MEMORANDUM OPINION AND ORDER
Amit
P. Mehta United States District Judge
I. INTRODUCTION
On May
10, 2016, the U.S. Food and Drug Administration
(“FDA”) published a final rule
“deeming” cigars, pipe tobacco, and certain other
products (e.g., e-cigarettes) subject to the federal Food,
Drug, and Cosmetic Act (“FD&C Act”), 21
U.S.C. §§ 301, et seq., as amended by the
Family Smoking Prevention and Tobacco Control Act of 2009
(“TCA”). Known as the “Deeming
Rule, ” the FDA's action subjects these newly
“deemed” products to comparable statutory and
regulatory requirements already imposed on cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco. At the same time, the FDA promulgated a separate
rule, referred to as the “User Fee Rule, ” which
assesses “user fees” on manufacturers and
importers of cigars and pipe tobacco, but not other newly
deemed products, like e-cigarettes. The FDA is statutorily
authorized to collect user fees for the purpose of funding
the FDA's regulation of tobacco products under the
FD&C Act and the TCA.[1]
Plaintiffs
in this case are three non-profit associations that represent
cigar manufacturers, importers, distributors, suppliers, and
consumers, as well as premium cigar and tobacco retail shops.
They brought this action in July 2016 against the FDA and its
Commissioner, and the U.S. Department of Health and Human
Services (“HHS”) and its Secretary (collectively,
“Defendants”), challenging the Deeming Rule and
the User Fee Rule on a host of grounds.[2] For reasons
explained later in this opinion, not all of Plaintiffs'
challenges to the Rules are presently before the court.
Instead, the court addresses only the following subset of
challenges: (1) the imposition of health warning requirements
for cigar packaging and advertisements; (2) the assessment of
user fees on cigar and pipe tobacco products, but not on
another newly deemed product, e-cigarettes; (3) the treatment
of retailers who blend pipe tobacco in-store as
“manufacturers” subject to the regulatory
requirements of 21 U.S.C. § 387e; and (4) the
classification of pipes as “components” of
tobacco products, thereby subjecting pipe makers to
regulation. Plaintiffs also have moved to preliminarily
enjoin implementation and enforcement of the Deeming
Rule's health warning requirements.
For the
reasons set forth below, the court grants in part and denies
in part the parties' cross-motions for partial summary
judgment and denies Plaintiffs' motion for a preliminary
injunction as moot. The Deeming Rule's health warning
requirements are upheld in all respects, as is the User Fee
Rule in its entirety. The court also affirms the agency's
classification of pipes as “components or parts”
of tobacco products under the TCA. The court, however,
concludes that Defendants' rationale for subjecting
retailers who blend pipe tobacco in-store to the requirements
of 21 U.S.C. § 387e is arbitrary and capricious and
therefore remands that issue to the FDA for further
consideration.
II.
BACKGROUND
A.
Statutory Background
In
2009, Congress enacted the TCA to “provide authority to
the [FDA] to regulate tobacco products under the [FD&C
Act] by recognizing it as the primary Federal regulatory
authority with respect to the manufacture, marketing, and
distribution of tobacco products, ” and “to
authorize the [FDA] to set national standards controlling the
manufacture of tobacco products and the identity, public
disclosure, and amount of ingredients used in such products,
” among other purposes. Family Smoking Prevention and
Tobacco Control Act, Pub. L. No. 111-31, § 3, 123 Stat.
1776, 1781-82 (2009). Congress made 49 legislative findings
in the Act, in which it acknowledged the “inherent
dangerous[ness]” of tobacco products and nicotine and
the strong public interest in regulating tobacco products and
their advertising and promotion, and discussed Congress's
interest in reducing youth tobacco use, in light of judicial
findings that major U.S. tobacco companies specifically
targeted and marketed their products to youth. TCA § 2.
Congress further recognized that no other federal agency
except the FDA “possesses the scientific expertise
needed to implement effectively all provisions of the
[TCA].” TCA § 2(45).
In
light of those findings, the TCA authorized the Secretary of
Health and Human Services to regulate the manufacture,
distribution, and marketing of tobacco products. TCA §
901, codified at 21 U.S.C. § 387a (entitled “FDA
authority over tobacco products”). The legislation
immediately subjected “all cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco”
to a panoply of statutory and regulatory requirements, and
also reserved future application of the TCA to “any
other tobacco products that the Secretary [of Health and
Human Services] by regulation deems to be subject to
this chapter.” 21 U.S.C. § 387a(b) (emphasis
added). Congress defined “tobacco product” to
mean “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). The FDA's decision in 2016
to “deem” cigars and pipe tobacco as
“tobacco products, ” and thus subject them to
regulation, gave rise to this litigation.
B.
Regulatory Background
1.The
Cigar Product
Federal
regulations define “cigar” to mean any
“roll of tobacco that is wrapped in leaf tobacco or any
substance containing tobacco” that is “not a
cigarette.” 21 C.F.R. § 1143.1. There are three
major categories of cigar products: (1) little cigars, (2)
cigarillos, and (3) traditional cigars. See
Defs.' Cross-Mot. for Partial Summ. J. & Mem. in
Support, ECF No. 74 [hereinafter Defs.' Cross-Mot.], at
6-7. Little cigars resemble cigarettes in size and tobacco
content and thus “are positioned as cheaper substitutes
for cigarettes.” See Id. at 7. Cigarillos are
a shorter, slimmer version of traditional cigars and,
generally speaking, contain between 3 and 10 pounds of
tobacco per thousand units. See Id. at 8.
Traditional cigars are the largest cigar product, varying in
length and diameter. See Id. While little cigars and
cigarillos are machine-rolled, traditional cigars may be
either machine-rolled or hand-rolled. See id.
Within
the category of traditional cigars are a sub-category known
as “premium cigars.” See Id. Premium
cigars typically are hand-rolled, made with a higher-grade
tobacco, or are more expensive. See Id. The term
“premium cigar” is not, however, defined by
federal statute or regulation. See id.
2.
The Existing FTC Health Warning Statements Regime
Long
before the FDA's action in 2016, cigar products already
were subject to some federal regulation. More than a decade
earlier, in 2000, in settlements with the Federal Trade
Commission (“FTC”), the seven largest U.S. cigar
companies agreed to include warnings about significant
adverse health risks on their packaging and advertisements.
See, e.g., Decision & Order, In the Matter
of Swedish Match N. Am., Inc., Docket No. C-3970 (F.T.C.
Aug. 18, 2000), 2000 WL 1207446. The FTC settlements
represented the first national requirements for health
warnings on cigar products and applied to approximately 95
percent of the U.S. cigar market at the time. See
Press Release, FTC, Nationwide Labeling Rules for Cigar
Packaging and Ads Take Effect Today (Feb. 13, 2001),
https://www.ftc.gov/news-events/press-releases/2001/02/nationwide-labeling-rules-cigar-packaging-and-ads-take-effect.
Pursuant
to the consent orders, which remain in effect today, the
covered cigar companies must display one of the five
following health warning statements “clearly and
conspicuously” on their advertising and packaging:
SURGEON GENERAL WARNING: Cigar Smoking Can Cause Cancers Of
The Mouth And Throat, Even If You Do Not Inhale.
SURGEON GENERAL WARNING: Cigar Smoking Can Cause Lung Cancer
And Heart Disease.
SURGEON GENERAL WARNING: Tobacco Use Increases The Risk Of
Infertility, Stillbirth And Low Birth Weight.
SURGEON GENERAL WARNING: Cigars Are Not A Safe Alternative To
Cigarettes.
SURGEON GENERAL WARNING: Tobacco Smoke Increases The Risk Of
Lung Cancer And Heart Disease, Even In Nonsmokers.
See Decision & Order, In the Matter of
Swedish Match N. Am., Inc., 2000 WL 1207446, at *3.
The FTC
consent orders specify the size and formatting of the health
warnings, and require that they appear on the principal
display panel on cigar packages and be rotated at random on a
12-month basis. See Id. at *4-7, *10-12.
Additionally,
the FTC consent orders require the health warnings to appear
on visual advertisements in a set-off, rectangular box to
ensure that the warnings are readily visible and conspicuous.
Id. at *5-8. For audio advertisements, the health
warning statement must be delivered so that an ordinary
consumer can hear and comprehend it. Id. at *8-9.
Cigar companies also were required to submit for FTC
approval, in advance of the consent orders' effective
date, a plan for the rotation and display of the health
warnings on cigar packages and advertisements. Id.
at *11-12.
3.FDA
Rules
a.
The Deeming Rule
i.
Proposed Rule
In the
years following Congress's enactment of the TCA, cigar
products were free from FDA regulation because cigars were
not expressly listed in the Act's definition of
“tobacco product.” A harbinger of change arrived
in the spring of 2014. On April 25, 2014, the FDA issued a
Proposed Rule that would make, or “deem, ”
cigars, pipe tobacco, and e-cigarettes subject to the TCA.
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, 79
Fed. Reg. 23, 142 (Apr. 25, 2014) (“Proposed Deeming
Rule”). In the Proposed Deeming Rule, the FDA announced
for consideration two options which “would provide two
alternatives for the scope of the deeming provisions and,
consequently, the application of the additional specific
provisions.” Id. at 23, 143. Under Option 1,
the FDA would deem all products meeting the statutory
definition of “tobacco product”-including cigars
and pipe tobacco-except accessories of deemed products to be
subject to the TCA. Id. Under Option 2, the FDA
would deem “only a subset of cigars” and
“exclude from the scope of [the] proposed rule certain
cigars that we refer to as ‘premium cigars.'”
Id. To effectuate this carve-out, Option 2 proposed
a definition for “covered cigar” as:
[A]ny cigar as defined in this part, except a cigar that: (1)
Is wrapped in whole tobacco leaf; (2) contains a 100 percent
leaf tobacco binder; (3) contains primarily long filler
tobacco; (4) is made by combining manually the wrapper,
filler, and binder; (5) has no filter, tip, or non-tobacco
mouthpiece and is capped by hand; (6) has a retail price
(after any discounts or coupons) of no less than $10 per
cigar (adjusted, as necessary, every 2 years, effective July
1st, to account for any increases in the price of tobacco
products since the last price adjustment); (7) does not have
a characterizing flavor other than tobacco; and (8) weighs
more than 6 pounds per 1000 units.
Id. at 23, 150. The FDA noted that, while it had
proposed a definition with respect to Option 2, it remained
“concerned that any attempts to create a subset of
premium cigars that are excluded from regulatory authority
might sweep other cigar products under its umbrella.”
Id. The FDA therefore sought comment as to how to
refine this definition, within the context of Option 2,
“to ensure that the exclusion would apply only to those
cigars that, because of how they are used, may have less of a
public health impact than other types of cigars.”
Id.
The FDA
sought comment on both options. Its purpose was “to
determine whether all cigars should be subject to deeming and
what provisions of the proposed rule may be appropriate or
not appropriate for different kinds of cigars, ” as
well as to determine the “relative merits of Option 1
versus Option 2, taking into account what is appropriate for
the public health, including possible benefits to the public
health or possible negative public health consequences of
adopting one Option or the other.” Id. at 23,
143, 23, 145. As to Option 2, the FDA noted that while
“all cigars are harmful and potentially addictive, it
has been suggested that different kinds of cigars may have
the potential for varying effects on public health, based on
possible differences in their effects on dual use, youth
initiation[, ] and frequency of use by youth and young
adults.” Id. at 23, 150. Plaintiffs and
numerous other members of the public submitted detailed
comments on the Proposed Deeming Rule.
ii.
Final Rule
a.
Health warning requirements
The FDA
selected Option 1 and promulgated the final Deeming Rule on
May 10, 2016, thus deeming all categories of cigars,
including those referred to as “premium cigars, ”
to be subject to the TCA. See Final Rule Deeming 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, 29, 020 (May 10, 2016)
(codified at 21 C.F.R. pts. 1100, 1140, 1143) (“Deeming
Rule”). In support of its decision, the FDA stated that
it “concluded that deeming all cigars, rather than a
subset, more completely protects the public health.”
Id. The FDA found that: “(1) All cigars pose
serious negative health risks, (2) the available evidence
does not provide a basis for FDA to conclude that the
patterns of premium cigar use sufficiently reduce the health
risks to warrant exclusion, and (3) premium cigars are used
by youth and young adults.” Id.
Under
the Deeming Rule as originally announced, the newly deemed
products would be subject to comparable TCA provisions and
regulatory requirements to which cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco were
already subject. Id. at 28, 976. These requirements
include:
(1) Enforcement action against products determined to be
adulterated or misbranded (other than enforcement actions
based on lack of a marketing authorization during an
applicable compliance period);
(2) Required submission of ingredient listing and reporting
of [harmful and potentially harmful constituents];
(3) Required registration of tobacco product manufacturing
establishments and product listing;
(4) Prohibition against sale and distribution of products
with modified risk descriptors (e.g., “light, ”
“low, ” and “mild” descriptors) and
claims unless FDA issues an order authorizing their
marketing;
(5) Prohibition on the distribution of free samples; and
(6) Premarket review applications and approvals.
Id.
And
there is more. The Deeming Rule also sets out comprehensive
warning statement requirements, for both cigar product
packaging and advertisements. By August 10, 2018, cigar
product packages must display one of the six following health
warning statements:
(i) WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
(ii) WARNING: Cigar smoking can cause lung cancer and heart
disease.
(iii) WARNING: Cigars are not a safe alternative to
cigarettes.
(iv) WARNING: Tobacco smoke increases the risk of lung cancer
and heart disease, even in nonsmokers.
(v)(A) WARNING: Cigar use while pregnant can harm you and
your baby.[3] . . .
(vi) WARNING: This product contains nicotine. Nicotine is an
addictive chemical.
21 C.F.R. § 1143.5(a)(1). These health warnings must be
displayed on a rotating basis. See Id. On cigar
packages, each of the six health warning statements
“must be randomly displayed in each 12-month period, in
as equal number of times as is possible on each brand of
cigar sold in product packaging and be randomly distributed
in all areas of the United States in which the product is
marketed.” Id. § 1143.5(c)(1). On cigar
advertisements, the health warning statements “must be
rotated quarterly in alternating sequence in each
advertisement for each brand of cigar.” Id.
§ 1143.5(c)(2). Each cigar company must submit for FDA
approval a plan for rotating warnings twelve months before
advertising or commercially marketing a cigar product.
Id. § 1143.5(c)(3).
The
Deeming Rule also specifies the placement and size of the
required health warnings. With respect to packaging, each
warning statement must “appear directly on the
package” and must be “located in a conspicuous
and prominent place on the two principal display panels of
the package, ” comprising “at least 30 percent of
each of the principal display panels.” Id.
§ 1143.5(a)(2). For cigars that are sold individually
and not in a product package, the health warning statements
must be posted at the retailer's point-of-sale on an 8.5
by 11-inch “clear, legible, and conspicuous”
sign. Id. § 1143.5(a)(3). As to print and other
visual advertisements, the warning statement must be located
in the “upper portion of the area of the
advertisement” and occupy “at least 20 percent of
the area of the advertisement.” Id. §
1143.5(b).[4]
These
size mandates are more demanding than the size requirements
under the FTC consent orders. According to Plaintiffs, the
required package warnings are 195 to 237 percent larger on
any one panel than under the FTC warnings scheme. And, when
the Deeming Rule's additional requirement to cover a
second display panel is included, Plaintiffs assert that the
FDA's mandate covers approximately 390 to 475 percent
more of a package's surface area than is required under
the FTC's consent orders.
b.
Related deemed products
In
addition to cigars, pipe tobacco, and e-cigarettes, the
Deeming Rule also deemed the “components or
parts” of those newly deemed products to be subject to
the TCA. The FDA defines the statutory term “component
or part” to mean:
[A]ny 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) [t]o be used with or for the human
consumption of a tobacco product. Component or part excludes
anything that is an accessory of a tobacco product.
81 Fed. Reg. at 29, 102; 21 C.F.R. § 1100.3. Within the
category of “component or part, ” the FDA
included pipes used to consume pipe tobacco. 81 Fed. Reg. at
29, 042.
Although
it had the authority to do so, the FDA did not deem
“accessories” of the newly deemed tobacco
products subject to the TCA. The agency reasoned that
“accessories, unlike components or parts, are expected
to have little direct impact on the public health.”
Id. at 28, 975. The FDA defined
“accessories” to mean “any product”
intended or reasonably expected to be used with or for the
human consumption of a tobacco product, but not containing,
made, or derived from, tobacco, that is: (1) “not
intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of
a tobacco product, ” or (2) “intended or
reasonably expected to affect or maintain the performance,
composition, constituents, or characteristics of a tobacco
product, ” but solely: (i) “controls moisture
and/or temperature of a stored tobacco product, ” or
(ii) provides an external heat source to initiate but not
maintain combustion of a tobacco product.” Id.
at 29, 102; 21 C.F.R § 1100.3. The FDA identified as
examples of unregulated accessories items like
“ashtrays, spittoons, hookah tongs, cigar clips and
stands, and pipe pouches, ” as well as “humidors
or refrigerators that solely control the moisture and/or
temperature of a stored product and conventional matches and
lighters that solely provide an external heat source to
initiate but not maintain combustion of a tobacco
product.” 81 Fed. Reg. at 28, 975.
b.
The User Fee Rule
To
fund the regulation of tobacco products under the TCA,
Congress requires the FDA to “assess user fees on, and
collect fees from, each manufacturer and importer of tobacco
products subject to this subchapter.” See 21
U.S.C. § 387s. The user fees “are available only
for the purpose of paying the costs of the activities of the
[FDA] related to the regulation of tobacco products under . .
. the [TCA].” Id. § 387s(c)(2).
When it
promulgated the final Deeming Rule, the FDA simultaneously
issued the User Fee Rule. Under that Rule, the FDA announced
its intention to collect information from domestic
manufacturers and importers of cigars and pipe tobacco in
order to calculate the amount of user fees to be collected
from these entities. See Requirements for the Submission
of Data Needed To Calculate User Fees for Domestic
Manufacturers and Importers of Cigars and Pipe Tobacco,
81 Fed. Reg. 28, 707 (May 10, 2016); 21 C.F.R. § 1150.5.
Domestic manufacturers and importers of cigars and pipe
tobacco were required to submit information to support the
assessment of user fees to the FDA on August 20, 2016. 81
Fed. Reg. at 28, 707; 21 C.F.R. § 1150.5. Because the
FDA performs class allocations only on a full fiscal-year
basis, domestic manufacturers and importers of cigars and
pipe tobacco became subject to user fee assessments on
October 1, 2016, the first full fiscal year following the
User Fee Rule's effective date of August 8, 2016. 81 Fed.
Reg. At 28, 707.
Notably,
the User Fee Rule excluded from coverage other newly deemed
products, such as e-cigarettes. The FDA explained that it
lacked the statutory authority to impose user fees on any
newly deemed products other than cigars and pipe tobacco.
See Id. at 28, 711-12.
c.
FDA's July 2017 Announcement of a “New
Comprehensive Plan”
The
presidential election of 2016 ushered in change to the
FDA's approach to the Deeming Rule. On July 28, 2017, the
FDA announced a “new comprehensive plan” for
regulating tobacco products and nicotine. See
Pls.' Mot. for Partial Summ. J., ECF No. 62 [hereinafter
Pls.' Mot.], Ex. D, ECF No. 62-4 [hereinafter FDA Press
Release]. In accordance with the plan, the FDA delayed
implementation of some provisions of the Deeming Rule, but
allowed others to go into effect. For instance, the agency
extended until August 8, 2021, the compliance period for
tobacco manufacturers to submit applications for newly deemed
products that were on the market as of August 8, 2016.
See Joint Status Report (dated Sept. 5, 2017), ECF
No. 51 [hereinafter Sept. 5, 2017 JSR], ¶ 3; FDA Press
Release. The health warning requirements, on the other hand,
were left undisturbed.
The FDA
also announced its intention to issue Advance Notices of
Proposed Rulemaking (“ANPRM”). The contemplated
rulemaking included a focus on the previous issue of whether
to regulate premium cigars. An ANPRM, the FDA stated, would
seek public comment on “the patterns of use and
resulting public health impacts from premium cigars, which
were included in the FDA's 2016 rule.” FDA Press
Release. Commenting on the FDA's “new comprehensive
plan, ” Mitch Zeller, Director of the FDA's Center
for Tobacco Products, explained: “Public input on these
complex issues will help ensure the agency has the proper
science-based policies in place to meaningfully reduce the
harms caused by tobacco use.” Id.
d.
Recent Regulatory Developments
In
December 2017, the FDA formally announced its intention to
initiate a rulemaking process focused on the question of
premium cigars. See “Premium Cigars; Request
for Scientific Information, ” Agency Rule List -
Fall 2017: Department of Health and Human Services,
Unified Agenda of Regulatory and Deregulatory Actions, OIRA,
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201710&RIN=0910-AH88.
The FDA observed that while it had received comments in
response to the Proposed Deeming Rule “claiming that
the health risks associated with cigar use generally, or with
the use of premium cigars in particular were not significant
because of the way such products are used, ” these
comments ultimately failed to provide an adequate scientific
basis for excluding those products from regulation.
Id. The FDA therefore announced its intention to
issue an ANPRM to request scientific information “that
might support” exempting premium cigars from regulation
or regulating them in a manner different from other cigars.
Id.
The
agency issued the ANPRM in late March 2018. See
Defs.' Notice of Publication of ANPRM, ECF No. 91. It
explained that in light of “the ongoing interest from
many parties and sectors, such as industry and Members of
Congress, in the regulatory status of premium cigars, ”
the purpose of the ANPRM is “to request relevant new
and different information, data, and analysis not submitted
in response to FDA's proposed deeming rule . . . that
could inform FDA's regulation of premium cigars.”
See Regulation of Premium Cigars, 83 Fed. Reg. 12,
901, 12, 902 (Mar. 26, 2018). Specifically, the FDA invited
submission of comments, data, research results, and other
information related to three topics: (1) the definition of
premium cigars; (2) usage patterns of premium cigars; and (3)
public health considerations associated with premium cigars.
Id. at 12, 903. The FDA also asked the public to
submit studies or information regarding the Deeming
Rule's current health warning statements, and requested
comment on “whether any additional or alternative
warning statements would be appropriate.” Id.
at 12, 904.
C.
Procedural Background
The
Cigar Association of America, the International Premium Cigar
and Pipe Retailers Association, and Cigar Rights of America
(collectively, “Plaintiffs”) filed suit in this
court, seeking declaratory, injunctive, and other relief from
the Deeming Rule and challenging the legality of the User Fee
Rule.
After
Defendants filed their Answer, Plaintiffs filed an initial
motion for summary judgment on February 13, 2017. Thereafter,
the newly installed FDA administration signaled an openness
to evaluating the agency's approach to aspects of the
Deeming Rule. The parties accordingly requested multiple
extensions of the briefing deadlines in order “to allow
new leadership personnel at [HHS] to more fully consider the
issues raised in [the] case and determine how best to
proceed.” Joint Mot. to Amend Scheduling Order (dated
May 1, 2017), ECF No. 34, at 1. The court granted the
requests, resulting in over four months of extensions. After
the FDA's July 2017 announcement of its new comprehensive
plan for the regulation of tobacco products, the parties
sought one final 30-day extension of the briefing schedule.
Joint Mot. to Amend Scheduling Order (dated Aug. 1, 2017),
ECF No. 40, at 2-3. The court also granted this motion.
Minute Order Aug. 7, 2017.
In a
Joint Status Report dated September 5, 2017, the parties
explained that, as a result of the FDA's announcement,
they had agreed to defer resolution of certain of
Plaintiffs' challenges to the Deeming Rule. Specifically,
the parties agreed that Plaintiffs' challenges relating
to the premarket review process, the FDA's decision to
deem premium cigars subject to regulation, and the
agency's cost-benefit analysis underlying the Deeming
Rule-claims asserted in Counts I, IV, and V of
Plaintiffs' Complaint-“should await the further
regulatory action that the FDA has announced it intends to
pursue, because those ...