Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 1 of 5 PageID# 18883
`Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 1 of 5 Page|D# 18883
`
`
`
`
`
`
`EXHIBIT 16
`
`EXHIBIT 16
`
`
`

`

`Reynolds Completes 2020 PMTA Submissions with Vuse Alto E-Cigarette Applications
`Page 1 of 4
`Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 2 of 5 PageID# 18884
`Case 1:20-cv-OO393-LO-TCB Document 729-6 Filed 06/16/21 Page 2 of 5 Page|D# 18884
`
`We use cookies to
`
`personalise content and
`
`ads, to provide social
`media featu es nd to
`
`' our social rn di
`
`,
`
`RQWWCOm P 'stmsmpz'w
`Submissloms With Vuse Alto
`E-ifiigasefie Applications
`CrogprggrsAIto applications are final FDA submission for deemed
`products, representing both Vuse and VELO portfolios
`
`.
`
`.
`
`-- Reynolds completes 2020 deemed product PMTA submissions for
`one of the broadest portfolios in the industry
`
`-- Reynolds has provided the FDA with more than 530,000 pages of
`scientific data for review as pa rt of all PMTA applications submitted
`
`-- More than 8,600 scientific documents were submitted as part of the
`six grouped filings made
`
`NEWS PROVIDED BY
`
`Reynolds American Inc. —'
`
`Sep 04, 2020,1058 ET
`
`WINSTON-SALEM, N.C., Sept. 4, 2020 /PRNewswire/-- Reynolds American Inc.
`
`("Reynolds") announces today its final submission of a group of Premarket
`
`Tobacco Product Applications ("PMTAs") to the US. Food and Drug
`
`Administration ("FDA") through RJ. Reynolds Vapor Company ("RJRV"), seeking
`
`orders authorizing the marketing of Vuse Alto electronic nicotine delivery
`
`systems ("ENDS") under Section 910(c)(l)(A)(i) of the Federal Food, Drug, and
`
`Cosmetic Act ("FD&C Act" or the "Act"), as amended by the Family Smoking
`
`Prevention and Tobacco Control Act.
`
`https://www.prnewswire.com/news-releases/reynolds-completes-ZOZO-pmta-submissions-. ..
`
`9/13/2020
`1199_RESP00016076
`
`

`

`Reynolds Completes 2020 PMTA Submissions with Vuse Alto E-Cigarette Applications
`Page 2 of 4
`Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 3 of 5 PageID# 18885
`Case 1:20-cv-OO393-LO-TCB Document 729-6 Filed 06/16/21 Page 3 of 5 Page|D# 18885
`
`Today/'5~ Lcjzjsrtcg)géaoéaiggclféplications concludes a multi-year application process
`laungmgqgfimefJDA's September 9,2020 deadline for PMTAs. Reynolds
`
`first @Gbrfifiififé‘ddé WWA application in October of 2019 for Vuse Solo, and
`cl“
`t
`d t
`submniet goleaadudiififcghalépplications for its Vuse Ciro and V .
`'
`,.
`.- o o ucts
`
`ana yse ourtra 10.
`e
`_
`_
`.
`in Agrgbgkagzgommlications for VELCB WM pou-
`80508811 uted
`
`in Aegastseritnseyéawfiwe VELO product PMTAs have been accepted by the FDA
`with our social m _d_ia,
`afterat vgllisfi‘nu %%tanlél}%e¥Vh'le the Vuse products are currently In substantive
`scierplgifiicereview by the FDA.
`
`"Completing our 2020 PMTA submissions is a key milestone for us as we continue
`
`creating innovative products responsibly —so adult tobacco consumers have a
`
`choice available when they are ready for an alternative to combustible tobacco
`
`products," noted Guy Meld rum, the CEO of Reynolds American. "Today marks
`
`completion of a critical hurdle of submitting PMTAs for every newly-deemed
`
`tobacco product offered by Reynolds for one of the broadest portfolios of
`
`products in the industry."
`
`Thirteen Vuse Alto ENDS products are included in the Vuse Alto PMTAs,
`
`comprised of an ENDS component (the Vuse Alto Power Unit) and 12 closed
`
`e-liquid cartridges. Vuse Alto Cartridges are available in four flavors, each in three
`
`nicotine levels. The Vuse Alto Power Unit works in combination with all 12 closed
`
`e-liquid cartridges.
`
`Vuse Alto currently offers flavor pods in Menthol, Rich Tobacco and Golden
`
`Tobacco via www.vusevapor.com and retailers nationwide. A PMTA was also
`
`submitted for Mixed Berry flavor pods.
`
`If the Vuse Alto PMTAs receive a
`
`marketing order from the FDA, adult consumers would have four flavor options in
`
`a variety of nicotine levels to suit their preferences.
`
`https://www.prnewswire.com/news-releases/reynolds-completes-2020-pmta-submissions-. ..
`
`9/13/2020
`1199_RESP00016077
`
`

`

`Reynolds Completes 2020 PMTA Submissions with Vuse Alto E-Cigarette Applications
`Page 3 of 4
`Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 4 of 5 PageID# 18886
`Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 4 of 5 Page|D# 18886
`
`The Vuse brand offers innovative vapor products for adult tobacco consumers
`We use cookies to
`
`evolwagopgeggmgfi arreflecting a longstanding commitment to transform the
`
`tobamlfiwfiesfiy Wléleveloping products that are innovative, consumer-
`accemedalgegtfir Srémd to sibl marketed.
`Email};
`ERR/3
`y
`se our tra Ic
`also share information
`
`_
`_
`) Cookie Settings
`mm
`
`_
`J Accept Cookies
`
`about y'glur use four
`Dr. James gularImee {to ioles' Executive Vice President and Head of Scientific &
`Wl th ours CIal
`Reglélakgfiggfig‘fauasamgzfig "In order to provide regulators with confidence in
`
`know‘il‘ilgerfibw these important products are made, marketed and regulated, we
`
`sought to build a package of the available best science to describe product
`
`analyses, information on human health risks, and assessments showing that
`
`these Vuse Alto products are appropriate for the protection of public health —
`
`including assessments on users and nonusers of tobacco products."
`
`Dr. Figlar continued: "Additionally, we are heartened by the FDA's recent
`
`enforcement actions against illegally marketed tobacco products, as well as their
`
`recent decision to make public a list of legally sold tobacco products for which
`
`PMTAs were submitted by the deadline, which will make it easier for retailers to
`
`identify illegal products that should be pulled from shelves after September 9.
`
`This sort of regulatory enforcement ensures consumers have up-to-date, reliable
`
`information available on these highly-regulated products."
`
`The PMTA process allows the FDA to evaluate whether these products should
`
`remain on the market as part of the FDA's public health mission. While these
`
`commercially proprietary applications include relative risk information based on
`
`FDA guidance, the marketing orders sought do not make modified risk claims
`
`regarding Vuse or VELO products.
`
`About Reynolds American Inc.
`
`https://www.prnewswire.com/news-releases/reynolds-completes-2020-pmta-submissions-. ..
`
`9/13/2020
`1199_RESP00016078
`
`

`

`Reynolds Completes 2020 PMTA Submissions with Vuse Alto E-Cigarette Applications
`Page 4 of 4
`Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 5 of 5 PageID# 18887
`Case 1:20-cv-00393-LO-TCB Document 729-6 Filed 06/16/21 Page 5 of 5 Page|D# 18887
`
`Reynolds American Inc. is an indirect, wholly owned subsidiary of British
`We use cookies to
`
`Amegrgcarhggbagggrplagd and the US. parent company of R. J. Reynolds Tobacco
`
`Cor‘rfifi’énly same Féclfi‘atural Tobacco Company, Inc.; American Snuff Company,
`e i
`featur s a
`to
`,
`,
`LLC; Rifle noilds wor Company; and Kentucky BioPro -
`no.
`a
`
`e
`analyse urtraf IC.
`also share information
`
`_
`_
`) Cookie Settings
`
`_
`J Accept Cookies
`
`- 81303:: %§i#8foiszglbsat§co Company (RJ RT) is the second-largest U.S. tobacco
`With our OCla media,
`mmpagfimglstpgands include Newport, Camel and Pall Mall.
`
`- ngfiQESFe Natural Tobacco Company, Inc. manufactures and markets Natural
`
`American Spirit products in the United States.
`
`- American Snuff Company, LLC is the nation's second-largest manufacturer
`
`ofsmokeless tobacco products. Its leading brands are Grizzly and Kodiak.
`
`- R. J. Reynolds Vapor Company (RJRV) markets vapor products and modern
`
`oral products, including VUSE, VELO and REVEL.
`
`- Kentucky BioProcessing, Inc. conducts research and development related to
`
`protein expression and extraction from tobacco plants.
`
`To learn more about Reynolds American Inc. and its operating companies, please
`
`visit www.reynoldsamerican.com.
`
`Engage Socially
`
`Twitter: https://www.twitter.com/RAI_News
`
`Linked I n: https://www.l inkedin.com/compa ny/rj-reynolds/
`
`Facebook: https://www.facebook.com/ReynoldsAmericanInc/
`
`SOURCE Reynolds American Inc.
`
`https://www.prnewswire.com/news-releases/reynolds-completes-2020-pmta-submissions-. ..
`
`9/13/2020
`1199_RESP00016079
`
`