Case: 20-55930, 05/14/2021, ID: 12113451, DktEntry: 30, Page 1 of 39
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`No. 20-55930
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`
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`
`
`In the
`United States Court of Appeals for the Ninth Circuit
`____________________________
`
`R.J. REYNOLDS TOBACCO COMPANY, ET AL.
`Plaintiffs-Appellants,
`v.
`
`COUNTY OF LOS ANGELES, ET AL.,
`Defendants-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 AMICI CURIAE PUBLIC HEALTH LAW CENTER, ACTION ON
`SMOKING AND HEALTH, CALIFORNIA STATE ASSOCIATION OF
`COUNTIES, CHANGELAB SOLUTIONS, INTERNATIONAL
`CITY/COUNTY MANAGEMENT ASSOCIATION, INTERNATIONAL
`MUNICIPAL LAWYERS ASSOCIATION, LEGAL RESOURCE CENTER
`FOR PUBLIC HEALTH POLICY, NATIONAL ASSOCIATION OF
`COUNTIES, NATIONAL LEAGUE OF CITIES, PUBLIC HEALTH
`ADVOCACY INSTITUTE, AND U.S. CONFERENCE OF MAYORS IN
`SUPPORT OF DEFENDANTS-APPELLEES AND AFFIRMANCE
`____________________________
`
`
`
`
`
`Rachel Bloomekatz
`1148 Neil Avenue
`Columbus, Ohio 43201
`(614) 259-7611
`rachel@bloomekatzlaw.com
`Counsel for Amici Curiae
`
`
`
`
`i
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`CORPORATE DISCLOSURE STATEMENT
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`No publicly held corporation owns 10% or more of the stock in any amicus
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`curiae. Nor is any amicus curiae a subsidiary of any parent company.
`
`
`
`/s/ Rachel Bloomekatz
`Rachel Bloomekatz
`
`Counsel for Amici Curiae
`
`
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`TABLE OF CONTENTS
`
`
`Corporate Disclosure Statement .................................................................................. i
`
`Table of Contents ........................................................................................................ ii
`
`Table of Authorities .....................................................................................................iv
`
`Introduction ................................................................................................................. 1
`
`Interest of Amici Curiae .............................................................................................. 4
`
`Argument ..................................................................................................................... 6
`
`I.
`
` The TCA preserved long-established state and local government
`authority over tobacco product sales within their borders. ......................... 6
`
`A. The TCA expressly preserves local government authority
`over tobacco retail sales. ................................................................. 7
`
`B. The TCA only preempted local regulations that would
`force manufacturers to change their processes for each
`local jurisdiction. .......................................................................... 10
`
`II.
`
` Los Angeles County’s restriction on the sale of flavored tobacco
`products is not a “product standard” preempted by the TCA. ................ 13
`
`A. The Ordinance is not a “product standard” because it does
`not require manufacturers to create tobacco products in
`any particular way. ........................................................................ 13
`
`B. The industry’s contrary arguments are wrong. ............................. 15
`
`C. No circuit court has ever concluded that a ban on the sale
`of flavored tobacco products is a “product standard.” ................. 20
`
`III.
`
` Los Angeles County’s Ordinance is not impliedly preempted
`because local sales bans on flavored tobacco products do not pose
`an obstacle to the FDA’s regulatory authority. ......................................... 21
`
`A. There is a “high threshold” for obstacle preemption
`especially where Congress has explicitly preserved state
`authority. ....................................................................................... 22
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`ii
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`B. The Ordinance is not impliedly preempted by the FDA’s
`inaction on menthol. .................................................................... 23
`
`C. The industry’s implied preemption argument would have
`grave consequences for local public health laws that often
`serve as policy laboratories. .......................................................... 25
`
`Conclusion ................................................................................................................. 27
`
`Form 8: Certificate of Compliance ............................................................................ 28
`
`Certificate of Service .................................................................................................. 29
`
`Addendum: Identity of Amici Curiae
`
`
`
`
`
`
`iii
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`TABLE OF AUTHORITIES
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`Page(s)
`
`CASES
`
`AATCLC v. FDA,
`No. 4:20-cv-04012-KAW (N.D. Cal. Nov. 12, 2020) ........................................... 23
`
`Altria Grp., Inc. v. Good,
`555 U.S. 70 (2008) ................................................................................................... 7
`
`Austin v. Tennessee,
`179 U.S. 343 (1900) ......................................................................................... 2, 3, 6
`
`Bates v. Dow Agrosciences LLC,
`544 U.S. 431 (2005) ................................................................................................. 7
`
`Berger v. Philip Morris USA, Inc.,
`185 F. Supp. 3d 1324 (M.D. Fla. 2016) ............................................................ 9, 25
`
`Chamber of Comm. v. Whiting,
`563 U.S. 582 (2011) ......................................................................................... 22, 23
`
`Cote v. R.J. Reynolds Tobacco Co.,
`909 F.3d 1094 (11th Cir. 2018) .............................................................................. 9
`
`Graham v. R.J. Reynolds Tobacco Co.,
`857 F.3d 1169 (11th Cir. 2017) .................................................................. 6, 12, 24
`
`Indep. Gas & Serv. Stations Ass’n v. Chicago,
`112 F. Supp. 3d 749 (N.D. Ill., 2015) ....................................................... 17, 20, 21
`
`Nat’l Ass’n of Tobacco Outlets, Inc. v. City of Providence,
`731 F.3d 71 (1st Cir. 2013) .................................................................. 10, 12, 17, 20
`
`Nat’l Meat Ass’n v. Harris,
` 565 U.S. 452 (2012) ......................................................................................... 17, 18
`
`P.R. Dep’t of Consumer Affairs v. Isla Petroleum Corp.,
`485 U.S. 495 (1998) ............................................................................................... 24
`
`R.J. Reynolds Tobacco Co. v. City of Edina,
`482 F. Supp. 3d 875 (D. Minn. 2020) ................................................................... 20
`
`iv
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`Rice v. Santa Fe Elevator Corp.,
`331 U.S. 218 (1947) ................................................................................................. 7
`
`Riegel v. Medtronic, Inc.,
`552 U.S. 312 (2008) ............................................................................................... 22
`
`U.S. Smokeless Tobacco Mfg. Co. LLC v. City of New York,
`708 F.3d 428 (2d Cir. 2013) ........................................................................... passim
`
`United States v. Lopez,
`514 U.S. 549 (1995) ............................................................................................... 25
`
`Wyeth v. Levine,
`555 U.S. 555 (2009) ........................................................................................ passim
`
`STATUTES
`
`15 U.S.C. § 1334(c) ........................................................................................... 12, 18
`
`21 U.S.C. § 387 .................................................................................................. passim
`
`Family Smoking Prevention and Tobacco Control Act of 2009,
` Pub. L. No. 111-31, 123 Stat. 1776 ................................................................ passim
`
`REGULATIONS
`
`16 C.F.R. § 1303 ........................................................................................................ 26
`
`21 C.F.R. § 1140.3 .................................................................................................... 11
`
`21 C.F.R. § 1143.3(a)(1) ........................................................................................... 11
`
`80 Fed. Reg. 34650 (June 17, 2015) .......................................................................... 26
`
`Beverly Hills, Cal., Mun. Code 4-2-2101 et seq. ......................................................... 7
`
`Cal. Revenue and Taxation Code § 30003 ............................................................... 16
`
`Manhattan Beach, Cal., Ordinance 20-0007 ............................................................... 7
`
`San Francisco Health Code § 19S.2 .......................................................................... 16
`
`
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`v
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`OTHER AUTHORITIES
`
`Micah Berman, Eleventh Circuit Finds Tobacco Suits Preempted: Trouble for
`Future Public Health Regulations? YALE J. ON REG. (Apr. 19, 2015) ................. 25
`
`CTFK, Fact Sheet (Oct. 23, 2020),
` https://perma.cc/JGX3-3VZP .............................................................................. 2, 3
`
`DHHS, Preventing Tobacco Use Among Youth and Young Adults: A Rep’t of
`the Surgeon Gen. (2012), https://perma.cc/6EEU-PHH5 .................................. 2, 5
`
`
`DHHS, The Health Consequences of Smoking—50 Years of Progress: A Rep’t of
`the Surgeon Gen. (2014), https://perma.cc/L4P8-SGVP ........................................ 4
`
`FDA, Press Release, FDA Commits to Evidence-Based Actions Aimed at Saving
`Lives and Preventing Future Generations of Smokers (April 29, 2021),
` https://perma.cc/QDA4-KYRW ................................................................... 3, 4, 23
`
`James G. Hodge, Jr., The Role of New Federalism and Public Health Law,
`12 J.L. & Health 309 (1998) .................................................................................. 25
`
`Gerald Markowitz & David Rosner, LEAD WARS (2013) ......................................... 26
`
`Alexander C. Wagenaar & Kelli A. Komro, NATURAL EXPERIMENTS: DESIGN
` ELEMENTS FOR OPTIMAL CAUSAL INFERENCE 24 (2011) ..................................... 26
`
`
`vi
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`INTRODUCTION1
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`Los Angeles County’s Ordinance does one thing—it prohibits tobacco retailers
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`from selling certain flavored tobacco products within the County’s borders. Tobacco
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`manufacturers can still make their products with whatever processes, ingredients,
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`components, filters, and other properties they choose, so long as they are complying
`
`with federal regulations. The Ordinance does not require the manufacture of any
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`special cigarette, cigar, vape product, or chew tobacco. And the County does not
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`even prohibit the possession or use of flavored tobacco products within its borders.
`
`Nor does it prohibit the manufacture of any flavored tobacco products in its
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`jurisdiction. Instead, what the Ordinance mandates is that of all tobacco products
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`that manufacturers place in the stream of commerce, some—those imparting a
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`distinct non-tobacco taste or aroma—cannot be sold within its borders. That’s it.
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`It is, therefore, a measure “relating to or prohibiting the sale” of tobacco
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`products—which the Tobacco Control Act (TCA) explicitly says states and local
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`governments can adopt—not a “product standard,” which Congress said was reserved
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`to the Food and Drug Administration (FDA). See 21 U.S.C. § 387g, p. Thus, as the
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`district court held, the Ordinance is not preempted.
`
`
`1 All parties consent to the filing of this brief, and no counsel for any party
`authored it in whole or part or paid money to fund the brief’s preparation and
`submission.
`
`1
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`
`

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`Los Angeles County, following the Surgeon General’s reporting, determined
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`that this Ordinance was necessary to reduce youth access to flavored tobacco. See
`
`DHHS, Preventing Tobacco Use Among Youth and Young Adults: A Rep’t of the
`
`Surgeon Gen. 537–38 (2012), https://perma.cc/6EEU-PHH5 (“SG Rep’t”). Flavors
`
`hook youth on nicotine, leading to deleterious and fatal health consequences. The
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`tobacco companies want this Court to believe that, given what they characterize as
`
`their “longstanding efforts to keep tobacco products away from youth,” such
`
`measures are unnecessary. RJR Br. at 13. But the evidence shows just the opposite.
`
`Tobacco companies have long used flavors to attract youth and get new generations
`
`addicted to their products. SG Rep’t at 538. So the County did what localities in the
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`United States have had authority to do for over a century: it prohibited the sale of
`
`certain tobacco products. See Austin v. Tennessee, 179 U.S. 343, 362 (1900).
`
`Los Angeles County joined 300 local jurisdictions across the country and two
`
`states that have banned or restricted the sale of flavored tobacco products to curb
`
`youth use and protect the health and safety of their residents. CTFK, Fact Sheet
`
`(Oct. 23, 2020), https://perma.cc/JGX3-3VZP. And the tobacco companies have
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`sued many of them—states, municipalities, counties, and townships, large and small.
`
`No court in the country has held that any of these regulations is preempted by the
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`TCA. Unsurprisingly the lower court here agreed. Undeterred, the tobacco
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`companies continue to argue that these hundreds of local laws—including 101 laws
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`2
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`within the Ninth Circuit’s jurisdiction—should be invalidated. Id. This Court too
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`should reject the industry’s plea. Reversing the lower court would not only part ways
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`with every other sister circuit and court to reach the issue, but it would endanger
`
`hundreds of democratically enacted state and local public health laws targeted at
`
`protecting vulnerable groups.
`
`Given the threat to local public health regulation, amici submit this brief first
`
`to explain why Los Angeles County’s regulation is not a “product standard” and,
`
`hence, why it is not expressly preempted by the TCA. Under the TCA, a “product
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`standard” is a restriction on the manufacturer; for example, specifying the
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`ingredients the manufacturer may use. Like every other category mentioned in the
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`TCA’s preemption clause, a product standard is directed to manufacturers and to
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`pre-market activities—not to retail sales bans, which are explicitly preserved for local
`
`governments. Adopting the tobacco industry’s interpretation would enlarge the scope
`
`of the TCA’s preemption clause in ways that could upend the historic power of local
`
`governments to regulate tobacco sales.
`
`Furthermore, this Court should reject the plaintiffs’ argument that the
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`Ordinance is impliedly preempted because it poses an “obstacle” to the FDA’s
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`decision to allow flavored tobacco products on the market. That argument was
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`wrong when made, and is now upended by the FDA’s announcement that it will
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`propose a rule banning the manufacture of menthol cigarettes and cigars. Press
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`3
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`

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`Release (April 29, 2021), https://perma.cc/QDA4-KYRW. Forced to backtrack, the
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`industry will no doubt attempt to reframe its argument. But however it attempts to
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`do so should be rejected. Regardless of the FDA’s decisions, the TCA provides a
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`framework for shared and often overlapping federal and local regulation of tobacco
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`products that allows local governments to be more protective than the FDA.
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`Adopting the plaintiffs’ argument would expand obstacle preemption beyond its
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`narrow moorings, threatening local authority not only as to tobacco restrictions, but
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`also in other areas of public health.
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`INTEREST OF AMICI CURIAE
`
`Amici curiae are 11 of the nation’s leading nonprofit organizations supporting
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`state and local government authority to protect public health. They are committed to
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`supporting democratically enacted policies by state and local governments that
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`educate the public about, and protect the public from, the devastating health
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`consequences of tobacco. 2 Tobacco use remains the leading preventable cause of
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`death nationally, killing more than 480,000 Americans annually. DHHS, The
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`Health Consequences of Smoking—50 Years of Progress: A Rep’t of the Surgeon
`
`Gen. 678 (2014), https://perma.cc/L4P8-SGVP. Flavored
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`tobacco products—
`
`especially menthol—have played a key role in this epidemic because flavored
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`2 A further description of each amicus is included as an addendum.
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`4
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`products provide a gateway for youth to initiate tobacco use, getting each new
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`generation addicted. SG Rep’t (2012) at 537–539.
`
`Amici submit this brief to protect the authority of state and local governments
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`to enact public health measures regarding tobacco products that will protect their
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`communities. Amici recognize that local governments play a historic and critical role
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`in protecting the health of their communities. Each community has a different
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`experience with health concerns, even with respect to tobacco control. Various social
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`groups—based on age, race, sexual orientation, income, history of tobacco-industry
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`targeting, and intersections of these and other factors—may be more or less likely to
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`use tobacco products and may use different products. Because of these variations,
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`state and local governments may determine that different approaches are necessary
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`to address the health needs and advance health equity in their communities. And the
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`TCA empowers them to do so. The tobacco industry’s efforts to expand the scope
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`of the TCA’s preemption would hamper local democratic efforts to address public
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`health and health equity—the opposite of the power Congress explicitly “preserved”
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`and “saved” for state and local governments in the TCA.
`
`To forward local democracy and public health, amici have worked with
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`governments at every level—Tribal, federal, state, and local—to implement policies to
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`protect health. Therefore, they are particularly well suited to address the role that
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`5
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`state and local governments have historically played in tobacco control and how the
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`TCA preserved that prominent role going forward.
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`ARGUMENT
`
`I.
`
`
`
`The TCA preserved long-established state and local government authority
`over tobacco product sales within their borders.
`
`State and local governments have a long and robust history of regulating and
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`even prohibiting tobacco product sales, stretching back more than a century. The
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`Supreme Court, in upholding Tennessee’s ban on the sale of cigarettes in 1900, held
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`that states were not “bound to furnish a market” for cigarettes, and instead could
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`exercise their police powers to protect the health and welfare of their citizens,
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`particularly youth, from the “deleterious” effects of smoking. Austin, 179 U.S. at
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`346, 348. The Court found it untenable to “force [cigarettes] into the markets of a
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`state, against its will.” Id. at 362. Fast forward 120 years and local jurisdictions are
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`again prohibiting or limiting the sale of tobacco products to protect the health of
`
`their citizens, particularly youth, even after the TCA in 2009. In the past decades,
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`state and local governments have passed countless laws restricting and prohibiting
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`the sale of tobacco products in various ways—prohibiting sales in vending machines,
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`prohibiting sales near schools, prohibiting sales to those under 21 (even before the
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`federal statute), and, as Los Angeles County has done, restricting sales of flavored
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`tobacco products. See Graham v. R.J. Reynolds Tobacco Co., 857 F.3d 1169, 1190–
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`91 (11th Cir. 2017) (en banc) (discussing historic and recent state and local tobacco
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`6
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`

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`restrictions). Some localities have banned sales of cigarettes and vape products
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`entirely from retail stores. See, e.g., Beverly Hills, Cal., Mun. Code 4-2-2101 et seq.;
`
`Manhattan Beach, Cal., Ordinance 20-0007. The history of tobacco regulation is,
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`indeed, largely one of state and local action, as the FDA lacked authority to regulate
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`tobacco products until Congress enacted the TCA in 2009.
`
`
`
`The TCA, while it finally gave the FDA authority to regulate tobacco, did not
`
`strip state and local governments of their historic police power to prohibit and
`
`restrict tobacco sales. “[T]he historic police powers of the States [are] not to be
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`superseded by the Federal Act unless that was the clear and manifest purpose of
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`Congress.” Altria Grp., Inc. v. Good, 555 U.S. 70, 77 (2008) (quoting Rice v. Santa
`
`Fe Elevator Corp., 331 U.S. 218, 230 (1947)) (alteration in original). Thus, to the
`
`extent there is any ambiguity in the scope of the TCA’s preemption, the Court
`
`should “accept the reading that disfavors pre-emption.” Id. (quoting Bates v. Dow
`
`Agrosciences LLC, 544 U.S. 431, 449 (2005)); see Wyeth v. Levine, 555 U.S. 555,
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`565 (2009).
`
`A. The TCA expressly preserves local government authority over tobacco
`retail sales.
`
`The text of the TCA explicitly states that it is “preserving” for the states this
`
`historic power to adopt measures “relating to or prohibiting the sale” of tobacco
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`products, and it establishes only a narrow scope of preemption that does not infringe
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`upon such power.
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`7
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`Section 916 of the TCA delineates the relationship between state and federal
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`authority over
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`tobacco products
`
`through
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`three separate clauses. First,
`
`the
`
`“preservation clause” makes clear that the FDA does not have exclusive authority, or
`
`even “primary” authority (as plaintiffs assert at 2, 9) in the area of tobacco control.
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`Instead, the federal government sets the floor, and state and local governments can
`
`adopt their own regulations “with respect to tobacco products that [are] in addition
`
`to, or more stringent than,” the FDA’s rules, “including . . . [any] measure relating to
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`or prohibiting the sale, distribution, possession, exposure to, access to, advertising
`
`and promotion of, or use of tobacco products by individuals of any age.” 21 U.S.C.
`
`§ 387p(a)(1).
`
`Second, the preemption clause carves out eight limited exceptions to the
`
`preservation clause and reserves them to the FDA. These issues are of unique
`
`federal concern because they address the manufacturing stage before a product hits
`
`the market: “tobacco product
`
`standards, premarket
`
`review, adulteration,
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`misbranding, labeling, registration, good manufacturing standards, or modified risk
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`tobacco products.” Id. § 387p(a)(2)(A).
`
`Third, the savings clause provides an exception to the preemption clause,
`
`returning some authority to local governments even when they reach the eight
`
`preempted areas. The preemption clause, it says, does “not apply to requirements
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`relating to the sale” of tobacco products. Id. § 387p(a)(2)(B).
`
`8
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`The upshot: while the TCA gave the FDA authority to set national standards
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`for tobacco products (something it previously had no authority over), it expressly
`
`codified that state and local governments are still free to be more protective than the
`
`national standard and—critical here—even restrict or prohibit tobacco sales within
`
`their jurisdictions. Berger v. Philip Morris USA, Inc., 185 F. Supp. 3d 1324, 1335
`
`(M.D. Fla. 2016), aff’d sub nom. Cote v. R.J. Reynolds Tobacco Co., 909 F.3d
`
`1094 (11th Cir. 2018) (“Although the federal government has chosen to regulate
`
`aspects of the cigarette industry while stopping itself short of banning cigarettes, it
`
`did not
`
`intend
`
`to
`
`force the states to accept
`
`that cigarettes must remain
`
`on their markets.”).
`
`Congress considered in earlier drafts of the TCA a more expansive
`
`preemption provision that would have invalidated local flavor prohibitions. But
`
`Congress rejected that approach. Instead, it decided to allow states and local
`
`governments to ban tobacco sales, either fully or as to certain products. As the
`
`Second Circuit detailed: “Earlier versions of § 907 would have expressly reserved to
`
`the federal government authority to ban the sale of entire categories of tobacco
`
`products.” See U.S. Smokeless Tobacco Mfg. Co. LLC v. City of New York, 708
`
`F.3d 428, 433 n.1 (2d Cir. 2013) (citing five previous drafts). “These draft versions of
`
`the provision that ultimately became § 907(d)(3) were eventually rewritten to deny
`
`9
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`such power only to the FDA, and as enacted into law, this provision of the []TCA
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`does not forbid such bans by state and local governments.” Id.
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`Thus, contrary to the industry’s argument, the TCA did not overturn the
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`historic power of local governments to eliminate tobacco product sales in their
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`entirety or to restrict particular types of tobacco sales. Nothing in the TCA says
`
`localities cannot “absolutely prohibit such sales.” RJR Br. at 5. Quite the opposite:
`
`the TCA expressly preserved that power, courts have upheld it, and hundreds have
`
`localities have duly enacted ordinances doing just that.
`
`B.
`
`The TCA only preempted local regulations that would force
`manufacturers to change their processes for each local jurisdiction.
`
`The TCA’s preemption clause bars state regulation of tobacco products only
`
`“narrowly,” and focuses on one regulated entity—manufacturers. Nat’l Ass’n of
`
`Tobacco Outlets, Inc. v. City of Providence, 731 F.3d 71, 82 (1st Cir. 2013). As the
`
`text, structure, and purpose of the statute all demonstrate, the TCA “reserves
`
`regulation at the manufacturing stage exclusively to the federal government, but
`
`allows states and localities to continue to regulate sales and other consumer-related
`
`aspects of the industry.” U.S. Smokeless Tobacco Mfg. Co., 7087 F.3d at 434.
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`Congress was concerned about localities placing various and conflicting
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`standards on manufacturers, which would require tobacco companies to make
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`individualized products, apply separate labels, or follow unique processes for each
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`jurisdiction that enacted a law. Accordingly, one of the articulated purposes of the
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`TCA is “to authorize the [FDA] to set national standards controlling the
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`manufacture of tobacco products and the identity, public disclosure, and amount of
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`ingredients used in such products.” 21 U.S.C. § 387 note (emphasis added).
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`Looking to the text of the preemption clause, it is clear that each of the eight
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`enumerated categories addresses the manufacture or premarket stage of tobacco
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`products, not their sale at retail. For example, “premarket review” requires
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`manufacturers to submit applications for new products, and requires the FDA to
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`review “the components, ingredients, additives, and properties,” as well as “the
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`methods used in . . . the manufacture . . . of, [new] tobacco product[s].” 21 U.S.C.
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`§ 387j(b)(1). Similarly, “registration” is directed at persons who own or operate “any
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`establishment . . . engaged in the manufacture, preparation, compounding, or
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`processing of a tobacco product.” Id. § 387e(b). The plaintiffs point to “labeling” (at
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`28), but that too is a component of manufacturing because a tobacco product
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`includes its packaging. See 21 C.F.R. § 1140.3 (defining “manufacturer” as including
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`one who “labels a finished tobacco product”); id. § 1143.3(a)(1) (making it
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`“unlawful for any person to manufacture . . . such product unless the tobacco
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`product package bears the . . . required warning statement on the package label.”).
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`“Adulteration” also targets manufacturers and the conditions where they make
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`tobacco products. A tobacco product is “adulterated” if, among other things, “it has
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`been prepared, packed, or held under insanitary conditions . . . .” 21 U.S.C
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`§ 387b(2). The preemption of “good manufacturing standards” speaks for itself—it
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`also targets the manufacturers of tobacco products, not retail sellers. The same is
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`true of “modified risk tobacco products”—manufacturers submit information to the
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`FDA to prove a product has reduced risk to consumers and only then can it go to
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`market as a modified risk product. See 21 U.S.C. § 387k.
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`This balance—between exclusive nationwide manufacturing standards and
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`local sales control—is consistent with all of Congress’s previous tobacco legislation
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`that preceded the TCA. In previous acts, such as the Federal Cigarette Labeling and
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`Advertising Act, Congress balanced strong
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`local control with protecting
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`manufacturers from having to redo their labels or revise their advertisements to
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`comply with each local jurisdiction’s proscription. And these previous enactments
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`otherwise left intact local government authority to restrict and even fully prohibit
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`tobacco sales. See Graham, 857 F.3d at 1187–88 (reviewing the six congressional
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`statutes that preceded the TCA). Indeed, when the U.S. Supreme Court struck
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`down one local government’s decision to prohibit tobacco advertisements near
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`schools—without requiring
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`the manufacturer
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`to change
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`the content of
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`the
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`advertisements—Congress responded by clarifying that such local regulations were
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`acceptable. See Nat’l Ass’n of Tobacco Outlets, 731 F.3d at 80 (explaining that
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`15 U.S.C. § 1334(c) “was enacted in response to a portion of the Lorillard
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`Supreme Court decision.”). As long as such an ordinance does not force
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`manufacturers to make new ads for every jurisdiction, it is not preempted. Here too
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`manufacturers are not forced to make new products for each jurisdiction. While the
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`TCA gave the FDA exclusive authority to standardize manufacturing regulations
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`nationwide and the regulatory process to bring a product to market, consumer-retail
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`sales provisions are still within state and local power. U.S. Smokeless Tobacco Mfg.,
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`708 F.3d at 434.
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`II.
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`Los Angeles County’s restriction on the sale of flavored tobacco products is
`not a “product standard” preempted by the TCA.
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`Following the unique structure of the TCA, the district court rejected the
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`industry’s argument that the Ordinance should be considered a preempted “product
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`standard.” This Court should affirm.
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`A. The Ordinance is not a “product standard” because it does not require
`manufacturers to create tobacco products in any particular way.
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`Alongside the other categories of manufacturing regulations that the TCA
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`preempts (discussed supra), the TCA bars state and local governments from
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`establishing “product standards.” 21 U.S.C. § 387p(a)(2)(A). The TCA does not
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`define a “product standard” but the text of § 907—describing existing and future
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`product standards—as well as the structure of the TCA’s preemption provisions,
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`make plain that sales restrictions like the County’s are not “product standards.”
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`Consider the two “product standards” that Congress set forth in § 907 of the
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`TCA—they are both “standards” that manufacturers have to meet in making their
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`“product[s].” The first product standard states that “a cigarette or any of its
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`component parts (including the tobacco, filter, or paper) shall not contain, as a
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`constituent (including a smoke constituent) or additive, an artificial or natural flavor
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`(other than tobacco or menthol) or an herb or spice.” Id. § 387g(a)(1)(A) (emphasis
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`added). This regulates the contents of cigarettes by dictating what manufacturers can
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`put in cigarettes. The second product standard provides that a “tobacco product
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`manufacturer shall not use tobacco . . . that contains a pesticide chemical residue
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`that is” greater than a specifi