Case 1:20-cv-00393-LO-TCB Document 829-2 Filed 01/21/22 Page 1 of 3 PageID# 21594
`Case 1:20-cv-00393-LO-TCB Document 829-2 Filed 01/21/22 Page 1 of 3 PagelD# 21594
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`EXHIBIT 2
`EXHIBIT 2
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`Case 1:20-cv-00393-LO-TCB Document 829-2 Filed 01/21/22 Page 2 of 3 PageID# 21595
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`RAI Strategic Holdings, Inc.
`and
`R.J. Reynolds Vapor Company
`v.
`Altria Client Services LLC,
`Philip Morris USA, Inc.,
` and Philip Morris Products S.A.
`
`
`Civil Action No. 1:20-cv-00393-LO-TC
`
`Amended and Supplemental Opening Expert Report
`of Paul K. Meyer
`
`TM Financial Forensics, LLC
`April 26, 2021
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`CONFIDENTIAL BUSINESS INFORMATION – SUBJECT TO THE PROTECTIVE ORDER
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`Case 1:20-cv-00393-LO-TCB Document 829-2 Filed 01/21/22 Page 3 of 3 PageID# 21596
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`49.
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`December 7, 2020.52 And, on July 7, 2020, the FDA authorized marketing of IQOS as a
`MRTP.53 In contrast, to date, no e-cigarette has received PMTA authorization. Indeed,
`former FDA Commissioner David Kessler stated that he “wouldn’t bet on” any e-
`cigarettes surviving the FDA review.54
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`I understand that one major impediment to PMTA authorization for e-cigarettes is
`concern over youth use/abuse of e-cigarettes, a concern was expressed by, for example,
`the FDA, HHS, and CDC.55 In contrast, I understand that IQOS’ characteristics and sales
`practices position it away from youth use.56 For example, IQOS does not come in fruit
`or candy flavors that are more likely to appeal to youth, and is sold with restrictions that
`impede access to the product by nonsmokers and youth.57 I understand that the FDA did
`not find youth abuse of IQOS but, instead, observed that “[t]he data from countries where
`IQOS® is marketed, specifically Italy and Japan, show low uptake by youth and current
`nonsmokers,” and that “limited options in terms of flavor choice and the price of the
`IQOS® device may reduce the appeal to youth,” concluding that “[o]verall, the current
`evidence indicates IQOS® uptake by youth and nonsmokers will be low.”58
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`50.
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`I understand that IQOS was uniquely designed to appeal to smokers not only by delivering
`nicotine but by approximating as closely as possible the overall sensorial experience of
`smoking—an experience which, as I discuss throughout this Report, is highly valued by
`consumers.59
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`52 https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-
`marketing-orders; https://www fda.gov/media/144701/download.
`53 https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-iqos-tobacco-heating-system-
`reduced-exposure-information; deposition of Nicholas Gilley (Reynolds Vice President of Marketing Performance),
`December 3, 2020: pp. 150, 265.
`54 “Former FDA chief: ‘I don’t see how’ regulators keep Juul, other e-cigarettes, on the market,” October 25, 2019:
`1199_RESP00014222-229 (at 222, 224).
`55 Based on discussions with Stacy Ehrlich; https://www fda.gov/news-events/press-announcements/fda-warns-
`firms-remove-unauthorized-e-liquid-products-market-first-letters-issued-manufacturers-did.
`56 Based on discussions with Stacy Ehrlich.
`57 See, e,g., “Altria launches Iqos tobacco device in US, and the timing couldn’t be better,” CNBC, October 4, 2019:
`1199_RESP50006476-484 (at 479-480).
`58 PMTA Coversheet: Technical Project Lead Review (TPL), May 15, 2017: 1199_RESP00011697-818 (at 772).
`59 “Factors that influence smokers’ and ex-smokers’ use of IQOS: a qualitative study of IQOS users and ex-users in
`the UK,” Tompkins, Charlotte N E, November 23, 2019:
`https://tobaccocontrol.bmj.com/content/tobaccocontrol/30/1/16 full.pdf, p. 20: 1199_RESP00011896-903 (at 900)
`(“Participants commonly claimed that the overall sensory experience of using IQOS was equivalent to, or better than
`smoking combustible cigarettes, which accounted for continued use.”).
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`CONFIDENTIAL BUSINESS INFORMATION – 18 of 178
`SUBJECT TO PROTECTIVE ORDER
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