Case 1:20-cv-00393-LO-TCB Document 1017-5 Filed 02/11/22 Page 1 of 7 PageID# 28801
`Case 1:20-cv-00393-LO-TCB Document 1017-5 Filed 02/11/22 Page 1 of 7 PagelD# 28801
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`EXHIBIT E
`EXHIBIT E
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`Case 1:20-cv-00393-LO-TCB Document 1017-5 Filed 02/11/22 Page 1 of 7 PagelD# 28801
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`EXHIBIT E
`EXHIBIT E
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`Case 1:20-cv-00393-LO-TCB Document 1017-5 Filed 02/11/22 Page 2 of 7 PageID# 28802
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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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`1396 through 1603
`Washington, D.C.
`February 1, 2021
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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 1017-5 Filed 02/11/22 Page 3 of 7 PageID# 28803
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` 1396
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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, February 1, 2021
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` 17
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` 18 EVIDENTIARY HEARING - VOLUME VI - 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 1017-5 Filed 02/11/22 Page 4 of 7 PageID# 28804
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` 1403
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` 1 JUDGE CHENEY: Please proceed, Mr. Grant.
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` 2 MR. GRANT: Thank you, Judge.
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` 3 DIRECT EXAMINATION
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` 4 BY MR. GRANT:
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` 5 Q. Can you please introduce yourself to the Judge
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` 6 and tell him what you do?
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` 7 A. Yes. Good morning, Judge Cheney. My name is
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` 8 Stacy Ehrlich. I'm a partner at the law firm of
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` 9 Kleinfield, Kaplan & Becker in Washington, D.C., where I've
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` 10 practiced for the last 25 years.
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` 11 Q. And where did you go to law school?
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` 12 A. I went to Harvard Law School.
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` 13 Q. Can you tell the Judge what sort of law you
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` 14 practice?
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` 15 A. Sure. My expertise and -- and that of my firm
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` 16 is -- is FDA regulatory law for the most part. I also do
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` 17 some Federal Trade Commission advertising law, and for the
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` 18 last decade or so, a large percentage of my practice has
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` 19 focused on tobacco and nicotine products.
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` 20 Q. Okay. Now, have you worked on any of these
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` 21 tobacco substantial equivalence applications that we've
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` 22 heard a lot about?
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` 23 A. Yes. Since 2011, I've worked on at least 100
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` 24 substantial equivalence reports, at least dozens of which
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` 25 have been authorized by FDA.
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`Heritage Reporting Corporation
`(202) 628-4888
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`Case 1:20-cv-00393-LO-TCB Document 1017-5 Filed 02/11/22 Page 5 of 7 PageID# 28805
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` 1404
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` 1 Q. Okay. And we've heard a lot of talk about
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` 2 PMTAs. Have you advised on any of those?
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` 3 A. Yeah, I would say I've advised on at least 15
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` 4 PMTAs, and one -- one of -- most are still pending, but one
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` 5 has been authorized.
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` 6 Q. Okay. And I think we heard that -- from
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` 7 Mr. Clissold that he hadn't worked on any MRTPAs, and from
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` 8 Ms. Gilchrist, they're fairly rare. Have you worked on any
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` 9 of those?
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` 10 A. Yes. In fact, I have worked on one MRTP that
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` 11 has been authorized by FDA.
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` 12 Q. Okay. Have you been recognized by any outside
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` 13 organizations for your work in FDA law?
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` 14 A. Yes, for example, I routinely am recognized in
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` 15 the Best Lawyers of America and Super Lawyers for FDA law.
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` 16 Q. Okay. And outside of your practice and your
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` 17 client work, can you describe your professional involvement
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` 18 in FDA regulatory issues relating to tobacco products?
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` 19 A. Sure, I speak and write very frequently on these
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` 20 issues. I also served a term on the Board of Directors of
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` 21 the Food & Drug Law Institute, and I'm currently serving my
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` 22 second term on the FDL I Tobacco and Nicotine Products
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` 23 Committee.
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` 24 MR. GRANT: Your Honor, at this time, we would
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` 25 tender Ms. Ehrlich as an expert in the field of FDA law and
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`Heritage Reporting Corporation
`(202) 628-4888
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`Case 1:20-cv-00393-LO-TCB Document 1017-5 Filed 02/11/22 Page 6 of 7 PageID# 28806
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` 1416
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` 1 A. Yeah, the judge focused a lot on that issue. It
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` 2 found that there was an epidemic-level rise in -- in youth
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` 3 use of e-cigarettes, and it observed that this was a clear
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` 4 public health crisis.
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` 5 Q. Okay. In light of those findings, what did the
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` 6 judge order in the case?
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` 7 A. So the judge ordered that all applications
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` 8 needed to be submitted by September 9th, 2020, and for
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` 9 timely filed PMTAs, they could stay on the market while FDA
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` 10 reviewed any pending PMTAs for up to one year.
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` 11 Q. Okay. Per the court's order, when does that
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` 12 one-year grace period begin?
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` 13 A. The -- the beginning of that one-year grace
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` 14 period is -- is the -- the application's filing.
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` 15 Q. Okay. Does the FDA's sort of discretionary
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` 16 level of enforcement impact in any way the status of
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` 17 products that are sold that are not in compliance with the
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` 18 Maryland District Court's order as being either lawful or
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` 19 unlawful?
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` 20 A. No. All -- like I said, all e-cigarette
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` 21 products are illegal products. And those that are not
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` 22 covered by the Maryland court's enforcement discretion
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` 23 policy are subject to immediate enforcement and -- and are
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` 24 not permitted on the market.
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` 25 Q. Now, we had some witnesses testify that the
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`Heritage Reporting Corporation
`(202) 628-4888
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`Case 1:20-cv-00393-LO-TCB Document 1017-5 Filed 02/11/22 Page 7 of 7 PageID# 28807
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` 1477
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` 1 JUDGE CHENEY: So no -- so no one-year period is
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` 2 applicable to IQOS; is that -- am I picking that up
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` 3 correctly?
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` 4 THE WITNESS: Right. Well, IQOS is authorized.
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` 5 So it would -- it wouldn't matter anyway. The one-year
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` 6 period is only for products that are required to be
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` 7 authorized and have not obtained authorization.
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` 8 So -- so that -- but also IQOS is not considered
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` 9 deemed product. So for many reasons, it doesn't apply to
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` 10 IQOS.
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` 11 JUDGE CHENEY: Is it your expert opinion that
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` 12 the Vuse products are being sold illegally?
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` 13 THE WITNESS: Yes, they are illegal products.
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` 14 JUDGE CHENEY: Is there a difference between
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` 15 being marketed illegally and being sold illegally? And the
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` 16 reason I ask that question, if it helps you understand it,
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` 17 is whether the distinctions that some people are making in
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` 18 this case have to do with marketing statements versus the
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` 19 sale of the product?
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` 20 THE WITNESS: Right, no, I mean -- I'm sorry.
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` 21 JUDGE CHENEY: So to rephrase my question, does
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` 22 the one-year period apply to marketing statements, sales of
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` 23 products, or both?
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` 24 THE WITNESS: So the product itself is illegal.
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` 25 So any sales of the product would be illegal. I suppose if
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`Heritage Reporting Corporation
`(202) 628-4888
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`
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