Sottera, Inc. v. Food & Drug Administration

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued September 23, 2010 Decided December 7, 2010

No. 10-5032

SOTTERA, INC., DOING BUSINESS AS NJOY,
APPELLEE

v.

FOOD & DRUG ADMINISTRATION, ET AL.,
APPELLANTS

Appeal from the United States District Court
for the District of Columbia
(No. 1:09-cv-00771-RJL)

Alisa B. Klein, Attorney, U.S. Department of Justice,
argued the cause for appellants. With her on the briefs were
Ronald C. Machen, Jr., U.S. Attorney, Mark B. Stern and
Samantha L. Chaifetz, Attorneys, Ralph S. Tyler, Chief
Counsel, United States Department of Health and Human
Services, Eric M. Blumberg, Deputy Chief Counsel, and
Karen E. Schifter, Associate Chief Counsel. Drake S. Cutini,
Attorney, U.S. Department of Justice, entered an appearance.

William B. Schultz was on the brief for amici curiae
American Academy of Pediatrics, et al. in support of
appellants.
 2

Gregory G. Garre argued the cause for appellee Sottera,
Inc. With him on the brief were Richard P. Bress, John R.
Manthei, and Jessica E. Phillips.

Deborah M. Shelton and Christopher M. Loveland were
on the brief for amici curiae Smokefree Pennsylvania, et al. in
support of appellee.

Daniel J. Popeo, Richard A. Samp, Coleen E. Klasmeier,
and Rebecca K. Wood were on the brief for amicus curiae
Washington Legal Foundation in support of appellee.

Before: GARLAND and KAVANAUGH, Circuit Judges, and
WILLIAMS, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge
WILLIAMS.

Opinion concurring in the judgment filed by Circuit
Judge GARLAND.

WILLIAMS, Senior Circuit Judge: Sottera, Inc., which
does business as NJOY, is an importer and distributor of
“electronic cigarettes” or “e-cigarettes,” a product that enables
users to inhale vaporized nicotine. The question before us is
whether Congress has authorized the Food and Drug
Administration (“FDA”) to regulate e-cigarettes under the
drug/device provisions of the Federal Food, Drug, and
Cosmetic Act (“FDCA”), 21 U.S.C. § 351 et seq., or under the
Family Smoking Prevention and Tobacco Control Act of 2009
(the “Tobacco Act”), Pub. L. 111-31, 123 Stat. 1776. We
think that the statutes, properly read in light of the Supreme
Court’s decision in FDA v. Brown & Williamson, 529 U.S.
120 (2000), locate the product under the Tobacco Act.
 3

* * *

Electronic cigarettes are battery-powered products that
allow users to inhale nicotine vapor without fire, smoke, ash,
or carbon monoxide. NJOY Compl. at 2. Designed to look
like a traditional cigarette, each e-cigarette consists of three
parts: the nicotine cartridge, the atomizer or heating element,
and the battery and electronics. The plastic cartridge serves as
the mouthpiece and contains liquid nicotine, water, propylene
glycol, and glycerol. Id. at 5. The atomizer vaporizes the
liquid nicotine, and the battery and electronics power the
atomizer and monitor air flow. Id. When the user inhales, the
electronics detect the air flow and activate the atomizer; the
liquid nicotine is vaporized, and the user inhales the vapor.
Id.

NJOY has imported and distributed e-cigarettes since
2007. Id. at 2, 4. The liquid nicotine in each e-cigarette is
derived from natural tobacco plants, Decl. of John Leadbeater
at 2, and NJOY claims that its product is marketed and labeled
for “smoking pleasure,” rather than as a therapeutic or
smoking cessation product. NJOY Compl. at 2; Decl. of John
Leadbeater at 2. On April 15, 2009 the FDA ordered that a
shipment of NJOY’s e-cigarettes be denied entry into the
United States, asserting that the e-cigarettes appeared to be
adulterated, misbranded, or unapproved drug-device
combinations under the FDCA. April 20, 2009 Notice of
FDA Action.

Also in April 2009, another importer and distributor of e-
cigarettes, Smoking Everywhere, Inc., sought a preliminary
injunction barring the FDA and various officials from denying
their products entry into the United States and from regulating
e-cigarettes under the drug/device provisions of the FDCA.
Smoking Everywhere Compl. at 1-2, 7. NJOY joined as an
intervenor-plaintiff and filed its own complaint and request
 4

for a preliminary injunction. NJOY Compl. at 3; Mem. Op. at
7.

Smoking Everywhere and NJOY argued that the FDA can
regulate electronic cigarettes, as they propose to market them,
only under the Tobacco Act, claiming that the Supreme
Court’s opinion in Brown & Williamson foreclosed FDCA
drug/device jurisdiction over tobacco products marketed
without claims of therapeutic effect. The district court agreed
and granted the injunction. While this appeal was pending,
Smoking Everywhere voluntarily dismissed its complaint
against the FDA, leaving NJOY as the sole appellee. See
NJOY Br. at 4.

When deciding whether to grant a preliminary injunction,
a district court must consider four familiar factors: whether
“(1) the plaintiff has a substantial likelihood of success on the
merits; (2) the plaintiff would suffer irreparable injury were an
injunction not granted; (3) an injunction would substantially
injure other interested parties; and (4) the grant of an
injunction would further the public interest.” Ark. Dairy Co-
op Ass’n, Inc. v. U.S. Dep’t of Agric., 573 F.3d 815, 821 (D.C.
Cir. 2009) (citing Serono Labs., Inc. v. Shalala, 158 F.3d
1313, 1317-18 (D.C. Cir. 1998)). We review the district
court’s weighing of these factors under an abuse of discretion
standard, but review questions of law de novo. Id.; see also
Davis v. Pension Benefit Guarantee Corp., 571 F.3d 1288,
1291 (D.C. Cir. 2009).

* * *

Under the FDCA, the FDA has authority to regulate
articles that are “drugs,” “devices,” or drug/device
combinations. 21 U.S.C. § 321(g)(1) defines drugs to include
 5

(B) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or
other animals; and (C) articles (other than food) intended
to affect the structure or any function of the body of man
or other animals.

21 U.S.C. § 321(g)(1)(B) & (C). The statute defines devices
similarly, see 21 U.S.C. § 321(h)(2) & (3); products that are
“combination[s] of a drug, device, or biological product” are
regulated as combination products, see 21 U.S.C. § 353(g)(1).

Until 1996, the FDA had never attempted to regulate
tobacco products under the FDCA (with one exception,
irrelevant for reasons discussed below) unless they were sold
for therapeutic uses, that is, for use in the “diagnosis, cure,
mitigation, treatment, or prevention of disease” under
§ 321(g)(1)(B). Cf. Action on Smoking and Health v. Harris,
655 F.2d 236 (D.C. Cir. 1980). But in that year, the FDA
changed its long-held position, promulgating regulations
affecting tobacco products as customarily marketed, i.e., ones
sold without therapeutic claims. See Regulations Restricting
the Sale and Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and Adolescents, 61 Fed. Reg.
44,396 (Aug. 28, 1996). The agency asserted that nicotine is a
drug that affects the structure or function of the body under
§ 321(g)(1)(C) and that cigarettes and smokeless tobacco were
therefore drug/device combinations falling under the FDA’s
regulatory purview, even absent therapeutic claims. See 61
Fed. Reg. at 44,397, 44,400.

In FDA v. Brown & Williamson, the Supreme Court
rejected the FDA’s claimed FDCA authority to regulate
tobacco products as customarily marketed. Looking to the
FDCA’s “overall regulatory scheme,” the “tobacco-specific
legislation” enacted since the FDCA, and the FDA’s own
frequently asserted position, it held that Congress had “ratified
 6

. . . the FDA’s plain and resolute position that the FDCA gives
the agency no authority to regulate tobacco products as
customarily marketed.” 529 U.S. at 126, 159.

To fill the regulatory gap identified in Brown &
Williamson, Congress in 2009 passed the Tobacco Act, Pub.
L. No. 111-31, 123 Stat. 1776, 21 U.S.C. §§ 387 et seq.,
providing the FDA with authority to regulate tobacco
products. The act defines tobacco products so as to include all
consumption products derived from tobacco except articles
that qualify as drugs, devices, or drug-device combinations
under the FDCA:

(rr) (1) The term “tobacco product” means any product
made or derived from tobacco that is intended for human
consumption, including any component, part, or
accessory of a tobacco product . . .

(2) The term “tobacco product” does not mean an article
that is a drug under [the FDCA’s drug provision], a
device under [the FDCA’s device provision], or a
combination product described in [the FDCA’s
combination product provision].

21 U.S.C. § 321(rr).

The Tobacco Act itself states that it does not “affect,
expand, or limit” the FDA’s jurisdiction to regulate products
under the drug/device provisions of the FDCA, 21 U.S.C.
§ 387a(c)(1), and the district court and parties themselves
appear to agree that the Tobacco Act did not expand the
category of drugs, devices, and combination products subject
to FDCA jurisdiction in the wake of Brown & Williamson.
See Mem Op. 9 n.4. The question before us, therefore, is
whether the FDA can regulate electronic cigarettes under the
 7

FDCA’s drug/device provisions or whether it can regulate
them only under the Tobacco Act’s provisions.

The FDA at one point argues that its decision to regulate
electronic cigarettes under the FDCA’s drug/device provisions
is entitled to Chevron deference. See Chevron U.S.A. Inc. v.
Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984). FDA Br. at
20. But in fact the case does not turn on matters of statutory
interpretation. Rather, as the FDA itself argues, the Tobacco
Act did not alter the FDA’s authority under the FDCA. FDA
Br. at 19; FDA Reply Br. at 21. And with respect to tobacco
products, the breadth of that authority is governed by the
Supreme Court’s decision in Brown & Williamson. We
therefore turn to that case.

* * *

In Brown & Williamson the Supreme Court addressed the
FDA’s regulation of cigarettes and smokeless tobacco
products under the FDCA. It began by noting that the FDCA
seeks to ensure that the FDA will approve products only if
they are safe and effective for their intended use. 529 U.S. at
133. Yet the FDA had itself found that tobacco products are
“unsafe,” “dangerous,” and “cause great pain and suffering
from illness.” Id. at 134 (quoting 61 Fed. Reg. 44,412). If
tobacco products were drug/device combinations under the
FDCA, the FDA would have no choice but to ban them. Id. at
135.

Clearly that could not be the case, the Court reasoned.
After all, Congress had declared, in a provision of the U.S.
Code then in force, that tobacco was “one of the greatest basic
industries of the United States,” id. at 137 (quoting 7 U.S.C.
§ 1311(a)), and it had also passed six separate statutes relating
to tobacco since 1965. Id. at 137-38. See Federal Cigarette
 8

Labeling and Advertising Act, Pub. L. 89-92, 79 Stat. 282;
Public Health Cigarette Smoking Act of 1969, Pub. L. 91-222,
84 Stat. 87; Alcohol and Drug Abuse Amendments of 1983,
Pub. L. 98-24, 97 Stat. 175; Comprehensive Smoking
Education Act, Pub. L. 98-474, 98 Stat. 2200; Comprehensive
Smokeless Tobacco Health Education Act of 1986, Pub. L.
99-252, 100 Stat. 30; Alcohol, Drug Abuse, and Mental
Health Administration Reorganization Act, Pub. L. 102-321,
§ 202, 106 Stat. 394. Finally, citing its decision in MCI
Telecommunications Corp. v. AT&T Co., 512 U.S. 218
(1994), the Court noted that “Congress could not have
intended to delegate a decision of such economic and political
significance to an agency in so cryptic a fashion.” Brown &
Williamson, 529 U.S. at 160. So the Court held that the
FDA’s claim of FDCA jurisdiction failed.

For our purposes, the central question is whether Brown
& Williamson’s reading of the FDA’s authority under the
drug/device provisions of the FDCA applies only to tobacco
products for which Congress has passed specific regulatory
statutes or whether it extends to all tobacco products as
customarily marketed. The FDA argues that Brown &
Williamson takes a statute-specific approach, excluding the
FDA from regulating only those tobacco products that at the
time of Brown & Williamson had been the subject of specific
federal legislation. FDA Br. at 14. Though Brown &
Williamson is not crystal clear, we think the better reading is
that the FDA lacks FDCA drug/device authority to regulate all
tobacco products marketed without claims of therapeutic
effect, i.e., as customarily marketed.

Brown & Williamson’s focus was not on the particular
products that the six statutes cover or even on the six statutes
themselves; at no point did it quote the precise language in
which the six statutes identified covered products. Rather,
Brown & Williamson considered the context of each statute to
 9

show that Congress was actively thinking about “the tobacco
problem. ” 529 U.S. at 145. In situating the statutes, Brown
& Williamson found that “[i]n adopting each statute, Congress
has acted against the backdrop of the FDA’s consistent and
repeated statements that it lacked authority under the FDCA to
regulate tobacco absent claims of therapeutic benefit by the
manufacturer.” Id. at 144.

Brown & Williamson concentrated overwhelmingly on
the unifying theme of historic FDA policy towards tobacco
products—a policy that it saw as undifferentiated except with
regard to the presence or absence of claims of therapeutic
effect. See, e.g., id. at 145 (“[T]obacco marketed for chewing
or smoking without accompanying therapeutic claims, does
not meet the definitions in the Food, Drug, and Cosmetic
Act…” (citing Letter to Directors of Bureaus, Divisions and
Directors of Districts from FDA Bureau of Enforcement (May
24, 1963))); id. at 146 (“In the 73 years since the enactment of
the original Food and Drug Act, and in the 41 years since the
promulgation of the modern Food, Drug, and Cosmetic Act,
the FDA has repeatedly informed Congress that cigarettes are
beyond the scope of the statute absent health claims
establishing a therapeutic intent on behalf of the manufacturer
or vendor” (citing Brief for Appellee (FDA) in Action on
Smoking and Health v. Harris, 655 F.2d 236 (D.C. Cir.
1980))); id. at 146 (noting that the FDA’s predecessor agency,
the Bureau of Chemistry, stated it lacked authority to regulate
tobacco products absent therapeutic claims); id. at 155
(quoting the FDA’s General Counsel as defining regulatory
scope over tobacco products based on therapeutic purpose);
id. at 158 (citing the FDA Deputy Commissioner stating that
FDA’s jurisdiction was limited to tobacco products bearing
“drug claims”); id. at 158 (citing the Commissioner of the
FDA stating that FDA’s jurisdiction was limited to tobacco
products bearing “health claims”).
 10

Moreover, discussing the record before Congress in the
period when it passed these six statutes, Brown & Williamson
noted that Congress knew of both “the adverse health
consequences of tobacco use” and of “nicotine’s
pharmacological effects.” Id. at 138. Nonetheless, Congress
“considered and rejected bills that would have granted the
FDA” jurisdiction over tobacco products. Id. at 144.

In this light, Brown & Williamson interprets the six
statutes not as a particular carve-out from the FDCA for
cigarettes and smokeless tobacco (plus any additional
products covered in the six statutes, which the FDA briefs
make no effort to itemize), but rather as “a distinct regulatory
scheme to address the problem of tobacco and health”—one
that Congress intended would “preclude[] any role for the
FDA” with respect to “tobacco absent claims of therapeutic
benefit by the manufacturer.” Id. In doing so, Congress also
“persistently acted to preclude a meaningful role for any
administrative agency in making policy on the subject of
tobacco and health.” Id. at 156. As customarily marketed,
tobacco products were to remain the province of Congress.

Reflecting on the history and structure of tobacco
regulation, Brown & Williamson concluded,

Congress has affirmatively acted to address the issue of
tobacco and health, relying on the representations of the
FDA that it had no authority to regulate tobacco. It has
created a distinct scheme to regulate the sale of tobacco
products, focused on labeling and advertising, and
premised on the belief that the FDA lacks such
jurisdiction under the FDCA. As a result, Congress’
tobacco-specific statutes preclude the FDA from
regulating tobacco products as customarily marketed.

Id. at 156.
 11

Brown & Williamson therefore did not preclude the FDA
from regulating only those products for which Congress had
passed specific statutes. Rather, it recognized that Congress
had consciously developed a statutory scheme for tobacco and
health that distinguished tobacco products as customarily
marketed from ones marketed for therapeutic purposes.
“Thus, what Congress ratified was the FDA’s plain and
resolute position that the FDCA gives the agency no authority
to regulate tobacco products as customarily marketed.” Id. at
159.

At oral argument the FDA observed with some justice
that the regulatory scheme before the Court in Brown &
Williamson addressed only cigarettes and smokeless tobacco;
it would have us infer that the Court used the incessantly
repeated phrase “tobacco products” as a shorthand, confined
to the products before the Court (supplemented by whatever
additional products were reached by the six statutes). We find
no evidence of any such restrictive intent; certainly the Court
did not use the familiar economizing form: “cigarettes and
smokeless tobacco (‘tobacco products’).”

The Tobacco Act is wholly consistent with this reading of
Brown & Williamson. Written to address the regulatory gap
that the case identified, the Tobacco Act provides the FDA
with regulatory authority over tobacco products without
requiring therapeutic claims. Besides leaving the FDA’s
authority under the drug/device provisions of the FDCA
undisturbed, see 21 U.S.C. § 321(rr)(2) & § 387a(c)(1), the act
broadly defines tobacco products as extending to “any product
made or derived from tobacco,” 21 U.S.C. § 321(rr)(1)
(emphasis added). To be sure, this definition could align with
a variety of interpretations of Brown & Williamson’s scope
(including the one FDA proffers here), but our reading is
squarely within that range.
 12

The FDA responds that its treatment of the Favor
Smokeless Cigarette in 1987 supports its reading of Brown &
Williamson. FDA Br. at 14-15. We think not. Favor was a
small tube containing a nicotine solution, enabling the user to
inhale nicotine vapor without smoke. Id. at 14. Though the
Smokeless Cigarette was marketed without therapeutic claims,
the FDA warned Favor that it was an unapproved new drug.
Id. at 14-15. The FDA’s claimed authority over Favor was,
however, never challenged or adjudicated in court. Nor did
Brown & Williamson address the Smokeless Cigarette,
perhaps because neither side brought it before the Court
(perhaps in turn because the individuals litigating the case
were unaware of it). In its argument in Brown & Williamson,
the FDA stated that “the only instances in which the agency
had found that tobacco products were drugs involved cases in
which there were express market claims of therapeutic value.”
Pet’rs’ Br., FDA v. Brown & Williamson, 529 U.S. 120 (2000)
(No. 98-1152), 1999 WL 503874 at *37 (emphasis added). In
fact, one of the FDA’s arguments in Brown & Williamson was
that the agency was “free to change its position” as long as it
provided a reasoned justification for the change. Id. at *38
(emphasis added). And that would likely have been true—but
for the Court’s conclusion that Congress had ratified what the
Court understood as the FDA’s invariable exclusion of
tobacco products made without claims of therapeutic effect.

The FDA has also offered a consequentialist argument,
namely, that understanding Brown & Williamson in this
fashion leaves the FDA severely thwarted in any effort to
nudge e-cigarettes toward relatively healthful forms (or at
least away from relatively unhealthful ones). Whether such a
consequentialist argument should play any role in our
interpretation of Brown & Williamson is questionable, but no
matter. In fact the Tobacco Act gives the FDA broad
regulatory authority over tobacco products, including, for
instance, authority to impose restrictions on their sale, and on
 13

the advertising and promotion of such products, see 21 U.S.C.
§ 387f(d), to regulate the mode of manufacture of tobacco
products, see id. § 387f(e), and to establish standards for
tobacco products, see id. § 387g. To the extent that Congress
believed Brown & Williamson left an insufficiently regulative
environment for cigarettes, smokeless tobacco, cigars, and
other tobacco products, it found the Tobacco Act an adequate
remedy.

Together, Brown & Williamson and the Tobacco Act
establish that the FDA cannot regulate customarily marketed
tobacco products under the FDCA’s drug/device provisions,
that it can regulate tobacco products marketed for therapeutic
purposes under those provisions, and that it can regulate
customarily marketed tobacco products under the Tobacco
Act.

* * *

As to NJOY’s likelihood of success on the merits, the
firm claims that its electronic cigarettes use a liquid nicotine
mixture derived from tobacco and that its products are not
marketed for therapeutic uses, NJOY Compl. at 5; Decl. of
John Leadbeater at 2; the FDA appears not to challenge either
claim. Still, the district court noted that the factual record on
NJOY is meager and that the FDA may establish that NJOY
does in fact make therapeutic claims regarding its electronic
cigarettes. Mem. Op. at 25 n. 17. Until such time, the
definitional line laid down in Brown & Williamson (as we
understand it) leaves the FDA without jurisdiction over these
products under the FDCA’s drug/device provisions. On the
merits, then, NJOY is likely to succeed.

We also find that the district court did not abuse its
discretion in finding that the balance of harms tips toward
 14

NJOY. In showing irreparable harm, the injury to the party
must “be both certain and great; it must be actual and not
theoretical.” Wisconsin Gas Co. v. FERC, 758 F.2d 669, 674
(D.C. Cir. 1985). The FDA’s refusal to admit NJOY’s
products into the United States obviously destroyed the firm’s
ability in the United States to cover its costs for purchase or
production of e-cigarettes. The district court’s finding that
this loss would be irreparable absent an injunction appears
entirely reasonable. Mem. Op. at 29. Regarding harm to third
parties and to the public interest, the district court observed
that the FDA had cited no evidence to show that electronic
cigarettes harmed anyone. Id. at 30. More significantly, the
court rightly found that the FDA has authority under the
Tobacco Act to regulate electronic cigarettes, enabling it to
mitigate or perhaps extinguish any harm to public health. Id.
at 31. Given the likelihood of NJOY’s success on the merits,
the irreparable harm to NJOY’s business, and the FDA’s
unquestioned Tobacco Act authority to mitigate any public
harm, the district court did not abuse its discretion in granting
the preliminary injunction.

* * *

As we have already noted, the FDA has authority to
regulate customarily marketed tobacco products—including e-
cigarettes—under the Tobacco Act. It has authority to
regulate therapeutically marketed tobacco products under the
FDCA’s drug/device provisions. And, as this decision is
limited to tobacco products, it does not affect the FDA’s
ability to regulate other products under the “structure or any
function” prong defining drugs and devices in 21 U.S.C.§ 321
(g) and (h), as to the scope of which—tobacco products
aside—we express no opinion. Of course, in the event that
Congress prefers that the FDA regulate e-cigarettes under the
FDCA’s drug/device provisions, it can always so decree.
 15

The judgment of the district court is

Affirmed.
 GARLAND , Circuit Judge, concurring in the judgment:
Although I join my colleagues in the disposition of this case, I do
so based on different reasoning. I do not read FDA v. Brown &
Williamson, 529 U.S. 120 (2000), as barring the FDA from
regulating “electronic cigarettes” under the Food, Drug, and
Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., because I do not
believe the Supreme Court intended its use of the term “tobacco
products” to extend to products that do not contain tobacco.
The Tobacco Control Act of 2009, Pub. L. No. 111-31, 123 Stat.
1776, however, expressly extends to products that are merely
“derived from” tobacco. Accordingly, at least in the absence of
a contrary agency interpretation entitled to Chevron deference,
I read the Tobacco Control Act as requiring the FDA to regulate
products like electronic cigarettes under that Act, rather than
under the FDCA.

I

In Brown & Williamson, the Supreme Court held that the
FDA lacks authority to regulate “tobacco products” under the
drug/device provisions of the FDCA, unless those products are
marketed with therapeutic claims. 529 U.S. at 144, 158-59. On
its face, the natural meaning of the term “tobacco product” is a
product -- like cigarettes or chewing tobacco -- that contains
tobacco. Although it is true that the liquid nicotine in NJOY’s
electronic cigarettes is derived from tobacco, it seems less
natural to regard that fact as sufficient to transform NJOY’s
plastic cartridges -- which contain no tobacco -- into a tobacco
product. As NJOY acknowledges, its reading leads to the
counterintuitive conclusion that a syringe filled with injectable
nicotine is a tobacco product as well. Oral Argument Tr. 40-41.

On many, although not all, occasions on which Brown &
Williamson used the term “tobacco products,” the Court coupled
it with an express reference to tobacco or to products that plainly
 2

contain tobacco.1 At no point did the Court state that the FDA
was barred from regulating “nicotine” (or a product containing
nicotine but not tobacco) under the FDCA. Thus, the most
straightforward reading of the term “tobacco products” is as
short-hand for products that contain tobacco. Compare 529 U.S.
at 155 (describing several congressional statutes as “creating a
distinct regulatory scheme for cigarettes and smokeless
tobacco”), with id. at 159 (describing the same statutes as
“creat[ing] a distinct regulatory scheme for tobacco products”)
(emphases added).

This reading is consistent with the context in which the
Court decided Brown & Williamson. In that case, the Court

1
See, e.g., 529 U.S. at 126, 127, 128, 129 (using the term
“tobacco products” in reference to the FDA’s rule concerning the sale
of “cigarettes and smokeless tobacco”); id. at 129 (describing that rule
-- which was limited to cigarettes and smokeless tobacco -- as
requiring that a specified statement appear on “all tobacco product
packages”); id. at 134 (noting that the FDA had found “tobacco
products” to cause “tobacco-related illnesses, such as cancer,
respiratory illnesses, and heart disease” -- illnesses that the FDA
associated with tobacco, not nicotine); id. at 142 (noting that “tobacco
products” cannot “be safe within the meaning of the FDCA” because,
“[a]s the FDA has documented in great detail, cigarettes and
smokeless tobacco are an unsafe means to obtaining any
pharmacological effect”); id. at 145 (describing the FDA’s 1964
testimony that it lacked authority to label cigarette packages as
testimony that it lacked jurisdiction to regulate “tobacco products”);
id. at 146 (citing, in support of the proposition that the FDA had never
before “asserted authority to regulate tobacco products as customarily
marketed,” the fact that the “FDA has repeatedly informed Congress
that cigarettes are beyond the scope of the statute absent health
claims”).
 3

upheld a challenge to a 1996 FDA rule asserting authority to
regulate the sale of cigarettes and smokeless tobacco under the
FDCA. 529 U.S. at 126-30 (citing Regulations Restricting the
Sale and Distribution of Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents, 61 Fed. Reg. 44,396 (Aug. 28,
1996)). Because all of the products at issue in the rule contained
tobacco, the Court had no occasion to opine upon the FDA’s
authority to regulate a product, like electronic cigarettes, that
does not. Indeed, although a product indistinguishable from
electronic cigarettes had been introduced some ten years earlier
-- the “Favor Smokeless Cigarette,” which consisted of a small
tube containing an inhalable nicotine solution -- there is no
indication in Brown & Williamson that the Court had ever heard
of it. (The FDA had asserted authority to regulate Favor in
1987, notwithstanding that it was marketed without therapeutic
claims. Regulatory Letter from FDA to Advanced Tobacco
Prods. Inc. (Feb. 9, 1987) (J.A. 425-26)).

But the most telling indication that the holding of Brown &
Williamson does not extend to electronic cigarettes is that the
Court’s reasoning does not apply to products that do not contain
tobacco. The Supreme Court’s chief rationale for its holding had
two premises. First, the Court determined that, “if tobacco
products were ‘devices’ under the FDCA, the FDA would be
required to remove them from the market.” 529 U.S. at 135. It
reached this conclusion because the FDA may only approve a
product for marketing under the FDCA if it is safe and effective
for its intended use, and the FDA had “exhaustively
documented” that tobacco products are unsafe for any
pharmacological use. Id. at 133-35. Second, the Court found
that Congress had “foreclosed the removal of tobacco products
from the market” through “tobacco-specific legislation” passed
subsequent to the FDCA. Id. at 137, 143. Thus, the Court
concluded: “If they cannot be used safely for any therapeutic
 4

purpose, and yet they cannot be banned, they simply do not fit”
within the FDCA’s regulatory scheme. Id. at 143.

Neither premise holds true for pure nicotine or for a
tobacco-free product that delivers nicotine. First, unlike
products containing tobacco, which the FDA has found to be
associated with “cancer, respiratory illnesses, and heart disease,”
529 U.S. at 134-35, the FDA has not found that nicotine or
tobacco-free products that deliver nicotine are inherently unsafe.
To the contrary, the FDA has approved several such products
marketed with therapeutic claims, determining that they satisfy
the FDCA safety requirements that Brown & Williamson
determined “tobacco products” could not meet. See FDA Br. 16
(noting that the FDA has approved nicotine gums and
transdermal patches). Indeed, the FDA states that “it may well
be possible for a manufacturer of ‘electronic cigarettes’ . . . to
satisfy the FDCA’s safety, effectiveness, and labeling
requirements and obtain FDA approval.” Id.

Second, the “tobacco-specific legislation” the Court found
dispositive in Brown & Williamson simply does not address
products that deliver nicotine but contain no tobacco. As the
Court explained, Congress had “directly addressed the problem
of tobacco and health through legislation on six occasions since
1965.” 529 U.S. at 137.2 Those statutes impose labeling and

2
The Court listed the following six statutes: “Federal Cigarette
Labeling and Advertising Act (FCLAA), Pub. L. 89-92, 79 Stat. 282;
Public Health Cigarette Smoking Act of 1969, Pub. L. 91-222, 84 Stat.
87; Alcohol and Drug Abuse Amendments of 1983, Pub. L. 98-24, 97
Stat. 175; Comprehensive Smoking Education Act, Pub. L. 98-474, 98
Stat. 2200; Comprehensive Smokeless Tobacco Health Education Act
of 1986, Pub. L. 99-252, 100 Stat. 30; Alcohol, Drug Abuse, and
Mental Health Administration Reorganization Act, Pub. L. 102-321,
§ 202, 106 Stat. 394.” 529 U.S. at 137-38.
 5

advertising requirements that “create a distinct regulatory
scheme for cigarettes and smokeless tobacco.” Id. at 155; see id.
at 143-44, 148-49. Moreover, Congress has declared that “[t]he
marketing of tobacco constitutes one of the greatest basic
industries of the United States,” id. at 137 (quoting 7 U.S.C.
§ 1311(a)), making it “highly unlikely” that the legislature would
have subjected the industry to a regulatory regime that could
substantially or entirely shut it down, id. at 160. “[T]he
collective premise of these statutes,” the Court said, is “that
cigarettes and smokeless tobacco will continue to be sold in the
United States.” Id. at 139.

This “collective premise” does not extend to products, like
electronic cigarettes, that contain only nicotine. None of the
statutes the Court referenced regulate such products, and the
statutory labeling requirements and advertising restrictions the
Court cited do not apply to electronic cigarettes. See FDA Br.
10, 13-14. Nor can it be said that FDA regulation of a novel
product like electronic cigarettes would threaten the health of the
American tobacco industry. As NJOY avers, it “imports one
hundred percent of its supply of E-cigarettes from overseas
manufacturers, and, upon information and belief, there is no
domestic manufacturer of E-cigarettes or their component parts.”
NJOY Compl. ¶ 18 (J.A. 40).

Finally, the Brown & Williamson Court also noted that, “[i]n
adopting each statute, Congress . . . acted against the backdrop
of the FDA’s consistent and repeated statements that it lacked
authority under the FDCA to regulate tobacco absent claims of
therapeutic benefit by the manufacturer.” 529 U.S. at 144
(emphasis added). “Under these circumstances,” the Court
concluded, “it is evident that Congress’ tobacco-specific
statutes . . . effectively ratified the FDA’s long-held position that
it lacks jurisdiction under the FDCA to regulate tobacco
 6

products.” Id. (emphasis added). But the backdrop of pre-1996
statements to which the Court referred did not include statements
that the FDA lacked authority over a product like nicotine,
which is merely derived from tobacco. Rather, as the Court’s
citations make clear, the FDA’s statements to Congress referred
to its lack of jurisdiction either over “tobacco,” id. at 145, or
over specific products that plainly contain tobacco, like
cigarettes, id. at 145-46. See, e.g., id. at 145 (citing FDA
statement that “[t]obacco marketed for chewing or smoking
without accompanying therapeutic claims, does not meet the
definitions . . . for food, drug, device or cosmetic” in the FDCA).
And in fact, as noted above, in 1987 the FDA had asserted
authority to regulate a product that is materially
indistinguishable from electronic cigarettes -- the Favor
Smokeless Cigarette -- apparently without challenge.

In sum, I see nothing in the words, context, or rationale of
Brown & Williamson that supports interpreting that case as
barring the FDA from regulating electronic cigarettes under the
drug/device provisions of the FDCA. Although I agree with my
colleagues that these considerations do not justify reading Brown
& Williamson as merely a “carve-out from the FDCA for
cigarettes and smokeless tobacco,” Slip Op. at 10, they do justify
reading it as a carve-out only for products that contain tobacco.
See 529 U.S. at 144 (holding that Congress intended to
“preclude[] any role for the FDA” with respect to “tobacco
absent claims of therapeutic benefit” (emphasis added)). The
Supreme Court had no reason to opine on the status of a product
that contains no tobacco, and there is no indication in the
opinion that it meant to do so. As my colleagues’ opinion rests
on the supposition that it did, I cannot join their rationale.
 7

II

But Brown & Williamson is not the end of the story. In
2009, Congress passed the Tobacco Control Act, which states:
“Tobacco products . . . shall be regulated by the Secretary under
this [Act] and shall not be subject to the provisions of [the
drug/device subchapter of the FDCA].” 21 U.S.C. § 387a(a).
Moreover, unlike Brown & Williamson, which used the term
“tobacco products” without defining it, the Tobacco Control Act
includes a definition: “The term ‘tobacco product’ means any
product made or derived from tobacco that is intended for
human consumption.” 21 U.S.C. § 321(rr)(1) (emphasis added).
Because the nicotine in NJOY’s electronic cigarettes is “derived
from” natural tobacco, NJOY Compl. ¶ 1, it appears that the
FDA may regulate it only pursuant to the provisions of the
Tobacco Control Act.

The FDA disagrees with this conclusion, contending that the
Tobacco Control Act does not narrow the FDA’s preexisting
authority under the FDCA. In support, agency counsel cites
another definitional provision of the Tobacco Control Act, which
states that “[t]he term ‘tobacco product’ does not mean an article
that is a drug . . . , a device . . . , or a combination product” under
the FDCA. 21 U.S.C. § 321(rr)(2). In the FDA’s view, this
provision preserves for regulation under the FDCA any product
“made or derived from tobacco” that Brown & Williamson did
not carve out of the FDCA’s coverage. And because Brown &
Williamson’s carve-out did not extend to nicotine-only products,
the agency maintains that such products are not necessarily
“tobacco products” within the meaning of the Tobacco Control
Act.3

3
Like the FDA, NJOY reads § 321(rr)(2) as leaving the boundary
between tobacco products and drugs where it was prior to the passage
 8

There is no doubt that § 321(rr)(2) introduces a note of
ambiguity into the analysis. But it is a stretch to conclude that,
having just used one express statutory subsection to include
products “derived from” tobacco within the definition of
“tobacco product,” § 321(rr)(1), Congress then immediately
employed the next, ambiguous subsection to carve them out
again. Rather, it is more likely that § 321(rr)(2) is an expression
of Congress’ intent to preserve Brown & Williamson’s holding
that even a product made from tobacco -- for example, a
cigarette -- remains a drug, device, or drug/device combination
that can be regulated under the FDCA if it is marketed for
therapeutic purposes. Hence, the better reading is that
§ 321(rr)(2) simply makes clear that products made or derived
from tobacco that are marketed for therapeutic purposes are not
“tobacco products” within the meaning of the Tobacco Control
Act, and are therefore subject to regulation under the drug/device
provisions of the FDCA.

In the usual circumstance, of course, a judge’s view of the
“better” reading of a statute administered by an agency is not
necessarily dispositive. “If a statute is ambiguous, and if the
implementing agency’s construction is reasonable, Chevron
requires a federal court to accept the agency’s construction of the
statute, even if the agency’s reading differs from what the court
believes is the best statutory interpretation.” Nat’l Cable &
Telecomm. Ass’n v. Brand X Internet Servs., 545 U.S. 967, 980
(2005) (citing Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837,
843-44 & n.11 (1984)). In United States v. Mead Corp., 533

of the Tobacco Control Act. However, because NJOY reads Brown
& Williamson as having removed nicotine-only products from the
FDCA’s drug/device authority, it concludes that such products are
“tobacco products” under the Tobacco Control Act and so may not be
regulated under the FDCA.
 9

U.S. 218 (2001), however, the Supreme Court held Chevron
deference appropriate only for statutory interpretations with the
“force of law,” id. at 229, and ruled that an agency’s litigation
briefs -- unlike, for example, its regulations -- do not warrant
such deference, id. at 238 n.19. See also Bowen v. Georgetown
Univ. Hosp., 488 U.S. 204, 212-13 (1988) (declining to accord
Chevron deference to “agency litigating positions”); Landmark
Legal Found. v. IRS, 267 F.3d 1132, 1135-36 (D.C. Cir. 2001)
(denying Chevron deference to an interpretation “developed in
litigation”).4

In this case, there is no agency pronouncement that calls for
Chevron deference. Other than its briefs, which do not qualify,
the only expression of the FDA’s view regarding electronic
cigarettes is the agency’s 2008 detention order barring the
importation of NJOY’s products. But that order was issued
before Congress passed the Tobacco Control Act in 2009 and
hence does not construe it at all. “Chevron being inapplicable

4
As the FDA observes, the Court has accorded deference to briefs
in which agencies interpret their own regulations. See Auer v.
Robbins, 519 U.S. 452 (1997). The Court, however, distinguishes
between agency interpretations of regulations and agency
interpretations of statutes. See Couer Alaska, Inc. v. Southeast Alaska
Conservation Council, 129 S. Ct. 2458, 2473 (2009) (finding
interpretive memo “not subject to sufficiently formal procedures to
merit Chevron deference” under Mead, but still entitled to deference
under Auer “because it interprets the agencies’ own regulatory
scheme”); see also Mead, 533 U.S. at 246 (Scalia, J., dissenting)
(noting and criticizing the distinction); John F. Manning,
Nonlegislative Rules, 72 GEO . WASH . L. REV . 893, 943-44 (2004)
(observing that Mead narrowed the range of agency
statutory interpretations that are entitled to Chevron deference, while
leaving “intact the related but freestanding principle” of Auer
deference).
 10

here in light of Mead, [the court] must decide for [itself] the best
reading” of the Act. Landmark Legal Found., 267 F.3d at 1136.
And the best reading is to give full effect to the Tobacco Control
Act’s definition of “tobacco product” as “any product made or
derived from tobacco,” 21 U.S.C. § 321(rr)(1), as well as to its
injunction that “[t]obacco products . . . shall be regulated” under
that Act and “shall not be subject to the provisions” of the
FDCA, 21 U.S.C. § 387a(a).

III

In the absence of an authoritative agency interpretation, I
conclude that, unless a product derived from tobacco is marketed
for therapeutic purposes, the FDA may regulate it only under the
provisions of the Tobacco Control Act. Accordingly, because
NJOY’s electronic cigarettes are derived from tobacco, I join my
colleagues’ disposition. What the result would be were the FDA
to offer a contrary statutory interpretation in the form of a
regulation, I leave for the day the agency decides to take that
step.