N.D. Cal. 24-cv-01992 dckt 000027_000 filed 2024-06-27-2

Case 4:24-cv-01992-HSG Document 27 Filed 06/27/24 Page 1 of 29
1 ISAAC C. BELFER (D.C. Bar No. 1014909)

OLIVER MCDONALD (N.Y. Bar No. 5416789)
2 Trial Attorneys
SARAH WILLIAMS (D.C. Bar No. 1006622)
3
Senior Trial Attorney
4 Consumer Protection Branch
Civil Division
5 U.S. Department of Justice
PO Box 386
6 Washington, DC 20044-0386
Telephone: 202-305-7134 (Belfer)
7
Telephone: 202-305-0168 (McDonald)
8 Telephone: 202-616-4269 (Williams)
Fax: 202-514-8742
9 Isaac.C.Belfer@usdoj.gov
Oliver.J.McDonald@usdoj.gov
10 Sarah.Williams@usdoj.gov
11
Counsel for Defendants
12 (see signature page for complete list)
13 UNITED STATES DISTRICT COURT FOR THE
14 NORTHERN DISTRICT OF CALIFORNIA
15 OAKLAND DIVISION
16 AFRICAN AMERICAN TOBACCO CONTROL

LEADERSHIP COUNCIL, ACTION ON Case No. 4:24-cv-1992-HSG
17 SMOKING AND HEALTH, NATIONAL
MEDICAL ASSOCIATION, and AMERICAN
18 MEDICAL ASSOCIATION,
19 Plaintiffs, DEFENDANTS’ NOTICE OF MOTION,
20 MOTION TO DISMISS, AND
v.
MEMORANDUM IN SUPPORT
21 U.S. DEPARTMENT OF HEALTH AND
(Administrative Procedure Act Case)
22 HUMAN SERVICES, XAVIER BECERRA, in his
official capacity as Secretary of the U.S. DATE: September 12, 2024
23 Department of Health and Human Services; U.S. Time: 2:00 p.m.
FOOD AND DRUG ADMINISTRATION; Judge: Hon. Haywood S. Gilliam, Jr.
24 ROBERT CALIFF, in his official capacity as
Commissioner of Food and Drugs; CENTER FOR
25
TOBACCO PRODUCTS; BRIAN KING in his
26 official capacity as the Center for Tobacco
Products, Director.
27
Defendants.
28
DEFS.’ NOTICE OF MOT., MOT. TO DISMISS, & MEM. IN SUPPORT – CASE NO. 4:24-CV-1992-HSG
1 TABLE OF CONTENTS
2 NOTICE OF MOTION ................................................................................................................................1
3 MOTION TO DISMISS ..............................................................................................................................1
4 MEMORANDUM OF POINTS AND AUTHORITIES .............................................................................1
5 PRELIMINARY STATEMENT .....................................................................................................1
6 STATEMENT OF THE ISSUES.....................................................................................................2
7 BACKGROUND .............................................................................................................................3
8 I. The Tobacco Control Act of 2009 .......................................................................... 3
9 II. Notice-and-Comment Rulemaking ......................................................................... 4
10 III. FDA’s Rulemaking Process Regarding Menthol Cigarettes .................................. 6
11 IV. Plaintiffs’ Past and Present Litigation..................................................................... 9
12 LEGAL STANDARD....................................................................................................................10
13 DISCUSSION ................................................................................................................................11
14 I. Plaintiffs Have Not Met Their Burden To Establish Standing ............................. 11
15 II. The Court Lacks Subject-Matter Jurisdiction Because Plaintiffs Have

Failed To Identify Any Discrete Action that FDA Is Legally Required
16 To Take ................................................................................................................. 17
17 III. In the Alternative, the Amended Complaint Fails To State a Plausible
18 Claim for Relief Because Plaintiffs Have Failed To Identify Any
Discrete Action that FDA Is Legally Required To Take ...................................... 20
19
CONCLUSION ..............................................................................................................................22
20
21
22
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25
26
27
28
ii
1 TABLE OF AUTHORITIES
2 Cases
3 Alvarado v. Table Mountain Rancheria,

509 F.3d 1008 (9th Cir. 2007) .................................................................................................. 17, 18, 20
4
Am. Diabetes Ass’n v. U.S. Dep’t of the Army,
5 938 F.3d 1147 (9th Cir. 2019) .................................................................................................. 10, 14, 18
Ashcroft v. Iqbal,
6
556 U.S. 662 (2009) ....................................................................................................................... passim
7 Associated Gen. Contractors of Am., San Diego Chapter, Inc. v. Cal. Dep’t of Transp.,
713 F.3d 1187 (9th Cir. 2013) .............................................................................................................. 11
8
Bell Atl. Corp. v. Twombly,
9 550 U.S. 544 (2007) .............................................................................................................................. 11
10 Blunt v. Lower Merion Sch. Dist.,
767 F.3d 247 (3d Cir. 2014) ................................................................................................................. 15
11
Bolden-Hardge v. Off. of Cal. State Controller,
12 63 F.4th 1215 (9th Cir. 2023) ............................................................................................................... 11
Brown v. Food for Life Baking Co.,
13
658 F. Supp. 3d 732 (N.D. Cal. 2023) .................................................................................................. 21
14 Clapper v. Amnesty Int’l USA,
568 U.S. 398 (2013) .............................................................................................................................. 11
15
DaimlerChrysler Corp. v. Cuno,
16 547 U.S. 332 (2006) .............................................................................................................................. 10
17 Daniels-Hall v. Nat’l Educ. Ass’n,
629 F.3d 992 (9th Cir. 2010) ................................................................................................................ 21
18
FDA v. Alliance for Hippocratic Medicine,
19 144 S. Ct. 1540, 2024 WL 2964140 (2024)................................................................................... passim
Fleck & Assocs., Inc. v. City of Phoenix,
20
471 F.3d 1100 (9th Cir. 2006) .............................................................................................................. 11
21 Friends of the Earth v. Sanderson Farms, Inc.,
992 F.3d 939 (9th Cir. 2021) ................................................................................................................ 15
22
Havens Realty Corp. v. Coleman,
23 455 U.S. 363 (1982) ....................................................................................................................... passim
24 Hells Canyon Pres. Council v. U.S. Forest Serv.,
593 F.3d 923 (9th Cir. 2010) .......................................................................................................... 17, 19
25
In Def. of Animals v. Sanderson Farms, Inc.,
26 No. 20-CV-05293-RS, 2021 WL 4243391 (N.D. Cal. Sept. 17, 2021) .............................. 14, 15, 16, 17
Kokkonen v. Guardian Life. Ins. Co.,
27
511 U.S. 375 (1994) ........................................................................................................................ 10, 11
28
iii
1 La Asociacion de Trabajadores de Lake Forest v. City of Lake Forest,

624 F.3d 1083 (9th Cir. 2010) ............................................................................................ 11, 14, 15, 16
2
Leite v. Crane Co.,
3 749 F.3d 1117 (9th Cir. 2014) .............................................................................................................. 10
4 McKart v. United States,

395 U.S. 185 (1969) .............................................................................................................................. 20
5 Nat’l Taxpayers Union, Inc. v. United States,
6 68 F.3d 1428 (D.C. Cir. 1995) .............................................................................................................. 15

Neitzke v. Williams,
7 490 U.S. 319 (1989) .............................................................................................................................. 11
8 Norton v. S. Utah Wilderness All. (SUWA),
542 U.S. 55 (2004) ......................................................................................................................... passim
9
San Luis Unit Food Producers v. United States,
10 709 F.3d 798 (9th Cir. 2013) .................................................................................................... 17, 18, 20
11 Spokeo, Inc. v. Robins,

578 U.S. 330 (2016) .............................................................................................................................. 11
12 Steel Co. v. Citizens for a Better Env’t,
13 523 U.S. 83 (1998) ................................................................................................................................ 10

Summers v. Earth Island Inst.,
14 555 U.S. 488 (2009) .............................................................................................................................. 11
15 Thornhill Pub. Co. v. Gen. Tel. & Elecs. Corp.,
594 F.2d 730 (9th Cir. 1979) .......................................................................................................... 10, 19
16
Statutes
17 5 U.S.C. § 706(1) .......................................................................................................................... 17, 20, 22
18 21 U.S.C. §
387 ...................................................................................................................................................... 1, 3
19 387g(a) .................................................................................................................................................... 3
20 387g(a)(1) ............................................................................................................................................... 3
387g(a)(1)(A) ........................................................................................................................................ 17
21 387g(a)(3)(B)(i) ...................................................................................................................................... 3
387g(b) .................................................................................................................................................... 3
22 387g(c)(1) ............................................................................................................................................... 4
387g(c)(2) ............................................................................................................................................... 4
23 387g(c)(4) ............................................................................................................................................... 4
24 387g(d)(1) ...................................................................................................................................... passim
387g(d)(1)(A)................................................................................................................................. passim
25 387g(d)(1)(B) .................................................................................................................................. 19, 22
393(d)(2) ................................................................................................................................................. 1
26 393(e) ...................................................................................................................................................... 3
27 Family Smoking Prevention and Tobacco Control Act of 2009, Pub L. No. 111-31, 123 Stat. 1776,
codified at 21 U.S.C. §§ 387–387u ..................................................................................................... 1, 3
28
iv
1 Rules
2 Fed. R. Civ. P. 12(b)(1)......................................................................................................................... 1, 10

Fed. R. Civ. P. 12(b)(6)...................................................................................................................... passim
3
Fed. R. Evid. 201(b) .................................................................................................................................. 21
4
Other Authorities
5 Regulatory Planning and Review, Exec. Order No. 12,866,
58 Fed. Reg. 51,735 (Oct. 4, 1993)..................................................................................................... 4, 5
6
Improving Regulation and Regulatory Review, Exec. Order No. 13,563,
7 76 Fed. Reg. 3821 (Jan. 21, 2011) .......................................................................................................... 5
8 Tobacco Product Standard for Menthol in Cigarettes, 87 Fed. Reg. 26,454
(proposed May 4, 2022) ...................................................................................................................... 1, 6
9
Establishment of Tobacco Product Standards for Menthol in Cigarettes and Characterizing
10 Flavors in Cigars; Extension of Comment Period, 87 Fed. Reg. 36,786 (June 21, 2022) ...................... 7
Modernizing Regulatory Review, Exec. Order No. 14,094,
11
88 Fed. Reg. 21,879 (Apr. 11, 2023) .................................................................................................. 4, 5
12 Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions—Fall 2023,
89 Fed. Reg. 9292 (Feb. 9, 2024) ........................................................................................................... 6
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
v
1 NOTICE OF MOTION
2 PLEASE TAKE NOTICE that on September 12, 2024, at 2:00 p.m., in the United States
3 Courthouse at Oakland, California, Defendants U.S. Department of Health and Human Services (HHS),
4 Xavier Becerra, U.S. Food and Drug Administration (FDA), Dr. Robert Califf, Center for Tobacco
5 Products, and Dr. Brian King will move to dismiss this action.
6 MOTION TO DISMISS
7 Defendants hereby move to dismiss this action pursuant to Federal Rules of Civil Procedure
8 12(b)(1) and 12(b)(6) for the reasons set forth in the following Memorandum of Points and Authorities.
9 MEMORANDUM OF POINTS AND AUTHORITIES
10 PRELIMINARY STATEMENT
11 The Family Smoking Prevention and Tobacco Control Act of 2009 (the “Tobacco Control Act”
12 or “Act”) prohibited most characterizing flavors in cigarettes, but expressly exempted menthol from the
13 flavor prohibition and deferred the question of whether to prohibit menthol as a characterizing flavor in
14 cigarettes to the expert judgment of FDA.1 Pub L. No. 111-31, 123 Stat. 1776, codified at 21 U.S.C.
15 §§ 387–387u. After the Act’s passage, FDA engaged in extensive study of menthol and, approximately
16 two years ago, proposed a tobacco product standard that, if finalized, would prohibit menthol as a
17 characterizing flavor in combustible cigarettes. Tobacco Product Standard for Menthol in Cigarettes, 87
18 Fed. Reg. 26,454 (proposed May 4, 2022). The proposed rule has generated immense public interest
19 from competing viewpoints, which will inform FDA’s decision whether to promulgate a final rule on
20 menthol as a characterizing flavor in cigarettes or, alternatively, terminate the rulemaking proceeding
21 without issuing a final rule. See 21 U.S.C. § 387g(d)(1).
22 Plaintiffs are four public health groups that seek to force FDA to promulgate the final rule they
23 desire—prohibiting menthol as a characterizing flavor in cigarettes—on their preferred timeline. They
24 argue that FDA has unreasonably delayed promulgating a final rule in violation of the Administrative
25
26
27 1
Because the Act authorizes the Secretary of Health and Human Services to carry out his
responsibilities under the Act through the FDA Commissioner, see 21 U.S.C. § 393(d)(2), this brief
28
often refers to FDA rather than the Secretary.
1
1 Procedure Act (APA). However, for two reasons, the Court lacks subject-matter jurisdiction over their
2 claims.
3 First, for the same reasons the Supreme Court recently rejected the plaintiffs’ assertion of
4 organizational standing in FDA v. Alliance for Hippocratic Medicine, 144 S. Ct. 1540, 2024 WL
5 2964140 (2024), Plaintiffs here have failed to meet their burden to show organizational standing under
6 Article III of the U.S. Constitution. Plaintiffs have not alleged any concrete injury from the alleged delay
7 in promulgating a final rule prohibiting menthol as a characterizing flavor in cigarettes, such as an
8 impediment to their operations. At most, they have alleged a setback to their abstract social interests,
9 which is insufficient to establish standing. Although Plaintiffs allege that the alleged delay has caused
10 them to divert resources that could be used for other priorities, the Supreme Court expressly rejected this
11 theory of standing because it would impermissibly allow plaintiffs to manufacture their own standing.
12 Second, the Court lacks subject-matter jurisdiction over Plaintiffs’ unreasonable delay claim
13 because Plaintiffs have not shown that the agency failed to take a discrete agency action that it is
14 required to take. The Tobacco Control Act does not require FDA to promulgate a final rule regarding
15 menthol in cigarettes, let alone the particular menthol prohibition Plaintiffs seek on the timeline they
16 prefer. Instead, FDA has discretion under the Act to issue a final rule, continue the rulemaking
17 proceeding, or terminate the rulemaking proceeding.
18 Finally, even if the requirement to show that the agency failed to take a discrete agency action
19 that it is required to take were not jurisdictional, Plaintiffs would fail to state a claim for relief because
20 they have not plausibly alleged the elements of an unreasonable delay claim.
21 STATEMENT OF THE ISSUES
22 1. Whether the Court lacks subject-matter jurisdiction because Plaintiffs have failed to
23 establish organizational standing.
24 2. Whether the Court lacks subject-matter jurisdiction or, in the alternative, the amended
25 complaint fails to state a plausible claim for relief, because Plaintiffs have failed to
26 identify a discrete action that the agency is legally required to take.
27
28
2
1 BACKGROUND
2 I. The Tobacco Control Act of 2009
3 The Tobacco Control Act established a comprehensive scheme for regulating tobacco products in
4 the United States by broadly delegating regulatory authority to the Secretary of Health and Human
5 Services, who is authorized to carry out his responsibilities under the Act through the FDA
6 Commissioner. Pub L. No. 111-31, 123 Stat. 1776, codified at 21 U.S.C. §§ 387–387u; see supra n.1. It
7 prohibited all characterizing flavors in cigarettes except for tobacco and menthol flavors, the latter of
8 which Congress intentionally deferred for further study and delegated to the discretion of FDA. See 21
9 U.S.C. § 387g(a)(1) (excepting menthol from the flavor prohibition), § 387g(e) (requiring that FDA
10 refer to the Tobacco Products Scientific Advisory Committee for report and recommendation “the issue
11 of the impact of the use of menthol in cigarettes on the public health, including such use among children,
12 African-Americans, Hispanics, and other racial and ethnic minorities”). Under the Act, FDA may
13 promulgate a regulation, known as a tobacco product standard, addressing menthol as a characterizing
14 flavor in cigarettes if the agency “determines that the standard would be appropriate for the protection of
15 the public health.” Id. § 387g(d)(1)(A).
16 Recognizing that FDA has the requisite “scientific expertise,” 21 U.S.C. § 387 note (Statutory
17 Notes, Finding 44), Congress directed the agency to evaluate a complex range of factors when making
18 this determination. Id. § 387g(a)–(b). For example, FDA must “consider scientific evidence” concerning
19 “the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of
20 the proposed standard,” as well as “the increased or decreased likelihood that existing users of tobacco
21 products will stop using such products” and “that those who do not use tobacco products will start using
22 such products.” Id. § 387g(a)(3)(B)(i). The agency must also “consider information submitted in
23 connection with a proposed standard,” including information “regarding the technical achievability of
24 compliance with such standard” and “concerning the countervailing effects of the tobacco product
25 standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the
26 creation of a significant demand for contraband . . . and the significance of such demand.” Id. § 387g(b).
27
28
3
1 II. Notice-and-Comment Rulemaking
2 Under the Tobacco Control Act, the Secretary of Health and Human Services “shall publish in
3 the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of
4 any tobacco product standard.” 21 U.S.C. § 387g(c)(1). The proposed rule must comply with certain
5 requirements, including that it “set forth a finding with supporting justification that the tobacco product
6 standard is appropriate for the protection of the public health” and provide “for a comment period of not
7 less than 60 days.” Id. § 387g(c)(2), (4). “After the expiration” of that comment period “and after
8 consideration of” comments, “the Secretary shall—(A) if the Secretary determines that the standard
9 would be appropriate for the protection of the public health, promulgate a regulation establishing a
10 tobacco product standard and publish in the Federal Register findings on the matters” in the proposed
11 rule; “or (B) publish a notice terminating the proceeding for the development of the standard together
12 with the reasons for such termination.” Id. § 387g(d)(1).
13 In order to promote “regulations that are effective, consistent, sensible, and understandable,” the
14 Executive Branch has established a regulatory system that provides for “planning and coordination,”
15 while respecting “the primacy of Federal agencies in the regulatory decision-making process,” through
16 executive orders and policies that describe procedures without creating any enforceable rights against
17 the United States. Regulatory Planning and Review, Exec. Order No. 12,866, 58 Fed. Reg. 51,735,
18 51,735, 51,744 (Oct. 4, 1993). The regulatory system is intended to be “accessible and open to the
19 public,” and to ensure “the integrity and legitimacy of regulatory review and oversight.” Id. at 51,735.
20 As permitted by applicable law, it aims to “protect[] and improve[]” the public health, among other
21 things, “without imposing unacceptable or unreasonable costs on society.” Id. Consistent with those
22 principles, agencies “should afford the public a meaningful opportunity to comment on any proposed
23 regulation,” id. at 51,740, and “regulatory actions should be informed by input from interested or
24 affected communities,” Modernizing Regulatory Review, Exec. Order No. 14,094, 88 Fed. Reg. 21,879,
25 21,879 (Apr. 11, 2023); see also Richard L. Revesz, Administrator, Office of Information and
26 Regulatory Affairs (OIRA), Mem. on Broadening Public Participation and Community Engagement in
27 the Regulatory Process (OIRA Public Participation Memo) (July 19, 2023), at 1, https://perma.cc/P7YJ-
28 WUCQ (“Public involvement in the development of regulations can lead to more effective and equitable
4
1 regulations; greater trust in government and democratic accountability; and increased public
2 understanding of the regulatory process.”); Cass R. Sunstein, Administrator, OIRA, Mem. on Exec.
3 Order 13,563, at 2 (Feb. 2, 2011), https://perma.cc/VM37-YRDH (“A central goal of public
4 participation is to improve the content of rules, and open exchanges of information by interested parties
5 can be helpful in that endeavor.”).
6 The Office of Information and Regulatory Affairs in the Office of Management and Budget
7 (OMB) is the government’s central authority for review of regulations and coordinates what is known as
8 the interagency review process at both the proposed and final rule stages. See Exec. Order No. 12,866,
9 58 Fed. Reg. at 51,736, 51,740; The White House, Information and Regulatory Affairs, https://www.
10 whitehouse.gov/omb/information-regulatory-affairs/ (last visited June 26, 2024). Among other things,
11 “[c]oordinated review of agency rulemaking is necessary to ensure that regulations are consistent with
12 applicable law, the President’s priorities, and the principles set forth in” Executive Order 12,866 and
13 subsequent executive orders. Exec. Order 12,866, 58 Fed. Reg. at 51,737. “At any time during the OIRA
14 review process, an agency may withdraw its rule from review and choose not to move forward with it or
15 to resubmit it [to OIRA] after further consideration.” OIRA, FAQ, https://www.reginfo.gov/public/jsp/
16 Utilities/faq.jsp (last visited June 26, 2024) (click “OIRA”).
17 OIRA also works to “promote equitable and meaningful participation by a range of interested or
18 affected parties.” Exec. Order 14,094, 88 Fed. Reg. at 21,879; see OIRA Public Participation Memo,
19 https://perma.cc/P7YJ-WUCQ. For example, OIRA maintains the website, www.reginfo.gov, which
20 provides a guide to the federal rulemaking process. OIRA, FAQ, https://www.reginfo.gov/public/jsp/
21 Utilities/faq.jsp (last visited June 26, 2024). The General Services Administration also maintains
22 www.regulations.gov, which provides a portal for the public to find, read, and comment on specific
23 proposed regulations. See https://www.regulations.gov/ (last visited June 26, 2024); Improving
24 Regulation and Regulatory Review, Exec. Order No. 13,563, 76 Fed. Reg. 3821 (Jan. 21, 2011) (stating
25 that agencies should provide “a meaningful opportunity to comment through the internet”).
26 Additionally, Executive Order 12,866 “establishes a process for persons not employed by the
27 executive branch . . . to request meetings with OIRA officials regarding the substance of regulatory
28 actions under OIRA review.” Exec. Order 14094, 88 Fed. Reg. at 21,880; see Exec. Order 12866, 58
5
1 Fed. Reg. at 51,742–43. Known as “12,866 meetings” or “E.O. 12,866 meetings,” they “offer members
2 of the public an opportunity to provide information to OIRA that may be relevant for the regulatory
3 review process, such as pointing out potential impacts of a regulation or offering alternatives.” The
4 White House, Hearing from You: How OIRA Meets with the Public, https://www.whitehouse.gov/omb/
5 information-regulatory-affairs/modernizing-regulatory-review/hearing-from-you-how-oira-meets-with-
6 the-public/ (last visited June 26, 2024). OIRA invites representatives from the agency taking the
7 regulatory action to such meetings, although those meetings are not a substitute for comments submitted
8 to the agency under its applicable regulatory procedures. OIRA, Guidance Implementing Section 2(e) of
9 Executive Order 14094 (Modernizing Regulatory Review), at 2 (Dec. 20, 2023), https://perma.cc/JAT5-
10 V9DQ.
11 Finally, twice annually, OIRA helps coordinate the publication of a Unified Agenda of Federal
12 Regulatory and Deregulatory Actions to keep the public informed about the actions that administrative
13 agencies plan to take. U.S. General Services Administration, Unified Agenda of Federal Regulatory and
14 Deregulatory Actions, https://www.gsa.gov/policy-regulations/policy/federal-regulation-policy/unified-
15 agenda-of-federal-regulations (last visited June 26, 2024). Entries in the Unified Agenda “give the
16 public notice of” agencies’ “plans to review, propose, and issue regulations,” and represent agencies’
17 “predict[ions,] . . . but dates and schedules are subject to change.” Introduction to the Unified Agenda of
18 Federal Regulatory and Deregulatory Actions—Fall 2023, 89 Fed. Reg. 9292, 9293 (Feb. 9, 2024). “The
19 Unified Agenda does not create a legal obligation on agencies to adhere to schedules in this publication
20 or to confine their regulatory activities to those regulations that appear within it.” Id.
21 III. FDA’s Rulemaking Process Regarding Menthol Cigarettes
22 On May 4, 2022, FDA published a proposed tobacco product standard that, if finalized, would
23 prohibit menthol as a characterizing flavor in cigarettes. Tobacco Product Standard for Menthol in
24 Cigarettes, 87 Fed. Reg. 26,454. The proposal followed years of scientific analysis, review, and
25 evaluation by FDA subject-matter experts regarding the issue of menthol as a characterizing flavor in
26 cigarettes and was accompanied by forty-nine single-spaced pages setting forth and justifying FDA’s
27 finding that the proposal was appropriate for the protection of the public health, with reference to
28 numerous supporting scientific studies. Id. Interested members of the public began submitting comments
6
1 on the proposal as soon as it was published, and FDA granted a request to extend the comment period to
2 a total of 90 days to provide additional time for the public to prepare and submit comments.2 FDA
3 received approximately 175,000 comments on the proposed standard’s public docket. See Menthol
4 Comment Docket, https://www.regulations.gov/docket/FDA-2021-N-1349 (last visited June 27, 2024).
5 Additionally, FDA has received open letters from multiple members of Congress expressing interest in
6 the proposed standard. See, e.g., Letter to FDA Commissioner (July 31, 2023), https://perma.cc/N8YL-
7 E7ZZ (signed by thirty-three members of the U.S. House of Representatives); Letter to FDA
8 Commissioner (July 24, 2023), https://perma.cc/24ZC-V43E (signed by four U.S. senators); Letter to
9 FDA Commissioner (Apr. 28, 2023), https://perma.cc/8Y29-Q7UC (signed by twenty-one U.S.
10 senators); Letter to FDA Commissioner (June 2, 2022), https://perma.cc/N6TF-4LMY (signed by 16
11 members of the U.S. House of Representatives).
12 FDA’s engagement with the public on the proposed standard has also gone beyond public
13 comments and written letters. For example, on June 13 and 15, 2022, the agency held virtual listening
14 sessions to expand public engagement in the process, and each session lasted over four hours. FDA,
15 Listening Sessions: FDA’s Recently Proposed Tobacco Product Standards (June 13–15, 2022).3 The
16 proposed standard was also a major topic of discussion at an August 22, 2023, listening session
17 regarding developing a strategic plan for FDA’s Center for Tobacco Products. See FDA, Listening
18 Session: Developing FDA’s Center for Tobacco Products’ Strategic Plan (Aug. 22, 2023).4 Additionally,
19
20 2
See Tobacco Product Standard for Menthol in Cigarettes (“Menthol Comment Docket”),
21 Docket No. FDA-2021-N-1349, https://www.regulations.gov/docket/FDA-2021-N-1349 (last visited
June 27, 2024); Establishment of Tobacco Product Standards for Menthol in Cigarettes and
22 Characterizing Flavors in Cigars; Extension of Comment Period, 87 Fed. Reg. 36,786 (June 21, 2022);
CTP Newsroom, Comment Period Closed for FDA Proposed Rules Prohibiting Menthol Cigarettes and
23 Flavored Cigars (Aug. 10, 2022), https://www.fda.gov/tobacco-products/ctp-newsroom/comment-
period-closed-fda-proposed-rules-prohibiting-menthol-cigarettes-and-flavored-cigars.
24
3
https://www.fda.gov/tobacco-products/ctp-newsroom/listening-sessions-fdas-recently-
25 proposed-tobacco-product-standards-06132022 (recordings of listening sessions) (content current as of
Aug. 15, 2022); see FDA CTP Listening Session Transcript 06/13/2022, https://www.regulations.gov/
26
document/FDA-2021-N-1349-175873 (Aug. 5, 2022); FDA CTP Listening Session Transcript
27 06/15/2022, https://www.regulations.gov/document/FDA-2021-N-1349-175874 (Aug. 5, 2022).
4
https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-
28
tobacco-products-strategic-plan-08222023 (content current as of Aug. 23, 2023).
7
1 on January 12, 2023, FDA provided a webcast with a Center for Tobacco Products subject-matter expert
2 to help the public better understand how FDA was evaluating pertinent scientific studies. See FDA
3 Grand Rounds: The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a
4 Characterizing Flavor in Cigarettes and Flavors in Cigars (Jan. 12, 2023).5
5 Throughout the process, FDA has treated the proposed standard as “a top priority.” See Brian
6 King, Director, FDA Center for Tobacco Products, A Year in Review: FDA’s Progress on Tobacco
7 Product Regulation in 2023 (A Year in Review) (Feb. 22, 2024).6 FDA spent months considering the
8 comments and drafting a preamble explaining the rationale for a final rule. See id. The draft final rule
9 and its preamble were sent to OIRA for interagency review in October 2023. See id.
10 Like FDA, OIRA has dedicated significant resources to evaluating the proposed standard and
11 facilitating public involvement. See, e.g., Summary of EO 12,866 Meetings for RIN 0910-AI60 (12,866
12 Meetings Summary), https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=202310&rin=
13 0910-AI60&viewRule=true (last visited June 27, 2024). For example, since OIRA began its review of
14 the proposed rule, it has granted 172 E.O. 12,866 meetings with interested members of the public and
15 has invited representatives of HHS and FDA to attend. See id. These meetings have continued while this
16 case has been pending, including several meetings in April and May 2024. See id. At the present time,
17 the draft final rule is still with OIRA for interagency review. See OIRA, Pending EO 12866 Regulatory
18 Review, RIN: 0910-AI60, Tobacco Product Standard for Menthol in Cigarettes, https://www.reginfo.
19 gov/public/do/eoDetails?rrid=341268 (last visited June 27, 2024).
20 In the fall 2022 and spring 2023 Unified Agendas, HHS indicated that it expected to promulgate
21 a final rule in August 2023. Unified Agenda Summary on RIN 0910-AI60, https://www.reginfo.gov/
22 public/do/eAgendaViewRule?RIN=0910-AI60 (last visited June 27, 2024) (click “Fall 2022” and
23 “Spring 2023”). In the fall 2023 Unified Agenda, HHS updated its expectation to indicate that it
24 expected to promulgate a final rule in March 2024. 89 Fed. Reg. at 9363. On April 26, 2024, Secretary
25
5
https://www.fda.gov/science-research/fda-grand-rounds/fda-grand-rounds-scientific-basis-
26
proposed-tobacco-product-standards-prohibit-menthol-characterizing (content current as of Jan. 18,
27 2023).
6
https://www.fda.gov/tobacco-products/ctp-newsroom/year-review-fdas-progress-tobacco-
28
product-regulation-2023 (content current as of Feb. 22, 2024).
8
1 of Health and Human Services Xavier Becerra issued a public statement explaining the status of the
2 proposed rule. HHS, Secretary Becerra Statement on the Proposed Menthol Cigarette Rule (Apr. 26,
3 2024), https://www.hhs.gov/about/news/2024/04/26/secretary-becerra-statement-proposed-menthol-
4 cigarette-rule.html. Secretary Becerra emphasized that the rule had “garnered historic attention.” Id. He
5 noted that the agency had received “an immense amount of feedback,” including on a variety of topics
6 such as “civil rights and criminal justice.” Id. In light of those circumstances, Secretary Becerra said it
7 was “clear that there are still more conversations to have, and that will take significantly more time.” Id.
8 IV. Plaintiffs’ Past and Present Litigation
9 Plaintiffs are four public interest groups with broad policy objectives related to public health. See
10 Dkt. No. 14 (“Am. Compl.”) ¶¶ 18–38. In a prior lawsuit, they alleged that FDA had delayed an early
11 step of the rulemaking process: making a determination about whether to propose a tobacco product
12 standard regarding menthol as a characterizing flavor in cigarettes. Afr. Am. Tobacco Control
13 Leadership Council, et al. v. U.S. Dep’t of Health & Human Servs., et al., No. 4:20-cv-4012-KAW (N.D.
14 Cal.), Dkt. No. 52, Second Am. Compl. (First Supp.), ¶¶ 154–55. Even when FDA stated that it
15 “intend[ed] to issue a proposed rule to prohibit menthol as a characterizing flavor in cigarettes” and
16 “intend[ed] to make this proposed rule one of the Agency’s highest priorities,” Plaintiffs continued to
17 demand judicial intervention on the proposed rule. See Case No. 4:20-cv-4012-KAW, Dkt. No. 50-1,
18 FDA Resp. to Citizen Pet., at 14 (Apr. 29, 2021); Case No. 4:20-cv-4012-KAW, Dkt. No. 65, Pls.’
19 Suppl. Br. in Opp’n to Defs.’ 2d Mot. to Dismiss, at 1, 12 (Sept. 21, 2021). However, the court imposed
20 no deadlines on FDA, and the agency published the notice of proposed rulemaking as planned. Case No.
21 4:20-cv-4012-KAW, Dkt. No. 73, Order, at 4 (Nov. 17, 2021). Plaintiffs voluntarily dismissed the case
22 before the parties, or the court, addressed the merits. Case No. 4:20-cv-4012-KAW, Dkt. No. 81, Notice
23 of Voluntary Dismissal (June 1, 2022).
24 In the present action, Plaintiffs allege that FDA has delayed a later step of the rulemaking
25 process: “promulgating a final rule banning menthol as a characterizing flavor in combustible
26 cigarettes.” Am. Compl. ¶ 170. They argue that this alleged delay has generally made their “work more
27 difficult” and has caused them to continue spending resources on educational efforts regarding menthol
28 cigarettes. E.g., id. ¶ 24.
9
1 LEGAL STANDARD
2 Under Federal Rule of Civil Procedure 12(b)(1), a complaint must be dismissed if the court lacks
3 subject-matter jurisdiction over the plaintiff’s claims. Federal courts are “presume[d]” to lack subject-
4 matter jurisdiction, DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 342 n.3 (2006), and it is the
5 plaintiff’s burden to establish it, Kokkonen v. Guardian Life. Ins. Co., 511 U.S. 375, 377 (1994). To
6 establish jurisdiction, a plaintiff “must allege facts, not mere legal conclusions.” Leite v. Crane Co., 749
7 F.3d 1117, 1121 (9th Cir. 2014); see Ashcroft v. Iqbal, 556 U.S. 662, 677–79 (2009). Jurisdiction must
8 be “established as a threshold matter” and, where it is not established, “the only function remaining to
9 the court is that of announcing the fact and dismissing the cause.” Steel Co. v. Citizens for a Better
10 Env’t, 523 U.S. 83, 94 (1998).
11 A defendant “may challenge the plaintiff’s jurisdictional allegations in one of two ways.” Leite,
12 749 F.3d at 1121. A facial attack “accepts the truth of the plaintiff’s allegations but asserts that they are
13 insufficient on their face to invoke federal jurisdiction.” Id. (quotations omitted). “The district court
14 resolves a facial attack as it would a motion to dismiss under Rule 12(b)(6): Accepting the plaintiff’s
15 allegations as true and drawing all reasonable inferences in the plaintiff’s favor, the court determines
16 whether the allegations are sufficient as a legal matter to invoke the court’s jurisdiction.” Id.
17 By contrast, a factual attack “contests the truth of the plaintiff’s factual allegations.” Leite, 749
18 F.3d at 1121. In a factual attack, the court “may review evidence beyond the complaint without
19 converting the motion to dismiss into a motion for summary judgment.” Am. Diabetes Ass’n v. U.S.
20 Dep’t of the Army, 938 F.3d 1147, 1151 (9th Cir. 2019) (quotations omitted). The plaintiff “must
21 support her jurisdictional allegations with competent proof,” Leite, 749 F.3d at 1121 (quotations
22 omitted), and “[n]o presumptive truthfulness attaches to plaintiff’s allegations,” Thornhill Pub. Co. v.
23 Gen. Tel. & Elecs. Corp., 594 F.2d 730, 733 (9th Cir. 1979) (quotations omitted). The plaintiff “bears
24 the burden of proving by a preponderance of the evidence that each of the requirements for subject-
25 matter jurisdiction has been met.” Leite, 749 F.3d at 1121.
26 Under Rule 12(b)(6), a complaint must “state[] a plausible claim for relief [to] survive[] a motion
27 to dismiss.” Iqbal, 556 U.S. at 679. “Threadbare recitals of the elements of a cause of action, supported
28 by mere conclusory statements, do not suffice.” Id. at 678. The Court must dismiss a complaint under
10
1 Rule 12(b)(6) if the plaintiff’s claims fail as a matter of law, Neitzke v. Williams, 490 U.S. 319, 326–27
2 (1989), or if the complaint lacks factual allegations sufficient to raise a “right to relief above the
3 speculative level,” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007).
4 DISCUSSION
5 I. Plaintiffs Have Not Met Their Burden To Establish Standing
6 This Court lacks subject-matter jurisdiction because, on the face of the amended complaint,
7 Plaintiffs have failed to meet their burden to establish standing. See Kokkonen, 511 U.S. at 377; La
8 Asociacion de Trabajadores de Lake Forest v. City of Lake Forest, 624 F.3d 1083, 1087 (9th Cir. 2010).
9 To establish Article III standing, Plaintiffs “must clearly allege facts demonstrating each element” of
10 standing, Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016) (cleaned up): (1) an injury in fact that is
11 “concrete, particularized, and actual or imminent”; (2) “fairly traceable to the challenged action”; and
12 (3) likely “redressable by a favorable ruling,” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013).
13 “If a plaintiff seeks prospective relief, she must show [a] threat of future injury [that] is ‘actual and
14 imminent, not conjectural or hypothetical.’” Bolden-Hardge v. Off. of Cal. State Controller, 63 F.4th
15 1215, 1220 (9th Cir. 2023) (quoting Summers v. Earth Island Inst., 555 U.S. 488, 493 (2009)). When, as
16 here, plaintiffs assert organizational standing “to sue on their own behalf for injuries they have
17 sustained,” they “must satisfy the usual standards for injury in fact, causation, and redressability that
18 apply to individuals.” All. for Hippocratic Med., 2024 WL 2964140, at *13 (quoting and citing Havens
19 Realty Corp. v. Coleman, 455 U.S. 363, 378–379 (1982)).7
20 The Supreme Court’s recent decision in FDA v. Alliance for Hippocratic Medicine, in which the
21 Court held that organizational plaintiffs did not have standing to challenge FDA’s actions modifying the
22 conditions of use for mifepristone, 2024 WL 2964140, at *4, *9, establishes that Plaintiffs here do not
23
7
In addition to establishing standing on its own behalf, an organizational plaintiff can attempt to
24 establish “associational” standing on behalf of its members by showing that “(1) at least one of its
25 members would have standing to sue in his own right, (2) the interests the suit seeks to vindicate are
germane to the organization’s purpose, and (3) neither the claim asserted nor the relief requested
26 requires the participation of individual members in the lawsuit.” Fleck & Assocs., Inc. v. City of
Phoenix, 471 F.3d 1100, 1105–06 (9th Cir. 2006). But Plaintiffs do not identify any of their members or
27 attempt to show that any such member “would have standing to sue in his own right.” Id.; see Associated
Gen. Contractors of Am., San Diego Chapter, Inc. v. Cal. Dep’t of Transp., 713 F.3d 1187, 1194 (9th
28
Cir. 2013).
11
1 have standing. Like the plaintiffs in Alliance, Plaintiffs have not alleged that they face any “direct
2 monetary injuries” or other concrete harm from the challenged conduct—here, the alleged delay in
3 promulgating a final rule prohibiting menthol cigarettes. All. for Hippocratic Med., 2024 WL 2964140,
4 at *9. Instead, Plaintiffs are education and advocacy organizations with only ideological objections to
5 the alleged delay—“mere bystander[s]” with no “personal stake” in the dispute. Id. at *5. For example,
6 the amended complaint alleges that the alleged delay has “undermine[d]” or “hinder[ed]” the efforts of
7 Plaintiff National Medical Association (NMA) to “promote healthy lifestyles among African Americans
8 and other underserved populations,” “eliminate health disparities,” “promote smoking cessation,” and
9 “achieve parity and justice in medicine.” Am. Compl. ¶ 35.
10 Plaintiffs allege that they have had to “divert resources that could be used for other” priorities.
11 Am. Compl. ¶ 35; see id. ¶¶ 24, 30. But the plaintiffs in Alliance for Hippocratic Medicine made the
12 same argument—that “standing exists when an organization diverts its resources in response to a
13 defendant’s actions”—and the Supreme Court held that argument was “incorrect.” All. for Hippocratic
14 Med., 2024 WL 2964140, at *13. In particular, the plaintiffs could not establish standing by spending
15 resources on activities such as “public education” to “the detriment of other spending priorities.” Id. The
16 Court explained that “an organization that has not suffered a concrete injury caused by a defendant’s
17 action” (or inaction) “cannot manufacture its own standing” simply “by expending money” on such
18 activities. Id. To permit such plaintiffs to sue “would mean that all the organizations in America would
19 have standing to challenge almost every federal policy that they dislike, provided they spend a single
20 dollar opposing those policies”—“an expansive theory of standing” that the Court rejected. Id.
21 The Court contrasted the plaintiffs’ insufficient alleged injuries to the injuries found sufficient in
22 Havens Realty, in which the Court held that a housing counseling organization “had standing to bring a
23 claim under the Fair Housing Act” against an apartment complex owner that gave the organization’s
24 employees false information about apartment availability. All. for Hippocratic Med., 2024 WL 2964140,
25 at *13. In Havens Realty, the defendant’s “actions directly affected and interfered with [the plaintiff]’s
26 core business activities—not dissimilar to a retailer who sues a manufacturer for selling defective goods
27 to the retailer.” Id. In Alliance for Hippocratic Medicine, by contrast, the challenged agency conduct
28 “ha[d] not imposed any similar impediment to the [plaintiffs’] advocacy businesses.” Id. at *14.
12
1 This analysis disposes of Plaintiffs’ standing claims. The amended complaint asserts that the
2 alleged delay in promulgating the menthol rule has caused the first two named Plaintiffs—African
3 American Tobacco Control Leadership Council (AATCLC) and Action on Smoking and Health
4 (ASH)—“to continue devoting resources and efforts to educate the public about the dangers of menthol
5 cigarettes” instead of “directing [their] resources and efforts to advancing [their] other organizational
6 goals, such as helping to reduce the harms of tobacco on society.” Am. Compl. ¶ 24; see id. ¶ 30. But
7 AATCLC and ASH “cannot manufacture [their] own standing” by choosing to spend resources on
8 “public education” to “the detriment of other spending priorities.” All. for Hippocratic Med., 2024 WL
9 2964140, at *13.
10 AATCLC and ASH also do not allege “a concrete injury.” All. for Hippocratic Med., 2024 WL
11 2964140, at *13. For example, they have not shown that the alleged delay, which if anything preserves
12 the regulatory status quo, interferes with their “core business activities” or “imped[es]” their operations.
13 Id. at *13–14. To the contrary, the amended complaint alleges that AATCLC and ASH are continuing
14 their existing educational activities. Am. Compl. ¶¶ 24, 30. Although the amended complaint makes the
15 conclusory allegations that FDA’s “ongoing refusal to ban menthol in combustible cigarettes makes
16 [AATCLC’s and ASH’s] work more difficult,” Am. Compl. ¶ 24; see id. ¶ 30, these allegations are
17 “naked assertion[s] devoid of further factual enhancement” that are insufficient to withstand a motion to
18 dismiss, Iqbal, 556 U.S. at 678 (quotations omitted).
19 Regarding the third named Plaintiff, NMA, the vague allegation that the alleged delay “forces
20 [NMA] to divert resources that could be used for other health policies” also does not establish standing.
21 Am. Compl. ¶ 35. As an initial matter, the amended complaint does not identify these “other health
22 policies” or say what NMA is choosing to spend its resources on instead. Id. Moreover, NMA “cannot
23 manufacture [its] own standing” by choosing to spend resources on this unidentified activity to “the
24 detriment” of “other health policies.” All. for Hippocratic Med., 2024 WL 2964140, at *13; Am. Compl.
25 ¶ 35. And like AATCLC and ASH, NMA does not allege “a concrete injury,” such as any interference
26 with its “core business activities” or any “impediment” to its operations. Id. at *13–14. As discussed
27 above, the amended complaint alleges that the alleged delay has “undermine[d]” or “hinder[ed]” NMA’s
28 efforts to achieve various goals, such as “promot[ing] healthy lifestyles among African Americans and
13
1 other underserved populations.” Am. Compl. ¶ 35. At the outset, these conclusory allegations are
2 insufficient because they are “naked assertion[s] devoid of further factual enhancement,” Iqbal, 556 U.S.
3 at 678 (quotations omitted), lacking any explanation of how NMA’s efforts have been undermined or
4 hindered. Moreover, these allegations describe, at most, “a setback to the organization’s abstract social
5 interests,” yet a plaintiff must allege “far more than” that to establish organizational standing. All. for
6 Hippocratic Med., 2024 WL 2964140, at *13 (quoting Havens Realty, 455 U.S. at 379).
7 Like the first three Plaintiffs, the fourth named Plaintiff, American Medical Association (AMA),
8 fails to allege “a concrete injury,” such as any interference with its “core business activities” or any
9 “impediment” to its operations. All. for Hippocratic Med., 2024 WL 2964140, at *13–14. The amended
10 complaint alleges that AMA’s “objectives are to promote the science and art of medicine and the
11 betterment of public health.” Am. Compl. ¶ 37. But it does not allege that AMA is less able to achieve
12 these objectives because of the alleged delay, and even if it had, that would still amount to merely “a
13 setback to the organization’s abstract social interests,” which is insufficient to establish standing. All. for
14 Hippocratic Med., 2024 WL 2964140, at *13 (quoting Havens Realty, 455 U.S. at 379).
15 Finally, prior to Alliance for Hippocratic Medicine, the Ninth Circuit had held that “[a]n
16 organization suing on its own behalf can establish an injury when it suffered both a diversion of its
17 resources and a frustration of its mission.” La Asociacion de Trabajadores, 624 F.3d at 1088 (quotations
18 omitted). This standard is no longer good law after Alliance for Hippocratic Medicine, which expressly
19 rejected the notion that “standing exists when an organization diverts its resources in response to a
20 defendant’s actions.” 2024 WL 2964140, at *13. But even if the Ninth Circuit’s standard remained
21 viable, it would not be met here.
22 Under prior Ninth Circuit decisions, an organizational plaintiff’s “diversion of its resources,” La
23 Asociacion de Trabajadores, 624 F.3d at 1088, requires “changing resource allocation, not merely going
24 about ‘business as usual.’” In Def. of Animals v. Sanderson Farms, Inc., No. 20-CV-05293-RS, 2021
25 WL 4243391, at *4 (N.D. Cal. Sept. 17, 2021) (quoting Am. Diabetes Ass’n, 938 F.3d at 1154).
26 Moreover, the plaintiff must have been “forced to choose between suffering an injury and diverting
27 resources to counteract the injury” and must accordingly “show that it would have suffered some other
28 injury if it had not diverted resources to counteracting the problem.” La Asociacion de Trabajadores,
14
1 624 F.3d at 1088 & n.4. To show the required “frustration of its mission,” id. at 1088 (quotations
2 omitted), an organizational plaintiff must show a “concrete and demonstrable injury to [its] activities.”
3 Havens Realty, 455 U.S. at 379. “Frustration of mission cannot be just a setback to an organization’s
4 values or interests” but “must result in an actual impediment to the organization’s real world efforts on
5 behalf of such principles.” In Def. of Animals, 2021 WL 4243391, at *3 (quotations omitted).
6 None of the Plaintiffs satisfy the Ninth Circuit’s standard. As discussed above, AATCLC and
7 ASH claim that the alleged delay has caused them “to continue devoting resources and efforts to educate
8 the public about the dangers of menthol cigarettes” instead of “directing [their] resources and efforts to
9 advancing [their] other organizational goals, such as helping to reduce the harms of tobacco on society.”
10 Am. Compl. ¶ 24; see id. ¶ 30. But “merely continuing ongoing activities,” such as Plaintiffs’ ongoing
11 educational activities, “does not satisfy” the Ninth Circuit’s diversion-of-resources requirement. Friends
12 of the Earth v. Sanderson Farms, Inc., 992 F.3d 939, 942 (9th Cir. 2021) (organizations do not divert
13 resources “when they go about their business as usual” (quotations omitted)); see Nat’l Taxpayers
14 Union, Inc. v. United States, 68 F.3d 1428, 1434 (D.C. Cir. 1995) (organization “cannot convert its
15 ordinary program costs into an injury in fact”); Blunt v. Lower Merion Sch. Dist., 767 F.3d 247, 286 (3d
16 Cir. 2014) (“additional expenditures . . . consistent with [an organization’s] typical activities” do not
17 confer standing). Indeed, “AATCLC was formed to educate the Black community and public about
18 tobacco use and cessation,” Am. Compl. ¶ 18, and it can hardly claim to be injured by continuing the
19 very activity it was formed to do. Moreover, even if AATCLC and ASH had alleged that they are
20 providing education beyond what they normally provide, they still have not “show[n] that [they] would
21 have suffered some other injury [to their activities] if [they] had not diverted resources” to providing
22 such further education. Asociacion de Trabajadores, 624 F.3d at 1088; see Havens Realty, 455 U.S. at
23 379.
24 AATCLC and ASH also have not established “frustration of [their] mission.” La Asociacion de
25 Trabajadores, 624 F.3d at 1088 (quotations omitted). As discussed above, their allegations that the
26 alleged delay makes their “work more difficult,” Am. Compl. ¶ 24; see id. ¶ 30, are “naked assertion[s]
27 devoid of further factual enhancement” that are insufficient to withstand a motion to dismiss. Iqbal, 556
28 U.S. at 678 (quotations omitted). AATCLC and ASH do not allege any “concrete and demonstrable
15
1 injury to [their] activities,” Havens Realty, 455 U.S. at 379, such as “an actual impediment to the
2 organization[s’] real world efforts on behalf of” their goals, In Def. of Animals, 2021 WL 4243391, at *3
3 (quotations omitted); see Havens Realty, 455 U.S. at 379. To the contrary, the amended complaint
4 alleges that AATCLC and ASH are continuing their existing educational activities. Am. Compl. ¶¶ 24,
5 30.
6 NMA fares no better. As discussed above, it vaguely asserts that the alleged delay “forces [it] to
7 divert resources that could be used for other health policies.” Am. Compl. ¶ 35. But NMA does not
8 allege that it “would have suffered some other injury if it had not diverted [its] resources.” La
9 Asociacion de Trabajadores, 624 F.3d at 1088. NMA also has not established a “frustration of [its]
10 mission.” Id. (quotations omitted). It asserts that the alleged delay “undermines [its] efforts” toward
11 various goals, such as “promot[ing] healthy lifestyles among African Americans and other underserved
12 populations” and “achiev[ing] parity and justice in medicine,” Am. Compl. ¶ 35. As discussed above,
13 however, these conclusory allegations are “naked assertion[s] devoid of further factual enhancement,”
14 Iqbal, 556 U.S. at 678 (quotations omitted), and at most allege “a setback to the organization’s abstract
15 social interests,” All. for Hippocratic Med., 2024 WL 2964140, at *13 (quoting Havens Realty, 455 U.S.
16 at 379) (internal quotation marks omitted). NMA does not show a “concrete and demonstrable injury to
17 [its] activities.” Havens Realty, 455 U.S. at 379; see In Def. of Animals, 2021 WL 4243391, at *5
18 (organizational plaintiff lacked standing where it did “not adequately plead any concrete way in which
19 its mission has been frustrated,” but “only plead[ed] facts showing the abstract interests it fights for have
20 been set back by” the defendant’s conduct).
21 Finally, AMA does not meet the Ninth Circuit’s standard for organizational standing. It does not
22 allege any “diversion of its resources,” let alone that it “would have suffered some other injury if it had
23 not diverted [its] resources.” La Asociacion de Trabajadores, 624 F.3d at 1088. It also has not
24 established a “frustration of [its] mission,” id. (quotations omitted), because it does not identify any of
25 its activities, let alone allege a “concrete and demonstrable injury” to its activities, Havens Realty, 455
26 U.S. at 379. Although the amended complaint alleges that “[t]he AMA’s objectives are to promote the
27 science and art of medicine and the betterment of public health,” Am. Compl. ¶ 37, it does not allege “an
28 actual impediment to the organization’s real world efforts on behalf of such principles.” In Def. of
16
1 Animals, 2021 WL 4243391, at *3 (quotations omitted). A mere “setback to an organization’s values or
2 interests” is insufficient. Id. (quotations omitted); see All. for Hippocratic Med., 2024 WL 2964140, at
3 *13; Havens Realty, 455 U.S. at 379.
4 In sum, none of the Plaintiffs establish organizational standing under Alliance for Hippocratic
5 Medicine. And even if the Ninth Circuit’s preexisting standard for organizational standing remained
6 viable after that decision, it also would not be satisfied here.
7 II. The Court Lacks Subject-Matter Jurisdiction Because Plaintiffs Have Failed To Identify Any
8 Discrete Action that FDA Is Legally Required To Take
9 Plaintiffs’ sole claim is that Defendants have unreasonably delayed issuing a final rule
10 prohibiting menthol cigarettes. See Am. Compl. ¶¶ 167–75 (citing 5 U.S.C. § 706(1)). Unreasonable
11 delay claims are limited to where “an agency failed to take a discrete agency action that it is required to
12 take.” Norton v. S. Utah Wilderness All. (SUWA), 542 U.S. 55, 64 (2004); see id. at 63 (“the only agency
13 action that can be compelled under the APA is action legally required”); 5 U.S.C. § 706(1). Put another
14 way, the APA “carefully circumscribed” judicial review of unreasonable delay claims “to situations
15 where an agency has ignored a specific legislative command.” Hells Canyon Pres. Council v. U.S.
16 Forest Serv., 593 F.3d 923, 932 (9th Cir. 2010).8 This requirement is jurisdictional. San Luis Unit Food
17 Producers v. United States, 709 F.3d 798, 803–04 (9th Cir. 2013); Alvarado v. Table Mountain
18 Rancheria, 509 F.3d 1008, 1019-20 (9th Cir. 2007). And it furthers important administrative law
19 policies: it “protect[s] agencies from undue judicial interference with their lawful discretion” and
20 “avoid[s] judicial entanglement in abstract policy disagreements which courts lack the expertise and
21 information to resolve.” SUWA, 542 U.S. at 55–56.
22 Plaintiffs allege that FDA has unreasonably delayed issuing a final rule that would add menthol
23 to the list of prohibited “characterizing flavors” under 21 U.S.C. § 387g(a)(1)(A). See Am. Compl.
24 ¶¶ 170–73. But the Tobacco Control Act does not “legally require[]” FDA to issue such a final rule,
25
8
26 The Supreme Court has explained that this requirement reflects the APA’s “carr[ying] forward
the traditional practice prior to its passage” of compelling agency action through writs of mandamus,
27 which were “normally limited to enforcement of a specific, unequivocal command, the ordering of a
precise, definite act . . . about which an official had no discretion whatever.” SUWA, 542 U.S. at 63
28
(cleaned up) (omission in original).
17
1 SUWA, 542 U.S. at 63, and thus the Court lacks jurisdiction over Plaintiffs’ unreasonable delay claim,
2 see San Luis Unit Food Producers, 709 F.3d at 803–04; Alvarado, 509 F.3d at 1019–20.
3 As discussed above, the Act provides:
4 After the expiration of the period for comment on a notice of proposed

rulemaking published under subsection (c) respecting a tobacco product
5 standard and after consideration of comments submitted under subsections
(b) and (c) and any report from the Tobacco Products Scientific Advisory
6
Committee, the Secretary shall--
7
(A) if the Secretary determines that the standard would be appropriate for
8 the protection of the public health, promulgate a regulation establishing a
tobacco product standard and publish in the Federal Register findings on
9 the matters referred to in subsection (c); or
10 (B) publish a notice terminating the proceeding for the development of the
standard together with the reasons for such termination.
11
12 21 U.S.C. § 387g(d)(1) (emphasis added). There is no statutory deadline for FDA to take either of these
13 actions.
14 Here, publicly available facts, which are properly considered in a factual attack on subject-matter
15 jurisdiction, see Am. Diabetes Ass’n, 938 F.3d at 1151, show that the requisite determination in 21
16 U.S.C. § 387g(d)(1)(A)—i.e., that the final rule would be appropriate for the protection of the public
17 health—has not been made. FDA sent the draft final rule to OIRA in October 2023, see A Year in
9
18 Review (Feb. 22, 2024), and the draft rule remains with OIRA for interagency review, see OIRA,
19 Pending EO 12866 Regulatory Review, RIN: 0910-AI60, Tobacco Product Standard for Menthol in
20 Cigarettes, https://www.reginfo.gov/public/do/eoDetails?rrid=341268 (last visited June 27, 2024). As
21 recently as May 2024, OIRA has held E.O. 12,866 meetings with interested members of the public and
22 has invited representatives of HHS and FDA to attend. See 12,866 Meetings Summary, https://www.
23 reginfo.gov/public/do/eom12866SearchResults?pubId=202310&rin=0910-AI60&viewRule=true (last
24 visited June 27, 2024). And Secretary Becerra recently explained that, in light of the “historic attention”
25 and “immense amount of feedback” on the proposed rule, “[i]t’s clear that there are still more
26 conversations to have, and that will take significantly more time.” HHS, Secretary Becerra Statement on
27
9
28
18
1 the Proposed Menthol Cigarette Rule (Apr. 26, 2024), https://www.hhs.gov/about/news/2024/04/26/
2 secretary-becerra-statement-proposed-menthol-cigarette-rule.html. These facts disprove Plaintiffs’
3 unsupported allegation that, by February 1, 2023, the agency had “determined the [proposed rule] was
4 still appropriate for the protection of public health,” Am. Compl. ¶ 159—an allegation that is entitled to
5 “[n]o presumptive truthfulness” in the context of the government’s motion to dismiss, which makes a
6 “factual attack on subject matter jurisdiction,” Thornhill Pub., 594 F.2d at 733.10
7 Because the draft rule is still with OIRA for interagency review and the agency has not made the
8 requisite determination in subsection (A) of the statute, the agency is not required to promulgate a final
9 rule under subsection (A). See 21 U.S.C. § 387g(d)(1)(A). Instead, the agency may continue the
10 rulemaking proceeding; for example, it “may withdraw its rule” from the interagency review process
11 and “resubmit it [to OIRA] after further consideration.” OIRA, FAQ, https://www.reginfo.gov/public/
12 jsp/Utilities/faq.jsp (last visited June 26, 2024) (click “OIRA”). The agency may also terminate the
13 rulemaking proceeding under subsection (B). See 21 U.S.C. § 387g(d)(1)(B). Thus, issuing a final rule,
14 as Plaintiffs demand, is not a discrete action FDA “is required to take,” SUWA, 542 U.S. at 64, and the
15 agency has not “ignored a specific legislative command,” Hells Canyon Pres. Council, 593 F.3d at 932.
16 Even if the Court were to find that FDA must take some action regarding menthol cigarettes,
17 there would be no basis to order FDA to issue a final rule prohibiting menthol cigarettes, as Plaintiffs
18 demand. Am. Compl. at 49. The Supreme Court has held that “when an agency is compelled by law to
19 act within a certain time period, but the manner of its action is left to the agency’s discretion, a court can
20 compel the agency to act, but has no power to specify what the action must be.” SUWA, 542 U.S. at 65.
21 Here, FDA is not required “to act within a certain time period,” but even if it were, the “manner of its
22 action” would be “left to the agency’s discretion” under the Tobacco Control Act. Id. FDA would have
23 discretion either to issue a final rule under subsection (A) or to terminate the rulemaking proceeding
24 under subsection (B). 21 U.S.C. § 387g(d)(1). Thus, even if the Court could compel FDA to take some
25 form of action, it could not “specify what the action must be.” SUWA, 542 U.S. at 65. In particular, the
26
27 10
Furthermore, Plaintiffs’ assertion that FDA has taken an action that qualifies as a
determination pursuant to 21 U.S.C. § 387g(d)(1)(A) is a legal conclusion that would not be entitled to a
28
presumption of truth even in a facial attack on subject-matter jurisdiction. See Iqbal, 556 U.S. at 678.
19
1 Court could not order FDA to issue the final rule prohibiting menthol cigarettes that Plaintiffs demand.
2 See Am. Compl. at 49.
3 Importantly, FDA’s statutory discretion at this stage accords with basic principles of
4 administrative law. The Supreme Court has explained the importance of allowing agencies to “develop
5 the necessary factual background upon which decisions should be based” and to complete their normal
6 decision-making processes uninterrupted, especially where, as here, the decision at issue “involve[s]
7 exercise of discretionary powers granted the agency by Congress” and “require[s] application of special
8 expertise.” McKart v. United States, 395 U.S. 185, 194 (1969). The Court should reject Plaintiffs’
9 attempt at a judicial end-run around the normal administrative process.
10 In sum, the Tobacco Control Act does not “legally require[]” FDA to take the action Plaintiffs
11 demand, SUWA, 542 U.S. at 63, and thus the amended complaint must be dismissed for lack of subject-
12 matter jurisdiction, see San Luis Unit Food Producers, 709 F.3d at 803–04; Alvarado, 509 F.3d at 1019–
13 20.
14 III. In the Alternative, the Amended Complaint Fails To State a Plausible Claim for Relief
15 Because Plaintiffs Have Failed To Identify Any Discrete Action that FDA Is Legally Required
16 To Take
17 As discussed above, unreasonable delay claims under 5 U.S.C. § 706(1) are limited to where “an
18 agency failed to take a discrete agency action that it is required to take.” SUWA, 542 U.S. at 64. And
19 this requirement is jurisdictional. See supra p. 17 (citing San Luis Unit Food Producers, 709 F.3d at
20 803–04; Alvarado, 509 F.3d at 1019–20). But even if this requirement were not jurisdictional and were
21 simply an element of an unreasonable delay claim, Plaintiffs’ failure to satisfy it would require that the
22 amended complaint be dismissed under Rule 12(b)(6) for failure to state a plausible claim for relief.
23 The agency is required to promulgate a final rule only if it first “determines that the [rule] would
24 be appropriate for the protection of the public health.” 21 U.S.C. § 387g(d)(1)(A). Reciting the statutory
25 language verbatim, Plaintiffs allege that the agency made this determination by February 1, 2023. Am.
26 Compl. ¶ 159. As discussed above and below, information subject to judicial notice shows that this
27 allegation is not true. Moreover, this allegation, which concerns whether FDA had taken an action that
28 qualifies as a determination pursuant to 21 U.S.C. § 387g(d)(1)(A), is a legal conclusion that is not
20
1 entitled to a presumption of truth in reviewing a motion to dismiss under Rule 12(b)(6). See Iqbal, 556
2 U.S. at 678. This legal conclusion also is not “supported by factual allegations.” Id. at 679.
3 Information publicly available on federal government websites, of which the Court can take
4 judicial notice, shows that the agency had not made the requisite determination under subsection (A) by
5 February 1, 2023, and still has not made that determination. In ruling on a motion to dismiss under Rule
6 12(b)(6), courts may consider facts “properly subject to judicial notice,” and need not “accept as true
7 allegations that contradict” those facts. Daniels-Hall v. Nat’l Educ. Ass’n, 629 F.3d 992, 998 (9th Cir.
8 2010). Information subject to judicial notice includes information that “is publicly available on a
9 government website,” Brown v. Food for Life Baking Co., 658 F. Supp. 3d 732, 738 (N.D. Cal. 2023), as
10 such information “is not subject to reasonable dispute because it . . . can be accurately and readily
11 determined from sources whose accuracy cannot reasonably be questioned,” Fed. R. Evid. 201(b); see
12 Daniels-Hall, 629 F.3d at 998–99.
13 Federal government websites show that, on February 1, 2023, FDA had not even submitted a
14 draft final rule to OIRA. They show that, as discussed above, the draft final rule was sent to OIRA in
15 October 2023, see A Year in Review (Feb. 22, 2024),11 and that it remains with OIRA for interagency
16 review, see OIRA, Pending EO 12866 Regulatory Review, RIN: 0910-AI60, Tobacco Product Standard
17 for Menthol in Cigarettes, https://www.reginfo.gov/public/do/eoDetails?rrid=341268 (last visited June
18 27, 2024). They further show that OIRA has held E.O. 12,866 meetings as recently as May 2024, see
19 12,866 Meetings Summary, https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=
20 202310&rin=0910-AI60&viewRule=true (last visited June 27, 2024), and that Secretary Becerra
21 recently explained that “there are still more conversations to have,” which “will take significantly more
22 time,” HHS, Secretary Becerra Statement on the Proposed Menthol Cigarette Rule (Apr. 26, 2024),
23 https://www.hhs.gov/about/news/2024/04/26/secretary-becerra-statement-proposed-menthol-cigarette-
24 rule.html. This information, which is subject to judicial notice in reviewing a motion to dismiss under
25 Rule 12(b)(6), indicates that the agency has not yet “determine[d] that the [rule] would be appropriate
26 for the protection of the public health” pursuant to 21 U.S.C. § 387g(d)(1)(A).
27
11
28
21
1 Because the agency has not made the requisite determination in subsection (A), it is not required
2 to promulgate a final rule and may instead continue the rulemaking proceeding or terminate it under
3 subsection (B). Id. § 387g(d)(1). Issuing a final rule is not a discrete action FDA “is required to take.”
4 SUWA, 542 U.S. at 64. Thus, even if this requirement were not jurisdictional, Plaintiffs would fail to
5 state an unreasonable delay claim under 5 U.S.C. § 706(1), and the amended complaint would properly
6 be dismissed under Rule 12(b)(6).
7 CONCLUSION
8 For the foregoing reasons, the amended complaint should be dismissed.
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1 Dated: June 27, 2024 Respectfully submitted,
2 OF COUNSEL: BRIAN M. BOYNTON

Principal Deputy Assistant Attorney General
3
SAMUEL R. BAGENSTOS
4 General Counsel ARUN G. RAO
Deputy Assistant Attorney General
5 MARK RAZA
Chief Counsel AMANDA N. LISKAMM
6 Food and Drug Administration Director
Deputy General Counsel
7
Department of Health and Human LISA K. HSIAO
8 Services Senior Deputy Director, Civil Litigation
9 WENDY S. VICENTE HILARY K. PERKINS

Deputy Chief Counsel, Litigation Assistant Director
10
11 KWABENA AKOWUAH /s/ Isaac C. Belfer

Associate Chief Counsel ISAAC C. BELFER (D.C. Bar No. 1014909)
12 Office of the Chief Counsel OLIVER MCDONALD (N.Y. Bar No. 5416789)
U.S. Food and Drug Administration Trial Attorneys
13 10903 New Hampshire Avenue SARAH WILLIAMS (D.C. Bar No. 1006622)
White Oak 32, Room 4520 Senior Trial Attorney
14 Silver Spring, MD 20993-0002 Consumer Protection Branch
15 Civil Division
U.S. Department of Justice
16 P.O. Box 386
Washington, D.C. 20044-0386
17 Telephone: 202-305-7134 (Belfer)
Telephone: 202-305-0168 (McDonald)
18 Telephone: 202-616-4269 (Williams)
19 Fax: 202-514-8742
Isaac.C.Belfer@usdoj.gov
20 Oliver.J.McDonald@usdoj.gov
Sarah.Williams@usdoj.gov
21
Counsel for Defendants U.S. Department of
22
Health and Human Services; Xavier Becerra,
23 in his official capacity as Secretary of the
U.S. Department of Health and Human Services;
24 U.S. Food and Drug Administration; Robert
Califf, in his official capacity as Commissioner of
25 Food and Drugs; Center for Tobacco Products; and
Brian King, in his official capacity as Director of the
26
Center for Tobacco Products
27
28
23
1 CERTIFICATE OF SERVICE
2 I, the undersigned, hereby certify that on June 27, 2024, I electronically filed the foregoing with
3 the Clerk of the Court using the CM/ECF system, which will send notification of such filing to the
4
following:
5
Christopher K. Leung: chris@impact-lit.com
6
There are no manual recipients. I certify under penalty of perjury under the laws of the United
7
8 States of America that the foregoing is true and correct.
10 Dated: June 27, 2024 /s/ Isaac C. Belfer

ISAAC C. BELFER
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Case 4:24-cv-01992-HSG Document 27 Filed 06/27/24 Page 1 of 29

1 ISAAC C. BELFER (D.C. Bar No. 1014909)

13 UNITED STATES DISTRICT COURT FOR THE

14 NORTHERN DISTRICT OF CALIFORNIA

16 AFRICAN AMERICAN TOBACCO CONTROL

2 NOTICE OF MOTION ................................................................................................................................1

3 MOTION TO DISMISS ..............................................................................................................................1

4 MEMORANDUM OF POINTS AND AUTHORITIES .............................................................................1

5 PRELIMINARY STATEMENT .....................................................................................................1

6 STATEMENT OF THE ISSUES.....................................................................................................2

8 I. The Tobacco Control Act of 2009 .......................................................................... 3

9 II. Notice-and-Comment Rulemaking ......................................................................... 4

10 III. FDA’s Rulemaking Process Regarding Menthol Cigarettes .................................. 6

11 IV. Plaintiffs’ Past and Present Litigation..................................................................... 9

14 I. Plaintiffs Have Not Met Their Burden To Establish Standing ............................. 11

15 II. The Court Lacks Subject-Matter Jurisdiction Because Plaintiffs Have

3 Alvarado v. Table Mountain Rancheria,

1 La Asociacion de Trabajadores de Lake Forest v. City of Lake Forest,

4 McKart v. United States,

6 68 F.3d 1428 (D.C. Cir. 1995) .............................................................................................................. 15

11 Spokeo, Inc. v. Robins,

13 523 U.S. 83 (1998) ................................................................................................................................ 10

2 Fed. R. Civ. P. 12(b)(1)......................................................................................................................... 1, 10

9 MEMORANDUM OF POINTS AND AUTHORITIES

21 without issuing a final rule. See 21 U.S.C. § 387g(d)(1).

23 desire—prohibiting menthol as a characterizing flavor in cigarettes—on their preferred timeline. They

7 in promulgating a final rule prohibiting menthol as a characterizing flavor in cigarettes, such as an

17 proceeding, or terminate the rulemaking proceeding.

21 STATEMENT OF THE ISSUES

23 establish organizational standing.

26 identify a discrete action that the agency is legally required to take.

2 I. The Tobacco Control Act of 2009

13 promulgate a regulation, known as a tobacco product standard, addressing menthol as a characterizing

15 the public health.” Id. § 387g(d)(1)(A).

1 II. Notice-and-Comment Rulemaking

12 with the reasons for such termination.” Id. § 387g(d)(1).

3 Order 13,563, at 2 (Feb. 2, 2011), https://perma.cc/VM37-YRDH (“A central goal of public

5 can be helpful in that endeavor.”).

10 whitehouse.gov/omb/information-regulatory-affairs/ (last visited June 26, 2024). Among other things,

15 to resubmit it [to OIRA] after further consideration.” OIRA, FAQ, https://www.reginfo.gov/public/jsp/

16 Utilities/faq.jsp (last visited June 26, 2024) (click “OIRA”).

19 https://perma.cc/P7YJ-WUCQ. For example, OIRA maintains the website, www.reginfo.gov, which

20 provides a guide to the federal rulemaking process. OIRA, FAQ, https://www.reginfo.gov/public/jsp/

14 Deregulatory Actions, https://www.gsa.gov/policy-regulations/policy/federal-regulation-policy/unified-

21 III. FDA’s Rulemaking Process Regarding Menthol Cigarettes

4 Comment Docket, https://www.regulations.gov/docket/FDA-2021-N-1349 (last visited June 27, 2024).

9 FDA Commissioner (Apr. 28, 2023), https://perma.cc/8Y29-Q7UC (signed by twenty-one U.S.

10 senators); Letter to FDA Commissioner (June 2, 2022), https://perma.cc/N6TF-4LMY (signed by 16

11 members of the U.S. House of Representatives).

4 Characterizing Flavor in Cigarettes and Flavors in Cigars (Jan. 12, 2023).5

12 Meetings Summary), https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=202310&rin=

19 gov/public/do/eoDetails?rrid=341268 (last visited June 27, 2024).

8 IV. Plaintiffs’ Past and Present Litigation

23 of Voluntary Dismissal (June 1, 2022).

25 process: “promulgating a final rule banning menthol as a characterizing flavor in combustible

28 cigarettes. E.g., id. ¶ 24.

10 Env’t, 523 U.S. 83, 94 (1998).

25 matter jurisdiction has been met.” Leite, 749 F.3d at 1121.

5 I. Plaintiffs Have Not Met Their Burden To Establish Standing