FDA, are those
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` 6 products allowed to be sold and continue to be sold while
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` 7 their application is pending before FDA?
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` 8 A. Yes. Under both the court order and under FDA's
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` 9 enforcement discretion policy that has been publicly
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` 10 announced, those products can be marketed for the next year
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` 11 while undergoing FDA review, as long as they submitted an
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` 12 application by that September 9th deadline.
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` 13 Q. Okay. In terms of statements by FDA, in terms
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` 14 of what FDA has said, has FDA ever said that it is going to
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` 15 take enforcement action against any product that had a
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` 16 timely-filed PMTA, even at the expiration of that year?
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` 17 A. FDA has not said that they are going to do that
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` 18 at the end of that year.
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` 19 Q. Okay. And there -- there's been a suggestion, I
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` 20 think you were -- you were listening to the opening
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` 21 statements yesterday, a suggestion made by Respondents
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` 22 yesterday that products will be removed from the market or
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` 23 may be unavailable after the expiration of this year period
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` 24 if there is no ruling made by FDA.
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` 25 Based on your knowledge of what products are on
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`Heritage Reporting Corporation
`(202) 628-4888
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`Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 4 of 7 PageID# 10713
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` 537
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` 1 the market and when PMTAs were filed, what's your opinion
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` 2 about that?
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` 3 A. Yeah, so the -- the opening statement yesterday
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` 4 seemed to imply that one year after the application was
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` 5 submitted, if FDA hadn't approved it, the -- the product
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` 6 would have to be taken off the market.
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` 7 I -- I am not aware that that's FDA's policy.
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` 8 And, in fact, if it was, we would have heard about a lot of
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` 9 PMTAs being withdrawn because FDA usually takes longer than
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` 10 a year, at least historically, to review a PMTA.
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` 11 And I'm not aware of any such statement or -- or
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` 12 policy.
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` 13 Q. Just by way of example, again, for one product,
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` 14 I think it was mentioned -- there was a discussion about a
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` 15 Vuse products that had a PMTA filing in October of 2019.
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` 16 Do you recall that discussion from yesterday?
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` 17 A. Yes, yes.
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` 18 Q. Is that product -- that would have expired in
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` 19 October of last year. Is that product still on the market
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` 20 today?
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` 21 A. Yes, it is.
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` 22 Q. Has FDA ever taken enforcement action against
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` 23 that product?
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` 24 A. Not at all.
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` 25 Q. Have they indicated any intent to or desire to?
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`Heritage Reporting Corporation
`(202) 628-4888
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`Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 5 of 7 PageID# 10714
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` 1 A. Not to my knowledge, no.
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` 2 MR. BAYUK: That's all the questions I have.
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` 3 Thank you, Mr. Clissold.
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` 4 MR. GRANT: Your Honor, perhaps just a half a
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` 5 dozen questions, if it please the Court, before we end the
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` 6 day?
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` 7 JUDGE CHENEY: What does half a dozen questions
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` 8 mean for time to you?
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` 9 MR. GRANT: Five minutes.
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` 10 JUDGE CHENEY: Okay. Let me ask Mr. Clissold,
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` 11 how do you feel about that?
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` 12 THE WITNESS: Fine.
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` 13 JUDGE CHENEY: Okay. Let me check in with
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` 14 Ms. Sladic. What is your cross looking like?
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` 15 MS. SLADIC: Currently, the Staff does not have
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` 16 any questions. We'll see where Respondents go. And I
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` 17 might have a few follow-ups, but --
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` 18 JUDGE CHENEY: Okay.
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` 19 MR. GRANT: Your Honor, I want to be clear. My
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` 20 cross-examination is longer than five minutes, but I was
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` 21 asking to begin it and do the first five minutes. That's
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` 22 what I was asking.
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` 23 JUDGE CHENEY: Oh, we're not going to do that.
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` 24 MR. GRANT: Okay.
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` 25 JUDGE CHENEY: Yeah, we are done with our
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`Heritage Reporting Corporation
`(202) 628-4888
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`Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 6 of 7 PageID# 10715
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` 571
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` 1 yes.
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` 2 Q. Okay. You can take that down, please.
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` 3 Now, you talked a little bit about what's going
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` 4 to happen based on this court order in Maryland in your
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` 5 direct examination. You're aware that because of the court
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` 6 ruling in this Maryland case, American Academy of
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` 7 Pediatrics versus FDA, that if a PMTA was submitted by the
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` 8 September 9, 2020 deadline, that the FDA would allow a
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` 9 product to remain on the market for up to one year, unless
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` 10 there's a negative action by the FDA on the application.
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` 11 That's the current state of the law, isn't it?
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` 12 A. That's the order, yes, sir.
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` 13 Q. Okay. Now -- and, again, this is something that
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` 14 you covered on direct. As you read the court order, if the
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` 15 FDA wanted to extend that one-year grace period that begins
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` 16 with the date of application, it would have to go back and
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` 17 ask permission of the court, right?
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` 18 A. Yeah.
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` 19 Q. And just because a product is available doesn't
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` 20 mean that it's on the market in compliance with that court
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` 21 order, does it?
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` 22 A. So, yeah, there could be products that have not
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` 23 submitted a PMTA yet and yet remain on the market.
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` 24 Q. Right. There are products that are on the
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` 25 market unlawfully, right, or not in accordance with the
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`Heritage Reporting Corporation
`(202) 628-4888
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`

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`Case 1:20-cv-00393-LO-TCB Document 477-5 Filed 03/11/21 Page 7 of 7 PageID# 10716
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` 829
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` 1 CERTIFICATE OF REPORTER
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` 2 TITLE: Certain Tobacco Heating Articles
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` 3 INVESTIGATION NO: 337-TA-1199
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` 4 HEARING DATE: January 27, 2021
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` 5 LOCATION: Washington, D.C. - Remote
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` 6 NATURE OF HEARING: Evidentiary Hearing
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` 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 27, 2021
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` 10 SIGNED:
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` 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.
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` 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.
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` SIGNED:
` 24 Signature of the Court Reporter
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` 25
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`Heritage Reporting Corporation
`(202) 628-4888
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