Full opinion text
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. 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. 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. The Court wishes to reassure the many worried vapers who followed these proceedings closely that this ease 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 “eigalikes” that comprise a large portion of the e-eigarette 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” vap-ing 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 devícés 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 thé 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. TABLE OF CONTENTS BACKGROUND.. .370 I. Statutory Background — -the Relevant Provisions of the Tobacco Control Act...370 A. The Deeming Provision and the Definition of “Tobacco Product”.. .372 B. Premarket Review... 372 1. The Substantial Equivalence Pathway.. .372 2. The Premarket Review Process ...373 C. Ban on Distribution of Free Samples... 373 D. Ban on Modified Risk Statements ...374 II. Regulatory Background... 375 III. Factual & Procedural Background, . ,377. STANDARD OF REVIEW.. .379 ANALYSIS.. .380 I. FDA did not exceed its statutory authority when it deemed both open system vaping devices and nicotine-free liquids to be “tobacco products.”... 380 A. The D.C. Circuit has not yet decided the issue.. .380 B. The FDA has the statutory authority to regulate open-system vaping devices,.. 381 1. The FDA’s characterization of an empty vaping device as a “component” of a tobacco product survives step one of the Chevron analysis...382 2. The FDA’s interpretation is reasonable under Chevronstep two.. .385 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 . . ,386 1. Plaintiffs have standing to challenge the application of the rulemak-ing to nicotine-free products because they manufacture those products ...387 ■ 2. Plaintiffs’ challenge to the regulation of nicotine-free products is ripe.. .388 3. The agency’s interpretation of the definition of “tobacco product” to include certain non-nicotine-containing e-liquids meets the Chevron test.. .389 II. The FDA’s decision to deem e-cigarettes to be tobacco products comports with the APA.. .391 A. Legal Standard... 391 B. The APA dispute is justicia-ble... 392 C. The FDA’s decision to deem e-cigarettes to be tobacco products is reasonable and supported by the record. . .393 D. Plaintiffs’ arguments that the Rule is arbitrary and capricious are not persuasive... 396 E. The agency appropriately rejected plaintiffs’ suggested regulatory alternatives. . .397 F. The decision not to change the grandfather date for substantially equivalent products is not arbitrary and capricious ...398 G. FDA’s imposition of compliance deadlines was not arbitrary and capricious ...399 III. The Deeming Rule is not invalid due to any deficiencies in the cost-benefit analysis... 400 A. The agency was not required to do a cost-benefit analysis... 400 B. Even if Michigan v. EPA does apply, the agency complied with its requirements ...402 C. The agency’s consideration of costs and benefits satisfied the APA...403 IV. The agency complied with the purely procedural requirements of the Regulatory Flexibility Act.. .407 V. The Deeming Rule is not unconstitutional; RSF has abandoned its equal protection claim, and its due process argument fails... 408 VI. The marketing restrictions in the Tobacco Control Act do not violate the First Amendment.. .410 A. Central Hudson has not been supplanted by Sorrell... 411 B. The Tobacco Control Act’s ban on the distribution of free samples is constitutional ...412 1. The Tobacco Control Act’s ban on the distribution of free samples regulates conduct, not speech... 412 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.. .415 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... 416 4. The ban on free samples is not more extensive than necessary to serve FDA’s substantial interest.. .417 C. The regulation of modified-risk tobacco products satisfies the Central Hudson test... 419 CONCLUSION.. .421 BACKGROUND I. Statutory Background — the Relevant Provisions of the Tobacco Control Act The Tobacco Control Act was enacted in 2009. 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,” TCÁ § 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 tb 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 at- 21 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. Dor 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 accéssory 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)(l). 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" tó FDA approval: the less onerous “substantial equivalence” pathway, and the more demanding “premarket review” pathway. 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). 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.”^ U.S.C. § 387j(b)(l). The FDA must either approve or deny a premarket review application within 180 days. 21 U.S.C. § 387j(c)(l)(A). A denial may only be based on one of the fohr 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). . 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-l. Congress directed the agency to permit the distribution of free samples of smokeless tobacco “in a qualified adult-only facility,” 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 subpara-graph.” Id. § 387a-l(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)(l). 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 moré 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)(l). 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). 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:” Manufacturers 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. 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. 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. 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 temperature of a stored product or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product. Id. The agency explained that it was declining to regulate accessories of the newly-deemed tobacco products because “accessories, unlike components or parts, are expected to have little direct impact on the public health.” Id. III. Factual & Procedural Background An e-cigarette, or electronic nicotine delivery device, is a battery powered device that heats an “e-liquid.” An individual uses an e-cigarette by inhaling a vapor through the mouthpiece of a device that heats an “e-liquid,” producing a vapor which the user inhales through a mouthpiece. Deck of Jeffrey Stamler (Dkt. # 20-2] (“Stamler Deck”) ¶ 3. There are two main types of e-cigarettes on the market today: closed systems and open systems. Id. ¶8. In a closed systein, “the amount of liquid, flavor, and nicotine content (if any) is set by the manufacturer and cannot be altered by the consumer.” Id. ¶ 9. Closed-system products are available in both a single-use, disposable form — also known as a “ciga-like” — and a “rechargeable”' form, into which a user can insert a “proprietary replacement cartridge” that contains the e-liquid. Id.-, RSF. Compl. ¶22. In an open system, the device has a chamber or cartridge that can be refilled, and “the consumer separately purchases e-liquid of his or her choosing.” Stamler Deck ¶ 10. Consumers can purchase e-liquid directly from a manufacturer, or they can gó to a retail establishment called a “vape shop.” Id. Nicopure is a limited liability company based in Florida. Nicopure Compl. ¶ 9. It “distributes battery-powered vaping devices under the Triton, Reactor, Tracer, and G6 brand names.” Id. Triton, Reactor, and Tracer are all open-system devices, and G6 is a closed-system device. Id. “Ni-copure also manufactures and distributes nicotine-and-non-nicotine ‘e-liquid’ under the Halo and eVo brand names.” Id. On May 10, 2016, Nicopure filed suit to challenge the legality of the Deeming Rule in four respects. In Count I, Nicopure alleges that the FDA exceeded its statutory authority in violation of sections 706(2)(A) and (C) of the APA when it enacted the Deeming Rule, because the Rule’s “definition of ‘tobacco product’ and attendant proposed reach of its provisions is unambiguously foreclosed by, and is an unreasonable construction of, the text of the [TCA].” Nicopure Compl. ¶ 34. At the hearing, Nicopure focused in particular on the Rule’s application to open system devices and nicotine-free e-liquids. Hr’g Tr. at 13:14-14:15. But it also objects to the application of the rule to “hundreds of products that are neither • made nor derived from tobacco nor intended for human consumption,” such as “programmable software, batteries, digital display/lights, and glass or plastic vials.” Nicopure Compl. ¶¶ 21, 26 (internal quotation marks and alterations omitted). Notably, Nico-pure does not argue that the FDA did not have the legal authority to deem e-cigarettes to be tobacco products. Nicopure’s Count II alleges that it was arbitrary and capricious for the FDA to enact a rule that requires e-cigarette manufacturers to undergo premarket review. Nicopure Compl. ¶¶ 36-45. The company maintains that the Deeming Rule “fails to come to grips with the extraordinary burden this approval regime will have, both on manufacturers and on FDA itself,” id. ¶41, and that the Rule “arbitrarily discounts the safety benefits offered by vap-ing devices and e-liquids.” Id. ¶ 42. In Count III, Nicopure alleges that the FDA violated the APA in promulgating the Rule because its cost-benefit analysis was deficient. It alleges that the FDA “overstates the Rule’s benefits, fails to quantify the Rule’s benefits, understates the Rule’s tremendous costs, and erroneously concludes that the Rule’s benefits outweigh its costs.” Id. ¶ 48. Finally, Count IV brings two challenges under the First Amendment: that the restriction on modified-risk statements prohibits manufacturers from making truthful and nonmisleading statements about their products, and that the ban on the distribution of free samples violates Nicopure’s right to free speech. Id. ¶¶ 54-55. Nicopure requests that the Court vacate the Deeming Rule and declare it unlawful. Id., Relief Requested. The Right to be Smoke Free plaintiffs filed their eight-count complaint about a month later, on June 20, 2016. RSF Compl. The plaintiffs are “national and state-wide trade associations representing the entire ENDS industry (i.e., manufacturers, distributors, and retailors).” Id. at 1. In Count I, RSF asserts that the Deeming Rule is arbitrary and capricious because it did not establish a new “Grandfather Date for ENDS products,” and because the agency failed to “apply its enforcement authority so that some ENDS manufacturers, including e-liquid companies, would have the opportunity to forego the [pre-market review] pathway and avail themselves of the option to ■ submit SE Reports.” Id. ¶ 75. Count II alleges that the agency’s “application of the [premarket] process to ENDS products violates the APA, and, thus, should be set aside as unlawful and enjoined.” Id. ¶ 82. In Count III, RSF objects to the fact that the FDA, in, implementing the TCA, treated e-cigarettes in the same manner that it treats cigarettes, and it posits that this “one size fits all” approach violates the due process and equal protection clauses of the Constitution. Id. ¶¶ 88-89. Count IV alleges that the ban on free samples violates the First Amendment and the APA. Id. ¶¶ 90-100. In Count V, RSF alleges that the TCA’s modified risk provision requires “manufacturers of tobacco products to secure FDA's approval before making truthful, nonmis-leading claims about their products,” in violation of the First Amendment and the APA. Id. ¶¶ 101-10. Count VI challenges the definition of “tobacco product” under the APA. Id. ¶¶ 111-17. Count VII alleges that the FDA violated the Regulatory Flexibility Act, 5 U.S.C. § 601, et seq., by failing-to conduct an appropriate cost-benefit analysis. Id. ¶¶ 117-27. And Count VIII alleges that the failure to conduct an appropriate cosh-benefit analysis violates the APA. Id. ¶¶ 128-33. RSF requests a declaration that the Deeming Rule violates the APA, the Regulatory Flexibility Act, and the First .Amendment, and that that the Tobacco Control Act itself violates the First Amendment, the Due Process Clause, and the Equal Protection Clause. Id., Request for Relief. In light of the substantial overlap between the two sets of allegations, the Court consolidated the cases. See Order (June 28, 2016) [Dkt. # 19]. STANDARD OF REVIEW Summary judgment is appropriate when the pleadings and evidence show that “there is no genuine dispute as to any material fact and [that] the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a), Hotvever, in cases involving review of agency action under the Administrative Procedure Act, Rule 56 does not apply due to the limited role of a court in reviewing the administrative record. Select Specialty Hosp.-Akron, LLC v. Sebelius, 820 F.Supp.2d 13, 21 (D.D.C. 2011). Under the APA, the agency’s role is to resolve factual issues and arrive at' a decision that is supported by the administrative record, and the court’s role is to “determine whether or not as a matter of law the evidence in the administrative record permitted the agency to make the decision it did.” Occidental Eng’g Co. v. INS, 753 F.2d 766, 769-70 (9th Cir. 1985), citing Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 415, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971); see also Richards v. INS, 554 F.2d 1173, 1177 & n.28 (D.C. Cir. 1977). In reviewing an agency’s interpretation of a statute, courts use the two-stép analysis outlined in Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Step one involves determining whether Congress has spoken directly to the precise question at issue. If it has, “the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress,” and that is the end of the matter. Id.; Nat’l Treasury Emps. Union v. Fed. Labor Relations Auth., 392 F.3d 498, 500 (D.C. Cir. 2004). If the statute is silent or ambiguous on the question, Chevron instructs the Court to go on to a second step and determine “whether the agency’s answer is based on a permissible construction of the statute.” Chevron, 467 U.S. at 843, 104 S.Ct. 2778. An. agency’s interpretation will warrant deference if it is reasonable. Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 702, 111 S.Ct. 2524, 115 L.Ed.2d 604 (1991). 'ANALYSIS I. FDA did not exceed its statutory authority when it deemed both open system vaping devices and nicotine-free liquids to be “tobacco products.” ' In Count I of Nicopure’s complaint, and in Count VI of the RSF complaint, plaintiffs challenge FDA’s statutory authority to regulate two specific vaping products: open-system vaping devices that do not contain any e-liquid, and e-liquids that do not contain nicotine or that are not made or derived from tobacco. See Nicopure Compl. ¶¶ 33-34; RSF Compl. ¶¶ 111-17; Nieopure Mem. at 9-14. Congress mandated in the TCA that “tobacco products ,.. shall be. regulated by the Secretary,” and it made clear that its mandate applied not only to “all cigarettes, cigarette tobacco, roll your own tobacco, and smokeless tobacco,” but also to “any other tobacco products that the Secretary by regulation deems to be subject” to its provisions. 21 U.S.C. § 387a. Congress defined “tobacco product” to include: any product made or derived from tobacco that is intended for human con- . sumption, 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)(l) (emphasis added). Nieopure argues that its “open-system vaping devices (and their constituent parts)” are not “tobacco products” because they are “neither ‘made or derived from tobacco,’ nor intended for human consumption!;,]” and that Nicopure’s “non-nicotine containing e-liquids are not ‘made or derived from tobacco.’” Nieopure Mem. at 9. The FDA takes the position that all of these items are “components” and “parts” of tobacco products and that therefore, they are covered by the statutory definition.,. The Court finds that the FDA was well within its statutory authority to regulate the narrow set of products at issue in this case. A. The D.C. Circuit has not yet decided the issue. At the outset, defendants argue that judgment should be entered in their favor because the D.C. Circuit already ruled on the legality of the regulation of e-cigarettes in Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010). While it is true that the Court of Appeals addressed the issue of the regulation of -some electronic cigarettes in that opinion, it did not decide the precise issues presented in this lawsuit. The plaintiffs in Sottera manufactured what are referred to in this ease as closed-system e-cigarettes: the Court described the products at issue as “battery-powered products that allow users to inhale nicotine vapor without' fire, smoke, ash, or carbon monoxide” that were “[designed to look like a traditional cigarette.” Id. at 893. After the agency blocked the importation of plaintiffs’ products because they “appeared to be adulterated, misbranded, or unapproved drug-device combinations under the FDCA,” plaintiffs sought a preliminary injunction, seeking a ruling that their products could only be regulated under the TCA, and not under the FDCA. Id. The D.C. Circuit held that while the “FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions ... it can regulate tobacco products marketed for therapeutic purposes under those provisions, and ... it can regulate customarily marketed tobacco products under the [TCA],” Id. at 898. Thus, at the,urging of the e-cigarette industry, the. Court recognized that “the FDA has authority under the [TCA] to regulate electronic cigarettes, enabling it to mitigate or perhaps extinguish any harm to the public health.” Id. While the decision is an important part of the legal backdrop of this case, the Sottera Court’s rejection of the drug/device provisions of the FDCA as a basis to regulate e-eigarettes does not answer the questions posed here: whether a particular category of ENDS products can be regulated as “components or parts” of tobacco products. Defendants note that the only difference between the products at issue in Sottera and the products sold by plaintiffs is the fact that plaintiffs manufacture open-system vaping devices. Defs.’ Cross-Mem. at '24. And the agency suggests that the Court should not be swayed by what it sees as a change in position by the industry: Having insisted in Sottera that e-cigarettes are regulable as tobacco products, manufacturers cannot now avoid that conclusion simply by making their products refillable. Indeed, while the ques-tion presented in Sottera was whether e-cigarettes should, be regulated as drugs/devices or instead as tobacco products, the choice Plaintiffs offer here ..is markedly different: whether refillable e-cigarettes should be regulated as tobacco products, or, as Plaintiffs urge, not at all. Id. at 24-25. But plaintiffs have conceded that most ENDS products may be lawfully regulated under the TCA, and notwithstanding Sottera, the Court must go on to utilize the Chevron analysis to determine, as' a- matter of first impression, whether the agency has' interpreted the statute properly. B. The FDA has the statutory authority to regulate open-system vaping devices. The threshold determination — whether the agency’s reading of “component or part” to include empty open vaping devices, or nicotine-free- liquids sold separately, is consistent with the TCA — turns on “whether Congress has directly spoken to the precise question at issue.” Chevron, 467 U.S. at 842, 104 S.Ct. 2778. The D.C. Circuit has explained: Under the first step of Chevron, the reviewing court “must first exhaust the traditional tools of statutory construction to determine whether Congress has spoken to the precise question at issue.” The traditional tools include examination of the statute’s text, legislative history, and structure, as well as its purpose. Bell Atl. Tel. Cos. v. FCC, 131 F.3d 1044, 1047 (D.C. Cir. 1997), quoting Nat. Res. Def. Council v. Browner, 57 F.3d 1122, 1125 (D.C. Cir. 1995). The court is required to utilize these methods to determine whether Congress has “unambiguously foreclosed the agency’s statutory interpretation.” Catawba Cty. v. EPA, 571 F.3d 20, 35 (D.C. Cir. 2009). Congress may have done so in one of two ways: either by prescribing a precise course of conduct other than the one chosen by the agency, or by granting the agency a range of interpretive discretion that the agency has clearly exceeded ... And if the agency has either violated Congress’s precise instructions or exceeded the statute’s clear boundaries then, as Chevron puts it, “that is the end of the matter” — the agency’s interpretation is unlawful. Vill. of Barrington v. Surface Transp. Bd., 636 F.3d 650, 659-60 (D.C. Cir. 2011). Starting with the text, it is true that Congress did not specifically define the words “component” or “part” in the TCA. But “the absence of a statutory definition does not render a word ambiguous.” Nat. Res. Def. Council v. EPA, 489 F.3d 1364, 1373 (D.C. Cir. 2007). In the absence of an express statutory definition, courts are simply bound to give the terms used in the statute their ordinary meaning. Petit v. U.S. Dep’t of Educ., 675 F.3d 769, 781 (D.C. Cir. 2012). The burden is on the plaintiffs challenging the agency interpretation to “do more than offer a reasonable, or even the best, interpretation” of the statute; plaintiffs must instead show “that the statute unambiguously forecloses the agency’s interpretation.” Id., quoting Vill. of Barrington, 636 F.3d at 661. In other words, if a court determines “that statutory ambiguity has left the agency with a range of possibilities and that the agency’s interpretation falls within that range, then the agency will have survived Chevron step one.” Vill. of Barrington, 636 F.3d at 660. The Court must therefore begin with the plain language of the TCA. Lindeen v. SEC, 825 F.3d 646, 653 (D.C. Cir. 2016), quoting Cmty. for Creative Non-Violence v. Reid, 490 U.S. 730, 739, 109 S.Ct. 2166, 104 L.Ed.2d 811 (1989). The statutory definition of a “tobacco product” authorizes the FDA to extend the provisions of the TCA to cover: 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)(l). In exercising its deeming authority to regulate e-cigarettes under the TCA, the FDA defined the terms “component or part” together to mean: “any software or assembly of materials intended or reasonably expected: (1) to 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. According to the FDA, applying this definition means that the term “tobacco product” covers not only all-in-one electronic nicotine delivery systems, but also empty open system devices and liquids sold separately, including nicotine-free liquids intended to be mixed with nicotine-based liquids. Defs.’ Cross-Mem. at 25-40. Since the agency justifies these two applications of the statute on different grounds, and it has raised threshold jurisdictional issues with respect to the challenge to the regulation of e-liquids, this opinion will address the agency’s authority to regulate the two challenged products separately. 1. The FDA’s characterization of an empty vaping device as a “component” of a tobacco product survives step one of the Chevron analysis. The FDA’s approach to empty vap-ing devices is not inconsistent with the ordinary meaning of the terms “component” and “part” that are used in the statute, and therefore, it is not foreclosed by the TCA. To shed light on the ordinary meaning of an undefined statutory term, the Court turns to the dictionary. See, e.g., Taniguchi v. Kan Pac. Saipan, Ltd., 566 U.S. 560, 132 S.Ct. 1997, 2002, 182 L.Ed.2d 903 (2012). The word “component” is defined in the Merriam Webster dictionary as “a constituent part,” Component, Merriam-Webster Dictionary, http://www.merriam-webster. com/dictionary/ component, and the dictionary offers the example of stereo components. Id. Similarly, the Oxford English Dictionary defines “component” to mean “[a] constituent element or part.” Oxford English Dictionary, 2d ed. (1989). The word “part” is defined by Merriam-Webster as “an essential portion or integral element,” Part, Merriam-Webster Dictionary, http://www.merriamwebster.com/ dictionary/part, and by the Oxford English Dictionary as “[a] piece or section of something which together with another or others makes up the whole (whether actually separate from the rest or not),” and as “[a]n essential element; an integral portion of a larger whole.” Oxford English Dictionary, 3d ed. (2005). The agency’s interpretation is entirely consistent with the plain meaning of the statute: the device — which contains the heating element and the battery — and the liquid are the “components” of an electronic nicotine delivery system just as an amplifier and a speaker are “components” of a stereo system. And while a sophisticated audiophile might have some choices to make about what to include in a sound system today, the device plus the liquid are undeniably the two essential components of an open vaping system: a consumer cannot use a vaping device for its primary purpose without adding the liquid, and there is nothing to do with the liquid without' the device. (Indeed, it might be fair to say that the device is the electronic nicotine delivery system.) Putting aside the dictionary, a better analogy might be that just as an empty fountain pen is obviously a “component” of an ink pen (or “writing system”), even when the ink is sold separately, and it is no less of a pen than a cartridge pen that comes packaged together with several disposable cartridges, so too the empty open device, is a “component” of an electronic nicotine delivery system, particularly since plaintiffs agree that the device would constitute a tobacco product if it were simply packaged together with a few e-liquid cartridges. Hr’g Tr. at 14:22-15:5. There is no logic to plaintiffs’ contention that the packaging should be dispositive, and the Court finds that the physical separation of the liquid from the device at the point of sale is of no significance. Both are “components,” Plaintiffs attempt to avoid this plain reading of the text of the statutory definition by pointing to the structure of the TCA. They argue that because Congress used,the term “component” in other parts of the statute to “refer to items inseparable from the product made or derived from tobacco,” and “not to refer to separate products not so made or derived,” the vaping devices at issue here cannot be considered to be “components” or “parts.” Nicopure Mem. at 11, citing Japan Whaling Ass’n v. Am. Cetacean Soc’y, 478 U.S. 221, 238-39, 106 S.Ct. 2860, 92 L.Ed.2d 166 (1986) (“Without strong evidence to the contrary,” the Supreme Court “doubt[s] that Congress intended the same phrase to have significantly different meanings in two adjoining paragraphs of the same subsection”). In other words, according to plaintiffs, any “component” or “part” referred to in the TCA must be inseparable from the whole notwithstanding the ordinary definitions of the terms. But a review of the statute does not bear this out. Plaintiffs first point to 21 U.S.C. § 387(17), a provision that defines the term “smoke constituent” to include “any chemical or chemical compound in mainstream or sidestream' tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product.” Nicopure Mem. at 11. They also cite 21 U.S.C. § 387d(a), which requires manufacturers to list “all ingredients ,.. added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product.” Id. And finally, plaintiffs rely on 21 U.S.C. § 387g(a)(1)(A), which prohibits “a cigarette or any of its component parts (including the tobacco, filter, or paper)” from containing flavors'. Taking those portions' of the statute together, plaintiffs argue that the context of the TCA as a whole supports their argument that the terms “component or part” must mean a part physically connected to the whole. But “[t]o prevail on its Chevron Step One argument, [plaintiffs have] to do better than concoct an interpretation purportedly based on the statute’s context. [Plaintiffs] ‘must show that the statute unambiguously forecloses the [agency’s] interpretation.’” Pharm. Research & Mfrs. of Am. v. FTC, 790 F.3d 198, 207 (D.C. Cir. 2015), quoting Vill. of Barrington, 636 F.3d at 661. Plaintiffs “context” argument fails to meet that standard. The three provisions cited do not prove plaintiffs’ point because none specifically defines the terms “component” or “part,” and each either uses the terms in passing, or simply lists examples of what components of a particular type of tobacco product might be. The fact that the components of a conventional cigarette may be physically connected to that item does not mean that the components of an entirely different sort of product must be. Finally, the D.C. Circuit has directed reviewing courts to “exhaust the traditional tools of statutory construction,” including examining.a statute’s purpose, when they embark on the “search for the plain meaning of the statute.” Bell Atl. Tel. Cos., 131 F.3d at 1047. Here, Congress specified that the purpose of the TCA was to give the agency flexibility in regulating tobacco products, and particularly those products that may be attractive, to minors. The list of statutory purposes set out in the legislation includes: “to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco;” “to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and.pro-móte less harmful tobacco products;” and “to impose appropriate regulatory controls on the tobacco industry.” TCA §§ 3(2), (4), (8). These unequivocal statements of the intent behind the legislation support the Court’s finding that the agency’s commonsense interpretation. is not inconsistent with the statutory definition of a tobacco product. Thus, the Court finds that the FDA’s conclusion that it has the authority to regulate open vaping systems, even' if they are empty and packaged alone, is not precluded by the statute and survives analysis under the first step of the Chevron test. 2. The FDA’s interpretation is reasonable under Chevron step two. In the court’s view, the ordinary terms, “component” and “part” are not ambiguous, and .the FDA’s exercise of its deeming authority to cover the products at issue falls squarely within the limits of the statute. But to the extent the statute is ambiguous, for all of the same reasons, the agency’s interpretation “is based on a permissible construction of the statute,” Chevron, 467 U.S. at 843, 104 S.Ct. 2778, and therefore, it “merits judicial deference.” Bell Atl. Tel. Cos., 131 F.3d at 1047. The Court should “defer to the agency’s permissible interpretation,” so long as “the agency has offered a reasoned explanation for why it chose that interpretation.” Vill. of Barrington, 636 F.3d at 660. At Chevron step two, a court. “may not ■ disturb an agency rule unless it is ‘arbitrary or capricious in substance, or manifestly contrary to the statute.’ ” Mayo Found. for Med. Educ. & Research v. United States, 562 U.S. 44, 53, 131 S.Ct. 704, 178 L.Ed.2d 588 (2011), quoting Household Credit Servs., Inc. v. Pfennig, 541 U.S. 232, 242, 124 S.Ct. 1741, 158 L.Ed.2d 450 (2004). There is no linguistic or statutory basis for plaintiffs’ contention that a component or part may only be regulated if it is “physically part of a product containing tobacco (or material derived from tobacco) when: introduced into commerce.” Pis.’ Reply at 6; Nicopure Mem. at 10-12. Plaintiffs do not dispute that a vaping device can be regulated as a tobacco product when it comes all in one piece, or even in two' pieces in one box. ' See Hr’g Tr. at 14:22-15:2 (“[Plaintiffs’ counsel]: If it’s sold in a kit with' a nicotine-containing liquid, then that kit or that product that’s being sold ... would meet the definition of tobacco product because the product[ ].: includes the e-liquids that’s got the nicotine derived from tobacco.”). But the definition of “tobacco product” is not limited to products made or derived from tobacco since it specifically includes “components” and “parts” of tobacco products. 21 U.S.C. § 321(rr)(1). Plaintiffs object to the characterization of an empty ENDS device as a component on the basis that those devices are “separate consumer produces] that contain[] neither tobacco nor anything derived from tobacco.” See Nicopure Mem. at 10. But an empty open vaping system is not a generic consumer item with multiple potential functions, like a box or a bowl.- The purpose of those items might not be evident until the consumer chooses to use them in a certain way. But an open-system vaping device is a unique item with a single function, and it is fundamental to the vaping process: you can’t vape without it. Therefore, the FDA’s interpretation of the term “component” to encompass an empty open system vaping device is based on a permissible construction of the TCA. Chevron, 467 U.S. at 843, 104 S.Ct. 2778. The Court reaches the same conclusion with respect to plaintiffs’ challenge to the agency’s treatment of e-liquids, but it must first address the jurisdictional questions raised by the defense. 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. Plaintiffs challenge that portion of the Rule that purports to cover e-liquids that do not contain nicotine. In light of the definition of a tobacco product in section 321(rr)(l) of the TCA, the agency acknowledged in the Deeming Rule that it did not have the power to regulate e-liquids that are not made or derived from tobacco, or e-liquids that are not components or parts of a tobacco product. See, e.g., Deeming Rule, 81 Fed. Reg. at 29,017. However, it stated its intention to regulate the entire line of e-liquid cartridges, “including cartridges that include varying degrees of nicotine or those that do not contain nicotine, if they meet the definition of component or part.” Id. The FDA then advanced the position that an e-liquid without nicotine can be a “component” of a tobacco product under the TCA, and therefore subject to FDA regulation, “if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product (e.g., with liquid nicotine).” Id, The Rule goes on to provide: FDA is not bound by the manufacturer or distributor’s subjective claims of intent. Rather, FDA can consider the totality of the circumstances, including direct and circumstantial objective evidence, which encompasses a variety of factors such as the circumstances surrounding the distribution of the product or the context in which it is sold ... and sales data. Id. at 29,015. Plaintiffs maintain that this aspect of the Rule contravenes the TCA, see Nicopure Mem. at 13-14, and before addressing the merits, defendants briefly argue that the Court lacks jurisdiction to hear this claim. They argue that plaintiffs lack standing because they have