Et Al.,: in The United States District Court For The District of Columbia

Case 1:16-cv-01460-APM Document 80 Filed 12/04/17 Page 1 of 31
IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA
CIGAR ASSOCIATION OF AMERICA,

et al.,
Plaintiffs,
v. Civil Action No. 16-1460 (APM)
UNITED STATES FOOD AND DRUG

ADMINISTRATION, et al.,
Defendants.
REPLY IN SUPPORT OF DEFENDANTS

CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT
TABLE OF CONTENTS
TABLE OF AUTHORITIES ......................................................................................................... iii
INTRODUCTION ...........................................................................................................................1
ARGUMENT ...................................................................................................................................1
I. THE DEEMING RULES HEALTH WARNING REQUIREMENTS ARE CONSISTENT WITH THE
FIRST AMENDMENT AND THE TCA .......................................................................................1
A. The Health Warnings Are Consistent with the First Amendment ...........................1
1. The Health Warnings Are Properly Analyzed under Zauderer ...................1
2. The Health Warnings Are Rationally Related to the Governments

Interest..........................................................................................................3
3. Even if Central Hudson Applies, the Health Warnings Withstand

Review .........................................................................................................9
B. The Requirement to Submit a Plan for Rotating the Health Warnings Does
Not Constitute a Prior Restraint .............................................................................14
C. The FDA Made the Requisite Statutory Findings Before Adopting the
Health Warning Requirements ...............................................................................16
II. THE FDAS ASSESSMENT OF USER FEES IS CONSISTENT WITH STATUTORY

AUTHORITY ........................................................................................................................17
III. THE FDA REASONABLY INTERPRETED THE TCA TO TREAT BLENDING TOBACCO AS
MANUFACTURING ...............................................................................................................20
IV. THE FDA PERMISSIBLY CONSIDERED PIPES TO BE COMPONENTS OR PARTS OF

TOBACCO PRODUCTS ..........................................................................................................22
CONCLUSION ..............................................................................................................................25
ii
TABLE OF AUTHORITIES
Federal Cases
American Beverage Institute v. City and County of San Francisco,

871 F.3d 884 (9th Cir. 2017) ...................................................................................................... 6
American Meat Institute v. U.S. Department of Agriculture,

760 F.3d 18 (D.C. Cir. 2014) (en banc) ......................................................................... 4, 5, 6, 9
Bad Frog Brewery v. N.Y. State Liquor Auth.,

134 F.3d 87 (2d Cir. 1998) ....................................................................................................... 13
Burgess v. United States,

553 U.S. 124 (2008) ................................................................................................................. 21
Business Roundtable v. SEC,

647 F.3d 1144 (D.C. Cir. 2005) ............................................................................................... 25
Capital Broad. Co. v. Acting Attorney Gen.,

405 U.S. 1000 (1972) ................................................................................................................. 7
Central Hudson Gas & Elec. Corp. v. Public Serv. Commn of N.Y.,
447 U.S. 557 (1980) .......................................................................................................... passim
Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.,

467 U. S. 837, 866 (1984) ...................................................................................... 20, 23, 24, 25
Discount Tobacco City & Lottery, Inc. v. United States,

674 F.3d 509 (6th Cir. 2012) .............................................................................................. 6, 7, 8
Fla. Bar v. Went For It, Inc.,

515 U.S. 618 (1995) ........................................................................................................... 11, 12
Hutchins v. Dist. of Columbia,

188 F.3d 531 (D.C. Cir. 1999) ................................................................................................. 11
Lorillard Tobacco Co. v. Reilly,

533 U.S. 525 (2001) ................................................................................................................... 4
Nicopure Labs LLC v. FDA,

--- F. Supp. 3d ---, No. 16-878, 2017 WL 3130312 (D.D.C. July 21, 2017) ..................... 23, 25
Nutritional Health Alliance v. Shalala,

144 F.3d 220 (2d Cir. 1998) ..................................................................................................... 15
iii
Pearson v. Shalala,
164 F.3d 650 (D.C. Cir. 1999) ................................................................................................... 3
Pharm. Research & Mfrs. of Am. v. FTC,

790 F.3d 198, 207 (D.C. Cir. 2015) ......................................................................................... 23
Posadas de P.R. Assocs. v. Tourism Co.,

478 U.S. 328 (1986) ................................................................................................................... 7
Public Citizen, Inc. v. La. Atty Disciplinary Bd.,

632 F.3d 212 (5th Cir. 2011) .................................................................................................... 10
Pursuing Am.s Greatness v. FEC,

831 F.3d 500 (D.C. Cir. 2016) ............................................................................................... 2, 3
R.J. Reynolds Tobacco Co. v. FDA,

696 F.3d 1205 (D.C. Cir. 2012) ....................................................................................... 4, 8, 11
Spirit Airlines, Inc. v. U.S. Dept of Transp.,

687 F.3d 403 (D.C. Cir. 2012) ................................................................................................... 3
United States v. Article of Drug Bacto-Unidisk,

394 U.S. 784 (1969) ................................................................................................................. 23
United States v. Gonzales,

520 U.S. 1 (1997) ..................................................................................................................... 23
United States v. Sperry Corp.,

493 U.S. 52 (1989) ................................................................................................................... 19
Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio,

471 U.S. 626 (1985). ......................................................................................................... passim
Federal Statutes and Regulations
5 U.S.C. 706 ......................................................................................................................... 11, 16

7 U.S.C. 518d ....................................................................................................................... 17, 18
15 U.S.C. 1333 ............................................................................................................................. 9
15 U.S.C. 1335 ............................................................................................................................. 7
21 C.F.R. 1143.5 ...................................................................................................................... 2, 7
21 U.S.C. 321(rr)(1) ................................................................................................................... 23
21 U.S.C. 387 ................................................................................................................. 19, 21, 22
21 U.S.C. 387e ........................................................................................................................... 21
21 U.S.C. 387f ........................................................................................................................... 13
21 U.S.C. 387g ........................................................................................................................... 23
21 U.S.C. 387s ............................................................................................................... 17, 18, 20
iv
26 U.S.C. 52 ............................................................................................................................... 18
26 U.S.C. 518d ........................................................................................................................... 18
26 U.S.C. 5702 ..................................................................................................................... 17, 18
79 Fed. Reg. at 23,146 .................................................................................................................. 16
79 Fed. Reg. at 23,166 .................................................................................................................... 3
81 Fed. Reg. at 28,711 ............................................................................................................ 19, 20
81 Fed. Reg. at 28,975 .................................................................................................................. 24
81 Fed. Reg. at 28,978 .................................................................................................................. 19
81 Fed. Reg. at 28,988 .................................................................................................................. 10
81 Fed. Reg. at 28,995 .................................................................................................................. 21
81 Fed. Reg. at 28,996 .................................................................................................................. 21
81 Fed. Reg. at 29,020 .................................................................................................................. 13
81 Fed. Reg. at 29,062 .................................................................................................................. 16
81 Fed. Reg. at 29,064 .................................................................................................................... 3
81 Fed. Reg. at 29,072 .................................................................................................................. 15
81 Fed. Reg. at 29,073 .................................................................................................................. 15
Pub. L. No. 111-31, 3................................................................................................................. 24
Legislative Materials
155 Cong. Rec. H4367 (Apr. 1, 2009) .......................................................................................... 20

155 Cong. Rec. H6626 (June 12, 2009) ........................................................................................ 20
155 Cong. Rec. S6010 (June 3, 2009) .......................................................................................... 20
Other Authorities
World Health Organizations Framework Convention on Tobacco Control ........................ 5, 8, 15
v
INTRODUCTION
The government has long required commercial disclosures related to consumer health and
safety. Those interests explain and justify disclosures that are now ubiquitous, from Drug
Facts labels on over-the-counter drugs, to Nutrition Facts labels on food, to country-of-origin
labels on meat. In this case, Plaintiffs neither dispute that their cigar and pipe tobacco products
pose significant risks to human health, nor deny that the warning labels at issue are entirely
accurate. Those disclosures are fully consistent with the First Amendment, regardless of the test
applied, as they are appropriately tailored in view of the significant risks at stake.
Plaintiffs other claims also miss the mark. The agencys assessment of user fees simply
tracks the plain text of the statute, and Plaintiffs offer no coherent alternative reading. Retailers
who blend pipe tobacco meet the statutory definition of a tobacco product manufacturer, despite
Plaintiffs attempt to conjure an alternative definition from an inapplicable section of the statute.
And given that pipes are undeniably fundamental to smoking pipe tobacco, they properly fall
within the regulatory definition of a component or part, which merits substantial deference
under Chevron. The Court should grant summary judgment to Defendants.
ARGUMENT
I. THE DEEMING RULES HEALTH WARNING REQUIREMENTS ARE CONSISTENT WITH

THE FIRST AMENDMENT AND THE TCA
A. The Health Warnings Are Consistent with the First Amendment
1. The Health Warnings Are Properly Analyzed under Zauderer
Plaintiffs do not dispute that cigars and pipe tobacco present significant health risks. Nor
do they deny that the health warnings advising consumers of those risks are entirely accurate.
Such disclosures are routinely analyzed under Zauderer, not Central Hudson, and Plaintiffs
identify no case to the contrary.
1
Although the D.C. Circuit has noted that there may be a point at which the compulsion
to speak becomes more like a speech restriction than a disclosure, Pursuing Am.s Greatness v.
FEC, 831 F.3d 500, 507 n.3 (D.C. Cir. 2016), this case comes nowhere close to that undefined
line. Here, as in Zauderer itself, the disclosures ban no speech: they do not prevent [Plaintiffs]
from conveying information to the public, but only require[ them] to provide somewhat more
information than they might otherwise be inclined to present. Id. at 507.
Plaintiffs claim that the warnings clearly make[] the government the predominant
speaker on cigar packages and advertising. Pls. Reply 4. But the warnings cover only 30% of
two panels of cigar boxes and 20% of advertisements, leaving the remaining 70% of those
panels, the rest of cigar boxes, and 80% of advertising free for manufacturers to convey any
message they wish. Plaintiffs nevertheless complain that the format of the warningsblack text
on a white background, or white text on a black background, in at least 12-point font, 21 C.F.R.
1143.5(a)(2)will somehow overtake their message. Pls. Reply 5. But if the warnings
were instead seamlessly integrated into the packages color and design scheme, as Plaintiffs
prefer, id., they would effectively be camouflaged. Although Plaintiffs colorfully suggest that
tobacco stores will become a menagerie of government speech where warnings are
unnecessarily repeated, it is hardly an assault on customers senses to place a warning at each
cash register in large retail stores with multiple checkout aisles, only one of which a
consumer would pass through. Pls. Br. 6 (emphasis in original). And while the warnings would
appear on each product on a display shelf, that is little different from Drug Facts labels
required on drugs sold over the counter, or Nutrition Facts labels required on food. To be sure,
those disclosures do not necessarily appear on the front of product packagingbut unlike cigars
2
and pipe tobacco, most over-the-counter drug and food products are not addictive and do not
pose significant health risks when consumed as intended.
Regardless, Plaintiffs fail to explain how the health warnings prevent them from
communicating anything at all. They vaguely refer to manufacturers and retailers carefully
sculpted message to their prospective customers, id. at 6, and the subtle hues and intricate
designs on a cigar box, id. at 7. But as for how the warnings actually prevent [Plaintiffs] from
conveying information to the public, Pursuing Am.s Greatness, 831 F.3d at 507, they are
silent. The warnings ban no speech, and they are properly analyzed as disclosures under
Zauderer.
2. The Health Warnings Are Rationally Related to the Governments

Interest
The health warnings are readily sustained under Zauderer, as they are reasonably related
to the governments asserted interests: to help consumers better understand and appreciate the
risks and characteristics of tobacco products and to help correct misperceptions about the newly
deemed products. 81 Fed. Reg. at 29,064; 79 Fed. Reg. at 23,166. There is ample evidence that
consumers misapprehend the grave health risks of cigars and pipe tobacco. And the record
overwhelmingly shows that more prominent warnings are more likely to be seen and
remembered by consumers.
a. Plaintiffs do not dispute that, in general, the governments interest in ensuring the
accuracy of consumer information in the marketplace is sufficient under Zauderer; indeed, such
an interest is substantial. Spirit Airlines, Inc. v. U.S. Dept of Transp., 687 F.3d 403, 415 (D.C.
Cir. 2012); see also Pearson v. Shalala, 164 F.3d 650, 656 (D.C. Cir. 1999) (the government
has a substantial interest in promoting the health, safety, and welfare of its citizens); Defs. Br.
23 & n.15. They claim, instead, that tobacco products are so unique among consumer products
3
that only an interest in the reduction of underage use will suffice. Pls. Reply 8. That is
mistaken, and the cases they cite cannot bear the weight Plaintiffs place on them. In Lorillard
Tobacco Co. v. Reilly, 533 U.S. 525 (2001), for example, the Court considered a Massachusetts
law prohibiting the outdoor advertising of cigars within 1,000 feet of schools or playgrounds,
which effectively barred advertising in 87 to 91% of the entire city of Boston. Id. at 536, 562.
While Plaintiffs emphasize that the Court focused on whether the advertising ban was
sufficiently related to the States substantial, and even compelling interest in preventing
underage tobacco use, id. at 564 (quoted in Pls. Reply 8), that is unsurprising, as it was the only
interest advanced by the State to defend the law, id. at 53334, 564. Likewise, in R.J. Reynolds
Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012), the court found that the only explicitly
asserted interest in either the Proposed or Final Rule is an interest in reducing smoking rates, id.
at 1218, and thus would not accept the governments attempt to reformulate its interest as
purely informational, id. at 1221. But neither Lorillard nor R.J. Reynolds states, or even
suggests, that only an interest in reducing smoking rates (underage or otherwise) could qualify
as substantial.
Plaintiffs contention to the contrary is further undermined by the D.C. Circuits en banc
decision in American Meat Institute v. U.S. Department of Agriculture, 760 F.3d 18 (D.C. Cir.
2014) (en banc). While Plaintiffs argue that American Meat overruled only a small and precise
kernel of R.J. Reynolds, Pls. Reply 9, there can be little doubt that the court embraced the
position that the disclosure of health or other information about consumer products qualifies as a
sufficient interest under Zauderer, with no requirement that the disclosure actually change
consumer behavior. As the D.C. Circuit explained, although under Central Hudson . . . [the
Supreme Court] has commonly required evidence of a measures effectiveness, . . . as the Court
4
recognized in Zauderer, such evidentiary parsing is hardly necessary where the government uses
a disclosure mandate to achieve a goal of informing consumers about a particular product trait,
assuming of course that the reason for informing consumers qualifies as an adequate interest.
Id. at 26. Indeed, in dissent, Judge Brownthe author of R.J. Reynoldsremarked on the
breadth of this holding, which she understood to mean that Zauderer . . . encompass[es]
factual and noncontroversial disclosure mandates aimed at providing more information to some
consumers, and that a reasonably crafted disclosure mandate . . . advances [the governments]
interest in making the purely factual and uncontroversial information accessible to recipients.
Id. at 37 (Brown, J., dissenting). If that is true in the context of meat labeling, it is difficult to see
how it could not be true for tobacco products, given their inherent addictiveness and adverse
health effects. The governments interest here is at least as weighty as the interest in American
Meat, and it is more than sufficient.
b. The health warnings are reasonably related to that interest. As noted, this test requires
no evidentiary parsing of a measures effectiveness. American Meat, 760 F.3d at 26.
Rather, under Zauderer, the means-end fit is self-evidently satisfied by a reasonably crafted
mandate to disclose purely factual and uncontroversial information about attributes of the
product or service being offered, absent a showing that the disclosure is unduly
burdensome. Id. Here, there is no dispute that the health warnings are entirely factual and
accurate, and they are eminently reasonable: indeed, at 30%, they are on the most conservative
end of the international consensus embodied in the World Health Organizations Framework
Convention on Tobacco Control, signed by the United States and ratified by 180 countries,
which calls for rotating warnings that should be 50% or more of the principal display areas but
shall be no less than 30% of the principal display areas. WHO Framework Convention on
5
Tobacco Control, art. 11.1(b) (2003), available at http://www.who.int/fctc/en; see Defs. Br. 19
20.
Plaintiffs are mistaken that the size of the health warnings renders them unduly
burdensomea contention that this Court should follow the Sixth Circuit in rejecting. See
Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012), cert.
denied sub nom. Am. Snuff Co. v. United States, 569 U.S. 946 (2013). Plaintiffs principally
argue that circuit decisions demonstrate that the warnings are too big to survive Zauderer, but
they focus on just one: the Ninth Circuits decision in American Beverage Institute v. City and
County of San Francisco, 871 F.3d 884 (9th Cir.), petition for rehg & rehg en banc filed, Nos.
16-16072, 16-16073 (9th Cir. Oct. 17, 2017). Although they acknowledge that the court there
found that the required disclosures (concerning the health effects of sugar-sweetened drinks) ran
afoul of Zauderer because they were not purely factual and uncontroversial, Pls. Reply 22
(citation omitted), they argue that the disclosures independently failed Zauderer for the simple
reason that they were too large, id. at 21. But the Ninth Circuits reasoning is not so easily
disentangled. Size alone does not render a disclosure impermissible; rather, to violate Zauderer,
it must be unduly burdensome in a way that chill[s] protected speech. American Meat, 760
F.3d at 26. And in American Beverage, it was the disclosures size plus its deceptive nature,
Am. Beverage, 871 F.3d at 895, that unduly burdened the plaintiffs speech, because the
manufacturers need to counter[] San Franciscos misleading message would leave them little
room to communicate their intended message, turning advertisements into little more than a
vehicle for debate, id. at 897 (emphasis added). In any event, as the Ninth Circuit recognized,
tobacco products are distinguishable from sugar-sweetened drinks given their physiologically
addictive qualities, id. at 897 n.11.
6
Plaintiffs assert that the FDA has ignor[ed] the Rules effect on retailers, citing the
supposed burdens of . . . duplicative and overlapping warning[s]. Pls. Reply 2324. But most
of the requirements that they emphasize fall not on retailers, but on manufacturers. It is
manufacturers who must include warnings on the product box and any branded picture[s] or
fixture[s] displayed in the store. Id. at 23. Retailers, on the other hand, need only display
warnings beside the register if they sell individual, unpackaged cigars, 21 C.F.R. 1143.5(a)(3),
and on advertisements that they themselves create, so long as any manufacturer advertisements
they post contain proper warnings, id. 1143.5(b)(2)(3). As for radio spots, the Supreme Court
sustained a complete ban for cigarettes in 1972, Capital Broad. Co. v. Acting Attorney Gen., 405
U.S. 1000 (1972), summarily affg, 333 F. Supp. 582 (1971) (three-judge court), which Congress
extended to little cigars the following year, 15 U.S.C. 1335, and the less intrusive restriction
here is little different from the disclosures routinely required on television advertisements for
drugs. Cf. Posadas de P.R. Assocs. v. Tourism Co., 478 U.S. 328, 346 & n.10 (1986) (collecting
laws regulating advertising of alcohol, tobacco, and gambling).
Discount Tobacco rejected a similar First Amendment claim in the context of tobacco
products, and it points the way here. There, the Sixth Circuit considered a provision of the TCA
requiring manufacturers to reserve a significant portion of their packagingthe top 50% of the
front and back of cigarette packaging, 30% of the front and back of smokeless tobacco
packaging, and 20% of tobacco advertisingfor health warnings. 674 F.3d at 524. Congress
required the warnings to include both text (such as WARNING: Cigarettes are addictive) and
color graphics; it prescribed the text and directed the FDA to choose the graphics through
rulemaking. Id. at 524, 526 & n.3. Weighing a facial challenge filed before the graphics had
been selected, the Sixth Circuit applied Zauderer to reject a First Amendment challenge to both
7
the textual and graphic aspects of the warnings. With respect to the size of the textual warnings,
in particular, the court concluded that the [p]laintiffs . . . argument that the warnings are unduly
burdensome because their size drowns out their speech is unpersuasive. Id. at 567 (op. of
Stranch, J.). Relying principally on the WHO Framework Convention, it found that [a]mple
evidence supports the size requirement for the new warnings, and reasoned that the [p]laintiffs
have not shown that the remaining portions of their packages are insufficient for them to market
their products. Id.; see also id. at 53031 (op. of Clay, J.) (noting that Congress itself found[]
that larger warnings materially affect consumers awareness of the health consequences of
smoking and decisions regarding tobacco use, and concluding that the [p]laintiffs have not
shown that the remaining portions of their packaging are insufficient for them to place their
brand names, logos, or other information).
Try as they might, Plaintiffs cannot persuasively distinguish Discount Tobacco. They
note that in R.J. Reynolds the D.C. Circuit later set aside the specific graphic warnings that the
FDA promulgated for cigarettes in 2011. Pls. Reply 25. But the D.C. Circuit did so under
Central Hudson, finding the cigarette graphic warnings at issue there were not . . . purely
factual and uncontroversial and thus not eligible for review under Zauderer; the court cast no
such doubt, however, on the text or size of the cigarette warnings (which were, of course, even
larger than the cigar warnings here). R.J. Reynolds, 696 F.3d at 1216. Those graphics are not at
issue in this case. Plaintiffs think it crucial that Discount Tobacco was a facial challenge,
where it was not clear that warnings in glaring black-and-white text would disrupt the
subtle detailing and hues of their packaging. Pls. Reply at 25. But it is difficult to imagine
how the FDA could have settled on a more neutral scheme than black-on-white (or white-on-
black) text in sans-serif font. 21 C.F.R. 1143.5(a)(2)(ii)(iii). Plaintiffs argue that Discount
8
Tobacco was principally concerned with cigarettes, which they say have a better-documented
history of deception. Pls. Reply 2526. But that is irrelevant; it is settled that Zauderer . . .
reach[es] beyond problems of deception, sufficiently to encompass the disclosure mandates at
issue here. American Meat, 760 F.3d at 20. Finally, Plaintiffs claim that Discount Tobacco
concerned disclosures by manufacturers, but not retailers. Pls. Reply at 26. But that is
incorrect; the warnings in Discount Tobacco were also required to cover 20% of tobacco
advertising, 674 F.3d at 524, and were challenged by both manufacturers and retailers, id. at
554, because the requirements applied equally to retailers, 15 U.S.C. 1333(b)(1), (c)(4).
Discount Tobacco is materially indistinguishable, and this Court should likewise sustain the
health warnings under Zauderer.
3. Even if Central Hudson Applies, the Health Warnings Withstand

Review
Even if the Court were to agree with Plaintiffs that the disclosures at issue cross some
undefined line beyond which they must be considered restrictions on speech, they would survive
review under Central Hudson. The health warnings directly and materially advance the
governments interest in helping consumers understand the health consequences of using cigars
and pipe tobacco, and in helping correct misperceptions about the risks of those products.
Plaintiffs arguments to the contrary are wrong at each turn.
a. The FDA found abundant evidence of an unsubstantiated perception, especially
among young people, that cigars are less hazardous than cigarettes. 81 Fed. Reg. at 29070.
Plaintiffs do not dispute this, at least until the FTC consent decrees were signed in 2000. See
Pls. Reply 12. They contend, however, that the FDA has not shown that consumers today do
not understand the health risks of smoking cigars or pipe tobacco, asserting that some of the
studies the agency pointed to are stale. Id. (emphasis added). But comments received on the
9
proposed deeming rule itself, in 2014, demonstrate that these misperceptions have persisted. For
example, some commenters questioned the accuracy of the addictiveness warning as applied to
cigars, contending that cigar users do not always inhale. 81 Fed. Reg. at 28,988 (comment 11).
In fact, most cigar users inhale some smoke even if they do not intend to; regardless, because
cigar smoke dissolves in saliva, sufficient nicotine to create dependence is absorbed through
the oral mucosa. Id.; see also id. at 29,069 (comment 264) (explaining that the same is true for
large or premium cigars). Moreover, contrary to Plaintiffs claims, the record contains a
number of more recent studies showing that such misperceptions remain.1 There is no reason not
to credit this evidence under Central Hudson, see, e.g., Public Citizen, Inc. v. La. Atty
Disciplinary Bd., 632 F.3d 212, 224 (5th Cir. 2011) (defendant satisfied Central Hudson with
two . . . surveys and three focus groups), and, notably, Plaintiffs cite no evidence pointing in
the other direction.
b. Plaintiffs next argue that the record lacks sufficient evidence to show that the health
warnings would help close th[is] gap in perception. Pls. Reply 12. They do not deny that, in
1
For instance, a 2013 study, based on 2010 survey data, found that smokers of little cigars and
cigarillos were more likely to report perceiving the harm of little cigars, cigarillos, and cigars to
be less than that of cigarettes when compared to nonusers. 81 Fed. Reg. at 29,070 (citing
Sterling et al. (2013) (AR 26,039)). A 2005 study, based on survey data from the spring and fall
of 2001, found that 34.9% of high school cigar users thought cigars are not as bad for you as
cigarettes, compared to 9.1% of never-users. Soldz & Dorsey (2005) at 555 (AR 26,054). A
2006 study, based on 2004 survey data, found that 16.9% of college freshmen incorrectly
perceived [cigars] to be less harmful than regular cigarettes. Smith et al. (2006) at 979 (AR
7109). A 2004 study, based on interview data from the spring and summer of 2001, found that
the product of choice among youth ages 1115 in two Florida counties was a cigarillo . . . that
contains between five and twelve times the nicotine of cigarettes, which users tend not to
recognize . . . as tobacco and believe t[o] contain no nicotine. Page & Evans (2003) at 64 (cited
in Cullen et al. (2011) at 1955 n.15 (AR 7708) and Pls. Reply 12 n.4, and attached hereto for
reference). And a 2008 study based on 2005 focus group data found that the belief that little
cigars are not as addictive as cigarettes was widespread, and that some participants believed
little cigars were less harmful than cigarettes. Jolly (2008) at 4 (AR 7719).
10
general, [u]sers are more likely to recall warnings that are in a larger size and that appear on the
front/major surfaces of the tobacco product package, as the FDA found. 81 Fed. Reg. at
29,989; see Defs. Br. 1920 (citing supporting studies). However, they fault the agency for
extrapolating from its experience with other [tobacco] products, such as cigarettes, and for not
attempting to quantify the size of the expected benefits. Id. at 13. Their demand for such
evidence directly from cigar and pipe tobacco studies is misguided, particularly in the context of
intermediate scrutiny under Central Hudson. As the Supreme Court has explained, the
government may justify speech restrictions by reference to studies and anecdotes pertaining to
different locales altogether, or even, in a case applying strict scrutiny, . . . based solely on
history, consensus, and simply common sense. Fla. Bar v. Went For It, Inc., 515 U.S. 618,
62829 (1995); see also Hutchins v. Dist. of Columbia, 188 F.3d 531, 544 (D.C. Cir. 1999)
(under intermediate First Amendment scrutiny, a city may rely on evidence from other cities that
is reasonably believed to be relevant to the problem). Thus, there is no warrant to ignore, for
example, the studies of cigarette warning labels finding no reason to doubt that the principles
identified in this work could be applied to other tobacco products, such as cigars and pipe
tobacco. Centre for Behavioral Research in Cancer (1992) at 6 (AR 18848).
On this score, Plaintiffs mistakenly assert that this Court should rely on the three extra-
record declarations of their supposed expert. Pls. Reply at 15 & n.7. But as explained in R.J.
Reynolds, even though this case raises constitutional claims, [b]ecause [it] involves a challenge
to final agency action, the Administrative Procedure Act governs our review of the record. See 5
U.S.C. 706(2)(B) (providing that the APA applies to allegations that the agency action is
contrary to constitutional right, power, privilege, or immunity). R.J. Reynolds, 696 F.3d at
121718 (emphasis added). If Plaintiffs believed there was insufficient recent evidence to
11
support the rule at the time it was proposed, they should have submitted their experts views
during the public comment process.
c. Plaintiffs also miss the mark in arguing that the warning labels are not narrowly
tailored. They begin with the curious assertion that the question whether the least restrictive
means test . . . applies to commercial speech is the subject of substantial debate. Pls. Reply
15. But the Supreme Court has unambiguously explained that the least restrictive means test
has no role in the commercial speech context, Fla. Bar, 515 U.S. at 632, and Plaintiffs cite no
case to the contrary. Thus, all that is required is a fit that is not necessarily perfect, but
reasonable. Id. (citations omitted). The health warnings meet that test.
Plaintiffs characterize the existing FTC warnings as an obvious less restrictive
alternative, and spill much ink criticizing the FDA for not conducting a serious analysis of
whether they were adequate. Pls. Reply 1617. But, as explained, misconceptions about the
health risks of cigars have persisted despite those warnings, see supra at 910 & n.1, and nothing
in Central Hudson requires the government to settle for a means that has been unable to achieve
the desired objective, Fla. Bar, 515 U.S. at 632. Also, the FTC warnings are required only on
cigars made by the seven largest U.S. manufacturers, which in 2000 represented about 95% of
the market, a percentage that has decreased significantly since. See PRIA 4445 (AR 10,635
36) (estimating that 56% of machine-made cigar UPCs and 18% of hand-rolled cigar UPCs carry
FTC warnings); see also FRIA 109 & n.68 (AR 24,020) (estimating that, overall, 20% of cigar
UPCs bear FTC warnings, a figure that is lower than the proportion of cigar units actually sold
with warnings, because cigars made by smaller manufacturers not covered by the FTC consent
decrees tend to have lower sales volume). And pipe tobacco, of course, is not covered by the
FTC warning regime at all.
12
The other less restrictive alternatives that Plaintiffs suggestraising the minimum legal
age to buy tobacco products, strengthening penalties for the sale of tobacco to minors, and
addressing social factors underlying underage tobacco use, Pls. Reply 17fare no better.
These suggestions rest on the faulty assumption that the rules purpose is to reduce underage
tobacco use, id., rather than to help inform consumers and correct misperceptionsa goal that
extends equally to adults, and which these suggestions do nothing to advance in any event. Even
if the agency had the authority to take these measures, but see, e.g., 21 U.S.C. 387f(d)(3)
(barring FDA from raising the minimum age of sale), Central Hudson does not require that the
Government make progress on every front before it can make progress on any front. Bad Frog
Brewery v. N.Y. State Liquor Auth., 134 F.3d 87, 100 (2d Cir. 1998) (cited in Pls. Reply 17).
Plaintiffs next assert that premium cigars are distinct from other cigars because they
are not flavored, not as attractive to youth, and thus particularly undeserving of health warnings.
Pls. Reply 18. But, again, Plaintiffs ignore the governments interest: to help inform consumers
(including adults) and correct misperceptions about health risks. Because premium cigars are
often made by smaller manufacturers, they are unlikely to bear FTC warnings, yet Plaintiffs cite
no evidence that they are safer than other cigars. And contrary to Plaintiffs assertion, the FDA
expressly declined to create a carve-out for premium cigars, finding insufficient evidence at that
time to support the notion that they present different health risks. 81 Fed. Reg. at 29,020.
Indeed, because the bulk of the established data on the health effects of cigar smoking is based
on smokers of traditional, large cigars, that data is applicable to the toxicity of premium cigars,
given that they share the same characteristics and are generally smoked in similar ways. Id.
While the agency has announced that it will take another look at that issue going forward, at the
time of the deeming rule, it reasonably concluded that there are no data indicating that premium
13
cigar users are not susceptible to [the] health risks common to all cigars, id.risks that
Plaintiffs do not dispute.
B. The Requirement to Submit a Plan for Rotating the Health Warnings Does
Not Constitute a Prior Restraint
Equally mistaken is Plaintiffs claim that the requirement to submit a proposed plan for
rotating the required warnings 12 months before marketing a cigar product constitutes a prior
restraint. That claim was not raised in the complaint, and it is not ripe for review. Regardless,
even assuming the prior restraint doctrine applies, the estimated 12-month period for FDA
review of rotation plans is reasonable in view of the governments interest in helping inform
consumers and correct misperceptions about the health risks of cigar usea goal that rotating
warnings substantially furthers.
Plaintiffs offer virtually no answer to the argument that they waived this claim by not
raising it in the complaint. See Defs. Br. 3233. Their single-sentence response, buried in a
footnote, is that the Complaint challenges the Rules warnings scheme as a whole, not just the
actual warnings themselves, and plainly asserts claims under the First Amendment. Pls. Reply
29 n.10. That is not enough. The complaint challenged the size of the warnings, but said
nothing at all about their rotation, much less about a prior restraintone of several distinct
species of First Amendment claims. Plaintiffs complaint failed to fairly put Defendants on
notice of this claim, and it was absent from their first summary judgment brief. ECF No. 22.
Their attempt to raise it now should be rejected.
Moreover, the claim is not ripe, as any hardship to Plaintiffs is entirely speculative.
Defs. Br. 3334. Plaintiffs hypothesize that the FDA may be unable to complete its review of
proposed rotation plans before the August 2018 compliance deadline. But they offer no evidence
to back up that prediction, and in the event of a backlog, the agency would consider a
14
compliance policy to ensure that cigar entities are not delayed from marketing their products.
81 Fed. Reg. at 29,073.
In any event, even assuming the prior restraint doctrine applies to commercial speecha
point that is by no means clear, Defs. Br. 3435it need only survive intermediate scrutiny
under Central Hudson, see Pls. Reply 27. The rotation plan requirement does so. Plaintiffs
argument that the warning plan process has nothing to do with the governments interest in
better informing consumers is mistaken. Id. at 2728. In fact, rotation ensure[s] that the
different health warning messages are reaching as many individuals as possible, 81 Fed. Reg. at
29,072, and the importance of this feature is widely recognized: the WHO Framework
Convention calls for rotating warnings; the Comprehensive Smokeless Tobacco Health
Education Act requires the rotation of warnings for smokeless tobacco products; and rotation
of warning statements already occurs under the FTC consent decrees. Id. at 29,073.
Contrary to Plaintiffs suggestion, the rotation plan requirement is also narrowly tailored.
Plaintiffs propose that the agency conduct after-the-fact surveillance of cigar products to monitor
compliance with the rotation requirement. But the reason for requiring approval is not to make
things cheaper or easier for the agency, as Plaintiffs intimate, Pls. Reply 28, but to pave the
way for manufacturers unfamiliar with rotation requirements to promptly comply, and to build in
time to correct deficiencies before manufacturing and distribution begin and costs are sunk. See
81 Fed. Reg. at 29,072. In view of these concerns, the 12-month review period estimated here is
not more extensive than necessary. Central Hudson, 447 U.S. at 566; see also Nutritional
Health Alliance v. Shalala, 144 F.3d 220, 228 (2d Cir. 1998) (rejecting prior restraint challenge
to 540-day period for FDA premarket review of labeling claims).
15
C. The FDA Made the Requisite Statutory Findings Before Adopting the Health
Warning Requirements
Before adopting the health warning requirements, the FDA made the findings required by
statute, as Defendants opening brief explained. Defs. Br. 3739. Plaintiffs offer no sound
reason to conclude otherwise. First, they argue that the FDA could not permissibly make the
requisite findings in the proposed rule, but cite no authority for the proposition. Pls. Reply 30.
Regardless, they acknowledge that the final rule referred back to the Proposed Rule, id. at 30
n.11 (citing 81 Fed. Reg. at 29,062), and, in any event, they point to no intervening evidence that
they claim should have changed the agencys mind. Thus, even if this were error, it was
harmless. See 5 U.S.C. 706 (due account shall be taken of the rule of prejudicial error).
Second, Plaintiffs suggest that the FDAs findings were insufficiently specific. Pls. Br. 30. But
the agency based its conclusion on a number of factors, including the addictiveness of nicotine,
the well-established adverse health effects of cigars and pipe tobacco, consumer confusion and
misinformation, and the likelihood of cessation or uptake. See 79 Fed. Reg. at 23,146. While
Plaintiffs may disagree with the agencys conclusions, they do not contend that it ignored a
statutory factor. Third, Plaintiffs recycle an out-of-context quote from the FDAs regulatory
impact analysis, which they imply shows that there is no evidence that warning labels on cigar or
pipe tobacco are effective, Pls. Reply 31, but which in fact refers to the unremarkable point that
because the warnings are new to these products, their benefits cannot be precisely quantified, as
Defendants have already explained at length, Defs. Br. 39. Fourth, Plaintiffs erroneously argue
that Defendants have failed to contest[] various issues: Plaintiffs cost-benefit analysis claim
has been held in abeyance at their request, ECF No. 51, 5; ECF No. 68 at 4 n.3; the FTC
warnings are addressed supra at 910 & n.1, 12; and premium cigars are addressed supra at 13
14.
16
II. THE FDAS ASSESSMENT OF USER FEES IS CONSISTENT WITH STATUTORY AUTHORITY
Plaintiffs concede that, by operation of statute, cigars and pipe tobacco must be assessed
user fees. Their claim that the FDA arbitrarily declined to assess user fees on other newly
deemed products, such as e-cigarettes, cannot be squared with the statutory text, and finds no
support in its structure or purpose.
The statutory text is plain, as fully set forth in Defendants opening brief. Defs. Br. 41
44. In short, Congress instructed the FDA to assess user fees on, and collect such fees from,
each manufacturer and importer of tobacco products subject to Chapter IX in accordance with
the requirements of Section 919. 21 U.S.C. 387s(a). Section 919 sets forth the total amount of
user fees to be collected each year, id. 387s(b)(1), and provides that the total shall be
allocated among six classes of tobacco productscigarettes, cigars, snuff, chewing tobacco, pipe
tobacco, and roll-your-own tobaccoby the percentage determined under section 625(c) of [the
Fair and Equitable Tobacco Reform Act (FETRA)] for each such class of product, id.
387s(b)(2)(B). And that section of FETRA, in turn, lists percentage allocations for the same
six classes of tobacco products, which total 100%. 7 U.S.C. 518d(c)(1). Moreover, Section
919 further provides that allocations among manufacturers and importers within each class shall
be the percentage determined for purposes of allocations under subsections (e) through (h) of
Section 625 of FETRA. 21 U.S.C. 387s(b)(4). FETRA, in turn, provides that this allocation is
based on their share of gross domestic volume, defined as the volume of tobacco products
removed and not exempt from excise taxes under the Internal Revenue Code (IRC). 7
U.S.C. 518d(a)(2), (e). The IRC, in turn, limits its definition of removal to the same six
classes of tobacco products. 26 U.S.C. 5702(c), (j).
17
Plaintiffs focus on a single word in this interlocking statutory scheme, noting that Section
919 refers to assessing user fees on each manufacturer and importer of tobacco products
subject to Chapter IX. Pls. Reply 34 (quoting 21 U.S.C. 387s(a)). But reading that word in
isolation ignores Congresss instructionin the same sentenceto assess user fees in
accordance with the rest of Section 919, 21 U.S.C. 387s(a), and would effectively nullify the
remainder of that section and the provisions of FETRA and the IRC that it incorporates.
Plaintiffs make no serious effort to explain how user fees could be assessed on e-
cigarettes (or, for that matter, other newly deemed products) in accordance with the statutory
text. To begin, assessing user fees on an additional class of products would depart from the
percentage allocations set forth in FETRA for the six listed classes. 7 U.S.C. 518d(c)(1). Even
if that were possible, FETRA provides no standard to measure the share of gross domestic
volume of other classes of products. For one thing, that term is defined as the volume of
tobacco products removed and not exempt from federal excise taxes, 26 U.S.C. 518d(a)(2),
but products outside the six listed classes cannot be removed and are not currently subject to
such taxes, see 26 U.S.C. 52, 5702(c), (j). For another, while FETRA sets forth parameters to
measure volumefor example, cigarettes are counted in sticks, snuff in poundsthose
parameters are limited to the six listed classes. 7 U.S.C. 518d(g)(3). Thus, Plaintiffs proposal
that the agency adopt a metric by which 20 cigarettes = 1 e-cigarette = 1 standard container of
moist snuff = 4 large cigarsa suggestion in fact made by a commenter, not the agency, cf.
Pls. Reply 3637 (quoting 81 Fed. Reg. at 28,712)not only lacks any grounding in the
statutory text, but in fact directly contradicts it.2
2
Similarly, while Plaintiffs deny that their reading would require [the] imposition of user fees
on repackers and relabelers, Pls. Reply 36, they fail to explain why not: if the FDA used the
18
Plaintiffs fallback arguments concerning the statutes structure and purpose are
misplaced, and in any event cannot overcome its plain text. They suggest, for example, that a
user fee is generally imposed in exchange for a service and is not meant to benefit others.
Pls. Br. 34 (emphasis omitted). But the [Supreme] Court has never held that the amount of a
user fee must be precisely calibrated to the use that a party makes of Government services.
United States v. Sperry Corp., 493 U.S. 52, 6061 (1989). On the contrary, it has recognized
that when the Federal Government applies user charges to a large number of parties, it probably
will charge a user more or less than it would under a perfect user-fee system. Id. Thus, while
Plaintiffs correctly note that, under the statute, tobacco products that are not subject to
regulation do not have to pay user fees, Pls. Reply 34 (citing 21 U.S.C. 387s(b)(2)(B)(iii)),
it does not follow that the statute requiresor even permitsthe FDA to charge a user fee for
every product it deem[s] . . . subject to regulation, as Plaintiffs erroneously contend, id.
Plaintiffs think it anomalous that e-cigarettes should not share in the responsib[ility]
for paying for th[e] regulation, a possibility they say the legislative history suggests
Congress had not even considered. Pls. Reply 36. Indeed, they argue that the allocation
formula included all classes of tobacco products that were in existence at the time of enactment,
so there is no basis to argue that Congress somehow foresaw and intended to exclude . . .
classes of tobacco products that [the] FDA might later deem. Id. at 35. But e-cigarettes were
available in the United States by early 2007, 81 Fed. Reg. at 28,978, and Congress was well
definition of tobacco product manufacturer from 21 U.S.C. 387(20), as Plaintiffs suggest, it

would have to include repackers and relabelers, which are not accounted for in FETRA because
they do not remove products under the IRC, 81 Fed. Reg. at 28,711. And Plaintiffs offer no
response whatsoever to the various other absurdities generated by their reading of the statute.
See Defs. Br. 44.
19
aware of them when it passed the TCA in 2009, see, e.g., 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 its a nicotine delivery device.).3
Nevertheless, it declined to include them in the statutory allocation formula. Equally mistaken is
Plaintiffs suggestion that, on the FDAs reading, the regulatory scheme is no longer self-
funding. Pls. Reply 36. In fact, the the total amount of user fees authorized for each fiscal
year, 21 U.S.C. 387s(b)(1), is assessed regardless of how they are allocated, id. 387(b)(2).
Even if the agencys interpretation were not compelled by the statutory text, it is at least a
reasonable one that warrants deference under Chevron. See 81 Fed. Reg. at 28,71112 (setting
forth reasons why, even if the statute were ambiguous, the FDA would adopt the same
interpretation of the statute in an exercise of its discretion). Plaintiffs suggestion to the
contrary is meritless.
III. THE FDA REASONABLY INTERPRETED THE TCA TO TREAT TOBACCO BLENDERS AS
MANUFACTURERS
Plaintiffs do not dispute that the FDA properly deemed pipe tobacco subject to Chapter
IX of the FDCA. Nor do they deny that retailers who blend pipe tobacco meet the statutory
definition of a tobacco product manufacturer. Their claim, rather, is that a provision of Section
905, which concerns who must register with the FDA and submit a list of products, should be
read to exclude retailers, and that that reading should apply not just to Section 905 but to the
entirety of Chapter IX. They are wrong on both counts.
3
See also 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-heated cigarette.); 155
Cong. Rec. H4367 (Apr. 1, 2009) (statement of Rep. Buyer) ([T]he[re] are now . . . dissolvable
tobacco products. . . . These are orbs or strips that you can lay on your tongue or a stick thats a
little like an oversized toothpick that you can stick in your mouth.).
20
To begin, Plaintiffs premisethat Section 905 carves out retailers from its scope, Pls.
Reply 18is mistaken. See Defs. Br. 4950. Section 905 provides that the term manufacture,
preparation, compounding, or processing shall include certain activities in furtherance of the
distribution of the product from the place of manufacture to the person who makes final
delivery or sale. 21 U.S.C. 387e(a)(1). The word include is a term of expansion, not
exclusion. See, e.g., Burgess v. United States, 553 U.S. 124, 131 n.3 (2008). Here, the term
clarifies that certain distributors are covered by Section 905, but it does nothing to limit the
meaning of manufacture, much less exclude retailers. The term retailer is separately defined
for purposes of Chapter IX. Id. 387(14). If Congress had meant to exclude retailers for
purposes of Section 905, it surely would have said so. Regardless, even if Plaintiffs reading of
Section 905 were correct, there would be no basis to apply it to the rest of Chapter IX. The
provision of Section 905 on which Plaintiffs rely applies only in this section, id. 387e(a),
while the definition of tobacco product manufacturer applies more generally in this chapter,
id. 387that is, all of Chapter IX.
Plaintiffs argue that there is little need for regulatory oversight of retailers who blend pipe
tobacco because, they presume, blenders would use FDA-authorized tobacco products. Pls. Br.
39. But that presumption may not be correct, and under Plaintiffs reading of the statute, there
would be no way for the FDA to know what, exactly, was in these blends. Regardless,
blending may alter the chemical or perception properties of the new product (e.g., nicotine
level, pH, smoothness, harshness, etc.), 81 Fed. Reg. at 28,996, and may also raise levels of
HPHCs [harmful or potentially harmful constituents] in the product, id. at 28,995. Treating
blenders as manufacturers closes what would be a loophole in the regulatory scheme by
subjecting these blended products to oversight.
21
Plaintiffs claim that Defendants have conceded, Pls. Reply 40, that the FDAs
interpretation is unreasonable because it imposes a significant burden and expense on numerous
small businesses in violation of the the APA together with the Regulatory Flexibility Act,
Pls. Br. 46, is baffling. Plaintiffs themselves indicated that they were not pressing their
APA/RFA claim at this time, ECF No. 51, 5, and the Court held it in abeyance, ECF No. 68 at
4 n.3.
At bottom, the definitions of manufacturer and retailer are not mutually exclusive.
Tobacco blenders, even of already-authorized tobacco products, are assembl[ing] and
process[ing] a new product by mixing, which meets the statutory definition of a tobacco
product manufacturer by any measure, 21 U.S.C. 387(20), regardless of where the blender is
in the supply chain.
IV. THE FDA PERMISSIBLY CONSIDERED PIPES TO BE COMPONENTS OR PARTS OF

TOBACCO PRODUCTS
Plaintiffs claim that the FDA improperly considered pipes to be regulable as
components or parts of tobacco products likewise fails. Pipes are undeniably fundamental to
smoking pipe tobacco; without them, pipe tobacco cannot be used for its primary purpose. In
arguing otherwise, Plaintiffs fail to grapple with the breadth of the statutory definition of
tobacco product, the deference owed to the agencys interpretation under Chevron, and the
leading case addressing the deeming rule, Nicopure Labs, LLC v. FDAwhich they do not even
acknowledge, much less distinguish.
Plaintiffs do not dispute that, under the TCA, it is not only things made or derived from
tobacco that are tobacco products, but also any component, part, or accessory thereof,
whether or not made or derived from tobacco, 21 U.S.C. 321(rr)(1)a provision that, like
other parts of the FDCA, should be construed as broad[ly] as its literal language indicates,
22
United States v. Article of Drug Bacto-Unidisk, 394 U.S. 784, 798 (1969); see United States v.
Gonzales, 520 U.S. 1, 5 (1997) (Read naturally, the word any has an expansive meaning, that
is, one or some indiscriminately of whatever kind.); Defs. Br. 5253. Nevertheless, they urge
the Court to graft an extrastatutory limitation onto the term component or partthat it must be
physically integrated with a tobacco product. Pls. Reply 40. There is no basis to do so.
To prevail on [their] Chevron Step One argument, [Plaintiffs have] to do better than
concoct an interpretation purportedly based on the statutes context. [They] must show that the
statute unambiguously forecloses the [agencys] interpretation. Pharm. Research & Mfrs. of
Am. v. FTC, 790 F.3d 198, 207 (D.C. Cir. 2015). Here, Plaintiffs argue that component should
be read narrowly to mean ingredient or additive, which appear beside it in some provisions
of the statute. Pls. Reply 40. But that limitation is squarely refuted by other provisions of the
statute, which make clear that component has a much broader meaning, including, for
example, the filter and paper of a cigarette. 21 U.S.C. 387g(a)(1)(A); Defs. Br. 53. Plaintiffs
respond that a cigarettes filter and paper are consumed, while a pipe is not. Pls. Reply 41.
But that limitation is equally absent from the statutory text, which extends to any component
or part, and the FDA reasonably declined to add it. See Nicopure Labs LLC v. FDA, --- F. Supp.
3d ---, No. 16-878, 2017 WL 3130312, at *17 (D.D.C. July 21, 2017), appeal docketed, No. 17-
5196 (D.C. Cir. Aug. 31, 2017) (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.). In Nicopure, the court rejected a virtually identical argument and
upheld the agencys interpretation under Chevron step one, concluding that the agencys
interpretation is entirely consistent with the plain meaning of the statute. Id. at *16 (the device
23
plus the liquid are undeniably the two essential components of an open vaping system).
Plaintiffs offer no persuasive reason for this Court to chart a different course.
In any event, the FDAs interpretation of the term component or part, which Congress
left undefined, is entirely reasonable and merits deference under Chevron step two. Plaintiffs
halfheartedly disagree, claiming that the agency did no expert, scientific work to justify its
interpretation. Pls. Reply 40. Not so. In defining component or part to include things
intended or reasonably expected to affect a products performance, composition, constituents, or
characteristics, 81 Fed. Reg. at 29,102, the FDA was attentive to Congresss intent that the
agency have the authority to address issues of particular concern to public health officials, set
national standards controlling the manufacture of tobacco products, and regulate the levels of
tar, nicotine, and other harmful components. Pub. L. No. 111-31, 3(2), (3), (5). As the
agency explained, products that meet the definition of component or part are expected to have
an impact on public health, while accessories, by contrast, are expected to have little direct
impact on the public health. 81 Fed. Reg. at 28,975. And while Plaintiffs suggest that pipes
vary for aesthetic reasons, they do not deny the obvious fact that pipe design affects the
performance, constituents, and characteristics of pipe tobacco. For example, the size and
shape of the bowl and air passage will affect the draw, and thus the rate of delivery of smoke
including nicotine, carcinogens, and other constituents. Likewise, some pipes have filters, see,
e.g., AR 87,232, which, like cigarette filters, can affect taste, harshness, and the mixture of
chemicals delivered to the user, see 21 U.S.C. 387d(a)(1) (requiring submission of health
information about filters); Surgeon Generals Report (2014) at 8 (AR 14,588) (noting suggestive
evidence that ventilated filters in cigarettes increased the risk of adenocarcinoma).
24
Perhaps recognizing the weakness of their statutory argument, Plaintiffs also contend that
the FDA failed to adequately consider and justify the economic burdens of the rule on the
manufacturers of artisan, handcrafted pipes, citing Business Roundtable v. SEC, 647 F.3d 1144
(D.C. Cir. 2005), and, in a footnote, the RFA and the APA. Pls. Reply 4142 & n.16. But,
like their argument concerning retailers who blend pipe tobacco, their APA/RFA claim regarding
the economic consequences of the rule, Compl. 117, has been held in abeyance, ECF No. 68
at 4 n.3. In any event, the agency fully discharged any such obligation here.4
In short, there is no linguistic or statutory basis for Plaintiffs contention that pipes are
not regulable as components or parts of tobacco products. Nicopure, 2017 WL 3130312, at *18.
Whether under Chevron step one or two, this claim should be rejected.
CONCLUSION
For the foregoing reasons, in addition to those set forth in Defendants opening brief,
summary judgment should be entered in favor of Defendants and against Plaintiffs on Counts II,
III, VI, VII, VIII, and IX of the complaint.
Dated: December 4, 2017 Respectfully submitted,
Of counsel: BRETT A. SHUMATE

Deputy Assistant Attorney General
BRIAN R. STIMSON
Acting General Counsel JOEL McELVAIN
Food and Drug Division Assistant Branch Director
Office of General Counsel
U.S. Dept of Health and Human Services /s/ Eric Beckenhauer
ERIC B. BECKENHAUER
REBECCA K. WOOD Trial Attorney
Chief Counsel U.S. Department of Justice
4
Business Roundtable is in any event inapposite. There, the statute expressly required the SEC
to consider the effect of a new rule upon efficiency, competition, and capital formation, id. at
1148 (quoting 15 U.S.C. 78c(f), 78w(a)(2), 80a2(c))a unique provision that imposes a
statutory obligation on the SEC to determine as best it can the economic implications of the
rule, 647 F.3d at 1148 (citation omitted). The text of the TCA says nothing comparable.
25
Food and Drug Administration Civil Division, Federal Programs Branch

Associate General Counsel 20 Massachusetts Ave. NW
Food and Drug Division Washington, DC 20530
Tel: (202) 514-3338
PERHAM GORJI Fax: (202) 616-8470
Deputy Chief Counsel for Litigation E-mail: Eric.Beckenhauer@usdoj.gov
WENDY S. VICENTE Counsel for Defendants

Senior Counsel
Office of the Chief Counsel
Food and Drug Administration
10903 New Hampshire Avenue
White Oak 31, Room 4562
Silver Spring, MD 20993-0002
26
Case 1:16-cv-01460-APM Document 80-1 Filed 12/04/17 Page 1 of 15
Journal of Ethnicity in Substance Abuse
ISSN: 1533-2640 (Print) 1533-2659 (Online) Journal homepage: http://www.tandfonline.com/loi/wesa20
Cigars, Cigarillos, and Youth
J. Bryan Page PhD & Sian Evans PhD
To cite this article: J. Bryan Page PhD & Sian Evans PhD (2004) Cigars, Cigarillos, and Youth,
Journal of Ethnicity in Substance Abuse, 2:4, 63-76, DOI: 10.1300/J233v02n04_04
To link to this article: https://doi.org/10.1300/J233v02n04_04
Published online: 22 Sep 2008.
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Download by: [DEA Library] Date: 03 December 2017, At: 13:13

Cigars, Cigarillos, and Youth:

Emergent Patterns
Downloaded by [DEA Library] at 13:13 03 December 2017
in Subcultural Complexes
J. Bryan Page, PhD
Sian Evans, PhD
ABSTRACT. In order to answer questions about discrepancies in self-

reported tobacco use between youth from different race/ethnic catego-
ries, the authors set out to observe and characterize tobacco use among
youth in two Florida counties. Their observations and interviews led to
identification of a pattern of tobacco use that had not appeared before in
the literature on tobacco use, the emergent phenomenon of Black & Mild
consumption, especially among African American youth. Teams of field
workers conducted direct observations of tobacco use among youths be-
tween the ages of 11 and 15, recruiting them and their families into
open-ended interviews to determine how youths in that age range initiate
and maintain tobacco use. Observational notes and in-depth interviews
(all transcribed to word processing files) provided the corpus of data on
which the investigators based this study. In addition, information from
additional sources, including informal interviews with store owners, rap
videos, and queries in other parts of the United States, helped to verify
that patterns found in Miami had appeared throughout Florida and in
many other parts of the United States. Initial observations took place in
the environs of one middle school in southern Miami/Dade County, but
additional observations and interviews that contributed to the study took
J. Bryan Page is affiliated with the University of Miami Department of Anthropology.

Sian Evans is affiliated with the Dumond Conservancy, Fort Lauderdale, Florida.
Address correspondence to: J. Bryan Page, Department of Anthropology, 102 Merrick
LC 2005, Coral Gables, FL 33124 (E-mail: Bryan.page@miami.edu).
Journal of Ethnicity in Substance Abuse, Vol. 2(4) 2003
http://www.haworthpress.com/web/JESA
2003 by The Haworth Press, Inc. All rights reserved.
Digital Object Identifier: 10.1300/J233v02n04_04 63
64 JOURNAL OF ETHNICITY IN SUBSTANCE ABUSE
place in sites near other schools, convenience stores, shopping centers, and
city streets. African American, Hispanic, and white non-Hispanic young
people between 11 and 15 years of age took part in this study, only after
field workers obtained informed consent from their parents. Field work-
ers conducted observations of approximately 250 youth in various set-
tings in two counties in Florida, Miami/Dade and Alachua. They elicited

40 in-depth interviews, including one whole family interview and four
focus groups. The interviews that contributed to this paper were four
in-depth sessions with young African American males recruited at the
middle school where key observations took place.
Field observations produced a pattern of tobacco use not characterized
in the literature, in which a cigarillo called Black & Mild that contains
between five and twelve times the nicotine of cigarettes has become the
product of choice among African American and other youth. Young us-
ers of these cigarillos tend not to recognize them as tobacco and believe
that they contain no nicotine. Further inquiry revealed that this pattern of
smoking was widespread in various parts of the United States. Use of
commercial cigarettes has become increasingly expensive, and minority
youth with limited money may have sought products that deliver strong
nicotine for not much money. Although more research will answer this
question definitively, these results suggest that the emergence of Black
& Milds and related products may help to explain patterns of response to
large-scale studies of tobacco use in which African American youth re-
port less tobacco consumption than other youth. Items on tobacco use in
surveys administered among North American youth need reframing in
terms of cigar smoking to reflect the cultural significance of Black &
Milds and related products among African American youth. [Article
copies available for a fee from The Haworth Document Delivery Service:
1-800-HAWORTH. E-mail address: <docdelivery@haworthpress.com> Website:
<http://www.HaworthPress.com> 2003 by The Haworth Press, Inc. All rights re-
served.]
KEYWORDS. Minority youth, cigar consumption, direct observation, in-

depth interview
INTRODUCTION
Self-reports of tobacco use among minority youth, particularly Afri-

can American youth, do not equal levels of smoking found among White
J. Bryan Page and Sian Evans 65
non-Hispanic youth in the United States (CDC, 1999; 2000a; 2000b). In

an attempt to explain similar results in Florida (Florida Youth Tobacco
Study, 2000), the state office of tobacco control supported a brief ethno-
graphic study of middle school students consumption of tobacco. The
following paper attempts to put some results of that study into the con-
text of tobacco marketing and other large social processes.
BACKGROUND
When Italian and Spanish explorers first saw natives of the New World
puffing smoke from twists of brown leaves, their curiosity was so piqued
that they asked to take whiffs of the smoke (Billings, 1875). It is not
clear how the name cigar came to denote leaf-wrapped cylinders of
cut tobacco, although Hoffman and Hoffman (1998) claim that Mayan
smokers speaking to Spanish adventurers used the verb sikar to denote
what they were doing with twists of tobacco leaves tied with twine
(smoking them). Our own Mayanist source tells us, however, that con-
temporary Maya uses the verb tsuts (to suck) when it refers to the con-
sumption of cigarettes (Allan Burns, personal communication). The
origins of the noun used thereafter to name sticks of smoking tobacco
comprised entirely of tobacco leavesthe cigar, therefore remain ob-
scure. These products, in fact, did not excite widespread consumption of
tobacco in the rest of the world after their discovery by Europeans.
Rather, pipe smoking and nasal insufflation of snuff spread rapidly in
the sixteenth and seventeenth centuries, penetrating most of the known
world by 1700 (Goodman, 1993). The cigar seems to have developed pri-
marily in the circum-Caribbean area and diffused slowly to other parts
of the world as a companion product to the more popular cut and pow-
dered forms of the drug.
The contemporary cigar consists of cut tobacco wrapped in tobacco
leaf, with some variants wrapped in reconstituted leaf or leaf-like paper
containing leaf fragments and/or tobacco extract (Hoffman and Hoffman,
1998). Official classification of cigars consists of only two types: large
(weighing over three pounds per thousand) and small (weighing under
three pounds per thousand). Many variants of the cigar appear for sale
in displays set out by grocery stores, convenience stores, gas stations,
and sundries stores, ranging in size from the large premium cigar, a
preparation of cut tobacco and natural wrapper leaf over 20 centimeters
long, to the smallest cigar, with paper wrapper at slightly over six centi-
meters. One segment of the small cigar category, plastic-tipped cigarillos,
is of particular interest, based on the findings of the ethnography men-

tioned above.
Cigar smoking in the United States has, since the late nineteenth cen-
tury had steady general appeal, gradually tapering toward the end of the
twentieth century (Gerlach et al., 1998). Nevertheless, in the last de-
cade, some varieties of this behavior, especially those involving large,

premium cigars, have had a transformation of image (Burns, 1998; Slade,
1998). Conspicuous consumption of premium cigars became highly
fashionable in the mid-1990s, thanks to innovative marketing on the
part of entrepreneurs seeking to place cigar smoking in the context of
epicurean behavior to make it attractive to people interested in consum-
ing fine food and drink. This trend is particularly striking in the rise of
cigar smoking among people with incomes in excess of $75,000 per
year (Gerlach et al., 1998). It does not, however, completely explain the
rise by 47 percent in total cigar consumption in the United States between
1993 and 1996.
Another component in that rise in cigar consumption had, in all like-
lihood, nothing to do with the chic end of the cigar market. Consump-
tion of small cigars rose by thirteen percent between 1993 and 1997,
from 1.28 billion to 1.45 billion (Gerlach et al., 1998). The most impor-
tant products in this trend have been plastic-tipped small cigars manu-
factured by two companies, Swisher International and John Middleton,
accounting for a total of 34.5 percent of the total market share among
large cigars and cigarillos (Slade, 1998).1 These products, which stores
sell in five-packs or individually, retail for between $0.40 and $0.70
each, obviously not in the category of conspicuous consumption. Who,
then, is buying and smoking these tobacco products in greater numbers
than before? The ethnographic study presented below did not set out to
answer this question, but in fact happened upon a possible answer.
The State of Florida has, since 1997, had the unique opportunity to
mount a well-funded campaign to prevent tobacco use among youth. This
funding, part of a massive settlement won by the state from cigarette
manufacturers (about $200 million, cf. Sly et al., 2001), included mon-
ies for the purpose of evaluating the impact of prevention efforts in the
State of Florida. Surveys for the purpose of monitoring self-reported to-
bacco use among Floridas young people represented the largest part of
this evaluative effort. In spring of 2001, however, the state and their
evaluative contractor, the University of Miami, partly inspired by Tyas
and Pederson (1995), concluded that they needed a qualitative study of
smoking among youth age 11-15 to explain some features of their sur-
vey data on tobacco use. Specifically, they needed explanations for the
very low rates of self-reported cigarette use among African American

respondents (under 10 percent, cf. Florida Youth Tobacco Study, 2000).
Furthermore, self-reported use of other tobacco products did not com-
pensate for this deficit, nor did the generally lower socioeconomic sta-
tus of the African American students.
Comparisons of tobacco consumption between African-descended

and European-descended populations in the United States have generally
focused on self-reported cigarette smoking and its consequences (Novotny
et al., 1988; Prez Estable et al., 1998), but they have not paid attention to
the possibility of qualitatively different cultural patterns of smoking,
with the possible exception of the preference among African American
smokers for menthol flavored cigarettes, which make it possible to in-
hale more deeply than with non-flavored varieties (Prez Estable et al.,
1998). This kind of information can come from surveys, because sur-
veys ask questions about prestructured categories of products (i.e., ciga-
rettes) and their known variants (e.g., menthol cigarettes). It also runs
the risk of medicalizing race, but that is another story. If, however, the
responding population perceives the categories of tobacco product that
they use as outside the prestructured categories specified by the survey,
the instrument is almost powerless to detect them. When we apply sur-
veys to culturally distinctive populations, we run the risk of this kind of
error.
The investigators needed a strategy to determine whether or not the
pattern found in the FYS, low use of tobacco by African American youth,
was true. We concluded that a qualitative study would provide the most
illuminating information.
As originally conceived, the brief, qualitative studies of tobacco use
among youth were to take place in three different locales: Miami/Dade
County, Alachua County, and Leon County. Because of time constraints,
no qualified project director could be found to conduct the study in Tal-
lahassee and environs, so the project ultimately involved only the Mi-
ami and Gainesville sites.
Each site pursued a plan of training graduate and undergraduate stu-
dents to conduct the planned field observations and interviews. The
time required to obtain internal review board (IRB) clearance for the
study gave the site leaders time to train field workers in observational
and interviewing skills. In both sites, the field teams had to submit two
revisions of the human subjects protocols to obtain final approval. Field
observations for this study took place between March 15 and June 15,
2001.
METHODS
In both sites, the field teams used a straightforward approach of iden-

tifying venues where young people smoke in public and beginning with
general observations of smoking behavior. Once they had developed a
clear sense of which of the observed young people smoked, they ap-
proached these individuals. The field workers explained that they were
conducting a study sponsored by the University of Miami. They asked
to approach the parents of the new contacts for permission to interview
both parents and children further. The requirement for parental permis-
sion before conducting any interviews became a test of the field work-
ers patience and ingenuity, but in the end, only children of fully con-
sented parents participated in the interview phases of the two projects.
Approximately 20 percent of the youth approached by the field team re-
fused to introduce the field workers to their parents.
The field teams original intention for use of observational data was
to gain a general picture of smoking behaviors among middle school age
students, but in fact, several other kinds of information emerged from
this research activity. Public smoking behavior among younger adoles-
cents was considerably rarer than we had originally thought, and in cer-
tain semi-enclosed mall sites, security officers enforced no smoking rules.
In Gainesville, the site team had difficulty in finding sites where public
smoking among young adolescents took place. In Miami, the environs
of middle schools proved especially productive in the search for young
public smokers, also open-air shopping malls and a bowling alley.
One of the venues chosen for study in Miami was a middle school in
South Miami/Dade County. This school has a high percentage of Afri-
can American students and extensive space near the school where pub-
lic smoking can take place. The observations and interview materials
presented below emanate from one field workers experiences in at-
tempting to observe public smoking at that particular site. She conducted
observations primarily in the morning before school, producing field
notes describing each observational session, a total of ten hours onsite.
Later interviews required an additional six hours at that particular site
and its environs.
RESULTS
One pattern of tobacco use identified through observation led the proj-
ects investigative team to a series of inquiries that pointed out an im-
portant correction of the states survey data on tobacco use among minority
youth. The senior field worker, a primatologist by training, was con-
ducting general observations outside a middle school when she noticed
a particular tobacco product that she had not seen in other venues. This
product, the Black & Mild cigarillo, appeared to be extremely popular
among African American middle school students in this observational

site.
An interview with one African American participant revealed that in
a shopping center adjacent to a predominantly African American mid-
dle school, the males smoked Black & Milds. The smoking took place
in a well-hidden, covered area at the rear of the shopping center. This
site had been observed by the primatologist (Dr. Evans), but she had not
been able to make any observations of this particular area because it was
impossible to view from any vantage point outside the immediate area.
Dr. Evans then began making direct observations in this area and found
a high density of males, nearly all African American, smoking Black &
Milds. She continued to observe similar smoking sessions on each of
the next eight school day mornings.
Dr. Evans also observed several Hispanic males smoking Black &
Milds in the vicinity of this school, and these cigarillos were frequently
shared among all male smokers in this group. Many older (eighteen
years plus) African American males frequented the area before the mid-
dle school opened for classes. Black & Milds appeared to be their pre-
ferred choice of tobacco also. No other tobacco products were observed,
although on one occasion (Monday, June 4, 2001) three black males
were observed with hand rolled cigarettes behind their ears. One His-
panic male, fourteen years of age, was observed purchasing a single
Black & Mild from one of the convenience stores in the shopping cen-
ter, and then handing it to another Hispanic male. Dr. Evans purchased
Black & Milds from the same store and was asked whether she wanted a
pack or just one. One Black & Mild costs $.50 when purchased at the
convenience store. One Black & Mild, however, lasts considerably lon-
ger than a regular cigarette. A fourteen-year-old African American
male with several quarters in his hand was observed waiting outside the
same store for an older Black male to come out. When the older male
emerged, he saw Dr. Evans and did not approach the student who was
waiting.
All African American males who were interviewed from this loca-
tion smoked Black & Milds but did not consider them to be cigarettes.
No females from this site had been observed to smoke, and none had re-
ported smoking in the interview session. Interviews with two Hispanic
males were interrupted frequently by another Hispanic male who gained

access to the interview by sharing his Black & Mild with the interviewee.
These field experiences exemplified the Black & Mild phenomenon,
but reports from the team in Gainesville indicated that similar patterns
of smoking were occurring there among young African American peo-
ple. Our own student field workers, most of whom were not minorities,
recalled smoking Black & Milds in high school and not identifying
themselves as smokers, nor the product as tobacco. One of the Miami
team wrote the following narrative describing his own experiences with
Black & Milds:
Many of my friends had begun smoking around the time that I was
a junior in high school, but I had always refused because I was an
athlete and did not want the addiction of smoking to hurt my ath-
letic performance. After half of my junior year was over, I began
to be more curious in what the big hype was about smoking. When
I first tried a cigarette, I could not understand how anyone could do
it. I was coughing so hard that my eyes began to water, and the taste
was so horrible that I dont even think I had more than two drags.
Around the same time I was offered a Black & Mild Cigar (B&M).
In fact, it was an older African American who suggested them to
me, saying that the taste was much better, and you dont have to in-
hale if you choose not to. With most cigars the tobacco is so potent
that it is impossible to inhale deeply, but not with B&Ms. When I
first tried one, I did not hate the taste, but by the time I finished it I
had accepted the taste. Also by the time I had finished it, I was ex-
tremely light headed, and many times after that I had received a
buzz from smoking this cigar. It is not hard to inhale without a
problem of coughing. I began to smoke these whenever I got a
chance. I either bought them separately, in a five pack, or a twenty
pack. I would inhale with every puff I took. I was not addicted to
them, but I did and do love the taste. Eventually, because I had be-
come used to the tobacco and inhaling the smoke, I began to
smoke cigarettes, but I did not receive the light-headedness as
much as I did with the B&Ms.
My African American friend also showed me how to freak a

B&M. This means to roll the cigar in your hands back and forth to
loosen up the tobacco while it is still in plastic. Then you remove
only the top of the plastic, near the tip, you continue to roll the ci-
gar back and forth between your palms to remove the tobacco into
the plastic wrap. After all the tobacco is out, you separate the to-
bacco paper from the tip. Once this is done very carefully you pull
out the inner paper that is wrapped by the tobacco paper. You
throw out the inner paper, and with a lighter melt the tip around the
initial tobacco paper (if done properly, it should look exactly how
it was purchased with no creases or burn holes in the paper). Then
you fill the tobacco back into the tobacco paper, packing the to-
bacco to fit all of it in. By freaking a B&M, you are supposed to
feel more of a buzz because you are smoking only tobacco and no
paper inside of it. The paper inner paper also makes it burn slow,
but if you pack the tobacco tightly it is hard to notice the differ-
ence. This same concept can be used when individuals put mari-
juana in with the tobacco or use all marijuana and discard the
tobacco, but it still appears that a person is smoking a cigar with a
plastic tip and not a rolled blunt.
Elsewhere, the process described above is called hyping. This ac-

count helped us to understand the motivations of young people who
smoke Black & Milds, and the process of learning how to smoke them.
The narrator added a cautionary note in his admission of moving on to
cigarettes.
As the initial observations raised the research teams consciousness
of Black & Milds, we began to encounter evidence of their presence in
increasingly broad contexts. First, we found that they, or similar prod-
ucts such as Swisher Sweets and Backwoods cigarillos, as well as
Hav-a-Tampa Jewels enjoyed strong popularity throughout Miami/Dade
county, especially among African American males. The latter products,
however, are somewhat more expensive than Black & Milds, which
seem to dominate the local market. Black & Milds have achieved iconic
status in the subcultural contexts that surround rap music. Music videos
depict rappers either smoking Black & Milds or carrying them behind
their ears. These facts lead to the hypothesis that the phenomenon that
our team first observed near a predominantly African American middle
school may be very widespread, not just in Florida, but elsewhere in the
country.
Further inquiry with colleagues working in other parts of the County
brought additional information about the cigarillo phenomenon. Sev-
eral other brands of cheroots and cigarillos have gained recent popular-
ity among young African Americans, but the Black & Mild seems to
have particular appeal to fans and adherents of Hip-Hop. One conve-
nience store manager in North Dade stated that he had a choice of either
selling these products to minors on demand or risking broken glass or
other vandalism, both far more immediate threats to his livelihood than
the states sanctions against selling to minors.
By itself, this finding would constitute little more than an interesting
local variant of statewide patterns, but additional information led us to

examine this behavior in terms of implications for surveys on tobacco
use among minority youth. That information included reports from our
own field team that they could recall smoking Black & Milds in high
school, and that when they did so, they did not believe that they were
smoking tobacco. One assistant called her friends in a neighboring state
to tell them that their younger siblings who smoke Black & Milds could
have been in our tobacco study, to which the friends replied, Black &
Milds are tobacco?
Manufactured and distributed by John Middleton, Inc., of Pennsylva-
nia (the people who make Prince Albert pipe tobacco), Black & Milds
had been on the market since 1968, but had not sold especially well until
the mid-1990s. The field team reported that cigarillos similar to the
Black & Mild had appeared in a number of rap videos in recent years,
some including mention of the brand name in the lyrics of the song.
Having had our consciousness raised concerning this particular tobacco
product, the field team members began looking for displays of Black &
Mild cigarillos in gas stations and convenience stores, both in Miami
and in Gainesville, finding that most stores had them in prominent dis-
play. When asked, proprietors told us that Black & Milds were a popu-
lar product. Shortly after the field teams discovery, a local nightclub
advertised on the radio that it would give away a free pack of Black &
Milds to the first 150 customers to enter that club on Saturday night. A
brief report by Yerger, Pearson and Malone (2001) reinforced the no-
tion that perception of some varieties of cigars, especially Black &
Milds, remained outside the category of cigars. In focus group inter-
views with young African Americans in the San Francisco Bay area,
Malone, Yerger, and Pearson (2001) elicited very similar views to those
found among middle-school students in South Dade.
Patterns of procuring and smoking Black & Mild cigarillos also
stimulated the investigators interest, because the apparent consumers
were not old enough to purchase them legally, and these smokes repre-
sented very strong preparations of tobacco, delivering roughly seven
times the nicotine of a standard cigarette.2 A nearby convenience store
provided a venue for determining how 14-year-olds gained access to their
cigarillos of choice. They either made the purchases themselves or en-

listed an older schoolmate to buy the Black & Milds.
DISCUSSION
Data collected by the state on tobacco use have indicated consistently

that cigarette smoking has been markedly less prevalent among African
American school children than among white non-Hispanic or Hispanic
school children (Florida Youth Tobacco Study, 2001). These surveys
also asked questions about cigars, and affirmative responses had been
higher than those for cigarettes, but not significantly higher than those
for White non-Hispanic students. Price per pack of name brand ciga-
rettes rose markedly in the last eight years, with current prices well in
excess of three dollars per pack. Because the packs have seals that may
only be broken by the buyer, stores cannot sell individual cigarettes or
partial packs. For a 14-year-old African American youth, $3.50 to $4.00
may not be an accessible price. On the other hand, Black & Milds may
be sold individually (they are individually wrapped within the 5-pack)
at $0.50 per cigarillo or in packs of five at between $1.69 and $2.50. For
a maximum price of $2.50, the equivalent of 35 cigarettes worth of nic-
otine was available to young consumers. Furthermore, until 2001, the
pack did not even have the Surgeon Generals warning about the dan-
gers of tobacco smoking to health.
The young people (predominantly boys) sitting on the curb in front of the
middle school had access to a strong source of nicotine for a price that
they could afford, especially if they pooled their money and shared their
smokes. For that low price, they bought exposure to strong nicotine that
they inhaled deeply, according to our observations. This characteriza-
tion of pattern in specific cultural and economic contexts helped the in-
vestigators to interpret survey findings from around the state as follows:
Some percentage of African American school children in Florida is
smoking a strong tobacco product that they identify as neither cigar nor
cigarette. When they come to the item that asks about cigarettes on the
school questionnaire, they answer, no. The cigar question may also get
a no, but a certain amount of cigar smoking serves as a vehicle for
marijuana in blunts, another product not to be confused with the slen-
der cigarillo. These young people may or may not look for the Black &
Mild alternative on the questionnaire form, depending on whether or
not they associate this product with tobacco. Our interviewees told us
that some do and some do not. Nevertheless, the only way that Black &
Mild will appear among their responses is if they write it into an other
category.
The inaccessibility of cigarettes and the accessibility of Black &
Milds has an analog in the history of street drugs in the United States.
Before 1983, cocaine hydrochloride was the dominant product in illegal
drug networks. Its price, $45 to $100 per gram, was prohibitively high,
making the minimum effective dose of the drug (200mg at $10 to $20)
inaccessible to people with low incomes. With the introduction of ready
rock, or as it was later known, crack cocaine, the price of a minimum
effective dose dropped to $5.00, and later as little as $3.00, opening ac-
cess to a whole new segment of the U.S. populationthe inner cities
(Smith and Page, 1996). Apparently, the availability of a strong nicotine
preparation, Black & Milds, in a product offered at an accessible price
led to that products finding a niche in a market where that product had
not had any previous foothold.
Clearly, this seemingly modest finding has what mathematicians call
generality far beyond the confines of a South Dade middle school.
The extent of this generality will require further investigation, now fa-
cilitated by the inclusion of specific questions about cheroots and cigar-
illos on the next iterations of widely applied questionnaires. One won-
ders, however, how long these instruments would have continued miss-
ing the Black & Mild phenomenon without this perspective. In the
meantime, it may be worthwhile for the prevention efforts in Florida to
begin including cigarillos in their plans for future efforts to effect pri-
mary prevention of tobacco use and to evaluate those efforts.
Somehow, within the last ten years, the relatively obscure product
consisting of leaf wrapper reinforced with paper, and cut pipe tobacco
with a plastic tip has come to command a substantial market, not just in
Miami, but in the United States as a whole. As recently as six years ago,
John Middleton Companys cigarillo was not nearly as important to to-
bacco consumption among youth as it is today. It is almost ubiquitous in
convenience stores in Miami and elsewhere in the State of Florida, and
these establishments sell individual Black & Milds for $0.40 to $0.50
each or $2 to $2.50 for a package of five. In addition, their equivalents
may occupy similar niches in other, similar markets. The fact that Swishers
cigarillos commanded 24.5 percent of the total cigar market in 1996
may indicate that some markets outside Miami are dominated by those
products.
The last ten years correspond to a rapid increase in the price of to-
bacco cigarettes in the United States (CDC, 2002). Although public per-
ception tends to lay blame for these rises in price of cigarettes on taxes,
the wholesale price of cigarettes held steady over the last 40 years at 65
percent of the total pre-retail price. This rise has the impact of making a
pack of cigarettes out of reach for middle school students from working
class families ($3.00 to $4.00 per pack). Black & Milds occupy an eco-
nomic niche in the overall tobacco market that makes a delivery system
with seven times the nicotine of a cigarette available for $0.50 each to
young adolescents.
The perception that Black & Milds are not tobacco may help explain
why African American youths who respond to surveys on tobacco are
less likely than White non-Hispanics to report that they use tobacco.
Armed with this new knowledge, the states next assessment of tobacco
use among its school children will avoid the omission of Black & Milds
and products of their ilk, but in fact, the large-scale instrumentation that
attempts to measure prevalence of covert and semi-covert behaviors
needs constant corrective strategies. Ethnographic study of tobacco use
has the potential for identifying and characterizing many more uniden-
tified and uncharacterized tobacco-using behaviors. We recommend
this approach, especially in the quest for understanding the process of
learning how to use tobacco.
NOTES
1. This particular grouping ignores the official differentiation between large and
small, lumping all cigars of cigarillo size and larger into a single pool. It also expresses
consumption in terms of smokeable units rather than weight.
2. According to Hoffman and Hoffman (6) small cigars of this kind weigh up to 2.5
times the weight of a cigarette, and they expose the smoker to a range of two to five
times the direct flow nicotine per gram of cigar weight as compared with the rate per
gram of cigarette weight. The full calculation of this particular products potential for
exposure to nicotine may be as low as five times, or as high as twelve times that of a to-
bacco cigarette. Our estimate of seven times the nicotine may be somewhat conserva-
tive, taking into account the use of pipe tobacco rather than cigar tobacco, but only
specific testing of this product will tell the whole story.
REFERENCES
Billings, E. R. (1875) Tobacco: Its History, Varieties, Culture, Manufacture, and Com-
merce. Hartford: American Publishing Company.
Burns, D. M. (1998) Cigar smoking: Overview and current state of the science. In David
M. Burns, ed. Cigars: Health Effects and Trends. Bethesda: NIH Publications
# 98-4302, 1998: 1-19.
Centers for Disease Control (1999) Tobacco Use Among Middle and High School Stu-
dentsFlorida, 1998 and 1999. MMWR Highlights: 48 (12).
Centers for Disease Control (2000a) Trends in Cigarette Smoking Among High School
Students in the United States. MMWR Highlights: 49(33).
Centers for Disease Control (2000b) Tobacco Use Among Middle and High School
Students: The National Youth Tobacco Use Survey. MMWR Highlights 49(3).
Centers for Disease Control (2002) Trends in State and Federal Cigarette Tax and Re-
tail PriceUnited States, 1955-1995. Tobacco Information Prevention Source
TIPS. URL:http://www.cdc.gov/tobacco/research_data/economics/cigtax.htm
Florida Youth Tobacco Study (2000) Florida Youth Tobacco Survey Results. Talla-
hassee: Florida Department of Health.
Gerlach, K. K., Cummings, K. M., Hyland, A., Gilpin, E. A., Johnson, M. D., Pierce, J. P.
(1998) Trends in cigar consumption and smoking prevalence. In David M. Burns,
ed. Cigars: Health Effects and Trends. Bethesda: NIH Publications # 98-4302: 21-53.
Goodman, J. Tobacco in History: The Cultures of Dependence. New York: Routledge, 1993.
Hoffman, D., Hoffman, I. (1998) Chemistry and toxicology. In David M. Burns, ed.
Cigars: Health Effects and Trends. Bethesda: NIH Publications # 98-4302, 55-76.
Malone, R. E., Yerger, V., Pearson, C. (2001) Cigar Risk Perceptions in focus groups of
urban African American youth. J Substance Abuse 13:549-561.
Novotny, T. E., Warner, K. E., Kendrick, J. S., Remington, P. L. (1988) Smoking by blacks and
whites: Socioeconomic and demographic differences. AJPH 78(9):1187-1189.
Prez-Estable, E., Herrera, B., Jacob, P., Benowitz, N. L. (1998) Nicotine metabolism
and intake in black and white smokers. JAMA 280(2): 152-156.
Slade, J. (1998) Marketing and promotion of cigars. In David M. Burns, ed. Cigars:
Health Effects and Trends. Bethesda: NIH Publications # 98-4302, 195-217.
Sly, D. F., Hopkins, R. S., Trapido, E., Ray, S. (2001) Influence of a counteradvertising
media campaign on initiation of smoking: The Florida truth campaign. AJPH
91(2): 233-238.
Smith, P. C., Page, J. B. (1996) Homeless adults and crack. In Dale D. Chitwood, James
E. Rivers, and James A. Inciardi, eds. The American Pipe Dream. New York: Har-
court Brace College Publishers,104-114.
Tyas, S. L., Pederson, L. (1995) Psychosocial factors related to adolescent smoking: A
critical review of the literature. Tobacco Control 7:409-420.
Yerger, V., Pearson, C., Malone, R. E. (2001)When is a cigar not a cigar? African Ameri-
can youths understanding of cigar use. AJPH 91(2): 316-317.

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Case 1:16-cv-01460-APM Document 80 Filed 12/04/17 Page 1 of 31

IN THE UNITED STATES DISTRICT COURT

CIGAR ASSOCIATION OF AMERICA,

v. Civil Action No. 16-1460 (APM)

UNITED STATES FOOD AND DRUG

REPLY IN SUPPORT OF DEFENDANTS

TABLE OF AUTHORITIES ......................................................................................................... iii

1. The Health Warnings Are Properly Analyzed under Zauderer ...................1

2. The Health Warnings Are Rationally Related to the Governments

3. Even if Central Hudson Applies, the Health Warnings Withstand

II. THE FDAS ASSESSMENT OF USER FEES IS CONSISTENT WITH STATUTORY

IV. THE FDA PERMISSIBLY CONSIDERED PIPES TO BE COMPONENTS OR PARTS OF

American Beverage Institute v. City and County of San Francisco,

American Meat Institute v. U.S. Department of Agriculture,

Bad Frog Brewery v. N.Y. State Liquor Auth.,

Burgess v. United States,

Business Roundtable v. SEC,

Capital Broad. Co. v. Acting Attorney Gen.,

Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.,

Discount Tobacco City & Lottery, Inc. v. United States,

Fla. Bar v. Went For It, Inc.,

Hutchins v. Dist. of Columbia,

Lorillard Tobacco Co. v. Reilly,

Nicopure Labs LLC v. FDA,

Nutritional Health Alliance v. Shalala,

Pharm. Research & Mfrs. of Am. v. FTC,

Posadas de P.R. Assocs. v. Tourism Co.,

Public Citizen, Inc. v. La. Atty Disciplinary Bd.,

Pursuing Am.s Greatness v. FEC,

R.J. Reynolds Tobacco Co. v. FDA,

Spirit Airlines, Inc. v. U.S. Dept of Transp.,

United States v. Article of Drug Bacto-Unidisk,

United States v. Gonzales,

United States v. Sperry Corp.,

Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio,

Federal Statutes and Regulations

5 U.S.C. 706 ......................................................................................................................... 11, 16

155 Cong. Rec. H4367 (Apr. 1, 2009) .......................................................................................... 20

World Health Organizations Framework Convention on Tobacco Control ........................ 5, 8, 15

Facts labels on over-the-counter drugs, to Nutrition Facts labels on food, to country-of-origin

under Chevron. The Court should grant summary judgment to Defendants.

I. THE DEEMING RULES HEALTH WARNING REQUIREMENTS ARE CONSISTENT WITH

A. The Health Warnings Are Consistent with the First Amendment

1. The Health Warnings Are Properly Analyzed under Zauderer

identify no case to the contrary.

information than they might otherwise be inclined to present. Id. at 507.

unnecessarily repeated, it is hardly an assault on customers senses to place a warning at each

pose significant health risks when consumed as intended.

2. The Health Warnings Are Rationally Related to the Governments

Meat, and it is more than sufficient.

no evidentiary parsing of a measures effectiveness. American Meat, 760 F.3d at 26.

addictive qualities, id. at 897 n.11.

laws regulating advertising of alcohol, tobacco, and gambling).

brand names, logos, or other information).

reach[es] beyond problems of deception, sufficiently to encompass the disclosure mandates at

health warnings under Zauderer.

3. Even if Central Hudson Applies, the Health Warnings Withstand

Plaintiffs arguments to the contrary are wrong at each turn.

a. The FDA found abundant evidence of an unsubstantiated perception, especially

the other direction.

tobacco. Centre for Behavioral Research in Cancer (1992) at 6 (AR 18848).

during the public comment process.

Plaintiffs characterize the existing FTC warnings as an obvious less restrictive