Case 3:20-cv-04012 Document 1 Filed 06/17/20 Page 1 of 45
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`Christopher K. Leung (SBN 210325)
`Pollock Cohen LLP
`60 Broad St., 24th Fl.
`New York, NY 10004
`Tel.: (212) 337-5361
`Fax.: (347) 696-1227
`Chris@PollockCohen.com
`
`Counsel for Plaintiffs African American Tobacco
`Control Leadership Council and Action on Smoking
`and Health
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`
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF CALIFORNIA
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`SAN FRANCISCO DIVISION
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`Case No.:
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`COMPLAINT
`(Administrative Procedure Act Case)
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`Plaintiffs,
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`vs.
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`AFRICAN AMERICAN TOBACCO
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`CONTROL LEADERSHIP COUNCIL and
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`ACTION ON SMOKING AND HEALTH,
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`U.S. DEPARTMENT OF HEALTH AND
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`HUMAN SERVICES; ALEX M. AZAR II, in )
`his official capacity as Secretary of the U.S.
`)
`Department of Health and Human Services;
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`U.S. FOOD AND DRUG
`)
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`ADMINISTRATION; STEPHEN HAHN, in )
`his official capacity as Commissioner of the
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`U.S. Food and Drug Administration;
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`CENTER FOR TOBACCO PRODUCTS;
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`MITCH ZELLER in his official capacity as
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`the Center for Tobacco Products, Director,
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`)
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`Defendants.
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`Complaint
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`Case 3:20-cv-04012 Document 1 Filed 06/17/20 Page 2 of 45
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`1.
`Plaintiffs African American Tobacco Control Leadership Council (“AATCLC”)
`and Action on Smoking on Health (“ASH”) allege, upon knowledge as to themselves, and
`upon information and belief as to all other matters, as follows:
`INTRODUCTION
`2.
`In 2009, Congress passed—and President Obama signed into law—the Family
`Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (codified,
`in relevant part, at 15 U.S.C. §§ 1333–34 and 21 U.S.C. § 301 et seq.) (2009) (“Tobacco
`Control Act”). This Act authorized the U.S. Food & Drug Administration (“FDA”) to regulate
`tobacco products, 21 U.S.C. § 387a, and prohibited all flavors in cigarettes, save for tobacco
`and menthol (i.e., the “flavor ban”), id. § 387g(a)(1).
`3.
`Although it did not ban menthol at that time, Congress recognized that
`menthol cigarettes “may pose unique health risks to those who smoke them.”1 Congress was
`“especially concerned about proportionately higher rates of menthol cigarette use among
`African American smokers”; “the historic targeting of African Americans for menthol cigarette
`use by tobacco companies”; “the high rates of [menthol cigarette] use among … African
`American youth”; as well as the “higher rates of lung cancer documented among African
`American smokers as compared to non-African American smokers[.]”2
`4.
`Congress therefore took steps to ensure that the issue of menthol in cigarettes
`would be “an early focus” for FDA and that FDA would have “the authority to deal with these
`and other products.”3 It specifically directed FDA to (1) create a Tobacco Products Scientific
`Advisory Committee (“TPSAC” or “Committee”); (2) refer “[i]mmediately” to this Committee
`
`
`1 H. Rept. 111-58, Part 1, Tobacco Control Act, 111th Congress (2009–10), 38 (Energy and
`Commerce Comm.) (“H. Rept., Part 1”). Available at
`https://www.congress.gov/111/crpt/hrpt58/CRPT-111hrpt58-pt1.pdf.
`2 Id.
`3 Cong. Rec.—House, H4318, H4339 (Vol. 155, No. 55) (Apr. 1, 2009); Cong. Rec.—House,
`H6630, H6652 (Vol. 155, No. 88) (June 12, 2009). Available at
`https://www.congress.gov/congressional-record/2009/04/01/house-section/article/H4318-2.
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`Case 3:20-cv-04012 Document 1 Filed 06/17/20 Page 3 of 45
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`the issue of menthol in cigarettes and its effect on public health;4 and (3) reevaluate periodically
`the flavor ban (which had omitted menthol) “to determine whether such standard[] should be
`changed to reflect new medical, scientific, or other technological data,” including with respect
`to menthol. See 21 U.S.C. § 387g(a)(5).
`5.
`Congress repeatedly highlighted the urgent nature of the menthol inquiry,
`“urg[ing] the Secretary [of the U.S. Department of Health and Human Services (“HHS”)] to
`address these issues as quickly as practicable.” H. Rept., Part 1 at 38 (emphasis added).
`Indeed, Congress believed that it would be “critical for the Secretary to move quickly to
`address the unique public health issues posed by menthol cigarettes.” Id. at 38–39 (emphasis
`added).
`6.
`Following the Act’s passage, FDA formed the Tobacco Products Scientific
`Advisory Committee, which conducted an extensive survey assessing the scientific evidence
`concerning the public health impacts of menthol in cigarettes and concluded in a 2011 report
`that the “Removal of menthol cigarettes from the marketplace would benefit
`public health in the United States.” 2011 TPSAC Menthol Rept., at 225 (emphasis in
`original).
`7.
`The Committee’s Report further concluded that if menthol cigarettes had been
`removed from the marketplace in 2010, then (a) by 2020, roughly 17,000 premature deaths
`would have been avoided, and about 2.3 million people would not have started smoking; and
`(b) by 2050, the cumulative gains would have resulted in over 327,000 premature deaths
`avoided, and over 9.1 million people that would not have started smoking.
`8.
`For the African American community, this would have meant that (a) by 2020,
`roughly 4,700 premature deaths would have been avoided, and about 461,000 African
`Americans would not have started smoking; and (b) by 2050, over 66,000 premature deaths
`
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`4 See 21 U.S.C. § 387q(a); id. § 387g(e)(1).
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`would have been avoided, and over 1.6 million African Americans would not have started
`smoking.
`9.
`FDA then conducted a peer-reviewed investigation in 2013, which reached a
`similar conclusion: menthol cigarettes (a) were associated with youth smoking initiation and
`greater addiction, and (b) posed “a public health risk above that seen with nonmenthol
`cigarettes.”
`10.
`And yet, despite the findings of the TPSAC Report and FDA’s own
`investigation, reflecting new medical and scientific data, FDA did nothing until five years later
`in 2018, when then-FDA Commissioner Scott Gottlieb finally announced that FDA would
`advance a “Notice of Proposed Rulemaking that would seek to ban menthol in combustible
`tobacco products, including cigarettes and cigars.” FDA, Statement from FDA Commissioner
`Scott Gottlieb, M.D. (Nov. 15, 2018).5 “Now, armed with the additional years of data,
`comments from the public … and the perspective of [the FDA’s] Comprehensive Plan and its
`implementation,” FDA stated its intent to “accelerate the proposed rulemaking process to
`ensure that our policies on flavored tobacco products protect public health[.]” Id.
`11.
`But instead—without engaging in any reasoned decision-making or providing
`any coherent explanation for its decision—FDA reversed course in or around June 2019 and
`decided to allow menthol to remain on the market:
`a. On June 24, 2019, the HHS published its Spring 2019 inventory of rulemaking
`actions under development. See Regulatory Agenda, Ofc. of the Secretary,
`
`
`5 FDA, Statement from FDA Commission Scott Gottlieb , M.D., on proposed new steps to
`protect youth by preventing access to flavored tobacco products and banning menthol in
`cigarettes (Nov. 15, 2018). Available at https://www.fda.gov/news-events/press-
`announcements/statement-fda-commissioner-scott-gottlieb-md-proposed-new-steps-protect-
`youth-preventing-
`access?utm_campaign=111518_Statement_FDA%20Commissioner%20statement%20on%20pr
`oposals%20to%20address%20youth%20tobacco%20use&utm_medium=email&utm_source=El
`oqua.
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`HHS, 84 Fed. Reg. 29623 (June 24, 2019).6 This Agenda presented “the
`regulatory activities that the Department [i.e., HHS, FDA, and the defendant
`Center for Tobacco Products] expect[ed] to undertake in the foreseeable
`future,” id. at 29624 (citing various proposed rules, final rules, and long-term
`actions). Absent from HHS’s Spring inventory, however, was any plan by
`defendants to address menthol in cigarettes, much less any explanation as to
`why defendants’ about-face reflected new medical, scientific, or other
`technological data. See HHS Regulatory Agenda, generally.
`b. HHS’s Fall 2019 inventory of rulemaking actions also failed to include any
`reference or plan to address menthol in cigarettes, or else any explanation of
`defendants’ decision-making process on this important public health issue. See
`HHS, Agency Rule List – Fall 2019 (Dec. 26, 2019).7
`12. Defendants’ arbitrary and capricious actions are contrary to what the law
`requires, and harm the public health. And, defendants’ years of inaction and unreasonable
`refusal to act on this issue have almost certainly contributed to the increasing harms associated
`with menthol in cigarettes:
`a. In 2009—at the time the Tobacco Control Act was enacted—menthol
`cigarettes represented over 25% of all cigarettes smoked in the United States.
`See H. Rept., Part 1 at 39. Today, the most recent data shows that figure has
`increased to 36%.8
`
`
`6 Available at https://www.federalregister.gov/documents/2019/06/24/2019-12004/regulatory-
`agenda.
`7 Available at
`https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENC
`Y_RULE_LIST&currentPub=true&agencyCode=&showStage=active&agencyCd=0900.
`8 See Fed. Trade Commission, Cigarette Rept. for 2017, Table 7B (issued 2019). Available at
`https://www.ftc.gov/system/files/documents/reports/federal-trade-commission-cigarette-
`report-2017-federal-trade-commission-smokeless-tobacco-report/ftc_cigarette_report_2017.pdf.
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`b. In 2009, more than 12 million individual smokers used menthol cigarettes. See
`H. Rept., Part 1 at 39. Today, the data shows that over 19 million smokers use
`menthol cigarettes—i.e., a majority of the estimated 34 million smokers in the
`United States.9
`c. In 2009, nearly 70% of African Americans who smoked, used menthol
`cigarettes. See H. Rept., Part 1 at 39. Today, that figure has risen to over
`85%.10
`13.
`The COVID-19 pandemic has further showcased the myriad ways in which
`menthol cigarettes negatively impact the public health, and the African American community
`in particular. A study in the New England Journal of Medicine found that coronavirus patients
`in China who smoked were more than twice as likely as those who didn’t to have severe
`infections from COVID-19.11 An April 8, 2020 advisory from the Massachusetts Attorney
`General Maura Healey warned that “it is vital that people are aware of the serious potential
`risks associated with smoking or vaping and COVID-19,” noting that “flavored tobacco
`products could make lung infections like COVID-19 worse.”12 And early news reports
`concluded that the coronavirus was infecting and killing Black Americans at an alarmingly
`high rate, in part because African Americans’ higher rates of diabetes, heart disease and lung
`
`
`9 See U.S. Food & Drug Administration, Menthol and Other Flavors in Tobacco Products.
`Available at https://www.fda.gov/tobacco-products/products-ingredients-components/menthol-
`and-other-flavors-tobacco-products (last visited June 13, 2020) (noting that more than 19.5
`million people are current smokers of menthol cigarettes); Centers for Disease Control and
`Prevention, Smoking & Tobacco Use, Current Cigarette Smoking Among Adults in the United
`States (identifying an estimated 34.3 million adults who smoked cigarettes in 2017). Available at
`https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm.
`10 See FDA, Menthol and Other Flavors in Tobacco Products, id. (noting that 85.8 percent of
`African American smokers use menthol cigarettes).
`11 Available at https://www.nytimes.com/2020/04/09/health/coronavirus-smoking-vaping-
`risks.html (citing https://www.nejm.org/doi/full/10.1056/NEJMoa2002032).
`12 Available at https://www.mass.gov/doc/covid-vaping-advisory/download.
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`disease—all conditions that are highly correlated with tobacco use—make people more
`vulnerable to the new respiratory disease.13
`14.
`In sum, FDA’s delay, inaction, and failure “to move quickly” has been
`devastating, leading to millions of people initiating smoking cigarettes, and thousands of
`premature deaths.
`15.
`Plaintiff AATCLC and other many others have repeatedly called for FDA to
`fulfill its statutory duty to re-evaluate tobacco product standards and take up a rule to ban
`menthol cigarettes. FDA has failed to do so, refusing even to resolve a Citizen’s Petition that
`AATCLC filed more than seven years ago. After these years of inaction and the untold
`suffering defendants have caused, plaintiffs bring this lawsuit to compel appropriate action by
`defendants on this critical and urgent public health issue.
`JURISDICTION & VENUE
`16.
`Jurisdiction: This Court has jurisdiction over this action, pursuant to 28 U.S.C.
`§§ 1331 and 1346. Plaintiffs allege violations of the Administrative Procedure Act, Pub. L. No.
`404, 60 Stat. 237, ch. 324, §§ 1–12 (1946), and Section 907 of the Tobacco Control Act, 21
`U.S.C. § 387g. Their requested relief is authorized by 5 U.S.C. § 706(1) and 28 U.S.C. § 1651.
`The United States is also a defendant.
`17.
`Venue: Venue in this judicial district is appropriate, pursuant to 28 U.S.C. §
`1391(e)(1). Plaintiff African American Tobacco Control Leadership Council resides in this
`judicial district.
`18.
`Intradistrict Assignment: Pursuant to Civil L.R. 3-2(c), intradistrict assignment
`is proper in the San Francisco or Oakland Division, as this action arises in the County of San
`Francisco, where Plaintiff African American Tobacco Control Leadership Council maintains
`its principal place of business.
`
`
`13 Available at https://www.washingtonpost.com/nation/2020/04/07/coronavirus-is-infecting-
`killing-black-americans-an-alarmingly-high-rate-post-analysis-shows/?arc404=true.
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`Case 3:20-cv-04012 Document 1 Filed 06/17/20 Page 8 of 45
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`PARTIES
`19.
`Plaintiff African American Tobacco Control Leadership Council (“AATCLC”)
`brings this action on behalf of itself and its members. The AATCLC, which is based in San
`Francisco, California, was formed in 2008 to educate the African American community and
`public about tobacco use and cessation, and has led the fight to expose the predatory
`marketing of menthol cigarettes and flavored little cigars in the Black Community. The
`organization’s members include a cadre of dedicated community activists, academics, public
`health advocates, and researchers from across the country. FDA’s failure to address the harms
`caused by menthol in combustible cigarettes has adversely affected AATCLC, its members,
`and its work.
`20.
`The AATCLC’s mission is to save lives by partnering with community
`stakeholders and public health agencies to inform and affect the direction of tobacco policy,
`practices, and priorities, particularly as it affects the lives of Black Americans and African
`Immigrant populations. Its work includes educating the public about the effects of tobacco on
`these populations, and the need to regulate flavored tobacco products, including menthol
`cigarettes.
`21. One of the AATCLC’s key initiatives is the creation of Buffer Zones—local
`legislation that prohibits the sale of all flavored tobacco products, including menthol, within a
`500 to 1000-foot perimeter around schools. Establishing Buffer Zones to protect inner city
`children reduces their access to tobacco products, de-normalizes tobacco consumption, and
`pushes back against predatory targeting of these communities. The AATCLC has assisted
`Chicago, Minneapolis-St. Paul, Baltimore, and numerous California cities in adopting and
`implementing Buffer Zones.
`22.
`The AATCLC has expended and continues to expend significant resources to
`help create Buffer Zones and to perform other outreach, engagement and education of elected
`officials, clergy, community-based organizations, youth groups and the media concerning the
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`dangers of menthol cigarettes and their harmful effect on the lives of Black American and
`African Immigrant populations.
`23.
`The defendants’ unlawful refusal to ban menthol in tobacco products, and
`failure to periodically reevaluate and determine (much less explain) whether the Act’s existing
`flavor standard should be changed to reflect new data and protect the public health, makes the
`AATCLC’s work more difficult and impedes its efforts to educate the public about the dangers
`of menthol cigarettes. It also requires the AATCLC to divert resources that could otherwise be
`used to advance other organizational goals to focus on menthol-related concerns.
`24.
`In addition, as detailed below, on or about April 12, 2013, plaintiff AATCLC
`(together with others) submitted a Citizen Petition with the FDA. The Petition requested that
`the FDA take certain actions to decrease the harms caused by menthol cigarettes and provide
`cessation support to smokers of menthol cigarettes who wish to quit. Over seven years have
`passed since the AATCLC submitted this Petition, and the defendants still have not provided
`any substantive response.
`25.
`Plaintiff Action on Smoking and Health (“ASH”) is a non-profit organization
`headquartered in Washington, D.C. ASH was founded in 1967 and has spent the last fifty
`years battling against the tobacco industry. Its mission is to advocate for innovative legal and
`policy measures to end the global tobacco epidemic. ASH’s past accomplishments include
`helping to achieve restrictions on tobacco advertising and smoking bans in workplaces and
`various forms of public transit.
`26.
`ASH believes that the production, marketing and sale of cigarettes is a human
`rights violation. This is in part because the tobacco industry often targets their marketing to
`specific populations based on gender, race, sexual identity and age. Some of these groups
`smoke at much higher rates than the general population, and they are all protected by various
`international and regional human rights treaties and instruments. ASH is currently working to
`elevate tobacco as a human rights issue through (a) work with the Human Rights Council, the
`Framework Convention on Tobacco Control Conference of the Parties, and other
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`international bodies; (b) using human rights reporting mechanisms to encourage governments
`to advance tobacco control within their own countries; (c) providing legal resources, training,
`and support to advocates on how to use human rights norms to advance local tobacco control
`measures; and (d) maintaining a repository of human rights resources to assist allies in taking a
`human rights approach.
`27.
`ASH’s efforts include menthol-related initiatives. For example, on January 2,
`2020, ASH staff attended a public hearing of the D.C. City Council Judiciary and Public
`Safety Committee, which is considering a ban on the sale of flavored tobacco products. Both
`gave formal testimony in favor of the measure, and urged the Council to include menthol in
`the final law. ASH also provided information to the Committee concerning the Council’s
`authority to phase out the sale of tobacco products in the city. The defendants’ unlawful
`refusal to ban menthol in tobacco products, and failure to periodically reevaluate and
`determine whether the Act’s existing flavor standard should be changed to reflect new data and
`protect the public health, makes ASH’s work more difficult and impede its efforts to educate
`the public about the dangers of menthol cigarettes. It also requires ASH to divert resources
`that could be used to advance other organizational goals to focus on menthol-related concerns.
`28. Defendant U.S. Department of Health and Human Services (“HHS”) is the
`federal agency responsible for administering the Food, Drug and Cosmetic Act, 21 U.S.C. §
`301 et seq. (1982). HHS is headquartered in Washington, D.C.
`29. Defendant Alex M. Azar II is sued in his official capacity as the Secretary of the
`U.S. Department of Health and Human Services. As Secretary, Mr. Azar is ultimately
`responsible for HHS’s activities and policies and for implementing the Tobacco Control Act.
`Although the Secretary has delegated many responsibilities under the Act to the Commissioner
`of the Food and Drug Administration14, the Secretary has nonetheless reserved the authority to
`
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`14 See Pub. Citizen Health Research Grp. v. Comm’r, Food & Drug Admin., 740 F.2d 21, 23 n.1 (D.C. Cir.
`1984).
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`(a) establish procedural rules applicable to tobacco products, such as menthol cigarettes; and
`(b) present highly significant public issues involving the availability and marketability of
`tobacco products, including menthol cigarettes.
`30. Defendant U.S. Food and Drug Administration (“FDA”) is the federal agency
`charged with regulating the marketing of tobacco products in the United States, including
`menthol in combustible cigarettes. By statute, FDA “shall (1) promote the public health by
`promptly and efficiently reviewing clinical research and taking appropriate action on the
`marketing of regulated products in a timely manner[.]” 21 U.S.C. § 393(b); see also Tobacco
`Control Act findings, P.L. 111–31, Div A, § 2, 123 Stat. 1776, 1780 (June 22, 2009) (noting
`further that FDA possesses a “mandate to promote health and reduce the risk of harm”). FDA
`is headquartered in Silver Spring, Maryland.
`31. Defendant Stephen Hahn is sued in his official capacity as Commissioner of the
`FDA. FDA administers programs at HHS related to tobacco products. As Commissioner, Mr.
`Hahn is responsible for FDA’s activities and policies, including the agency’s implementation of
`the Tobacco Control Act.
`32. Defendant Center for Tobacco Products is the federal agency responsible for
`implementing the Tobacco Control Act and related matters assigned by the FDA
`Commissioner. See 21 U.S.C. § 387a(e). This Center is established within FDA and reports to
`the FDA Commissioner. See id. The Center is headquartered in Silver Spring, Maryland.
`33. Defendant Mitch Zeller is sued in his official capacity as the Center for Tobacco
`Products, Director. The Center implements the Secretary and FDA’s responsibilities under
`the Tobacco Control Act.
`FACTUAL & LEGAL BACKGROUND
`This section sets forth defendants’ obligations15 and their failure to “quickly”
`
`34.
`
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`15 This complaint accordingly refers defendants’ obligations globally where applicable, and
`specifies the relevant defendant when a particular defendant has a unique role.
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`Case 3:20-cv-04012 Document 1 Filed 06/17/20 Page 12 of 45
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`address the public health issue of menthol in cigarettes, to undertake a “periodic evaluation of
`tobacco product standards,” and to make a determination based on “new medical, scientific, or
`other technological data.”
`
`FDA and The Tobacco Control Act
`35.
`As shown below, FDA is well-aware of the critical public health issues and
`harms surrounding menthol in cigarettes. Nonetheless, FDA has unreasonably delayed and
`unlawfully withheld its duty to evaluate and determine whether to issue a tobacco product
`standard aimed at removing menthol from cigarettes for the protection of public health.
`36.
`The FDA’s knowing inaction on this issue is contrary to FDA’s mission
`statement and statutory obligations, as well as Congress’s expressed intent and direction to
`defendants when enacting the Tobacco Control Act.
`
`FDA’s mission is to protect the public health.
`37.
`By statute, FDA’s mission is to “promote the public health by promptly and
`efficiently reviewing clinical research and taking appropriate action on the marketing of regulated
`products in a timely manner,” 21 U.S.C. § 393(b)(1) (emphasis added).
`38.
`This mission includes “regulating the manufacturing, marketing, and
`distribution of tobacco products to protect the public health and reduce tobacco use by
`minors,” FDA.gov, What We Do,16 as well as “[p]rotecting consumers and enhancing public
`health by maximizing compliance of FDA regulated products and minimizing risk associated
`with those products,” FDA Reg. Procedures Manual, Intro., at 3 (Aug. 2018).17
`
`
`16 Available at https://www.fda.gov/about-fda/what-we-do.
`17 Available at https://www.fda.gov/media/71923/download. The Regulatory Procedures
`Manual “is a reference manual that provides internal procedures and related information to be
`used by FDA employees who process certain regulatory and enforcement matters in support of
`the agency’s public health mission.” FDA Reg. Procedures Manual at 1. This Manual further
`identifies some of FDA’s values, including the following: “We demonstrate our commitment to
`safeguarding the public health in our actions.” Id. at 3.
`
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`Case 3:20-cv-04012 Document 1 Filed 06/17/20 Page 13 of 45
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`39. HHS and FDA are also responsible for “identifying and addressing …
`disproportionately high and adverse human health … effects of its programs, policies, and
`activities on minority populations and low-income populations[.]” Executive Order 12898,
`§ 1-101 (Feb. 11, 1994).18
`
`Congress directed FDA to move quickly to address menthol.
`40.
`Section 907 of the Tobacco Control Act sets forth FDA’s obligation to address
`the public health problems caused by menthol cigarettes. See 21 U.S.C. § 387g.
`
`The Act mandates action by the Secretary on menthol.
`41.
`As noted above, when Congress enacted the Tobacco Control Act in 2009,
`Congress created a “tobacco product standard” that effectively banned all flavors in cigarettes,
`save for tobacco and menthol flavors. See 21 U.S.C. § 387g(a)(1)(A).19
`42.
`Significantly, however, this standard did not “limit the Secretary’s [i.e., FDA’s]
`authority to take action under this section or other sections of this Act applicable to menthol,”
`21 U.S.C. § 387g(a)(1)(A); see also H. Rept., Part 1 at 4 (granting FDA “the authority to require
`product changes in current and future tobacco products, such as the reduction or elimination
`of ingredients, additives, and constituents”).
`43. On the contrary, Congress expressly directed defendants to move quickly to
`gather evidence concerning “the impact of the use of menthol in cigarettes on the public
`health, including such use among children, African-Americans, Hispanics, and other racial and
`ethnic minorities,” 21 U.S.C. § 387g(e)(1), and then determine whether the tobacco product
`standard should be changed to ban it. 21 U.S.C. § 387g(a)(5).
`
`
`18 Available at https://www.archives.gov/files/federal-register/executive-orders/pdf/12898.pdf.
`19 Per the Act, “a cigarette or any of its component parts” is prohibited from containing “as a
`constituent … or additive, an artificial or natural flavor (other than tobacco or menthol) or an
`herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut,
`licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product
`or tobacco smoke.” 21 U.S.C. § 387g(a)(1)(A). This standard became effective on September 22,
`2009. See FDA, Enforcement of General Tobacco Standard Special Rule for Cigarettes, 74 Fed.
`Reg. 48974, Docket No. FDA-2009-N-0449 (Sept. 22, 2009).
`
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`Case No.:
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`44.
`In particular, the Act mandates further investigation concerning the use of
`menthol in cigarettes and requires that FDA “shall periodic[ally] evaluat[e]” the “tobacco
`product standards established under this section[, including the previously identified flavor
`ban, 21 U.S.C. § 387g(a)(1)(A),] to determine whether such standards should be changed to
`reflect new medical, scientific, or other technological data.” 21 U.S.C. § 387g(a)(5) (“Periodic
`Reevaluation of Tobacco Product Standards”).
`45.
`Taken together then, these above-identified subsections require FDA to (a)
`periodically re-evaluate the existing tobacco product standard, which does not currently ban
`menthol in cigarettes; and (b) “determine” whether such standard “should be changed” to (i)
`reflect new data, and (ii) to protect the public health.
`
`The Act creates an advisory committee to assist FDA.
`46.
`To assist FDA in making that determination, Congress directed FDA to create a
`Tobacco Products Scientific Advisory Committee. See 21 U.S.C. § 387g(e)(1).
`47.
`Per the Act, FDA “shall refer to the Committee for report and recommendation
`… the issue of the impact of the use of menthol in cigarettes on the public health, including
`such use among children, African-Americans, Hispanics, and other racial and ethnic
`minorities.” 21 U.S.C. § 387g(e)(1).
`48.
`The Committee’s review was also directed to address the considerations
`identified by subsections (a)(3)(B)(i)20 and (b)21—i.e., considerations that FDA would have
`
`
`20 “In making a finding described in subparagraph (A), [FDA] shall consider scientific evidence
`concerning (I) the risks and benefits the risks and benefits to the population as a whole, including
`users and nonusers of tobacco products, of the proposed standard; (II) the increased or decreased
`likelihood that existing users of tobacco products will stop using such products; and (III) the
`increased or decreased likelihood that those who do not use tobacco products will start using such
`products.” 21 U.S.C. § 387g(a)(3)(B)(i).
`21 “[FDA] shall consider information submitted in connection with a proposed standard
`regarding the technical achievability of compliance with such standard.” 21 U.S.C. § 387g(b)(1).
`“[FDA] shall consider all other information submitted in connection with a proposed standard,
`including information concerning the countervailing effects of the tobacco product standard on
`the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the
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`otherwise addressed in adopting an additional tobacco product standard or in considering any
`proposed standard. See 21 U.S.C. § 387g(e)(1).
`49.
`Such considerations would include “scientific evidence” concerning the risks
`and benefits of a “proposed standard,” 21 U.S.C. § 387g(a)(3)(B)(i)(I); “the technical
`achievability of compliance with such standard,” id. § 387g(b)(1); and “other information
`submitted in connection