1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 R.J. REYNOLDS TOBACCO Case No.: 20-CV-1290 JLS (WVG) COMPANY.; R.J. REYNOLDS VAPOR 12 COMPANY.; SANTA FE NATURAL ORDER (1) DENYING PLAINTIFFS’ 13 TOBACCO COMPANY., INC.; MOTION FOR PRELIMINARY AMERICAN SNUFF COMPANY, LLC; INJUNCTION AND (2) GRANTING 14 and MODORAL BRANDS INC., DEFENDANTS’ MOTION TO 15 DISMISS Plaintiffs,

16 v. (ECF Nos. 6, 26) 17 COUNTY OF SAN DIEGO; and HELEN 18 N. ROBBINS-MEYER, in her official capacity as the County of San Diego’s 19 Chief Administrative Officer, 20 Defendants. 21

22 This Order addresses the constitutionality of two county ordinances that permanently 23 ban the sale of various flavored tobacco products in San Diego County. Specifically before 24 the Court are Plaintiffs R.J. Reynolds Tobacco Company; R.J. Reynolds Vapor Company; 25 Santa Fe Natural Tobacco Company, Inc.; American Snuff Co., LLC; and Modoral Brands 26 Inc.’s (collectively, “Plaintiffs”) Motion for Preliminary Injunction (“Mot.,” ECF No. 6-1) 27 and Defendants County of San Diego and Helen N. Robbins-Meyer’s (collectively, 28 “Defendants”) Motion to Dismiss Plaintiffs’ Complaint (“MTD,” ECF No. 26). Also 1 before the Court is the brief of Medical and Public Health Amici Curiae filed in Opposition 2 to Plaintiffs’ Motion for Preliminary Injunction (“Amici Br.,” ECF No. 21). The Court 3 took these matters under submission without oral argument pursuant to Civil Local Rule 4 7.1(d)(1). See ECF No. 36. Having carefully considered the Parties’ pleadings, evidence, 5 arguments, and the applicable law, the Court DENIES Plaintiffs’ Motion for Preliminary 6 Injunction and GRANTS Defendants’ Motion to Dismiss, as follows. 7 BACKGROUND 8 On January 28, 2020, the San Diego County Board of Supervisors adopted 9 Regulatory Code Ordinance Number 10647 (the “Ordinance”), which was enacted on 10 February 27, 2020 and became effective on July 1, 2020. See generally San Diego County, 11 Cal., Code of Regulatory Ordinances, tit. 3, div. 2, ch. 8.8, §§ 32.871–32.895 (2020). The 12 Ordinance (1) permanently prohibits the sale or distribution of flavored smoking products 13 within San Diego County and (2) temporarily prohibits the sale or distribution of electronic 14 smoking devices within San Diego County for a period of one year. See generally id. 15 Plaintiffs seek to enjoin the County from enforcing the sales ban on flavored smoking 16 products. See generally Mot. 17 First, the Ordinance prohibits the sale of certain tobacco products. The Ordinance 18 bans “the sale or distribution of all flavored smoking products . . . in the unincorporated 19 area of the County.” San Diego County, Cal., Code of Regulatory Ordinances, tit. 3, div. 20 2, ch. 8.8, § 32.883(a) (2020). A “flavored smoking product” is defined as: 21 [A] product containing, made, or derived from tobacco or nicotine that is intended for smoking, and that emits a taste or 22 smell, other than the taste or smell of tobacco, including, but not 23 limited to, any taste or smell relating to fruit, menthol, mint, wintergreen, chocolate, cocoa, vanilla, honey, candy, dessert, 24 alcoholic beverage, herb, or spice. 25

26 Id. § 32.882(b). The ban exempts shisha, which is “a flavored smoking product that is 27 traditionally mixed with molasses, honey, fruit pulp, or dried fruits and is sold for use in a 28 water pipe known as a hookah.” Id. § 32.872(b). Additionally, the prohibition on the sale 1 of flavored smoking products does not apply to “a product that has been approved by the 2 Food and Drug Administration for sale as a tobacco cessation product or for other 3 therapeutic purposes, where the product is marketed and sold solely for such an approved 4 purpose.” Id. § 32.883(c). 5 The Ordinance was enacted to combat the health risks associated with youth tobacco 6 consumption. See generally id. § 32.881(a)–(g). The 2019 National Youth Tobacco 7 Survey conducted by the Centers for Disease Control and Prevention (“CDC”) and the 8 Food and Drug Administration (“FDA”) “showed that more than 5 million U.S. middle and 9 high school students reported current e-cigarette use . . . [and] 27.5 percent of high school 10 students reported current e-cigarette use, a percentage that has increased dramatically since 11 2018.” Id. § 32.881(c). The County found that “[f]lavors, such as fruit, menthol, mint, 12 candy, or dessert, hide the harshness of nicotine, making initiation of nicotine use easier 13 among youth.” Id. § 32.881(d). The County also was concerned with underage purchasers 14 having access to tobacco products. The 2018 Young Adult Tobacco Purchase Survey 15 “showed that tobacco and vape shops made sales to underage decoys 49.8 percent of the 16 time, twice the rate of any other category of retailer.” Id. § 32.881(g). 17 Second, the Ordinance temporarily banned, for a period of one year, the “sale or 18 distribution of an electronic smoking device . . . .” Id. § 32.893(a). An “Electronic 19 Smoking Device” is defined as: 20 [A]n electronic and/or battery-operated device, which can be used to deliver an inhaled dose of nicotine or other substances 21 whether manufactured, distributed, marketed, or sold as an 22 electronic cigarette, an electronic cigar, an electronic cigarillo, an electronic pipe, or any other product name or descriptor. 23 24 25 Id. § 32.892(b). Like the flavored smoking products sales ban, the temporary prohibition 26 on the sale of electronic smoking devices does not apply to “any product that the Food and 27 Drug Administration has either granted premarket approval, or approved for use as a 28 tobacco cessation product or for other therapeutic purposes where the product is marketed 1 and sold solely for such an approved purpose.” Id. The ban on the sale of electronic 2 smoking devices expired on February 28, 2021. Id. § 32.893(a). 3 The San Diego County Board of Supervisors was motivated to adopt the temporary 4 ban on electronic smoking devices because the “long-term health consequences of 5 electronic smoking devices are unclear, but evidence is mounting that there are serious 6 risks.” Id. § 32.891(d). Among the suspected health risks is an illness called e-cigarette 7 or vaping product use-associated lung injury (“EVALI”), which “has led to hospitalizations 8 and deaths nationwide . . . . There have been 41 confirmed or probable EVALI cases in 9 San Diego County as of December 18, 2019.” Id. § 32.892(g). The County was 10 particularly concerned with youth use of electronic smoking devices, which has increased 11 since 2018. Id. § 32.892(f). Additionally, the FDA has not approved e-cigarettes as an aid 12 to quit smoking, and “[s]tudies indicate no evidence of definitive long-term efficacy of e- 13 cigarettes as a cessation aid . . . .” Id. § 32.891(c). 14 On December 8, 2020, the San Diego County Board of Supervisors adopted 15 Ordinance No. 10699, (the “New Ordinance,” the Ordinance and the New Ordinance 16 collectively the “ordinances”), which repealed and added provisions in the San Diego 17 County Code regarding the sale of tobacco products in the unincorporated area of San 18 Diego County. See generally San Diego County, Cal., Code of Regulatory Ordinances, tit. 19 2, div. 1, ch. 26, §§ 21.2601–21.2610 (2021). As of July 1, 2021, the New Ordinance will 20 repeal the Ordinance’s current ban on flavored smoking products and replace it with a ban 21 on the sale of flavored tobacco products. Compare San Diego County, Cal., Code of 22 Regulatory Ordinances, tit. 3, div. 2, ch. 8.8, § 32.883 (2020) with San Diego County, Cal., 23 Code of Regulatory Ordinances, tit. 2, div. 1, ch. 26, § 21.2604 (2021). The New 24 Ordinance does not reinstate a ban on the sale of electronic smoking devices. See generally 25 San Diego County, Cal., Code of Regulatory Ordinances, tit. 2, div. 1, ch. 26 (2021). 26 Specifically, the New Ordinance provides, “A tobacco retailer, or any of the tobacco 27 retailer’s agents or employees, shall not sell, offer for sale, or possess with the intent to sell 28 or offer for sale, a flavored tobacco product or a tobacco product flavor enhancer.” Id. 1 § 21.2604(a). A “flavored tobacco product” is defined as: 2 [A]ny tobacco product that contains a taste or smell, other than the taste or smell of tobacco, that is distinguishable by an 3 ordinary consumer either prior to or during the consumption of 4 the product, including, but not limited to, any taste or smell relating to chocolate, cocoa, menthol, mint, wintergreen, vanilla, 5 honey, fruit or any candy, dessert, alcoholic beverage, herb or 6 spice. 7 8 Id. § 21.2602(i). The New Ordinance has exemptions for shisha products, loose leaf pipe 9 tobacco, and premium cigars. Id. § 21.2604(c)–(d). The practical effect of the change from 10 flavored smoking products to flavored tobacco products is that the New Ordinance 11 prohibits the sale of more types of products, not just those related to smoking. 12 Plaintiffs are corporations that develop, manufacture, market, and distribute flavored 13 smoking products, flavored tobacco products, flavored electronic smoking devices, and 14 menthol cigarettes. Complaint (“Compl.”) ¶¶ 9–11, ECF No. 1; Supplemental Complaint 15 (“Suppl. Compl.”) ¶ 3, ECF No. 39. Plaintiffs contend they will suffer “substantial 16 financial losses” due to the ordinances. Mot. at 21 (citing Declaration of Lamar W. 17 Huckabee (“Huckabee Decl.”) ¶ 8, ECF No. 6-4; Declaration of Christy L. Canary-Garner 18 (“Canary-Garner Decl.”) ¶ 6, ECF No. 6-3). 19 PROCEDURAL HISTORY 20 On July 9, 2020, Plaintiffs filed their Complaint seeking declaratory and injunctive 21 relief against Defendants. See generally Compl. On July 16, 2020, Plaintiffs filed their 22 Motion for a Preliminary Injunction or Summary Judgment. See generally Mot. 23 Defendants filed their Response in Opposition to Plaintiffs’ Motion (“Opp’n,” ECF. No. 24 15), and Plaintiffs filed a Reply in support of their Motion (“Reply,” ECF No. 16). On 25 September 15, 2020, Defendants filed their Motion to Dismiss for Failure to State a Claim. 26 See generally MTD. Plaintiffs filed a Response in Opposition to Defendants’ Motion to 27 Dismiss, ECF. No. 28, and Defendants filed a Reply in support of their Motion, ECF No. 28 30. 1 This action was originally assigned to the Honorable Roger T. Benitez, but the action 2 was transferred pursuant to the low-number rule to the Honorable Marilyn L. Huff on July 3 15, 2020 as related to Neighborhood Market Association, Inc. v. County of San Diego, Case 4 No. 3:20-cv-01124-JLS-WVG. See generally ECF No. 5. Both actions were reassigned 5 to this Court on August 4, 2020, when Judge Huff recused herself. See ECF No. 18. 6 On March 3, 2021, Plaintiffs requested leave to file a Supplemental Complaint, ECF 7 No. 37, which the Court granted, ECF No. 38. Plaintiffs added two new claims that the 8 New Ordinance is expressly and impliedly preempted by federal law. See generally Suppl. 9 Compl. At the Order of the Court, ECF No. 38, the Parties filed supplemental briefs 10 addressing the effect of the pending motions on Plaintiffs’ Supplemental Complaint, see 11 ECF Nos. 41, 42. 12 On August 28, 2020, California Governor Gavin Newsom approved California 13 Senate Bill 793 (“S.B. 793”), which prohibits the sale of flavored tobacco products or 14 tobacco product flavor enhancers in California. See generally S.B. 793, Act of Aug. 28, 15 2020, 2020 Cal. Legis. Serv. ch. 34 (to be codified at Cal. Health & Safety Code 16 § 104559.5). A referendum challenging S.B. 793 has suspended the operation of the 17 statewide flavored tobacco products sales ban unless and until it is approved by a majority 18 of voters in the November 8, 2022 election. See Cal. Sec. of State, Nov. 8, 2022 Qualified 19 Statewide Ballot Measures, at https://www.sos.ca.gov/elections/ballot-measures/qualified- 20 ballot-measures (last visited Mar. 19, 2021). Because S.B. 793 is not currently in effect, 21 the Court will not examine the effect of the state statute on the present action. 22 /// 23 /// 24 /// 25 /// 26 /// 27 /// 28 /// 1 MOTION FOR PRELIMINARY INJUNCTION 2 Plaintiffs request that the Court preliminarily enjoin Defendants from enforcing the 3 San Diego County ordinances, which ban the sale of flavored tobacco products. Mot. at 3. 4 Plaintiffs argue the ordinances are unconstitutional because they are expressly and 5 impliedly preempted by the Family Smoking Prevention and Tobacco Control Act 6 (“FSPTCA”). Mot. at 6. 7 I. Legal Standard 8 A preliminary injunction is an equitable remedy aimed at preserving the status quo 9 and preventing the occurrence of irreparable harm during the course of litigation. See Fed. 10 R. Civ. P. 65. “A plaintiff seeking a preliminary injunction must establish that he is likely 11 to succeed on the merits, that he is likely to suffer irreparable harm in the absence of 12 preliminary relief, that the balance of equities tips in his favor, and that an injunction is in 13 the public interest.” Winter v. Nat. Res. Def. Council,

(2008). “A 14 preliminary injunction is an extraordinary remedy never awarded as a matter of right.”

15 at 24. Although a plaintiff seeking a preliminary injunction must make a showing on each 16 factor, the Ninth Circuit employs a “version of the sliding scale” approach where “a 17 stronger showing of one element may offset a weaker showing of another.” All. for the 18 Wild Rockies v. Cottrell,

, 1131–35 (9th Cir. 2011). “[W]hen a plaintiff has 19 failed to show the likelihood of success on the merits, we ‘need not consider the remaining 20 three [Winter elements].’” Garcia v. Google, Inc.,

(9th Cir. 2015) (en 21 22 1 On a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), the Court may take into 23 account the Parties’ pleadings, any documents physically attached to those pleadings or incorporated by 24 reference therein, and any documents properly subject to judicial notice. See, e.g., Khoja v. Orexigen Therapeutics, Inc.,

(9th Cir. 2018) (judicial notice and incorporation by reference); 25 Vasquez v. Los Angeles Cnty.,

, 1249 (9th Cir. 2007) (Rule 12(b)(6) motion). “Nonetheless, in deciding a motion for preliminary injunction—unlike a motion to dismiss—the Court is not limited 26 solely to the pleadings and may consider affidavits or declarations along with other evidence submitted by the parties.” Walker v. Woodford,

(S.D. Cal. 2006) (citing Fed. R. Civ. P. 27 65; Univ. of Tex. v. Camenisch,

(1981); Flynt Distrib. Co. v. Harvey,

, 28 1394 (9th Cir. 1984)), aff’d,

(9th Cir. 2010). The Court is guided by these legal 1 banc) (alterations in original) (quoting Ass’n des Eleveurs de Canards et d’Oies du Quebec 2 v. Harris,

(9th Cir. 2013)). 3 II. Analysis 4 Plaintiffs argue that the flavored tobacco and flavored smoking products sales bans 5 violate the Supremacy Clause because the ordinances are expressly and impliedly 6 preempted by the FSPTCA, 21 U.S.C. §§ 387–387u. See generally Mot. The Court will 7 address Plaintiffs’ express and implied preemption arguments in turn. 8 A. Express Preemption 9 In determining whether the ordinances are expressly preempted by the FSPTCA, 10 Congress’s intent “is the ultimate touchstone.” Wyeth v. Levine,

(2009) 11 (quoting Medtronic, Inc. v. Lohr,

(1996)). “Where the federal statute 12 contains an express preemption clause, we must determine the substance and scope of the 13 clause.” Ass’n des Éleveurs de Canards et d’Oies du Quebec v. Becerra,

, 14 1146 (9th Cir. 2017). In so doing, the court assumes “that the historic police powers of the 15 States were not to be superseded by the Federal Act unless that was the clear and manifest 16 purpose of Congress.” Medtronic, Inc.,

(quoting Rice v. Santa Fe Elevator 17 Corp.,

(1947)). And finally, “when the text of a pre-emption clause is 18 susceptible of more than one plausible reading, courts ordinarily ‘accept the reading that 19 disfavors preemption.’” Altria Grp., Inc. v. Good,

(2008) (quoting Bates 20 v. Dow Agrosciences LLC,

(2005)). 21 With these principles in mind, the Court begins its analysis with the plain language 22 of the statute. The FSPTCA amends the Federal Food, Drug, and Cosmetic Act (“FDCA”) 23 to grant the FDA “the authority to regulate tobacco products.” H.R. Rep. No. 111–58, pt. 24 1, at 2 (2009) (the “FSPTCA Report”). The FSPTCA defines a “tobacco product” as “any 25 product made or derived from tobacco that is intended for human consumption, including 26 any component, part, or accessory of a tobacco product (except for raw materials other than 27 tobacco used in manufacturing a component, part, or accessory of a tobacco product),” 28 provided that such product is not “an article that is a drug under [

](g)(1), a 1 device under [

](h), or a combination product described in [21 U.S.C. 2 § 353](g).”

(rr)(1)–(2).2 3 The FSPTCA grants the FDA “the authority to regulate the sale, distribution, 4 advertising, promotion, and use of tobacco products if such actions would be in the interest 5 of the public health,” FSPTCA Report at 26, but prohibits the FDA from “banning a class 6 of nicotine products, such as all cigarettes, or reducing the nicotine level [of such products] 7 to zero,”

. The Act also “requires the [FDA] to establish tobacco product standards 8 to protect the public health.”

9 Section 916 of the FSPTCA, entitled “Preservation of State and Local Authority,” 10 contains three clauses that address the power of state and local governments to enact laws 11 relating to tobacco products: a preservation clause, a preemption clause, and a savings 12 clause. See 21 U.S.C. § 387p(a). The interaction of these three clauses governs whether 13 the ordinances are expressly preempted. First, the Preservation Clause explains that the 14 FSPTCA preserves state and local authority to enact and enforce: 15 any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, 16 requirements established under this subchapter, including a law, 17 rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising 18 and promotion of, or use of tobacco products by individuals of 19 any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. 20

21 Id. § 387p(a)(1). The broad authority preserved for the state and local governments is 22 limited only to the extent that a local law contravenes one of the specific prohibitions 23 enumerated in the Preemption Clause. The Preemption Clause expressly preempts: 24 /// 25

26 2 On May 10, 2016, the FDA exercised the authority Congress conferred upon it in 21 U.S.C. § 387a(b) to deem electronic cigarettes, the type at issue in the Ordinance, to be “tobacco products” subject to the 27 FSPTCA. Deeming Rule, 81 Fed. Reg. at 28,976 (“Products that meet the statutory definition of ‘tobacco 28 products’ include . . . ENDS (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable 1 arenqyu rireeqmuiernetm uenndt ewr hthiceh p irso vdiisffioernesn to ff rtohmis, sourb icnh aapdtdeirt iroenl attoin, ga ntyo 2 tobacco product standards, premarket review, adulteration, 3 misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products. 4

5 Id. § 387p(a)(2)(A). However, state and local laws that would otherwise fall within the 6 Preemption Clause are exempted if they fall within the Savings Clause, which clarifies that 7 the Preemption Clause: 8 does not apply to requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, 9 access to, the advertising and promotion of, or use of, tobacco 10 products by individuals of any age, or relating to fire safety standards for tobacco products. 11

12 Id. § 387p(a)(2)(B). 13 The Second Circuit has held that when these three clauses are read in conjunction, 14 the FSPTCA “distinguishes between manufacturing and the retail sale of finished 15 products; it reserves regulation at the manufacturing stage exclusively to the federal 16 government, but allows states and localities to continue to regulate sales and other 17 consumer-related aspects of the industry in the absence of conflicting federal regulation.” 18 U.S. Smokeless Tobacco Mfg. Co. v. City of New York,

(2d Cir. 2013). 19 Plaintiffs argue that the flavored smoking and tobacco products sales bans are 20 impermissible tobacco products standards, such that the ordinances would fall within the 21 FSPTCA’s Preemption Clause. See Mot. 6–11. Plaintiffs contend that they are likely to 22 succeed on the merits of their claim because the ordinances “establish[] a local 23 requirement that is ‘different from’ and ‘in addition to’ federal requirements related to 24 tobacco product standards,” and therefore the ordinances are expressly preempted.

at 25 6. Plaintiffs maintain that under the FSPTCA, tobacco product standards include 26 “provisions respecting the . . . additives [and] properties of the tobacco product.”

at 7 27 (alterations in original) (quoting 21 U.S.C. § 387g(a)(4)(B)(i)). Because additives include 28 “substances intended for use as flavorings,”

(1), Plaintiffs argue that “a 1 ban on the sale of flavored smoking products qualifies as a tobacco product standard 2 because the ban regulates additives,” Mot. at 7. Plaintiffs further argue that the Savings 3 Clause does not save the ordinances.

at 11–16. 4 Defendants maintain that because the ordinances are sales bans and not tobacco 5 product standards, there is no conflict with the FSPTCA. Opp’n at 14. Even if the Court 6 were to find the sales bans are tobacco product standards, Defendants argue that the 7 Savings Clause acts to save the ordinances because it contains “requirements relating to 8 the sale” of tobacco products.

; see 21 U.S.C. § 387p(a)(2)(B). 9 To determine whether the ordinances are expressly preempted, the Court must first 10 determine whether a sales ban on flavored smoking or tobacco products constitutes a 11 tobacco product standard within the meaning of the FSPTCA. Generally, section 387g 12 governs tobacco product standards, although the term “tobacco product standards” is not 13 expressly defined in the FSPTCA. See generally 21 U.S.C. § 387g. The FSPTCA 14 describes the tobacco product standards as including “provisions that are appropriate for 15 the protection of the public health.” Id. § 387g(a)(4). Tobacco product standards include 16 “provisions respecting the construction, components, ingredients, additives, constituents, 17 including smoke constituents, and properties of the tobacco product”; testing provisions; 18 provisions for nicotine yields; provisions for measurement of tobacco-product 19 characteristics; provisions related to labeling; and “a provision requiring that the sale and 20 distribution of the tobacco product be restricted but only to the extent that the sale and 21 distribution of a tobacco product may be restricted under a regulation under section 22 387f(d) of this title.” Id. § 387g(a)(4). Section 387f(d) states that the sale and distribution 23 of a tobacco product may be restricted by regulation if the Secretary determines that such 24 regulation would be appropriate “for the protection of the public health.” Id. § 387f(d). 25 The FSPTCA sets out two tobacco product standard “[s]pecial rules” and gives the 26 FDA authority to revise those rules as well as adopt additional tobacco standards. Id. 27 /// 28 /// 1 § 387g(a)(3). The “[s]pecial rule for cigarettes” concerns the flavor of cigarettes. The 2 rule prohibits cigarettes from: 3 contain[ing], as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or 4 menthol) or additive, an artificial or natural flavor (other than 5 tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, 6 licorice, cocoa, chocolate, cherry, or coffee, that is a 7 characterizing flavor of the tobacco product or tobacco smoke. 8

9 Id. § 387g(a)(1)(A) (the “Special Rule”). The Special Rule “is intended to prohibit the 10 manufacture and sale of cigarettes with certain ‘characterizing flavors’ that appeal to 11 youth.” FSPTCA Report at 37. 12 Referring to the Special Rule, Plaintiffs argue that “[i]f a ban on all flavored 13 cigarettes except menthol is a tobacco product standard—indeed, the paradigmatic 14 example of a tobacco product standard—then a state law or local ordinance that bans all 15 flavored smoking products including menthol is a tobacco product standard as well.” Mot. 16 at 8 (emphasis in original). However, the Second Circuit has held that a tobacco product 17 standard is a manufacturing regulation, and therefore a sales regulation like the one at 18 issue here is not a tobacco product standard unless it “clearly infringe[s] on the FDA’s 19 authority to determine what chemicals and processes may be used in making tobacco 20 products.” U.S. Smokeless Tobacco Mfg. Co., 708 F.3d at 434–35; see also R.J. Reynolds 21 Tobacco Co. v. Cnty. of Los Angeles,

, 1015 (C.D. Cal. 2020) (“[A] 22 sales ordinance that does not direct manufacturers as to which ingredients they may or 23 may not include is not a preempted tobacco product standard.”). The ordinances do not 24 “direct manufacturers as to which ingredients they may or may not include in their 25 products.” U.S. Smokeless Tobacco Mfg. Co.,

. 26 Plaintiffs present two alternate theories in an attempt to classify the ordinances’ 27 sales bans as tobacco product standards. First, Plaintiffs argue that the sales ban regulates 28 /// 1 additives of tobacco products, and second that it regulates properties of tobacco products. 2 Neither of these arguments is persuasive to the Court, for the following reasons. 3 First, Plaintiffs contend that because “additives” include “substances intended for 4 use as a flavoring,”

(1), “a ‘tobacco product standard’ includes any 5 provision respecting the substances intended for use as a tobacco-product flavoring,” Mot. 6 at 7. This argument is misplaced because the ordinances do not regulate additives. The 7 Ordinance bans the sale or distribution “of all flavored smoking products . . . .” San Diego 8 County, Cal., Code of Regulatory Ordinances, tit. 3, div. 2, ch. 8.8, § 32.883(a) (2020). 9 Flavored smoking products are defined as products that “emit[] a taste or smell, other than 10 the taste or smell of tobacco.” Id. § 32.882(b). Similarly, the New Ordinance bans the 11 sale of “a flavored tobacco product or a tobacco product flavor enhancer.” San Diego 12 County, Cal., Code of Regulatory Ordinances, tit. 2, div. 1, ch. 26, § 21.2604(a) (2021). 13 A “flavored tobacco product” is defined as “any tobacco product that contains a taste or 14 smell, other than the taste or smell of tobacco, that is distinguishable by an ordinary 15 consumer either prior to or during the consumption of the product.” Id. § 21.2602(i). 16 Neither of the ordinances specifies permitted or banned ingredients. These are sales bans 17 directed at what end products are available to consumers, not a directive to manufacturers 18 about what materials are permitted to make tobacco products. The latter would be a 19 tobacco product standard falling within the Preemption Clause, but the former is explicitly 20 contemplated by the FSPTCA and permitted. Therefore, the ordinances’ sales bans do not 21 regulate additives and cannot be considered tobacco product standards. This result is 22 required by the express terms of the FSPTCA, which state that the Act is not to be 23 “construed to limit the authority of . . . a State or political subdivision of a State . . . to 24 enact . . . and enforce any . . . measure . . . prohibiting the sale . . . of tobacco products.” 25 21 U.S.C. § 387p(a)(1). 26 Some courts have held that a sales ban could be considered a tobacco product 27 standard if the sales ban is a de facto manufacturing regulation. See U.S. Smokeless 28 Tobacco Mfg. Co.,

n.2. An example of such a de facto manufacturing 1 regulation can be found in the law at issue in National Meat Association v. Harris, 565

(2012). In National Meat Association, a California law prohibited 3 slaughterhouses from buying, processing, or selling nonambulatory animals or their meat. 4 See

at 458–59. The prohibition on the sale of meat derived from nonambulatory 5 animals was preempted by the Federal Meat Inspection Act because the “idea – and the 6 inevitable effect – of the provision is to make sure that slaughterhouses remove 7 nonambulatory pigs from the production process.”

. Therefore, the sales ban in 8 National Meat Association was preempted because the law “serves to regulate how 9 slaughterhouses must deal with non-ambulatory pigs on their premises.”

The only 10 way to determine whether a product was banned under the law in National Meat 11 Association was to consider how it was manufactured. This is not analogous to the present 12 regulation, which does not regulate how tobacco manufacturers manufacture products, but 13 instead determines what end products are allowed on retail shelves based on identifiable 14 end product characteristics. 15 The Honorable Dale S. Fischer of the U.S. District Court for the Central District of 16 California examined a similar flavored tobacco products sales ban in Los Angeles County. 17 See generally Cnty. of Los Angeles,

. The Central District court 18 concluded that the Los Angeles County sales ban on flavored tobacco products is not a de 19 facto manufacturing regulation because the ordinance banned the sale of “products [that] 20 can be identified based on how they are marketed and sold.”

Similarly, the San Diego 21 County ordinances at issue here identify banned products based on whether they “emit[] 22 a taste or smell, other than the taste or smell of tobacco . . . .” San Diego County, Cal., 23 Code of Regulatory Ordinances, tit. 3, div. 2, ch. 8.8, § 32.882(b) (2020); see also San 24 Diego County, Cal., Code of Regulatory Ordinances, tit. 2, div. 1, ch. 26, § 21.2602(i) 25 (2021) (defining “flavored tobacco product” as “any tobacco product that contains a taste 26 or smell, other than the taste or smell of tobacco”). Therefore, the ingredients or additives 27 used by the manufacturer are irrelevant because the banned products are identifiable at the 28 consumer stage if the product emits or contains a smell or taste other than tobacco. 1 Second, Plaintiffs argue that the term “properties” encompasses “flavors,” and 2 because the ordinances “regulate[]” flavors, they create tobacco product standards. Mot. 3 at 8 (citing 21 U.S.C. § 387g(a)(4)(B)(i)). To support this argument, Plaintiffs rely on a 4 proposed rule that purports to interpret the statutory language of the FSPTCA. See 5 Premarket Tobacco Product Applications and Recordkeeping Requirements,

50,566–637 (proposed Sept. 25, 2019) (“If the product does not have a listed product 7 property, such as . . . characterizing flavor, the application must state ‘none’ for that 8 property.”). Plaintiffs argue that because the proposed rule considers a tobacco product’s 9 “characterizing flavor” to be a “product property,” the Court should apply the same 10 interpretation to the FSPTCA’s tobacco product standards. See Mot. at 8. In the Ninth 11 Circuit, “proposed regulations carry no more weight than a position advanced on brief.” 12 Tedori v. United States,

(9th Cir. 2000) (citation omitted). If the 13 proposed rule were to become final, it would be entitled to deference by this Court under 14 Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc.,

(1984), but such is 15 not the case here. 16 Only one court that examined the constitutionality of a flavored tobacco product 17 sales ban agreed with Plaintiffs’ present argument and held that the ban fell within the 18 FSPTCA’s definition of tobacco product standards. See R.J. Reynolds Tobacco Co. v. 19 City of Edina, No. 20-CV-1402 (PJS/LIB),

, at *4 (D. Minn. Aug. 31, 20 2020). The Edina court found that “tobacco-product standards include ‘provisions 21 respecting the . . . properties’ of tobacco products, and there can be no dispute that a 22 provision respecting the flavor of a tobacco product is a provision respecting a ‘propert[y]’ 23 of that product.”

(quoting 21 U.S.C. § 387g(a)(4)). This made no difference in the 24 outcome of the case, however, because the Edina court found that, “[o]n its face, the 25 Ordinance falls within the scope of the Savings Clause, as it is a ‘requirement[ ] relating 26 to the sale . . . of . . . tobacco products by individuals of any age . . . .’” Id. (quoting 21 27 U.S.C. § 387p(a)(2)(B)) (alterations in original). However, this Court follows the Second 28 Circuit, which held that this reading of the Preemption Clause is overly broad. See U.S. 1 Smokeless Tobacco Mfg. Co.,

. If the Court found that a retail sales ban 2 on end products is a preempted tobacco product standard, it “would render superfluous 3 § 916’s three-part structure . . . [and] vitiate the preservation clause’s instruction that the 4 Act not be ‘construed to limit the authority of . . . a State or political subdivision of a State 5 . . . to enact . . . and enforce any . . . measure . . . prohibiting the sale . . . of tobacco 6 products.’” Id. (quoting 21 U.S.C. § 387p(a)(1)) (alterations in original). If possible, 7 statutes should be construed to give effect to every clause and word. See, e.g., Babbitt v. 8 Sweet Home Chapter of Cmtys. for a Great Or.,

(1995) (describing the 9 Court’s “reluctance to treat statutory terms as surplusage”). Accordingly, Plaintiffs’ 10 “properties” argument is similarly unavailing. 11 Other courts that have addressed whether similar local ordinances banning or 12 restricting access to flavored tobacco products were preempted by the FSPTCA have 13 uniformly held that they were not. See, e.g., Nat’l Ass’n of Tobacco Outlets v. City of 14 Providence,

, 82–83, 85 & n.11 (1st Cir. 2013) (holding that tobacco product 15 sales regulations are not tobacco product standards preempted by the FSPTCA and stating 16 that “whether those regulations have an impact on manufacturing is irrelevant”); U.S. 17 Smokeless Tobacco Mfg. Co.,

(holding an ordinance that banned the sale 18 of flavored tobacco products was not preempted by the FSPTCA); Cnty. of Los Angeles, 19 471 F. Supp. 3d at 1018 (same); Indeps. Gas & Serv. Stations Ass’ns v. City of Chicago, 20

(N.D. Ill. 2015) (holding that ordinance that restricted sale of 21 flavored tobacco near schools was not preempted by the FSPTCA); City of Edina, 2020

, at *3 (holding a ban on the sale of flavored tobacco products was a tobacco 23 product standard that falls within the Savings Clause and is therefore not preempted by 24 the FSPTCA). While not binding on this Court, the findings of these courts are persuasive. 25 Accordingly, the Court finds that the ordinances’ sales bans on flavored smoking and 26 tobacco products are not tobacco product standards and therefore are not expressly 27 preempted by the FSPTCA. 28 /// 1 In the absence of Ninth Circuit authority, this Court follows the First and Second 2 Circuits and concludes that the sales regulations in the ordinances do not “clearly infringe 3 on the FDA’s authority to determine what chemicals and processes may be used in making 4 tobacco products.” U.S. Smokeless Tobacco Mfg. Co.,

; see also Nat’l 5 Ass’n of Tobacco Outlets,

. Therefore, the ordinances do not constitute a 6 tobacco product standard, and Plaintiffs are unlikely to succeed on the merits of their 7 express preemption claim. 8 B. Implied Preemption 9 Next, Plaintiffs argue that the ordinances are impliedly preempted “because [they] 10 ‘stand[] as an obstacle to the accomplishment and execution of the full purposes and 11 objectives of Congress.’” Mot. at 16 (quoting Crosby v. Nat’l Foreign Trade Council, 12

(2000)). Plaintiffs contend that the sales bans (1) undermine the ability 13 of the FDA to set national standards for the manufacturing of tobacco products, (2) 14 undermine Congress and the FDA’s judgment that certain flavored smoking and tobacco 15 products should remain on the market, and (3) interfere with the regulatory process chosen 16 by Congress to effectuate its objective.

at 16–21. In response, Defendants argue that 17 the FSPTCA’s Preemption Clause expressly “‘defin[es] the pre-emptive reach’ of the Act 18 on State and local regulation of tobacco sales.” Opp’n at 21 (quoting Ass’n des Éleveurs 19 de Canards et d’Oies du Quebec v. Becerra,

(9th Cir. 2017)). 20 Defendants contend that “matters beyond that reach are not pre-empted.”

(quoting 21 Ass’n des Éleveurs de Canards et d’Oies du Quebec,

). 22 In analyzing implied preemption, “[a]s with express preemption, courts assume that 23 the historic police powers of the States are not superseded unless that was the clear and 24 manifest purpose of Congress.” Ass’n des Éleveurs de Canards et d’Oies du Quebec, 870 25 F.3d at 1149. “Implied preemption analysis does not justify a ‘freewheeling judicial 26 inquiry into whether a state statute is in tension with federal objectives’; such an endeavor 27 ‘would undercut the principle that it is Congress rather than the courts that pre-empts state 28 law.’” Chamber of Commerce of U.S. v. Whiting,

(2011) (quoting Gade 1 v. Nat’l Solid Wastes Mgmt. Ass’n,

(1992)). The language of the 2 FSPTCA’s Preemption Clause “implies that matters beyond that reach are not pre-empted.” 3 Ass’n des Éleveurs de Canards et d’Oies du Quebec,

(quoting Cipollone 4 v. Liggett Grp., Inc.,

(1992)); see Graham v. R.J. Reynolds Tobacco Co., 5

(11th Cir. 2017) (“Congress’ intent, of course, primarily is discerned 6 from the language of the pre-emption statute and the ‘statutory framework’ surrounding 7 it.”). 8 First, Plaintiffs argue that the ordinances are impliedly preempted because Congress 9 adopted the FSPTCA to “set national standards controlling the manufacture of tobacco 10 products and the . . . amount of ingredients used in such products.” Mot. at 14 (citing 21

note). This argument is unavailing because the Court concluded that the 12 ordinances do not set manufacturing standards or regulate the ingredients used in tobacco 13 products. See supra Section II.A. Generally, a ban on certain finished tobacco products 14 will not cause manufacturers to change the ingredients they use or the way that they 15 manufacture products; however, it is conceivable that a large enough sales ban on certain 16 products could change manufacturing behavior. See City of Edina,

, at 17 *6 (“[I]f every municipality in the United States adopted a similar ordinance, that would 18 as a practical matter amount to a nationwide ban on the use of certain ingredients, because 19 it would become impossible for manufacturers to sell a product that contained those 20 ingredients.”). However, this Court already determined that the ordinances do not regulate 21 the ingredients or additives used in products because the ordinances regulate the sale of 22 end products based on characterizing smells and tastes. The “clear and manifest purpose 23 of Congress,” Ass’n des Éleveurs de Canards et d’Oies du Quebec,

, was 24 to preserve state and local authority to enact such sales bans, as evidenced by the 25 Preservation Clause. The ordinances classify end products based on characterizing flavors 26 or smells; therefore, the ordinances do not infringe on the FSPTCA’s authority to regulate 27 the ingredients used in tobacco products. 28 /// 1 Second, Plaintiffs contend that the ordinances undermine Congress and the FDA’s 2 “judgment that certain flavored smoking [and tobacco] products—including menthol 3 cigarettes and menthol-flavored [electronic nicotine delivery system (“]ENDS[”)] 4 products—should remain on the market.” Mot. at 17; see also ECF No. 42 at 6. This 5 argument ignores that the FSPTCA expressly gives states and local governments the power 6 to prohibit the sale of tobacco products, even if those sales bans are stricter than the federal 7 ban, so long as the regulation is not covered by the Preemption Clause. See U.S. Smokeless 8 Tobacco Mfg. Co.,

(“While § 907(d)(3) prohibits the FDA from banning 9 entire categories of tobacco products throughout the country, 21 U.S.C. § 387g(d)(3), the 10 FSPTCA nowhere extends that prohibition to state and local governments. To the contrary, 11 the preservation clause of § 916 expressly preserves localities’ traditional power to adopt 12 any ‘measure relating to or prohibiting the sale’ of tobacco products.” (footnote omitted)); 13 see also Berger v. Philip Morris USA, Inc.,

, 1340–41 (M.D. Fla. 14 2016), aff’d sub nom. Cote v. R.J. Reynolds Tobacco Co.,

(11th Cir. 2018) 15 (“[S]tate-law prohibitions on cigarette sales can stand side-by-side with the fact that 16 Congress has tolerated cigarettes and purposefully refrained from banning them.”). By the 17 very language of the FSPTCA, a stricter sales ban can stand side-by-side with federal 18 regulations. 19 Plaintiffs argue that if Congress chooses not to act against a particular product, like 20 menthol-flavored ENDS products, Congress affirmatively intends for that product to 21 remain on the market. See Mot. at 18. However, failure to take active steps to prohibit a 22 product is not equivalent to an affirmative decision that the product should remain on the 23 national market. Cf. Astiana v. Hain Celestial Grp., Inc.,

(9th Cir. 2015) 24 (rejecting the defendant’s argument that “the FDA’s failure to issue specific regulations on 25 [use of the word ‘natural’] is tantamount to a conscious decision by the agency to permit 26 any use of this term a manufacturer sees fit”). 27 Finally, Plaintiffs argue that the ordinances “interfere[] with ‘the method chosen by 28 Congress to effectuate [its] objective.’” Mot. at 19 (quoting McDaniel v. Wells Fargo 1 Invs., LLC,

(9th Cir. 2013)). Plaintiffs contend that in the FSPTCA, 2 Congress “created a detailed regulatory process as the sole method for evaluating the 3 design and sale of new tobacco products . . . , [and] Congress intended to subject each new 4 tobacco product to one regulatory assessment conducted by FDA, not multiple rounds of 5 assessments by states and localities.”

As the Court has already determined, the 6 FSPTCA “reserves regulation at the manufacturing stage exclusively to the federal 7 government, but allows states and localities to continue to regulate sales and other 8 consumer-related aspects of the industry in the absence of conflicting federal regulation.” 9 U.S. Smokeless Tobacco Mfg. Co.,

. Thus, the Court disagrees with 10 Plaintiffs’ characterization of Congress’ objective in enacting the FSPTCA. 11 Accordingly, the Court finds the ordinances do not stand as obstacles to the 12 objectives of the FSPTCA, and Plaintiffs have not shown a likelihood of success on the 13 merits of their implied preemption claim. The Court need not address the remaining factors 14 necessary for injunctive relief because Plaintiffs have failed to establish any chance of 15 success on the merits of their express preemption or implied preemption claims. See 16 Garcia,

. Therefore, the Court DENIES Plaintiffs’ Motion for Preliminary 17 Injunction. See, e.g., Sports Form, Inc. v. United Press Int’l, Inc.,

(9th 18 Cir. 1982) (affirming district court’s denial of preliminary injunction where the plaintiff 19 “had failed to show any chance of success on the merits,” which “made a determination of 20 potential injury or a balancing of hardships unnecessary”). 21 MOTION TO DISMISS 22 Federal Rule of Civil Procedure 12(b)(6) permits a party to raise by motion the 23 defense that the complaint “fail[s] to state a claim upon which relief can be granted,” 24 generally referred to as a motion to dismiss. The Court evaluates whether a complaint 25 states a cognizable legal theory and sufficient facts in light of Federal Rule of Civil 26 Procedure 8(a), which requires a “short and plain statement of the claim showing that the 27 pleader is entitled to relief.” Although Rule 8 “does not require ‘detailed factual 28 allegations,’ . . . it [does] demand more than an unadorned, the-defendant-unlawfully- 1 harmed-me accusation.” Ashcroft v. Iqbal,

(2009) (quoting Bell Atl. 2 Corp. v. Twombly,

(2007)). In other words, “a plaintiff’s obligation to 3 provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and 4 conclusions, and a formulaic recitation of the elements of a cause of action will not do.” 5 Twombly,

(citing Papasan v. Allain,

(1986)). A 6 complaint will not suffice “if it tenders ‘naked assertion[s]’ devoid of ‘further factual 7 enhancement.’” Iqbal,

(citing Twombly,

). 8 To survive a motion to dismiss, “a complaint must contain sufficient factual matter, 9 accepted as true, to ‘state a claim to relief that is plausible on its face.’”

(quoting 10 Twombly,

); see also Fed. R. Civ. P. 12(b)(6). A claim is facially plausible 11 when the facts pled “allow the court to draw the reasonable inference that the defendant is 12 liable for the misconduct alleged.” Iqbal,

(citing Twombly,

556). That is not to say that the claim must be probable, but there must be “more than a 14 sheer possibility that a defendant has acted unlawfully.”

Facts “‘merely consistent 15 with’ a defendant’s liability” fall short of a plausible entitlement to relief.

(quoting 16 Twombly,

). This review requires context-specific analysis involving the 17 Court’s “judicial experience and common sense.”

(citation omitted). “[W]here 18 the well-pleaded facts do not permit the court to infer more than the mere possibility of 19 misconduct, the complaint has alleged—but it has not ‘show[n]’—‘that the pleader is 20 entitled to relief.’”

21 Where a complaint does not survive 12(b)(6) analysis, the Court will grant leave to 22 amend unless it determines that no modified contention “consistent with the challenged 23 pleading . . . [will] cure the deficiency.” DeSoto v. Yellow Freight Sys., Inc.,

, 24 658 (9th Cir. 1992) (quoting Schreiber Distrib. Co. v. Serv-Well Furniture Co.,

1393, 1401 (9th Cir. 1986)). 26 Defendants seek to have Plaintiffs’ Complaint and Supplemental Complaint 27 dismissed for failure to state a claim because there is no plausible argument that the 28 ordinances are expressly or impliedly preempted. See generally MTD; see also ECF No. 1 41 at 2–3. Defendants argue that “Plaintiffs cannot establish that the Act expressly or 2 impliedly preempts the Ordinance . . . [and] these defects cannot possibly be cured by 3 amendment . . . .”

. Plaintiffs bring only the claims for express and implied 4 preemption. See generally Compl.; Suppl. Compl. The Court already examined the merit 5 of these claims supra at Sections II.A–II.B and found that Plaintiffs have not proven a 6 likelihood of success on the merits of their express and implied preemption claims. 7 Therefore, the Court GRANTS Defendants’ Motion to Dismiss Plaintiffs’ 8 Complaint and Supplemental Complaint, as the Court does not find Plaintiffs’ preemption 9 claims plausible in light of the plain statutory language of the ordinances and the FSPTCA. 10 See Angelotti Chiropractic, Inc. v. Baker,

(9th Cir. 2015) (reversing 11 district court’s grant of preliminary injunction where there was no “serious question” going 12 to the merits of the claim and, consequently, reversing district court’s denial of motion to 13 dismiss as to that claim); Kelley v. Mortg. Elec. Registration Sys., Inc.,

(N.D. Cal. 2009) (granting motions to dismiss and therefore denying motion 15 for preliminary injunction for failure to show likelihood of success on the 16 merits); Washington v. O’Dell, No. 3:17-CV-1615-MMA-PCL,

, at *10 17 (S.D. Cal. Apr. 25, 2018) (denying preliminary injunction when granting motion to 18 dismiss); Physician’s Surrogacy, Inc. v. German, No. 17CV718-MMA (WVG),

638229, at *11 (S.D. Cal. Jan. 31, 2018) (same); Wallace v. Sosa, No. 16-CV-01501-BAS- 20 BGS,

, at *4–5 (S.D. Cal. Feb. 3, 2017) (same); Ananiev v. Aurora Loan 21 Servs., LLC, No. C 12-2275 SI,

, at *8 (N.D. Cal. July 10, 2012) (same). 22 CONCLUSION 23 For the reasons discussed above, the Court DENIES Plaintiffs’ Motion for 24 Preliminary Injunction (ECF No. 6) and GRANTS Defendants’ Motion to Dismiss (ECF 25 No. 26). Plaintiffs’ Complaint and Supplemental Complaint are DISMISSED 26 /// 27 /// 28 /// 1 || WITHOUT PREJUDICE. Plaintiffs may file an amended complaint within thirty (30) 2 || days of the date on which this Order is electronically docketed. 3 IT IS SO ORDERED. 4 || Dated: March 29, 2021 tt 5 jen Janis L. Sammartino 6 United States District Judge 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28