Case 1:20-cv-00393-LMB-WEF Document 1462-9 Filed 04/05/23 Page 1 of 5 PageID# 39623
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`Exhibit 9
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`Case 1:20-cv-00393-LMB-WEF Document 1462-9 Filed 04/05/23 Page 2 of 5 PageID# 39624
`CONTAINS CONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
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`RAI STRATEGIC HOLDINGS, INC. and
`R.J. REYNOLDS VAPOR COMPANY
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`Plaintiffs and Counterclaim
`Defendants,
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`v.
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`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTS S.A.
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`Defendants and Counterclaim
`Plaintiffs.
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`Case No. 1:20-cv-00393-LO-TCB
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`
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`PHILIP MORRIS PRODUCTS S.A.’S SUPPLEMENTAL RESPONSE TO
`REYNOLDS’ SIXTH SET OF INTERROGATORIES (NO. 23)
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`Case 1:20-cv-00393-LMB-WEF Document 1462-9 Filed 04/05/23 Page 3 of 5 PageID# 39625
`CONTAINS CONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
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`DEF_PUB_EDVA000057941; DEF_PUB_EDVA000057944; DEF_PUB_EDVA000057947;
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`DEF_PUB_EDVA000057956; DEF_PUB_EDVA000057960; DEF_PUB_EDVA000057964;
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`DEF_PUB_EDVA000057968; DEF_PUB_EDVA000057971 DEF_PUB_EDVA000058177;
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`DEF_PUB_EDVA000058180; DEF_PUB_EDVA000058183; DEF_PUB_EDVA000058186;
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`DEF_PUB_EDVA000058190; DEF_PUB_EDVA000058193; DEF_PUB_EDVA000058196;
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`DEF_PUB_EDVA000058199; DEF_PUB_EDVA000058202; DEF_PUB_EDVA000058205;
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`DEF_PUB_EDVA000058208; DEF_PUB_EDVA000058211; DEF_PUB_EDVA000058214;
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`DEF_PUB_EDVA000058217; DEF_PUB_EDVA000058220, DEF_PUB_EDVA000057709;
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`DEF_PUB_EDVA000057706; DEF_PUB_EDVA000057703; DEF_PUB_EDVA000057700;
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`DEF_PUB_EDVA000057697; DEF_PUB_EDVA000057694; DEF_PUB_EDVA000057691;
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`DEF_PUB_EDVA000057688; DEF_PUB_EDVA000057685; DEF_PUB_EDVA000057682;
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`DEF_PUB_EDVA000057679; DEF_PUB_EDVA000057589. It also has issued import alerts,
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`which blocked entry of over 33,000 illegal e-cigarettes in December 2020 alone. ITC Hr’g Tr.
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`1419:9-1420:4,
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`1451:4-22,
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`1452:14-1453:2,
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`1480:3-1481:16
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`(Ehrlich);
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`DEF_PUB_EDVA000057656; DEF_PUB_EDVA000057649. State and local authorities have
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`independently acted against illegal e-cigarettes as well. ITC Hr’g Tr. 1451:4-22 (Ehrlich);
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`DEF_PUB_EDVA000057974.
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`
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`FDA Authorizations For E-Cigarettes, Like VUSE, Cannot Be Assumed
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`The illegal status of the VUSE e-cigarettes may never be cured, as there is no guarantee
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`FDA will grant PMTA authorizations for these products. Earning PMTA authorization is a
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`difficult and time-consuming endeavor. To do so, a product must show it is appropriate for the
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`protection of public health – a level of harm assessment requiring voluminous data that takes years
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`to collect and that must undergo technical review by FDA specialists from a variety of scientific
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`disciplines.
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` 1199_RESP00010615; 1199_RESP00011697 at 1199_RESP00011707-708;
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`Case 1:20-cv-00393-LMB-WEF Document 1462-9 Filed 04/05/23 Page 4 of 5 PageID# 39626
`CONTAINS CONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
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`1199_RESP00010958. And just last month, in March 2021, more than forty Members of Congress
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`sent a letter to FDA demanding that it “deny issuing a marketing order for any e-cigarette that
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`poses an increased risk of youth initiation or addiction.” DEF_PUB_EDVA000056125.
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`Given the concerns over youth use of e-cigarettes, leaders in tobacco control and the
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`tobacco industry have expressed doubts about the viability of any e-cigarette PMTA being
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`authorized. For example, David Kessler, former FDA Commissioner and Co-Chair of President
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`Biden’s Coronavirus Taskforce, “wouldn’t want to bet” on any e-cigarettes surviving the FDA
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`review due to “the explosion in youth use” of those products and the uncertainty in the industry it
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`has caused. 1199_RESP00014222 at 1199_RESP00014224-25; ITC Hr’g. Tr. 1449:18-1450:10
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`(Ehrlich); see ITC Hr’g Tr. 572:21-573:25, 574:4-575:1 (Clissold). Reynolds’ Dr. Figlar and Mr.
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`Clissold both concede there is no guarantee that any e-cigarette will receive PMTA authorization.
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`ITC Hr’g Tr. 99:20-25 (Figlar); ITC Hr’g Tr. 564:10-16 (Clissold).
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`PMTAs for flavored e-cigarettes, like many submitted by Reynolds, face even greater
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`scrutiny. ITC Hr’g Tr. 1450:17-24, 1487:1-19 (Ehrlich); Figlar ITC Dep. 51:8-17, 87:4-14;
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`1199_RESP00012998; 1199_RESP00016076. In its Guidance on Enforcement Priorities for
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`ENDS, FDA stated that it is “concerned about the extraordinary popularity of flavored ENDS
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`products with youth,” particularly flavored cartridge-based e-cigarettes. 1199_RESP00014118 at
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`1199_RESP00014131; see DEF_PUB_EDVA000057623 at DEF_PUB_EDVA000057625
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`(describing flavors as the “core” of the epidemic rise in youth use of ENDS). Accordingly, FDA
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`has instructed that “[b]ecause of the potential impact of flavors on product toxicity and appeal to
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`youth and young adults, scientific reviews of flavors (e.g., toxicological analyses of flavor
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`additives, chemistry analyses, clinical studies, literature reviews) should be included in a PMTA
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`for an e-liquid.” 1199_RESP50000280 at 1199_RESP50000323.
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`25
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`Case 1:20-cv-00393-LMB-WEF Document 1462-9 Filed 04/05/23 Page 5 of 5 PageID# 39627
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this 8th day of June, 2021, I caused the foregoing to be served on
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`the following Plaintiffs/Counterclaim Defendants using
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`the designated email address:
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`RJREDVA@jonesday.com.
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`/s/ Maximilian A. Grant
`
`Maximilian A. Grant (VSB No. 91792)
`LATHAM & WATKINS LLP
`555 Eleventh Street, N.W., Suite 1000
`Washington, DC 20004
`Telephone: (202) 637-2200
`Facsimile: (202) 637-2201
`Email: max.grant@lw.com
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`Counsel for Defendant and Counterclaim
`Plaintiff Philip Morris Products S.A.
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