# Nicopure Labs, LLC v. Food and Drug Administration

> District Court, District of Columbia · July 21, 2017 · 266 F. Supp. 3d 360

URL: https://www.frixlaw.com/law-library/cases/4188357

## Case

- **Full name:** 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
- **Court:** District Court, District of Columbia
- **Decided:** July 21, 2017
- **Citations:** 266 F. Supp. 3d 360
- **Precedential status:** Published
- **Opinion:** Opinion by Jackson
- **Judges:** Judge Amy Berman Jackson
- **Nature of suit:** Civil
- **Cited by:** 15 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/4188357

## How later opinions describe it (automated extraction)

- holding statute that said the FDA “shall” regulate products that the Secretary deemed to be tobacco products did not permit consideration of costs because “[t]he statute does not limit the Secretary’s authority to deem to when he finds it ‘appropriate and necessary’ to do so”
- affirming the agency’s treatment of a rule’s benefits that were “difficult to quantify” because in addition to explaining “the reasons why quantification was not possible,” the agency “provided substantial detail on the benefits of the rule”
- rejecting the challenger's similar argument that "the context of the TCA as a whole supports [the] argument that the terms 'component or part' must mean a part physically connected to the whole"
- noting that the RFA “simply requires agencies to publish analyses that address specific topics,” and when they do so, they have “complied with the [RFA]”

## Opinion text

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
____________________________________
)
NICOPURE LABS, LLC, )
)
Plaintiff, )
)
v. ) Civil Action No. 16-0878 (ABJ)
)
FOOD AND DRUG )
ADMINISTRATION, et al., )
)
Defendants. )
____________________________________)
)
RIGHT TO BE SMOKE-FREE )
COALITION, et al., )
)
Plaintiffs, )
)
v. ) Civil Action No. 16-1210 (ABJ)
)
FOOD AND DRUG )
ADMINISTRATION, et al., )
)
Defendants. )
____________________________________)

MEMORANDUM OPINION

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.

1 See “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic
Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on
the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco
Products,” 81 Fed. Reg. 28,974 (May 10, 2016) (“Deeming Rule”). The Court will refer to these
products either as “e-cigarettes,” “electronic nicotine delivery systems,” or “ENDS.” The products
are known colloquially as “vaping” devices.

2 Nicopure’s complaint named the former Commissioner of Food and Drugs, Robert Califf,
and the former Secretary of Health and Human Services, Sylvia Matthews Burwell. Pursuant to
Federal Rule of Civil Procedure 25(d), their successors, Commissioner of Food and Drugs Scott
Gottlieb and Secretary of Health and Human Services Thomas E. Price have been automatically
substituted as defendants.
2
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.

3 On July 8, 2016, Nicopure filed its motion for summary judgment. Nicopure Labs, LLC’s
Mot. for Summ. J. [Dkt. # 20] (“Nicopure Mot.”); Mem. of P. & A. in Supp. of Nicopure’s Mot.
[Dkt. # 20-1] (“Nicopure Mem.”). RSF filed its motion for summary judgment on July 25, 2016,
joining in Nicopure’s arguments concerning the issues raised in both complaints, and focusing on
the issues unique to its motion. Pl. Trade Assocs.’ Mot. for Summ. J. [Dkt. # 21] (“RSF Mot.”);
Mem. of P. & A. in Supp. of RSF’s Mot. [Dkt. # 21-1] (“RSF Mem.”). The government filed an
opposition to both motions, as well as a cross-motion for summary judgment, on August 17, 2016.
Defs.’ Cross-Mot. for Summ. J. [Dkt. # 43] (“Defs.’ Cross-Mot.”); Mem. in Opp. to Pls.’ Mots.
for Summ. J. & in Supp. of Defs.’ Cross-Mot. [Dkt. # 43] (“Defs.’ Cross-Mem.”). Plaintiffs jointly
opposed the cross-motion and replied in support of their motions on August 26, 2016, Pls.’ Joint
Mem. in Opp. to Defs.’ Cross-Mot. & Reply in Supp. of Pls.’ Mots. for Summ. J. [Dkt. # 46]
(“Pls.’ Reply”), and defendants filed their cross-reply on September 9, 2016. Reply in Supp. of
Defs.’ Cross-Mot. [Dkt. # 48] (“Defs.’ Cross-Reply”). The Court also received amicus curiae
submissions from a number of groups in support of plaintiffs: Brief of Amicus Curiae Smoke-
Free Alternatives Trade Ass’n in Supp. of Pl.’s Mot. [Dkt. # 30]; Brief of Amicus Curiae the Nat’l
Center for Public Policy Research, and TechFreedom in Supp. of Pls. [Dkt. # 37]; Brief Amicus
Curiae of the Vape a Vet Project in Supp. of Pls. [Dkt. # 39]; Brief of Amici Curiae Clive Bates &
Fifteen Others in Supp. of Pls.’ Mot. [Dkt. # 41]. And it received an amicus curiae submission
from the Campaign for Tobacco-Free Kids and a number of other public health organizations in
support of defendants. Brief of Amici Curiae Public Health Orgs. in Supp. of Defs.’ Cross-Mot.
[Dkt. # 45]. The Court held a hearing on the cross-motions on October 11, 2016. Min. Entry (Oct.
11, 2016); Tr. of Mots. Hr’g [Dkt. # 50] (“Hr’g Tr.”).
3
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

4
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,

4 The term “cigalikes” refers to e-cigarettes that are designed to look like a traditional
cigarette, with a small built-in cartridge containing pre-filled liquid. RSF Compl. ¶ 22. The parties
refer to these devices as “closed systems,” because the consumer cannot refill the liquid cartridge.
See id.; Nicopure Compl. ¶ 4.
5
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

5 On June 8, 2017, the parties filed a joint notice alerting the Court that “the FDA has
announced that it is deferring enforcement of all future compliance deadlines under the Deeming
Rule for three months,” in order to give “new leadership personnel at the Department and Health
and Human Services and the FDA an opportunity to more fully consider the issues raised by the
deeming rule.” Joint Notice [Dkt. # 54]. While the Right to be Smoke Free Coalition believes
that the Court should withhold its decision on the pending cross-motions until the agency’s review
is complete, id. at 2, no party has moved to stay the action, and nothing in this opinion prohibits
the FDA from continuing to work with industry representatives to establish a mutually acceptable
schedule for the implementation of the Rule. This opinion will refer to the compliance deadlines
that are set out in the Rule itself, notwithstanding the fact that some of those deadlines have been
extended.
6
TABLE OF CONTENTS

BACKGROUND ........................................................................................................................... 9
I. Statutory Background – the Relevant Provisions of the Tobacco Control Act ............... 9
The Deeming Provision and the Definition of “Tobacco Product”..................... 11
Premarket Review ................................................................................................... 11
1. The Substantial Equivalence Pathway................................................................... 12
2. The Premarket Review Process .............................................................................. 13
Ban on Distribution of Free Samples ..................................................................... 14
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
The D.C. Circuit has not yet decided the issue...................................................... 26
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
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

7
II. The FDA’s decision to deem e-cigarettes to be tobacco products comports
with the APA. .............................................................................................................................. 44
Legal Standard......................................................................................................... 45
The APA dispute is justiciable................................................................................ 45
The FDA’s decision to deem e-cigarettes to be tobacco products is reasonable and
supported by the record. ..................................................................................................... 48
Plaintiffs’ arguments that the Rule is arbitrary and capricious
are not persuasive. ............................................................................................................... 51
The agency appropriately rejected plaintiffs’ suggested
regulatory alternatives. ....................................................................................................... 53
The decision not to change the grandfather date for substantially equivalent
products is not arbitrary and capricious. .......................................................................... 56
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
The agency was not required to do a cost-benefit analysis. ................................. 60
Even if Michigan v. EPA does apply, the agency complied with its
requirements. ....................................................................................................................... 62
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
Central Hudson has not been supplanted by Sorrell. ............................................ 76
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

8
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
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:

x “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);

x “Nicotine is an addictive drug,” id. § 2(3);

x “Tobacco is the foremost preventable cause of premature death in America,” id.
§ 2(13);

x “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);

6 The FDA has engaged in previous attempts to regulate the tobacco industry. In 1996, it
promulgated a rule that concluded that nicotine was a “drug” subject to the provisions of the
Federal Food, Drug, and Cosmetic Act. See 61 Fed. Reg. 44619 (1996). But the Supreme Court
rejected the agency’s interpretation in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120
(2000). The Court concluded that, in determining that nicotine was a “drug,” the FDA had
exceeded its statutory authority, and the Court struck down the regulation. Id. at 125–26. In 2009,
Congress responded to the Court’s decision by passing the Tobacco Control Act.
9
x 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:

x “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);

x “Virtually all new users of tobacco products are under the minimum legal age to
purchase such products,” id. § 2(4);

x “Tobacco advertising and marketing contribute significantly to the use of nicotine-
containing tobacco products by adolescents,” id. § 2(5);

x “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);

x “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”:

x “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);

x “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:

10
[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).

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. 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.”

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

11
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.

7 There is a third pathway – the “substantial equivalence exception” pathway, see 21 U.S.C.
§ 387j(a)(3)(A)(i)–(iii) – but that pathway is not implicated by the challenges brought in this case.

12
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

8 The term “characteristics” is defined by the TCA to mean “the materials, ingredients,
design, composition, heating source, or other features of a tobacco product.” 21 U.S.C.
§ 387j(a)(3)(B).

9 Plaintiffs refer to these applications by the acronym “PMTA,” or “premarket tobacco
application.” See Nicopure Compl. ¶ 38; RSF Compl. ¶ 34. To avoid confusion, the Court will
refer to this process as “premarket review,” and it will not use the acronym.

13
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

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).

10 The section of the TCA that provides standards for tobacco products indicates that the
Secretary of HHS “may adopt tobacco product standards” in addition to those set forth by statute
“if the Secretary finds that a tobacco product standard is appropriate for the protection of public
health,” and the statute provides factors for the Secretary to consider in making that determination.
21 U.S.C. § 387g(a)(3).

11 The statute defines “qualified adult-only facility” as “a facility or restricted area that”: (1)
requires appropriate authorities to check patrons’ photo ID and verify their dates of birth; (2) does
not sell, serve, or distribute alcohol; (3) is not located immediately across from a space used for
youth-oriented marketing; (4) is a temporary structure, operated for the purpose of distributing free
samples of smokeless tobacco; (5) is enclosed by a barrier; and (6) does not display any advertising
or brand names. 21 U.S.C. 387a–1(a)(2)(G).
14
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.

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

15
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

12 The TCA contains other provisions that are important to the protection of public health,
such as requiring that tobacco products bear a warning about the addictive nature of the products,
see 21 U.S.C. § 387f(d)(1)–(2), and banning all flavored cigarettes, but those provisions are not
relevant to the issues in this lawsuit.
16
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:

x 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

x The prohibition on the distribution of free samples.

Id.

17
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.

18
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

13 According to the Deeming Rule, the compliance periods depend on the pathway selected:
• A manufacturer that elects to submit a substantial equivalence report
must do so by February 8, 2018 – eighteen months after the Rule
became effective.

• A manufacturer submitting a premarket review application must do
so by August 8, 2018 – twenty-four months after the Rule became
effective.

• Under either approach, FDA will continue the compliance period for
at least twelve months while the applications are considered, and, on
a case-by-case basis, FDA will defer enforcement further – to give
the agency the time it needs to review and determine whether to
grant the requests.

Deeming Rule, 81 Fed. Reg. at 28,977–78. As the Court explained above, those compliance
deadlines have since been extended by three months. See Joint Notice at 2.

14 While the Deeming Rule recognizes that the TCA uses the term “component” and “part”
as distinct terms, the agency decided “for purposes of this final rule,” to use “the terms
‘component’ and ‘part’ interchangeably and without emphasizing the distinction between the
terms.” Deeming Rule, 81 Fed. Reg. at 28,975. But the agency also noted that it may “clarify the
distinctions between ‘component’ and ‘part’ in the future.” Id.

19
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 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.

Decl. of Jeffrey Stamler [Dkt. # 20-2] (“Stamler Decl.”) ¶ 3. There are two main types of e-

cigarettes on the market today: closed systems and open systems. Id. ¶ 8. In a closed system,

15 Plaintiffs complain that the FDA has defined “component or part” broadly enough to
encompass even batteries and software when they argue that the agency exceeded its authority.
See, e.g., Nicopure Mem. at 1, 10. But in the Deeming Rule, the agency specifically explained
that it intended “to limit enforcement of the premarket authorization provisions to finished tobacco
products,” “sealed in final packaging intended for consumer use.” Deeming Rule, 81 Fed. Reg. at
28,995. Therefore, as became clear during the hearing, plaintiffs’ claim is focused on the
application of the Deeming Rule to open system devices and nicotine-free liquids, and any
challenge to the application of the rule to batteries or other parts alone would be premature.
20
“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 “cigalike” – 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 Decl. ¶ 10. Consumers can purchase

e-liquid directly from a manufacturer, or they can go to a retail establishment called a “vape shop.”

Id. 16

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. “Nicopure 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

16 There is evidence in the record that pen-like open-system devices are also frequently used
for the purpose of smoking marijuana. See AR 15,582, 20,956–57.
21
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, Nicopure 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 vaping 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. 17

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.

17 The complaint also requested a preliminary injunction, but Nicopure never filed the
necessary motion, see Local Civil Rule 65.1, and it later abandoned its request for preliminary
relief. See Min. Entry (June 8, 2016).
22
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 [premarket 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, non-

misleading 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 cost-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. 18

18 RSF also requested “[a] preliminary and permanent injunction,” but they, too, failed to
comply with Local Rule 65.1.
23
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). However, 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 (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-step analysis

outlined in Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842–

43 (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. An agency’s interpretation will warrant deference if

it is reasonable. Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 702 (1991).

24
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; Nicopure

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
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) (emphasis added).

Nicopure 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.’” Nicopure Mem. at 9. 19 The FDA takes the position that all of these items

19 Throughout its pleadings in this case, Nicopure repeatedly quotes just a portion of the
statutory definition of “tobacco product” in this manner and omits the portion that includes any
“component, part, or accessory” of a tobacco product. See e.g., Nicopure Mem. at 1 (“Congress
expressly defined ‘tobacco product’ as a product made or derived from tobacco and intended for
human consumption. The majority of Nicopure’s products are neither.”). This leaves a misleading
impression and the deliberate excision undercuts the persuasive force of plaintiff’s arguments.
25
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.

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 case 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 “[d]esigned 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.

26
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-cigarettes 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 question 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.

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.

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.

27
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,

28
739 (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)(1).

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 vaping 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., 132 S. Ct. 1997, 2002 (2012).

29
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.merriam-

webster.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). 20

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

20 The frequent appearance of the word “part” in the definition of “component” suggests that
is was entirely appropriate for the FDA to consider them in tandem.

30
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.) 21

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.”

21 To supplement the textual analysis, the FDA seeks to draw support from the legislative
history of a related statute. It points out that when Congress authorized the Consumer Product
Safety Commission to require that liquid nicotine containers be child resistant in the Child Nicotine
Poisoning Prevention Act of 2015, Pub. L. No. 114-116, § 2(a), 130 Stat. 3 (2016), it expressly
recognized FDA’s authority to regulate e-cigarettes and their components, citing the FDCA, the
TCA, and the then-pending Notice of Proposed Rulemaking concerning vaping products:

Nothing in this Act shall be construed to limit or otherwise affect the
authority of the Secretary of Health and Human Services to regulate, issue
guidance, or take action regarding the manufacture, marketing, sale,
distribution, importation, or packaging, including child-resistant packaging,
of nicotine, liquid nicotine, liquid nicotine containers, electronic cigarettes,
electronic nicotine delivery systems or other similar products that contain
or dispense liquid nicotine, or any nicotine-related products . . .
See Defs.’ Cross-Mem. at 29–30, citing Child Nicotine Poisoning Prevention Act of 2015, Pub. L.
No. 114-116, § 2(b)(1), 130 Stat. 3 (2016). This provision in separate legislation does not provide
powerful evidence of what Congress had in mind when it enacted the TCA, but its
acknowledgement of the agency’s power to regulate not just liquid nicotine and electronic
cigarettes, but also nicotine delivery systems and “other similar products that contain or dispense”
nicotine suggests that the FDA’s reading of the statute is not inconsistent with Congressional
intent.
31
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 (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.

32
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 promote 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

33
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, 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 (2011), quoting Household Credit Servs., Inc. v.

Pfennig, 541 U.S. 232, 242 (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.” Pls.’ 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”

34
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 product[s] 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.

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.

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)(1) 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

35
reasonably expected to be used with or for the human consumption of a tobacco product (e.g., with

liquid nicotine).” Id. 22 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 not

alleged sufficient facts to demonstrate that their liquids are subject to the Rule. Defs.’ Cross-Mem.

at 33–35. Defendants also maintain that the claim is not ripe; they point out that plaintiffs do not

yet know if the FDA will initiate enforcement proceedings against their non-nicotine-based e-

liquids, and that, in light of the agency’s stated intention to review nicotine-free e-liquids on a

“case-by-case” basis, any challenge to that aspect of the regulation should wait until the agency

initiates an enforcement proceeding. Id. at 35–37. Therefore, the Court must determine whether

it has jurisdiction before it may go on to assess whether the agency’s interpretation of the statute

is reasonable.

22 As the agency explained at the hearing:

So the rule doesn’t purport to cover all nicotine-free e-liquids, it only
purports to cover them under certain circumstances, and those are when the
nicotine-free e-liquid is made or derived from tobacco. One example is a
tobacco-flavored e-liquid, regardless of its nicotine content. Another
example is if the nicotine-free e-liquid meets the definition of component
or part. And so one example of that that the FDA gave is nicotine-free e-
liquids that are intended to be mixed with liquid nicotine.
Hr’g Tr. at 30:15–31:7.

36
1. Plaintiffs have standing to challenge the application of the rulemaking
to nicotine-free products because they manufacture those products.
Article III of the Constitution restricts the power of the federal courts to hear only “Cases”

and “Controversies.” U.S. Const. art. III, § 2, cl. 1. A federal court is “forbidden . . . from acting

beyond its authority,” NetworkIP, LLC v. FCC, 548 F.3d 116, 120 (D.C. Cir. 2008), and a court

has “an affirmative obligation” to ensure that it has standing before reaching the merits of a dispute.

James Madison, Ltd. v. Ludwig, 82 F.3d 1085, 1092 (D.C. Cir. 1996), quoting Herbert v. Nat’l

Acad. of Scis., 974 F.2d 192, 196 (D.C. Cir. 1992).

“The doctrine of standing gives meaning to these constitutional limits by ‘identify[ing]

those disputes which are appropriately resolved through the judicial process.’” Susan B. Anthony

List v. Driehaus, 134 S. Ct. 2334, 2341 (2014) (alterations in original), quoting Lujan v. Defs. of

Wildlife, 504 U.S. 555, 560 (1992); see also Clapper v. Amnesty Int’l USA, 133 S. Ct. 1138, 1146

(2013) (“‘One element of the case-or-controversy requirement’ is that plaintiffs ‘must establish

that they have standing to sue.’”), quoting Raines v. Byrd, 521 U.S. 811, 818 (1997). This

“doctrine limits the category of litigants empowered to maintain a lawsuit in federal court to seek

redress for a legal wrong.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016).

“[T]he irreducible constitutional minimum of standing contains three elements.” Lujan,

504 U.S. at 560. First, the plaintiff must have suffered an “injury in fact,” or, in other words, “an

invasion of a legally protected interest which is (a) concrete and particularized, and (b) actual or

imminent.” Id. “Second, there must be a causal connection between the injury and the conduct

complained of,” or, said another way, the injury alleged must be “traceable to the challenged action

of the defendant.” Id. Third, it must be likely that “the injury will be redressed by a favorable

decision.” Id. at 561.

37
Defendants argue that plaintiffs have not alleged sufficient facts to show that the regulation

of nicotine-free liquids described in the Rule applies to their products, and that therefore, plaintiffs

have failed to allege they will suffer any actual or imminent harm. They complain that “plaintiffs

make no effort to explain how their nicotine-free e-liquids are manufactured, marketed, distributed,

or sold,” Defs.’ Cross-Mem. at 34, and that plaintiffs “make no showing that the nicotine-free e-

liquids they manufacture are . . . even subject to the deeming rule – by alleging, for example, that

those e-liquids are intended to be mixed with liquid nicotine.” Id. at 33.

Plaintiff Nicopure has supplied the Court with a declaration stating that it manufactures

approximately 160 different kinds of nicotine-free e-liquid, see Stamler Decl. ¶ 14, and therefore,

the Court finds that it has standing to challenge the agency’s decision to regulate these products as

part of the Rule. It is of little moment that plaintiffs have not specified whether their nicotine-free

liquids are or are not intended to be mixed with liquid nicotine, since the agency has already

specifically stated that it is not bound to take manufacturers at their word. Thus, under the terms

of the Rule, plaintiffs could be subject to enforcement proceedings if they do not submit their

nicotine-free e-liquids to the premarket review process. See 21 U.S.C. 387j(a)(2).

2. Plaintiffs’ challenge to the regulation of nicotine-free products is ripe.
The Court also finds that plaintiffs’ challenge to this aspect of the rule is ripe,

notwithstanding the agency’s assurances that, should plaintiffs violate the law, the agency would

assess whether enforcement was appropriate “after a ‘case-by-case’ review,” Defs.’ Cross-Mem.

at 36, quoting Deeming Rule, 81 Fed. Reg. at 29,032, which would “take into account ‘the totality

of the circumstances.’” Id., quoting 81 Fed. Reg. at 29,015.

“The ripeness doctrine generally deals with when a federal court can or should decide a

case. Part of the doctrine is subsumed into the Article III requirement of standing, which requires

a petitioner to allege inter alia an injury in fact that is ‘imminent’ or ‘certainly impending.’” Am.

38
Petrol. Inst. v. EPA, 683 F.3d 382, 386 (D.C. Cir. 2012). And “[e]ven if a case is ‘constitutionally

ripe,’ . . . there may also be ‘prudential reasons for refusing to exercise jurisdiction.’” Id., quoting

Nat’l Park Hosp. Ass’n v. Dep’t of Interior, 538 U.S. 803, 808 (2003). As the D.C. Circuit has

explained:

The fundamental purpose of the ripeness doctrine is “to prevent the courts,
through avoidance of premature adjudication, from entangling themselves
in abstract disagreements over administrative policies, and also to protect
the agencies from judicial interference until an administrative decision has
been formalized and its effects felt in a concrete way by the challenging
parties.”
Sprint Corp. v. FCC, 331 F.3d 952, 957 (D.C. Cir. 2003), quoting Nat’l Park Hosp., 538 U.S. at

807–08. While the constitutional aspect of ripeness may involve the same impending injury-in-

fact requirement that is necessary for standing, the prudential aspect of ripeness requires more: a

court must “balance[] ‘the fitness of the issues for judicial decision and the hardship to the parties

of withholding court consideration.’” Nat’l Treasury Emps. Union v. United States, 101 F.3d

1423, 1427–28 (D.C. Cir. 1996), quoting Abbott Labs. v. Gardner, 387 U.S. 136, 149 (1967), and

citing Duke Power Co. v. Carolina Envtl. Study Grp., Inc., 438 U.S. 59, 81–82 (1978). The fitness

of an issue for judicial decision depends on whether there are “contingent future events that may

not occur as anticipated, or indeed may not occur at all.” Thomas v. Union Carbide Agric. Prods.

Co., 473 U.S. 568, 580–81 (1985) (citations omitted).

In Abbott Laboratories, the Supreme Court considered two factors in evaluating whether a

pre-enforcement challenge was ripe for adjudication: First, it considered whether “the issue

tendered is a purely legal one,” and second, it asked whether the issue presented was a “final

agency action” under the APA. 387 U.S. at 149–50. “[P]urely legal claim[s]” are “presumptively

reviewable.” Nat’l Ass’n of Home Builders v. U.S. Army Corps of Eng’rs (“NAHB”), 417 F.3d

1272, 1282 (D.C. Cir. 2005), quoting Nat’l Mining Ass’n v. Fowler, 324 F.3d 752, 757 (D.C. Cir.

39
2003). And the D.C. Circuit has rejected the notion that a future exercise of agency discretion

makes a purely legal claim unripe. Id.

Defendants argue that plaintiffs do not know whether the FDA will ever initiate

enforcement proceedings against their non-nicotine-based e-liquids, and that in light of the

agency’s stated intention that it will review nicotine-free e-liquids on a “case-by-case” basis, any

challenge to that aspect of the regulation should wait until the agency decides to initiate an

enforcement proceeding. Defs.’ Cross-Mem. at 35–37.

But that line of reasoning has been rejected by binding D.C. Circuit precedent. In NAHB,

the plaintiffs challenged the issuance of certain permits by the Army Corps of Engineers under the

Clean Water Act. Id. at 1274. The Army Corps was authorized by statute to issue permits either

on a class-wide basis, or on a case-by-case basis. Id. The agency’s regulations required that a

“case-by-case” or “individual” permit be issued only after the agency completed a comprehensive

procedure, which included “site-specific documentation and analysis, public interest review,

public notice and comment, and, if necessary, a public hearing.” Id. at 1275. Plaintiffs challenged

the agency’s issuance of particular class-wide permits, and argued that the agency had exceeded

its statutory authority, and that it had acted in violation of the APA, when it issued certain

regulations surrounding those permits. Id. at 1277. The district court dismissed the case,

concluding that a plaintiff’s challenge was not a final agency action “until [his] individual permit

is rejected.” Id. at 1278.

But the Court of Appeals reversed the judgment of the district court, noting that the

question was better framed as a ripeness inquiry, and that the challenge was ripe for adjudication.

See id. at 1281. Plaintiffs, the Court of Appeals explained, were challenging the Army Corps’s

“statutory authority . . . and that the Corps failed to offer a reasoned basis for their [decision],” and

40
it held that those “purely legal” issues were ripe for adjudication. Id. at 1281–82. As to the Army

Corps’s argument that its decision was not “fit for review because their applicability to a given

activity remains within the Corps’[s] discretion,” the Court of Appeals replied, “[w]e have already

debunked this theory,” and it noted that just because “the Corps retains some measure of discretion

with respect to the [challenged decisions] does not make the [plaintiffs’] purely legal challenge

unripe.” Id. at 1282.

Plaintiffs here are in a similar posture to the plaintiffs in NAHB. The agency has indicated

that its enforcement activities against manufacturers who produce non-nicotine based e-liquids

will be undertaken on a case-by-case basis. Deeming Rule, 81 Fed. Reg. at 29,032. And while

defendants ask the Court to wait until the agency decides to enforce the statute on a manufacturer

of non-nicotine-based e-liquid, the Court can determine whether the statute authorizes the

regulation of those products in the first instance. The question in this case is not about whether

the regulation will apply to a particular nicotine-free e-liquid; the challenge is whether nicotine-

free e-liquids can be regulated at all. There may very well be future litigation about whether the

agency’s case-by-case review was lawful – but that is not the challenge being brought in this case.

So the Court can determine under Chevron whether the nicotine-free e-liquids at issue are

subject to regulation.

3. The agency’s interpretation of the definition of “tobacco product” to
include certain non-nicotine-containing e-liquids meets the Chevron
test.
Nicopure challenges whether the agency can lawfully regulate nicotine-free e-liquids. See

Nicopure Mem. at 9–14. Nicopure’s CEO has averred that 83% of the company’s products do

contain nicotine, Stamler Decl. ¶ 14, so the challenge relates to a relatively small percentage of the

liquids that Nicopure sells. The agency explains that the Deeming Rule only purports to regulate

nicotine-free e-liquids in three circumstances: (1) when e-liquids claiming to be nicotine-free

41
actually contain high levels of nicotine, Defs.’ Cross-Mem. at 37, quoting Deeming Rule, 81 Fed.

Reg. at 29,034; (2) when the e-liquid is tobacco flavored – because that flavor is “made or derived

from tobacco,” id., quoting Deeming Rule, 81 Fed. Reg. at 29,102; and (3) when the e-liquid is

reasonably expected to be mixed with liquid nicotine – because those liquids would be

“components or parts” of a tobacco product. Id., citing Deeming Rule, 81 Fed. Reg. at 29,017.

This approach comports with the statute.

There is no dispute in this case that e-liquids that are marketed as nicotine-free but that

actually contain nicotine, and e-liquids that are tobacco-flavored, are clearly and unambiguously

covered by the TCA’s definition of “tobacco product,” Chevron, 467 U.S. at 842, because both

are “made or derived from tobacco.” 21 U.S.C. § 321(rr)(1). 23 What Nicopure challenges is the

FDA’s authority to regulate those liquids that do not contain nicotine. 24

23 See Hr’g Tr. at 10:1–6 (conceding that plaintiffs are not challenging the agency’s authority
to regulate closed cartridge systems where the liquid in the system is nicotine that is made or
derived from tobacco); id. at 32:1–4 (not objecting to defendants’ argument that the agency can
regulate tobacco-flavored e-liquids).

24 While it may be true that some percentage of the Nicopure’s products are not tobacco based
and do not initially contain nicotine, see Stamler Decl. ¶ 6 (“Although some of Nicopure's e-liquid
products contain nicotine, others do not.”), any consumer who chooses to purchase a flavored
liquid online – including fruit or dessert flavored items with youthful appeal such as “grape vape”
or “cookie karma” – is immediately offered a choice to purchase the liquid at seven different levels
of nicotine content, ranging from 0 milligrams per milliliter to 24 milligrams per milliliter. See,
e.g., https://www.halocigs.com/e-liquid/premium-flavors/. So even e-liquids that do not “contain”
nicotine and sold with nicotine in them. Stamler avers that “of Nicopure’s approximately 950 e-
liquid SKU’s, 83% contain nicotine. The remaining e-liquid SKU’s do not contain nicotine and
are not made or derived from tobacco.” Stamler Decl. ¶ 14. But he does not specify what portion
of its sales ultimately involve that relatively small percentage of nicotine-free liquids, and of those,
which are sold to retail outlets where the nicotine can also be added, according to the users’
individual specifications. Indeed, the declaration makes clear that Nicopure’s open-system devices
are popular “because of their flexibility and options.” Id. ¶ 12.

42
The agency takes the position that it may lawfully regulate an e-liquid that does not contain

nicotine as a “component” of a tobacco product where the e-liquid “is intended or reasonably

expected to be used with or for the human consumption of a tobacco product (e.g., with liquid

nicotine).” Deeming Rule, 81 Fed. Reg. at 29,017. The Court must give the term “component”

its ordinary meaning, Petit, 675 F.3d at 781, and the burden is on the plaintiffs to show “that the

statute unambiguously forecloses the agency’s interpretation.” Id., quoting Vill. of Barrington,

636 F.3d at 661 (emphasis in original).

Plaintiffs advance the theory that because “Congress defined ‘tobacco product’ to mean a

product ‘made or derived from tobacco[,] FDA does not have license to extend that definition to

products not made or derived from tobacco, regardless of the circumstances.” Pls.’ Reply at 8.

But plaintiffs are ignoring the applicable half of the statutory definition. The agency is not relying

on a showing that nicotine-free e-liquids are “made or derived from tobacco” to justify its authority

to regulate them; it contends that a nicotine-free e-liquid is a “component” of a tobacco product

which is comprised of several components. Deeming Rule, 81 Fed. Reg. at 29,017.

This interpretation is not inconsistent with the TCA. The statutory definition of a regulable

“tobacco product” specifically includes any component of a tobacco product, 21 U.S.C. § 321(rr),

and if an ENDS device with nicotine or a tobacco derivative in it is, as plaintiffs acknowledge, a

tobacco product, then a nicotine-free liquid that gets added to the mix – to provide flavor or make

the inhalation experience less harsh – becomes a “component” of the tobacco product when it is

added.

So because plaintiffs have not met their burden to show “that the statute unambiguously

forecloses the agency’s interpretation,” Vill. of Barrington, 636 F.3d at 661, the agency’s

43
interpretation can be upheld at Chevron step one. 25 And plaintiffs have not proffered any reasons

for why it would be an unreasonable interpretation at step two.

II. The FDA’s decision to deem e-cigarettes to be tobacco products comports with the
APA.
In Count II of Nicopure’s complaint, and in Count II of RSF’s complaint, plaintiffs allege

that the decision to subject companies to premarket review is arbitrary and capricious in violation

of the Administrative Procedure Act. Nicopure Compl. ¶¶ 35–45; RSF Compl. ¶¶ 76–82. And in

Count III of Nicopure’s complaint and Count VIII of RSF’s complaint, plaintiffs allege that the

agency’s cost-benefit analysis was unlawful because the agency failed to consider alternatives and

failed to adequately quantify the costs and the benefits of the Deeming Rule. Nicopure Compl.

¶¶ 46–51; RSF Compl. ¶¶ 128–33.

Plaintiffs find fault in many aspects of the regulatory regime. But the requirements that

plaintiffs claim are unreasonable flow automatically from the statute. Thus, the only issue to be

resolved is whether the final agency action – the decision to deem ENDS products to be subject to

the TCA – was arbitrary and capricious. The remainder of plaintiffs’ concerns are better directed

to Congress.

It is important to note at the outset that the decision to deem e-cigarettes to be tobacco

products will not ban e-cigarettes from the market. It will unquestionably subject the products to

heightened regulation, but the deeming decision does not – and could not – completely ban those

products from the market. The question before the Court, therefore, is whether it was reasonable

25 Plaintiffs observe that under the terms of the statute, the agency may only regulate nicotine
that is made or derived from tobacco, and that therefore, it cannot regulate products containing
synthetic nicotine. Hr’g Tr. at 10:7–13; 11:10–17. But neither plaintiff seems to manufacture
products that contain synthetic nicotine – nicotine that is made or derived in a laboratory or from
other non-tobacco sources. See id. at 35:3–15. So the Court does not need to reach the issue of
whether the agency may lawfully regulate e-liquids that contain synthetic nicotine.

44
for the agency to conclude that vaping should no longer be completely unregulated, given the

marked increase in use, the absence of any regulation of the products and manufacturers in the

market, and the potential for public harm given the known dangers of nicotine.

Legal Standard

Under the Administrative Procedure Act, 5 U.S.C. § 701 et seq., 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., 753 F.2d at 769–70, citing Overton Park, 401 U.S. at 415; see also Richards, 554 F.2d at

1177 & n.28. A court must “hold unlawful and set aside agency action, findings, and

conclusions” that are “arbitrary, capricious, an abuse of discretion, or otherwise not in

accordance with law,” 5 U.S.C. § 706(2)(A), in excess of statutory authority, id. § 706(2)(C), or

“without observance of procedure required by law,” id. § 706(2)(D). However, the scope of

review is narrow. Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,

463 U.S. 29, 43 (1983). The agency’s decision is presumed to be valid, see Overton Park, 401

U.S. at 415, and the court must not “substitute its judgment for that of the agency.” State Farm,

463 U.S. at 43. A court must be satisfied, though, that the agency has examined the relevant

data and articulated a satisfactory explanation for its action, “including a ‘rational connection

between the facts found and the choice made.’” Alpharma, Inc. v. Leavitt, 460 F.3d 1, 6 (D.C.

Cir. 2006), quoting State Farm, 463 U.S. at 43.

The APA dispute is justiciable.

While the APA allows for judicial review of agency decisions for “[a] person suffering

legal wrong because of agency action, or adversely affected or aggrieved by agency action within

45
the meaning of a relevant statute,” 5 U.S.C. § 702, agency action is unreviewable “to the extent

that . . . agency action is committed to agency discretion by law.” Id. § 701(a)(2). Judicial review

is foreclosed where the relevant statute is “drawn so that a court would have no meaningful

standard against which to judge the agency’s exercise of discretion.” Heckler v. Chaney, 470 U.S.

821, 830 (1985); see also Sierra Club v. Jackson, 648 F.3d 848, 855 (D.C. Cir. 2011); Steenholdt

v. FAA, 314 F.3d 633, 638 (D.C. Cir. 2003). The Supreme Court has cautioned that this exception

to the APA should be construed narrowly. See Webster v. Doe, 486 U.S. 592, 599 (1988)

(“[S]ubsection (a)(2) applies ‘in those rare instances where statutes are drawn in such broad terms

that in a given case there is no law to apply.’”), quoting Overton Park, 401 U.S. at 410; Barlow v.

Collins, 397 U.S. 159, 166 (1970) (“Preclusion of judicial review . . . is not lightly to be inferred.”).

The Court has recently cautioned that there is a “strong presumption” in favor of judicial review

of administrative action, Mach Mining, LLC v. EEOC, 135 S. Ct. 1645, 1651 (2015), quoting

Bowen v. Mich. Acad. of Family Physicians, 476 U.S. 667, 670 (1986), which can be rebutted

where a “statute’s language or structure demonstrates that Congress wanted an agency to police

its own conduct.” Id.

The agency argues that its decision to deem is so committed to agency discretion that it is

unreviewable. Defs.’ Cross-Mem. at 39–40. It points to the deeming provision of the TCA, id. at

39, which gives the Secretary of HHS the authority to apply the TCA’s provisions “to any other

tobacco products that the Secretary by regulation deems to be subject to [the TCA],” 21

U.S.C.§ 387a(b), and it argues that “Congress’s choice of the deferential word ‘deems’ and the

absence of any standard – beyond the requirement that the product meet the definition of a ‘tobacco

product’ – demonstrate that Congress committed the exercise of this authority to the agency’s

broad discretion.” Defs.’ Cross-Mem. at 39.

46
The government relies primarily on Webster v. Doe, 486 U.S. 592 (1998) for the

proposition that the Secretary’s decision to “deem” is committed to agency discretion. See Defs.’

Cross-Mem. at 7–8. In Webster, the Supreme Court reviewed a provision of the National Security

Act of 1947, which provided that the Director of the CIA “may, in his discretion, terminate the

employment of any officer or employee of the Agency whenever he shall deem such termination

necessary or advisable in the interests of the United States.” Webster, 486 U.S. at 594, quoting 50

U.S.C. § 403(c). The Court observed that Congress gave the CIA responsibility “to protect all

sources of intelligence information from disclosure,” and thus vested “extraordinary deference [in]

the Director.” Id. at 601. The Court concluded that because “[s]hort of permitting cross-

examination of the Director concerning his views of the Nation’s security and whether the

discharged employee was inimical to those interests,” there was “no basis on which a reviewing

court could properly assess an Agency termination decision.” Id. at 600.

The D.C. Circuit disagreed with government’s reading of Webster in Marshall County

Health Care Authority v. Shalala, 988 F.3d 1221 (D.C. Cir. 1993). In Marshall County, the

government cited Webster for the proposition that it was the word “deem” in the National Security

Act in Webster that made the Director’s decision unreviewable. See id. at 1224. The Court of

Appeals rejected that argument; it explained that that lack of justiciability in Webster stemmed not

from the word “deem,” but rather from the phrase “advisable in the interests of the United States.”

Id. And it noted that in Webster, “[t]he statute, after all, dealt with national security – an area in

which the judiciary almost invariably defers to the executive branch.” Id.

In this case, when the Secretary exercised the authority to “deem” e-cigarettes to be tobacco

products, the agency was interpreting the statutory definition of “tobacco product.” So while it is

47
true that the statute did not provide standards for when and how the agency was to exercise its

discretion to deem, the Court concludes that the decision is reviewable.

However, the language of the deeming provision – with its use of the words “may” and

“deem,” is the kind of language that, even if judicial review is permitted, “fairly exudes deference.”

Webster, 486 U.S. at 600. And the Court of Appeals has reaffirmed that APA review in cases like

this one should be undertaken with deference. See Nuclear Energy Inst., Inc. v. EPA, 373 F.3d

1251, 1289 (D.C. Cir. 2004) (advising that when a court reviews an agency’s evaluation of

“scientific data within its technical expertise,” its review should be “extremely deferential”),

quoting Huls Am. Inc. v. Browner, 83 F.3d 445, 452 (D.C. Cir. 1996). Courts review scientific

judgments of the agency “not as the chemist, biologist, or statistician that [courts] are qualified

neither by training nor experience to be, but as a reviewing court exercising [its] narrowly defined

duty of holding agencies to certain minimal standards of rationality.” Ctr. for Biological Diversity

v. EPA, 749 F.3d 1079, 1087–88 (D.C. Cir. 2014) (quoting “[d]ecades of decisions” of the Court

of Appeals on scientific deference), quoting Ethyl Corp. v. EPA, 541 F.2d 1, 36 (D.C. Cir. 1976).

The Court’s APA review must therefore be undertaken with that deference in mind.

The FDA’s decision to deem e-cigarettes to be tobacco products is reasonable
and supported by the record.
The decision to deem e-cigarettes to be tobacco products is not arbitrary and capricious for

a number of reasons. First and foremost, nicotine is indisputably harmful. Deeming Rule, 81 Fed.

Reg. at 28,988 (describing nicotine as “one of the most addictive substances used by humans”).

There is evidence in the record that e-cigarettes “may deliver as much nicotine as other tobacco

products,” id. at 29,029, 29,031, and even when they deliver less amounts of nicotine, “lower levels

of nicotine . . . still have the potential to addict users.” Id. at 29,031.

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Second, the agency explained that “adolescents appear to be particularly vulnerable to the

adverse effects of nicotine on the central nervous system,” and that nicotine may have lasting

effects on adolescent brain development. Id. at 29,029, 29,033. And the agency detailed the

“alarming” rise in e-cigarette use by middle and high school students. Id. at 29,028. In particular,

the agency cited data showing that “the rate of e-cigarette use” among high school students

“increased from 1.7 percent in 2011 to 7.7 percent in 2013, and 2.7 percent of high school students

who had never tried a cigarette indicated that they were considering using e-cigarettes in the next

year.” Id. While the agency acknowledged that “long-term studies are not yet available to

determine whether these youth and young adults are only experimenting with tobacco use,

becoming established ENDS users or dual users, or transitioning to combusted products,” it also

noted the absence of evidence that would enable it “to conclude that youth and young adults are

using ENDS as a means to quit smoking.” Id. The FDA also explained that “[r]esearchers noted

that some teens are more likely to use e-cigarettes prior to combustible tobacco products for several

reasons including the availability of e-cigarettes in flavors attractive to youth.” Id. at 28,985.

Moreover, the increase in adolescent users is not the entire story. Among adults, the use

of e-cigarettes has more than doubled between 2012 and 2014 – from 1.4 percent to 3.7 percent.

See AR 23,871, AR 15,666. And the agency found that:

[E]vidence from the most recent studies on ENDS use among young adults
and adults indicates that among adults who had never smoked cigarettes,
prevalence of ever e-cigarette use was highest among young adults aged 18
to 24 and decreased with increasing age. However, current cigarette
smokers and recent former smokers (i.e., those who quit smoking within the
past year) were more likely to use e-cigarettes than long-term former
smokers (i.e., those who quit smoking more than 1 year ago) and adults who
had never smoked. Current cigarette smokers who had tried to quit in the
past year were also more likely to use e-cigarettes than those who had not
tried to quit. It is noted that it cannot be determined by the research findings:
(1) Whether former cigarette smokers who now exclusively use e-cigarettes
would not have ceased smoking cigarettes regardless of e-cigarette use; and

49
(2) whether the e-cigarette use preceded quitting or the quitting occurred
first and then was followed by later e-cigarette use.
Deeming Rule, 81 Fed. Reg. at 28,985.

Furthermore, given the proliferation of these products, “[a]t present, there is significant

variability in the concentration of chemicals amongst products – including variability between

labeled content and concentration . . . and actual content and concentration.” Deeming Rule, 81

Fed. Reg. at 28,984. In other words, the manufacturers, if they remain unregulated, are free to

mislabel their products without consequence. See id. at 29,034; id. at 29,029 (“Absent a regulatory

standard, FDA acknowledges that it may not be possible to account for the wide variability of

concentrations of constituents in [e-cigarette] flavors.”). So the agency concluded that requiring

premarket review of e-cigarettes, and regulating modified-risk claims, would benefit public health.

In light of all of those findings, and in light of the deference that the Court must give the

agency on APA review, the Court finds that there is a rational relationship between the facts found

and the choice made. See Alpharma, 430 F.3d at 6. The Court’s conclusion is buttressed by these

Congressional findings in the TCA, which apply with equal force to the regulation of e-cigarettes:

x “Nicotine is an addictive drug,” TCA § 2(3);

x “Virtually all new users of tobacco products are under the minimum legal
age to purchase such products,” id. § 2(4);

x “Tobacco advertising and marketing contribute significantly to the use of
nicotine-containing products by adolescents,” id. § 2(5);

x “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);

x “It is in the public interest for Congress to enact legislation that provides
the Food and Drug Administration with the authority to regulate tobacco
products and the advertising and promotion of such products,” id. § 2(12);

x “It is essential that the Food and Drug Administration review products sold
or distributed for use to reduce risks or exposures associated with tobacco

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products and that it be empowered to review any advertising and labeling
for such products,” id. § 2(36);

x “It is also essential that manufacturers, prior to marketing such products, be
required to demonstrate that such products will meet a series of rigorous
criteria, and will 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.” Id. 26
Plaintiffs’ arguments that the Rule is arbitrary and capricious are not
persuasive.
Plaintiffs argue that the decision to deem e-cigarettes to be tobacco products is arbitrary

and capricious because the Deeming Rule is “at war with itself regarding the rationale for

regulating vaping products;” it will “undermine the TCA’s core goal of reducing the deaths and

disease resulting from use of tobacco products;” and it “fails to consider numerous alternatives

that would avoid a ‘significant degree of product exit’ while still achieving Congress’s public-

26 The legislative history reflects that Congress was well aware of the advent of e-cigarettes
at the time that the TCA was passed. Defs.’ Cross-Mem. at 28 & n.9, citing 155 Cong. Rec. H6626
(June 12, 2009) (statement of Rep. Buyer) (“[I]n the marketplace right now, there are many
different types of products . . . [Y]ou have an electronic cigarette, whereby it’s a nicotine delivery
device.”), and 155 Cong. Rec. H4367 (Apr. 1, 2009) (statement of Rep. Buyer) (expressing
concern that “these new innovative types of nicotine delivery devices could not make their access
to the market.”); 155 Cong. Rec. S6010 (June 3, 2009) (statement of Sen. Burr) (“Then we have a
new category called electronic cigarettes . . . It actually runs off a battery. It extracts the nicotine
and delivers it into the system in a totally different way than the tobacco-headed cigarette.”).
Indeed, Senator Burr seemed to propose that all electronic cigarettes should be “grandfathered” in
to the SE pathway. 155 Cong. Rec. S6335–36 (June 9, 2009) (statement of Sen. Burr) (“There are
electronic cigarettes . . . and other products that have less risk. All those products in February
2007 were not in the marketplace. They are banned. They are eliminated. What are we asking
the FDA to do? We are asking them to grandfather three categories of products and let all adults
who choose to use a tobacco product choose from the most risky categories . . . Any claim – any
claim – that [the proposed TCA] reduces the cost of health care is only because we have
grandfathered in smokers who will die sooner, not that we have allowed them a pathway through
this bill to ever experience not only products that are currently on the marketplace that reduce the
risk from 100 percent to as little as 1 percent, but we have completely eliminated any additional
innovation in product in the future . . . .”). The fact that Congress passed the TCA in its current
form notwithstanding the concerns raised by Congressman Buyer and Senator Burr provides
further support for the conclusion that the Secretary’s decision to deem e-cigarettes to be tobacco
products, and therefore subject to premarket review, is reasonable and fully consistent with the
intent of the statute.
51
health objective.” Nicopure Mem. at 15–26. And RSF seems to argue that the decision to subject

e-cigarettes to the premarket review requirement is arbitrary and capricious because the agency

“offers no evidence or explanation as to how such manufacturers will be able to conduct the

necessary long-term clinical health studies, which FDA concedes do not exist, within the two year

compliance period.” RSF Compl. ¶ 79.

Once the Secretary of HHS made the decision to deem ENDS as tobacco products, the

requirement of premarket review is established by statute. So the question is not whether it is

arbitrary and capricious to make these plaintiffs comply with those requirements. The question is,

instead, whether it was reasonable for the agency to determine that it was appropriate to subject

ENDS products – the majority of which plaintiffs agree are covered by the statute – to the

regulatory regime that Congress specifically determined must be imposed on all tobacco products.

Nicopure also argues that the Deeming Rule ignores evidence “that vaping products are far

less risky than cigarettes.” Nicopure Mem. at 19 (emphasis in original). It states that the agency

has disregarded evidence that “inhalation of e-vapor ‘is of less risk to a user than the inhalation of

. . . smoke from combusted tobacco products,’ and that use of vaping products ‘is likely less

hazardous for an individual user than continued smoking of traditional cigarettes.’” Id., quoting

Deeming Rule, 81 Fed. Reg. at 29,033, 29,035. For that reason, Nicopure argues that the Rule is

“at war with itself.” Nicopure Mem. at 15–16. But this argument is not persuasive. Just because

there is evidence that e-cigarettes may be less risky than conventional cigarettes does not mean

that e-cigarettes are not risky at all, and the agency detailed its concerns about the addictive nature

and health risks of nicotine inhalation alone, particularly in adolescents. See Deeming Rule, 81

Fed. Reg. at 28,981 (“The Surgeon General has long recognized that the addictive nature of

tobacco products is due to the presence of highly addictive nicotine that can be absorbed into the

52
bloodstream.”); id. at 28,983–85 (“FDA noted in the [notice of proposed rulemaking] that many

public health benefits will flow from deeming tobacco products (including e-cigarettes and other

ENDS). Even if a category of products were to prove generally beneficial, individual products

within that category may raise concerns. For example, some products may be particularly

attractive to youth or deliver unexpected high levels of toxicants.”).

Moreover, the record before the agency included a substantial volume of comments

submitted by public health organizations such as the American Academy of Family Physicians,

the American Academy of Pediatrics, the Cancer Action Network, the American Heart

Association, the American Lung Association, and the American Psychological Association – all

of which urged the agency to “strengthen[]” and make “comprehensive” the proposed Deeming

Rule, in order to “prevent the manufacturers of tobacco products from designing and marketing

their products in ways that undercut the full potential of the Tobacco Control Act to achieve its

lifesaving objectives.” Comments of 24 Public Health Organizations to the Proposed Deeming

Rule (Dkt. No. FDA-214-N-0189) (Aug. 8, 2014) at 4; see also AR 145,543 (including the first

page of those comments). Given the deference that the Court gives to scientific judgments, Ctr.

for Biological Diversity, 749 F.3d at 1087–88, the Court finds that plaintiffs’ objections do not

overcome the agency’s scientific judgment that regulation of ENDS products under the TCA is in

the interest of public health.

The agency appropriately rejected plaintiffs’ suggested regulatory
alternatives.
As the D.C. Circuit has explained, agencies “ha[ve] wide discretion to determine where to

draw administrative lines,” ExxonMobil Gas Mktg. Co. v. FERC, 297 F.3d 1071, 1085 (D.C. Cir.

2002), quoting AT&T Corp. v. FCC, 220 F.3d 607, 627 (D.C. Cir. 2000), and courts “are generally

unwilling to review line-drawing performed by [the agency] unless a [challenger] can demonstrate

53
that the lines drawn . . . are patently unreasonable, having no relationship to the underlying

regulatory problem.” Id., quoting Cassell v. FCC, 154 F.3d 478, 485 (D.C. Cir. 1998). But

agencies must also consider “reasonable alternatives” as part of the requirement of “reasoned

decisionmaking.” See Am. Gas Ass’n v. FERC, 593 F.3d 14, 19 (D.C. Cir. 2010); see also State

Farm, 463 U.S. at 43 (requiring agencies to “articulate a satisfactory explanation for its action

including a rational connection between the facts found and the choice made.”).

Nicopure argues that the agency failed to “meaningfully” consider alternatives to the

premarket review requirement, including three options in particular. Nicopure Mem. at 21. First,

Nicopure contends that the agency should have waited to deem until the agency had “sufficient

data to reach a conclusion – one way or the other – regarding the health effects of vaping products

before choosing whether and how to regulate them.” Id. at 23 (emphasis in original). Second,

Nicopure contends that the agency should have adopted the European Union’s approach to

regulating vaping products, which includes many of the same requirements, but does not require

premarket review. Id. at 24. Third, Nicopure faults the agency for failing to consider “crafting a

streamlined [premarket review] process for products, such as vaporizers, that fall on the safer side

of the risk continuum.” Id.

The law is clear that plaintiffs are not entitled to the regulatory alternative that they prefer.

Rather, the Court must give appropriate deference to the expertise of the agency, and ensure that

the agency considered the alternatives proffered by the plaintiffs and rejected them for reasons that

are rational.

And it bears repeating that premarket review is a creature of statute and not a new

regulatory requirement dreamed up and imposed on ENDS manufacturers by the FDA. The EU

model would subject manufacturers to disclosure, advertising, good manufacturing practices,

54
misbranding, and other requirements, but it would not require manufacturers to obtain premarket

review. See Nicopure Mem. at 24. Whatever one might think about the benefits of the EU

approach as a policy matter, a rule that adopted that approach would have been contrary to the

TCA, because the TCA requires that all tobacco products must undergo some kind of premarket

review. 21 U.S.C. § 387j(a). Plaintiffs argue that the agency could exercise enforcement

discretion – and that it exercised similar discretion in allowing for an extended compliance

schedule. See Pls.’ Reply at 18. There is certainly nothing in the statute or the Rule that would

bar the parties from engaging in constructive negotiations to establish a more manageable timeline.

But the fact that there may be reasons for the agency to be flexible when implementing the

premarket review requirements does not mean it was unreasonable for the agency to decline to

adopt the EU approach and eliminate premarket review altogether. See Deeming Rule, 81 Fed.

Reg. at 28,998.

Similarly, plaintiffs’ argument about a “streamlined” premarket review process,

see Nicopure Mem. at 24, finds little support in the TCA, and the agency appropriately rejected

that argument as well. See Deeming Rule, 81 Fed. Reg. at 28,998. As the agency concluded, “all

tobacco products going through the [premarket] pathway must meet all the requirements for a

premarket authorization in section 910 of the [FDCA] before FDA can issue such an

authorization.” Id.

Finally, the agency did consider the suggestion that it should defer the deeming regulation

indefinitely, and it rejected it, finding that it did not have to “meet a particular public health

standard to deem tobacco products.” See Deeming Rule, 81 Fed. Reg. at 28,983. And it supported

its decision by setting out the public health benefits of the rule in great detail. Id. at 28,983–85.

55
The decision not to change the grandfather date for substantially equivalent
products is not arbitrary and capricious.
In Count I of the Right to be Smoke-Free complaint, plaintiffs complain that under the

Deeming Rule, no ENDS products will be able to utilize the substantial equivalence pathway for

approval, and this will “effectively ban ENDS products from the marketplace.” RSF Compl. ¶ 74.

RSF alleges: “FDA had the authority and statutory duty to either establish a new Grandfather Date

for ENDS products or apply its enforcement authority so that some ENDS manufacturers,

including e-liquid companies, would have the opportunity to forego the [premarket review]

pathway and avail themselves of the option to submit SE reports.” Id. ¶ 75. But he

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/4188357. Public record. Not legal advice.