Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 1 of 32 Page ID #:1
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`GEORGE K. JAWLAKIAN (SBN 296692)
`JAWLAKIAN LAW GROUP APC
`16130 VENTURA BOULEVARD, SUITE 500
`ENCINO, CA 91436
`TELEPHONE: 213-805-6500
`FACSIMLE: 844-633-2467
`Attorney for Plaintiffs
`CA SMOKE & VAPE ASSOCIATION, INC., d/b/a CARR
`ACE SMOKE SHOP
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
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`
`
`CA SMOKE & VAPE
`ASSOCIATION, INC., D/B/A CARR,
`and ACE SMOKE SHOP,
`Plaintiffs,
`
`Case No.: 2:20-cv-4065
`COMPLAINT FOR
`DECLARATORY AND
`INJUNCTIVE RELIEF
`
`
`
`
`v.
`COUNTY OF LOS ANGELES, and
`HILDA L. SOLIS, MARK RIDLEY-
`THOMAS, SHEILA KUEHL,
`JANICE HAHN, and KATHRYN
`BARGER, EACH IN HIS OR HER
`OFFICIAL CAPACITY AS A
`MEMBER OF THE BOARD OF
`SUPERVISORS,
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`Defendants.
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`COMPLAINT FOR DECLARATORY
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`Plaintiffs, CA SMOKE & VAPE ASSOCIATION, INC., D/B/A CARR
`(“CARR”), and one of its members, ACE SMOKE SHOP, a partnership, (“ACE”
`together with CARR, collectively, “Plaintiffs”), by and through their undersigned
`counsel, submit this Complaint for Declaratory Judgment and Injunctive relief
`against Defendants – County of Los Angeles, The Board of Supervisors of the
`County of Los Angeles, (“the Board”) and the individual members of the Board of
`Supervisors, each in his or her official capacity (all Defendants collectively referred
`to as “LA County”) – and allege as follows:
`INTRODUCTION
`Plaintiffs, seek to enjoin the County of Los Angeles from enforcing its
`1.
`recently enacted ordinance, amending and adding various sections to Title 7 –
`Business Licenses, and Title 11 – Health and Safety, of the Los Angeles County
`Code (the “Ordinance,” attached hereto as Exhibit 1), requiring businesses to
`obtain two additional licenses, imposing tobacco product standards, and prohibiting
`the sale of and the possession with intent to sell “flavored tobacco products,”
`including menthol, within the County of Los Angeles. Id. The great majority of
`vapor products and devices sold in LA County would be prohibited under this
`Ordinance. Nader Decl. ¶¶ 9-10.1
`
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`1 The declarations of Nader Farargi (“Nader Decl.”), Samir Elmoghrabi (“Samir Decl.”),
`Jacob Grair (“Jacob Decl.”), and John Dunham (“Dunham Decl.”) are filed concurrently
`with Plaintiff’s Complaint.
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`COMPLAINT FOR DECLARATORY
`AND INJUNCTIVE RELIEF
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 3 of 32 Page ID #:3
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`LA County claims the purpose of the Ordinance is to curb tobacco use
`2.
`amongst minors and to protect the public health from vaping illnesses. Yet the
`Ordinance exempts vaping products that contain tetrahydrocannabinol (“THC”),
`which, according to the Food and Drug Association (“FDA”), is the primary source
`linked to the outbreak of recent illnesses. 2 Similarly, the Ordinance makes no
`distinction between the black-market vaping products at the center of that outbreak,
`and the FDA regulated products produced by legitimate manufacturers. 3 Instead, the
`Ordinance implements a blanket prohibition on the sale of flavored tobacco
`products to all persons, threatening to destroy an entire industry and the livelihoods
`of Los Angeles County residents.
`The Ordinance defines “characterizing flavor” as “a taste or aroma,
`3.
`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
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`2 FDA, Lung Illnesses Associated with Use of Vaping Products (revised April. 13, 2020),
`https://www.fda.gov/news-events/public-health-focus/lung-illnesses-associated-use-
`vaping-products.
`3 Lena Sun, What we know about mysterious vaping linked illnesses, The Washington Post
`(January 10, 2020), available at
`<https://www.washingtonpost.com/health/2019/09/07/what-we-know-about-mysterious-
`vaping-linked-illnesses-deaths/>.
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`COMPLAINT FOR DECLARATORY
`AND INJUNCTIVE RELIEF
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`with or otherwise added to any tobacco product or nicotine delivery device,
`including electronic smoking devices.” Gov. Code, § 11.35.020(c).
`Plaintiffs seek relief on the grounds that the federal statutory law
`4.
`preempts the Ordinance under the Supremacy Clause of the United States
`Constitution.
`Plaintiffs also seek relief on the grounds that the Ordinance is invalid
`5.
`under the Fourteenth Amendment of the Constitution.
`Plaintiffs will be irreparably harmed by the Ordinance’s imminent
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`enforcement, as they will be forced to shut down their business operations entirely.
`The Ordinance will destroy Los Angeles County’s 48 million dollar
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`nicotine vapor product industry, and damage the livelihoods of the 450 workers that
`it employs.
`The Ordinance will likely precipitate a public-health crisis, as vapor-
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`products users turn either to combustible cigarettes or to black-market sources to
`obtain vapor products.
`The balance of the equities favors Plaintiffs, as they merely seek to
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`preserve the status quo while Defendants pursue stricter regulation of “flavored”
`tobacco products.
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`COMPLAINT FOR DECLARATORY
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 5 of 32 Page ID #:5
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`JURISDICTION AND VENUE
`This action arises under and pursuant to the Constitution of the United
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`States, including the Supremacy Clause, U.S. Const., art. VI, § 3; U.S. Const., art.
`XIV § 1; and the Civil Rights Act of 1871, 42 U.S.C. §§ 1983 and 1988.
`11. Because this Action arises under the Constitution and laws of the
`United States, this Court has jurisdiction under 28 U.S.C. §§ 1331 and 1367.
`This Court is authorized to grant declaratory and injunctive relief
`12.
`pursuant to 28 U.S.C. §§ 2201 and 2202.
`13. Venue for this Complaint is proper in the Central District of California
`pursuant to 28 U.S.C. § 1391 because the events giving rise to the suit occurred in
`this District, the Defendants reside in this District, the Defendants adopted Los
`Angeles County Code sections 7.83 and 11.35 in this District, and Defendants seek
`to enforce sections 7.83 and 11.35 against Plaintiffs in this District.
`PARTIES
`14. CARR is a local non-profit industry trade association, comprised of
`wholesalers, manufacturers of nicotine-containing flavored e-liquids, and primarily
`brick-and-mortar retailers. CARR has members located in the County of Los
`Angeles, that are subject to the recently enacted Ordinance, and sell, inter alia,
`nicotine products containing flavored e-liquids, and other tobacco products. The
`great majority of Los Angeles County CARR members have an inventory
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`composition of approximately 90% to 95% in flavored tobacco products. Nader
`Decl. ¶¶ 9-10.
`15. ACE SMOKE SHOP (“ACE”), a partnership. is a CARR member.
`Prior to the Ordinance’s enactment, ACE operated a successful vapor-products
`retail store in Los Angeles County, California. ACE and its employees now face
`financial ruin as a result of the Ordinance. Jacob Decl. ¶ 15.
`16. Defendant County of Los Angeles is a public entity constituted under
`the Constitution and the laws of the State of California.
`17. Defendant Board of Supervisors is the duly elected governing body of
`Defendant County of Los Angeles.
`18. Defendants Hilda L. Solis, Mark Ridley-Thomas, Sheila Kuehl, Janice
`Hahn, and Kathryn Barger, are the duly elected members of the Board of
`Supervisors, and each is sued in his or her official capacity as a member of the
`Board of Supervisors and not individually.
`FACTUAL BACKGROUND
`Flavored Vapor Products, Widely Used by Former Smokers, Are a Less
`Harmful Alternative to Combustible Cigarettes
`In recent years, many lifetime smokers have used the assistance of
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`vapor products to reduce or permanently stop using combustible cigarettes. Jacob
`Decl. ¶ 7. Vapor products, also known as “electronic cigarettes,” “e-cigarettes,” or
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`“electronic nicotine delivery systems (ENDS),” are handheld electronic devices that
`are used in conjunction with or contain flavored e-liquid. Nader Decl. ¶ 5. The
`majority of vapor products and devises sold in LA County would be considered
`“flavored tobacco products” and prohibited under this Ordinance. Nader Decl. ¶ 10.
`20. A large and growing body of scientific evidence indicates that ENDS
`products, while not completely harmless, do not pose the same harms and health
`risks, and are substantially less harmful, than traditional combustible tobacco
`products. This is due in part to the fact that the e-liquid used in ENDS products do
`not contain tobacco and do not result in a combustion process which produces
`smoke and numerous harmful by-products, like the emission of particulate matter
`such as tar, carbon monoxide, and many other harmful substances.4
`21. Moreover, there is considerable evidence that the overwhelming
`majority ENDS products consumers, are now former cigarette smokers who have
`turned to ENDS products as a smoke-free alternative to reduce or outright quit
`smoking, and to avoid the significant health hazards associated with combustible
`tobacco products.5
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`4 Linda Bauld, The evidence keeps piling up: e-cigarettes are definitely safer than
`smoking, The Guardian (December 29, 2017),
`<https://www.theguardian.com/science/sifting-the-evidence/2017/dec/29/e-cigarettes-
`vaping-safer-than-smoking> (accessed April 20, 2020).
`5 Paul Blair, New CDC Data, More Than 9 Million Adults Vape Regularly in the United
`States, (November 9, 2015), < https://www.atr.org/new-cdc-data-more-9-million-adults-
`vape-regularly-united-states> (accessed April 20, 2020).
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`22. Commissioned by the Food and Drug Administration ("FDA"), The
`National Academies of Sciences, Engineering and Medicine completed an
`exhaustive peer-reviewed literature and found that: “across a range of studies and
`outcomes, e-cigarettes pose less risk to an individual than combustible tobacco
`cigarettes,” including conclusive evidence that substituting such products for
`combustible cigarettes “reduces users’ exposure to numerous toxicants and
`carcinogens” and substantial evidence that switching results in reduced short-term
`adverse health outcomes in several organ systems.6
`23. Mitchell Zeller, the Director of the Center for Tobacco Products at the
`FDA, recently acknowledged in sworn testimony in a federal court proceeding that
`some ENDS products may reduce harm and help some addicted smokers end
`combustible tobacco use. Director Zeller further noted in his sworn testimony that
`"[d]ramatically and precipitously reducing availability of [vapor] products" in the
`fashion embodied in the Ordinance "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.”7
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`6 Kathleen Stratton et al., Public Health Consequences of E-Cigarettes, Nat’l Acad. Sci.,
`Eng’r & Med. 12 (2018), available at
`https://www.ncbi.nlm.nih.gov/books/NBK507171/pdf/Bookshelf_NBK507171.pdf.
`7 Declaration of Mitchell Zeller, American Academy of Pediatrics v Food and Drug
`Admin, No 8:18-cv-00883-PWG (D. Md. 2019) at 115.
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`Public health authorities around the world have come to similar
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`conclusions. The United Kingdom’s Royal College of Physicians has concluded
`that the potential hazard to health arising from long-term use of vapor products is,
`at most, five percent (5%) of the comparable harm resulting from the use of
`traditional combustible cigarettes.8
`The impact of the availability of a wide variety of vapor products,
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`including non-tobacco and non-menthol flavored e-liquids, on consumer demand
`for traditional combustible cigarettes has been significant. Flavored nicotine vapor
`products are widely used by adults. For example, a cross-sectional study of current
`or former adult smokers in the United States who used e-cigarettes found that that
`82.8 percent used flavored nicotine vaping products, while only 17.2 percent used
`tobacco-flavored nicotine vaping products.9
`26. Another study of American adults who frequently used e-cigarettes
`found that “[c]urrent e-cigarette use among participants was dominated by use of
`non-tobacco flavors, mainly fruit/fruit beverage, dessert/pastry, and/or
`candy/chocolate, sweet flavors.”10 The authors concluded that their findings
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`8 Royal College of Physicians Tobacco Advisory Group, Nicotine Without Smoke:
`Tobacco Harm Reduction (April 28, 2016),
`<https://www.rcplondon.ac.uk/projects/outputs/nicotine-withoutsmoke-tobacco-harm-
`reduction-0> (accessed April 20, 2020).
`9 Paul T. Harrell et al. E-Cigarettes and Expectancies: Why Do Some Users Keep
`Smoking?, 110Addiction 1833–43 (2015), available at
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609252/pdf/nihms707991.pdf
`10 Christopher Russell et al., Changing Patterns of First E-Cigarette Flavor Used and
`Current Flavors Used by 20,836 Adult Frequent E-Cigarette Users in the USA, 15 Harm
`Reduction Journal 1–14 (2018).
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`“suggest that access to a variety of non-tobacco flavored e-liquid may be important
`for encouraging and assisting adults to use e-cigarettes in place of conventional
`cigarettes.”11
`Enforcement of the LA County Ordinance would ban all flavored
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`vapor products and eliminate a viable method for longtime cigarette smokers to quit
`the use of combustible cigarettes.
`II. Health Problems Erroneously Attributed to ENDS Products
`Prior to the summer of 2019, ENDS products had been available to
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`United States consumers for approximately a decade. During the time, Plaintiffs
`assert that there were no reports of adverse health problems resulting from the use
`of ENDS products.
`29. Beginning in the summer of 2019, numerous media reports began
`circulating that individuals across the United States who vaped were suffering from
`severe pulmonary issues, colloquially termed as "vaping related" illnesses.
`30. While federal and state health officials initially cast blame upon ENDS
`products, subsequent investigation and testing of the suspected products used by
`these individuals revealed that the severe pulmonary issues were most likely caused
`by the illicit addition of THC.12
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`11 Id.
`12 Michelle Minton, Update: Big Picture in 'Vaping-Linked' Lung Poisonings, Competitive
`Enterprise Institute (September 16, 2019), available at < https://cei.org/blog/update-big-
`picture-vaping-linked-lung-poisonings>.
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`COMPLAINT FOR DECLARATORY
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 11 of 32 Page ID #:11
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`31. Neither THC nor marijuana is included as an ingredient of any ENDS
`product permitted for retail sale in the United States under federal law, nor is either
`included as an ingredient in any products sold by Plaintiffs. Nader Decl. ¶ 5.
`The illegal vapor cartridges that contain THC and/or marijuana have
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`also been reported to contain significant amounts of vitamin E acetate, which is a
`diluting and thickening agent that makes cannabis oil more affordable. 13
`33. According to the FDA, the primary cause of recent illnesses relating to
`vapor products has been attributed to the THC-containing products14 Indeed, the
`majority of patients who have been monitored for vape related lung illnesses have
`disclosed that they exclusively consume vaping products containing THC.”15
`III. The Tobacco Industry is a Vital Part of the LA County Economy
`The national vaping-products industry, which employs approximately
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`166,000 people, is a “dynamic part of the U.S. economy, accounting for $24.46
`billion annually in economic output.” Dunham Decl. ¶ 5. Of that, approximately
`$48 million is traceable to the unincorporated areas of Los Angeles County, where
`
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`13 Lena Sun, What we know about mysterious vaping linked illnesses, The Washington Post
`(January 10, 2020), available at
`<https://www.washingtonpost.com/health/2019/09/07/what-we-know-about-mysterious-
`vaping-linked-illnesses-deaths>.
`14 FDA, Lung Illnesses Associated with Use of Vaping Products (revised April 13, 2020),
`<https://www.fda.gov/news-events/public-health-focus/lung-illnesses-associated-use-
`vaping-products>.
`15 Id.
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`the vapor-products industry directly or indirectly employs just under 450 people. Id.
`at ¶ 11.
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`The wages and benefits earned annually by those 450 employees total
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`almost $7.3 million, and the direct economic output attributable to retail vape shops
`and vapor-liquid manufacturing exceeds $18 million. Id. at ¶ 13.
` The study conducted by John Dunham focused exclusively on small
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`vapes shops that only sell e-liquid related products, and does not account for the
`economic loss that would be suffered by the 753 tobacco retailers within the
`unincorporated areas of LA County sell all tobacco products.16
`IV. The Ordinance Prohibits the Sale of Flavored Tobacco Products
`37. On September 24, 2019, the Los Angeles County Board of Supervisors
`enacted the Ordinance prohibiting the sale of all flavored tobacco products,
`imposing new tobacco product standards, and requiring retailers apply for and
`maintain two new business licenses.
`38. During the meeting, board members discussed the increased use of
`vaping products amongst individuals under the age of 21, and referenced citations
`
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`16 California Department of Tax and Fee Administration, California Cigarette & Tobacco
`Product Licenses, (April 4, 2019) available at: <https://www.cdtfa.ca.gov/taxes-and-
`fees/cigarette-licensees.htm> accessed on (April 20, 2020).
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`to statistics on youth vaping according to the internal research of the Los Angeles
`County Department of Health.17
`The board also relied on a recently modified C.D.C. report detailing
`39.
`540 cases of individuals experiencing sudden and severe lung illness associated
`with vaping.18
`40. During the same meeting, the board affirmatively stated that the
`Ordinance would not ban online sales of flavored tobacco.19
`41. However in its final draft, the Ordinance, the prescribed definitions
`contained therein, and the LA County Code in its entirety, do not specify whether
`enforcement of the Ordinance would be limited to in-person sales, and fail to
`specify whether online or out-of-state sales would be exempted from enforcement.
`As defined, various provisions of the Ordinance require tobacco retailers to
`maintain an active license regardless of whether the tobacco product sales are
`conducted in-person, online, or sold to out-of-state residents:
`“Tobacco Retailer” means any person who sells, offers for sale or
`distribution, exchanges, or offers to exchange for any form of consideration,
`tobacco, tobacco products, or tobacco paraphernalia without regard to the
`quantity sold, distributed, exchanged, or offered for exchange.
`L.A. Cnty. Code § 11.35.020(V) (emphasis added).
`“Tobacco Retailing” means selling, offering for sale, exchanging, or offering
`to exchange for any form of consideration, tobacco, tobacco products, or
`
`17 The Meeting Transcript of The Los Angeles County Board of Supervisors, Pg. 81, ¶ 17
`(September 24, 2019) available at
`http://file.lacounty.gov/SDSInter/bos/sop/transcripts/1061879_092419.pdf
`18 Id. at 83.
`19 Id. at 80.
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`tobacco paraphernalia without regard to the quantity sold, offered for sale,
`exchanged, or offered for exchange.
`L.A. Cnty. Code § 11.35.020(W).
`In addition to the Tobacco Retail License, any Tobacco Shop in an
`unincorporated area of the County, devoted exclusively or predominantly to
`the sale of tobacco, tobacco products, and tobacco paraphernalia, must have a
`valid business license as required by Title 7 of this Code.
`L.A. Cnty. Code § 11.35.055(A).
` The provisions above, whether read in a vacuum or within the
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`context of the Los Angeles County Code, impose a licensing requirement through
`any sales channel.
`In connection with the licensing requirements, the Ordinance imposes
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`a categorical prohibition banning the sale of all flavored tobacco products;
`“It 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.”
`L.A. Cnty. Code § 11.35.070(E) (emphasis added).
`Even if we ignore the Ordinance’s basic provisions and assume online
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`sales would not be subject to enforcement; the Ordinance would still prohibit all
`flavored tobacco product sales within the county, and even penalize retailers who
`“posses” flavored tobacco products with “the intent to sell,” without defining the
`“intent to sell” anywhere in this Ordinance or within the Los Angeles County Code.
`Without such necessary definitions, retailers who sell non-flavored tobacco
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`COMPLAINT FOR DECLARATORY
`AND INJUNCTIVE RELIEF
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 15 of 32 Page ID #:15
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`products in-store, but possess flavored tobacco products with the intent to sell
`online or out of state, would still be in clear violation of this Ordinance.
`45. As explained in greater detail below, the Ordinance’s outright
`prohibition of all flavored products, and the Ordinance’s modification of tobacco
`product standards relating to the use of characterizing flavors and tobacco products,
`are exclusively reserved for and preempted by the Family Smoking Prevention and
`Tobacco Control Act.
`Federal Preemption of Flavored Tobacco Products
`V.
`Flavored tobacco products, including flavored e-liquids, are heavily
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`regulated by the FDA.
`In 2009, Congress enacted the Family Smoking Prevention and
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`Tobacco Control Act (the “Act”), (21 U.S.C. §§ 387-387u), the Act vests the FDA
`with authority to regulate the retail sales, ingredient formulations, and labeling, of
`tobacco products to protect the public health generally. 21 U.S.C. § 387, et seq.
`Cigarettes, smokeless tobacco, and roll-your-own tobacco products were
`immediately covered by the FDA’s authority when the TCA went into effect. 21
`U.S.C. § 387a(b).
`In enacting the TCA, Congress granted the FDA regulatory authority
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`over tobacco products and tobacco product standards because the "FDA is the only
`agency with the right combination of scientific expertise, regulatory experience and
`public health mission to oversee these [tobacco] products effectively." 155 Cong.
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 16 of 32 Page ID #:16
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`Rec. H6652 (daily ed. June 12,2009) (statement of Rep. Waxman); see also 155
`Cong. Rec. S6021 (daily ed. June 3, 2009) (statement of Sen. Hagan) (the TCA
`"grants FDA extremely broad authority to take action that it considers to be in the
`interest of public health").
`49. When Congress enacted the TCA, it created one specific tobacco
`product standard in the form of a “Special Rule for Cigarettes” in addition to a
`series of other tobacco product standards. The Special Rule for Cigarettes prohibits
`the use in cigarettes of “characterizing flavors” other than tobacco or menthol
`stating that:
`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.
`21 U.S.C. § 387g(a)(1)(A). (emphasis added).
`50. Menthol cigarettes are an issue exclusively reserved to FDA. Congress
`was reluctant to ban all characterizing flavors in all tobacco products because of the
`potentially negative public health and economic consequences. Congress excluded
`menthol cigarettes from the federal ban, because there was a significant risk of a
`black market for them. A report submitted by the Congressional Committee on
`Energy and Commerce points out that regulating products like menthol cigarettes, a
`widely used product, would pose issues of public health as any such regulation may
`lead to heavily addicted smokers suffering from “sudden withdrawal” with
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 17 of 32 Page ID #:17
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`“unknown consequences.”20 The report also points out: “the sudden removal of a
`legal source for such a product without the type of consideration and review that
`FDA will be able to conduct might unnecessarily increase the illegal black-market
`risk, which could also pose a health hazard to users.”21 Lastly, the report reiterates
`that “[t]he law provides FDA the authority to require product changes in current
`and future tobacco products, such as the reduction or elimination of ingredients,
`additives, and constituents (including smoke constituents).”22
`In addition to establishing tobacco product standards, the TCA grants
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`FDA the power to revise the Special Rule for Cigarettes in accordance with the
`statutes rulemaking procedures. Moreover, the TCA specifically calls upon the
`FDA to establish a Tobacco Products Scientific Advisory Committee to specifically
`address the issue of menthol cigarettes.23 Plus, the Act provides that the FDA is to
`make a decision on the further regulation of menthol cigarettes.24
`The standard adopted by Congress reflects a clear congressional
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`decision to limit the ban on characterizing flavors to cigarettes, and not to extend it
`to other tobacco products.
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`20 TCA Report H.R., Committee on Energy and Commerce, at 38 (March 26, 2009).
`21 Id.
`22 Id.
`23 See 21 U.S.C. § 387g(e)(1)
`24 See 21 U.S.C. §§ 387g(e)(3), (f)(3).
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`COMPLAINT FOR DECLARATORY
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 18 of 32 Page ID #:18
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`In addition to prohibiting cigarettes with characterizing flavors other
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`than menthol and tobacco, the TCA provides FDA with the authority to ensure the
`existence of uniform, national tobacco product standards, and preempts state and
`municipal regulations as follows:
`No 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 this chapter 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) (emphasis added).
`The TCA further expanded the FDA’s authority by adding Chapter IX
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`to the federal Food, Drug and Cosmetic Act (“FDCA”), and significantly altering
`federal regulation of tobacco products by granting FDA the statutory authority to
`regulate tobacco products, including flavored tobacco products.
`55. On May 10, 2016, the FDA published its Final Rule Deeming Tobacco
`Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. 81 FR 28973
`(“Final Rule”). The Final Rule brings all tobacco products, including flavored e-
`liquids and ENDS devices, under the FDA’s control and jurisdiction.25
`Since the Final Rule took effect, all new tobacco products, including
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`flavored tobacco products, have been required to comply with a number of
`regulatory requirements imposed by the TCA and enforced by the FDA.
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`25 See 81 Fed. Reg. 28,973 – 29,106 (May 10, 2016).
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`COMPLAINT FOR DECLARATORY
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`Case 2:20-cv-04065-DSF-KS Document 1 Filed 05/04/20 Page 19 of 32 Page ID #:19
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`57. Under the TCA, tobacco product manufacturers are now required to
`file with the FDA, all ingredients found in their finished tobacco products 21
`U.S.C. § 387d(a)(3), health, toxicological, behavioral, or physiologic effects of their
`products under 21 U.S.C. § 387d(a)(4), That same year, all U.S. businesses that
`engaged in the manufacture of tobacco products were required to register their
`establishment(s) with the FDA and open them to FDA inspection under 21 U.S.C.