Case 4:20-cv-04012-KAW Document 52 Filed 05/21/21 Page 1 of 51
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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, Action on Smoking and
`Health, American Medical Association, and
`National Medical Association
`
`
`
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF CALIFORNIA
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`OAKLAND DIVISION
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`Case No.: 4:20-cv-4012-KAW
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`SECOND AMENDED COMPLAINT
`(FIRST SUPPLEMENT)
`(Administrative Procedure Act Case)
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`AFRICAN AMERICAN TOBACCO
`CONTROL LEADERSHIP COUNCIL,
`ACTION ON SMOKING AND HEALTH,
`AMERICAN MEDICAL ASSOCIATION,
`and NATIONAL MEDICAL
`ASSOCIATION,
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`
`
`
`
`U.S. DEPARTMENT OF HEALTH AND
`HUMAN SERVICES; XAVIER BECERRA,
`in his official capacity as Secretary of the U.S.
`Department of Health and Human Services;
`U.S. FOOD AND DRUG
`ADMINISTRATION; JANET
`WOODCOCK, in her official capacity as
`Acting Commissioner of the U.S. Food and
`Drug Administration; CENTER FOR
`TOBACCO PRODUCTS; MITCH
`ZELLER in his official capacity as the Center
`for Tobacco Products, Director,
`
`
`
`
`Plaintiffs,
`
`vs.
`
`Defendants.
`
`Second Amended Complaint (First Supplement)
`Case No.: 4:20-cv-4012-KAW
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`Page 1 of 51
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`1.
`Plaintiffs African American Tobacco Control Leadership Council
`(“AATCLC”), Action on Smoking on Health (“ASH”), American Medical Association
`(“AMA”), and National Medical Association (“NMA”) 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
`
`
`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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`Advisory Committee (“TPSAC” or “Committee”); (2) refer “[i]mmediately” to this Committee
`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
`
`
`4 See 21 U.S.C. § 387q(a); id. § 387g(e)(1).
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`Second Amended Complaint (First Supplement)
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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
`allowed 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 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. But FDA has failed to do so. Until AATCLC filed this lawsuit, FDA refused even
`to resolve a Citizen’s Petition that AATCLC filed more than seven years ago, asking FDA to
`add menthol to the list of prohibited characterizing flavors in cigarettes and cigarette smoke as
`directed by Section 907(a)(1)(A) of the Tobacco Control Act, 21 U.S.C. § 387g.
`16. On April 29, 2021, FDA finally responded to the 2013 Citizen Petition. See
`Dkt. 50-1 (“Response”). FDA “grant[ed]” the Petition, id. at 2, stating that “based on our
`consideration of the existing scientific evidence in the record, FDA believes eliminating
`menthol as a characterizing flavor in cigarettes would benefit public health and, therefore, the
`Agency intends to issue a proposed rule to prohibit menthol as a characterizing flavor in
`cigarettes.” Id. at 10.
`17.
`The FDA issued a news release the same day, also announcing its intention to
`ban menthol cigarettes.14 As explained by Acting FDA Commissioner Janet Woodcock, M.D.:
`“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars
`will help save lives, particularly among those disproportionately affected by these deadly
`products. With these actions, the FDA will help significantly reduce youth initiation, increase
`the chances of smoking cessation among current smokers, and address health disparities
`
`
`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.
`14 Available at https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-
`based-actions-aimed-saving-lives-and-preventing-future-generations-smokers.
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`experienced by communities of color, low-income populations, and LGBTQ+ individuals, all
`of whom are far more likely to use these tobacco products.”15
`18. Unfortunately, FDA failed to take any action to begin the rulemaking process.
`Nor did it commit to any firm deadline to act on the statements in its press release and Citizen
`Petition response, which mirror the (never-implemented) statements made almost three years
`ago by then-FDA Commissioner Gottlieb. See n.5, supra (Statement from FDA Commissioner
`Scott Gottlieb, M.D. announcing that FDA “armed with additional years of data” would
`advance a “Notice of Proposed Rulemaking that would seek to ban menthol in combustible
`tobacco products, including cigarettes and cigars.”) Despite this history, the FDA’s 2021 news
`release suggests that the agency would take a year, if not more, to even begin the
`rulemaking process.16 This is the same rule-making process FDA committed to advancing
`in 2018, with zero observable progress to date. This proposed timeline is indefensible, and
`only serves to confirm that judicial oversight and intervention will be required.
`19. Under these circumstances, the law requires more than another promise of
`future action that may never be fulfilled. By defendants’ own admission, the evidence
`conclusively demonstrates that a menthol ban “will help save lives, particularly among those
`disproportionately affected by these deadly products.” After 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.
`
`
`15 “Available at https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-
`based-actions-aimed-saving-lives-and-preventing-future-generations-smokers.
`16 “The FDA is working toward issuing proposed product standards within the next
`year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors
`(including menthol) in cigars; the authority to adopt product standards is one of the most
`powerful tobacco regulatory tools Congress gave the agency.” FDA Commits to Evidence-Based
`Actions Aimed at Saving Lives and Preventing Future Generations of Smokers (Apr. 29, 2021)
`(emphasis added), available at https://www.fda.gov/news-events/press-announcements/fda-
`commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers.
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`JURISDICTION & VENUE
`20.
`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.
`21.
`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.
`22.
`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.
`
`PARTIES
`23.
`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.
`24.
`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
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`these populations, and the need to regulate flavored tobacco products, including menthol
`cigarettes.
`25. 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.
`26.
`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
`dangers of menthol cigarettes and their harmful effect on the lives of Black American and
`African Immigrant populations.
`27.
`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.
`28.
`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 did not provide a
`substantive response until this lawsuit was filed. On April 29, 2021, almost a year after
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`Plaintiffs commenced litigation, FDA finally provided a response, which is deficient for the
`reasons discussed in Section V, below.
`29.
`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.
`30.
`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
`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.
`31.
`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
`
`Second Amended Complaint (First Supplement)
`Case No.: 4:20-cv-4012-KAW
`
`Page 11 of 51
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`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 impedes 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.
`32.
`Plaintiff American Medical Association (“AMA”) is an Illinois not-for-profit
`corporation headquartered in Chicago, Illinois. The AMA is the largest professional
`association of physicians, residents, and medical students in the United States. All of the state
`medical associations and most of the major specialty medical societies are represented in the
`AMA House of Delegates, with the AMA serving as the overall umbrella and voice of
`organized medicine in the United States. The AMA represents virtually all United States
`physicians, residents, and medical students through its policymaking process. AMA members
`practice and reside in all States, including California. AMA members practice in all areas of
`medical specialization.
`33.
`The AMA’s objectives are to promote the science and art of medicine and the
`betterment of public health. Since its founding in 1847, the AMA has played a crucial role in
`the development of medicine in the United States. For the last fifty years, it has also devoted
`substantial resources to anti-tobacco efforts aimed at improving public health. In keeping with
`this objective, the AMA and its members work tirelessly to educate the public about and
`protect the public from the devastating health consequences of tobacco use, the leading cause
`of preventable death in the United States. This work includes reviewing and synthesizing the
`latest scientific knowledge, preparing and distributing resources concerning tobacco use and
`cessation, and advocating for regulation and taxation of tobacco products at the federal, state,
`and local levels.
`34. More recently, AMA has also increased its focus on health equity. The AMA
`recognizes that systemwide bias and institutionalized racism contribute to inequities across the
`U.S. health care system. The AMA is committed to fighting for greater health equity by
`identifying and eliminating inequities through advocacy, community leadership and education.
`
`Second Amended Complaint (First Supplement)
`Case No.: 4:20-cv-4012-KAW
`
`Page 12 of 51
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`This includes working to eliminate the use of menthol-flavored tobacco products, which
`represent a disproportionate and growing share of tobacco use by African Americans, and the
`direct cause of thousands of preventable deaths in the African American community. For
`example, the AMA has sent numerous letters to and attended meetings with government
`officials to encourage the elimination of menthol-flavored cigarettes.
`35.
`The defendants’ unlawful failure to evaluate and determine whether the Act’s
`existing flavor standard should be changed to reflect new data and protect the public health,
`and to ban menthol flavoring in cigarettes, interferes with the work of the AMA and its
`members. Among other things, the defendants’ unlawful conduct undermines the efforts of
`AMA and its members to educate patients about the dangers of menthol cigarettes and achieve
`health equity for all patients. It also forces AMA to divert resources that could be used to
`advance other public health initiatives.
`36.
`Plaintiff National Medical Association (“NMA”) is a Maryland corporation
`headquartered in Silver Spring, Maryland. It is a 501(c)(3) national professional and scientific
`organization representing the interests of more than 50,000 African American physicians and
`the patients they serve—the largest and oldest such organization in the United States. The
`NMA is committed to improving the quality of health in communities of color and among
`disadvantaged people through its membership, professional development, community health
`education, advocacy, research and partnerships with federal and private agencies.
`37.
`The NMA is particularly steadfast in its commitment to the elimination of
`health disparities and the promotion of healthy lifestyles among African Americans and other
`underserved populations. In furtherance of these goals, the NMA conducts national consumer
`education programs on cancer, cardiovascular disease and stroke, HIV/AIDS, women’s
`health, asthma, smoking cessation, immunization, traffic safety, breastfeeding, clinical trials, as
`well as other issues that impact the lives of African Americans. Throughout its history the
`National Medical Association has focused primarily on health issues related to African
`
`Second Amended Complaint (First Supplement)
`Case No.: 4:20-cv-4012-KAW
`
`Page 13 of 51
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`Americans and medically underserved populations; however, its principles, goals, initiatives
`and philosophy encompass all racial and ethnic groups.
`38.
`As the nation’s only organization devoted to the needs of African American
`physicians, health professionals and their patients, the NMA serves as the conscience of the
`medical profession in the ongoing fight to eliminate health disparities in the nation’s health
`care delivery system. The NMA has been an unwavering advocate for health policies that
`improve the quality and availability of health care of African Americans and other underserved
`populations. For instance, the National Medical Association was the force behind such
`landmark reforms as Medicare and Medicaid. Today, the NMA continues to provide
`leadership in shaping the national health policy agenda through continued involvement in a
`variety of critical policy matters, including with respect to smoking. For example, the NMA
`passed an August 3, 2017 resolution during their Annual Meeting of the House of Delegates,
`supporting a prohibition on the sale of flavored tobacco products, including mentholated
`cigarettes. As noted on the NMA’s website, African Americans have the highest surveyed rate
`of desire to quit smoking but are less successful in quit attempts than white and Hispanic
`smokers. This is due in part to the anesthetic effects of menthol in mentholated cigarettes and
`the high rate of mentholated cigarette use among African Americans. This is