Public Copy - Sealed Material Deleted
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 1 of 16
`
`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,
`Respondent.
`________________
`On Petition for Review of an Order of the U.S. Food and Drug Administration
`________________
`
`PETITIONER JUUL LABS, INC.’S REDACTED EMERGENCY MOTION
`FOR TEMPORARY ADMINISTRATIVE STAY
`________________
`
`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 24, 2022
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 1 of 16
`
`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,
`Respondent.
`________________
`On Petition for Review of an Order of the U.S. Food and Drug Administration
`________________
`
`PETITIONER JUUL LABS, INC.’S REDACTED EMERGENCY MOTION
`FOR TEMPORARY ADMINISTRATIVE STAY
`________________
`
`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 24, 2022
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 2 of 16
`
`CORPORATE DISCLOSURE STATEMENT
`Pursuant to Federal Rule of Appellate Procedure 26.1(a) and Circuit Rules
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`18(a)(4) and 26.1, Juul Labs, Inc. (a private, nongovernmental party) certifies that it
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`does not have a parent corporation. Atria Group, Inc. owns a minority share of Juul
`
`Labs, Inc., and no other publicly held corporation owns 10 percent or more of the
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`stock of Juul Labs, Inc.
`
`i
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 3 of 16
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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. A copy of the order is attached as Exhibit
`
`2. FDA has not consented to the requested relief, which is an administrative stay
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`pending this Court’s consideration of JLI’s forthcoming emergency motion to stay.
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`C. Related Cases.
`The June 23, 2022 order denying JLI’s applications has not been previously
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`before this Court or any other court. Moreover, counsel is not aware of any other
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`related cases currently pending in any other court involving substantially the same
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`parties and the same or similar issues.
`
`ii
`
`
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`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 4 of 16
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`June 24, 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
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 5 of 16
`Material Under Seal Deleted
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`EMERGENCY MOTION FOR ADMINISTRATIVE STAY
`This is an emergency request for an administrative stay until this Court can
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`receive full briefing on petitioner Juul Labs, Inc.’s forthcoming emergency motion
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`for a stay pending review. JLI plans to file that motion by noon eastern on June 27,
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`2022. Specifically, pursuant to Federal Rule of Appellate Procedure 18(a)(2), JLI
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`submits this Emergency Motion for Administrative Relief asking this Court to
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`temporarily stay enforcement of the U.S. Food and Drug Administration’s
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`Marketing Denial Order of JLI’s Premarket Tobacco Product Applications, which
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`FDA issued yesterday, until this Court resolves JLI’s forthcoming emergency motion
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`for a stay pending review of FDA’s Order.
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`FDA’s extraordinary and unlawful action, which demands that JLI
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`immediately halt essentially all of its business operations, warrants the emergency
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`interim relief requested. The purpose of an “administrative stay is to give the court
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`sufficient opportunity to consider the merits of the motion for a stay pending appeal.”
`
`Cobell v. Norton, 2004 WL 603456, at *1 (D.C. Cir. Mar. 24, 2004); see also Twelve
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`John Does v. Dist. of Columbia, 841 F.2d 1133, 1137 (D.C. Cir. 1988) (describing
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`entry of a temporary administrative stay to permit time for full consideration of
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`motions). Without an administrative stay,
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`—all before this Court has any
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`1
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 6 of 16
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`opportunity to consider the merits of JLI’s arguments. Ex. 1, Decl. of David Dickey
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`¶ 9.
`
`JLI manufactures, markets, and sells the JUUL System, which is an electronic
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`nicotine-delivery system designed as an alternative to combustible cigarettes for
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`adult current smokers. In July 2020 and pursuant to the process established by FDA,
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`JLI submitted a 125,000-page premarket tobacco application, seeking authorization
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`to market Virginia tobacco and menthol flavors in 3.0% and 5.0% nicotine
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`concentrations. In support of its application, JLI conducted numerous nonclinical
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`and clinical studies to evaluate individual health risks among users of JUUL
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`products; developed an extensive behavioral-research program to assess tobacco-use
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`patterns among purchasers of JUUL products—in particular complete switching
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`from combustible cigarettes among adult smokers; and performed population
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`modeling and analysis demonstrating the net-population benefit of marketing JUUL
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`products over time. Among other things, these studies showed that JLI’s products
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`significantly reduce exposure to harmful and often deadly toxins compared to
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`combustible cigarettes, transition and completely switch adult smokers from
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`combustible cigarettes at rates well above the published literature for other
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`alternative products, and had limited appeal among non-tobacco users. In addition,
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`JLI proposed significant data-driven measures to mitigate the potential for underage
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`2
`
`
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`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 7 of 16
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`use focused on limiting appeal, restricting access, and enforcing against third parties
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`that otherwise could undermine underage-use prevention.
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`Nevertheless, on June 23, 2022, FDA issued its order denying JLI’s
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`application. See Ex. 2, Marketing Denial Order at 1, 12. It did so despite authorizing
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`applications by competing manufacturers of similar ENDS devices.1 And it did so
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`after immense political pressure from Congress once it became politically
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`convenient to blame JLI for youth vaping, even though several of its competitors
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`now have a larger market share and much higher underage-use rates.2 Indeed,
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`FDA’s press release seems to allude to that political pressure. See Ex. 3, June 23,
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`2022 FDA News Release (comments by FDA Commissioner Robert M. Califf,
`
`1 See, e.g., Press Release, U.S. Food & Drug Administration, FDA Issues
`Marketing Decisions on Vuse Cibe and Vuse Ciro E-Cigarette Products (May, 12,
`2022),
`https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-
`marketing-decisions-vuse-vibe-and-vuse-ciro-e-cigarette-products
`(noting
`issuance of marketing granted orders to R.J. Reynolds Vapor Company for its
`Vuse Vibe e-cigarette device, as well as for its Vuse Ciro e-cigarette device);
`Press Release, U.S. Food & Drug Administration, FDA Issues Marketing
`Decisions on NJOY Daily E-Cigarette Products
`(June 10, 2022),
`https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-
`decisions-njoy-daily-e-cigarette-products (noting issuance of marketing granted
`orders to NJOY LLC for its tobacco-flavored Daily disposable e-cigarettes).
`2 See generally, Examining Juul’s Role In The Youth Nicotine Epidemic: Part I,
`Hearing Before the Subcomm. on Econ. and Consumer Pol’y., H. Comm. on
`Oversight and Reform, 116th Cong. (2019); Examining Juul’s Role In The Youth
`Nicotine Epidemic: Part II, Hearing Before the H. Subcomm. on Econ. and
`Consumer Pol’y., H. Comm. on Oversight and Reform, 116th Cong. (2019).
`3
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 8 of 16
`Material Under Seal Deleted
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`M.D). To make matters worse, FDA ordered JLI not to “introduce or deliver for
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`introduction [its] products into interstate commerce,” Ex. 2, at 1, and its press release
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`threatened retailers across the country that they would “risk enforcement action” if
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`they failed to immediately remove all JLI products from their shelves, Ex. 3, at 1.
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`This regulation by press release had its intended effect.
`
` JLI’s only prospect for meaningful relief that
`
`permits it to continue selling its products is an immediate stay.
`
`At every turn, FDA has singled JLI out and denied JLI an orderly process to
`
`resolve FDA’s largely technical concerns. Officials with knowledge of FDA’s order
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`first leaked to the Wall Street Journal that the agency would deny JLI’s applications
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`a full day before its actual decision. Ex. 4 (“FDA to Order Juul E-Cigarettes Off
`
`U.S. Market”). FDA then issued a press release with quotes from the FDA
`
`Commissioner and other FDA officials that is more strident and threatening than the
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`4
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 9 of 16
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`agency’s typical statements when issuing denial orders.3 And when JLI requested
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`an administrative stay to avoid a massive and irreparable disruption to its business,
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`FDA refused. Ex. 5, Decl. of Sean Griffin ¶¶ 5–8.
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`Regulation through leaks and press releases is no way to handle agency action,
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`much less to order a company to cease essentially all business operations. FDA’s
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`decision is arbitrary and capricious and lacks substantial evidence, and an immediate
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`administrative stay is critical to protect JLI, its commercial partners, and its
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`customers. For that reason, JLI readily satisfies the four factors necessary for
`
`obtaining an administrative stay. It is likely to “prevail on the merits,” of its petition,
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`the “prospect of irreparable injury” to JLI is substantial, there is “no possibility of
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`harm” to the government, and the “public interest” favors maintaining the status quo.
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`D.C. Cir. R. 18(a)(1); Nken v. Holder, 556 U.S. 418, 426 (2009); see also 5 U.S.C.
`
`§705.
`
`JLI is likely to succeed on the merits of its petition. FDA’s order is arbitrary
`
`and capricious because it fails to “reasonably consider[] the relevant issues and
`
`reasonably explain[]” itself. FCC v. Prometheus Radio Project, 141 S. Ct. 1150,
`
`1158 (2021). It also “departs from agency precedent without explanation” in the
`
`3 Compare Ex. 3 with Press Release, U.S. Food & Drug Administration, FDA
`Issues Marketing Denial Orders to Fontem US for myblu Products (Apr. 8, 2022),
`https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-
`denial-orders-fontem-us-myblu-products.
`5
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 10 of 16
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`form of a “reasoned analysis.” Ramaprakash v. FAA, 346 F.3d 1121, 1124 (D.C. Cir.
`
`2003). FDA’s decision cannot be squared with the applicable statutes or science.
`
`The order did not analyze the entirety of JLI’s application before rendering its
`
`decision, despite acknowledging that its decision must be a holistic one. Ex. 2, at 1,
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`12. The order does not hide from this fact: FDA concedes that it “has not” entirely
`
`evaluated all “aspects of [JLI’s] application, including for example, the potential
`
`benefit to adults as compared to the risk to youth posed by [JLI] . . . products.” Id.
`
`at 12. This statement directly contradicts FDA’s own press release, which purports
`
`to tie JLI to the “rise in youth vaping.” Ex. 3, at 1. In fact, the order raises narrow
`
`toxicology concerns based on single-assay test results without weighing those
`
`isolated data points against the studies after studies JLI submitted demonstrating that
`
`its products are not toxic and contain many fewer potentially harmful constituents
`
`than combustible cigarettes. FDA’s failure to evaluate all relevant factors amounts
`
`to arbitrary action. See Michigan v. EPA, 576 U.S. 743,752. The Fifth Circuit has
`
`faulted FDA for precisely this sort of practice when reviewing another PMTA
`
`application. See Wages & White Lion Invs., LLC v. United States Food & Drug
`
`Admin., 16 F.4th 1130, 1135–40 (5th Cir. 2021).
`
`Also problematic is FDA’s departure from its common practices related to the
`
`withdrawal of marketed products. FDA has often refrained from abrupt, all-out
`
`product bans; instead, it typically grants transition periods for similarly disruptive
`
`6
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 11 of 16
`Material Under Seal Deleted
`
`agency action even where—unlike here—a product poses a significant safety risk.
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`See, e.g., 73 Fed. Reg. 7565 (Feb. 2, 2008); 50 Fed. Reg. 27492 (July 3, 1985); 44
`
`Fed. Reg. 45764, 45765 (Aug. 3, 1979) (granting a transition period of 125 days
`
`notwithstanding a “health risk posed by the continued use” of a new animal drug in
`
`light of the “economic disruption” that would be caused by “an immediate ban”).
`
`Indeed, in the only case where FDA has ever invoked its emergency power to
`
`suspend a drug’s approval in light of “an imminent hazard to the public health,” 21
`
`U.S.C. § 355(d), the agency still allowed for a “90-day transition period” to avoid
`
`disruption, 44 Fed. Reg. at 45765 (discussing In re: New Drug Applications for
`
`Phenformin, Order of the Secretary Suspending Approval, at 59 (July 25, 1977)).
`
`FDA has provided no analysis, much less a “reasoned analysis,” to depart from that
`
`common practice here. Ramaprakash, 346 F.3d at 1124. Quite the opposite. FDA
`
`admits it “has not received clinical information to suggest an immediate hazard
`
`associated with the use of the JUUL device or JUULpods.” Ex. 3, at 1.
`
`Absent an immediate administrative stay, JLI will also suffer significant
`
`irreparable harm.
`
`7
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 12 of 16
`Material Under Seal Deleted
`
` See Morgan Stanley DW Inc. v. Rothe, 150 F. Supp. 2d 67, 77
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`(D.D.C. 2001).
`
`Ass’n of Am. v. FDA, 317 F. Supp. 3d 189, 195 (D.D.C. 2018); see also Ala. Ass’n of
`
`Realtors v. HHS, 141 S. Ct. 2485, 2489 (2021) (spending “with no guarantee of
`
`eventual recovery” is “irreparable harm”).
`
` See Cigar
`
`Finally, the balance of the harms and the public interest also strongly favor an
`
`immediate administrative stay. “Where, as here, ‘the Government is the opposing
`
`party,’ the last two factors ‘merge’: ‘the government’s interest is the public interest.”
`
`Shawnee Tribe v. Mnuchin, 984 F.3d 94, 103 (D.C. Cir. 2021) (quoting Nken, 556
`
`8
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 13 of 16
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`U.S. at 435). Here, those merged factors weigh decisively in favor of relief.
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`FDA cannot credibly argue that there is a critical and urgent public interest in
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`removing JLI’s products from the market right now, rather than after this Court
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`reviews FDA’s action. See Cigar Ass’n, 317 F. Supp. 3d at 563. FDA has taken
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`almost two years—and almost four times the 180-day review period Congress
`
`specified, see 21 U.S.C. § 387j(c)(1)(A)—to review JLI’s application and issue its
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`marketing-denial order. Throughout that time, FDA exercised its enforcement
`
`discretion to allow JLI’s products to remain on the market. See Ex. 6, Enforcement
`
`Priorities for Electronic Nicotine Delivery Systems / Guidance for Industry at 27;
`
`Ex. 7, Statement from Janet Woodcock, M.D. FDA’s leisurely decision-making
`
`process and its own press release show that there is no urgent public-health
`
`emergency requiring the immediate removal of JLI’s products. Moreover, “[t]here
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`is generally no public interest in the perpetuation of unlawful agency action,”
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`Shawnee Tribe, 984 F.3d at 103, and that is even more true where it is causing chaos
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`in the U.S. ENDS market.
`
`JLI’s forthcoming motion to stay will elaborate on these arguments. What
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`matters for present purposes is that an interim administrative stay is warranted
`
`pending this Court’s disposition of the forthcoming emergency motion to stay that
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`JLI will file early next week.
`
`9
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 14 of 16
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`For the foregoing reasons, JLI respectfully requests that the Court
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`immediately enter an administrative stay of FDA’s June 23, 2022 order until the
`
`Court resolves JLI’s forthcoming emergency motion to stay.
`
`Respectfully submitted,
`
`s/John C. O’Quinn
`JOHN C. O’QUINN
` Counsel of Record
`JASON M. WILCOX
`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 24, 2022
`
`
`
`
`10
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 15 of 16
`
`
`CERTIFICATE OF COMPLIANCE
`I hereby certify that:
`
`1. This motion complies with the type-volume limitation of Federal Rule of
`
`Appellate Procedure 27(d) because it contains 2,237 words, excluding the parts of
`
`the brief exempted by Federal Rule of Appellate Procedure 32(f) and Circuit Rule
`
`32(e)(1).
`
`2. This motion complies with the typeface requirements of Federal Rule of
`
`Appellate Procedure 32(a)(5) and the typestyle requirements of Federal Rule of
`
`Appellate Procedure 32(a)(6) because it has been prepared in a proportionally spaced
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`typeface using Microsoft Word 2016 in 14-point font.
`
`June 24, 2022
`
`s/John C. O’Quinn
`John C. O’Quinn
`
`
`
`
`
`
`
`
`
`USCA Case #22-1123 Document #1951872 Filed: 06/24/2022 Page 16 of 16
`
`
`CERTIFICATE OF SERVICE
`I hereby certify that on June 24, 2022, I electronically filed the foregoing with
`
`the Clerk of the Court for the United States Court of Appeals for the District of
`
`Columbia Circuit by using the CM/ECF system. I also caused the foregoing to be
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`served by electronic and first-class mail on:
`
`Samuel R. Bagenstos, General Counsel
`United States Department of Health and Human Services
`200 Independence Ave., SW Room 713-F
`Washington, DC 20201-0004
`sameul.bagenstos@fda.hhs.gov
`
`Mark Raza, Chief Counsel
`Office of the Chief Counsel
`United States Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993-0002
`mark.raza@fda.hhs.gov
`
`Daniel J. Barry, Acting General Counsel
`United States Department of Health and Human Services
`200 Independence Ave., SW, Room 713-F
`Washington, DC 20201-0004
`daniel.barry@hhs.gov
`
`Xavier Becerra, Secretary
`United States Department of Health and Human Services
`200 Independence Ave., SW
`Washington, D.C. 20201-0004
`xavier.becerra@hhs.gov
`
`
`
`s/John C. O’Quinn
`John C. O’Quinn
`
`
`
`12
`
`
`
`
`
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