Petition for Writ of Certiorari — R.J. Reynolds Tobacco Company, et al., Petitioners v. County of Los Angeles, California, et al.

Supreme Court briefOct 7, 2022

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APPENDIX

TABLE OF CONTENTS

Page

APPENDIX A: Opinion of the United States

Court of Appeals for the Ninth Circuit

(Mar. 18, 2022) ................................................. 1a

APPENDIX B: Order of the United States

District Court for the Central District

of California Granting Defendants’

Motion to Dismiss and Denying

Plaintiffs’ Motion for Summary

Judgment as Moot (Aug. 7, 2020) .................. 49a

APPENDIX C: Order of the United States

District Court for the Central District of

California Denying Plaintiffs’ Motion for

Preliminary Injunction (July 13, 2020) ......... 55a

APPENDIX D: Order of the United States

Court of Appeals for the Ninth Circuit

Denying Rehearing (May 11, 2022) ............... 73a

APPENDIX E: Statutory Provisions

Food, Drug, and Cosmetic Act (FDCA)

FDCA § 301, 21 U.S.C. § 331 .................... 75a

FDCA § 900, 21 U.S.C. § 387 .................... 89a

FDCA § 901, 21 U.S.C. § 387a .................. 95a

FDCA § 902, 21 U.S.C. § 387b .................. 98a

FDCA § 907, 21 U.S.C. § 387g ................ 100a

FDCA § 910, 21 U.S.C. § 387j ................. 112a

FDCA § 916, 21 U.S.C. § 387p ................ 124a

TABLE OF CONTENTS

(continued)

Page

Los Angeles County Code of Ordinances

L.A. Cnty. Code § 7.83.020 ..................... 126a

L.A. Cnty. Code § 11.35.020 ................... 129a

L.A. Cnty. Code § 11.35.070 ................... 135a

APPENDIX A

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

R.J. REYNOLDS TOBACCO

COMPANY; AMERICAN SNUFF

COMPANY; SANTA FE NATURAL

TOBACCO COMPANY, INC.,

Plaintiffs-Appellants,

No. 20-55930

D.C. No.

2:20-cv-04880DSF-KS

COUNTY OF LOS ANGELES;

COUNTY OF LOS ANGELES BOARD

OF SUPERVISORS; HILDA L. SOLIS;

MARK RIDLEY-THOMAS; SHEILA

KUEHL; JANICE HAHN; KATHRYN

BARGER, each in his or her

official capacity as a member of

the Board of Supervisors,

OPINION

Defendants-Appellees.

Appeal from the United States District Court

for the Central District of California

Dale S. Fischer, District Judge, Presiding

Argued and Submitted October 19, 2021

Pasadena, California

Filed March 18, 2022

Before: Ryan D. Nelson and Lawrence VanDyke,

Circuit Judges, and Karen E. Schreier,*

District Judge.

Opinion by Judge VanDyke;

Dissent by Judge Nelson

SUMMARY**

Preemption / Tobacco Control Act

The panel affirmed the district court’s dismissal of

an action brought by tobacco companies, alleging that

the Family Smoking Prevention and Tobacco Control

Act (“TCA”) preempts the County of Los Angeles’s ban

on the sale of all flavored tobacco products.

The panel held that the TCA authorizes the Food

and Drug Administration to regulate tobacco products

and expressly preempts some contrary state or local

regulations, while also expressly preserving and

saving from preemption other state and local

regulatory authority over tobacco. The panel held

that the TCA’s text, framework, and historical context

reveal that it carefully balances federal and local

power by carving out the federal government’s sole

authority to establish the standards for tobacco

products, while preserving state, local, and tribal

The Honorable Karen E. Schreier, United States District

Judge for the District of South Dakota, sitting by designation.

This summary constitutes no part of the opinion of the

court. It has been prepared by court staff for the convenience of

the reader.

authority to regulate or ban altogether sales of some

or all tobacco products.

The panel wrote that the TCA’s “unique tripartite

preemption structure” governed its analysis. The

TCA includes a “preservation clause,” which preserves

state, local, and tribal power to enact any regulation

concerning tobacco products that is “in addition to or

more stringent” than those promulgated by the TCA.

The TCA’s preemption clause reads as follows: “No . . .

political subdivision of a State may establish or

continue in effect with respect to a tobacco product

any requirement which is different from, or in

addition to, any requirement under the provisions of

[the TCA] relating to tobacco product standards,

premarket review, adulteration, misbranding,

labeling, registration, good manufacturing standards,

or modified risk tobacco products.” An immediately

following savings clause instructs that the preemption

clause “does not apply to requirements relating to the

sale, distribution, possession, information reporting to

the State, exposure to, access to, the advertising and

promotion of, or use of, tobacco products by

individuals of any age, or relating to fire safety

standards for tobacco products.”

The panel held that, properly understood, the TCA’s

preemption clause does not preclude non-federal sales

regulations such as the County’s sales ban. But even

if it did, the County’s sales ban would nonetheless be

exempted from preemption because it falls within that

clause’s text as an allowed local requirement relating

to the sale of tobacco products. Either way, the TCA

does not expressly preempt the County’s sales ban.

The panel also held that, because the TCA explicitly

preserves local authority to enact more stringent

regulations than the TCA, the County’s sales ban does

not pose an impermissible obstacle to the TCA’s

purposes or objectives regarding flavored tobacco.

Accordingly, the County’s sales ban is neither

expressly nor impliedly preempted.

Dissenting, Judge R. Nelson wrote that because Los

Angeles’s ban falls within the TCA’s preemption

clause and is neither preserved nor saved, he would

hold that it is expressly preempted. Judge R. Nelson

wrote that the ban fell within the preemption clause

because it was a requirement different from or in

addition to any TCA requirement relating to tobacco

product standards, which can relate both to

manufacturing and to sales. Judge R. Nelson wrote

that, by its terms, the preservation clause does not

apply to the preemption clause, but rather clarifies

that no other provision of the statute has any

preemptive effect and that the authorities of federal

agencies and Indian tribes are not preempted by the

TCA. Finally, Judge R. Nelson would hold that the

savings clause only saves for states the authority to

enact age requirements.

COUNSEL

Noel J. Francisco (argued), Christian G. Vergonis,

Ryan J. Watson, and Andrew J. M. Bentz, Jones Day,

Washington, D.C.; Jason C. Wright, Jones Day, Los

Angeles, California; for Plaintiffs-Appellants.

Kent R. Raygor (argued) and Valerie E. Alter,

Sheppard Mullin Richter & Hampton LLP, Los

Angeles, California, for Defendants-Appellees.

Cory L. Andrews and John M. Masslon II, Washington

Legal Foundation, Washington, D.C., for Amicus

Curiae Washington Legal Foundation.

Rob Bonta, Attorney General; Renu R. George, Senior

Assistant Attorney General, Nicholas M. Wellington

and James V. Hart, Supervising Deputy Attorneys

General; Peter F. Nascenzi, Deputy Attorney General;

Office of the Attorney General, Sacramento,

California; for Amicus Curiae State of California.

Jordan Raphael, Byron Raphael LLP, Los Angeles,

California; Dennis A. Henigan, Campaign for

Tobacco-Free Kids, Washington, D.C.; for Amici

Curiae Public Health and Medical Organizations.

Rachel Bloomekatz, Columbus, Ohio, for 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.

OPINION

VANDYKE, Circuit Judge:

I. INTRODUCTION

Until just over a decade ago, tobacco products were

regulated almost exclusively by the states and local

governments, with little federal involvement. Then

beginning in the late 1990’s, the U.S. Food and Drug

Administration first sought to exert federal regulatory

authority over such products. This initial attempt

was swiftly rebuffed by the Supreme Court, which

concluded the FDA lacked that authority under thenexisting statutes. See FDA v. Brown & Williamson

Tobacco Corp., 529 U.S. 120, 126 (2000). In response,

Congress passed the Family Smoking Prevention and

Tobacco Control Act (“TCA”), Pub. L. No. 111-31, 123

Stat. 1776 (2009), codified at 21 U.S.C. § 387 et seq.,

which authorized the FDA to regulate tobacco

products and expressly preempted some contrary

state or local regulations, while also expressly

preserving and saving from preemption other state

and local regulatory authority over tobacco.

The boundary between the TCA’s preemption

clause and its preservation and savings clauses is the

subject of the dispute in this case. The County of Los

Angeles claims that the TCA’s preservation and

savings clauses permit its decision to ban the sale of

all flavored tobacco products. Predictably, multiple

tobacco companies have challenged the County’s ban,

arguing that the TCA’s preemption clause both

expressly and impliedly preempts the ban.

The TCA’s unique tripartite preemption structure

governs our analysis of these issues.

Its text,

framework, and historical context reveal that it

carefully balances federal and local power by carving

out the federal government’s sole authority to

establish the standards for tobacco products, while

preserving state, local, and tribal authority to

regulate or ban altogether sales of some or all tobacco

products. Properly understood, the TCA’s preemption

clause does not preclude non-federal sales regulations

such as the County’s sales ban challenged in this case.

But even if it did, the County’s sales ban would

nonetheless be exempted from preemption by the

TCA’s savings clause because it easily falls within

that clause’s text as an allowed local “requirement[]

relating to the sale . . . of[] tobacco products.” 21

U.S.C. § 387p(a)(2)(B). Either way, the TCA does not

expressly preempt the County’s sales ban. And given

that the TCA explicitly preserves local authority to

enact “more stringent” regulations than the TCA, the

County’s sales ban does not pose an impermissible

obstacle to the TCA’s purposes or objectives regarding

flavored tobacco. It is therefore neither expressly nor

impliedly preempted, and we affirm the district court.

II. BACKGROUND

1. States and Localities Historically Possessed

Broad Power to Regulate and Ban Tobacco

Products.

The TCA’s tripartite preemption provision can be

properly understood only against the historical

backdrop of states and localities’ longstanding role as

the primary regulators of tobacco products. See

Stewart v. Dutra Const. Co., 543 U.S. 481, 487 (2005)

(interpreting a federal statute by looking to the

“backdrop against which Congress” acted). Over a

century ago, the Supreme Court first recognized that

states, because of public health concerns, could

prohibit the sale of cigarettes. See Austin v. State of

Tennessee, 179 U.S. 343, 348–49 (1900) (“[W]e think it

within the province of the legislature to say how far

[cigarettes] may be sold, or to prohibit their sale

entirely . . . provided no discrimination be used . . . and

there be no reason to doubt that the act in question is

designed for the protection of the public health.”). In

the intervening century, and in response to growing

awareness of the harmful effects of cigarettes,

Congress enacted various statutory provisions

focusing on consumer education through advertising

and labeling requirements.

See, e.g., Federal

Cigarette Labeling and Advertising Act (“FCLAA”),

Pub. L. No. 89-92, 79 Stat. 282 (1965) (codified as

amended at 15 U.S.C. §§ 1331–1341), see also Graham

v. R.J. Reynolds Tobacco Co., 857 F.3d 1169, 1186–87

(11th Cir. 2017) (en banc) (surveying the development

of federal tobacco laws).1 But these federal statutes

See also Public Health Cigarette Smoking Act of 1969, Pub.

L. No. 91-222, 84 Stat. 87; Alcohol and Drug Abuse Amendments

of 1983, Pub. L. No. 98-24, 97 Stat. 175; Comprehensive Smoking

Education Act of 1984, Pub. L. No. 98-474, 98 Stat. 2200 (1984);

Comprehensive Smokeless Tobacco Health Education Act of

1986, Pub. L. No. 99-252, 100 Stat. 30. While “the ADAMHA

Reorganization Act, Pub. L. No. 102-321, 106 Stat. 323 (1992),

condition[ed] certain block grants on states making it unlawful

for any manufacturer, retailer, or distributor of tobacco products

to sell or distribute any such product to any individual under the

age of 18,” Graham, 857 F.3d at 1187 (citation and internal

quotation marks omitted), the strings attached to federal grants

did not preempt state or local authority from regulating the sale

or ban of these products; quite the opposite, they strongly

incentivized states to exercise their traditional authority over

tobacco-related sales. See 42 U.S.C. § 300x-26.

never preempted state and localities’ traditional

power to restrict or ban sales of tobacco products. See

id.

During this period, states also played key roles in

indirectly regulating tobacco products through

litigation. In the 1990s, after numerous heads of

major tobacco companies denied under oath the

addictiveness of nicotine, several states sued their

companies. See Regulation of Tobacco Products

(Part 1): Hearings Before the Subcomm. on Health &

the Env’t, 103d Cong. 628 (1994); Barry Meier,

Remaining States Approve the Pact on Tobacco Suits,

N.Y. TIMES, Nov. 21, 1998, at A1. The lawsuits

resulted in a “landmark agreement” between the

tobacco companies and the states, where the

companies agreed to monetary payments and

permanent injunctive relief. See Lorillard Tobacco v.

Reilly, 533 U.S. 525, 533 (2001).

Meanwhile, states continued to enact laws

regulating the sale and use of cigarettes and tobacco

products, including imposing numerous restrictions

on tobacco sales.2 These restrictions included, for

See, e.g., Stop Tobacco Access to Kids Enforcement

(“STAKE”) Act, 1994 Cal. Stat. 1009 (codified at Cal. Bus. & Prof.

Code §§ 22950–64) (including mandates such as “no cigarette or

tobacco product shall be sold, offered for sale, or distributed from

a vending machine or appliance, or any other coin or token

operated mechanical device designed or used for vending

purposes, id. § 22960(a)); see also Cigarette and Tobacco

Products Licensing Act of 2003 (codified at Cal. Bus. & Prof. Code

§§ 22970–22995)

(requiring

licensing

throughout

the

distribution chain from manufacturer to retailer); Cal. Rev. &

Tax. Code §§ 30131–30131.6 (significantly increasing the state’s

cigarette and tobacco taxes to fund, in part, anti-smoking

efforts).

10a

example, prohibitions on sales of tobacco products in

vending machines and near schools. See Paul A.

Diller, Why Do Cities Innovate in Public Health?

Implications of Scale and Structure, 91 Wash. U. L.

Rev 1219, 1231–35 (2014) (discussing state and local

bans of flavored cigarettes passed before the TCA).

Some localities even banned sales of cigarettes and

vape products entirely from retail stores. See, e.g.,

Manhattan Beach, Cal., Ordinance 20-0007. Because

the FDA lacked authority to regulate tobacco products

until Congress enacted the TCA in 2009,3 the history

of tobacco regulation is, until recently, one of state and

local action.

2. The TCA Continued to Preserve State and

Local Power Over Tobacco Sales.

Given this extensive background of state and local

tobacco regulation, it would have been surprising if

Congress had broadly jettisoned the longstanding

tradition of states and localities’ role in the regulation

of sales of tobacco products when it enacted the TCA

in 2009. The text of the TCA itself demonstrates that

it did not. Instead, Congress made an “explicit

decision to preserve for the states a robust role in

regulating, and even banning, sales of tobacco

See R.J. Reynolds Tobacco Co. v. City of Edina, 482 F.

Supp. 3d 875, 880–81 (D. Minn. 2020) (observing that the TCA

“was partly a response to the FDA’s earlier unsuccessful attempt

to assert jurisdiction over tobacco products in order to enact agespecific tobacco regulations” (citing Brown & Williamson

Tobacco Corp., 529 U.S. at 125–26)); see also U.S. Smokeless

Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329, 336

(S.D.N.Y. 2010) (same).

11a

products.” U.S. Smokeless Tobacco Mfg. Co. v. City of

New York, 708 F.3d 428, 436 (2d Cir. 2013).

Specifically, the TCA sought to “authorize the

[FDA] to set national standards controlling the

manufacture of tobacco products and the identity,

public disclosure, and amount of ingredients used in

such products.” Pub. L. No. 111-31, 123 Stat. 1778

(2009) (emphasis added). In doing so, the TCA

balances state and federal power over tobacco

regulation by way of a unique three-layered

preservation provision.4 The first clause of the

provision, labeled the preservation clause, broadly

preserves state, local, and tribal power to enact any

regulation concerning tobacco products that is “in

addition to or more stringent” than those promulgated

by the TCA:

Except as provided in [the preemption clause],

nothing in this subchapter, or rules promulgated

under this subchapter, shall be construed to limit

Because this is a case about preemption, it is easy to refer

to 21 U.S.C. § 387p of the TCA as a “preemption provision.” But

it is more properly characterized as a “preservation provision.”

While § 387p does contain the preemption clause that forms the

basis of Appellants’ challenge to the County’s ban (see id.

§ 387p(a)(2)(A)), that preemption clause is sandwiched between

two clauses that expressly preserve and exempt from preemption

broad non-federal regulatory authority over tobacco products (see

id. §§ 387p(a)(1), (a)(2)(B)). Indeed, even the title of § 387p

(“Preservation of State and Local Authority”) evinces its

predominant purpose to preserve rather than preempt nonfederal regulatory authority. This overall structure of the TCA’s

“preservation provision” cannot be overemphasized, and as

discussed further below, distinguishes the TCA’s preemption

clause from dissimilar provisions in other federal statutes

considered by the Supreme Court.

12a

the authority of a . . . political subdivision of a

State . . . to enact, adopt, promulgate, and enforce

any law, rule, regulation, or other measure with

respect to tobacco products that is in addition to,

or more stringent than, requirements established

under this subchapter, including a law, rule,

regulation, or other measure relating to or

prohibiting the sale, distribution, possession,

exposure to, access to, advertising and promotion

of, or use of tobacco products by individuals of

any age, information reporting to the State, or

measures relating to fire safety standards for

tobacco products. No provision of this subchapter

shall limit or otherwise affect any State, tribal, or

local taxation of tobacco products.

21 U.S.C. § 387p(a)(1) (emphasis added).

particular relevance here, the TCA expressly reserves

localities’ ability to enact any regulations “relating to

or prohibiting the sale . . . or use of tobacco products

by individuals of any age.” Id.5

There is a scrivener’s error in both the TCA’s preservation

and savings clauses. Both clauses contain similar statements

allowing nonfederal laws “relating to or prohibiting the sale . . .

or use of tobacco products by individuals of any age.” Id.

§ 387p(a)(1) (emphasis added); see also id. § 387p(a)(2)(B)

(similar). The drafters of these clauses used the preposition “by”

in the last prepositional phrase “by individuals of any age,”

presumably because the preposition “by” matches the closest

object (“use”) in the preceding series of objects (thus, “use . . . by

individuals of any age”). But while the preposition “by” makes

sense for some of the other objects in the series (e.g.,

“possession . . . by individuals of any age”), it doesn’t make sense

for others, such as “sale” (it should be “sale . . . [to] individuals of

any age”) or “advertising and promotion” (“advertising and

13a

The TCA then immediately follows its broad

preservation clause with a preemption clause that

expressly overrides the preservation clause in the case

of any conflict between the two provision’s terms. The

preemption clause reads:

No . . . political subdivision of a State may

establish or continue in effect with respect to a

tobacco product any requirement which is

different from, or in addition to, any requirement

under the provisions of this subchapter relating

to tobacco product standards, premarket review,

adulteration, misbranding, labeling, registration,

good manufacturing standards, or modified risk

tobacco products.

Id. § 387p(a)(2)(A) (emphasis added). While the TCA

does not explicitly define “tobacco product standards,”

it uses that phrase elsewhere in the TCA when

referring to various characteristics of tobacco

products, such as “the construction, components,

ingredients, additives, constituents . . . and properties

of the tobacco products” (among other references). See

id. § 387g(a)(4)(B)(i). It also uses the phrase broadly

encompassing

some

federal

“sale

and

distribution . . . restrict[ions],” id. § 387g(a)(4)(B)(v)—

including the federal ban on most flavored cigarettes,

id. § 387g(a)(1)(A)—as well as tobacco labeling

requirements. Id. § 387g(a)(4)(C).

Immediately following the TCA’s preemption

clause, a savings clause then excepts various broadly

defined categories from preemption.

See id.

promotion . . . [to] individuals of any age”). Correcting for this

drafting error, we replace the word “by” with a bracketed “[to]”

in subsequent quotations in this opinion where appropriate.

14a

§ 387p(a)(2)(B).

Specifically, the savings clause

instructs that the preemption clause

does not apply to requirements relating to the

sale, distribution, possession, information

reporting to the State, exposure to, access to, the

advertising and promotion of, or use of, tobacco

products by individuals of any age, or relating to

fire safety standards for tobacco products.

Id. § 387p(a)(2)(B).

3. Los Angeles County Banned the Sale of

Flavored Tobacco Products.

In September 2019, as part of amendments to its

business licenses and health and safety code, Los

Angeles County joined at least three states and over

300 local jurisdictions across the country by enacting

a prohibition on the sale of flavored tobacco products.

The County’s ordinance reads:

[I]t shall be a violation of this Chapter for a

tobacco retailer/licensee or its agent(s) or

employee(s) to sell or offer for sale, or to possess

with the intent to sell or offer for sale, any

flavored tobacco product or any component, part,

or accessory intended to impart, or imparting a

characterizing flavor in any form, to any tobacco

product or nicotine delivery device, including

electronic smoking devices.

LOS ANGELES COUNTY, CAL., CODE § 11.35.070(E)

(2019); see also CTFK, Fact Sheet (Oct. 23, 2020),

https://perma.cc/JGX3-3VZP. The ordinance defines

“flavored tobacco product” as “any tobacco product, as

defined in this Chapter, which imparts a

characterizing flavor.” Id. § 11.35.020(J). It further

defines “characterizing flavor” as “a taste or aroma,

15a

other than the taste or aroma of tobacco, imparted

either prior to or during consumption of a tobacco

product.” Id. § 11.35.020(C). The ordinance therefore

only permits the sale of tobacco products with either

the taste or aroma of tobacco, or no taste or aroma at

all. See id.

4. The District Court Dismissed Appellants’

Case.

Appellants R.J. Reynolds Tobacco Company,

American Snuff Company, LLC, and Santa Fe

Natural Tobacco Company, Inc. (Appellants) sued the

County of Los Angeles and various County officials

(Appellees), alleging that the TCA expressly and

impliedly preempts the County’s ordinance. The

district court first denied Appellants’ motion for a

preliminary injunction, finding that they were not

likely to succeed on the merits of their claims. It then

subsequently granted Appellees’ Rule 12(b)(6) motion,

incorporating the reasoning from its denial of the

preliminary injunction. It also denied Appellants’

motion for summary judgment as moot. Judgment

was later entered, and Appellants appeal that

judgment.

III. JURISDICTION AND

STANDARD OF REVIEW

“We have appellate jurisdiction under 28 U.S.C.

§ 1291.” Kashem v. Barr, 941 F.3d 358, 369 (9th Cir.

2019). “A dismissal for failure to state a claim

pursuant to Federal Rule of Civil Procedure 12(b)(6)

is reviewed de novo.” Marder v. Lopez, 450 F.3d 445,

448 (9th Cir. 2006). “We [also] review de novo a

district court’s application of preemption principles.”

16a

U.S. Smokeless Tobacco Mfg. Co., 708 F.3d at 432

(citation omitted).

IV. DISCUSSION

“The Supremacy Clause provides that the laws of

the United States ‘shall be the supreme Law of the

Land . . . any Thing in the Constitution or Laws of any

State to the Contrary notwithstanding.’” Gonzalez v.

Arizona, 677 F.3d 383, 391–92 (9th Cir. 2012) (en

banc) (quoting U.S. Const. art. VI, cl. 2). “Under our

system of dual sovereignty, courts deciding whether a

particular state law is preempted under the

Supremacy Clause must strive to maintain the

delicate balance between the States and the Federal

Government, especially when Congress is regulating

in an area traditionally occupied by the States.” Id.

(citations and internal quotation marks omitted).

The TCA’s text, framework, and historical context

reflect its attempt to strike such a balance. Its unique

preemption structure gives the federal government

exclusive power to set “tobacco product standards,”

while preserving state, local, and tribal authority to

regulate or ban sales of those products altogether.

Consistent with this structure, it would be a mistake

to read “tobacco product standards” in the TCA’s

preemption clause so broadly as to encompass the type

of sales ban challenged in this case—particularly

since the TCA both expressly preserves and exempts

from preemption local authority over that exact type

of regulation. The preemption clause therefore does

not cover the County’s sales ban. But even if it did,

the savings clause “saves” it from preemption because

a sales ban qualifies as a “requirement[] relating to

the sale” of tobacco products.

17a

We therefore hold that TCA does not expressly

preempt the County’s sales ban. And given that

Congress explicitly preserved local authority to enact

the very type of sales ban at issue here, we also reject

Appellants’ claim of implied preemption.

1. The TCA Does Not Expressly Preempt the

County’s Sales Ban.

The TCA’s text, structure, and historical context

precludes express preemption in this case. “Where, as

here, Congress has specifically addressed the

preemption issue, our task is primarily one of

interpreting what Congress has said on the subject.”

U.S. Smokeless Tobacco Mfg. Co., 708 F.3d at 432.6

The parties dispute whether a presumption against

preemption applies, but the Supreme Court has already

determined that if a “statute contains an express pre-emption

clause, we do not invoke any presumption against pre-emption

but instead focus on the plain wording of the clause, which

necessarily contains the best evidence of Congress’ pre-emptive

intent.” Puerto Rico v. Franklin California Tax-Free Tr.

(Franklin), 579 U.S. 115, 125 (2016) (citation and internal

quotation marks omitted); see also Int’l Bhd. of Teamsters, Loc.

2785 v. Fed. Motor Carrier Safety Admin., 986 F.3d 841, 853 (9th

Cir. 2021) (relying on Franklin in determining that the existence

of an express presumption clause negated any presumption

against preemption); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th

Cir. 2016) (same). Appellees argue that these cases suggest that

only unambiguous express preemption clauses override the

presumption. But this runs counter to Franklin, where the

majority and dissent’s debate over the scope of the preemption

clause at issue in that case demonstrates that it was not, in fact,

unambiguous.

See 579 U.S. at 135–37 (Sotomayor, J.,

dissenting). Appellees also rely on two post-Franklin cases from

our court that rely on the presumption of preemption when

evaluating an express preemption clause. See Miller v. C.H.

18a

We “begin with the wording of [the TCA’s

preemption provision], but we must also consider the

statute as a whole to determine whether the local

ordinance actually conflicts with the overall federal

regulatory scheme.” Id. (citation omitted); see also

Brown & Williamson Tobacco Corp., 529 U.S. at 133

(“It is a fundamental canon of statutory construction

that the words of a statute must be read in their

context and with a view to their place in the overall

statutory scheme.” (citation and internal quotation

marks omitted)).

In interpreting statutes

wholistically, we must strive to “giv[e] effect to each

word and mak[e] every effort not to interpret a

provision in a manner that renders other provisions of

the same statute inconsistent, meaningless or

superfluous.” Shelby v. Bartlett, 391 F.3d 1061, 1064

(9th Cir. 2004) (citation omitted). We also “assum[e]

that the ordinary meaning of that language accurately

expresses the legislative purpose.” Engine Mfrs. Ass’n

v. S. Coast Air Quality Mgmt. Dist., 541 U.S. 246, 252

(2004) (citation omitted).

The Preemption Clause Doesn’t Cover the

County’s Sales Ban.

Applying these well-established principles, we first

conclude that the phrase “tobacco product standards”

in the TCA’s preemption clause does not encompass

the County’s sales ban.

Robinson Worldwide, Inc., 976 F.3d 1016, 1021 (9th Cir. 2020);

California Ins. Guarantee Ass’n v. Azar, 940 F.3d 1061, 1067 (9th

Cir. 2019). But the parties in both of those cases failed to address

Franklin. Pursuant to Franklin and our court’s application of

Franklin, therefore, our focus is on the meaning of the TCA’s text

without any presumptive thumb on the scale.

19a

We begin with the text of all three adjacent

clauses—preservation, preemption, and savings—

considered together. In § 387p of the TCA, the initial

preservation clause broadly preserves state, local, and

tribal authority to enact a variety of regulations that

are “in addition to, or more stringent than” the TCA’s

requirements. See 21 U.S.C. § 387p(a)(1). While

under the TCA the federal government sets the

regulatory floor, the plain text of the preservation

clause allows state, local, and tribal governments to

go beyond that, including even “prohibiting the sale . . .

of tobacco products [to] individuals of any age.” Id.

(emphasis added).

The subsequent preemption clause then carves out

eight limited exceptions to the preservation clause,

each of which relates most obviously to the production

or marketing stages—and not the retail sale—of

tobacco products:

“tobacco product standards,

premarket review, adulteration, misbranding,

labeling, registration, good manufacturing standards,

or modified risk tobacco products.” Id. § 387p(a)(2)(A).

For example, the TCA describes “adulteration” in

terms of various issues that could arise during the

manufacturing or marketing stages. See id. § 387b.

Similarly, “registration” requires that “every person

who owns or operates any establishment in any State

engaged

the

manufacture,

preparation,

compounding, or processing of a tobacco product or

tobacco products shall register with the Secretary the

name, places of business, and all such establishments

of that person.” Id. § 387e(b) (emphasis added). And

to qualify as a “modified risk tobacco product,” details

about the manufacturing and marketing processes

must be provided. See id. § 387k(d).

20a

While the TCA does not explicitly define “tobacco

product standards,” it describes that phrase in terms

of the manufacturing and marketing stages. See e.g.,

§ 387g(a)(4)(B)(i)

(requiring

tobacco

product

standards to include, where appropriate, “provisions

respecting the construction, components, ingredients,

additives, constituents, including smoke constituents,

and properties of the tobacco product”). Consistent

with its surrounding categories, it makes sense to

view “tobacco product standards” in the TCA’s

preemption clause as most naturally referring to

standards pertaining to the production or marketing

stages up until the actual point of sale. See Rizo v.

Yovino, 950 F.3d 1217, 1224 (9th Cir. 2020) (en banc)

(noting the “well-settled rule[] of statutory

construction” that “words grouped together should be

given similar or related meaning to avoid giving

unintended breadth to the Acts of Congress” (citation

and internal quotation marks omitted)).

This is not to say that the phrase “tobacco product

standards” is incapable of being read more broadly.

Since the phrase is not defined by the TCA, it could in

theory conceivably encompass essentially anything

and everything related to tobacco products that might

influence how they are produced. For example,

“tobacco product standards” could encompass

“labeling,” since how tobacco products must be labeled

will, no doubt, affect how they are produced. Indeed,

as noted above, the TCA itself “include[s]” labeling

under the “tobacco product standards” that the FDA

is elsewhere empowered to regulate.

See id.

§ 387g(a)(4)(C).

But reading “tobacco product standards” in the

preemption clause so capaciously runs immediately

21a

into several textual problems. First, the preemption

clause itself lists “labeling” as a separate preempted

category, which would be redundant if “tobacco

product standards” in that same clause was meant to

have its broadest possible interpretation.

Second, reading “tobacco product standards” as

covering any non-federal regulations that even

indirectly affect such standards would render much of

the preceding preservation clause a nullity. Every

state or local regulation “relating to or prohibiting the

sale . . . of tobacco products” (preservation clause) can

be said to “relate to tobacco product standards”

(preemption clause) in some indirect way. If Congress

had meant to broadly preempt all such state and local

sales regulations or bans via the ambiguous “tobacco

product standards” language in the preemption

clause, why would it have “preserved” to states and

localities that authority in the very proceeding

provision?

In short, reading “tobacco product

standards” in the TCA’s preemption clause broadly

creates superfluity problems in both the TCA’s

preemption clause and its preservation clause,

whereas reading “tobacco product standards” in the

preemption clause more narrowly avoids these

interpretive problems.

The savings clause immediately follows the

preemption clause and “except[s]” broad categories

from preemption, including “requirements relating to

the sale . . . of[] tobacco products [to] individuals of any

age.” Id. § 387p(a)(2)(B). In doing so, the TCA

reinforces what it first established in the preservation

clause: that the regulation and prohibition of tobacco

product sales falls squarely within the purview of

states, localities, and tribal entities. The savings

22a

clause also solidifies the narrower interpretation of

“tobacco product standards” discussed above. If

“tobacco product standards” was to be interpreted as

broadly encompassing (and therefore preempting)

states and localities’ laws “relating to or prohibiting

the sale” of tobacco products, then one must assume

that Congress (1) included a superfluous

“preservation” of states and localities’ ability to

regulate sales, while simultaneously (2) taking away

their ability to do just that in the preemption clause,

while also simultaneously (3) giving back their ability

to do just that in the savings clause when it broadly

“except[ed]” from the preemption clause any state or

local “requirements relating to the sale” of tobacco

products. That tortured path is avoided only by

reading the preemption clause’s “tobacco product

standards” as not reaching state and local sales bans.

In short, the TCA’s text sandwiches limited

production and marketing categories of preemption

between clauses broadly preserving and saving local

authority, including any “requirements relating to the

sale” of tobacco products. This unique “preservation

sandwich” enveloping the TCA’s preemption clause

reveals a careful balance of power between federal

authority and state, local, and tribal authority,

whereby Congress has allowed the federal

government to set the standards regarding how a

product would be manufactured and marketed, but

has left states, localities, and tribal entities the ability

to restrict or opt out of that market altogether. We

are not alone in reaching this interpretation of the

TCA’s unique preemption structure: when evaluating

whether the TCA preempted a local ordinance

prohibiting the sale of flavored tobacco products

23a

except in tobacco bars, the Second Circuit similarly

determined that the TCA’s preemption provision

“distinguishes between manufacturing and the retail

sale of finished products; it 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 in the absence of conflicting

federal regulation.” U.S. Smokeless Tobacco Mfg. Co.,

708 F.3d at 434.

This interpretation is consistent with the historical

“backdrop against which Congress” acted in enacting

the TCA. See Stewart, 543 U.S. at 487. As previously

noted, the states and localities have historically

played a primary role in regulating the sale of tobacco

products. And after the Supreme Court over a century

ago explicitly ruled that states have the power to opt

out of the tobacco product market, none of the

subsequent federal enactments have stripped

localities of this power. The TCA effectively carves out

federal power from a historical body of state and local

authority by setting the floor for production and

marketing standards, while still preserving states

and localities’ broad power over regulation of the sales

of those products. The County’s sales ban fits

comfortably within the historical authority of states,

localities, and tribal entities that Congress clearly

preserved in the TCA’s preservation sandwich.

Appellants’ arguments to the contrary are

unpersuasive. The crux of Appellants’ argument is

that the County’s sales ban qualifies as the

“paradigmatic tobacco product standard” and

therefore falls under the preemption clause. But not

only does this interpretation contravene the TCA’s

24a

text, framework, and historical context for the reasons

just articulated, it also nullifies key aspects of the

preservation clause and undermines the commonly

understood meaning of the phrase “product standard.”

First, as already discussed, interpreting “tobacco

product standards” to encompass the County’s sales

ban at issue here renders meaningless the

preservation clause’s “preservation” of localities’

authority to “prohibit sales.” Under Appellants’ broad

interpretation of “tobacco product standards,” it is

hard to imagine any sales prohibition—which the

preservation clause expressly preserves—that would

not be preempted under the preemption clause. It is

unlikely that Congress would purport to preserve

something for state and local authority, only to

preempt it in the very next provision. “Such a broad

reading of the preemption clause, which collapses the

distinction between sales and product regulations,

would render superfluous [the preservation statute]’s

three-part structure, and in particular would vitiate

the preservation clause’s instruction that the [TCA]

not be ‘construed to limit the authority of a State or

political subdivision of a State to enact and enforce

any measure prohibiting the sale of tobacco

products.’” U.S. Smokeless Tobacco Mfg. Co., 708 F.3d

at 434 (quoting 21 U.S.C. § 387p(a)(1)) (alteration

marks omitted).

“Because statutes should be

construed, if possible, to give effect to every clause and

word,” we agree with our sister circuit and “adopt a

narrower reading of the preemption clause that also

gives effect to the preservation clause.” Id. (internal

citations and alterations omitted).

Second, Appellants’ interpretation unnecessarily

trades the most common and natural understanding

25a

of “product standards” for the broadest interpretation

possible. While there can be a relationship between

product standards and sales bans, we must not lose

sight that they are, in fact, different things. A total

ban on all tobacco products would not naturally be

characterized as merely a “tobacco product standard.”

Compare Ban, Merriam-Webster’s Dictionary Online,

https://www.merriam-webster.com/dictionary/ban

(last visited Dec. 26, 2021) (“to prohibit especially by

legal means”), with Standard, Merriam-Webster’s

Dictionary

Online,

https://www.merriamwebster.com/dictionary/standard

(last

visited

Dec. 26, 2021) (“a level of quality, achievement, etc.

that is considered acceptable or desirable”); see also

United States v. Carter, 421 F.3d 909, 911 (9th Cir.

2005) (“[A] fundamental canon of statutory

construction is that, unless otherwise defined, words

will be interpreted as taking their ordinary,

contemporary, common meaning.”

(citation and

internal quotation marks omitted)); United States v.

TRW Rifle 7.62X51mm Caliber, One Model 14 Serial

593006, 447 F.3d 686, 689 (9th Cir. 2006) (recognizing

“the common practice of consulting dictionary

definitions to clarify [statutory terms’] ordinary

meaning” (citation omitted)).

While regulations

regarding the length or diameter of a cigarette are

easily considered a “product standard,” for example,

banning the sale of cigarettes over a certain length or

diameter is just as obviously not directly a regulation

of a tobacco product standard. It is merely banning

the sale of a certain type of tobacco product, not

dictating how that product must be produced.

It is true that the Supreme Court has repeatedly

found that a state or local sales ban can run afoul of

26a

the preemptive force of a federal product standard,

because in some cases the sales ban undermined the

federal standards protected by broad federal

preemption clauses. See Nat’l Meat Ass’n v. Harris,

565 U.S. 452, 455 (2012); Engine Mfrs. Ass’n, 541 U.S.

246, 252 (2004). Appellants lean heavily on these two

cases, arguing that the County’s sales ban is similarly

doomed by the TCA’s preemption of state or local

tobacco product standards. But neither National

Meat nor Engine Manufacturers considered anything

like the preservation sandwich included in the TCA.

In National Meat, the Supreme Court held that the

Federal Meat Inspection Act (FMIA), which “regulates

the inspection, handling, and slaughter of livestock for

human consumption,” expressly preempted a

California law that prohibited the buying or selling of

nonambulatory animals (i.e., animals that cannot

walk). 565 U.S. at 455, 458–59.7 In doing so, the

Court emphasized that “[t]he FMIA’s preemption

clause sweeps widely.” Id. at 459. It therefore

rejected the respondent’s attempted distinction

between sales bans and the meat production process.

Instead, the Court reasoned that “the sales ban . . .

functions as a command to slaughterhouses to

structure their operations in the exact way the

remainder of [the California law] mandates.” Id. at

464. “[I]f the sales ban were to avoid the FMIA’s

While the FMIA’s preemption provision included a savings

clause, this clause did not save states’ ability to regulate sales.

See id. at 458 n.3 (“The preemption provision also includes a

saving clause, which states that the Act ‘shall not preclude any

State . . . from making requirement[s] or taking other action,

consistent with this [Act], with respect to any other matters

regulated under this [Act].” (quoting 21 U.S.C. § 678)).

27a

preemption clause,” it explained, “then any State

could impose any regulation on slaughterhouses just

by framing it as a ban on the sale of meat produced in

whatever way the State disapproved. That would

make a mockery of the FMIA’s preemption provision.”

Id. Notably, nothing in the FMIA’s preemption

provision expressly preserved or saved states or

localities’ authority to regulate sales. See 21 U.S.C.

§ 678. And whereas the Supreme Court in National

Meat saw no distinction between a sales ban and the

production process in that case, in this case Congress

has statutorily recognized precisely that distinction

when it expressly preempted non-federal “tobacco

product standards,” while in the same statutory

section expressly preserved and exempted from

preemption state and local “requirements relating

to . . . sale[s].”

Like it did in National Meat, the Supreme Court

also rejected an attempted distinction between

general production processes and sales bans when

interpreting the Clean Air Act (CAA)’s preemption

provision in Engine Manufacturers. 541 U.S. at 253–

55. The CAA’s preemption provision provided that

“[n]o State or any political subdivision thereof shall

adopt or attempt to enforce any standard relating to

the control of emissions from new motor vehicles or

new motor vehicle engines subject to this part.” 541

U.S. at 252 (quoting 42 U.S.C. § 7543(a)). The local

regulation challenged in Engine Manufacturers

“prohibit[ed] the purchase or lease by various public

and private fleet operators of vehicles that do not

comply with stringent emission requirements.” Id. at

248.

The respondents argued that the CAA’s

preemption provision’s reference to “standards” only

28a

referred to “a production mandate that requires

manufacturers to ensure that the vehicles they

produce have particular emissions characteristics,

whether individually or in the aggregate.” Id. at 253

(citation and internal alteration omitted). But the

Court rejected this argument, reasoning in part that

“[t]he language of [the CAA’s preemption provision] is

categorical. It is . . . impossible to find in it an

exception for standards imposed through purchase

restrictions

rather

than

directly

upon

manufacturers.” Id. at 256; see also id. at 255

(concluding that “treating sales restrictions and

purchase restrictions differently for pre-emption

purposes” had “no basis in the text of the statute”).

The Court ultimately “decline[d] to read into [the

preemption provision] a purchase/sale distinction that

is not to be found in the text of [the preemption

provision] or the structure of the CAA.” Id. at 255.

The TCA includes a fundamentally different

preemption provision than either of the provisions

considered by the Supreme Court in National Meat

and Engine Manufacturers. Neither of the federal

statutes in those cases sandwiched their preemption

clause between preservation and savings clauses that

explicitly and repeatedly reiterated local authority

over product sales. Unlike the preemption provisions

considered in those cases—which the Supreme Court

characterized

“sweep[ing]

widely”

and

“categorical”—the TCA’s plain text distinguishes

between tobacco product standards and state or local

regulation of the final sale of tobacco products,

preempting the former while allowing the latter.

National Meat and Engine Manufacturers are

inapposite and don’t control this case. Rather than

29a

following precedent interpreting very different federal

statutory language, we must instead be guided by the

TCA’s unique text, framework, and history.

Alternatively, the Savings Clause Saves

the County’s Sales Ban from Preemption.

Even if we read “tobacco product standards” as

broadly as Appellants urge and therefore concluded

that the County’s sales ban fell within the text of the

TCA’s preemption clause, the ban would still be

“except[ed]” from preemption by the TCA’s savings

clause. A ban on the sale of flavored tobacco products

is, simply put, a requirement that tobacco retailers or

licensees throughout the County not sell flavored

tobacco products. It therefore fits within the savings

clause as a “requirement[] relating to the sale . . . of[]

tobacco products [to] individuals of any age.” 21

U.S.C.A. § 387p(a)(2)(B).

Appellants nevertheless contend that the savings

clause doesn’t apply. They first argue that the savings

clause only saves sales requirements, not sales

prohibitions, from preemption. In support, they

contrast the saving clause’s omission of the phrase “or

prohibiting” with the preservation clause’s inclusion

of that phrase.

Compare id. § 387p(a)(2)(B)

(“requirements relating to the sale . . . of[] tobacco

products”), with id. § 387p(a)(1) (“requirements . . .

relating to or prohibiting the sale . . . of tobacco

products”) (emphasis added). To give meaning to both

phases, Appellants argue, the saving clause’s

omission of the word “prohibiting” must mean that

state and local governments can broadly impose sales

“requirements,” but must stop short of “prohibiting”

the sale of any tobacco products. Appellants conclude

30a

by claiming that a holding otherwise would render the

preemption clause a “dead letter,” by allowing states

and localities the ability to indirectly regulate tobacco

product standards by simply banning any disapproved

products.

The problem with Appellants’ argument is that the

preemption clause also omits the word “prohibiting.”

Like the savings clause, the preemption clause simply

references “any requirement . . . relating to tobacco

products standards.” Id. § 387p(a)(2)(A). So if

Appellants are correct that § 387p draws a sharp

distinction between “prohibitions” versus mere

“requirements relating to the sale . . . of[] tobacco

products,” then the plain text of the preemption clause

itself doesn’t preempt any tobacco product

“prohibitions.” See R.J. Reynolds Tobacco Co. v. City

of Edina, 482 F. Supp. 3d 875, 881–82 (D. Minn. 2020)

(rejecting the same argument on similar rationale);

see also U.S. Smokeless Tobacco Mfg. Co. v. City of

New York, No. 09-10511, 2011 WL 5569431, at *7

(S.D.N.Y. Nov. 15, 2011) (rejecting a similar argument

and concluding that “as the Preemption Clause is

itself silent regarding sales prohibitions, it seems far

more likely that prohibitions are preserved and never

preempted, and therefore need never be saved”), aff’d,

708 F.3d 428 (2d Cir. 2013).

Appellants attempt to avoid the textual import of

their argument by parsing out the preemption clause’s

use of the word “any,” such that the preemption

clause’s reference to “any requirement . . . relating to

tobacco products standards” means that it also

includes prohibition-type requirements. But aside

from injecting an enormous amount of hidden

meaning into the word “any,” this argument runs into

31a

the same problem as Appellants’ “tobacco products

standards” argument:

if the preemption clause

preempts all state and local regulations prohibiting

the sale of tobacco products, then the preservation

clause’s preservation of those exact prohibitions is

rendered entirely superfluous. Because “[w]e avoid

statutory interpretations that render entire sections

of the statute superfluous,” United States v. Leon H.,

365 F.3d 750, 753 (9th Cir. 2004), we decline to assign

different meanings to the preemption and saving’s

clause use of word “requirement.”

Appellants’

the-County-may-regulate-but-notprohibit-sales argument would also create a

hopelessly inadministrable standard.

Appellants

concede that “state and local governments retain their

broad, traditional power to regulate the sale of tobacco

products”—which would include “restrictions on

where products may be sold (e.g., not near schools)”—

but argue that the “one thing they cannot do is

prohibit the sale of those products.” But as other

courts have observed, “it would be nearly impossible

to distinguish a permissible ‘restriction’ from an

impermissible ‘prohibition’” because “[n]early any

regulation can be characterized as a ‘prohibition,’

including the . . . restrictions that [Appellants]

contend are within the meaning of the word

‘requirement.’” City of Edina, 482 F. Supp. 3d at 881

n.4. For example, a restriction on sales of tobacco

products near schools, which Appellants concede is

permissible, can easily be characterized as a

prohibition of tobacco sales in a specified area (which,

by way of banning such sales only throughout the

County, is exactly what the County’s sales ban does

here).

Or by way of another example, under

32a

Appellants’ interpretation of the savings clause, a city

could impose a 105-year-old minimum age

“requirement” for purchases of flavored tobacco

products, which would lead to effectively the same

result as the County’s sales ban.

Because

“prohibitions” can almost always be practically

achieved by mere well-crafted partial “regulations,” it

makes little sense to interpret the savings clause as

drawing the amorphous line that Appellants urge.

“We must avoid an interpretation that would produce

absurd results,” United States v. LKAV, 712 F.3d 436,

444 (9th Cir. 2013) (citation and internal quotation

marks omitted), and the better understanding is that

Congress intended to allow the federal government

the sole authority to set tobacco product standards,

while retaining for states and localities their

longstanding authority to say: “not here.”

Nor is Appellants’ “dead letter” argument

persuasive. Even though the preemption clause does

not preempt sales bans, it’s hardly useless. It still

preempts states from setting actual product

standards. A state cannot require tobacco companies

to make their products according to any particular

standard—only the federal government can do that.

But a state can place restrictions on the retail sale of

a tobacco product, including banning its sale

altogether. In other words, as noted above, the

balance of power struck by the TCA allows state and

local governments to opt out of the market, but it

doesn’t allow them to otherwise set parameters for

that market that conflict with the federal

government’s tobacco product standards. That is the

“delicate balance” established by Congress in § 387p’s

unique preservation sandwich.

33a

Appellants finally argue that the savings clause’s

reference to “individuals of any age” limits the scope

of the clause to age-based requirements. But “[a]s

other courts have noted, [Appellants]’ interpretation

turns the plain meaning of this phrase on its head.”

City of Edina, 482 F. Supp. 3d at 880. The actual text

of the phrase reveals the opposite of Appellants’

interpretation. “Of any age” suggests that state and

local governments are not limited to enacting only

age-based rules, but rather can enact regulations for

people “of any age”—in other words, for everyone. See

U.S. Smokeless Tobacco Mfg. Co., 703 F. Supp. 2d at

345 (“Indeed, read literally, the saving clause does not

relate to the sale or distribution of tobacco products to

anyone at all—only by anyone—and that ‘anyone’ can

be a person of any age.”).

Appellants argue that this interpretation renders

the phrase superfluous, but it actually clarifies that

states and local governments are not limited to

enacting regulations tied to certain age ranges. This

makes sense given the TCA’s framework and

historical context, where the TCA preserved state,

local, and tribal authority to enact regulations “in

addition to, or more stringent than, requirements . . .

relating to or prohibiting the sale . . . of tobacco

products,” 21 U.S.C. § 387p(a)(1), and where the

federal government had previously attempted to

assert jurisdiction over tobacco products to enact agespecific tobacco regulations. See Brown & Williamson

Tobacco Corp., 529 U.S. at 125–26 (holding that FDA,

which had promulgated regulations to reduce tobacco

use among children and adolescents, lacked

jurisdiction to regulate tobacco products). In other

words, the TCA expressly preserves local authority to

34a

enact more stringent requirements than the federal

government, which had a history of attempting to

target specific ages when enacting tobacco

regulations. Because the County banned the sale of

flavored tobacco products to all individuals “of any

age,” the savings clause squarely applies.

Appellants’ superfluity argument suffers from

another flaw, which is that adding “individuals of any

age” to pretty much any statutory text will in some

respects always be superfluous. For example, if a

statute prohibits “driving cars without a license,”

adding “by individuals of any age” to the prohibition

technically does nothing because nothing in the basic

prohibition itself indicates it is age-limited. But a

legislature might add such “superfluous” language to

the prohibition if it is concerned that something about

the history of such prohibitions could tempt courts to

read into the prohibition an implicit age restriction.

That best explains why § 387p repeatedly clarifies

that the powers preserved to non-federal governments

are not age-restricted, particularly since so much

historic tobacco product regulation has involved age

restrictions.

2. The TCA Does Not Impliedly Preempt the

Sales Ban.

Finally, the TCA also does not impliedly preempt

the County’s sales ban. Appellants argue that the

County’s sales ban poses an obstacle to the FDA’s

current judgment that menthol cigarettes should

remain on the market. “[O]bstacle preemption occurs

when a state law stands as an obstacle to the

accomplishment and execution of the full purposes

and objectives of Congress.” Chamber of Com. of

35a

United States v. Bonta, 13 F.4th 766, 774 (9th Cir.

2021) (citation and internal quotation marks omitted).

With implied preemption, “we start with the

assumption that the historic police powers of the

States are not preempted unless that was the clear

and manifest purpose of Congress.” In re Volkswagen

“Clean Diesel” Mktg., Sales Pracs., & Prod. Liab.

Litig., 959 F.3d 1201, 1212 (9th Cir. 2020) (citation

and internal quotation marks omitted). Courts also

“give[] great weight to Congress’ inclusion of a

provision preserving states’ enforcement authority.”

Id. at 1213.

Here, while the TCA permitted the FDA to enact

future regulations upon making certain findings, see

21 U.S.C. § 387g(a)(3)(A)–(B), it did not mandate that

certain tobacco flavors must remain available for sale.

And while the TCA bans all cigarette flavors except

menthol and tobacco, id. § 387g(a)(1)(A), it nowhere

prohibits states from going further. To the contrary,

as discussed above, the preservation clause explicitly

allows states, localities, and tribal entities to enact

regulations “more stringent than” the TCA’s

requirements—including regulations “relating to or

prohibiting the sale . . . of tobacco products.” Id.

§ 387p(a)(1). Given that the TCA does not mandate

that certain flavors must remain available for sale,

and expressly preserves local authority to enact sales

regulations more stringent than the TCA, the

County’s sales ban does not “stand[] as an obstacle to

the accomplishment and execution of the full purposes

and objectives of Congress” expressed in the TCA.

Chamber of Com. of United States, 13 F.4th at 774

(citation omitted). It is therefore not impliedly

preempted.

36a

V. CONCLUSION

For the reasons stated herein, the County of Los

Angeles’s ban on the sale of flavored tobacco products

is neither expressly nor impliedly preempted by the

Tobacco Control Act.

The district court is

AFFIRMED.

R. NELSON, Circuit Judge, dissenting:

Twice we have been reversed for interpreting an

express preemption clause to allow states and

municipalities to defeat its entire purpose with a sales

ban. Still, the majority thinks that this time is

different, in particular because this statute has a

preservation clause and a savings clause. But those

clauses can’t get the majority where it needs to go.

The Tobacco Control Act’s (TCA’s) preservation clause

does not limit the preemption clause at all. Instead,

it clarifies that no other section of the statute (or

regulation promulgated under it) has a preemptive

effect and that federal agencies (including the armed

forces) and Indian tribes are unaffected by the

preemption clause. And the savings clause only

allows states to enact age bans.

Because Los

Angeles’s ban falls within the preemption clause and

is neither preserved nor saved, I would hold that it is

expressly preempted.1

We GRANT Appellees’ unopposed request for judicial

notice.

I agree with the majority that there is no presumption

against express preemption, and that the ban is not impliedly

preempted.

37a

In the last two decades, the Supreme Court has

twice reversed us for failing to find California

regulations expressly preempted. Engine Mfrs. Ass’n

v. S. Coast Air Quality Mgmt. Dist., 541 U.S. 246

(2004); Nat’l Meat Ass’n v. Harris, 565 U.S. 452 (2012).

In Engine Manufacturers, Los Angeles’s Air Quality

Management District required public and private

fleet operators to purchase cars which met certain

emission specifications. See 541 U.S. at 248–49. The

manufacturers sued and argued that the rule was

preempted by the Clean Air Act, see id., which says

that states cannot adopt “standard[s] relating to the

control of emissions from new motor vehicles,” 42

U.S.C. § 7543(a).

Los Angeles argued that a “standard” was only “a

production mandate” that required manufacturers to

do certain things, and thus that its purchase

requirement was not preempted because it was not a

standard but a sales regulation. 541 U.S. at 254–55.

The Supreme Court soundly rejected the argument,

reasoning that “a standard is a standard even when

not

enforced

through

manufacturer-directed

regulation.” Id. at 254. Los Angeles’s rule didn’t

regulate car manufacturers directly, but by banning

the sale of cars made in some ways, it effectively

forced manufacturers to make cars in certain other,

state-approved ways. Id. Even though it did not

regulate manufacturers directly, the Supreme Court

held that it was a standard all the same. Id.

The Supreme Court built on this reasoning in

National Meat, 565 U.S. at 452–68. In that case,

California banned slaughterhouses from selling meat

38a

from animals that could no longer walk. Id. at 455.

Meat manufacturers argued that the law was

preempted by the Federal Meat Inspection Act

(FMIA), which prohibits states from adopting

“requirements within the scope of [the FMIA] with

respect to premises, facilities and operations of any

establishment at which inspection is provided

under . . . [the FMIA] which are in addition to, or

different than those made under [the FMIA].” Id. at

458; 21 U.S.C. § 678. California argued much Los

Angeles had in Engine Manufacturers—that its rule

only regulated sales, not manufacturing, and thus

was not preempted. Nat’l Meat, 565 U.S. at 463. The

Supreme Court again soundly rejected the argument.

Rather than read it as just an “incentive” or

“motivator,” as California had asked it to, the Court

held that the sales ban “instead functions as a

command to slaughterhouses to structure their

operations in the exact way” provided for by the law.

Id. at 463–64. The Court further reasoned that if a

ban like this were not preempted, then “any State

could impose any regulation on slaughterhouses just

by framing it as a ban on the sale of meat produced in

whatever way the State disapproved,” which “would

make a mockery of the FMIA’s preemption provision.”

Id. at 464.

Of course, these cases and this case each deal with

a different express preemption provision. But the

import of Engine Manufacturers and National Meat is

clear. When Congress expressly preempts state

regulation, states can’t get around Congress’s

prohibition by disguising that type of regulation as a

sales ban.

39a

Engine Manufacturers and National Meat require

us to hold that Los Angeles’s ban is covered by the

preemption clause. Still, the majority, relying on the

TCA’s preservation clause and savings clause, holds

that this case is different. It is not. I first explain why

the ban is covered by the preemption clause, and then

explain why the ban is neither preserved nor saved.

The TCA’s preemption clause provides that “[n]o

State or political subdivision of a State may establish

or continue in effect with respect to a tobacco product

any requirement which is different from, or in

addition to, any requirement under the provisions of

[the TCA] relating to tobacco product standards.” 21

U.S.C. § 387p(a)(2)(A). Whether Los Angeles’s ban is

preempted thus depends on whether it is a

requirement different from or in addition to any TCA

requirement relating to tobacco product standards. It

is, and the statute itself shows why.

The TCA provides that no cigarette shall have any

“artificial or natural flavor (other than tobacco or

menthol).” Id. § 387g(a)(1). In the same section, the

statute then calls this requirement a “tobacco product

standard.” Id. § 387g(a)(2). Congress has spoken:

Cigarettes cannot have any flavors except tobacco and

menthol, and that requirement is a tobacco product

standard. In other words, a flavor ban is a tobacco

product standard.

Los Angeles’s sales ban is also a ban aimed at

flavors, but it operates at the point of sale, rather than

at the manufacturing stage. So, if Los Angeles’s ban

is not a tobacco product standard, it must be because

40a

tobacco product standards can relate only to

manufacturing, and not to sales.

The problem for Los Angeles is that the Supreme

Court has already rejected that argument. See Engine

Mfrs., 541 U.S at 254. The majority holds that tobacco

product standards are only about what can happen at

the manufacturing process, not afterwards. But that’s

exactly the argument that the Supreme Court has

twice rejected. Of course, the statute in Engine

Manufacturers was not the TCA. But it used the same

term—“standard”—and just like the statute at issue

there, nothing in the TCA expressly limits tobacco

product standards to manufacturing.

So tobacco product standards can be aimed at the

manufacturing stage or the sales stage. The TCA

itself contains a flavor ban aimed at the

manufacturing stage and calls it a tobacco product

standard. That flavor ban is a tobacco product

standard, so Los Angeles’s ban of sales of certain

flavors must be a tobacco product standard, too.

Since Los Angeles’s ban is itself a tobacco product

standard, the only remaining question is whether Los

Angeles’s ban is a requirement with respect to a

tobacco product “which is different from, or in addition

to, any requirement under the provisions of [the TCA]

relating to tobacco product standards.” 21 U.S.C.

§ 387p(a)(2)(A). It is.

There’s no dispute that Los Angeles’s ban is

different from or in addition to the TCA’s flavor ban.

And the TCA’s flavor ban is related to tobacco product

standards, because it is one. So our inquiry is limited

to whether Los Angeles’s ban and the TCA’s tobacco

product standard are “requirements.” I would hold

41a

that they are, for three reasons. First, the majority

and Los Angeles both concede that the sales ban is a

requirement, for the purpose of the savings clause,

and I agree with the majority that the word should

keep the same meaning across different subsections.

Second, it would be incongruous to read the

preemption clause to cover all requirements relating

in any way to tobacco product standards, but then not

to cover tobacco product standards themselves. And

third, National Meat itself held that a sales ban can

be a preempted requirement. 565 U.S. at 459–64.

Several other courts have interpreted these

provisions of the TCA. None of them have adopted the

majority’s reading. The majority reasons that it is

“not alone” because the Second Circuit adopted a

similar analysis.

Majority at 21–22; see U.S.

Smokeless Tobacco Mfg. Co. v. City of New York, 708

F.3d 428, 434 (2d Cir. 2013). But the Second Circuit

upheld a more limited regulation that still allowed

sales of flavored tobacco, and just required that they

take place in tobacco bars. Id. at 431. That court did

adopt a version of the majority’s sales vs.

manufacturing distinction, but in doing so, it was

careful to avoid implying that a complete sales ban

would be permissible. Id. at 436. I agree with the

Smokeless Tobacco court that a regulation of how

sales may take place is not a tobacco product

standard. But a flavor ban remains a preempted

tobacco product standard even if it operates at the

point of sale. And the Edina court forcefully rejected

the majority’s analysis, reasoning that courts

adopting the manufacturing vs. sales distinction had

“provided little in the way of justification” and even

sometimes “little more than ipse dixit.” R.J. Reynolds

42a

Tobacco Co. v. City of Edina, 482 F. Supp. 3d 875, 878

(D. Minn. 2020). I agree.

In reaching the opposite conclusion, distinguishing

Engine Manufacturers and National Meat, and

holding that Los Angeles’s ban is not covered by the

preemption clause, the majority first relies heavily on

the preservation clause. But the majority ignores the

plain language of that clause. By its terms, the

preservation clause does not apply to the preemption

clause at all. Instead, it has three separate functions,

none of which affect the preemption clause.

First, the preservation clause begins with the words

“[e]xcept as provided in paragraph (2)(A),” which is

the preemption clause. The preservation clause then

preserves state authority from all sections elsewhere

in the TCA. The preemption clause has no qualifier.

Because it is qualified by the preemption clause, the

preservation clause preserves nothing that falls

within the preemption clause; it is a command that

other sections of the TCA do not have any preemptive

effect.

Second, unlike the other two clauses, the

preservation clause also refers to “rules promulgated

under the [TCA].” 21 U.S.C. § 387p(a)(1). The second

function of the preservation clause is to prohibit

regulations from having any preemptive effect.

Third, unlike the preemption and savings clauses,

the preservation clause applies not just to states and

political subdivisions of states, but also to federal

agencies (including the armed forces) and the

governments of Indian tribes.

Because the

preemption and savings clauses apply only to states

43a

and political subdivisions, the preservation clause

thus clarifies that federal agencies and Indian tribes

are not preempted from doing anything at all.

The majority declines to adopt my reading of the

preemption clause, arguing that it would make the

preservation clause “a nullity.” Majority at 20. But

my interpretation does no such thing.

The

preservation clause has three important functions: It

“clears the field” for the preemption clause by

clarifying that neither other sections of the TCA nor

regulations pursuant to the TCA can have a

preemptive effect, and it applies to federal agencies

and the governments of Indian tribes. My reading of

the preemption clause does not disturb these

functions.

Having dealt with the preservation clause, the

majority’s argument now hangs just on the savings

clause. While a closer call than the preservation

clause, the savings clause can’t bear the majority’s

argument either.

The savings clause saves from preemption

“requirements relating to the sale, distribution,

possession, information reporting to the State,

exposure to, access to, the advertising and promotion

of, or use of, tobacco products by individuals of any

age.” 21 U.S.C. § 387p(a)(2)(B). The question is thus

whether Los Angeles’s ban is a “requirement[]

relating to the sale . . . of tobacco products [to]

44a

individuals of any age.” Id.2 I would hold that it is

not. The savings clause only saves for states the

authority to enact age requirements. Any other

reading makes the clause “[to] individuals of any age”

superfluous.

First, “a statute should not be construed so as to

render any of its provisions mere surplusage.” United

States v. Wenner, 351 F.3d 969, 975 (9th Cir. 2003).

But that’s exactly how the majority construes the TCA

here. If “[to] individuals of any age” allows any kind

of ban, then Congress should have just left the entire

phrase out, because it adds nothing. The savings

clause would read just as well without the phrase: it

would cover, in relevant part, “requirements relating

to the sale of[] tobacco products.”

21 U.S.C.

§ 387p(a)(2)(B) (altered to omit “by individuals of any

age”). Plus, if Congress intended to allow any kind of

ban, and if Los Angeles’s reading is right, then

Congress also might as well have said, “by individuals

of any hair color” or “by individuals of any religious

persuasion.” Los Angeles’s reading is thus not

permitted.

Second, that “of any age” refers to age bans is

supported by the statutory context. One of Congress’s

main priorities in passing the TCA was addressing

underage smoking. See Tobacco Control Act, Pub. L.

No. 111-31, Div. A, § 2, 123 Stat. 1,781 (2009) (codified

at 21 U.S.C. § 387). But in 2009, many states already

had laws restricting tobacco sales to young adults, not

just minors. See, e.g., S.B. 300, 1997 Sen., Reg. Sess.

I agree with the majority that the clause covers

requirements relating to the sale of tobacco products “to” people

of any age, and not “by” people of any age. Majority at 12 n.5.

45a

(Ala. 1997) (nineteen years old). Congress was

concerned about underage smoking and did not want

to block the states’ efforts to address smoking by

young adults. So when Congress preempted some

tobacco regulation, it made sure to continue to allow

states to set any age restrictions, to avoid interfering

with states’ efforts to combat smoking among young

people generally.

On “of any age,” the Second and First Circuits

adopted the majority’s reading, but their reasoning

was not convincing. In Smokeless Tobacco, when

quoting the TCA’s savings clause, the Second Circuit

just left off the “by individuals of any age” language

entirely. See 708 F.3d at 435. The First Circuit did

the same in National Association of Tobacco Outlets,

Inc. v. City of Providence, 731 F.3d 71, 82 (1st Cir.

2013).

The district court in Edina, on the other hand,

addressed the argument in depth. See 482 F. Supp.

3d at 880–81. But contrary to its holding (“of any age”

allows any ban), its reasoning supports the opposite

outcome. The Edina court pointed first to the

“broader context of the Act,” reflecting that the FDA

had tried before to enact age restrictions, and second

to the “congressional findings memorialized in the

Act, which highlight the problem of tobacco use by

children and adolescents.” Id. The court reasoned

that “[a]gainst this backdrop, Congress would have

reason to emphasize that, although the Act grew out

of concerns over tobacco use by minors, state and local

governments are not limited to enacting age-related

restrictions.” Id. at 881. In support of this point, the

court cited the district court’s opinion in Smokeless

Tobacco, which held that the TCA’s “reference to

46a

‘individuals of any age’ was Congress’[] way of saying

that the carve-outs for state prerogative would not be

limited to enacting laws aimed only at minors.” 482

F. Supp. 3d at 881 (citing 703 F. Supp. 2d 329, 348

(S.D.N.Y. 2010)).

I agree with this reasoning, but it supports the

opposite conclusion. The S.D.N.Y. had it exactly right:

Congress wasn’t limited to saving laws aimed just at

minors.

Rather, it saved age bans aimed at

individuals of any age—minors or adults. That’s why

Congress included the phrase “individuals of any age.”

Congress was focused on smoking by young people

and some states already banned cigarette sales to

young adults. These are reasons to think that

Congress was trying to save only age bans, not other

bans.

The majority avoids my interpretation by arguing

that it leads to an absurd result—that states cannot

ban flavored tobacco products but can simply set a

minimum age of 105. But an age ban with a minimum

age of 105 is not really an age ban; it is, in effect, a

blanket ban. Courts are well-equipped to tell the

difference between a real age ban and a purported age

ban that is really a de facto ban. That the line might

be hard to draw in some hypothetical future case is no

reason to throw the baby out with the bathwater. We

must avoid reading statutes in absurd ways, United

States v. LKAV, 712 F.3d 436, 444 (9th Cir. 2013)

(citation and internal quotation marks omitted), but

no canon of statutory interpretation requires us to

avoid any reading of a statute under which one can

craft an absurd argument.

47a

III

To sum up, first, the preservation clause does not

affect the preemption clause. Instead, it clarifies that

no other provision of the statute (or regulation made

under it) has any preemptive effect. It also clarifies

that the authorities of federal agencies and Indian

tribes are not preempted by the TCA. Second, the

preemption clause preempts all requirements

different from or in addition to the TCA’s

requirements relating to tobacco product standards.

That includes Los Angeles’s ban, which is itself a

tobacco product standard enforced at the point of sale.

And third, the savings clause only permits states and

municipalities to enact age bans. Los Angeles’s ban is

thus preempted.

The majority reads these three clauses as a

“preservation sandwich served up by the TCA.”

Majority at 25. But in holding that Los Angeles’s ban

is not preempted, the majority has actually folded

itself into a pretzel. The majority argues that the

preemption clause is “hardly useless,” because the

federal government is still the only one that can

technically set standards. Majority at 30–31. But

under

the

majority’s

reading,

states

and

municipalities can ban anything made with standards

that they don’t like, and thus can “opt out of [the

federal standards]” entirely. Id. This is the very

reasoning that the Supreme Court says “make[s] a

mockery” of a preemption clause. Nat’l Meat, 565 U.S.

at 464. By construing the TCA’s preemption clause to

allow sales bans that defeat its entire purpose, the

majority does just that.

48a

I would hold that Los Angeles’s ban is preempted by

the TCA. I thus respectfully dissent.

49a

APPENDIX B

UNITED STATES DISTRICT COURT

CENTRAL DISTRICT OF CALIFORNIA

R.J. REYNOLDS

TOBACCO COMPANY,

et al.,

Plaintiffs,

COUNTY OF LOS

ANGELES, et al.,

Defendants.

CV 20-4880 DSF (KSx)

Order GRANTING

Defendants’ Motion to

Dismiss (Dkt. 33) and

DENYING Plaintiffs’

Motion for Summary

Judgment as Moot

(Dkt. 32)

Defendants move to dismiss the complaint in its

entirety. Dkt. 33 (Mot.). Plaintiffs oppose, Dkt. 37

(Opp’n), and move for summary judgment, Dkt. 32-1

(MSJ). The Court deems this matter appropriate for

decision without oral argument. See Fed. R. Civ. P.

78; Local Rule 7-15. For the reasons stated below,

Defendants’ motion to dismiss is GRANTED and

Plaintiffs’ motion for summary judgment is DENIED

as moot.

I. BACKGROUND

Los Angeles County Code Section 11.35 (the

Ordinance) regulates the sale of tobacco.

Amendments to the Ordinance were passed at the

September 24, 2019 County Board of Supervisors

meeting and became effective on May 1, 2020. See

Dkt. 1 (Compl.) ¶¶ 22, 28. The Ordinance prohibits

tobacco retailers from “sell[ing] or offer[ing] for sale,

or . . . possess[ing] with the intent to sell or offer for

50a

sale, any flavored tobacco product or any component,

part, or accessory intended to impart, or imparting a

characterizing flavor in any form, to any tobacco

product or nicotine delivery device, including

electronic smoking devices.” Id. § 11.35.070(E). A

“Flavored Tobacco Product” is defined as “any tobacco

product . . . which imparts a characterizing flavor.” Id.

§ 11.35.020(J). A “tobacco product” is “[a]ny product

containing, made, or derived from tobacco or nicotine,”

including cigarettes, and “[a]ny electronic smoking

device that delivers nicotine or other substances,”

including e-cigarettes and vaping devices.

Id.

§ 11.35.020(U)(1)–(2). A “characterizing flavor” is

defined as:

a taste or aroma, other than the taste or aroma of

tobacco, imparted either prior to or during

consumption of a tobacco product or any

byproduct produced by the tobacco product,

including, but not limited to, tastes or aromas

relating to menthol, mint, wintergreen, fruit,

chocolate, vanilla, honey, candy, cocoa, dessert,

alcoholic beverage, herb, or spice. Characterizing

flavor includes flavor in any form, mixed with or

otherwise added to any tobacco product or

nicotine delivery device, including electronic

smoking devices.

Id. § 11.35.020(C).

II. LEGAL STANDARD

“Rule 12(b)(6) allows an attack on the pleadings for

failure to state a claim on which relief can be granted.

“[W]hen ruling on a defendant’s motion to dismiss, a

judge must accept as true all of the factual allegations

contained in the complaint.” Erickson v. Pardus, 551

51a

U.S. 89, 94 (2007) (per curiam). However, a court is

“not bound to accept as true a legal conclusion couched

as a factual allegation.” Ashcroft v. Iqbal, 556 U.S.

662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly,

550 U.S. 544, 555 (2007)). “Nor does a complaint

suffice if it tenders ‘naked assertion[s]’ devoid of

‘further factual enhancement.’” Id. (alteration in

original) (quoting Twombly, 550 U.S. at 557). A

complaint must “state a claim to relief that is

plausible on its face.” Twombly, 550 U.S. at 570. This

means that the complaint must plead “factual content

that allows the court to draw the reasonable inference

that the defendant is liable for the misconduct

alleged.” Iqbal, 556 U.S. at 678. There must be

“sufficient allegations of underlying facts to give fair

notice and to enable the opposing party to defend itself

effectively . . . and factual allegations that are taken

as true must plausibly suggest an entitlement to

relief, such that it is not unfair to require the opposing

party to be subjected to the expense of discovery and

continued litigation.” Starr v. Baca, 652 F.3d 1202,

1216 (9th Cir. 2011).

Ruling on a motion to dismiss will be “a contextspecific task that requires the reviewing court to draw

on its judicial experience and common sense. But

where the well-pleaded facts do not permit the court

to infer more than the mere possibility of misconduct,

the complaint has alleged — but it has not ‘show[n]’

— ‘that the pleader is entitled to relief.’” Iqbal, 556

U.S. at 679 (alteration in original) (citation omitted)

(quoting Fed. R. Civ. P. 8(a)(2)).

As a general rule, leave to amend a complaint that

has been dismissed should be freely granted. Fed. R.

Civ. P. 15(a). However, leave to amend may be denied

52a

when “the court determines that the allegation of

other facts consistent with the challenged pleading

could not possibly cure the deficiency.” Schreiber

Distrib. Co. v. Serv-Well Furniture Co., 806 F.2d 1393,

1401 (9th Cir. 1986).

III. DISCUSSION

A. Express Preemption (Count I)

Plaintiffs allege that the Family Smoking

Prevention and Tobacco Control Act (the FSPTCA), 21

U.S.C. §§ 387–387u, expressly preempts the

Ordinance because it “is ‘different from, or in addition

to,’ the requirements of federal law” “relating to

federal ‘tobacco product standards.’” Compl. ¶ 38. As

set forth in the Court’s Order denying Plaintiffs’

motion for a preliminary injunction, Dkt. 35 (PI

Order), preemption under the FSPTCA is governed by

a Preemption Clause, a Preservation Clause, and a

Savings Clause:

• Preemption Clause. “[W]ith respect to a tobacco

product,”

the

FSPTCA

preempts,

“any

requirement which is different from, or in

addition to, any requirement under the

provisions of this subchapter relating to tobacco

product

standards,

premarket

review,

adulteration, misbranding, labeling, registration,

good manufacturing standards, or modified risk

tobacco products.” 21 U.S.C. § 387p(a)(2)(A).

• Preservation Clause. “Except as provided in [the

Preemption Clause],” the FSPTCA does not limit

the County’s authority to enact requirements

“relating to or prohibiting the sale, distribution,

possession, exposure to, access to, advertising

and promotion of, or use of tobacco products by

53a

individuals of any age, information reporting to

the State, or measures relating to fire safety

standards for tobacco products.” 21 U.S.C.

§ 387p(a)(1).

• Savings Clause. The Preemption Clause “does

not apply to requirements relating to the sale,

distribution, possession, information reporting to

the State, exposure to, access to, the advertising

and promotion of, or use of, tobacco products by

individuals of any age, or relating to fire safety

standards for tobacco products.” 21 U.S.C.

§ 387p(a)(2)(B).

For the reasons stated in the PI Order, id. at 3–12,

the Court concludes that the Ordinance is not

expressly preempted by the FSPTCA because it does

not regulate tobacco product standards and therefore

is protected by the Preservation Clause, which

permits states and localities to prohibit the sale of

tobacco products even if those sales bans are stricter

than federal law. Because this is a question of

statutory interpretation only, the Court concludes

that “the allegation of other facts consistent with the

challenged pleading could not possibly cure the

deficiency.” Schreiber, 806 F.2d at 1401. Therefore,

Count I is DISMISSED with prejudice.

B. Implied Preemption (Count II)

Plaintiffs allege that the Ordinance is also

impliedly preempted because it “undermines the

[FSPTCA’s] ability to set . . . national standards” for

“controlling the manufacture of tobacco products and

the . . . amount of ingredients used in such products,”

Compl. ¶¶ 42–43 (third alteration in original), and

because it “directly conflicts with the federal

54a

government’s ongoing and active efforts to address

flavors in tobacco products,” id. ¶ 46. For the reasons

stated in the PI Order, id. at 12–14, the Court

concludes the Ordinance is not impliedly preempted

by the FSPTCA because the FSPTCA expressly gives

state and local governments the power to prohibit the

sale of tobacco products. That is so even if those sales

bans are stricter than the federal ban, so long as the

regulation does not set a tobacco product standard.

The Court concludes the Ordinance does not. Because

this is a question of statutory interpretation only, the

Court concludes that “the allegation of other facts

consistent with the challenged pleading could not

possibly cure the deficiency.” Schreiber, 806 F.2d at

1401. Therefore, Count II is DISMISSED with

prejudice.

IV. CONCLUSION

Defendants’ motion to dismiss is GRANTED. The

Complaint is DISMISSED with prejudice. Plaintiffs’

motion for summary judgment is DENIED as moot.

IT IS SO ORDERED.

Date: August 7, 2020

Dale S. Fischer

United States District Judge

55a

APPENDIX C

UNITED STATES DISTRICT COURT

CENTRAL DISTRICT OF CALIFORNIA

R.J. REYNOLDS

TOBACCO COMPANY,

et al.,

Plaintiffs,

CV 20-4880 DSF (KSx)

Order DENYING

Plaintiffs’ Motion for

Preliminary Injunction

(Dkt. 17)

COUNTY OF LOS

ANGELES, et al.,

Defendants.

Plaintiffs R.J. Reynolds Tobacco Company,

American Snuff Company, LLC, and Santa Fe

Natural Tobacco Company, Inc. move for an order

enjoining Defendant County of Los Angeles from

enforcing a County ordinance that prohibits the sale

of flavored tobacco products. Dkt. 17-1 (Mot.). The

County opposes. Dkt. 28 (Opp’n). The Court deems

this matter appropriate for decision without oral

argument. See Fed. R. Civ. P. 78; Local Rule 7-15. For

the reasons stated below, the motion is DENIED.

I. BACKGROUND

Los Angeles County Code Section 11.35 (the

Ordinance) regulates the sale of tobacco.

Amendments to the Ordinance were passed at the

September 24, 2019 County Board of Supervisors

meeting, enacted on November 1, 2019, and became

effective on May 1, 2020.

Relevant here, the

Ordinance prohibits tobacco retailers from “sell[ing]

56a

or offer[ing] for sale, or . . . possess[ing] with the intent

to sell or offer for sale, any flavored tobacco product or

any component, part, or accessory intended to impart,

or imparting a characterizing flavor in any form, to

any tobacco product or nicotine delivery device,

including

electronic

smoking

devices.”

Id. § 11.35.070(E). A “Flavored Tobacco Product” is

defined as “any tobacco product . . . which imparts a

characterizing flavor.” Id. § 11.35.020(J). A “tobacco

product” is “[a]ny product containing, made, or

derived from tobacco or nicotine,” including cigarettes,

and “[a]ny electronic smoking device that delivers

nicotine or other substances,” including e-cigarettes

and vaping devices. Id. § 11.35.020(U)(1)–(2). A

“characterizing flavor” is defined as:

a taste or aroma, other than the taste or aroma of

tobacco, imparted either prior to or during

consumption of a tobacco product or any

byproduct produced by the tobacco product,

including, but not limited to, tastes or aromas

relating to menthol, mint, wintergreen, fruit,

chocolate, vanilla, honey, candy, cocoa, dessert,

alcoholic beverage, herb, or spice. Characterizing

flavor includes flavor in any form, mixed with or

otherwise added to any tobacco product or

nicotine delivery device, including electronic

smoking devices.

Id. § 11.35.020(C).

II. LEGAL STANDARD

“A preliminary injunction is an extraordinary

remedy never awarded as a matter of right.” Winter

v. Natural Res. Def. Council, 555 U.S. 7, 24 (2008). “A

plaintiff seeking a preliminary injunction must

57a

establish that he is likely to succeed on the merits,

that he is likely to suffer irreparable harm in the

absence of preliminary relief, that the balance of

equities tips in his favor, and that an injunction is in

the public interest.” Id. at 20. Although a plaintiff

seeking a preliminary injunction must make a

showing on each factor, the Ninth Circuit employs a

“version of the sliding scale” approach where “a

stronger showing of one element may offset a weaker

showing of another.” Alliance for the Wild Rockies v.

Cottrell, 632 F.3d 1127, 1131–35 (9th Cir. 2011).

Under this approach, a court may issue a preliminary

injunction where there are “serious questions going to

the merits and a balance of hardships that tips

sharply towards the plaintiff . . . , so long as the

plaintiff also shows that there is a likelihood of

irreparable injury and that the injunction is in the

public interest.” Id. at 1135 (internal quotation

marks omitted). “When the government is a party, the

last two factors (equities and public interest) merge.”

E. Bay Sanctuary Covenant v. Trump, 950 F.3d 1242,

1271 (9th Cir. 2020).

III. DISCUSSION

Plaintiffs contend that they are likely to succeed on

the merits of their claims that the Ordinance is

unconstitutional under the Supremacy Clause. The

Court disagrees.

Because Plaintiffs have not

established that they are likely to succeed on the

merits or even that there are serious questions going

to the merits, the Court need not consider the other

Winter factors. See Garcia v. Google, Inc., 786 F.3d

733, 740 (9th Cir. 2015) (en banc) (“[W]hen a plaintiff

has failed to show the likelihood of success on the

merits, we need not consider the remaining three

58a

[Winter elements]” (alteration in original) (internal

quotation marks omitted) (quoting Ass’n des Eleveurs

de Canards et d’Oies du Quebec v. Harris, 729 F.3d

937, 944 (9th Cir. 2013))).

A. Express Preemption

Plaintiffs contend that the Family Smoking

Prevention and Tobacco Control Act (the FSPTCA), 21

U.S.C. §§ 387–387u, expressly preempts the

Ordinance because the Ordinance impermissibly

“establishes a state requirement that is ‘different

from’ and ‘in addition to’ federal requirements related

to tobacco product standards.” Mot. at 11. Preemption

under the FSPTCA is governed by a Preemption

Clause, a Preservation Clause, and a Savings Clause:

• Preemption Clause. “[W]ith respect to a tobacco

product,”

the

FSPTCA

preempts,

“any

requirement which is different from, or in

addition to, any requirement under the

provisions of this subchapter relating to tobacco

product

standards,

premarket

review,

adulteration, misbranding, labeling, registration,

good manufacturing standards, or modified risk

tobacco products.” 21 U.S.C. § 387p(a)(2)(A).

• Preservation Clause. “Except as provided in [the

Preemption Clause],” the FSPTCA does not limit

the County’s authority to enact requirements

“relating to or prohibiting the sale, distribution,

possession, exposure to, access to, advertising

and promotion of, or use of tobacco products by

individuals of any age, information reporting to

the State, or measures relating to fire safety

standards for tobacco products.” 21 U.S.C.

§ 387p(a)(1).

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• Savings Clause. The Preemption Clause “does

not apply to requirements relating to the sale,

distribution, possession, information reporting to

the State, exposure to, access to, the advertising

and promotion of, or use of, tobacco products by

individuals of any age, or relating to fire safety

standards for tobacco products.” 21 U.S.C.

§ 387p(a)(2)(B).

Under the Preemption Clause, the first question the

Court must answer is whether the Ordinance relates

to “tobacco product standards.” The FSPTCA has a

section on “Tobacco Product Standards.” 21 U.S.C.

§ 387g. That section sets out two “[s]pecial rules,” id.

§ 387g(a)(1), and then gives the FDA authority to

revise those rules, id. § 387g(a)(2), and adopt

additional tobacco standards, id. § 387g(a)(3). The

first of those special rules is the “Special rule for

cigarettes”

which

prohibits

cigarettes

from

“contain[ing], as a constituent (including a smoke

constituent) or additive, an artificial or natural flavor

(other than tobacco or menthol) . . . .” 21 U.S.C.

§ 387g(a)(1)(A) (the Special Rule). Plaintiffs contend

that “[i]f a ban on all flavored cigarettes except

menthol is a tobacco product standard — indeed, the

paradigmatic example of a tobacco product standard

— then a state law or local ordinance that bans all

flavored tobacco products including menthol is a

tobacco product standard as well.” Mot. at 12; see also

id. at 13 (“at a bare minimum, the County’s ban on

‘menthol cigarettes’ is ‘different from’ and ‘in addition

to’ the Tobacco Control Act’s express allowance

(subject to FDA’s authority) of menthol cigarettes”).

Additionally, future tobacco product standards “shall,

where appropriate for the protection of the public

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health, include . . . provisions respecting the

construction, components, ingredients, additives,

constituents, including smoke constituents, and

properties of the tobacco product.” 21 U.S.C.

§ 387g(a)(4)(B)(i). Plaintiffs note that both “additives”

and “properties” of tobacco products include flavoring.

Mot. at 11 (“‘additives’ include ‘substances intended

for use as a flavoring.’” (quoting 21 U.S.C. § 387(1));

Dkt. 31 (Reply) at 8–9 (“A ‘property’ of a product is an

‘attribute, characteristic, or quality’ of the product”

and “the ‘taste or aroma’ of a product is an ‘attribute,

characteristic, or quality’ of the product.” (first

quoting Oxford English Dictionary, “Property” (2020),

available at https://www.oed.com; then quoting

Webster’s Third New International Dictionary 1818

(1981)).1 Plaintiffs contend that putting all of these

provisions together, “a ‘tobacco product standard’

includes any provision respecting the substances

intended for use as a tobacco-product flavoring.” Mot.

Plaintiffs also point to various advance notices of proposed

rulemaking, and other FDA documents, purportedly

“contemplating the adoption of ‘tobacco product standard[s]’

banning various flavored tobacco products, including menthol

cigarettes and flavored vapor products.” Mot. at 12–13; see also

Reply at 9. For example, in a recently released FDA Guidance

document, the FDA explains that the final guidance “is not

setting tobacco product standards, such as a tobacco product

standard restricting or eliminating the use of flavors in ENDS.”

Mot. at 12–13 (citing FDA, Enforcement Priorities for Electronic

Nicotine Delivery Systems (ENDS) and other Deemed Products

on the Market Without Premarket Authorization 34 (Apr. 2020)).

However, the various FDA documents are not controlling and the

Court concludes that these documents do not require the

Ordinance to be considered a tobacco product standard.

61a

at 11–12.

analysis.

The Court disagrees with Plaintiffs’

The courts to have addressed the preemption of

local flavored tobacco bans have held that the local

ordinances were not preempted. See Nat’l Ass’n of

Tobacco Outlets, Inc. v. City of Providence, R.I., 731

F.3d 71, 85 (1st Cir. 2013); U.S. Smokeless Tobacco

Mfg. Co. LLC v. City of New York, 708 F.3d 428, 436

(2d Cir. 2013); Indeps. Gas & Serv. Stations

Associations, Inc. v. City of Chicago, 112 F. Supp. 3d

749, 754 (N.D. Ill. 2015). The Ordinance at issue here

is more restrictive than the ordinances previously

held not to be preempted. Nevertheless, the Court

finds those cases to be instructive.

In U.S. Smokeless Tobacco, the Second Circuit

concluded that a ban on flavored tobacco products was

not a tobacco product standard because the ordinance

addressed only “whether final tobacco products are

ultimately characterized by — or marketed as having

— a flavor” and “is not easily read to direct

manufacturers as to which ingredients they may or

may not include in their products.” 708 F.3d at 435.

The Second Circuit concluded that so long as a sales

regulation does not “clearly infringe on the FDA’s

authority to determine what chemicals and processes

may be used in making tobacco products,” it is not a

tobacco product standard and is not preempted. Id. at

434. The court of appeals contrasted the Special Rule

that “prohibits manufacturers from producing

cigarettes that contain ‘an artificial or natural flavor’

as a constituent or additive” with the New York

ordinance, which “explicitly does not turn on ‘the use

of additives or flavorings,’ but rather on whether the

product itself imparts ‘a distinguishable taste or

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aroma.’” Id. The Ordinance here also defines

“characterizing flavor” based on “a taste or aroma” —

not constituents or additives. See L.A. Cty. Code

§ 11.35.020(C). The County contends, therefore, that

like the New York ordinance, the Ordinance here “is

not attempting to tell manufacture[r]s how to make

their products. Rather, the Ordinance bans the sale

of a final product, i.e., tobacco products with ‘a taste

or aroma, other than the taste or aroma of tobacco’

regardless of how that taste or aroma comes to be,

which sales regulation the FSPTCA expressly

preserves for state and local governments.” Opp’n at

17–18 (emphases in original). Plaintiffs point out that

“there is only one way a taste or aroma other than the

taste or aroma of tobacco can come to be in a tobacco

product — through an additive.” Reply at 8.

Assuming, without concluding, that this is true, this

fact does not change the analysis of the Second

Circuit, which the Court finds to be persuasive.

Plaintiffs also contend that U.S. Smokeless Tobacco

is distinguishable because the Second Circuit noted

(in dicta) that the ordinance in that case “regulates a

niche product, not a broad category of products such

as cigarettes or smokeless tobacco.” Mot. at 13

(quoting U.S. Smokeless Tobacco, 708 F.3d at 436).

However, this comment did not control the court’s

analysis of whether the ordinance at issue was a

tobacco product standard.

Regardless of which

tobacco products are included and which flavors are

prohibited, the reasoning underlying the Second

Circuit’s opinion remains the same — a sales

ordinance that does not direct manufacturers as to

which ingredients they may or may not include is not

a preempted tobacco product standard. And if an

63a

ordinance is not a product standard, it does not matter

if it is “different from, or in addition to” a federal

product standard.2

Plaintiffs further contend that the Ordinance here,

unlike the ordinance in U.S. Smokeless Tobacco, is

“directed at the manufacturing process” because the

Ordinance “regulates what can be ‘mixed with or

otherwise added to any tobacco product.’” Mot. at 14

(quoting L.A. Cty. Code § 11.35.020(C)). Plaintiffs’

selective quotation is misleading. The entire sentence

says that a “characterizing flavor” can be a “flavor in

any form, mixed with or otherwise added to any

tobacco product or nicotine delivery device, including

electronic smoking devices.” L.A. Cty. Code

Plaintiffs relatedly contend that U.S. Smokeless Tobacco and

National Ass’n are distinguishable because they were not

complete prohibitions on flavored tobacco products, and

therefore appropriately fell into the Savings Clause. Mot. at 18–

19. The New York City ordinance prohibited the sale, “except in

a tobacco bar,” of “any flavored tobacco product,” which was

defined as “any item, not including cigarettes, that contains both

tobacco and ‘a constituent that imparts a characterizing flavor’

. . . ‘other than the taste or aroma of tobacco, menthol, mint or

wintergreen.’” U.S. Smokeless Tobacco, 708 F.3d at 431. The

similar Providence ordinance prohibited the sale, “except in a

smoking bar,” of any “flavored tobacco product,” which “expressly

excludes cigarettes” and includes other tobacco products that

“contain[] a constituent that imparts a characterizing flavor,”

National Ass’n, 731 F.3d at 74 & n.2, except for the “taste or

aroma of tobacco, menthol, mint or wintergreen,” Nat’l Ass’n of

Tobacco Outlets, Inc. v. City of Providence, No. CA 12-96-ML,

2012 WL 6128707, at *8 (D.R.I. Dec. 10, 2012). The County

contends that because the Ordinance does not prohibit tobaccoflavored products, it is not a complete ban either. Opp’n at 20–

21. Because the issue of whether an ordinance is a regulation or

a ban is only potentially relevant to application of the Savings

Clause, the Court does not wade into this dispute.

64a

§ 11.35.020(C). The County notes that “[t]he point of

this clarifying language is . . . to state that the sale of

tobacco products with flavors other than tobacco, no

matter how they are created, and whether nontobacco flavor is added during manufacture or

imparted during consumption, is banned.

The

Ordinance does not make any distinction between

tobacco products with flavors other than tobacco

based on how flavor is added, but rather bans the sale

of them wholesale based on their sensory impact on

the consumer.” Opp’n at 18 (emphasis in original).

The Court agrees and interprets this part of the

definition of “characterizing flavor” only to ensure

that devices that impart flavor “in any form” during

consumption are included in the ban. It does not

address “mixing or adding” constituents or additives

during the manufacturing stage.

Next, Plaintiffs contend that because the FSPTCA

enforces its tobacco product standards “through a ban

on the sale of offending products,” it is no answer to

say that because the Ordinance prohibits sales, it is

not a tobacco product standard. See Mot. at 14. The

Second Circuit persuasively rejected a similar

argument. In U.S. Smokeless Tobacco, the Second

Circuit contrasted the ordinance at issue with the

challenged state law in Nat’l Meat Ass’n v. Harris, 565

U.S. 452 (2012), which “expressly prohibited the sale

of meat that was not produced in accordance with

specific rules to be applied at the slaughterhouse,”3

The Federal Meat Inspection Act preempts any requirements

“with respect to premises, facilities and operations of any

establishment at which inspection is provided under” the act,

such as slaughterhouses. Nat’l Meat, 565 U.S. at 458. The

challenged state law in National Meat prohibited the processing

65a

noting that the flavored tobacco ban “does not concern

itself with the mode of manufacturing, or with the

ingredients that may be included in tobacco products.”

U.S. Smokeless Tobacco, 708 F.3d at 435 n.2. Instead,

because the FSPTCA expressly incorporates a

distinction between sales regulations and “regulation

at the manufacturing stage,” a different result is

warranted. Id. at 434. 4 Holding otherwise would

“render superfluous § 916’s three-part structure, and

in particular would vitiate the preservation clause’s

instruction that the Act not be ‘construed to limit the

authority of . . . a State or political subdivision of a

State . . . to enact . . . and enforce any . . . measure . .

. prohibiting the sale . . . of tobacco products.’”

Id. (alterations in original) (quoting 21 U.S.C.A.

§ 387p(a)(1)); see also Nat’l Ass’n, 731 F.3d at 82, 83

n.10 (holding that a flavored tobacco ban was not a

or selling of meat from nonambulatory animals for human

consumption. Id. at 458–59. The Supreme Court held that

because the sales ban aided other sections of the law that more

directly regulated slaughterhouse operations, and because the

“idea — and the inevitable effect — of the provision is to make

sure that slaughterhouses remove nonambulatory pigs from the

production process,” the sales ban was a preempted regulation of

“how slaughterhouses must deal with non-ambulatory pigs on

their premises.” Id. at 463–64.

The First Circuit also emphasized that the preemption

clause in National Meat “did not contain a savings clause

expressly exempting regulations ‘relating to the sale’ of the

product from preemption,” Nat’l Ass’n, 731 F.3d at 82, and that

the same is true regarding the preemption provision at issue in

Engine Manufacturers Ass’n v. South Coast Air Quality

Management District, 541 U.S. 246 (2004), id. at 83 n.10 (“[T]he

statutory scheme at issue there, like that in National Meat, did

not contain a preservation clause that directly exempted sales

regulations from preemption.”).

66a

“sales restriction[] effectively and impermissibly

impos[ing] a new product or manufacturing standard

in violation of the preemption provision,” noting that

“the distinction between sales and manufacturing

regulations is clearly supported by 21 U.S.C.

§ 387p(a)(1)”); Indeps Gas, 112 F. Supp. 3d at 754 (“an

ordinance that banned tobacco products flavored

using a particular manufacturing process might be

preempted by the FSPTCA,” but the ordinance at

issue “regulates flavored tobacco products without

regard for how they are manufactured . . . and,

accordingly, is exempt from the FSPTCA’s preemption

clause”).

Additionally, as the Second Circuit aptly explained,

the flavored tobacco ban at issue “prohibits the sale of

a recognized category of tobacco products,

characterized by their flavor and marketed as a

distinct product. Plaintiffs’ effort to characterize the

ordinance as a manufacturing standard is

tantamount to describing a ban on cigarettes as a

manufacturing standard mandating that cigars be

manufactured in minimum sizes and with tobacco-leaf

rather than paper wrappings.”

U.S. Smokeless

Tobacco, 708 F.3d at 435 n.2. A prohibition on the sale

of a distinct product is simply not a product standard.5

As the County points out, this conclusion further

distinguishes National Meat because “in that case the

end product — meat — was the same regardless of

whether processed from an ambulatory or

nonambulatory animal.

Thus, the only way to

determine whether a product was banned was to

For this reason, the Court finds Plaintiffs’ parade of

horribles, Mot. at 17, unpersuasive.

67a

consider how it was manufactured.” Opp’n at 19

(emphasis in original). Here, banned products can be

identified based on how they are marketed and sold.

Finally, the Court acknowledges the general

presumption that “when the text of a pre-emption

clause is susceptible of more than one plausible

reading, courts ordinarily ‘accept the reading that

disfavors pre-emption.’” CTS Corp. v. Waldburger,

573 U.S. 1, 19 (2014) (quoting Altria Grp., Inc. v.

Good, 555 U.S. 70, 77 (2008)). “The effect of that

presumption is to support, where plausible, ‘a narrow

interpretation’ of an express pre-emption provision, . .

. especially ‘when Congress has legislated in a field

traditionally occupied by the States[.]’” Id. (first

quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485

(1996); then quoting Altria, 555 U.S. at 77). 6 The

Plaintiffs contend that any presumption against preemption

“has no place” where there is an express preemption clause.

Reply at 7 (quoting Puerto Rico v. Franklin California Tax-Free

Tr., 136 S. Ct. 1938, 1946 (2016)). However, the Supreme Court

in Franklin did not so hold. Rather, it held that it would not

invoke the presumption against preemption where the statute’s

language was plain. Franklin, 136 S. Ct. at 1946. The

presumption addressed above applies where there is ambiguity.

Plaintiffs’ argument assumes the primary disputed issue in this

case — that the Ordinance qualifies as a tobacco product

standard. See Reply at 8. Plaintiffs also note that “[t]he

Supreme Court has ‘repeatedly declined to give broad effect to

saving clauses where doing so would upset the careful regulatory

scheme established by federal law.’” Mot. at 16 (citing Geier v.

Am. Honda Motor Co., 529 U.S. 861, 870 (2000)). This applies

only to the scope of savings clauses, not to the scope of

preemption clauses. And even if it somehow applied here, the

regulatory scheme is not intended to prevent states and localities

from prohibiting the sale of tobacco products, as stated explicitly

by the Preservation Clause.

68a

Supreme Court recognized no later than 1900 that a

“cigarette ban [i]s the type of legislation that states

may enact ‘for the preservation of the public health or

safety’ under their police powers.” Graham v. R.J.

Reynolds Tobacco Co., 857 F.3d 1169, 1190–91 (11th

Cir. 2017) (quoting Austin v. State of Tennessee,

179 U.S. 343, 349 (1900)). Here, to the extent the

Preemption Clause is “susceptible of more than one

plausible reading,” the Court accepts the narrower

plausible interpretation — that the flavored tobacco

ban is not a tobacco product standard. See U.S.

Smokeless Tobacco, 708 F.3d at 433 (2d Cir. 2013) (“if

there is any ambiguity as to whether the local and

federal laws can coexist, we must uphold the

ordinance”); see also U.S. Smokeless Tobacco Mfg. Co.

v. City of New York, No. 09 CIV. 10511 CM, 2011 WL

5569431, at *7 (S.D.N.Y. Nov. 15, 2011) (“[A]s the

Preemption Clause is itself silent regarding sales

prohibitions, it seems far more likely that prohibitions

are preserved and never preempted, and therefore

need never be saved. Insofar as the latter inference is

more consistent with the statute’s language,

structure, and purpose, I opt for it.”).7

Although raised primarily in the context of the Savings

Clause, the Court addresses two additional arguments that could

equally apply to the Preservation Clause. First, Plaintiffs

contend that “the phrase ‘by individuals of any age’ limits the

scope of the saving clause to age-based requirements.” Mot. at

15; see also Reply at 13 (“The preservation clause is also limited

to age-based prohibitions in any event”). The plain meaning of

that phrase is the opposite of what Plaintiffs suggest — states

and localities are free to enact requirements regardless of age.

Rather than being “superfluous,” Reply at 12, the language

emphasizes that regulations are permissible beyond age-based

restrictions. Second, Plaintiffs contend that the Savings Clause

69a

For these reasons, the Court agrees with the First

and Second Circuits that a flavored tobacco ban is not

a regulation of tobacco product standards and

therefore is not preempted. The Court need not decide

whether the Savings Clause would save the

Ordinance if it did regulate tobacco product

standards. The Ordinance may very well have

negative foreseen or unforeseen consequences, not

just on the people who sell flavored tobacco products,

but also on the people who use them. Such concerns

should be directed to the appropriate legislative

bodies. Plaintiffs have not demonstrated serious

questions going to, or a likelihood of success on, the

merits of their express preemption claim.

B. Implied Preemption

Plaintiffs contend that even if the Ordinance is not

expressly preempted, it is “impliedly preempted

because it ‘stands as an obstacle to the

accomplishment and execution of the full purposes

and objectives of Congress.’” Mot. at 22 (citing Crosby

permits only regulations of “the time, place, and manner of the

product’s sale and distribution.” Mot. at 15. Plaintiffs provide

no support for such a claim. Plaintiffs may be importing to the

Savings Clause limitations found in another statute regulating

advertising and labeling: “a State or locality may enact statutes

and promulgate regulations, based on smoking and health, . . .

imposing specific bans or restrictions on the time, place, and

manner, but not content, of the advertising or promotion of any

cigarettes.” 15 U.S.C. § 1334(c). Plaintiffs have provided no

explanation as to why this requirement would apply to sales

regulations under the Savings (or Preservation) Clauses. The

district court in U.S. Smokeless Tobacco convincingly rejected

the argument that there is any “time, place, and manner”

limitation on tobacco product sales regulations. 2011 WL

5569431, at *5.

70a

v. Nat’l Foreign Trade Council, 530 U.S. 363, 373

(2000)). “As with express preemption, courts assume

that the historic police powers of the States are not

superseded unless that was the clear and manifest

purpose of Congress.” Ass’n des Éleveurs de Canards

et d’Oies du Québec v. Becerra, 870 F.3d 1140, 1153

(9th Cir. 2017) (internal quotation marks omitted)

(quoting Arizona v. United States, 567 U.S. 387, 400

(2012)).

First, Plaintiffs contend that the FSPTCA was

adopted to set national standards for the

manufacturing of, and the ingredients in, tobacco

products. Id. Because the Court has concluded that

the Ordinance is neither a manufacturing standard

nor does it regulate the ingredients of tobacco

products, the Ordinance is not an obstacle to this

purpose.

Second, Plaintiffs contend that the Ordinance

“would undermine Congress’s and the FDA’s

judgment that certain flavored tobacco products —

including menthol cigarettes — should remain on the

market.” Id. at 23. However, the FSPTCA expressly

gives state and local governments the power to

prohibit the sale of tobacco products, even if those

sales bans are stricter than the federal ban, so long as

the regulation is not covered by the Preemption

Clause. See U.S. Smokeless Tobacco, 708 F.3d at 433

(“While § 907(d)(3) prohibits the FDA from banning

entire categories of tobacco products throughout the

country, 21 U.S.C. § 387g(d)(3), the FSPTCA nowhere

extends that prohibition to state and local

governments. To the contrary, the preservation

clause of § 916 expressly preserves localities’

traditional power to adopt any ‘measure relating to or

71a

prohibiting the sale’ of tobacco products” (footnote

omitted)); see also Berger v. Philip Morris USA, Inc.,

185 F. Supp. 3d 1324, 1340–41 (M.D. Fla. 2016), aff’d

sub nom. Cote v. R.J. Reynolds Tobacco Co., 909 F.3d

1094 (11th Cir. 2018) (“state-law prohibitions on

cigarette sales can stand side-by-side with the fact

that Congress has tolerated cigarettes and

purposefully refrained from banning them”).8 In fact,

local regulations covered by the Preservation Clause,

like the Ordinance, can promote the purposes and

objectives of the FSPTCA by acting as testing grounds

for new and innovative policies aiming to protect

public health, and particularly the health of underage

purchasers. Therefore, the Ordinance does not stand

as an obstacle to the FSPTCA.

Plaintiffs have not demonstrated serious questions

going to, or a likelihood of success on, the merits of

their implied preemption claim.

IV. CONCLUSION

Plaintiffs’ motion for a preliminary injunction is

DENIED.

The cases cited by Plaintiffs, Reply at 16, largely pre-date the

FSPTCA (and the Preservation Clause) and address only claims

that cigarettes are defectively designed, not state or local power

to enact tobacco product bans. See, e.g., Pooshs v. Philip Morris

USA, Inc., 904 F. Supp. 2d 1009, 1025–26 (N.D. Cal. 2012)

(rejecting contention that cigarettes are defectively designed,

relying in part on Food & Drug Admin. v. Brown & Williamson

Tobacco Corp., 529 U.S. 120 (2000) which held that “[a] ban of

tobacco products by the FDA would therefore plainly contradict

congressional policy.” Id. at 139 (emphasis added)); see also

Graham, 857 F.3d at 1190 (“Although federal agencies have only

the authority granted to them by Congress, states are

sovereign”).

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IT IS SO ORDERED.

Date: July 13, 2020

Dale S. Fischer

United States District Judge

73a

APPENDIX D

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

R.J. REYNOLDS TOBACCO

COMPANY; AMERICAN

SNUFF COMPANY; SANTA

FE NATURAL TOBACCO

COMPANY, INC.,

No. 20-55930

D.C. No. 2:20-cv04880-DSF-KS

Central District

of California,

Plaintiffs-Appellants, Los Angeles

ORDER

COUNTY OF LOS

ANGELES; COUNTY OF

LOS ANGELES BOARD OF

SUPERVISORS; HILDA L.

SOLIS; MARK RIDLEYTHOMAS; SHEILA KUEHL;

JANICE HAHN; KATHRYN

BARGER, each in his or her

official capacity as a member

of the Board of Supervisors,

Defendants-Appellees.

Before: R. NELSON and VANDYKE, Circuit Judges,

and SCHREIER,* District Judge.

Judge Nelson has voted to grant rehearing en banc.

Judge VanDyke has voted to deny rehearing en banc,

and Judge Schreier has recommended to deny the

∗ The Honorable Karen E. Schreier, United States District

Judge for the District of South Dakota, sitting by designation.

74a

same. The full court has been advised of the petition

for rehearing en banc and no judge has requested a

vote on whether to rehear the matter en banc. Fed. R.

App. P. 35. Petitioner’s petition for rehearing en banc,

ECF No. 52, is DENIED.

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APPENDIX E

Federal Food, Drug, and Cosmetic Act § 301

21 U.S.C. § 331

Prohibited acts

The following acts and the causing thereof are

prohibited:

(a) The introduction or delivery for introduction

into interstate commerce of any food, drug, device,

tobacco product, or cosmetic that is adulterated or

misbranded.

(b) The adulteration or misbranding of any food,

drug, device, tobacco product, or cosmetic in

interstate commerce.

drug, device, tobacco product, or cosmetic that is

adulterated or misbranded, and the delivery or

proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction

into interstate commerce of any article in violation

of section 344, 350d, 355, or 360bbb-3 of this title.

(e) The refusal to permit access to or copying of any

record as required by section 350a, 350c, 350f(j),

350e, 354, 360bbb-3, 373, 374(a), 379aa, or 379aa-1

of this title; or the failure to establish or maintain

any record, or make any report, required under

section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k),

360b(a)(4)(C), 360b(j), (l) or (m), 360ccc-1(i), 360e(f),

360i, 360bbb-3, 379aa, 379aa-1, 387i, or 387t of this

title or the refusal to permit access to or verification

76a

or copying of any such required record; or the

violation of any recordkeeping requirement under

section 2223 of this title (except when such violation

is committed by a farm).

(f) The refusal to permit entry or inspection as

authorized by section 374 of this title.

(g) The manufacture within any Territory of any

food, drug, device, tobacco product, or cosmetic that

is adulterated or misbranded.

(h) The giving of a guaranty or undertaking

referred to in section 333(c)(2) of this title, which

guaranty or undertaking is false, except by a person

who relied upon a guaranty or undertaking to the

same effect signed by, and containing the name and

address of, the person residing in the United States

from whom he received in good faith the food, drug,

device, tobacco product, or cosmetic; or the giving of

a guaranty or undertaking referred to in section

333(c)(3) of this title, which guaranty or

undertaking is false.

(i)(1) Forging, counterfeiting, simulating, or falsely

representing, or without proper authority using any

mark, stamp, tag, label, or other identification

device authorized or required by regulations

promulgated under the provisions of section 344 or

379e of this title.

(2) Making, selling, disposing of, or keeping in

possession, control, or custody, or concealing any

punch, die, plate, stone, or other thing designed to

print, imprint, or reproduce the trademark, trade

name, or other identifying mark, imprint, or device

of another or any likeness of any of the foregoing

77a

upon any drug or container or labeling thereof so as

to render such drug a counterfeit drug.

(3) The doing of any act which causes a drug to be

a counterfeit drug, or the sale or dispensing, or the

holding for sale or dispensing, of a counterfeit drug.

(j) The using by any person to his own advantage,

or revealing, other than to the Secretary or officers

or employees of the Department, or to the courts

when relevant in any judicial proceeding under this

chapter, any information acquired under authority

of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,

360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc-1,

360ccc-2, 374, 379, 379e, 387d, 387e, 387f, 387g,

387h, 387i, or 387t(b) of this title concerning any

method or process which as a trade secret is entitled

to protection; or the violating of section 346a(i)(2) of

this title or any regulation issued under that

section..1 This paragraph does not authorize the

withholding of information from either House of

Congress or from, to the extent of matter within its

jurisdiction, any committee or subcommittee of

such committee or any joint committee of Congress

or any subcommittee of such joint committee.

(k) The alteration, mutilation, destruction,

obliteration, or removal of the whole or any part of

the labeling of, or the doing of any other act with

respect to, a food, drug, device, tobacco product, or

cosmetic, if such act is done while such article is

held for sale (whether or not the first sale) after

shipment in interstate commerce and results in

such article being adulterated or misbranded.

So in original.

78a

(l) Repealed. Pub.L. 105-115, Title IV, § 421, Nov.

21, 1997, 111 Stat. 2380.

(m) The sale or offering for sale of colored

oleomargarine or colored margarine, or the

possession or serving of colored oleomargarine or

colored margarine in violation of subsections (b) or

(n) The using, in labeling, advertising or other sales

promotion of any reference to any report or analysis

furnished in compliance with section 374 of this

title.

(o) In the case of a prescription drug distributed or

offered for sale in interstate commerce, the failure

of the manufacturer, packer, or distributor thereof

to maintain for transmittal, or to transmit, to any

practitioner licensed by applicable State law to

administer such drug who makes written request

for information as to such drug, true and correct

copies of all printed matter which is required to be

included in any package in which that drug is

distributed or sold, or such other printed matter as

is approved by the Secretary. Nothing in this

paragraph shall be construed to exempt any person

from any labeling requirement imposed by or under

other provisions of this chapter.

(p) The failure to register in accordance with

section 360 or 387e of this title, the failure to

provide any information required by section 360(j),

360(k), 387e(i), or 387e(j) of this title, or the failure

to provide a notice required by section 360(j)(2) or

387e(i)(3) of this title.

79a

(q)(1) The failure or refusal—

(A) to comply with any requirement prescribed

under section 360h, 360j(g), 387c(b), 387g, 387h,

or 387o of this title;

(B) to furnish any notification or other material

or information required by or under section 360i,

360j(g), 387d, 387i, or 387t of this title; or

360l or 387m of this title.

(2) With respect to any device or tobacco product,

the submission of any report that is required by or

under this chapter that is false or misleading in any

material respect.

(r) The movement of a device, drug, or tobacco

product in violation of an order under section 334(g)

of this title or the removal or alteration of any mark

or label required by the order to identify the device,

drug, or tobacco product as detained.

(s) The failure to provide the notice required by

section 350a(c) or 350a(e) of this title, the failure to

make the reports required by section 350a(f)(1)(B)

of this title, the failure to retain the records

required by section 350a(b)(4) of this title, or the

failure to meet the requirements prescribed under

section 350a(f)(3) of this title.

(t) The importation of a drug in violation of section

381(d)(1) of this title, the sale, purchase, or trade of

a drug or drug sample or the offer to sell, purchase,

or trade a drug or drug sample in violation of

section 353(c) of this title, the sale, purchase, or

trade of a coupon, the offer to sell, purchase, or

trade such a coupon, or the counterfeiting of such a

80a

coupon in violation of section 353(c)(2) of this title,

the distribution of a drug sample in violation of

section 353(d) of this title or the failure to otherwise

comply with the requirements of section 353(d) of

this title, the distribution of drugs in violation of

section 353(e) of this title, failure to comply with the

requirements under section 360eee-1 of this title,

the failure to comply with the requirements under

section 360eee-3 of this title, as applicable, or the

failure to otherwise comply with the requirements

of section 353(e) of this title.

(u) The failure to comply with any requirements of

the provisions of, or any regulations or orders of the

Secretary,

under

section

360b(a)(4)(A),

360b(a)(4)(D), or 360b(a)(5) of this title.

(v) The introduction or delivery for introduction

into interstate commerce of a dietary supplement

that is unsafe under section 350b of this title.

(w) The making of a knowingly false statement in

any statement, certificate of analysis, record, or

report required or requested under section 381(d)(3)

of this title; the failure to submit a certificate of

analysis as required under such section; the failure

to maintain records or to submit records or reports

as required by such section; the release into

interstate commerce of any article or portion

thereof imported into the United States under such

section or any finished product made from such

article or portion, except for export in accordance

with section 381(e) or 382 of this title, or with

section 262(h) of Title 42; or the failure to so export

or to destroy such an article or portions thereof, or

such a finished product.

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(x) The falsification of a declaration of conformity

submitted under section 360d(c) of this title or the

failure or refusal to provide data or information

requested by the Secretary under paragraph (3) of

such section.

(y) In the case of a drug, device, or food—

(1) the submission of a report or recommendation

by a person accredited under section 360m of this

title that is false or misleading in any material

respect;

(2) the disclosure by a person accredited under

section 360m of this title of confidential

commercial information or any trade secret

without the express written consent of the person

who submitted such information or secret to such

person; or

(3) the receipt by a person accredited under

section 360m of this title of a bribe in any form or

the doing of any corrupt act by such person

associated with a responsibility delegated to such

person under this chapter.

(z) Omitted

(aa) The importation of a prescription drug in

violation of section 384 of this title, the falsification

of any record required to be maintained or provided

to the Secretary under such section, or any other

violation of regulations under such section.

(bb) The transfer of an article of food in violation of

an order under section 334(h) of this title, or the

removal or alteration of any mark or label required

by the order to identify the article as detained.

82a

(cc) The importing or offering for import into the

United States of an article of food or a drug by, with

the assistance of, or at the direction of, a person

debarred from such activity under section

335a(b)(3) of this title.

(dd) The failure to register in accordance with

section 350d of this title.

(ee) The importing or offering for import into the

United States of an article of food in violation of the

requirements under section 381(m) of this title.

(ff) The importing or offering for import into the

United States of a drug or device with respect to

which there is a failure to comply with a request of

the Secretary to submit to the Secretary a

statement under section 381(o) of this title.

(gg) The knowing failure to comply with paragraph

(7)(E) of section 374(g) of this title; the knowing

inclusion by a person accredited under paragraph

(2) of such section of false information in an

inspection report under paragraph (7)(A) of such

section; or the knowing failure of such a person to

include material facts in such a report.

(hh) The failure by a shipper, carrier by motor

vehicle or rail vehicle, receiver, or any other person

engaged in the transportation of food to comply with

the sanitary transportation practices prescribed by

the Secretary under section 350e of this title.

(ii) The falsification of a report of a serious adverse

event submitted to a responsible person (as defined

under section 379aa or 379aa-1 of this title) or the

falsification of a serious adverse event report (as

defined under section 379aa or 379aa-1 of this title)

submitted to the Secretary.

83a

(jj)(1) The failure to submit the certification

required by section 282(j)(5)(B) of Title 42, or

knowingly submitting a false certification under

such section.

(2) The failure to submit clinical trial information

required under subsection (j) of section 282 of Title

42.

(3) The submission of clinical trial information

under subsection (j) of section 282 of Title 42 that is

false or misleading in any particular under

paragraph (5)(D) of such subsection (j).

(kk) The dissemination of a television

advertisement without complying with section 353c

of this title.

(ll) The introduction or delivery for introduction

into interstate commerce of any food to which has

been added a drug approved under section 355 of

this title, a biological product licensed under section

262 of Title 42, or a drug or a biological product for

which substantial clinical investigations have been

instituted and for which the existence of such

investigations has been made public, unless—

(1) such drug or such biological product was

marketed in food before any approval of the drug

under section 355 of this title, before licensure of

the biological product under such section 262 of

Title 42, and before any substantial clinical

investigations involving the drug or the biological

product have been instituted;

(2) the Secretary, in the Secretary’s discretion,

has issued a regulation, after notice and

comment, approving the use of such drug or such

biological product in the food;

84a

(3) the use of the drug or the biological product in

the food is to enhance the safety of the food to

which the drug or the biological product is added

or applied and not to have independent biological

or therapeutic effects on humans, and the use is

in conformity with—

(A) a regulation issued under section 348 of

this title prescribing conditions of safe use in

food;

(B) a regulation listing or affirming conditions

under which the use of the drug or the

biological product in food is generally

recognized as safe;

notification to the Secretary of a claim of

exemption from the premarket approval

requirements for food additives based on the

notifier’s determination that the use of the

drug or the biological product in food is

generally recognized as safe, provided that the

Secretary has not questioned the general

recognition of safety determination in a letter

to the notifier;

(D) a food contact substance notification that

is effective under section 348(h) of this title; or

(E) such drug or biological product had been

marketed for smoking cessation prior to

September 27, 2007; or

(4) the drug is a new animal drug whose use is

not unsafe under section 360b of this title.

85a

(mm) The failure to submit a report or provide a

notification required under section 350f(d) of this

title.

(nn) The falsification of a report or notification

required under section 350f(d) of this title.

(oo) The sale of tobacco products in violation of a

no-tobacco-sale order issued under section 333(f) of

this title.

(pp) The introduction or delivery for introduction

into interstate commerce of a tobacco product in

violation of section 387k of this title.

(qq)(1) Forging, counterfeiting, simulating, or

falsely representing, or without proper authority

using any mark, stamp (including tax stamp), tag,

label, or other identification device upon any

tobacco product or container or labeling thereof so

as to render such tobacco product a counterfeit

tobacco product.

(2) Making, selling, disposing of, or keeping in

possession, control, or custody, or concealing any

punch, die, plate, stone, or other item that is

designed to print, imprint, or reproduce the

trademark, trade name, or other identifying mark,

imprint, or device of another or any likeness of any

of the foregoing upon any tobacco product or

container or labeling thereof so as to render such

tobacco product a counterfeit tobacco product.

(3) The doing of any act that causes a tobacco

product to be a counterfeit tobacco product, or the

sale or dispensing, or the holding for sale or

dispensing, of a counterfeit tobacco product.

(rr) The charitable distribution of tobacco products.

86a

(ss) The failure of a manufacturer or distributor to

notify the Attorney General and the Secretary of

the Treasury of their knowledge of tobacco products

used in illicit trade.

(tt) Making any express or implied statement or

representation directed to consumers with respect

to a tobacco product, in a label or labeling or

through the media or advertising, that either

conveys, or misleads or would mislead consumers

into believing, that

(1) the product is approved by the Food and Drug

Administration;

(2) the Food and Drug Administration deems the

product to be safe for use by consumers;

(3) the product is endorsed by the Food and Drug

Administration for use by consumers; or

(4) the product is safe or less harmful by virtue

of—

(A) its regulation or inspection by the Food and

Drug Administration; or

(B)

its

compliance

with

regulatory

requirements set by the Food and Drug

Administration;

including

any

such

statement

representation

rendering

the

product

misbranded under section 387c of this title.

(uu) The operation of a facility that manufactures,

processes, packs, or holds food for sale in the United

States if the owner, operator, or agent in charge of

such facility is not in compliance with section 350g

of this title.

87a

(vv) The failure to comply with the requirements

under section 350h of this title.

(ww) The failure to comply with section 350i of this

title.

(xx) The refusal or failure to follow an order under

section 350l of this title.

(yy) The knowing and willful failure to comply with

the notification requirement under section 350f(h)

of this title.

(zz) The importation or offering for importation of

a food if the importer (as defined in section 384a of

this title) does not have in place a foreign supplier

verification program in compliance with such

section 384a of this title.

(aaa) The failure to register in accordance with

section 381(s) of this title.

(bbb) The failure to notify the Secretary in

violation of section 360bbb-7 of this title.

(ccc)(1) The resale of a compounded drug that is

labeled “not for resale” in accordance with section

353b of this title.

(2) With respect to a drug to be compounded

pursuant to section 353a or 353b of this title, the

intentional falsification of a prescription, as

applicable.

(3) The failure to report drugs or adverse events by

an entity that is registered in accordance with

subsection (b) of section 353b of this title.

(ddd)(1) The manufacture or the introduction or

delivery for introduction into interstate commerce

of a rinse-off cosmetic that contains intentionallyadded plastic microbeads.

88a

(2) In this paragraph—

(A) the term “plastic microbead” means any solid

plastic particle that is less than five millimeters

in size and is intended to be used to exfoliate or

cleanse the human body or any part thereof; and

(B) the term “rinse-off cosmetic” includes

toothpaste.

(eee) The failure to comply with any order issued

under section 360bbb-8d of this title.

89a

Federal Food, Drug, and Cosmetic Act § 900

21 U.S.C. § 387

Definitions

In this subchapter:

(1) Additive

The term “additive” means any substance the

intended use of which results or may reasonably be

expected to result, directly or indirectly, in its

becoming a component or otherwise affecting the

characteristic of any tobacco product (including any

substances intended for use as a flavoring or

coloring or in producing, manufacturing, packing,

processing,

preparing,

treating,

packaging,

transporting, or holding), except that such term

does not include tobacco or a pesticide chemical

residue in or on raw tobacco or a pesticide chemical.

(2) Brand

The term “brand” means a variety of tobacco

product distinguished by the tobacco used, tar

content, nicotine content, flavoring used, size,

filtration, packaging, logo, registered trademark,

brand name, identifiable pattern of colors, or any

combination of such attributes.

(3) Cigarette

The term “cigarette”—

(A) means a product that—

(i) is a tobacco product; and

(ii) meets the definition of the term “cigarette”

in section 1332(1) of Title 15; and

(B) includes tobacco, in any form, that is

functional in the product, which, because of its

90a

appearance, the type of tobacco used in the filler,

or its packaging and labeling, is likely to be

offered to, or purchased by, consumers as a

cigarette or as roll-your-own tobacco.

(4) Cigarette tobacco

The term “cigarette tobacco” means any product

that consists of loose tobacco that is intended for use

by consumers in a cigarette. Unless otherwise

stated, the requirements applicable to cigarettes

under this subchapter shall also apply to cigarette

tobacco.

(5) Commerce

The term “commerce” has the meaning given that

term by section 1332(2) of Title 15.

(6) Counterfeit tobacco product

The term “counterfeit tobacco product” means a

tobacco product (or the container or labeling of such

a product) that, without authorization, bears the

trademark, trade name, or other identifying mark,

imprint, or device, or any likeness thereof, of a

tobacco product listed in a registration under

section 387e(i)(1) of this title.

(7) Distributor

The term “distributor” as regards a tobacco product

means any person who furthers the distribution of

a tobacco product, whether domestic or imported, at

any point from the original place of manufacture to

the person who sells or distributes the product to

individuals for personal consumption. Common

carriers are not considered distributors for

purposes of this subchapter.

91a

(8) Illicit trade

The term “illicit trade” means any practice or

conduct prohibited by law which relates to

production,

shipment,

receipt,

possession,

distribution, sale, or purchase of tobacco products

including any practice or conduct intended to

facilitate such activity.

(9) Indian country

The term “Indian country” has the meaning given

such term in section 1151 of Title 18.

(10) Indian tribe

The term “Indian tribe” has the meaning given such

term in section 5304(e) of Title 25.

(11) Little cigar

The term “little cigar” means a product that—

(A) is a tobacco product; and

(B) meets the definition of the term “little cigar”

in section 1332(7) of Title 15.

(12) Nicotine

The term “nicotine” means the chemical substance

named 3-(1-Methyl-2-pyrrolidinyl) pyridine or

C[10]H[14]N[2], including any salt or complex of

nicotine.

(13) Package

The term “package” means a pack, box, carton, or

container of any kind or, if no other container, any

wrapping (including cellophane), in which a tobacco

product is offered for sale, sold, or otherwise

distributed to consumers.

92a

(14) Retailer

The term “retailer” means any person, government,

or entity who sells tobacco products to individuals

for personal consumption, or who operates a facility

where self-service displays of tobacco products are

permitted.

(15) Roll-your-own tobacco

The term “roll-your-own tobacco” means any

tobacco product which, because of its appearance,

type, packaging, or labeling, is suitable for use and

likely to be offered to, or purchased by, consumers

as tobacco for making cigarettes.

(16) Small tobacco product manufacturer

The term “small tobacco product manufacturer”

means a tobacco product manufacturer that

employs fewer than 350 employees. For purposes of

determining the number of employees of a

manufacturer under the preceding sentence, the

employees of a manufacturer are deemed to include

the employees of each entity that controls, is

controlled by, or is under common control with such

manufacturer.

(17) Smoke constituent

The term “smoke constituent” means any chemical

or chemical compound in mainstream or sidestream

tobacco smoke that either transfers from any

component of the cigarette to the smoke or that is

formed by the combustion or heating of tobacco,

additives, or other component of the tobacco

product.

93a

(18) Smokeless tobacco

The term “smokeless tobacco” means any tobacco

product that consists of cut, ground, powdered, or

leaf tobacco and that is intended to be placed in the

oral or nasal cavity.

(19) State; Territory

The terms “State” and “Territory” shall have the

meanings given to such terms in section 321 of this

title.

(20) Tobacco product manufacturer

The term “tobacco product manufacturer” means

any person, including any repacker or relabeler,

who—

(A)

manufactures,

fabricates,

assembles,

processes, or labels a tobacco product; or

(B) imports a finished tobacco product for sale or

distribution in the United States.

(21) Tobacco warehouse

(A) Subject to subparagraphs (B) and (C), the term

“tobacco warehouse” includes any person—

(i) who—

(I) removes foreign material from tobacco leaf

through nothing other than a mechanical

process;

(II) humidifies tobacco leaf with nothing other

than potable water in the form of steam or

mist; or

(III) de-stems, dries, and packs tobacco leaf for

storage and shipment;

94a

(ii) who performs no other actions with respect to

tobacco leaf; and

(iii) who provides to any manufacturer to whom

the person sells tobacco all information related to

the person’s actions described in clause (i) that is

necessary for compliance with this chapter.

(B) The term “tobacco warehouse” excludes any

person who—

(i) reconstitutes tobacco leaf;

(ii) is a manufacturer, distributor, or retailer of a

tobacco product; or

(iii) applies any chemical, additive, or substance

to the tobacco leaf other than potable water in the

form of steam or mist.

in subparagraph (A) shall not apply to the extent to

which the Secretary determines, through

rulemaking, that regulation under this subchapter

of the actions described in such subparagraph is

appropriate for the protection of the public health.

(22) United States

The term “United States” means the 50 States of

the United States of America and the District of

Columbia, the Commonwealth of Puerto Rico,

Guam, the Virgin Islands, American Samoa, Wake

Island, Midway Islands, Kingman Reef, Johnston

Atoll, the Northern Mariana Islands, and any other

trust territory or possession of the United States.

95a

Federal Food, Drug, and Cosmetic Act § 901

21 U.S.C. § 387a

FDA authority over tobacco products

(a) In general

Tobacco products, including modified risk tobacco

products for which an order has been issued in

accordance with section 387k of this title, shall be

regulated by the Secretary under this subchapter and

shall not be subject to the provisions of subchapter V.

(b) Applicability

This subchapter shall apply to all cigarettes, cigarette

tobacco, roll-your-own tobacco, and smokeless tobacco

and to any other tobacco products that the Secretary

by regulation deems to be subject to this subchapter.

(1) In general

Nothing in this subchapter, or any policy issued or

regulation promulgated thereunder, or in sections

101(a), 102, or 103 of Title I, Title II, or Title III of

the Family Smoking Prevention and Tobacco

Control Act, shall be construed to affect, expand, or

limit the Secretary’s authority over (including the

authority to determine whether products may be

regulated), or the regulation of, products under this

chapter that are not tobacco products under

subchapter V or any other subchapter.

(2) Limitation of authority

(A) In general

The provisions of this subchapter shall not apply

to tobacco leaf that is not in the possession of a

manufacturer of tobacco products, or to the

96a

producers of tobacco leaf, including tobacco

growers, tobacco warehouses, and tobacco grower

cooperatives, nor shall any employee of the Food

and Drug Administration have any authority to

enter onto a farm owned by a producer of tobacco

leaf without the written consent of such producer.

(B) Exception

Notwithstanding subparagraph (A), if a producer

of tobacco leaf is also a tobacco product

manufacturer or controlled by a tobacco product

manufacturer, the producer shall be subject to

this subchapter in the producer’s capacity as a

manufacturer.

The exception in this

subparagraph shall not apply to a producer of

tobacco leaf who grows tobacco under a contract

with a tobacco product manufacturer and who is

not otherwise engaged in the manufacturing

process.

Nothing in this subchapter shall be construed to

grant the Secretary authority to promulgate

regulations on any matter that involves the

production of tobacco leaf or a producer thereof,

other than activities by a manufacturer affecting

production.

(d) Rulemaking procedures

Each rulemaking under this subchapter shall be in

accordance with chapter 5 of Title 5. This subsection

shall not be construed to affect the rulemaking

provisions of section 102(a) of the Family Smoking

Prevention and Tobacco Control Act.

97a

(e) Center for Tobacco Products

Not later than 90 days after June 22, 2009, the

Secretary shall establish within the Food and Drug

Administration the Center for Tobacco Products,

which shall report to the Commissioner of Food and

Drugs in the same manner as the other agency centers

within the Food and Drug Administration. The

Center shall be responsible for the implementation of

this subchapter and related matters assigned by the

Commissioner.

(f) Office to assist small tobacco product

manufacturers

The Secretary shall establish within the Food and

Drug Administration an identifiable office to provide

technical and other nonfinancial assistance to small

tobacco product manufacturers to assist them in

complying with the requirements of this chapter.

(g) Consultation prior to rulemaking

Prior to promulgating rules under this subchapter,

the Secretary shall endeavor to consult with other

Federal agencies as appropriate.

98a

Federal Food, Drug, and Cosmetic Act § 902

21 U.S.C. § 387b

Adulterated tobacco products

A tobacco product shall be deemed to be adulterated

if—

(1) it consists in whole or in part of any filthy,

putrid, or decomposed substance, or is otherwise

contaminated by any added poisonous or added

deleterious substance that may render the product

injurious to health;

(2) it has been prepared, packed, or held under

insanitary conditions whereby it may have been

contaminated with filth, or whereby it may have

been rendered injurious to health;

(3) its package is composed, in whole or in part, of

any poisonous or deleterious substance which may

render the contents injurious to health;

(4) the manufacturer or importer of the tobacco

product fails to pay a user fee assessed to such

manufacturer or importer pursuant to section 387s

of this title by the date specified in section 387s of

this title or by the 30th day after final agency action

on a resolution of any dispute as to the amount of

such fee;

(5) it is, or purports to be or is represented as, a

tobacco product which is subject to a tobacco

product standard established under section 387g of

this title unless such tobacco product is in all

respects in conformity with such standard;

(6)(A) it is required by section 387j(a) of this title to

have premarket review and does not have an order

in effect under section 387j(c)(1)(A)(i) of this title; or

99a

(B) it is in violation of an order under section

387j(c)(1)(A) of this title;

(7) the methods used in, or the facilities or controls

used for, its manufacture, packing, or storage are

not in conformity with applicable requirements

under section 387f(e)(1) of this title or an applicable

condition prescribed by an order under section

387f(e)(2) of this title; or

(8) it is in violation of section 387k of this title.

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Federal Food, Drug, and Cosmetic Act § 907

21 U.S.C. § 387g

Tobacco product standards

(a) In general

(1) Special rules

(A) Special rule for cigarettes

Beginning 3 months after June 22, 2009, a

cigarette or any of its component parts (including

the tobacco, filter, or paper) shall not contain, as

a constituent (including a smoke constituent) or

additive, an artificial or natural flavor (other

than tobacco or menthol) or an herb or spice,

including strawberry, grape, orange, clove,

cinnamon, pineapple, vanilla, coconut, licorice,

cocoa, chocolate, cherry, or coffee, that is a

characterizing flavor of the tobacco product or

tobacco smoke. Nothing in this subparagraph

shall be construed to limit the Secretary’s

authority to take action under this section or

other sections of this chapter applicable to

menthol or any artificial or natural flavor, herb,

or spice not specified in this subparagraph.

(B) Additional special rule

Beginning 2 years after June 22, 2009, a tobacco

product manufacturer shall not use tobacco,

including foreign grown tobacco, that contains a

pesticide chemical residue that is at a level

greater than is specified by any tolerance

applicable under Federal law to domestically

grown tobacco.

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(2) Revision of tobacco product standards

The Secretary may revise the tobacco product

standards in paragraph (1) in accordance with

subsection (c).

(3) Tobacco product standards

(A) In general

The Secretary may adopt tobacco product

standards in addition to those in paragraph (1) if

the Secretary finds that a tobacco product

standard is appropriate for the protection of the

public health.

(B) Determinations

(i) Considerations

In making a finding described in subparagraph

(A), the Secretary shall consider scientific

evidence concerning—

(I) the risks and benefits to the population

as a whole, including users and nonusers of

tobacco products, of the proposed standard;

(II) the increased or decreased likelihood

that existing users of tobacco products will

stop using such products; and

(III) the increased or decreased likelihood

that those who do not use tobacco products

will start using such products.

(ii) Additional considerations

In the event that the Secretary makes a

determination, set forth in a proposed tobacco

product standard in a proposed rule, that it is

appropriate for the protection of public health

to require the reduction or elimination of an

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additive, constituent (including a smoke

constituent), or other component of a tobacco

product because the Secretary has found that

the additive, constituent, or other component

is or may be harmful, any party objecting to the

proposed standard on the ground that the

proposed standard will not reduce or eliminate

the risk of illness or injury may provide for the

Secretary’s consideration scientific evidence

that demonstrates that the proposed standard

will not reduce or eliminate the risk of illness

or injury.

(4) Content of tobacco product standards

A tobacco product standard established under this

section for a tobacco product—

(A) shall include provisions that are appropriate

for the protection of the public health, including

provisions, where appropriate—

(i) for nicotine yields of the product;

(ii) for the reduction or elimination of other

constituents, including smoke constituents, or

harmful components of the product; or

(iii) relating to any other requirement under

subparagraph (B);

(B) shall, where appropriate for the protection of

the public health, include—

(i) provisions respecting the construction,

components,

ingredients,

additives,

constituents, including smoke constituents,

and properties of the tobacco product;

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(ii) provisions for the testing (on a sample

basis or, if necessary, on an individual basis) of

the tobacco product;

(iii) provisions for the measurement of the

tobacco product characteristics of the tobacco

product;

(iv) provisions requiring that the results of

each or of certain of the tests of the tobacco

product required to be made under clause (ii)

show that the tobacco product is in conformity

with the portions of the standard for which the

test or tests were required; and

(v) a provision requiring that the sale and

distribution of the tobacco product be

restricted but only to the extent that the sale

and distribution of a tobacco product may be

restricted under a regulation under section

387f(d) of this title;

prescribe the form and content of labeling for the

proper use of the tobacco product; and

(D) shall require tobacco products containing

foreign-grown tobacco to meet the same

standards applicable to tobacco products

containing domestically grown tobacco.

(5) Periodic reevaluation of tobacco product

standards

The Secretary shall provide for periodic evaluation

of tobacco product standards established under this

section to determine whether such standards

should be changed to reflect new medical, scientific,

or other technological data. The Secretary may

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provide for testing under paragraph (4)(B) by any

person.

(6) Involvement of other agencies; informed

persons

In carrying out duties under this section, the

Secretary shall endeavor to—

(A) use personnel, facilities, and other technical

support available in other Federal agencies;

(B) consult with other Federal agencies

concerned with standard setting and other

nationally

internationally

recognized

standard-setting entities; and

joint or other conferences, workshops, or other

means, by informed persons representative of

scientific, professional, industry, agricultural, or

consumer organizations who in the Secretary’s

judgment can make a significant contribution.

(b) Considerations by Secretary

(1) Technical achievability

The Secretary shall consider information submitted

in connection with a proposed standard regarding

the technical achievability of compliance with such

standard.

(2) Other considerations

The Secretary shall consider all other information

submitted in connection with a proposed standard,

including

information

concerning

the

countervailing effects of the tobacco product

standard on the health of adolescent tobacco users,

adult tobacco users, or nontobacco users, such as

the creation of a significant demand for contraband

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or other tobacco products that do not meet the

requirements of this subchapter and the

significance of such demand.

(1) In general

The Secretary shall publish in the Federal Register

a notice of proposed rulemaking for the

establishment, amendment, or revocation of any

tobacco product standard.

(2) Requirements of notice

A notice of proposed rulemaking for the

establishment or amendment of a tobacco product

standard for a tobacco product shall—

(A) set forth a finding with supporting

justification that the tobacco product standard is

appropriate for the protection of the public

health;

(B) invite interested persons to submit a draft or

proposed

tobacco

product

standard

for

consideration by the Secretary;

on structuring the standard so that it does not

advantage

foreign-grown

tobacco

over

domestically grown tobacco; and

(D) invite the Secretary of Agriculture to provide

any information or analysis which the Secretary

of Agriculture believes is relevant to the proposed

tobacco product standard.

(3) Finding

A notice of proposed rulemaking for the revocation

of a tobacco product standard shall set forth a

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finding with supporting justification that the

tobacco product standard is no longer appropriate

for the protection of the public health.

(4) Comment

The Secretary shall provide for a comment period of

not less than 60 days.

(d) Promulgation

(1) In general

After the expiration of the period for comment on a

notice of proposed rulemaking published under

subsection (c) respecting a tobacco product

standard and after consideration of comments

submitted under subsections (b) and (c) and any

report from the Tobacco Products Scientific

Advisory Committee, the Secretary shall—

(A) if the Secretary determines that the standard

would be appropriate for the protection of the

public health, promulgate a regulation

establishing a tobacco product standard and

publish in the Federal Register findings on the

matters referred to in subsection (c); or

(B) publish a notice terminating the proceeding

for the development of the standard together

with the reasons for such termination.

(2) Effective date

A regulation establishing a tobacco product

standard shall set forth the date or dates upon

which the standard shall take effect, but no such

regulation may take effect before 1 year after the

date of its publication unless the Secretary

determines that an earlier effective date is

necessary for the protection of the public health.

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Such date or dates shall be established so as to

minimize, consistent with the public health,

economic loss to, and disruption or dislocation of,

domestic and international trade. In establishing

such effective date or dates, the Secretary shall

consider information submitted in connection with

a proposed product standard by interested parties,

including manufacturers and tobacco growers,

regarding the technical achievability of compliance

with the standard, and including information

concerning the existence of patents that make it

impossible to comply in the timeframe envisioned in

the proposed standard.

If the Secretary

determines, based on the Secretary’s evaluation of

submitted comments, that a product standard can

be met only by manufacturers requiring substantial

changes to the methods of farming the domestically

grown tobacco used by the manufacturer, the

effective date of that product standard shall be not

less than 2 years after the date of publication of the

final regulation establishing the standard.

(3) Limitation on power granted to the Food

and Drug Administration

Because of the importance of a decision of the

Secretary to issue a regulation—

(A) banning all cigarettes, all smokeless tobacco

products, all little cigars, all cigars other than

little cigars, all pipe tobacco, or all roll-your-own

tobacco products; or

(B) requiring the reduction of nicotine yields of a

tobacco product to zero,

the Secretary is prohibited from taking such

actions under this chapter.

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(4) Amendment; revocation

(A) Authority

The Secretary, upon the Secretary’s own

initiative or upon petition of an interested

person, may by a regulation, promulgated in

accordance with the requirements of subsection

product standard.

(B) Effective date

The Secretary may declare a proposed

amendment of a tobacco product standard to be

effective on and after its publication in the

Federal Register and until the effective date of

any final action taken on such amendment if the

Secretary determines that making it so effective

is in the public interest.

(5) Referral to Advisory Committee

(A) In general

The Secretary may refer a proposed regulation

for the establishment, amendment, or revocation

of a tobacco product standard to the Tobacco

Products Scientific Advisory Committee for a

report and recommendation with respect to any

matter involved in the proposed regulation which

requires the exercise of scientific judgment.

(B) Initiation of referral

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