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`Steven N. Geise (SBN 249969)
`JONES DAY
`sngeise@jonesday.com
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`Tel: (858) 314-1200
`
`[Additional counsel identified on signature page]
`Counsel for Plaintiffs
`R.J. Reynolds Tobacco Company; R.J. Reynolds
`Vapor Company; American Snuff Company, LLC;
`Santa Fe Natural Tobacco Company, Inc.;
`Neighborhood Market Association, Inc.; and
`Morija, LLC dba Vapin’ the 619
`
`Tommy Huynh (SBN 306222)
`ARNOLD & PORTER KAYE SCHOLER LLP
`Tommy.Huynh@arnoldporter.com
`Three Embarcadero Center, 10th Floor
`San Francisco, CA 94111-4024
`Tel: (415) 471-3100
`Fax: (415) 471-3400
`
`[Additional counsel identified on signature page]
`Counsel for Plaintiffs
`Philip Morris USA Inc; John Middleton Co.; U.S.
`Smokeless Tobacco Company LLC; and Helix
`Innovations LLC.
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`
`R.J. REYNOLDS TOBACCO COMPANY;
`R.J. REYNOLDS VAPOR COMPANY;
`AMERICAN SNUFF COMPANY, LLC;
`SANTA FE NATURAL TOBACCO
`COMPANY, INC.; PHILIP MORRIS USA
`INC.; JOHN MIDDLETON CO.; U.S.
`SMOKELESS TOBACCO COMPANY LLC;
`HELIX INNOVATIONS LLC;
`NEIGHBORHOOD MARKET
`ASSOCIATION, INC.; and MORIJA, LLC dba
`VAPIN’ THE 619,
`
`Plaintiffs,
`
`
`
`
`
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`
`
`Case No.
`COMPLAINT FOR
`DECLARATORY AND
`INJUNCTIVE RELIEF
`
`
`v.
`
`XAVIER BECERRA, in his official capacity as
`Attorney General of California; and SUMMER
`STEPHAN, in her official capacity as District
`Attorney for the County of San Diego,
`
`
`Defendants.
`
`COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
`
`'20
`
`CV1990
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`RBB
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`LAB
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`Plaintiffs R.J. Reynolds Tobacco Company (“RJRT”), R.J. Reynolds Vapor
`Company (“RJRV”), American Snuff Company, LLC (“ASC”), Santa Fe Natural
`Tobacco Company, Inc. (“Santa Fe”), Philip Morris USA Inc. (“PM USA Inc.”),
`John Middleton Co. (“JMC”), U.S. Smokeless Tobacco Company LLC (“UST”),
`Helix Innovations LLC (“Helix”), Neighborhood Market Association, Inc., and
`MORIJA, LLC dba Vapin’ the 619 bring this action for declaratory and injunctive
`relief against Defendants Xavier Becerra, in his official capacity as Attorney General
`of California, and Summer Stephan, in her official capacity as District Attorney for
`the County of San Diego.
`PRELIMINARY STATEMENT
`In an overbroad reaction to legitimate public-health concerns about
`1.
`youth use of tobacco products, the state of California recently enacted the most
`draconian ban on tobacco products of any state in the nation. California is rightly
`concerned with youth use of tobacco products. Although youth use of combustible
`cigarettes is at an all-time low, youth vaping and serious health issues from illicit
`products are at the heart of a national discussion. But California’s new law, Senate
`Bill 793, strikes far broader than necessary, banning menthol cigarettes, menthol-
`flavored vapor products, and myriad other flavored tobacco products manufactured
`and sold by Plaintiffs R.J. Reynolds Tobacco Company, R.J. Reynolds Vapor
`Company, American Snuff Company, LLC, and Santa Fe Natural Tobacco Company
`(collectively, “Reynolds”), and by Plaintiffs Philip Morris USA Inc., John Middleton
`Co., U.S. Smokeless Tobacco Company LLC, and Helix Innovations LLC
`(collectively, “PM USA”). SB793 also bans flavored tobacco products sold by
`Plaintiff Vapin’ the 619 as well as by members of Plaintiff Neighborhood Market
`Association.
`Reynolds and PM USA are committed to keeping tobacco products out
`2.
`of the hands of youth. Reynolds and PM USA have rigorous standards to ensure their
`marketing is accurate and responsibly directed to adult tobacco consumers aged
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`twenty-one and over. Reynolds and PM USA also have strict compliance policies for
`retailers who sell their products to prevent youth from purchasing tobacco products
`and support programs that train retailers to comply with age restrictions.
`The federal Food and Drug Administration shares Reynolds’s and PM
`3.
`USA’s goals, and, earlier this year, effectively banned the sale of flavored cartridge-
`based electronic nicotine delivery system (“ENDS”) products (other than tobacco- or
`menthol-flavored cartridge-based ENDS products). FDA, Enforcement Priorities for
`Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the
`Market Without Premarket Authorization (Revised) 19 (Apr. 2020), available at
`https://www.fda.gov/media/121384/download (“Enforcement Priorities”). In fact,
`the latest report from FDA finds that “1.8 million fewer U.S. youth are currently
`using e-cigarettes compared to 2019.” FDA Statement, National Survey Shows
`Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use
`of Disposable Products (Sept. 9, 2020), available at https://tinyurl.com/y3rpwfph.
`As FDA recognizes, “[t]his is good news” (id.), and it also shows that FDA’s efforts
`as well as those by industry leaders such as Reynolds and PM USA are paying off.
`California could have supplemented these efforts by targeting youth
`4.
`usage of vapor products (and other tobacco products) through increased enforcement
`of age restrictions or public-education campaigns. Instead, Senate Bill 793, which
`added Article 5 to Chapter 1 of Part 3 of Division 103 of the Health and Safety Code,
`bans sales to adult tobacco consumers in the state and, moreover, indiscriminately
`extends the ban to nearly every conceivable flavored tobacco product, from menthol
`cigarettes and smokeless tobacco to flavored vapor products and other flavored
`products. This categorical ban is unjustified.
`For one, Congress has already banned all characterizing flavors in
`5.
`cigarettes other than tobacco or menthol. 21 U.S.C. § 387g(a)(1)(A). And as to
`menthol, Congress left it to FDA to determine whether that flavor should be banned
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`when it comes to cigarettes. To date, even though FDA has studied the issue, FDA
`has chosen not to ban menthol in cigarettes.
`law could have adverse public health
`6. Moreover, California’s
`consequences. FDA’s Director of the Center for Tobacco Products has asserted that
`“[d]ramatically and precipitously reducing availability of [electronic nicotine
`delivery system products (“ENDS”)] could present a serious risk that adults,
`especially former smokers, who currently use ENDS products and are addicted to
`nicotine would migrate to combustible tobacco products.” Am. Acad. of Pediatrics v.
`FDA, No. 8:18-cv-883, Dkt. 120-1, at ¶ 15 (D. Md. filed June 12, 2019) (Decl. of
`Director of FDA’s Center for Tobacco Products Mitchell Zeller) (“Zeller Decl.”).
`This risk of migration is especially pronounced for menthol-flavored products. When
`FDA previously considered restrictions on flavored ENDS products, FDA declined
`to impose restrictions on menthol-flavored ENDS products precisely because adults
`who used those products “may be at risk of migrating back to cigarettes, which
`continue to be available in menthol flavor, in the absence of access to mint- and
`menthol-flavored ENDS products.” See FDA, Modifications to Compliance Policy
`for Certain Deemed Tobacco Products 19
`(Mar. 2019), available at
`https://tinyurl.com/yyywgoat.
`But not only is California’s law misguided, the sweeping ban is also
`7.
`preempted by federal
`law and
`therefore unconstitutional under
`the U.S.
`Constitution’s Supremacy Clause. In addition, California’s law violates the dormant
`Commerce Clause and is thus unconstitutional.
`First, federal law expressly preempts the state’s ban on flavored tobacco
`8.
`products. The manufacture of tobacco products is subject to intensive regulation by
`the federal Government. In striking a balance between federal authority and state
`authority over the regulation of tobacco products, Congress expressly denied states
`the ability to promulgate any requirement relating to tobacco product standards that
`are different from or in addition to federal standards. California’s ban on flavored
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`tobacco products, however, is a product standard because it regulates the ingredients,
`additives, and properties of those products. California’s ban is thus expressly
`preempted by federal law.
`Second, federal law also impliedly preempts California’s law because
`9.
`the state’s ban stands as an obstacle to the purposes of federal law. Congress
`authorized FDA to promulgate tobacco product standards that, in appropriate
`circumstances, can establish uniform, national standards for the manufacture of
`tobacco products and the ingredients used in such products. Congress and FDA have
`made the judgment that certain tobacco products, particularly menthol cigarettes,
`should remain available to adult users of tobacco products. California’s ban,
`however, conflicts with those federal goals and must give way.
`10. Third, because California’s law attempts to regulate manufacturers that
`are not within the state’s borders, the law violates the dormant Commerce Clause.
`And because California’s ban does so, it is unconstitutional and must be set aside.
`11. California has no legitimate interest in enforcing its unconstitutional
`law. The Court should thus grant injunctive and declaratory relief preventing the
`Defendants and their agents from violating the U.S. Constitution’s Supremacy Clause
`and Commerce Clause.
`
`PARTIES
`12. Plaintiff RJRT is a North Carolina corporation headquartered in
`Winston-Salem, North Carolina. RJRT is a leading manufacturer of tobacco
`products. In particular, RJRT develops, manufactures, markets, and distributes a
`variety of flavored tobacco products under a variety of brand names, including
`menthol cigarettes under the brand names Newport and Camel, among others, and
`flavored smokeless tobacco products under the brand name Camel SNUS.
`13. Plaintiff RJRV is a North Carolina corporation headquartered in
`Winston-Salem, North Carolina. RJRV develops, manufactures, markets, distributes,
`and sells menthol-flavored electronic nicotine delivery devices under the brand name
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`“VUSE” and a variety of flavored oral nicotine pouches and lozenges under the brand
`name VELO.
`14. Plaintiff ASC is a North Carolina corporation headquartered in
`Winston-Salem, North Carolina. ASC develops, manufactures, markets, and
`distributes a variety of flavored smokeless tobacco products, including under the
`brand name “Grizzly.”
`15. Plaintiff Santa Fe is a New Mexico corporation headquartered in
`Oxford, North Carolina. Santa Fe develops, manufactures, markets, and distributes
`menthol cigarettes under the brand name Natural American Spirit.
`16. All of the aforementioned flavored products manufactured and
`distributed by RJRT, RJRV, ASC, and Santa Fe qualify as “flavored tobacco
`product[s]” that are prohibited under Senate Bill 793.
`17. Plaintiff PM USA Inc. is a Virginia corporation and has its principal
`place of business in Richmond, Virginia. PM USA Inc. is a leading manufacturer of
`cigarettes in the United States. PM USA Inc. sells cigarettes under a number of
`leading brands, including Marlboro, Parliament, Virginia Slims, and L&M. Certain
`of PM USA Inc.’s products qualify as “flavored tobacco product[s]” that are
`prohibited under Senate Bill 793.
`18. Plaintiff JMC is a Pennsylvania limited liability company and has its
`principal place of business in Pennsylvania. JMC manufactures pipe tobacco and
`large machine-made cigars under a variety of brands, including Black & Mild,
`Kentucky Club, and Prince Albert. Certain of JMC’s products qualify as “flavored
`tobacco product[s]” that are prohibited under Senate Bill 793.
`19. Plaintiff UST is a Virginia limited liability company and has its
`principal place of business in Richmond, Virginia. UST manufactures moist
`smokeless tobacco under a variety of brand names, including Copenhagen, Skoal,
`Red Seal, and Husky. Certain of UST’s products qualify as “flavored tobacco
`product[s]” that are prohibited under Senate Bill 793.
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`20. Plaintiff Helix is a Delaware limited liability company and has its
`principal place of business in Richmond, Virginia. Helix manufactures oral nicotine
`pouches under the brand name “on!”. Certain of Helix’s products qualify as “flavored
`tobacco product[s]” that are prohibited under Senate Bill 793.
`21. Neighborhood Market Association is a local non-profit industry trade
`association comprised of various family-owned businesses within San Diego County,
`California. The Association has members who are tobacco retailers, wholesalers, and
`manufacturers located within the County that will be subject to Senate Bill 793 once
`it goes into effect. Many of the Association’s tobacco retailers sell flavored tobacco
`products, including those manufactured by RJRT, RJRV, ASC, and Santa Fe. Those
`retailers will no longer be able to sell “flavored tobacco product[s],” as defined in
`Senate Bill 793, once the law goes into effect. But for Senate Bill 793, those members
`who currently sell flavored tobacco products would continue to do so to consumers
`in California. Dozens of NMA’s members, including Vapin’ the 619, will likely have
`to close shop completely and lay off their employees if California’s ban goes into
`effect.
`22. MORIJA, LLC is headquartered in El Cajon, California. The company
`does business as Vapin’ the 619 and is a tobacco retailer with a retail establishment
`located on Clairemont Mesa Boulevard in the City of San Diego, California. The
`establishment exclusively sells electronic smoking devices and e-liquid tobacco
`products used in conjunction with such devices. In particular, the establishment sells
`flavored tobacco products as defined in Senate Bill 793. Vapin’ the 619 will no longer
`be able to sell “flavored tobacco product[s],” as defined in Senate Bill 793, once the
`law goes into effect. But for Senate Bill 793, Vapin’ the 619 would continue to sell
`flavored tobacco products to consumers in California. If Senate Bill 793 does go into
`effect, Vapin’ the 619 will likely have to close its store permanently and lay off its
`employees.
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`23. Defendant Xavier Becerra is sued in his official capacity as Attorney
`General of California. The Attorney General is “the chief law officer of the state”
`and exercises “direct supervision over every district attorney.” Cal. Const. art. V,
`§ 13. The California Constitution also imposes on the Attorney General the duty “to
`prosecute any violations of law” and grants him “all the powers of a district attorney”
`whenever he believes that the law is not being adequately enforced. Id. Because a
`violation of Senate Bill 793 is an “infraction,” the Attorney General has direct
`enforcement power of the law and supervises district attorneys who also have
`enforcement power. Cal. Gov. Code § 26500 (“[t]he district attorney is the public
`prosecutor” who “shall initiate and conduct on behalf of the people all prosecutions
`for public offenses”); see also Cal. Penal Code § 16 (defining “[c]rimes and public
`offenses” to include “infraction[s]”).
`24. Defendant Summer Stephan is sued in her official capacity as District
`Attorney for the County of San Diego. As District Attorney, Stephan has the power
`to enforce Senate Bill 793 because a violation of that law is an “infraction.” Cal. Gov.
`Code § 26500 (“[t]he district attorney is the public prosecutor” who “shall initiate
`and conduct on behalf of the people all prosecutions for public offenses”); see also
`Cal. Penal Code § 16 (defining “[c]rimes and public offenses” to include
`“infraction[s]”).
`
`JURISDICTION AND VENUE
`25. The Court has subject-matter jurisdiction under 28 U.S.C. § 1331
`because this action arises under the Constitution and laws of the United States.
`26. This Court also has authority to grant relief under the Declaratory
`Judgment Act, 28 U.S.C. § 2201 et seq.
`27. This judicial district is the proper venue under 28 U.S.C. § 1391(b)(2)
`because it is where a substantial part of the events giving rise to the claims occurred
`and where the effects of Senate Bill 793 will be felt. Prior to Senate Bill 793’s
`enactment, Reynolds’s and PM USA’s flavored tobacco products were sold by
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`retailers in this judicial district, including Reynolds’s products by members of
`Neighborhood Market Association. In addition, prior to Senate Bill 793’s enactment,
`members of Neighborhood Market Association as well as Vapin’ the 619 sold
`flavored tobacco products in this judicial district. Senate Bill 793 forbids the sale of
`nearly all flavored tobacco products in this judicial district, and will thus cause
`financial injury to Plaintiffs in this district.
`BACKGROUND
`The Tobacco Control Act and Federal Regulation of Tobacco Products
`28. The Family Smoking Prevention and Tobacco Control Act of 2009,
`Public Law 111-31, 123 Stat. 1776 (June 22, 2009), amended the Federal Food, Drug,
`and Cosmetic Act and established the U.S. Food and Drug Administration as “the
`primary Federal regulatory authority with respect to the manufacture, marketing, and
`distribution of tobacco products.” Id. § 3(1), 123 Stat. at 1781 (codified at 21 U.S.C.
`§ 387 note). The Tobacco Control Act applies to cigarettes, cigarette tobacco, roll-
`your-own tobacco, and smokeless tobacco products, as well as to any other tobacco
`products that FDA by regulation deems subject to the Act. 21 U.S.C. § 387a(b). The
`Act defines “tobacco product” as “any product made or derived from tobacco that is
`intended for human consumption.” 21 U.S.C. § 321(rr)(1).
`In 2016, FDA exercised its deeming authority, 21 U.S.C. § 387a(b), to
`29.
`bring within its regulatory authority all products meeting the statutory definition of a
`tobacco product, except accessories of the newly deemed tobacco products. See
`Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic
`Act, as Amended by the Family Smoking Prevention and Tobacco Control Act;
`Restrictions on the Sale and Distribution of Tobacco Products and Required Warning
`Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016).
`30. Congress passed the Tobacco Control Act to, inter alia, “authorize the
`[FDA] to set national standards controlling the manufacture of tobacco products and
`the … amount of ingredients used in such products.” Tobacco Control Act § 3(3),
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`123 Stat. at 1782 (codified at 21 U.S.C. § 387 note). To that end, the Act empowers
`FDA to adopt “tobacco product standards,” 21 U.S.C. § 387g, including “provisions
`respecting the … additives … [and] properties of the tobacco product,” id.
`§ 387g(a)(4)(B)(i). The term “additives” includes “substances intended for use as a
`flavoring.” Id. § 387(1).
`31. The Act also directly created tobacco product standards such as a
`“Special Rule for Cigarettes.” The Special Rule for Cigarettes bans the use in
`cigarettes of “characterizing flavor[s]” “other than tobacco or menthol.” 21 U.S.C.
`§ 387g(a)(1)(A). But the Act expressly reserves “menthol cigarettes” to FDA’s
`regulatory authority. See id. (noting “the Secretary’s authority to take action . . .
`applicable to menthol”). To date, the FDA has chosen not to ban the use of menthol
`in cigarettes.
`In fact, FDA has issued advance notices of proposed rulemaking
`32.
`(“ANPRMs”) contemplating the adoption of “tobacco product standard[s]” banning
`various flavored tobacco products, including menthol cigarettes and flavored vapor
`products. See, e.g., Menthol in Cigarettes, Tobacco Products; Request for Comments,
`78 Fed. Reg. 44,484, 44,485 (July 24, 2013); Regulation of Flavors in Tobacco
`Products, 83 Fed. Reg. 12,294, 12,299 (Mar. 21, 2018). But it has never banned
`menthol in cigarettes. And studies have shown that menthol cigarettes do not
`adversely affect initiation of or progression to smoking, and there is no clear
`association between menthol use and decreased smoking cessation. See RAI Services
`Company, Comment Letter on Advance Notice of Proposed Rulemaking Regarding
`Regulations of Flavors in Tobacco Products (July 18, 2018), available at
`https://www.regulations.gov/document?D=FDA-2017-N-6565-18265.
`33. The Tobacco Control Act expressly preempts state or local regulations
`that set forth requirements “different from, or in addition to,” any of the Tobacco
`Control Act’s or FDA’s requirements relating to federal “tobacco product standards.”
`Id. § 387p(a)(2)(A) (“Tobacco Preemption Clause”). The Tobacco Preemption
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`Clause ensures that tobacco product manufacturers will have to comply with just one
`set of product specifications nationwide—rather than having to grapple with
`potentially hundreds of different requirements set by different states and local
`jurisdictions governing the same products. See Tobacco Control Act § 3(3), 123 Stat.
`1782 (codified at 21 U.S.C. § 387 note).
`34. The Tobacco Control Act also contains a narrow saving clause, which
`provides that the Tobacco Preemption Clause “does not apply to requirements
`relating to the sale [and] distribution . . . of . . . tobacco products by individuals of
`any age.” Id. § 387p(a)(2)(B). But the saving clause narrows the category of
`permissible state and local requirements to those that turn on the “age” of the
`“individuals” buying or using the regulated tobacco products. See id. And even if the
`saving clause applies beyond age-based requirements, the clause does not protect
`state and local laws that prohibit a product’s sale and distribution altogether, but
`rather only more limited laws that regulate the time, place, and manner of the
`product’s sale and distribution. Compare id., with id. § 387p(a)(1).
`Plaintiffs and FDA Work To Keep Tobacco Products Away from Youth
`35. The original motivation for California’s ban on flavored tobacco
`products was to prevent youth usage of tobacco products. See Sen. Hill, SB 793
`Frequently Asked Questions (2020), available at https://tinyurl.com/yyomllfx. Both
`Plaintiffs and FDA are committed to keeping tobacco products out of the hands of
`youth.
`36. Reynolds and PM USA have taken active steps to prevent youth access
`to their products. Reynolds and PM USA are original sponsors and lead participants
`in the We Card program. Reynolds and PM USA require their contracted retailers to
`commit to participating in We Card. Since this partnership began in 1995, We Card
`has trained nearly half a million storeowners, managers, and frontline employees to
`help prevent youth access to tobacco products.
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`37. Reynolds has expanded those efforts, including through use of We
`Card’s “mystery shopper” program, which also will provide additional retailers with
`further education and training on verifying legal age of purchasers.
`In 2018, RJRV took targeted action to ensure youth were not obtaining
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`its vapor products. The company instituted a contract-based tiered compliance
`program that involves penalties on retailers that are found to have illegally sold
`VUSE products to youth. In conjunction with this program, RJRV also has its trade
`marketing representatives discussing the issue of underage youth access with each of
`RJRV’s contracted retailers on an ongoing basis. And the company provides access
`to additional materials and resources on preventing youth access to tobacco products
`via its online customer portal, engageVIP.com.
`In 2019, PM USA announced a new retailer incentive program to further
`39.
`encourage responsible retailing through age-validation technology at the point of
`purchase. To participate in the incentive program, retailers must implement a
`technological solution at a store’s point(s) of purchase, requiring the electronic scan
`of a consumer’s government-issued identification to complete a sales transaction
`involving the purchase of a tobacco product.
`40. FDA also has specifically addressed concerns about youth vaping. In a
`recent guidance for industry, FDA states that it “intends to prioritize enforcement for
`lack of marketing authorization against any flavored, cartridge-based ENDS product
`(other than a tobacco- or menthol-flavored ENDS product) that is offered for sale in
`the United States without regard to whether or when premarket application for such
`product has been submitted.” FDA, Enforcement Priorities 19. By way of
`background, when FDA promulgated its Deeming Rule, it brought ENDS products
`within its regulatory umbrella—meaning that before the products were sold, they
`needed FDA authorization. 81 Fed. Reg. 28,974. At the time, FDA said it would use
`its enforcement discretion and allow the products to stay on the market for some time
`even if they had not received FDA authorization. Id. at 28,977–78. FDA has now
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`changed course with regard to flavored, cartridge-based ENDS products (other than
`those that are tobacco- or menthol-flavored). FDA, Enforcement Priorities 19. The
`upshot of the new policy is that flavored, cartridge-based ENDS products (other than
`those that are tobacco- or menthol-flavored) can no longer be sold, unless and until
`FDA grants authorization for such products.
`In addition, as part of the same guidance referred to above, FDA stated
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`that it would prioritize enforcement against ENDS products for which the
`manufacturer has failed to take adequate measures to prevent minors’ access. Id. at
`3. And FDA will make enforcement a priority with respect to ENDS products that
`are “targeted to minors or whose marketing is likely to promote use of ENDS by
`minors.” Id.
`42. FDA has also issued numerous warning letters to entities that are
`improperly marketing or selling “unauthorized flavored, cartridge-based ENDS
`products” and other ENDS products that are being marketed or sold in ways that are
`appealing to youth. See, e.g., FDA News Release, FDA Warns Manufacturers and
`Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market
`(Apr. 27, 2020), at https://tinyurl.com/ybg9yny3 (announcing warning letters); FDA
`News Release, FDA Notifies Companies, Including Puff Bar, to Remove Flavored
`Disposable E-Cigarettes and Youth-Appealing E-Liquids from Market for Not
`Having Required Authorization (July 20, 2020), at https://tinyurl.com/y4shrbuj.
`Importantly, however, FDA has decided to allow the sale of menthol-
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`flavored ENDS products. That is, in part, to allow menthol cigarette smokers to
`transition to other “potentially less harmful” menthol-flavored products and also
`because “[d]ata shows that . . . menthol-flavored ENDS products are not as appealing
`to minors as other flavored ENDS products.” FDA, Enforcement Priorities 23–24,
`39. In FDA’s view, “[t]his approach”—effectively banning flavors except for
`menthol and tobacco—“strikes an appropriate balance between restricting youth
`access to such products, while maintaining availability of potentially less harmful
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`options for current and former adult smokers who have transitioned or wish to
`transition completely away from combusted [tobacco- and menthol-flavored]
`tobacco products.” Id. at 20. And, as of September 9, 2020, virtually all ENDS
`products must be off the shelves unless the product is the subject of a timely filed
`premarket tobacco product application under review by FDA. Id. at 3.
`The State’s Categorical Ban on Flavored Tobacco Products
`44. On August 28, 2020, the Governor of California signed Senate Bill 793
`into law, banning the sale of nearly all flavored tobacco products anywhere in the
`state. A copy is attached to this Complaint as Exhibit 1.
`45. The law states that tobacco retailers “shall not sell, offer for sale, or
`possess with the intent to sell or offer for sale, a flavored tobacco product or a tobacco
`product flavor enhancer.” SB 793 § 14559.5(b)(1).
`46. The law defines “[f]lavored tobacco product” as “any tobacco product
`that contains a constituent that imparts a characterizing flavor.” Id. § 104559.5(a)(4).
`“Tobacco product” means “[a] product containing, made, or derived from tobacco or
`nicotine that is intended for human consumption.” Cal. Health & Safety Code
`§ 104495(8)(A)(i). “Tobacco product” explicitly includes “cigarettes,” “chewing
`tobacco,”
`“snuff,”
`and
`electronic
`nicotine
`delivery
`systems.
`Id.
`§§ 104495(a)(8)(A)(i), (a)(8)(A)(ii). Senate Bill 793 defines “[c]haracterizing
`flavor” as “a distinguishable taste or aroma, or both, other than the taste or aroma of
`tobacco, imparted by a tobacco product or any byproduct produced by the tobacco
`product.” SB 793 § 104559.5(a)(1). The definition explicitly includes “menthol.” Id.
`The sales ban excludes a handful of products sold in certain situations, including
`shisha tobacco products, premium cigars, and loose leaf pipe tobacco. Id.
`§§ 104559.5(c), (d), (e).
`47. A person who violates the law “is guilty of an infraction and shall be
`punished by a fine of two hundred fifty dollars ($250) for each violation.” Id.
`§ 104559.5(f).
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`In short, the law bans nearly all kinds of flavored tobacco products,
`48.
`including the sale of all menthol flavored cigarettes, menthol flavored e-cigarettes,
`flavored smokeless tobacco products, and other flavored products.
`49.