Case 1:20-cv-00393-LO-TCB Document 881-1 Filed 01/21/22 Page 1 of 69 PageID# 23478
`Case 1:20-cv-00393-LO-TCB Document 881-1 Filed 01/21/22 Page 1 of 69 PagelD# 23478
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`EXHIBIT 1
`EXHIBIT1
`(PUBLIC)
`(PUBLIC)
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
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`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
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`RAL STRATEGIC HOLDINGS, INC. and
`R.J. REYNOLDS VAPOR COMPANY,
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`Plaintiffs and Counterclaim
`Defendants,
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`Civil Action No. 1:20-cv-393
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`v.
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`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTSS.A.,
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`Defendants and Counterclaim
`Plaintiffs.
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`AMENDED AND SUPPLEMENTED OPENING EXPERT REPORT
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`OF STACY EHRLICH
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`
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`426/91
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`Stacy Ehrlich
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`April 26, 2021
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`I.
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`SCOPE OF REPORT
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`1.
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`I was retained on behalf of Plaintiffs Altria Client Services, LLC (ACS), Philip
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`Morris USA, Inc. (PM USA), and Philip Morris Products S.A. (PMP) (collectively, Plaintiffs) to
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`provide opinions in the above-captioned case against Defendants RAI Strategic Holdings, Inc.
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`(RAISH) and R.J. Reynolds Vapor Company (RJRV) (collectively, Reynolds) regarding certain
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`aspects of damages related to Reynolds’ infringement of U.S. Patent Nos. 6,803,545 (the ’545
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`Patent); 10,104,911 (the ’911 Patent); 10,420,374 (the ’374 Patent); 10,555,556 (the ’556 Patent);
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`and 9,814,265 (the ’265 Patent), (collectively, Asserted Patents).1 Specifically, I was asked to
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`opine on the importance of the Asserted Patents to Reynolds in relation to its pursuit of premarket
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`authorization via premarket tobacco applications (PMTAs) and its pursuit of modified risk
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`authorization via modified risk tobacco product applications (MRTPAs) from the U.S. Food and
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`Drug Administration (FDA) for its VUSE e-cigarettes.2
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`2.
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`I submitted my initial opening expert report in this matter on February 24, 2021. I
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`understand that, since that date, additional depositions have been taken and additional documents
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`have been produced, including but not limited to, communications between FDA and Reynolds.
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`Accordingly, I have prepared this amended and supplemental report (“Report”) to account for the
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`additional evidence received after February 24, 2021, and to supersede my previous submission.3
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`3.
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`It is my opinion that, from a regulatory perspective, Reynolds derives particular
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`benefit from its infringement of the Asserted Patents because this technology is involved in and
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`important to FDA’s PMTA review of Reynolds’ VUSE e-cigarettes. Premarket authorization is
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`1 For purposes of my Report, I have assumed that Reynolds infringes the Asserted Patents. I
`offer no technical opinion related thereto.
`2 “E-cigarettes” also are known as “ENDS” products or “vaping” or “vape” products.
`3 I also have made corrections to certain footnote citations.
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`valuable and vital to Reynolds, given that, without it, its e-cigarettes will remain illegal and may
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`be forced off the U.S. market pursuant to provisions within the Federal Food, Drug, and Cosmetic
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`Act (FDCA).
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`4.
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`It is my opinion that, from a regulatory perspective, Reynolds derives particular
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`benefit from its infringement of the Asserted Patents because this technology is involved in and
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`important to FDA’s MRTPA review of Reynolds’ VUSE e-cigarettes.
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`.
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`II.
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`CREDENTIALS AND COMPENSATION
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`5.
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`I have been an attorney with Kleinfeld Kaplan and Becker LLP (KKB) in
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`Washington, DC since 1996. KKB is a boutique law firm established in 1967 that focuses on the
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`regulation of products under the jurisdiction of FDA and related federal and state agencies,
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`including the U.S. Federal Trade Commission (FTC).
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`6.
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`I have a B.A. in English, magna cum laude, from Emory University in Atlanta,
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`Georgia, and a J.D., cum laude, from Harvard Law School. I am admitted to practice in the District
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`of Columbia. I have been recognized by The Best Lawyers in America and Super Lawyers for
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`FDA Law. My Curriculum Vitae is included as Exhibit 1.
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`7.
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`I have been extensively involved in FDA’s regulation of tobacco and nicotine
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`products since prior to the enactment of the Family Smoking Prevention and Tobacco Control Act
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`(TCA) in 2009. I regularly advise clients in these industries, including serving as outside counsel
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`to the Coalition of Independent Tobacco Manufacturers of America, with whom I worked to
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`negotiate the small business provisions of the TCA. Over the past decade, I have counseled many
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`clients with respect to the development and preparation of tobacco product premarket submissions
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`to FDA, assisting numerous companies in obtaining marketing orders for their products.
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`8.
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`Additionally, I speak and write extensively on issues related to FDA regulation,
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`including nicotine and tobacco product regulation and enforcement. I have served on the Board
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`of Directors of the Food and Drug Law Institute (FDLI), and I am currently serving my second
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`term on the FDLI Tobacco and Nicotine Products Committee.
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`9.
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`10.
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`I am being compensated at the rate of $825 per hour.
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`Neither I nor my law firm has an interest in the outcome of this matter.
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`III. MATERIALS REVIEWED
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`11.
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`To inform my opinions in this Report, I have relied on the Initial Expert Reports4
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`of and interviews with Paul Meyer (for damages), Joseph McAlexander (for the ’545 and ’374
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`Patents), John Abraham (for the ’911 and ’556 Patents), and Henry Walbrink (for the ’265 Patent),
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`including, but not limited to, their descriptions of the characteristics of the Asserted Patents.
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`12.
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`A list of materials I considered in preparing this Report is included as Exhibits 2
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`(updated) and 3. I also relied on the education, experience, and knowledge that I have gained from
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`working in the FDA arena for over two decades.
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`13.
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`The materials referenced in my Report are exemplary in nature and intended to aid
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`understanding. I may rely at trial on these materials, as well as other documents and items
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`produced in this case, such as deposition exhibits, deposition and trial testimony, discovery
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`responses, and publicly available materials. I reserve the right to use visual aids, demonstratives,
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`and physical evidence at trial, including any materials that I considered in forming the opinions
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`described in this Report.
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`4 This includes any amendments and/or supplementation to these reports.
`4
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`14.
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`I understand that fact discovery remains ongoing as of the date of this Report, and
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`there are depositions still to be taken and discovery responses still to be answered. I therefore
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`reserve the right to amend, modify, or supplement my opinions if additional information becomes
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`available, including any information identified by Reynolds or any third party, testimony from
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`depositions yet to taken, any opinions rendered by Reynolds’ experts, or any relevant orders from
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`the Court. I also reserve the right to provide rebuttal opinions in response to opinions from any
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`experts and testimony from any fact witness.
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`IV. RELEVANT BACKGROUND
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`15.
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`I understand that Reynolds filed a patent infringement lawsuit against the Plaintiffs
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`on April 9, 2020. RAI Strategic Holdings, Inc. and R.J. Reynolds Vapor Co. v. Altria Client Servs.,
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`LLC.; Philip Morris USA Inc.; Altria Grp., Inc.; Philip Morris Int’l Inc.; and Philip Morris Prods.
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`S.A., No. 1:20-cv-393, Compl., Apr. 9, 2020. Reynolds subsequently amended its Complaint,
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`dropping U.S. Patent No. 8,314,591 and removing two holding companies, Altria Group, Inc. and
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`Philip Morris International Inc., from the case. RAI Strategic Holdings, Inc. and R.J. Reynolds
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`Vapor Co. v. Altria Client Servs., LLC.; Philip Morris USA Inc.; and Philip Morris Prods. S.A.,
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`No. 3:20-cv-257, Am. Compl., July 13, 2020.
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`16.
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`I understand that on June 29, 2020, the Plaintiffs filed counterclaims against
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`Reynolds for infringement of the Asserted Patents. Altria Client Servs. LLC and Philip Morris
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`USA Inc.’s Partial Answer to Compl. and Counterclaims, June 29, 2020; Philip Morris Prods.
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`S.A.’s Partial Answer to Compl. and Counterclaims, June 29, 2020. On July 27, 2020, after
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`Reynolds amended its Complaint, the Plaintiffs filed their Answers to the Amended Complaint
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`and Counterclaims.
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`17.
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`I understand that the Plaintiffs are asserting, inter alia, that:
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`5
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`a.
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`b.
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`c.
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`The VUSE Solo, Vibe, Ciro and Alto e-cigarettes practice the ’545, ’911,
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`and ’374 Patents;
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`The VUSE Vibe e-cigarette also practices the ’556 Patent; and
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`The VUSE Alto e-cigarette also practices the ’265 Patent.
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`V.
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`FDA’S REGULATION OF TOBACCO AND NICOTINE PRODUCTS
`A.
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`The Effect of the FDCA, the TCA, and the Deeming Rule on E-Cigarettes
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`18.
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`On its effective date, the TCA immediately subjected to FDA’s authority under
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`Chapter IX of the FDCA cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco,
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`and components, parts, and accessories of such products.5 The TCA provided that FDA may
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`promulgate regulations “deeming” other products to be subject to its tobacco product authorities
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`under the statute.6
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`19.
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`Even before the June 2009 enactment of the TCA, FDA began focusing on e-
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`cigarette products, turning away shipments of e-cigarettes imported from China in late 2008 and
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`early 2009 on the basis that they were unapproved drug delivery devices.7 The companies that
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`were the subject of these import refusals sued FDA in April 2009, asserting that e-cigarettes are
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`tobacco products, and FDA must regulate them as such. Ultimately, both the U.S. District Court
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`for the District of Columbia and the D.C. Circuit held that, in the absence of therapeutic claims,
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`FDA could regulate e-cigarettes only as tobacco products.8
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`5 21 U.S.C. § 387a(b).
`6 21 U.S.C. § 321(rr); 21 U.S.C. § 387a(b).
`7 See FDA IMPORT ALERT 66-41, (last visited Feb. 24, 2021), https://www.accessdata.fda.gov/
`cms_ia/importalert_190.html.
`8 Sottera, Inc. v. FDA, 627 F.3d 891, 898-899 (D.C. Cir. 2010); Smoking Everywhere, Inc. v.
`FDA, 680 F. Supp. 2d 62, 73 (D.D.C. 2010).
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`6
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`20.
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`In its Fall 2011 Unified Regulatory Agenda, FDA indicated that it intended to
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`publish a proposed rule in December 2011 that would deem products meeting the statutory
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`definition of “tobacco product” found at section 201(rr) of the FDCA to be subject to Chapter IX
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`of the Act. FDA issued that proposed rule in April 2014 and the final rule in May 2016.9 In
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`bringing all tobacco products under FDA’s regulatory authority, the Agency observed that “there
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`is significant variability in the concentration of chemicals among some products – including
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`variability between labeled content and concentration []. Without a regulatory framework, users
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`will be subject to significant variability among products raising potential public health and safety
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`issues.”10
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`21.
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`On May 10, 2016, after an extensive rulemaking process, FDA issued the so-called
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`“Deeming Rule,” which brought all products meeting the statutory definition of “tobacco product”
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`under FDA’s Chapter IX authority, including e-cigarettes and e-liquids. This meant that all
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`“deemed” new tobacco products had to have premarket authorization in order to be sold legally in
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`the United States. Products on the U.S. market as of February 15, 2007, were considered
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`“grandfathered” and therefore did not require such authorization. A new tobacco product would
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`have to obtain premarket authorization via a PMTA unless they could be shown to be “substantially
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`equivalent” to products already legally on the market – in which case they could obtain premarket
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`9 RJRITC_001246903-RJRITC_001247036 at RJRITC_001246933; Proposed Rule, Deeming
`Tobacco Products To Be Subject to the FDCA, as Amended by the TCA, Regulations on the Sale
`and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products,
`79 Fed. Reg. 23142 (Apr. 25, 2014), https://www.govinfo.gov/content/pkg/FR-2014-04-
`25/pdf/2014--09491.pdf.
`10 RJRITC_001246903-RJRITC_001247036 at RJRITC_001246933.
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`authorization through a Substantial Equivalence (SE) report – or could be shown to be exempt
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`from a substantial equivalence demonstration.11
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`B.
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`22.
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`FDA’s Series of Compliance Policies Post-Deeming Rule
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`Because no e-cigarette was on the U.S. market as of February 15, 2007, all e-
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`cigarettes sold as of the effective date of the Deeming Rule were immediately rendered illegal.12
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`Rather than requiring removal of all new deemed tobacco products from the market on the
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`Deeming Rule’s effective date, FDA announced a compliance policy whereby new tobacco
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`products in the newly deemed categories already on the U.S. market on the Deeming Rule’s
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`effective date could remain so until a specified deadline for submitting premarket applications.13
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`Although FDA provided this allowance to minimize market disruption, FDA’s compliance policy
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`“did not confer lawful marketing status on new tobacco products being marketed without the
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`necessary premarket authorization.”14
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`23.
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`FDA initially announced staggered compliance periods depending on the
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`complexity of the submission (12 months for SE exemption requests, 18 months for SE reports,
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`and 24 months for PMTAs).15 In July 2017, FDA announced a modified compliance policy as part
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`of a new comprehensive plan.16 This modified compliance policy was formalized in a guidance
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`document issued in August 2017.17
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`11 RJRITC_001246903-RJRITC_001247036 at RJRITC_001246904.
`12 1199_RESP00016448-1199_RESP00016459 at 1199_RESP00016459; RJRITC_001482215-
`RJRITC_001482222.
`13 Id.;RJRITC_001246903-RJRITC_001247036 at RJRITC_001246941.
`14 1199_RESP00014118-1199_RESP00014169 at 1199_RESP00014122.
`15 RJRITC_001246903-RJRITC_001247036 at RJRITC_001246907.
`16 1199_RESP00014118-1199_RESP00014169 at 1199_RESP00014123
`17 See Extension of Certain Tobacco Product Compliance Deadlines Related to the Final
`Deeming Rule Guidance for Industry, 82 Fed. Reg. 37,459 (Aug. 10, 2017), https://www.
`8
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`24.
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`The August 2017 compliance policy permitted the continued marketing until at
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`least August 8, 2022, of deemed non-combustible tobacco products, including e-cigarettes, that
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`were on the U.S. market on August 8, 2016, and qualified as new tobacco products. This version
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`of the compliance policy also permitted a product to remain marketed beyond the August 2022
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`date for an unlimited period of time during FDA’s review of a marketing application filed by that
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`deadline.18
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`25.
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`In 2018, FDA issued its “Strategic Policy Roadmap,” in which FDA pledged to
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`“take a fresh look at products that can deliver satisfying levels of nicotine to adults who want
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`access to it without burning tobacco” but that also have undergone “an appropriate series of
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`regulatory checkpoints.”19 The focus on potentially reduced risk products (PRRPs) embodied in
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`FDA’s Strategic Policy Roadmap was viewed as a groundbreaking policy shift.
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`C.
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`American Pediatrics, Vacatur of FDA’s Compliance Policy,
`and the September 9, 2020, PMTA Deadline
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`26.
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`By 2019, years had passed since FDA had issued the Deeming Rule, during which
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`time e-cigarettes and e-liquids remained on the market without the legally required PMTA
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`authorization, and thus without any FDA harm assessment. This delay troubled many entities
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`working in the health and harm reduction fields, particularly in the context of increasing youth use
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`of these illegal products. In April 2019, in light of these concerns, the American Academy of
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`Pediatrics (including its Maryland Chapter), the American Cancer Society Cancer Action Network,
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`the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free
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`Kids, the Truth Initiative, and individual physicians sued FDA for the delayed enforcement of the
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`govinfo.gov/content/pkg/FR-2017-08-10/pdf/2017-16839.pdf.
`18 Id. at 37,459-37,461.
`19 1199_RESP00010890-1199_RESP00010907 at 1199_RESP00010892.
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`premarket authorization provisions of the TCA, pleading that such inaction violated the
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`Administrative Procedure Act and highlighting the “epidemic” youth use of these yet-to-be-
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`evaluated products.20 Judge Paul Grimm held in favor of the plaintiffs and vacated FDA’s
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`compliance policy. Key elements from the court’s opinion include the following:
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`a.
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`The court found “a purposeful avoidance by the industry of complying with the
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`premarket requirements” and noted “the Industry’s lack of effort to obtain approval
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`without an immediate deadline.”21
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`b.
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`The court, plaintiffs, and defendants all agreed that “the recent epidemic-level rise
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`in youth e-cigarette use is a mounting public health crisis that demands a robust
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`regulatory response including through enforcement of the Tobacco Control Act’s
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`premarket review provision.”22
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`c.
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`“”[T]he Industry contends disingenuously that it cannot complete applications
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`without further formal guidance.”23
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`d.
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`“[T]here is currently insufficient data to draw a conclusion about the efficacy of e-
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`cigarettes as a cessation device. . . .”24
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`e.
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`“[T]here is substantial evidence that manufacturers have specifically targeted
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`youth, both with kid-friendly fruit and candy flavors and youth-directed
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`advertising.”25
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`20 Am. Academy of Pediatrics v. FDA, 399 F. Supp. 3d 479, 480 n.1, 486 (D. Md. 2019);
`1199_RESP00014118-1199_RESP00014169 at 1199_RESP00014123.
`21 Pediatrics, 399 F. Supp. 3d at 485.
`22 Id. at 483.
`23 Id. at 485.
`24 Id.
`25 Id.
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`f.
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`“[T]he record offers little assurance that, in the absence of a deadline for filing, the
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`Industry will do anything other than raise every roadblock it can and take every
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`available dilatory measure to keep its products on the market without approval.”26
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`27.
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`Judge Grimm ruled that an earlier hard deadline was necessary, “given the
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`uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that
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`a shorter deadline may have on manufacturers, the Industry’s recalcitrance, the continued
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`availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health
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`emergency.”27 The court ultimately ordered that all e-cigarette PMTAs must be submitted to FDA
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`by September 9, 2020, so as to prevent further circumvention of FDA review.28
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`28.
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`Under the Maryland district court order, if an e-cigarette (or other new deemed
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`tobacco product) submitted a PMTA by September 9, 2020, it could remain on the market “for a
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`period not to exceed one year from the date of application.”29 This is a different, stricter approach
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`than the one adopted by FDA in its now-vacated compliance policy that permitted an e-cigarette
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`to remain on the market for an unlimited period of time during FDA’s review of a timely-filed
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`PMTA.30 Consequently, even if an e-cigarette is covered by the Maryland district court order’s
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`26 Id. at 486.
`27 Id.
`28 Id.; Pediatrics, No. 8:18-cv-883, Dkt 179, Indicative Order (D. Md. Apr. 3, 2020);
`1199_RESP00014118-1199_RESP00014169 at 1199_RESP00014123-24.
`29 Pediatrics, 399 F. Supp. 3d at 487. Reynolds’ FDA expert, Dr. Clissold, testified in the ITC
`that the Maryland district court order was the current state of the law, that if FDA wanted to
`extend the one-year grace period established by the court, it would have to seek leave to do so,
`and that, just because a product is on the U.S. market, does not make it legal. Certain Tobacco
`Heating Articles and Components Thereof, Inv. No. 337-TA-1199, ITC Hr’g Tr. 571:3-572:2
`(Clissold) (“ITC Hr’g Tr.”).
`30 1199_RESP50000931-1199_RESP50000983 at 1199_RESP50000983-950.
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`one-year grace period from enforcement, that product nonetheless remains illegal under the
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`FDCA.31
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`29.
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`No enforcement discretion policy of any kind (court ordered or FDA implemented)
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`is applicable, however, unless a product was on the U.S. market on August 8, 2016, and has not
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`been physically modified or redesigned in any way after that date.32 If an e-cigarette on the U.S.
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`market as of August 8, 2016, is modified or redesigned after that date, it is treated by FDA as a
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`new tobacco product and is no longer covered by any enforcement discretion.33 This means that
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`the product cannot be marketed in the United States without PMTA authorization from FDA and,
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`to the extent it is on the market in the United States, must be removed from the market until FDA
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`grants PMTA authorization to the modified product.34
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`30.
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`31 1199_RESP00014118-1199_RESP00014169 at 1199_RESP00014122; Sara Harrison, The
`FDA Tells Congress E-Cigarettes Are Unsafe—and Illegal, WIRED, (Sept. 25, 2019),
`https://www.wired.com/story/the-fda-tells-congress-e-cigarettes-are-unsafe-and-illegal
`(confirming illegality of e-cigarettes and stating “it was ‘long past time’ for the agency to act”)
`(“Harrison Article”).
`32 See, e.g., FDA Notifies Companies, Including Puff Bar, to Remove Flavored Disposable E-
`Cigarettes and Youth-Appealing E-Liquids from Market for Not Having Required Authorization,
`FDA (July 20, 2020) https://www.fda.gov/news-events/press-announcements/fda-notifies-
`companies-including-puff-bar-remove-flavored-disposable-e-cigarettes-and-youth; Compliance
`Policy for Limited Modifications to Certain Marketed Tobacco Products, FDA at 3 (Nov. 2019),
`https://www.fda.gov/media/133009/download; FDA advances investigation into whether more
`than 40 e-cigarette products are being illegally marketed and outside agency’s compliance
`policy, FDA (Oct. 2018), https://www.fda.gov/news-events/press-announcements/fda-advances-
`investigation-whether-more-40-e-cigarette-products-are-being-illegally-marketed-and.
`33 See supra note 30.
`34 See supra note 30.
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
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`ee
`eeeeer—CCCCSCSC‘aCJ
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`31.
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`The VUSE Solo PMTA was submitted to FDA in October 2019, which meansthat
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`not only is the Solo illegally marketed,it also is no longer protected by the Marylanddistrict court
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`order’s one-year grace period.** Likewise, because the VUSE Vibe and VUSE Ciro PMTAswere
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`submitted to FDA on or around April 15, 2020, those products(also illegally marketed) have fallen
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`outside that grace period as well.*’ The VUSE Alto PMTA wassubmitted in September 2020, and
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`so that product, too, will be deprived of the enforcement protections of the Maryland district court
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`orderbeforethetrial in this case, absent authorization.*®
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`32.|The Marylanddistrict court judge explicitly retained jurisdiction over the case to
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`address any further delay, as needed.*?
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`D.
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`Enforcement of the TCA’s Premarket Authorization
`Requirement Post-American Pediatrics
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`33. With this new timeline from the Maryland district court, the manner in which FDA
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`handles PMTAreview of e-cigarettes is being followed closely by a variety of groups and
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`stakeholders. For example, in a January 2020letter, a bipartisan group of U.S. senators expressed
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`their interest in ensuring that PMTAreview is meaningful, and that illegal products are removed
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`from the U.S. market in prompt fashion.*° The letter states that “[flor years, delays by FDA to
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`3© 1199RESP00016076-1199RESP00016079.
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`39 Pediatrics, 399 F. Supp. 3dat 487(“I will retain jurisdiction to ensure that, if the needarises,
`further action could be taken by the Court”).
`Letter from U.S. Senators to Commissioner Hahn (Jan. 13, 2020), https://www.durbin.senate.
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`13
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`enforce the premarket review requirements of the TCA for all new tobacco products enabled
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`thousands of products to be marketed without undergoing a scientific review by FDA, including a
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`wide array of flavored, high-nicotine e-cigarettes targeted to youth.”41 This must change,
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`according to the senators:
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`Many of us have expressed to you and previous Commissioners our disappointment
`in FDA’s refusal to prevent manufacturers from marketing e-cigarettes without
`FDA’s authorization . . . Continued sale of unauthorized new tobacco products
`renders the PMTA requirement meaningless and is detrimental to the public
`interest. Accordingly, FDA must take appropriate enforcement action, which
`includes removing all unauthorized new tobacco products from the market.42
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`34.
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`FDA takes enforcement of the premarket review provisions of the FDCA very
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`seriously. As Mitch Zeller, Director of FDA’s Center for Tobacco Products (CTP), explained,
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`“[e]nsuring new tobacco products undergo a robust premarket evaluation by FDA is a critical part
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`of our mission to protect the public health, particularly youth, and to reduce tobacco-related disease
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`and death.”43 According to FDA, “[m]anufacturers cannot have settled expectations to market
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`unlawful products, especially in the face of evolving public health concerns.”44 Rather,
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`“[e]nforcing premarket authorization requirements will, consistent with the process set forth in the
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`Tobacco Control Act, ensure that the burden falls on manufacturers of ENDS products to
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`gov/imo/media/doc/Senate%20Ltr%20to%20FDA_PMTA%20Assessment%20Framework_v6%
`20(001).pdf.
`41 Id. at 1.
`42 Id. at 2.
`43 1199_RESP00016448-1199_RESP00016459 at 1199_RESP00016459; see
`1199_RESP00010890-1199_RESP00010907 at 1199_RESP00010892; 1199_RESP00014118-
`1199_RESP00014169 at 1199_RESP00014136; Nicopure Labs, v. FDA, 944 F.3d 267, 273-275
`(D.C. Cir. 2019); Nicopure Labs, v. FDA, 266 F. Supp. 3d 360, 395 (D.D.C. 2017). HHS, too,
`“is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under
`which no e-cigarettes are currently on the market legally.” 1199_RESP00010611-
`1199_RESP00010614 at 1199_RESP00010611.
`44 1199_RESP00014118-1199_RESP00014169 at 1199_RESP00014145.
`14
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`demonstrate that the manufacture and sale of their products is appropriate for the protection of the
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`public health.”45
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`35.
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`Accordingly, FDA has taken (and continues to take) enforcement action against
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`illegal products like e-cigarettes that are being sold in the United States without PMTA
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`authorization. A recent tweet by Acting FDA Commissioner, Janet Woodcock, makes this clear:46
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`
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`36.
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`There are many examples of FDA enforcement of the FDCA’s premarket
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`authorization requirements. In January 2021, FDA sent its first set of warning letters to entities
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`without premarket applications that are selling products (over 100,000) illegally in the United
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`States.47 In conjunction with these enforcement actions, CTP Director Mitch Zeller stated that
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`45 Id. at 1199_RESP00014146.
`46 Dr. Janet Woodcock (@DrWoodcockFDA), Twitter (Feb. 12, 2021, 12:47 PM),
`https://twitter.com/DrWoodcockFDA/status/1360284320938799104.
`47 FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters
`Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline, FDA (Jan.
`15, 2021) https://www.fda.gov/news-events/press-announcements/fda-warns-firms-remove-
`unauthorized-e-liquid-products-market-first-letters-issued-manufacturers-did.
`15
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`“[w]e want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping
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`a close watch on the marketplace and will hold companies accountable for breaking the law.”48
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`On February 12, 2021, FDA issued another wave of warning letters, citing e-liquid products that
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`are illegally marketed.49
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`37.
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`FDA has issued an alert to prevent the importation of non-complying e-cigarettes
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`from entering the United States – a move that since September 2020 has generated at least 180
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`detentions.50 Moreover, in December 2020, U.S. Customs and Border Protection, working in
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`48 Id.
`49 Warning Letter to Jojo's Smokeless World Inc. d/b/a: Mod Shield, FDA (Feb. 12, 2021),
`https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-
`letters/jojos-smokeless-world-inc-dba-mod-shield-613210-02122021; Warning Letter to Sugar
`Vapor Co., FDA (Feb. 12, 2021), https://www.fda.gov/inspections-compliance-enforcement-and-
`criminal-investigations/warning-letters/sugar-vapor-company-613223-02122021; Warning Letter
`to Elemental Vapor Bar, FDA (Feb. 12 2021), https://www.fda.gov/inspections-compliance-
`enforcement-and-criminal-investigations/warning-letters/elemental-vapor-bar-613022-02122021;
`Warning Letter to Vaporescence LLC d/b/a Vape King USA, FDA (Feb. 12, 2021),
`https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-
`letters/vaporescence-llc-dba-vape-king-usa-613228-02122021; Warning Letter to Take Off Corp,
`FDA (Feb. 12, 2021), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
`investigations/warning-letters/take-corp-613224-02122021; Warning Letter to DC Vapor, Inc.,
`FDA (Feb. 12, 2021), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
`investigations/warning-letters/dc-vapor-inc-613223-02122021; Warning Letter to The Vapor
`Spot, LLC, FDA (Feb. 12, 2021), https://www.fda.gov/inspections-compliance-enforcement-
`and-criminal-investigations/warning-letters/vapor-spot-llc-613225-02122021; Warning Letter to
`Premium Vapor Technologies LLC, FDA (Feb. 12, 2021), https://www.fda.gov/inspections-
`compliance-enforcement-and-criminal-investigations/warning-letters/premium-vapor-
`technologies-llc-613229-02122021; Warning Let