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`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 1 of 36
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`No. 22-1123
`
`UNITED STATES COURT OF APPEALS
`FOR THE DISTRICT OF COLUMBIA CIRCUIT
`________________
`JUUL LABS, INC.,
`
`Petitioner,
`
`v.
`
`U.S. FOOD AND DRUG ADMINISTRATION,
`Respondents.
`________________
`On Petition for Review of an Order of the U.S. Food and Drug Administration
`________________
`
`PETITIONER JUUL LABS, INC.’S CORRECTED REDACTED
`EMERGENCY MOTION FOR STAY PENDING REVIEW
`________________
`
`JOHN C. O’QUINN, P.C.
` Counsel of Record
`JASON M. WILCOX, P.C.
`DEVIN S. ANDERSON
`KIRKLAND & ELLIS LLP
`1301 Pennsylvania Avenue, NW
`Washington, DC 20004
`(202) 389-5000
`john.oquinn@kirkland.com
`Counsel for Petitioner Juul Labs, Inc.
`
`June 28, 2022
`
`

`

`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 2 of 36
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`CORPORATE DISCLOSURE STATEMENT
`
`Pursuant to Federal Rule of Appellate Procedure 26.1(a) and Circuit Rules
`
`18(a)(4) and 26.1, Juul Labs, Inc. (a private, nongovernmental party) certifies that it
`
`does not have a parent corporation. Altria Group, Inc. owns a minority share of Juul
`
`Labs, Inc., and no other publicly held corporation owns 10 percent or more of the
`
`stock of Juul Labs, Inc.
`
`i
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`

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`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 3 of 36
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`CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES
`
`A.
`
`Parties and Amici
`
`Petitioner is Juul Labs, Inc. (JLI), and respondent is the U.S. Food and Drug
`
`Administration (FDA). No amici curiae have appeared in this Court.
`
`B.
`
`Ruling Under Review
`
`JLI has petitioned for review of FDA’s June 23, 2022 order denying its
`
`premarket tobacco product applications (PMTAs). A copy of the order is included
`
`in the Appendices accompanying this motion. SA1–16. FDA has not consented to
`
`the requested relief, which is a stay pending appeal of FDA’s order.
`
`C.
`
`Related Cases
`
`The June 23, 2022 order denying Juul Labs’ applications has been previously
`
`before this Court on JLI’s Emergency Motion for Administrative Stay, but it has not
`
`otherwise been before this Court, or any other court. Counsel is also not aware of
`
`any other related cases currently pending in any other court involving substantially
`
`the same parties and the same or similar issues.
`
`ii
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`

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`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 4 of 36
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`June 28, 2022
`
`s/John C. O’Quinn
`JOHN C. O’QUINN
` Counsel of Record
`KIRKLAND & ELLIS LLP
`1301 Pennsylvania Avenue, NW
`Washington, DC 20004
`(202) 389-5000
`john.oquinn@kirkland.com
`
`Counsel for Petitioner Juul Labs, Inc.
`
`iii
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`

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`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 5 of 36
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`TABLE OF CONTENTS
`INTRODUCTION ..............................................................................................1
`BACKGROUND ................................................................................................4
`A.
`The JUUL System............................................................................4
`B.
`The Tobacco Control Act And FDA Regulation .................................6
`C.
`JLI’s PMTAs ...................................................................................7
`D.
`FDA’s Order ...................................................................................9
`E.
`Impact Of FDA’s Order ................................................................. 11
`ARGUMENT ................................................................................................... 12
`I.
`JLI Is Likely To Prevail On The Merits. ................................................... 12
`II.
`JLI’s Harms Are Irreparable and Imminent Without A Stay. ...................... 19
`III.
`The Balance Of Harms And The Public Interest Strongly Favor A
`Stay. ....................................................................................................... 21
`CONCLUSION ................................................................................................ 23
`
`iv
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`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 6 of 36
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Airmark Corp. v. F.A.A.,
`758 F.2d 685 ................................................................................................ 20
`Ala. Ass’n of Realtors v. Dep’t of Health & Human Servs.,
`141 S. Ct. 2485 (2021) ................................................................................. 22
`Am. Acad. of Pediatrics v. FDA,
`399 F. Supp. 3d 479 (D. Md. 2019) ........................................................... 7, 24
`Bally’s Park Place, Inc. v. NLRB,
`646 F.3d 929 (D.C. Cir. 2011) ...................................................................... 19
`Bidi Vapor LLC v. FDA,
`2022 WL 2237403 (11th Cir. Feb. 1, 2022) ..................................................... 4
`Breeze Smoke, LLC v. FDA,
`18 F.4th 499 (6th Cir. 2021) ......................................................................... 12
`Burlington N. & Sante Fe Ry. v. Surface Transp. Bd.,
`403 F.3d 771 (D.C. Cir. 2005) ...................................................................... 15
`Casino Airlines, Inc. v. NTSB,
`439 F.3d 715 (D.C. Cir. 2006) ...................................................................... 19
`Christopher v. SmithKline Beecham Corp.,
`567 U.S. 142 (2012) ..................................................................................... 20
`Cigar Ass’n of Am. v. FDA,
`5 F.4th 68 (D.C. Cir. 2021) ....................................................................... 7, 23
`Consol. Edison Co. of New York v. Bodman,
`445 F.3d 438 (D.C. Cir. 2006) ...................................................................... 21
`Cuomo v. United States N.R.C. Regulatory,
`772 F.2d 972 (D.C. Cir. 1985) ...................................................................... 12
`D.C. Fed’n of Civic Ass’ns v. Volpe,
`459 F.2d 1231 (D.C. Cir. 1972) .................................................................... 17
`v
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`

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`FCC v. Prometheus Radio Project,
`141 S. Ct. 1150 (2021) ........................................................................... 13, 14
`Genuine Parts Co. v. EPA,
`890 F.3d 304 (D.C. Cir. 2018) ...................................................................... 18
`Gripum LLC v. FDA,
`2021 WL 8874972 (7th Cir. Nov. 4, 2021) ...................................................... 4
`Luokung Tech. Corp. v. Dep’t of Defense,
`538 F. Supp. 3d 174 (D.D.C. May. 5, 2021) .................................................. 20
`Merrill Lynch, Pierce, Fenner & Smith Inc. v. Wertz,
`298 F. Supp. 2d 27 (D.D.C. 2002)................................................................. 21
`Morgan Stanley DW Inc. v. Rothe,
`150 F. Supp. 2d 67 (D.D.C. 2001)................................................................. 22
`Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins.
`Co.,
`463 U.S. 29 (1983) ................................................................................. 13, 18
`Multicultural Media, Telecom & Internet Council v. FCC,
`873 F.3d 932 (D.C. Cir. 2017) ...................................................................... 13
`Nat’l Lifeline Ass’n v. FCC,
`2018 WL 4154794 (D.C. Cir. Aug. 10, 2018) ................................................ 20
`Nat’l Lifeline Ass’n v. FCC,
`921 F.3d 1102 (D.C. Cir. 2019) .................................................................... 18
`Nken v. Holder,
`556 U.S. 418 (2009) ..................................................................................... 12
`Patriot, Inc. v. U.S. Dep’t of Hous. & Urban Dev.,
`963 F. Supp. 1 (D.D.C. 1997) ....................................................................... 23
`Pillsbury Co. v. FTC,
`354 F.2d 952 (5th Cir. 1966)......................................................................... 17
`Ramaprakash v. FAA,
`346 F.3d 1121 (D.C. Cir. 2003) .................................................................... 13
`
`vi
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`

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`
`Shafer & Freeman Lakes Env’t Conservation Corp. v. FERC,
`992 F.3d 1071 (D.C. Cir. 2021) .................................................................... 18
`Shawnee Tribe v. Mnuchin,
`984 F.3d 94 (D.C. Cir. 2021) .................................................................. 23, 25
`United States v. Diapulse Corp. of Am.,
`748 F.2d 56 (2d Cir. 1984) ........................................................................... 15
`Wages & White Lion Invs., LLC v. FDA,
`16 F.4th 1130 (5th Cir. 2021).................................................................... 4, 12
`Wash. Metro. Area Transit Comm’n v. Holiday Tours, Inc.,
`559 F.2d 841 (D.C. Cir. 1977) ...................................................................... 22
`Westar Energy, Inc. v. FERC,
`473 F.3d 1239 (D.C. Cir. 2007) .................................................................... 20
`Statutes
`5 U.S.C. §705 ................................................................................................... 12
`5 U.S.C. §706(2) ............................................................................................... 13
`21 U.S.C. §§387j(a)(1)–(2).................................................................................. 6
`21 U.S.C. §387j(c)(1)(A)................................................................................... 24
`21 U.S.C. §§387j(c)(4)–(5)............................................................................ 7, 14
`21 U.S.C. §387r(b)(1) ......................................................................................... 6
`21 U.S.C. § 389l(a) ........................................................................................... 12
`Family Smoking Prevention and Tobacco Control Act, Pub. L. 111-311, 3, 4, 6, 12,
`13, 14, 15, 23
`Tobacco Control Act, 21 U.S.C. §387r(b)(1) ....................................................... 6
`Rules
`D.C. Cir. R. 18(a)(1) ......................................................................................... 12
`Fed. R. App. P. 27(d) ........................................................................................... i
`
`vii
`
`

`

`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 9 of 36
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`Fed. R. App. P. 32(a)(5) ....................................................................................... i
`Fed. R. App. P. 32(a)(6) ....................................................................................... i
`Fed. R. App. P. 32(e)(1) ....................................................................................... i
`Fed. R. App. P. 32(f) ............................................................................................ i
`Other Authorities
`21 C.F.R. § 1114.47(b)(2)–(3) ........................................................................... 10
`81 Fed. Reg. 28,973 ...................................................................................... 6, 23
`81 Fed. Reg. at 28,977–78, 29,011, 29,014........................................................... 7
`81 Fed. Reg. at 29,007 ...................................................................................... 25
`
`viii
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`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 10 of 36
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`GLOSSARY OF ABBREVIATIONS
`
`Abbreviation
`ENDS
`FDA
`
`JLI
`PMTA
`TCA
`
`SA
`PA
`
`Definition
`Electronic nicotine delivery system(s)
`U.S. Department of Food and Drug
`Administration
`Juul Labs, Inc.
`Premarket tobacco product application(s)
`Family Smoking Prevention and Tobacco
`Control Act of 2009
`Sealed Appendix
`Public Appendix
`
`ix
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`

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`USCA Case #22-1123 Document #1952418 Filed: 06/28/2022 Page 11 of 36
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`INTRODUCTION
`Congress enacted the Family Smoking Prevention and Tobacco Control Act
`
`(TCA) to regulate tobacco products and encourage the development and introduction
`
`of alternatives to traditional cigarettes that reduce tobacco-related death and disease.
`
`The TCA permits FDA to withhold marketing authorization for tobacco products
`
`introduced after 2007, but only after considering the public-health impacts of such
`
`products on the population as a whole through the premarket-tobacco-product-
`
`application (PMTA) process. Juul Labs (JLI)’s PMTAs included over 110 scientific
`
`studies and over 125,000 pages of data and analysis demonstrating the substantial
`
`public-health benefits its electronic-nicotine-delivery-system (ENDS) products
`
`provide. Those studies show JUUL products are effective in switching smokers from
`
`combustible cigarettes, significantly reduce exposure to those harmful and often
`
`deadly toxicants, and have little appeal to non-smokers. Over two million adults
`
`have switched from cigarettes because of JLI’s products and over a million deaths
`
`could be avoided over the coming years—the exact outcome Congress intended.
`
`Instead of praising a significant public-health victory, FDA denied JLI’s
`
`applications for arbitrary reasons and demanded that retailers remove all JUUL
`
`products from their shelves or face immediate action. That decision cannot be
`
`squared with the TCA, the Administrative Procedure Act, or the science, nor is there
`
`cause for forcing JLI off the market immediately. The TCA became law in 2009, yet
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`FDA waited seven years to deem ENDS products subject to regulation at all, allowed
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`those products to remain on the market without even submitting a PMTA until
`
`September 2020, and then spent almost two years reviewing JLI’s applications.
`
`Whatever one thinks of FDA’s process, it shows there is no great public-health
`
`emergency if FDA’s order is put on hold.
`
`That drawn-out regulatory process produced a manifestly erroneous decision.
`
`Congress required FDA to evaluate all “valid scientific evidence” and weigh all
`
`potential public-health benefits against all potential public-health harms before
`
`rendering its decisions. FDA’s order acknowledged that “exposure to carcinogens
`
`and other toxicants present in cigarette smoke were greatly reduced with exclusive
`
`use” of JUUL products compared with combustible cigarettes. SA.32 (emphasis
`
`added). As it has with other PMTAs, FDA should have evaluated the totality of JLI’s
`
`evidence, which conclusively established that the public-health benefits of JUUL
`
`products significantly outweigh any potential risks.
`
`FDA instead rejected JLI’s applications for deeply flawed reasons. In more
`
`than two dozen places, FDA claimed JLI did not provide aerosol data measuring the
`
`toxicological impact of four chemicals. But JLI did provide that data—6,000 pages
`
`of it. Had FDA done a more thorough review (like it did for other applicants), it
`
`would have seen data showing that those chemicals are not observable in the aerosol
`
`that JUUL users inhale. Elsewhere, FDA raised technical toxicology concerns, while
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`again failing to consider data confirming that the aerosol that JUUL users actually
`
`inhale is substantially less toxic than cigarette smoke. No other applicant has had
`
`their application denied for similar reasons, and FDA offered no explanation for why
`
`it held JLI to a different standard.
`
`FDA reached these decisions against a backdrop of immense political
`
`pressure. Members of Congress through letters and at hearings pressed FDA
`
`officials to commit that JUUL products would not be authorized. One commentator
`
`even remarked that FDA had to deny JLI’s applications or risk significant budget
`
`cuts. That level of congressional interference is unprecedented, inappropriate, and
`
`tainted the entire agency process. The TCA mandates that FDA’s decision be based
`
`on science and evidence, not politics.
`
`Absent a stay pending appeal, FDA’s unlawful actions will cause JLI
`
`significant irreparable harm. FDA’s order affects every product JLI sells and every
`
`adult who has switched from combustible cigarettes to a JUUL product. Taking
`
`those products off store shelves—even temporarily—would permanently damage
`
`JLI’s brand, its relationships with its commercial partners,
`
`. Consumers will switch to other products or return to cigarettes as
`
`stores fill the shelf space JUUL products used to occupy.
`
`The public interest strongly favors a stay as well. As FDA officials have
`
`warned, removal of ENDS products creates a serious risk that individuals will revert
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`3
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`to combustible cigarettes or look for products on the illicit market. That significant
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`public-health risk will become a reality if JLI’s products are removed from the
`
`market while this appeal is pending.
`
`If this Court intervenes,
`
` and an
`
`important alternative will remain on the market for adult smokers who have
`
`transitioned or who deserve the opportunity to transition away from cigarettes. If
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`the Court does not intervene, JLI’s products will disappear from store shelves and
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`politics will have won over sound science and evidence. Courts around the country
`
`have issued stays in similar situations. Wages & White Lion Invs., LLC v. FDA, 16
`
`F.4th 1130, 1134 (5th Cir. 2021); Gripum LLC v. FDA, 2021 WL 8874972 at *1 (7th
`
`Cir. Nov. 4, 2021); Bidi Vapor LLC v. FDA, 2022 WL 2237403 at *3–4 (11th Cir.
`
`Feb. 1, 2022). JLI will brief its petition as expeditiously as the Court deems
`
`appropriate, but in the meantime, the Court should likewise stay enforcement of
`
`FDA’s arbitrary decision.
`
`BACKGROUND
`The JUUL System
`A.
`Congress has recognized that combustible cigarettes “cause[] over 400,000
`
`deaths in the United States each year” and that “approximately 8,600,000 Americans
`
`have chronic illnesses related to smoking.” Pub. L. No. 111-31, §2(13), 123 Stat.
`
`1776, 1777 (2009). JLI designed its JUUL products to address that problem by
`
`4
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`providing a less-harmful, noncombustible alternative for adult smokers. SA.63.
`
`Rather than burning tobacco, the JUUL System uses proprietary heating technology
`
`to heat a nicotine-containing liquid within a controlled temperature range to produce
`
`an aerosol that the user inhales. SA.87. JUUL products thus significantly reduce
`
`exposure to harmful or potentially harmful constituents associated with smoking
`
`cigarettes.
`
`Although JUUL was not the first ENDS product, it was one of the first devices
`
`that adult smokers found sufficiently satisfying to switch from combustible
`
`cigarettes. For these smokers, the product needs to be easy-to-use and satisfy the
`
`nicotine cravings they previously sated through cigarettes. The JUUL products
`
`overcame this challenge through a combination of features that ensure consistent
`
`nicotine delivery that more closely resembles the experience of cigarette smoking.
`
`SA.63-64; SA.94. Since JUUL products were introduced in 2015, millions of adult
`
`smokers have used JUUL products as a substitute for cigarettes. SA.64; SA.94.
`
`More than half switched from cigarettes completely. SA.94.
`
`JUUL products are sold in retail stores across the country. SA.64. Retailers
`
`who sell JUUL products must comply with JLI’s rigorous access restrictions to
`
`prevent underage sales, and JLI conducts “secret shopper” audits to confirm retailers
`
`are complying with those requirements. SA.64. Consumers can also purchase JUUL
`
`products from JLI’s website, where JLI uses industry-leading age-verification
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`5
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`techniques to ensure purchasers are at least 21 years old. SA.64–65. The U.S. is
`
`responsible for more than
`
` of its revenue. SA.68.
`
`The Tobacco Control Act And FDA Regulation
`B.
`Congress enacted the TCA to both regulate the tobacco industry and to
`
`“encourage the development of innovative products and treatments,” including
`
`treatments that are “nicotine-based,” to reduce the “consumption of tobacco” and the
`
`“harm associated with continued tobacco use.” 21 U.S.C. §387r(b)(1). The Act
`
`originally applied only to “cigarettes, cigarette tobacco, roll-your-own tobacco, and
`
`smokeless tobacco” products. Id. §387a(b). But Congress delegated to FDA
`
`discretion to “deem[]” other tobacco products subject to the TCA. Id.
`
`In 2016—almost seven years after Congress passed the TCA—FDA issued a
`
`rule “deeming” ENDS products subject to the Act. See 81 Fed. Reg. 28,973. FDA
`
`recognized that the inhalation of nicotine poses “less risk to the user than inhalation
`
`of nicotine delivered by smoke from combusted tobacco products.” Id. at 28,981.
`
`FDA nevertheless subjected ENDS products to the TCA’s “premarket review”
`
`requirements, even though many ENDS products (including JUUL products) were
`
`already on the market. Those requirements include obtaining FDA authorization.
`
`21 U.S.C. §§387j(a)(1)–(2).
`
`The pathway to authorization for virtually all ENDS products requires the
`
`manufacturer to submit a PMTA that demonstrates the product “is appropriate for
`
`6
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`the protection of the public health.” Id. §387j(c)(4). The public-health showing
`
`involves a comprehensive, holistic analysis based on studies and other “valid
`
`scientific evidence” that balances the “risks and benefits to the population as a
`
`whole, … taking into account (A) the increased or decreased likelihood that existing
`
`users of tobacco products will stop using such products; and (B) the increased or
`
`decreased likelihood that those who do not use tobacco products will starting using
`
`such products.” Id. §§387j(c)(4)–(5).
`
`FDA deferred its enforcement authority against ENDS products that were on
`
`the market while it completed the premarket-review process. See, e.g., 81 Fed. Reg.
`
`at 28,977–78, 29,011, 29,014; Cigar Ass’n of Am. v. FDA, 5 F.4th 68, 73–74 (D.C.
`
`Cir. 2021). It extended its compliance period for years, stating that ENDS
`
`manufacturers could submit applications all the way through August 2022. PA.409-
`
`11. Following a legal challenge to its deferred-enforcement policy, FDA was
`
`required to impose a 2020 application deadline and committed to act on the
`
`applications by September 9, 2021—a deadline FDA promptly missed for virtually
`
`every major ENDS product. See Am. Acad. of Pediatrics v. FDA, 399 F. Supp. 3d
`
`479, 481 (D. Md. 2019); see also PA.412-63.
`
`JLI’s PMTAs
`C.
`In July 2020, JLI submitted PMTAs with 125,000 pages of information, data,
`
`and analysis, seeking authorization to market two devices and four types of
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`7
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`JUULpods (Virginia Tobacco and Menthol flavors in 5.0% and 3.0% nicotine
`
`concentrations). SA.87. As part of that submission, JLI developed an extensive
`
`behavioral-research program to assess tobacco-use patterns among purchasers of
`
`JUUL products, focusing on those who switched from smoking from combustible
`
`cigarettes. SA.90. JLI conducted more than 75 nonclinical and 13 clinical studies
`
`to evaluate the potential health risks among users of its JUUL products. SA.88. JLI
`
`performed extensive modeling and analysis based on those studies as well.
`
`SA..88,92. The research showed that among adult smokers who initiated on JUUL
`
`products, over 50% completely switched from combustible cigarettes—a level far
`
`higher than other ENDS products. SA.90,91.
`
`JLI also put its products under the microscope, subjecting them to numerous
`
`comprehensive examinations to identify the presence and toxicity of certain
`
`substances. Much of JLI’s testing focused on the aerosols generated by heating the
`
`e-liquid in the JUULpods, because it is the aerosols that JUUL users ultimately
`
`inhale. SA.404. JLI’s PMTAs contained 6,000 pages of aerosol data. SA. 409. JLI
`
`conducted both in vitro (outside of a living organism) and in vivo (inside of a living
`
`organism) testing, and both targeted analysis (looking for specific chemicals) and
`
`non-targeted analysis (testing for thousands of chemicals at once) of the JUUL
`
`System aerosols. SA.405–06. By conducting both targeted and non-targeted
`
`8
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`analyses, JLI ensured that it was measuring for the presence of any potentially
`
`problematic compound in its aerosol. SA.405–06,410.
`
`JLI’s applications showed: (1) on average, 98% or greater reduction in
`
`harmful and potentially harmful constituents compared to combustible cigarettes;
`
`(2) on average, 82% or greater reduction in levels of harmful and potentially harmful
`
`constituents compared to IQOS, a heated tobacco product that received a marketing-
`
`granted order from FDA; and (3) similar or lower levels of harmful and potentially
`
`harmful constituents compared to other marketed ENDS products. SA.88-89.
`
`After receiving JLI’s initial submission, FDA issued one substantive PMTA
`
`deficiency letter. SA.16. JLI promptly responded with additional scientific data and
`
`analysis. JLI did not hear from FDA again on any substantive issues until its
`
`marketing-denial order.
`
`FDA’s Order
`D.
`On June 22, 2022, almost two years after JLI’s initial submission, JLI received
`
`word that FDA was planning to deny its application and order all JUUL products off
`
`the U.S. market. That notice came from the press, not FDA. PA.473–74.
`
`Apparently, officials with knowledge of FDA’s order leaked the matter to the press,
`
`which left JLI and the market in disarray and which violated FDA confidentiality
`
`rules. 21 C.F.R. § 1114.47(b)(2)–(3).
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`In the wake of that chaos, FDA issued its formal order the next day. SA.1-16;
`
`SA.17-61. FDA acknowledged that “exposure to carcinogens and other toxicants
`
`present in cigarette smoke were greatly reduced with exclusive use of the new
`
`products compared to [cigarette] smoking.” SA.29.
`
`Instead, FDA’s order identified
`
`
`
` with a subset of
`
`the toxicological data presented by JLI. The
`
` deficiency claimed that JLI had
`
`not submitted “mainstream aerosol yield data” showing whether certain “leachables”
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`(i.e., chemicals identified in the JUUL e-liquid from the pod) were present “when
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`the JUULpod products are used with the JUUL devices.” SA.31,24,29. FDA
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`claimed that this “precluded a finding that” the JUUL products “would be
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`appropriate for the protection of the public health.” SA.48.
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`SA.11.
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`At the same time, FDA’s press release stated that it “has not received clinical
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`information to suggest an immediate hazard associated with the use of the JUUL
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`device or JUULpods.” PA.475. FDA nevertheless demanded that JLI stop selling
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`its products and that wholesalers and retailers remove JUUL products “or risk
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`enforcement action.” PA.475. Commentators observed that JLI had been “singled
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`out”: there had been “so much opposition to Juul” from “legislators in state
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`legislatures and Congress,” that “FDA simply could not have authorized the sale of
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`JUUL” without provoking a “fierce” backlash and jeopardizing its funding. PA.478.
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`Impact Of FDA’s Order
`E.
`FDA’s order caused chaos.
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`.
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`JLI asked FDA for a stay within hours of its decision. FDA denied JLI’s
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`request. PA.482. JLI immediately petitioned for review under 5 U.S.C. § 706 and
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`21 U.S.C. § 389l(a). The next day, this Court issued an administrative stay and set
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`a briefing schedule for this motion.
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`ARGUMENT
`FDA’s denial of JLI’s applications is contrary to the TCA and is arbitrary and
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`capricious. An immediate stay pending is critical to protect JLI, its commercial
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`partners, and its customers, as JLI readily satisfies the four-factor balancing test.
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`D.C. Cir. R. 18(a)(1); Nken v. Holder, 556 U.S. 418, 426 (2009); see also Cuomo v.
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`United States N.R.C. Regulatory, 772 F.2d 972, 974 (D.C. Cir. 1985) (“high
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`probability of success on the merits” not required for stay if strong showing of
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`“irreparable injury”); 5 U.S.C. §705.1
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`I.
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`JLI Is Likely To Prevail On The Merits.
`The Administrative Procedure Act directs courts to “hold unlawful and set
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`aside agency action” that is “arbitrary, capricious, an abuse of discretion, or
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`otherwise not in accordance with law.” 5 U.S.C. §706(2). Review under the Act is
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`“highly deferential,” Ramaprakash v. FAA, 346 F.3d 1121, 1124 (D.C. Cir. 2003),
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`but “not toothless,” Multicultural Media, Telecom & Internet Council v. FCC, 873
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`F.3d 932, 937 (D.C. Cir. 2017). Agency action is arbitrary and capricious if the
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`agency’s “explanation for its decision ... runs counter to the evidence before the
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`agency, Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,
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`463 U.S. 29, 43 (1983), if the agency “departs from agency precedent without
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`1 As multiple courts have found, once FDA denied JLI’s oral stay request, JLI did
`not need to wait before seeking judicial review and a stay. See Wages & White Lion,
`16 F.4th at 1135 n.1; Breeze Smoke, LLC v. FDA, 18 F.4th 499, 503 (6th Cir. 2021).
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`explanation,” Ramaprakash, 346 F.3d at 1124, or the agency fails to “reasonably
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`consider[] the relevant issues,” FCC v. Prometheus Radio Project, 141 S. Ct. 1150,
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`1158 (2021). FDA got the science wrong—an issue JLI will address with the agency.
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`But FDA’s order also violates these administrative-law principles in at least three
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`ways, any one of which is sufficient to set aside the agency’s action.
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`First, FDA’s approach to JLI’s application—based solely on concerns with a
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`limited subset of the toxicology assessment—stands in stark contrast to how it has
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`handled applications by other manufacturers and defies the holistic public-health
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`assessment the TCA demands. When evaluating Philip Morris’ application for its
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`IQOS system (which contained actual tobacco), FDA rejected portions of the
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`company’s toxicological assessment as “experimental” “not independently
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`validated” and having “unknown utility for regulatory use.” SA.450 12 different
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`chemicals in IQOS aerosols were “potentially genotoxic and/or carcinogenic” and
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`were “present in higher concentration[s]” than in combustible cigarette smoke or
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`“not found” in cigarette smoke at all. SA.443. But FDA took into account a host of
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`other data and granted IQOS’s application. SA.490,503. Verve also received
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`authorization for its chewable-tobacco products despite a “dearth of health effects
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`data” and an “absence of original toxicology study data.” SA.592,567; see also
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`SA.710,728,729 (discounting similar issues to approve Vuse Solo PMTA).
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`This holistic approach FDA took with other applicants is consistent with
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`fundamental administrative-procedure principles and the TCA. An agency must
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`“reasonably consider[]” all “the relevant issues” before it, Prometheus, 141 S. Ct. at
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`1158, and the TCA directs FDA to examine all “valid scientific evidence,” and
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`balance all of the data, 21 U.S.C. §§387j(c)(4)–(5). FDA’s order itself says, “FDA
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`must weigh all potential public health benefits against all potential public health
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`harms.” SA.1 (emphasis added).
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` without offering any reason for treating JLI
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`different than similarly situated applicants, see United States v. Diapulse Corp. of
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`Am., 748 F.2d 56, 62 (2d Cir. 1984); Burlington N. & Sante Fe Ry. v. Surface Transp.
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`Bd., 403 F.3d 771, 776–77 (D.C. Cir. 2005) (similar). This discriminatory treatment
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`cuts across
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` deficiencies identified