`
`Case No. 20-55930
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`R.J. REYNOLDS TOBACCO COMPANY; AMERICAN
`SNUFF COMPANY; AND SANTA FE NATURAL TOBACCO
`COMPANY,
`Appellants,
`v.
`COUNTY OF LOS ANGELES; COUNTY OF LOS
`ANGELES BOARD OF SUPERVISORS; AND HILDA L. SOLIS,
`MARK RIDLEY-THOMAS, SHEILA KUEHL, JANICE HAHN,
`AND KATHRYN BARGER, EACH IN HIS OR HER OFFICIAL
`CAPACITY AS A MEMBER OF THE BOARD OF SUPERVISORS,
`Appellees.
`
`On Appeal from the United States District Court for the Central
`District of California No. 2:20-cv-4880 (Hon. Dale S. Fischer)
`
`BRIEF OF PUBLIC HEALTH AND MEDICAL
`ORGANIZATIONS AS AMICI CURIAE IN SUPPORT OF
`APPELLEES
`
`BYRON RAPHAEL LLP
`Jordan Raphael
`1055 West 7th Street, Suite 3300, Los Angeles, California 90067
`Tel: (213) 291-9800
`Fax: (213) 377-5771
`
`Of counsel:
`CAMPAIGN FOR TOBACCO-FREE KIDS
`Dennis A. Henigan
`1400 I St. NW, Suite 1200, Washington, DC, 20005
`Tel: (202) 481-9366
`Fax: (202) 296-5427
`
`Attorneys for Amici Curiae Public Health and Medical
`Organizations
`
`
`
`Case: 20-55930, 05/14/2021, ID: 12113436, DktEntry: 29, Page 2 of 52
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`
`DISCLOSURE STATEMENT
`
`Amici curiae are all non-profit organizations committed to advancing the
`
`public health. No party to this filing has a parent corporation, and no publicly held
`
`corporation owns 10% or more of the stock of any of the parties to this filing.
`
`ii
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`
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`TABLE OF CONTENTS
`
`DISCLOSURE STATEMENT ................................................................................. ii
`
`TABLE OF AUTHORITIES ................................................................................... iv
`
`STATEMENT OF INTEREST OF AMICI CURIAE ................................................ 1
`
`INTRODUCTION AND SUMMARY OF ARGUMENT ........................................ 3
`
`ARGUMENT ............................................................................................................. 7
`
`I. The County’s Tobacco Flavors Ordinance Affords County Residents
`Greater Protection Against the Public Health Harms of Menthol Cigarettes. ........... 7
`
` Menthol Cigarettes Increase Youth Initiation of Smoking. ............... 8
`
` Menthol Cigarettes Increase Addiction and Reduce Cessation. ......12
`
` Menthol Cigarettes Have Led to Significant Health Disparities for
`African Americans. ..............................................................................................14
`
`II. The Flavors Ordinance Provides the Residents of LA County Greater
`Protection against the Health Harms of Continued Sale of Flavored E-Cigarettes. 19
`
`The Flavors Ordinance Provides LA County Residents Greater
`III.
`Protection Against the Health Harms of Flavored Cigars. ......................................24
`
`IV. Appellants’ Account of FDA Activity on Flavored Tobacco Products is
`Misleading and Should Have No Impact on the Preemption Issue. ........................28
`
`CONCLUSION ........................................................................................................32
`
`
`
`
`
`
`
`iii
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`TABLE OF AUTHORITIES
`
`Cases
`
`Altria Group, Inc.v. Good,
`555 U.S. 70 (2008) ...............................................................................................31
`
`Am. Acad. Of Pediatric v. FDA,
`379 F.Supp. 3d 461, 494 (D.Md. 2019), appeal dismissed as moot, In re Cigar
`Ass’n of Am., 812 F. App’x 128 (4th Cir. 2020) ...................................................31
`
`Nat’l Ass’n of Tobacco Outlets, Inc. v. City of Providence, R.I.,
`731 F.3d 71 (1st Cir. 2013) .................................................................................... 5
`
`Nicopure Labs LLC v. FDA,
`944 F.3d 266 (D.C. Cir. 2019) .............................................................................23
`
`R. J. Reynolds Tobacco Co. v. Cnty. of Los Angeles,
`471 F.Supp.3d 1010 (C.D. Cal. 2020) ................................................................... 5
`
`U.S. Smokeless Tobacco Mfg. Co. LLC v. City of New York,
`708 F.3d 428 (2d. Cir. 2013) ..............................................................................5, 6
`
`Statutes
`
`15 U.S.C. § 1332(1)(a) .............................................................................................25
`
`Family Smoking Prevention and Tobacco Control Act,
`Pub. L. No. 111-31, 123 Stat. 1776 (2009) ............................................................ 3
`
`LOS ANGELES COUNTY CODE TITLE 11 ....................................................................19
`
`Regulations
`
`21 C.F.R. § 1143.1 ...................................................................................................25
`
`Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic
`Act, as Amended by the Family Smoking Prevention and Tobacco Control Act,
`79 Fed. Reg. 23,141 (Apr. 25, 2014) (proposed rule) ..........................................25
`
`iv
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`Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic
`Act, as Amended by the Family Smoking Prevention and Tobacco Control Act,
`81 Fed. Reg. 28,974 (May 10, 2016) (final rule) .................................... 26, 27, 28
`
`Regulation of Flavors in Tobacco Products,
`83 Fed. Reg. 12,294 (proposed Mar. 21, 2018) (to be codified at 21 C.F.R. pt.
`1100, 1140, 1143) ....................................................................................... 4, 8, 12
`
`Other Authorities
`
`Andrea C. Villanti et al.,
`Association of Flavored Tobacco Use With Tobacco Initiation and Subsequent
`Use Among US Youth and Adults, 2013-2015, 2(10) J. AM. MED. ASS’N
`NETWORK OPEN 1 (2019). ....................................................................................14
`
`Andrea S. Gentzke, et al.,
`Tobacco Product Use Among Middle and High School Student – United States,
`2020, 69(50) MORBIDITY & MORTALITY WKLY. REP. 1881 (Dec. 18, 2020) .... 20,
`26, 27
`
`B.W. Roper,
`A Study of People’s Cigarette Smoking Habits and Attitudes Volume I (1953). .17
`
`Bridget K. Ambrose et al.,
`Flavored Tobacco Product Use Among US Youth Aged 12-17 Years, 2013-2014,
`314 J. AM. MED. ASS’N 17, (2015). ..................................................................4, 27
`
`Campaign for Tobacco-Free Kids et al.,
`Stopping Menthol, Saving Lives: Ending Big Tobacco’s Predatory Marketing to
`Black Communities (Feb. 2021). ................................................................... 14, 27
`
`Campaign for Tobacco-Free Kids,
`Not Your Grandfather’s Cigar: A New Generation of Cheap and Sweet Cigars
`Threatens a New Generation of Kids (2013) .......................................................26
`
`CDC,
`Coronavirus Disease 2019 (COVID-19) – People with Certain Medical
`Conditions (Mar. 29, 2021). .................................................................................12
`
`v
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`
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`CDC,
`Health Equity Considerations and Racial and Ethnic Minority Groups (Apr. 19,
`2021).....................................................................................................................18
`
`Cristine D. Delnevo et al.,
`Banning Menthol Cigarettes: A Social Justice Issue Long Overdue, NICOTINE &
`TOBACCO RSCH (2021) .................................................................................. 10, 17
`
`Cristine D. Delnevo, et al.,
`Changes in the Mass Merchandise Cigar Market Since the Tobacco Control Act,
`3(2 Suppl 1) TOBACCO REG. SCIENCE S8 (2017). ................................................26
`
`Elizabeth C. Hair et al.,
`Association Between E-Cigarette Use and Future Combustible Cigarette Use:
`Evidence From a Prospective Cohort of Youth and Young Adults, 2017-2019,
`112 ADDICTIVE BEHAVIORS 1 (2020). ..................................................................24
`
`FDA,
`Electronic Nicotine Dlivery Systems (ENDS) and Other Deemed Products on the
`Market Without Premarket Authorization (Revised) (April 2020). .....................30
`
`FDA,
`FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing
`Future Generations of Smokers (Apr. 29, 2021) .............................................7, 29
`
`FDA,
`National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use,
`Concerning Uptick in Use of Disposable Products (Sept. 9, 2020). ...................31
`
`FDA,
`Preliminary Scientific Evaluation of the Possible Public Health effects of
`Menthol versus Nonmenthol Cigarettes (2013) ............................................ 10, 12
`
`Ganna Kostygina et al.,
`Tobacco Industry Use of Flavours to Recruit New Users of Little Cigars and
`Cigarillos, 25 TOBACCO CONTROL 66 (2016). .....................................................24
`
`Greta Zhu et al.,
`Evolution of Electronic Cigarette Brands from 2013-2014 to 2016-2017:
`Analysis of Brand Websites, 20(3) J. MED. INTERNET RSCH. e80 (2018). ...........21
`
`vi
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`HHS,
`Know the Risks: E-Cigarettes & Young People (2021) .......................................22
`
`Hope Landrine et al.,
`Cigarette Advertising in Black, Latino and White Magazines, 1998-2002: An
`Exploratory Investigation, 15(1) ETHNIC DISPARITIES 63 (2005). ......................15
`
`Joanne D’Silva et al.,
`Differences in Subjective Experiences to First Use of Menthol and Nonmenthol
`Cigarettes in a National Sample of Young Adult Cigarette Smokers, 20(9)
`NICOTINE & TOBACCO RSCH 1062 (2018). ...........................................................11
`
`Kaitlin M. Berry et al.,
`Association of Electronic Cigarette Use with Subsequent Initiation of Tobacco
`Cigarettes in U.S. Youths, 2(2) J. AM. MED. ASS’N NETWORK OPEN 1 (2019). ..23
`
`Karen A. Cullen et al.,
`e-Cigarette use among Youth in the United States, 2019 322(21) J. AM. MED.
`ASS’N 2095 (2019). ..............................................................................................19
`
`Lisa Henriksen et al.,
`Targeted Advertising, Promotion, and Price for Menthol Cigarettes in
`California High School Neighborhoods, 14 NICOTINE TOBACCO RSCH 116
`(2012). ..................................................................................................................16
`
`Mary T. Bassett et al,
`The Unequal Toll of COVID-19 Mortality by Age in the United States:
`Quantifying Racial/Ethnic Disparities (2020). ....................................................18
`
`Melissa Niksic,
`Flavored Smokes: Mmmmm...More Profits?, TOBACCO RETAILER (Apr. 2007). 25
`
`NASEM,
`Public Health Consequences of E-cigarettes (2018) ...........................................23
`
`Navid Hafez & Pamela M. Ling,
`Finding the Kool Mixx: How Brown & Williamson used Music Marketing to Sell
`Cigarettes, 15 TOBACCO CONTROL 359 (2006). ........................................... 15, 16
`
`Nina Schleicher et al., Stanford Prevention Research Center,
`California Tobacco Retail Surveillance Study, 2018 (2019). ..............................16
`
`vii
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`Office of the Surgeon General, HHS,
`Cardiovascular System, in How Tobacco Smoke Causes Disease: The Biology
`and Behavioral Basis for Smoking-Attributable Disease: A Report of the
`Surgeon General (2010). ......................................................................................22
`
`Office of the Surgeon General, HHS,
`E-Cigarette Use Among Youth and Young Adults, A Report of the Surgeon
`General (2016). ....................................................................................................22
`
`Office of the Surgeon General, HHS,
`Smoking Cessation, A Report of the Surgeon General (2020). .................... 13, 21
`
`Office of the Surgeon General, HHS,
`Surgeon General’s Advisory on E-Cigarette Use Among Youth (2018). ..... 19, 20
`
`Office of the Surgeon General, HHS,
`The Health Consequences of Smoking - 50 Years of Progress: A Report of the
`Surgeon General (2014). ............................................................................. 4, 9, 22
`
`Office of the Surgeon General, HHS,
`The Health Consequences of Smoking - 50 Years of Progress: A Report of the
`Surgeon General, Executive Summary (2014). ...................................................... 3
`
`Office on Smoking and Health, CDC,
`Electronic Nicotine Delivery Systems: Key Facts (2016). ...................................22
`
`Phillip S. Gardiner,
`The African Americanization of Menthol Cigarette use in the United States,
`6(Suppl 1) NICOTINE & TOBACCO RSCH S55 (2004). .........................................17
`
`Sabrina L. Smiley et al.,
`Retail Marketing of Menthol Cigarettes in Los Angeles, California: a Challenge
`to Health Equity, 18 PREVENTING CHRONIC DISEASE (2021). .............................17
`
`Sam N. Cwalina et al.,
`Adolescent Menthol Cigarette Use and Risk of Nicotine Dependence: Findings
`from the National Population Assessment on Tobacco and Health (PATH) Study,
`206 DRUG & ALCOHOL DEPENDENCE 1 (2019). ...................................................14
`
`SAMHSA, HHS,
`2019 National Survey on Drug Use and Health, Table 4.9A, Past Year Initiation
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`of Substance Use among Persons Aged 12 or Older Who Initiated Use Prior to
`Age 18, Prior to Age 21, and at Age 21 or Older: Numbers in Thousands, 2018
`and 2019 (Sept. 11, 2020). ...................................................................................26
`
`Sarah D. Mills et al.,
`The Relationship Between Menthol Cigarette Use, Smoking Cessation and
`Relapse: Findings from Waves 1 to 4 of the Population Assessment of Tobacco
`and Health Study, NICOTINE & TOBACCO RSCH (Oct. 16, 2020). ........................13
`
`Shu-Hong Zhu et al.,
`California Student Tobacco Survey, Results of the Statewide 2017-18 California
`Student Tobacco Survey (2019). ..........................................................................20
`
`Shu-Hong Zhu et al.,
`Four Hundred and Sixty Brands of E-cigarettes and Counting: Implications for
`Product Regulation, 23 TOBACCO CONTROL iii3 (2014). ....................................21
`
`Sunday Azagba et al.,
`Cigarette Smoking Behavior Among Menthol and Nonmenthol Adolescent
`Smokers, 66(5) J. OF ADOLESCENT HEALTH 545 (2020). .....................................13
`
`Teresa W. Wang et al.,
`E-cigarette Use Among Middle and High School Students – United States, 2020,
`69(37) MORBIDITY & MORTALITY WKLY. REP. 1310 (2020) .................. 19, 20, 21
`
`Teresa W. Wang, et al.,
`Tobacco Product Use and Associated Factors Among Middle and High School
`Students—United States, 2019, 68 MORBIDITY & MORTALITY WKLY. REP. 1
`(2019) ............................................................................................................ 10, 27
`
`Thuy Le & David Mendez,
`An Estimation of the Harm of Menthol Cigarettes in the United States from 1980
`to 2018, TOBACCO CONTROL (2021). ...................................................................11
`
`Tobacco Products Scientific Advisory Committee, FDA,
`Menthol Cigarettes and Public Health: Review of the Scientific Evidence and
`Recommendations (2011) .................................................................... 9, 12, 16, 17
`
`Valerie B. Yerger et al.,
`Racialized Geography, Corporate Activity, and Health Disparities: Tobacco
`
`ix
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`Industry Targeting of Inner Cities, 18(4 Suppl) J. Health Care Poor &
`Underserved 10 (2007). ........................................................................................15
`
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`Amici public health, medical, and community organizations submit this brief
`
`urging the Court to uphold the District Court orders granting Defendants’ Motion
`
`to Dismiss and Denying Plaintiffs’ Motion for Summary Judgment, thus upholding
`
`LA County’s ordinance prohibiting the retail sale of flavored tobacco products (the
`
`“Flavors Ordinance”).1 This brief is filed with the consent of the parties.
`
`STATEMENT OF INTEREST OF AMICI CURIAE
`
`Amici here include the following national, state, and local public health,
`
`medical, and community organizations:
`
`• African American Tobacco Control Leadership Council
`
`• American Academy of Pediatrics California
`
`• American Academy of Pediatrics, California Chapter 2
`
`• American Cancer Society Cancer Action Network
`
`• American College of Physicians, California Services Chapter
`
`• American Heart Association
`
`• American Lung Association
`
`• American Medical Association
`
`• Americans for Nonsmokers’ Rights
`
`
`1 Amici curiae affirm that no party’s counsel authored this brief in whole or
`in part, and that no party, party’s counsel, or other person (other than amici curiae,
`their members, or their counsel) contributed money that was intended to fund
`preparing or submitting this brief. See Fed. R. App. R. 29(a)(4)(E).
`
`1
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`• American Public Health Association
`
`• American Thoracic Society
`
`• Breathe Southern California
`
`• California Academy of Family Physicians
`
`• California Medical Association
`
`• California Public Interest Research Group
`
`• California Society of Addiction Medicine
`
`• California Thoracic Society
`
`• Campaign for Tobacco-Free Kids
`
`• Equality California
`
`• Kaiser Permanente
`
`• Los Angeles County Medical Association
`
`• OUT Against Big Tobacco Los Angeles
`
`• Parents Against Vaping E-cigarettes
`
`• Truth Initiative
`
`• St. John’s Well Child and Family Center
`
`As is evident from the description of the amici included in the Addendum to
`
`this brief, each of these groups works, on a daily basis, to reduce the devastating
`
`health harms of tobacco products. From pediatricians who counsel their young
`
`patients and their parents about the hazards of tobacco use, to organizations with
`
`2
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`
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`formal programs to urge users to quit, to groups representing parents and families
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`struggling to free young people from nicotine addiction, each of these
`
`organizations has a direct and immediate interest in curbing the sale of flavored
`
`tobacco products, as well as substantial expertise in the role those products play in
`
`enticing young people to use tobacco. Thus, these amici are particularly well suited
`
`to inform the Court of the substantial public health benefits to residents of LA
`
`County provided by the Flavors Ordinance. These benefits are a direct result of the
`
`Family Smoking Prevention and Tobacco Control Act’s (“Tobacco Control Act” or
`
`“TCA”), Pub. L. No. 111-31, 123 Stat. 1776 (2009), broad protection for local
`
`authorities to prohibit and regulate the retail sale of dangerous and addictive
`
`tobacco products, as LA County has done with its Flavors Ordinance.
`
`INTRODUCTION AND SUMMARY OF ARGUMENT
`
`Use of tobacco products is the leading cause of preventable death in the
`
`United States, resulting in 480,000 deaths per year.2 The tobacco industry has long
`
`understood that almost all new tobacco users begin their addiction as kids. Ninety
`
`percent of adult smokers began smoking in their teens.3 The industry has also
`
`
`2 Office of the Surgeon General (OSG), U.S. Department of Health and
`Human Services (HHS), The Health Consequences of Smoking - 50 Years of
`Progress: A Report of the Surgeon General, Executive Summary 2 (2014),
`https://www.hhs.gov/sites/default/files/consequences-smoking-exec-summary.pdf.
`3 OSG, HHS, The Health Consequences of Smoking - 50 Years of Progress:
`A Report of the Surgeon General 708 (2014),
`
`3
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`known that to successfully market their products to young people, flavored
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`products are essential. No matter what the tobacco product – from cigarettes to e-
`
`cigarettes to cigars – flavors significantly increase the appeal of tobacco products
`
`to youth. Data from the U.S. Food and Drug Administration (“FDA”)/National
`
`Institutes of Health (“NIH”) Population Assessment of Tobacco and Health
`
`(“PATH”) study found that almost 80% of 12-to-17 year-olds who had ever used a
`
`tobacco product initiated their use with a flavored product.4 Indeed, at least two-
`
`thirds of youth tobacco users reported using these products “because they come in
`
`flavors I like.”5 As the FDA has found, “the availability of tobacco products with
`
`flavors at these developmental stages attracts youth to initiate use of tobacco
`
`products and may result in lifelong use.”6 By enacting the Flavors Ordinance, LA
`
`County has sought to protect its residents – and particularly its young people –
`
`from the continuing and increasing scourge of flavored tobacco products that lure
`
`millions into a lifetime of addiction and contribute so significantly to disease and
`
`death.
`
`
`https://www.ncbi.nlm.nih.gov/books/NBK179276/pdf/Bookshelf_NBK179276.pdf
`.
`
`4 Bridget K. Ambrose et al., Flavored Tobacco Product Use Among US
`Youth Aged 12-17 Years, 2013-2014, 314 J. Am. Med. Ass’n 17, 1871-3, 1872
`(2015), https://jamanetwork.com/journals/jama/fullarticle/2464690.
`5 Id. at 1873.
`6 Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12,294, 12,295
`(proposed Mar. 21, 2018) (to be codified at 21 C.F.R. pt. 1100, 1140, 1143)
`(“Advance Notice of Proposed Rulemaking”).
`
`4
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`The Flavors Ordinance does not, as Appellants allege, interfere with the
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`statutory scheme under the Tobacco Control Act. To the contrary, the preservation
`
`of state and local authority to enact laws like the Flavors Ordinance is embedded in
`
`the federal scheme. As explained in detail in the County’s Principal Brief and as
`
`recognized by the District Court,7 the Tobacco Control Act both provides for
`
`exclusive federal authority over the regulation of activities engaged in by tobacco
`
`product manufacturers and others before a product is introduced into commerce,
`
`and preserves to states and localities the authority to determine whether a tobacco
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`product will be permitted to be sold to persons residing within their borders. The
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`First and Second Circuit Courts of Appeals reached the same conclusion in
`
`rejecting challenges to local restrictions on the sale of flavored tobacco products
`
`based on the alleged preemptive impact of the Tobacco Control Act. U.S.
`
`Smokeless Tobacco Mfg. Co. LLC v. City of New York, 708 F.3d 428, 433-35 (2d
`
`Cir. 2013) (upholding local sales restrictions on flavored tobacco products because
`
`their application to a particular product “depends on its characteristics as an end
`
`product, and not on whether it was manufactured in a particular way or with
`
`particular ingredients”); Nat’l Ass’n of Tobacco Outlets, Inc. v. City of Providence,
`
`R.I., 731 F.3d 71, 83 & n.11 (1st Cir. 2013) (upholding local restrictions on sale of
`
`
`7 Defendants-Appellees Brief, at 11-12; R. J. Reynolds Tobacco Co. v.
`County of Los Angeles, 471 F.Supp.3d 1010, 1014-17 (C.D. Cal. 2020).
`
`5
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`flavored tobacco products, given “Congress’ decision to exempt sales regulations
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`from preemption. . . .”).
`
`By broadly preserving state and local authority over tobacco product sales,
`
`the Tobacco Control Act provides localities like LA County the capacity to protect
`
`the health of their residents to a greater degree than may be afforded by federal
`
`regulation over manufacturer activities alone. Indeed, Section 916 of the TCA
`
`(entitled “Preservation of State and Local Authority”) expressly preserves state and
`
`local authority “…to enact…any law…in addition to…requirements established
`
`under this Chapter, including a law…relating to or prohibiting the sale…of tobacco
`
`products…” Far from interfering with the federal regulatory scheme, by providing
`
`additional public health protection, the Flavors Ordinance advances the Tobacco
`
`Control Act’s “objective of reducing the use and harmfulness of tobacco products,
`
`especially among young people.” U.S. Smokeless Tobacco, 708 F.3d at 436.
`
`Amici focus here on the significant public health benefits afforded by the
`
`Flavors Ordinance – precisely the kinds of benefits Congress intended to confer by
`
`its decree that state and local authority over the sale of tobacco products be broadly
`
`preserved to protect the public health. As explained in detail below, these benefits
`
`include protection against the public health harms of (1) menthol cigarettes; (2)
`
`flavored e-cigarettes; and (3) flavored cigars. As also explained below, the FDA
`
`has never decided “to allow certain flavored tobacco products, including menthol
`
`6
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`
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`cigarettes, to stay on the market,” as Appellants erroneously claim.8 Indeed, the
`
`FDA recently stated its intention to propose product standards within the next year
`
`to prevent the continued manufacture of menthol cigarettes and flavored cigars.9
`
`Thus, there is no basis for Appellants’ argument that the Flavors Ordinance is
`
`impliedly preempted because it stands as an obstacle to current federal policy on
`
`menthol cigarettes and flavored cigars; to the contrary, the Flavors Ordinance is
`
`entirely consistent with that policy. As for e-cigarettes, Appellants mischaracterize
`
`FDA action as “effectively banning” only certain flavored products, when in fact
`
`FDA has issued only Guidance describing its current enforcement policies, which
`
`do not bind the agency, are subject to change at any time, and therefore can have
`
`no preemptive effect on state and local laws.
`
`ARGUMENT
`
`I.
`
`The County’s Tobacco Flavors Ordinance Affords County Residents
`Greater Protection Against the Public Health Harms of Menthol
`Cigarettes.
`
`Contrary to Appellants’ assertion that “there is no scientific or other
`
`justification” for prohibiting the sale of menthol cigarettes, for which Appellants
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`
`8 Appellants’ Principal Brief, at 5.
`9 FDA, News release, FDA Commits to Evidence-Based Actions Aimed at
`Saving Lives and Preventing Future Generations of Smokers (Apr. 29, 2021),
`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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`7
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`Case: 20-55930, 05/14/2021, ID: 12113436, DktEntry: 29, Page 18 of 52
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`cite only their own comments to FDA,10 menthol cigarettes are a substantial threat
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`to public health because they increase the risk of youth initiation of smoking,
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`increase addiction, and disproportionately affect the African American community,
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`thus exacerbating serious health disparities. By preserving broad local authority to
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`adopt laws relating to or prohibiting the sale of tobacco products, the Tobacco
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`Control Act makes possible the additional public health benefits provided by the
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`Flavors Ordinance to the residents of LA County.
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` Menthol Cigarettes Increase Youth Initiation of Smoking.
`Although the tobacco companies are well aware that almost all new tobacco
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`
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`users begin their addiction as kids, they also know that, to novice smokers, tobacco
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`smoke can be harsh and unappealing. By masking the harshness and soothing the
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`irritation caused by tobacco smoke, menthol cigarettes make it easier for beginners
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`to experiment with cigarettes and ultimately become addicted. Thus, young
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`smokers are more likely to use menthol cigarettes than any other age group. As the
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`FDA has stated, “[m]ultiple studies show a greater use of menthol cigarettes by
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`younger smokers and less usage among older smokers.”11 The FDA’s Tobacco
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`Products Scientific Advisory Committee (“TPSAC”), after an extensive study of
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`the public health impact of menthol cigarettes, concluded in a 2011 Report that
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`10 See Appellants’ Principal Brief, at 11.
`11 Advance Notice of Proposed Rulemaking, supra note 6, at 12,296.
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`8
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`Case: 20-55930, 05/14/2021, ID: 12113436, DktEntry: 29, Page 19 of 52
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`menthol cigarettes increase the number of children who experiment with cigarettes
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`and who become regular smokers, increasing overall youth smoking, and that
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`young people who initiate using menthol cigarettes are more likely to become
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`addicted and long-term daily smokers.12 Since 90% of adult smokers begin
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`smoking in their teens,13 as a starter product for the young, menthol cigarettes are
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`critical to the tobacco industry’s need to recruit “replacement smokers” for the
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`one-half of long-term smokers who eventually die from tobacco-related disease. In
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`its 2011 Report, TPSAC projected that by 2020, about 2.3 million people will have
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`started smoking because of menthol cigarettes, leading to 17,000 premature
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`deaths.14 TPSAC concluded that “[r]emoval of menthol cigarettes from the
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`marketplace would benefit public health in the United States.”15
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`Two years after issuance of the TPSAC Menthol Report, FDA completed its
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`own independent, peer-reviewed evaluation of the science concerning menthol
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`cigarettes. FDA’s Preliminary Scientific Evaluation of the Possible Public Health
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`Effects of Menthol versus Nonmenthol Cigarettes (“FDA Report”) reached the
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`12 Tobacco Products Scientific Advisory Committee (TPSAC), FDA,
`Menthol Cigarettes and Public Health: Review of the Scientific Evidence and
`Recommendations at 136, 199-202 (2011), https://wayback.archive-
`it.org/7993/20170405201731/https:/www.fda.gov/downloads/AdvisoryCommittees
`/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UC
`M269697.pdf (“TPSAC Menthol Report”).
`13 OSG, supra note 3.
`14 TPSAC Menthol Report, supra note 12, at 221.
`15 Id. at 225.
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`9
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`Case: 20-55930, 05/14/2021, ID: 12113436, DktEntry: 29, Page 20 of 52
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`overall conclusion, consistent with TPSAC’s own findings, that it is “likely that
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`menthol cigarettes pose a public health risk above that seen with nonmenthol
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`cigarettes.”16
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`Since the reports from TPSAC and FDA, research has continued to
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`demonstrate the popularity of menthol cigarettes among youth and menthol’s role
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`in smoking initiation. According to the 2019 National Youth Tobacco Survey
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`(“NYTS”), half of current high school smokers use menthol cigarettes.17 Another
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`government survey, the National Survey of Drug Use and Health, found that
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`preference for menthol among cigarette smokers is inversely correlated with age.18
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`Data from Truth Initiative’s Young Adult Cohort Study, a national study of 18-34
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`year olds, likewise showed that 52% of new young adult smokers initiated with
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`16 FDA, Preliminary Scientific Evaluation of the Possible Public Health
`Effects of Menthol versus Nonmenthol Cigarettes 6 (2013),
`https://www.fda.gov/media/86497/download.
`17 Teresa W. Wang et al., Tobacco Product Use and Associated Factors
`Among Middle and High School Students—United States, 2019, 68(12) MORBIDITY
`& MORTALITY WKLY. REP. 1, 15 (2019),
`https://www.cdc.gov/mmwr/volumes/68/ss/pdfs/ss6812a1-H.pdf.
`18 Cristine D. Delnevo et al., Banning Menthol Cigarettes: A Social Justice
`Issue Long Overdue, NICOTINE & TOBACCO RSCH 1673, 1673 (2021),
`https://academic.oup.com/ntr/article/22/10/1673/5906409.
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`10
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`Case: 20-55930, 05/14/2021, ID: 12113436, DktEntry: 29, Page 21 of 52
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`menthol cigarettes.19 Initiation with menthol cigarettes was higher among black
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`smokers (93.1%) compared to white smokers (43.9%).20
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`The devastating health impact of menthol cigarettes is perhaps most
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`dramatically shown by a recent study by researchers from the University of
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`Michigan. With the same methodology used by TPSAC, the new study estimates
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`that, by slowing down the decline in smoking prevalence, during the 38-year
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`period from 1980-2018, menthol cigarettes were responsible for 10.1 million extra
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`smokers, or approximately 266,000 additional smokers every ye