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Nicopure Labs, LLC v. Food and Drug Administration

United States District Court, District of Columbia

July 21, 2017

NICOPURE LABS, LLC, Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION, et al., Defendants. RIGHT TO BE SMOKE-FREE COALITION, et al., Plaintiffs,
v.
FOOD AND DRUG ADMINISTRATION, et al., Defendants.

          MEMORANDUM OPINION

          AMY BERMAN JACKSON United States District Judge.

         An electronic cigarette, or “e-cigarette, ” is an electronic nicotine delivery device, comprised of a liquid, an atomizer or heating element that heats the liquid to create a vapor, and a battery that powers the heating element. Most liquids on the market contain nicotine.

         On May 10, 2016, the Food and Drug Administration exercised its discretion to deem e-cigarettes to be “tobacco products” subject to the set of federal laws that govern the promotion and marketing of conventional cigarettes.[1] Plaintiff Nicopure Labs, LLC, which manufactures the devices and the liquids, then brought this action against the FDA, the Acting Commissioner of Food and Drugs, and the Secretary of Health and Human Services, challenging the rule that announced the decision.[2] Nicopure claims that the deeming decision exceeded the agency's statutory authority under the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. (“FDCA”), as amended by the Family Smoking Prevention & Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1777 (2009) (“Tobacco Control Act” or “TCA”). Nicopure also contends that the deeming decision was arbitrary and capricious and should be set aside under the Administrative Procedure Act (“APA”), 5 U.S.C. § 706, and that several provisions of the Tobacco Control Act that now govern the vaping industry violate the company's First Amendment rights. Compl., Nicopure Labs, LLC v. FDA, 16-878 (ABJ) [Dkt. # 1] (“Nicopure Compl.”).

         In a separate action, the Right to be Smoke Free Coalition, American Vaping Association, Electronic Vaping Coalition of America, Georgia Smoke Free Association, Kentucky Vaping Retailers Association, Inc., Louisiana Vaping Association, Maryland Vaping Professionals, LLC, Ohio Vapor Association, Tennessee Smoke Free Association, and the New Jersey Retailers Coalition (collectively, “RSF”), filed their own challenge to the Deeming Rule on similar grounds. Compl., RSF v. FDA, 16-1210 (ABJ) [Dkt. # 1] (“RSF Compl.”). The Court consolidated the two cases, Order (June 28, 2016) [Dkt. # 19], and both sides have filed motions for summary judgment. After considering the record, the points and authorities set forth in the briefs submitted by both sides and the amici, and the arguments presented at a hearing on the motions, the Court will uphold the Deeming Rule.[3]

         The Court wishes to reassure the many worried vapers who followed these proceedings closely that this case is not about banning the manufacture or sale of the devices. That is not what the Deeming Rule does or what it was intended to accomplish. In the Deeming Rule, the FDA simply announced that electronic cigarettes, or electronic nicotine delivery systems (“ENDS”) would be subject to the same set of rules and regulations that Congress had already put in place for conventional cigarettes.

         The Rule requires manufacturers to subject their products to review before marketing them, to tell the truth when making any claims about their health benefits, and to warn consumers about the dangers of nicotine when offering a means to deliver the substance to consumers. In short, the manufacturers of e-cigarettes are now required to tell the 30 million people who use the devices what is actually in the liquid being vaporized and inhaled.

         This case does not pose the question - which is better left to the scientific community in any event - of whether e-cigarettes are more or less safe than traditional cigarettes. The Rule did not purport to take the choice to use e-cigarettes away from former smokers or other adult consumers; the issue is whether the FDA has the authority to require that the choice be an informed one.

         In the 2009 Tobacco Control Act, Congress mandated that “tobacco products” would be regulated by the Secretary of HHS, and it stated that the provisions of the statute would apply not only to cigarettes, but to other tobacco products that the Secretary deemed to be subject to the law in the future. In the rule in question in this case, the FDA exercised its discretion under the Act to deem e-cigarettes to be tobacco products subject to regulation under the Federal Food, Drug, and Cosmetic Act and the Tobacco Control Act. The agency unquestionably had the power to do so; indeed, the plaintiffs who brought this lawsuit and submitted 235 pages of argument to the Court do not challenge that general proposition even though they maintain that the agency should have taken a different approach to the task.

         In the first portion of the case, though, plaintiffs claim that the FDA exceeded the authority given to it by Congress because certain types of devices or liquids do not fall within the statutory definition of a tobacco product that may be deemed to be subject to the TCA. But that challenge is extremely narrow. The challenge to the FDA's authority is not about whether the FDA had the legal authority to regulate the “cigalikes”[4] that comprise a large portion of the e-cigarette market - the plaintiffs in this case concede that the agency may regulate those products. And plaintiffs do not challenge whether the FDA had the legal authority to regulate “closed” vaping systems, which use e-liquid that comes in a disposable cartridge.

         What plaintiffs do claim is that the agency exceeded its reach when it stated that the deeming rule also covers “open” vaping systems - those built with refillable cartridges that hold the liquid. Plaintiffs do not object to the regulation of all open system devices; they do not question the agency's power to regulate open vaping systems that are sold packaged together with liquid containing nicotine or tobacco flavor. What plaintiffs contend is that the agency could not lawfully undertake to regulate any open devices sold empty and on their own without any liquid, and that it had no authority to regulate e-liquids that do not contain nicotine. Nicopure Compl. ¶¶ 21, 34; RSF Compl. ¶¶ 43, 111-17. However, the FDA has plainly stated that the rule does not cover e-liquids that do not contain, or are not derived from, nicotine or tobacco, unless those liquids are reasonably intended to be used with nicotine-containing liquids.

         The Court concludes that the agency acted within the scope of its statutory authority: it was legally permitted to regulate that category of liquids, and to consider a refillable electronic nicotine delivery system to be a “component” of a tobacco product and therefore subject to regulation.

         Plaintiffs also ask the Court to find that it was arbitrary and capricious to subject electronic cigarette and liquid manufacturers to burdensome premarket review and labeling requirements, and that the cost-benefit analysis underlying the deeming decision was deficient. They also object to a number of the marketing restrictions triggered by the deeming decision on constitutional grounds.

         It bears repeating that the provisions the plaintiffs find most objectionable were not crafted by the FDA as part of the Deeming Rule. Instead, they are requirements of the Tobacco Control Act that was enacted by Congress. Congress gave the FDA broad authority to deem new products to be “tobacco products” subject to that existing statutory regime, and the Court finds that it was not arbitrary and capricious for the agency to decide to take that action with respect to e-cigarettes.

         This opinion will lay out the reasons for the Court's conclusions, and it will also explain why the new rules being applied to e-cigarettes do not violate the First or the Fifth Amendments to the Constitution, and why there was no requirement that the agency undertake the sort of formal cost-benefit analysis that plaintiffs claim was omitted here.

         When all is said and done, the Court will grant the agency's cross-motion for summary judgment, and it will deny plaintiffs' motions for summary judgment.[5]

         TABLE OF CONTENTS

         BACKGROUND...........................................................................................................................9

         I. Statutory Background - the Relevant Provisions of the Tobacco Control Act...............9

         A. The Deeming Provision and the Definition of “Tobacco Product”.....................11

         B. Premarket Review...................................................................................................11

         1. The Substantial Equivalence Pathway...................................................................12

         2. The Premarket Review Process..............................................................................13

         C. Ban on Distribution of Free Samples.....................................................................14

         D. Ban on Modified Risk Statements..........................................................................15

         II. Regulatory Background.................................................................................................17

         III. Factual & Procedural Background...............................................................................20

         STANDARD OF REVIEW........................................................................................................24

         ANALYSIS..................................................................................................................................25

         I. FDA did not exceed its statutory authority when it deemed both open system vaping devices and nicotine-free liquids to be “tobacco products.”...................................................25

         A, The D.C. Circuit has not yet decided the issue......................................................26

         B. The FDA has the statutory authority to regulate open-system vaping devices..................................27

         1. The FDA's characterization of an empty vaping device as a “component” of a tobacco product survives step one of the Chevron analysis.........................................29

         2. The FDA's interpretation is reasonable under Chevron step two.......................34

         C. Plaintiffs have standing to challenge the application of the Rule to non-nicotine-based e-liquids, and their challenge is ripe, but the agency's interpretation passes muster under Chevron..........................35

         1. Plaintiffs have standing to challenge the application of the rulemaking to nicotine-free products because they manufacture those products.............................37

         2. Plaintiffs' challenge to the regulation of nicotine-free products is ripe..............38

         3. The agency's interpretation of the definition of “tobacco product” to include certain non-nicotine-containing e-liquids meets the Chevron test..............................41

         II. The FDA's decision to deem e-cigarettes to be tobacco products comports with the APA..................44

         A. Legal Standard.........................................................................................................45

         B. The APA dispute is justiciable................................................................................45

         C. The FDA's decision to deem e-cigarettes to be tobacco products is reasonable and supported by the record........................48

         D. Plaintiffs' arguments that the Rule is arbitrary and capricious are not persuasive................................................................................................................51

         E. The agency appropriately rejected plaintiffs' suggested regulatory alternatives....................53

         F. The decision not to change the grandfather date for substantially equivalent products is not arbitrary and capricious...........................................................................56

         G. FDA's imposition of compliance deadlines was not arbitrary and capricious..................................57

         III. The Deeming Rule is not invalid due to any deficiencies in the cost-benefit analysis............................59

         A. The agency was not required to do a cost-benefit analysis..................................60

         B. Even if Michigan v. EPA does apply, the agency complied with its requirements....................62

         C. The agency's consideration of costs and benefits satisfied the APA...................63

         IV. The agency complied with the purely procedural requirements of the Regulatory Flexibility Act..........70

         V. The Deeming Rule is not unconstitutional; RSF has abandoned its equal protection claim, and its due process argument fails.................................................72

         VI. The marketing restrictions in the Tobacco Control Act do not violate the First Amendment.......................74

         A. Central Hudson has not been supplanted by Sorrell.............................................76

         B. The Tobacco Control Act's ban on the distribution of free samples is constitutional...................................78

         1. The Tobacco Control Act's ban on the distribution of free samples regulates conduct, not speech.............78

         2. Even if sampling is considered to be expression, plaintiffs concede that the government has a substantial interest in eliminating youth access to tobacco products........................................84

         3. The FDA has sufficient evidence to show that the sampling ban directly and materially advances the interest in eliminating youth access to tobacco products........................................85

         4. The ban on free samples is not more extensive than necessary to serve FDA's substantial interest...........................87

         C. The regulation of modified-risk tobacco products satisfies the Central Hudson test......................89

         CONCLUSION......................................................................................93

         BACKGROUND

         I. Statutory Background - the Relevant Provisions of the Tobacco Control Act

         The Tobacco Control Act was enacted in 2009.[6] Congress introduced the legislation by setting out forty-nine findings related to the public health risks posed by the use of tobacco products, and products containing nicotine in particular:

• “A consensus exists within the scientific and medical communities that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects, ” TCA § 2(2);
• “Nicotine is an addictive drug, ” id. § 2(3);
• “Tobacco is the foremost preventable cause of premature death in America, ” id. § 2(13);
• “It is in the public interest for Congress to adopt legislation to address the public health crisis created by actions of the tobacco industry, ” id. § 2(29);
• Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely, ” id. § (2)(34).

         In its findings, Congress emphasized the harms that arise when children use tobacco products, and the associated dangers of tobacco-related marketing to minors:

• “The use of tobacco products by the Nation's children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults, ” TCA § 2(1);
•“Virtually all new users of tobacco products are under the minimum legal age to purchase such products, ” id. § 2(4);
• “Tobacco advertising and marketing contribute significantly to the use of nicotine-containing tobacco products by adolescents, ” id. § 2(5);
• “Because past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products are needed, ” id. § 2(6);
• “Children, who tend to be more price sensitive than adults, are influenced by advertising and promotion practices that result in drastically reduced cigarette prices, ” id. § 2(24).

         Congress also made specific findings concerning the impact of what the statute calls “modified risk statements” - manufacturers' statements that certain products might reduce the risks associated with nicotine or tobacco - including labels announcing that a tobacco product is “low tar” or “light”:

• “Unless tobacco products that purport to reduce the risks to the public of tobacco use actually reduce such risks, those products can cause substantial harm to the public health, ” TCA § 2(37);
• “The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco products is to empower the Food and Drug Administration to require that products that tobacco manufacturers sold or distributed for risk reduction be reviewed in advance of marketing, and to require that the evidence relied on to support claims be fully verified, ” id. § 2(43).

         Finally, the statute recognizes that the FDA:

[I]s a regulatory agency with the scientific experience to identify harmful substances in products to which consumers are exposed, to design standards to limit exposure to those substances, to evaluate scientific studies supporting claims about the safety of products, and to evaluate the impact of labels, labeling, and advertising on consumer behavior in order to reduce the risk of harm and promote understanding of the impact of the product on health.

Id. § 2(44).

         A. The Deeming Provision and the Definition of “Tobacco Product”

         In light of those findings, Congress mandated in section 901 of the TCA that “[t]obacco products . . . shall be regulated by the Secretary [of Health and Human Services].” TCA § 901, codified at21 U.S.C. § 387a. This unequivocal assignment of responsibility goes on to provide:

This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.

Id., codified at 21 U.S.C. § 387a(b) (emphasis added).

         Congress then amended the definitions section of the Federal Food, Drug, and Cosmetic Act to define the term “tobacco product.” TCA § 101. For purposes of the TCA, a “tobacco product” is:

any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

21 U.S.C. 321(rr)(1). Neither the TCA nor the FDCA further defines the terms “component, ” “part, ” or “accessory.”

         B. Premarket Review

         In the TCA, Congress also imposes a number of regulatory requirements on all tobacco products. First, the statute requires that all “new tobacco products” must receive FDA approval before they may be introduced or delivered into interstate commerce. TCA § 910; 21 U.S.C. § 387j(a). The statute defines the term “new tobacco product” as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007.” Id. The law provides two main “pathways” to FDA approval: the less onerous “substantial equivalence” pathway, and the more demanding “premarket review” pathway.[7]

         1. The Substantial Equivalence Pathway

         One way to get a new tobacco product approved is to show that it is “substantially equivalent” to an existing tobacco product. 21 U.S.C. § 387j. The existing or “predicate” product to be used for comparison purposes must have been “commercially marketed . . . in the United States as of February 15, 2007.” 21 U.S.C. § 387j(a)(2)(A)(i)(I).

         To invoke the substantial equivalence or SE pathway, the sponsor of a new tobacco product must file a report demonstrating that the product is substantially equivalent to a product that had already been commercially marketed as of the February 2007 grandfather date. 21 U.S.C. § 387j(b). A new tobacco product is substantially equivalent to the predicate tobacco product if it:

(i) has the same characteristics of the predicate tobacco product; or
(ii) has different characteristics and the information submitted [in the substantial equivalence report] contains information . . . that demonstrates that it is not appropriate to regulate the product . . . because the product does not raise different questions of public health.

21 U.S.C. § 387j(a)(3)(A).[8] If the FDA concludes that the new tobacco product is substantially equivalent to the predicate tobacco product under either provision, it must issue an order allowing the product to be commercially marketed. 21 U.S.C. § 387j(c).

         2. The Premarket Review Process

         If a manufacturer of a new product cannot invoke the substantial equivalence pathway - because there was no predicate product on the market as of February 15, 2007 - it must obtain approval from FDA before it can market the product. See 21 U.S.C. 387j(a)(2). The sponsor of the new tobacco product must submit a detailed application that includes: “full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products, ” and “a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product.” 21 U.S.C. § 387j(b)(1).[9]

         The FDA must either approve or deny a premarket review application within 180 days. 21 U.S.C. § 387j(c)(1)(A). A denial may only be based on one of the four reasons set forth in the statute: (1) the applicant has failed to show that the marketing of the product is appropriate for public health; (2) the manufacturing, processing, or packing process does not conform to statutory requirements; (3) the label is false or misleading; or (4) the application does not conform with the standards set for tobacco products in 21 U.S.C. § 387g. 21 U.S.C. § 387j(c)(2).[10]

         C* Ban on Distribution of Free Samples

         In the TCA, Congress also specifically instructed the agency to regulate the distribution of free samples of tobacco products. TCA § 102. The statute directed the Secretary of Health and Human Services to reissue a 1996 final rule no sooner than 180 days after June 22, 2009, and it required that the rule amend the Federal Register to provide that “no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or other tobacco products (as that term is defined in section 201 of the [FDCA]).” 21 U.S.C. § 387a-1. Congress directed the agency to permit the distribution of free samples of smokeless tobacco “in a qualified adult-only facility, ”[11] but it also demanded that the agency develop clear rules governing certain public events: no free samples of smokeless tobacco may be distributed “at any football, basketball, baseball, soccer, or hockey event or any other sporting or entertainment event determined by the Secretary to be covered by this subparagraph.” Id. § 387a-1(2)(G).

         The agency did as Congress required. On March 19, 2010, the FDA promulgated a rule entitled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, ” 75 Fed. Reg. 13, 225-03 (Mar. 19, 2010). The rule, which is now codified at 21 C.F.R. part 1140, contains the required language. See 21 C.F.R. § 1140.16.

         D. Ban on Modified Risk Statements

         As part of the regulatory regime imposed on tobacco products in the TCA, Congress also addressed manufacturers' attempts to market certain products as being less harmful to health than other tobacco products. By amending section 911 of the FDCA, the TCA prohibits the introduction of “any modified risk tobacco product” into interstate commerce unless that product has been pre- cleared by the FDA. TCA § 101; 21 U.S.C. § 387k(a). A “modified risk tobacco product” is defined first as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” 21 U.S.C. § 387k(b)(1). Second, the definition applies to a product:

(i) the label, labeling, or advertising of which represents explicitly or implicitly that -
(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
(III) the tobacco product or its smoke does not contain or is free of a substance;
(ii) the label, labeling, or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or
(iii) the tobacco product manufacturer . . . has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising . . . that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

21 U.S.C. § 387k(b)(2)(A).

         A manufacturer that intends to market a tobacco product with modified risk representations must file an application with the Secretary of HHS demonstrating that any claims “relating to the effect of the product on tobacco-related diseases and health-related conditions” are supported by the scientific literature. 21 U.S.C. § 387k(d). An application may be granted “only if the Secretary determines that the applicant has demonstrated that” the product will:

(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

21 U.S.C. § 387k(g)(1).

         There is an exception to that provision, “if the Secretary makes the finding required” by subsection (g)(1), and makes several additional findings listed in subsection (g)(2), which requires proof that an order granting the application would promote the public health, is limited to a claim that a product “does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke, ” “scientific evidence is not available and . . . cannot be made available without conducting long-term epidemiological studies, ” and the available data “demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.” 21 U.S.C. 387k(g)(2)(A).[12]

         II. Regulatory Background

         On May 10, 2016, the FDA exercised the authority Congress conferred upon it in 21 U.S.C. § 387a(b) to deem e-cigarettes (and other products not relevant to this opinion) to be “tobacco products” subject to the TCA. Deeming Rule, 81 Fed. Reg. at 28, 976 (“Products that meet the statutory definition of ‘tobacco products' include . . . ENDS (including e-cigarettes, e-hookah, e- cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes”). The statute defines a “tobacco product” to include “any component, part, or accessory of a tobacco product, ” 21 U.S.C. § 321(rr), but the agency made clear that it was regulating only components and parts of the newly-deemed tobacco products, not their accessories. See Deeming Rule, 81 Fed. Reg. at 28, 975. According to the FDA, the purpose of the Rule was twofold:

(1) To deem all products that meet the definition of “tobacco product” under the law, except accessories of a newly deemed tobacco product, and subject them to the tobacco control authorities in chapter IX of the [FDCA] and FDA's implementing regulations; and (2) to establish specific restrictions that are appropriate for the protection of public health for the newly deemed tobacco products.

Id. The agency announced that the Rule would become effective ninety days after publication, and that the “newly deemed products will become subject to the same [FDCA] provisions and relevant regulatory requirements to which cigarettes ... are subject.” Id. at 28, 976.

         So, as of August 8, 2016, the manufacturers of ENDS products have been subject to the following two statutory provisions that govern cigarettes and other tobacco products:

• The prohibition of the sale or distribution of products bearing “modified risk” descriptors (such as “light, ” “low, ” or “mild”) and claims, without FDA approval; and
• The prohibition on the distribution of free samples.

Id.

         The TCA would have also authorized the agency to impose the premarket review requirement on manufacturers immediately, thereby halting sales until premarket applications were approved. See 21 U.S.C. § 387b (finding that a tobacco product is adulterated if it is required to have a premarket review order but does not have one); 21 U.S.C. § 331(a) (making it unlawful to introduce an adulterated tobacco product into interstate commerce). But as part of the Deeming Rule, the agency opted to implement the statutory requirement more gradually. The FDA announced that all new tobacco products will be required to submit applications for premarket authorization of their products through one of the pathways under a “staggered initial compliance period[] . . . followed by continued compliance periods for FDA review:”

[M]anufacturers of all newly deemed, new tobacco products will have a 12-, 18- or 24-month initial compliance period in which to prepare applications for marketing authorization, as well as a 12-month continued compliance period after those dates in which to obtain authorization from FDA (resulting in total compliance periods of 24, 30, or 36 months). After the close of the continued compliance period, products will be subject to enforcement unless they are grandfathered or are the subject of a marketing authorization order.

         Deeming Rule, 81 Fed. Reg. at 28, 977-78.[13]

         As part of the Deeming Rule, the FDA defined the terms that Congress failed to define in the TCA. The decision applies to “components” and “parts” of the newly deemed tobacco products, and the agency defined “component or part” as “any software or assembly of materials intended or reasonably expected: (1) [t]o alter or affect the tobacco product's performance, composition, constituents, or characteristics; or (2) to be used with or for the human consumption of a tobacco product.” Deeming Rule, 81 Fed. Reg. at 28, 975.[14] The agency provided a “nonexhaustive list of examples of components and parts used with electronic nicotine delivery systems (ENDS) (including e-cigarettes):”

E-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquid, and programmable software.

Id.[15]

         The agency added that its definition of “component or part . . . excludes anything that is an accessory of a tobacco product, ” and it defined the term “accessory” to mean:

any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) [i]s not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or ...

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