Rave Salon Inc v. Gottlieb ( 2020 )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
MOOSE JOOCE, et al.,
Plaintiffs,
v.
Case No. 18-cv-203 (CRC)
FOOD AND DRUG ADMINISTRATION,
et al.,
Defendants.
RAVE SALON, INC. d/b/a JOOSIE
VAPES,
Plaintiff,
v. Case No. 18-cv-1615 (CRC)
FOOD AND DRUG ADMINISTRATION,
et al.,
Defendants.
JEN HOBAN d/b/a MASTERPIECE
VAPORS, et al.,
Plaintiffs,
v. Case No. 19-cv-372 (CRC)
FOOD AND DRUG ADMINISTRATION,
et al.,
Defendants.
MEMORANDUM OPINION
Responding to the public health risks posed by dramatic increases in vaping, especially
among teens, the Food and Drug Administration in 2016 exercised its statutory authority to
regulate electronic cigarettes. 1 It did so by issuing a final rule that deemed e-cigarettes to be
“tobacco products” subject to regulation under the Family Smoking Prevention and Tobacco
Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (“Tobacco Control Act”). As a result of
this “Deeming Rule,” e-cigarettes are now subject to all the same types of regulations as
traditional cigarettes, including restrictions on advertising, a ban on sales to minors, and
requirements for nicotine warnings on packaging and advertisements.
In these consolidated cases, a collection of e-cigarette manufacturers and retailers
challenge the Deeming Rule under the Appointments Clause and the First Amendment of the
U.S. Constitution. First, they contend that the rule violates the Appointments Clause because the
FDA official who signed it was neither a Senate-confirmed “principal officer” nor a duly
appointed and supervised “inferior officer.” The Court will reject Plaintiffs’ challenge. Since
the Deeming Rule was issued, two Senate-confirmed FDA Commissioners have ratified it.
These ratifications were effective and cured any potential Appointments Clause defect in the
rule’s issuance. Because it upholds the ratifications, the Court need not decide the merits of
Plaintiffs’ constitutional argument. Second, Plaintiffs argue that a pre-clearance requirement in
the Tobacco Control Act now applicable to e-cigarettes violates the First Amendment because it
places the burden on manufacturers to show that certain of their marketing claims are truthful
and not misleading before they may make them. Since this case was filed, the D.C. Circuit
issued an opinion in Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019), on a
1
This Opinion uses the term “e-cigarettes” to refer to all electronic nicotine delivery
systems (ENDS) deemed to be tobacco products by the FDA, such as e-cigars, e-hookah, vape
pens, personal vaporizers, and electronic pipes. See 81 Fed. Reg. 28,974, 29,028 (May 10,
2016); APP 306. These products include both “cigalikes,” which mimic traditional cigarettes,
and electronic devices that resemble everyday objects like flash drives.
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substantially similar claim. The Court finds that Nicopure Labs directly controls the question
raised here and requires dismissal of Plaintiff’s First Amendment challenge.
I. Background
The Tobacco Control Act gives the Secretary of Health and Human Services authority to
regulate four enumerated categories of tobacco products—namely “all cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco”—as well as “any other tobacco
products that the Secretary by regulation deems to be subject to this subchapter.” 21 U.S.C. §
387a(b). The HHS Secretary delegated this ability to “deem” tobacco products subject to the Act
to the FDA Commissioner, who then sub-delegated that authority to the FDA’s Assistant
Commissioner for Policy (“ACP”). 2 See 21 U.S.C. § 393(d)(2)(E) (permitting the HHS
Secretary to delegate “such other functions as the Secretary may prescribe”); 2015 FDA Staff
Manual Guide (“SMG”) § 1410.10(1)(A)(14), J.A. 20 (delegation of authority to Commissioner);
2015 SMG § 1410.10(1)(A), J.A. 19 (delegation of authority to ACP). The HHS Secretary
expressly “reserve[d] the authority to approve regulations of the FDA” that “establish procedural
rules applicable to a general class” or “present highly significant public issues.” 2015 SMG
§ 1410.10(2)(A), J.A. 20. The FDA Commissioner, in turn, reserved the power to “continue to
exercise all delegated authority.” 2012 SMG § 1410.21(1)(G)(1), J.A. 43; id. § 1410.21(1)(A),
J.A. 40.
In 2014, the FDA issued a Notice of Proposed Rulemaking, signed by the ACP, seeking
comments on its plan to deem all tobacco products, including e-cigarettes, subject to regulation
2
The position has since been renamed the Associate Commissioner for Policy as a part of
an agency reorganization. This Opinion will use “ACP” to refer to both the Assistant
Commissioner and the Associate Commissioner as those positions had the same relevant
responsibility, namely to promulgate rules for the FDA under the Tobacco Control Act.
3
under the Tobacco Control Act. 80 Fed. Reg. 23,141 (Apr. 25, 2014), J.A. 141. At least one of
the Plaintiffs here submitted a comment to the FDA, arguing that the proposed rule did not take
into account the positive benefits of e-cigarette use (or “vaping”) and did not appropriately tailor
the regulations to the retail vaping industry in light of those benefits. Dennisa Moore, Joosie
Vapes Inc., Comment Letter on Proposed Rule Deeming Tobacco Products to be Subject to the
FDCA as amended by the Family Smoking Prevention and Tobacco Control Act (Aug. 6, 2014),
J.A. FDA 125272–74. None of the more than 135,000 commenters challenged the ACP’s
authority to sign the proposed or final rule.
The final Deeming Rule, also signed by the ACP, was issued two years later. 81 Fed.
Reg. at 28,973–29,106, J.A. 252–384. In response to comments received on the proposed rule,
the FDA considered “a robust body of scientific evidence about the uses and risks of e-
cigarettes,” Nicopure Labs, 944 F.3d at 273. This evidence included studies showing that e-
cigarettes have the potential ability to help adults quit smoking conventional cigarettes, as well
as studies indicating that young people who vape are more likely to begin smoking cigarettes. 81
Fed. Reg. at 29,036–41, J.A. 314–19. Balancing all the evidence, the FDA decided that risks of
nicotine addiction for non-smoking youth outweighed the purported (and disputed) benefits of
smoking cessation for adults. Id.
The Deeming Rule subjects e-cigarettes to the Tobacco Control Act and regulates their
distribution, marketing, and labeling in two general ways: first, to reduce youth access, it bans
sales to people under 18, requires ID checks for people under 26, and bans vending machine
sales except in adult-only facilities, 81 Fed. Reg. at 29,057, J.A. 335; second, to inform
consumers of the consequences of using the product, it requires packages and advertisements to
contain a warning about the addictive nature of nicotine, 81 Fed. Reg. at 29,060, J.A. 338. In
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addition, several provisions in the Tobacco Control Act and its implementing regulations
automatically applied to e-cigarettes upon issuance of the final rule, such as regulations on
misbranding, ingredient lists, and free samples. 81 Fed. Reg. at 29,051, J.A. 329. One provision
now applicable to e-cigarettes specifically challenged here is the Tobacco Control Act’s pre-
clearance requirement for “modified risk products.” The Act places the burden on a manufacture
to show that a tobacco product “is safer than other tobacco products” before it may market it as
such. The Act requires manufacturers “to substantiate such claims with evidence of their overall
public health effects in advance of marketing, and to show that the proposed product as marketed
will not mislead consumers as to its safety.” Nicopure Labs, 944 F.3d at 284.
Since its issuance, the Deeming Rule has been ratified by two Senate-confirmed FDA
Commissioners. In September 2016, FDA Commissioner Robert Califf ratified all of the
agency’s prior actions—including the Deeming Rule—as a part of a broad agency
reorganization. J.A. 144. And after this litigation began, Commissioner Scott Gottlieb
specifically ratified the Deeming Rule in April 2019. J.A. 231. He wrote:
I hereby affirm and ratify the Deeming Rule as of the date it was published in the
Federal Register on May 10, 2016, including all regulatory analysis certifications
contained therein. I undertake this action based on my careful review of the rule,
my knowledge of its provisions, and my close involvement in policy matters
relating to this rule and its implementation, as well as its public health importance.
Id.
According to Plaintiffs, between the time of the Rule’s promulgation and the
Commissioners’ ratifications, several additional studies showed that e-cigarettes may help adults
quit smoking cigarettes and reduce the adverse health effects of cigarettes. See Pls.’ Opening Br.
at 31–33 (citing studies). Other studies, Plaintiffs say, showed that certain regulations, which
result in higher e-cigarette prices, have the effect of increasing the number of young people who
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smoke conventional cigarettes. Id. at 34. Also during this interim period, the FDA issued
guidance documents that have adjusted some of the compliance deadlines in the final rule. Id.
Three sets of plaintiffs filed suit against the FDA alleging that the ACP was not
appointed consistent with the Appointments Clause and, therefore, that her execution of the
notice of proposed rulemaking and the final rule requires the court to “set aside” the Deeming
Rule. See, e.g., Moose Jooce Compl. ¶¶ 50–52 (quoting APA § 706(2)(A)). The parties have
filed cross-motions for summary judgment on that issue. The Court held a hearing on October
22, 2019.
Plaintiffs also challenge the premarket review requirement for “modified risk tobacco
products” under the First Amendment. See, e.g., Moose Jooce Compl. ¶¶ 54–57. The Court
stayed briefing on that issue to await the D.C. Circuit’s ruling on a substantially similar issue in
Nicopure Labs. See Minute Order, June 8, 2018. After the D.C. Circuit decided that case in
early December 2019, the Court asked the parties whether additional briefing was required.
Plaintiffs responded that further briefing is necessary because the issue decided by the Circuit is
distinguishable from the issues raised here, while the FDA maintained that the Circuit’s opinion
clearly forecloses Plaintiffs’ First Amendment claim. See Joint Status Report (“JSR”) (Dec. 17,
2019), ECF 42.
II. Legal Standards
Summary judgment may be granted when “there is no genuine issue as to any material
fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). Whether
an agency action violates the Appointments Clause is a pure question of law that is properly
decided by summary judgment. See, e.g., Estes v. U.S. Dep’t of the Treasury, 219 F. Supp. 3d
17, 38–39 (D.D.C. 2016); see also 5 U.S.C. § 706(2)(A) (requiring courts to “hold unlawful and
6
set aside agency action, findings, and conclusions found to be . . . arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law”).
III. Analysis
A. The Appointments Clause
1. Forfeiture
As a threshold matter, the FDA contends that Plaintiffs forfeited their Appointments
Clause challenge by not raising it during the rule’s notice-and-comment period. Gov’t’s Cross-
Mot. for Partial Summ. J. 18–20. They agency is correct that generally “a party must initially
present its comments to the [relevant] agency during the rulemaking in order for the court to
consider the issue,” Tex Tin Corp. v. EPA, 935 F.2d 1321, 1323 (D.C. Cir. 1991), and that
“[s]imple fairness . . . requires as a general rule that courts should not topple over administrative
decisions unless the administrative body . . . has erred against objection made at the time” of its
decision, Advocates for Highway & Auto Safety v. Fed. Motor Carrier Safety Admin., 429 F.3d
1136, 1150 (D.C. Cir. 2005) (quoting United States v. L.A. Tucker Truck Lines, Inc., 344 U.S.
33, 37 (1952)). Appointments Clause claims are not immune from forfeiture. See, e.g.,
Intercollegiate Broad. Sys., Inc. v. Copyright Royalty Bd., 574 F.3d 748, 755–56 (D.C. Cir.
2009) (“Intercollegiate I”) (declining to consider an Appointments Clause challenge not raised in
opening appellate brief).
But courts have discretion to consider an untimely objection in “rare cases.” Freytag, 501
U.S. at 879 (explaining, in the context of an agency adjudication, that avoiding “the disruption to
sound appellate process entailed by entertaining objections not raised below does not always
overcome what Justice Harlan called ‘the strong interest of the federal judiciary in maintaining
the constitutional plan of separation of powers.’” (quoting Glidden Co. v. Zdanok, 370 U.S. 530,
7
535–536 (1962) (Harlan, J., plurality opinion))). The Court chooses it exercise its discretion
here. Unlike the appellant in Intercollegiate I, Plaintiffs have offered a reason to “depart from
[the] normal forfeiture rule” and have offered a strong “justification for its delay.” 574 F.3d at
756. Rulemaking is different from adjudication. See Citizens Coal Council v. EPA, 447 F.3d
879, 904 n.25 (6th Cir. 2006) (noting that forfeiture rules “should not be applied freely in both”
rulemaking and adjudication contexts, “given the fundamental differences between the two
endeavors”). Even though the forfeiture rules may apply in both contexts, Styrene Info. &
Research Ctr. v. Sebelius, 994 F. Supp. 2d 71, 79 (D.D.C. 2013), and parties surely can forfeit
arguments not made before the agency during a comment period, see, e.g., Advocates for
Highway & Auto Safety, 429 F.3d at 1150, the differences between rulemaking and adjudication
counsel for a more lenient rule for unrepresented commenters who later wish to raise a
separation-of-powers argument. Interested parties who are not attorneys or represented by
counsel will naturally submit comments focusing on the rule’s potential impact on them. It
would be unfair to require them to raise esoteric legal arguments with the agency or else be
prevented later from arguing them to a court, especially when those arguments relate to
important separation-of-powers issues. Compare Intercollegiate I, 574 F.3d at 755–56 (applying
forfeiture rules to a represented party who failed to raise its Appointments Clause challenge in
an agency adjudication or its opening brief in federal court). Any prejudice to the agency pales
in comparison to the unfairness to Plaintiffs, particularly considering the FDA can rectify any
Appointments Clause problem through an effective ratification after litigation is commenced, see
Part III.B., supra.
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In the absence of any indication that Plaintiffs were represented during the comment
period, see Mot. Hr’g Tr. 27:11–15 (Oct. 22, 2019) (rough), the Court will exercise its discretion
to consider their Appointments Clause claim.
2. Ratification
a. Merits
Plaintiffs contend that the Deeming Rule is invalid because it was promulgated by an
FDA employee who had not been properly appointed as an officer of the United States and
therefore lacked authority under the Appointments Clause to issue binding agency rules. But the
Deeming Rule was ratified by two different FDA Commissioners after its publication in May
2016, and the D.C. Circuit has repeatedly held that an agency’s ratification of a prior decision or
action cures any potential Appointments Clause violation if “a properly appointed official has the
power to conduct an independent evaluation of the merits and does so.” Intercollegiate Broad.
Sys. v. Copyright Royalty Bd., 796 F.3d 111, 117 (D.C. Cir. 2015) (“Intercollegiate III”) (citing
FEC v. Legi-Tech, Inc., 75 F.3d 704 (D.C. Cir. 1996) and Doolin Security Savings Bank v.
Office of Thrift Supervision, 139 F.3d 203 (D.C. Cir. 1998)); see also Wilkes-Barre Hospital Co.
v. NLRB, 857 F.3d 364, 371 (D.C. Cir. 2017). It is the Plaintiffs’ burden to present evidence—
beyond the mere fact of ratification—“to suggest that the [agency] failed to conduct an
independent evaluation of the merits or make a detached and considered judgment.” Wilkes-
Barre, 857 F.3d at 371 (internal quotation marks omitted). An “independent judgment” does not
require the ratifier to “return to square one” of the administrative process. Rather, “the better
course” for courts is to take the ratification “at face value and treat it as an adequate remedy” for
an Appointments Clause violation. Legi-Tech, 75 F.3d at 708–09 (refusing to “forc[e] the
[agency] to start at the beginning of the administrative process”). The test is akin to “harmless
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error” under the APA. Doolin, 139 F.3d at 212–13 (explaining that the test for whether
ratification is an adequate remedy “echoes the harmless error analysis” that “stems from the last
sentence of § 706 of the Administrative Procedure Act: on judicial review of agency action, ‘due
account shall be taken of the rule of prejudicial error’”). Under this test, Plaintiffs bear the
burden of providing evidence that the results of redoing the notice-and-comment process would
yield a different result. Id.
In making that determination, the D.C. Circuit has instructed district courts not to look
behind the ratification “notwithstanding the possibility” that it is merely a “rubberstamp” of the
prior decision. Intercollegiate III, 796 F.3d at 118 n.1; see also Doolin, at 213 (holding that
courts should find a ratification effective even if it has “misgivings” about whether there was a
“real fresh deliberation”). To succeed, Plaintiffs must provide evidence of “continuing
prejudice” of the alleged error after the ratification, “and whether that degree of prejudice—if it
exists—requires dismissal.” Legi-Tech, 75 F.3d at 708; see Intercollegiate III, 796 F.3d at 124
(“[T]he subsequent proceeding is constitutionally suspect only if there is sufficient continuing
taint arising from the first.”). The Circuit has also cautioned against examining internal agency
deliberations regarding the ratification “absent a contention” that the ratifier was “actually
biased.” Legi-Tech, 75 F.3d at 709.
Plaintiffs argue that the highly deferential standard of review that the Circuit established
for agency ratifications in the cases cited above, all of which involved enforcement actions or
adjudications, does not apply in the context of rulemakings like the one at issue here. Pls.’
Reply/Opp’n 19–22. Rulemakings should be treated differently, Plaintiffs say, because the
APA’s procedural rulemaking requirements, including notice and opportunity for comment,
continue until the moment of ratification. Id. The Court is not persuaded. Plaintiffs offer no
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reason—other than the existence of APA procedures—for differentiating between ratifications of
rules and ratifications of enforcement decisions or agency adjudications. Adjudications are also
covered by a host of APA procedures, yet the Circuit has applied its ratification doctrine to
agency adjudications as well. See Intercollegiate III, 796 F.3d at 119. Up to that point, the
Circuit had only approved ratifications in the enforcement context, but it rejected the notion that
the type of agency proceeding mattered. Id. And it has since implied—though did not outright
decide—that rulemaking ratifications should be treated the same way. See Guedes v. Bureau of
Alcohol, Tobacco, Firearms and Explosives, 920 F.3d 1, 12 (D.C. Cir. 2019) (accepting the
parties’ agreement that the ratification was effective to cure an Appointments Clause problem
with a rulemaking).
Further, all the district courts in this District that have confronted the issue have applied
the Circuit’s ratification doctrine to rulemakings and have not required agencies to undergo the
entire APA notice-and-comment processes anew before upholding otherwise effective
ratifications. These courts have consistently held that a rulemaking “that would otherwise be
unlawful due to procedural or technical defects . . . can be cured through a subsequent lawful
ratification of that action.” Alfa Int’l Seafood v. Ross, No. 17-cv-31, 2017 WL 3738397, at *1
(D.D.C. June 22, 2017) (Mehta, J.) (explaining that the court would accept a general post-
litigation “statement [from the agency] acknowledging that [it] would re-promulgate the Rule in
the same manner, even if it were required to re-start the notice and comment process”); see also
State Nat’l Bank of Big Spring v. Lew, 197 F. Supp. 3d 177, 179–80 (D.D.C. 2016) (Huvelle, J.)
(rejecting the notion that a ratification of a rulemaking requires the agency to redo the full APA’s
notice-and-comment procedures because, “regardless of the type of administrative action, [D.C.
Circuit] decisions have consistently declined to impose formalistic procedural requirements
11
before a ratification is deemed to be effective”); Huntco Pawn Holdings, LCC v. U.S. Dep’t of
Defense, 240 F. Supp. 3d 206, 232 (D.D.C. 2016) (Kollar-Kotelly, J.) (holding that that a
ratification submitted to the court by a properly appointed official settles “any serious dispute
that the Final Rule, as published, reflects the decisions of the agency with authority to
promulgate it”).
Here, the ratifications by both Commissioner Califf and Commissioner Gottlieb cured
any potential Appointments Clause issue with the promulgation of the Deeming Rule.
First, both ratifying Commissioners made “a detached and considered judgment” of the
Deeming Rule. See Wilkes-Barre, 857 F.3d at 371. Commissioner Gottlieb ratified the
Deeming Rule explicitly “based on [his] careful review of the rule, [his] knowledge of its
provisions, and [his] close involvement in policy matters relating to this rule and its
implementation.” J.A. 231. He stated that he made a detached and considered judgment, and
Plaintiffs have not provided any evidence to the contrary. The Court must therefore take
Commissioner Gottlieb’s ratification “at face value.” Legi-Tech, 75 F.3d at 709. And while
perhaps a closer question, Commissioner Califf’s blanket ratification also meets the standards set
by the D.C. Circuit. In Wilkes-Barre, the Circuit approved of a ratification of all “the actions
taken during the period in which the Board lacked a valid quorum,” 857 F.3d at 271, which is
substantially similar to Commissioner Califf’s ratification of “any actions taken . . . which in
effect involved the authorities delegated herein prior to the effective date of this delegation,” J.A.
144. Plaintiffs’ counsel correctly noted at the hearing that the inference of “independent
judgment” was stronger in Wilkes-Barre because the ratifier was the same person—though now
validly appointed—who took the original actions. See Mot. Hr’g Tr. 5:17–6:3 (Oct. 22, 2019)
(rough). But again, the Circuit instructs that the independent judgment of the ratifiers should be
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taken “at face value,” unless a plaintiff provides contrary evidence. Legi-Tech, 75 F.3d at 709.
That evidence must be something more than the mere fact that the decision is being ratified. As
Plaintiffs have not met that burden, the Court will not look behind Commissioner’s Califf’s
blanket ratification either.
Second, Plaintiffs have not met their burden to show that any Appointments Clause
violation was prejudicial in the sense that redoing the administrative process would yield a
different result. 3 Plaintiffs’ primary contention of error is that neither of the ratifying
Commissioners discussed certain studies that were published between the issuance of the
Deeming Rule and the later ratifications. Pls.’ MSJ 30–37. By failing to acknowledge these
intervening studies, Plaintiffs argue, the Commissioners violated the basic APA rule requiring
agencies to consider important aspects of the problem before them. But Plaintiffs conflate
ratification doctrine with APA requirements prior to agency action. This explains why their
principal reliance on Butte County v. Hogen, 613 F.3d 190, 194 (D.C. Cir. 2010), is misplaced.
There, the Secretary of Interior issued a final decision to take into trust land on which an Indian
tribe wished to conduct gaming operations based on a years-old legal opinion by the
3
Citing Legi-Tech, Plaintiffs assert that a court must find that it is “virtually
inconceivable” that a new administrative process would yield a different result before it could
accept a ratification. Pls.’ Mot. for Partial Summ. J. 30–31 (“Pls.’ MSJ”); Pls.’ Reply/Opp’n 25–
27. But the Circuit did not create such a stringent test in Legi-Tech. In explaining why requiring
an agency to redo the administrative process is not the correct remedy, the Circuit merely noted
that “[e]ven were the Commission” to do so in that case, “it is virtually inconceivable that its
decisions would differ in any way the second time from that which occurred the first time.”
Legi-Tech, 75 F.3d at 708 (citing cases that explain that “remand to the agency is an unnecessary
formality where the outcome is clear”). The panel was merely explaining why, in light of
“human nature,” it would not generally be the case that the result of a redo of the administrative
process would be different. Id. at 709. Based on that understanding, the Circuit held that
“return[ing] to square one” is not required for an effective ratification. Id. at 708.
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Department’s Solicitor, while ignoring more recent evidence offered by the plaintiffs. The
Circuit found that the Secretary had violated the APA by not considering relevant information
before issuing his decision. See id. at 194–95. Butte County says little about the effectiveness of
a ratification, however. Agency ratifications, which by definition come after a final action has
been taken, are not governed by standard APA rules. As discussed, “regardless of the type of
administrative action, [Circuit] decisions have consistently declined to impose formalistic
procedural requirements before a ratification is deemed to be effective.” State Nat’l Bank, 197
F. Supp. 3d at 184.
It bears noting that the effective ratification of the Deeming Rule does not prevent
Plaintiffs from petitioning the FDA to repeal or amend the rule in light of the intervening studies.
See 5 U.S.C. § 553(e) (“Each agency shall give an interested person the right to petition for the
issuance, amendment, or repeal of a rule.”); cf. CTS Corp. v. EPA, 759 F.3d 52, 65 (D.C. Cir.
2014) (denying review based on the inability to comment on post-promulgation studies being
added to the final record because plaintiff “could have petitioned the EPA for either
reconsideration or a new rulemaking, or to reopen the notice-and-comment period.”). If
Plaintiffs are not satisfied with the agency’s response, they can seek judicial review. See id.§§ 702, 706; see also Shipbuilders Council of Am. v. United States, 868 F.2d 452, 456 (D.C. Cir.
1989) (“The denial of . . . a [section 553(e)] petition is subject to judicial review, provided that
the petitioner can establish the requisite article III standing.”).
In any case, the studies cited by Plaintiffs do not give the Court pause about whether a
new notice-and-comment period would have yielded different results. See Doolin, 139 F.3d at
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212–13. 4 The FDA considered studies that purported to show that e-cigarettes may be effective
as smoking cessation devices and healthier in some respects than conventional cigarettes. But it
nevertheless concluded that e-cigarettes “clearly have the potential to increase tobacco use and
net health costs for the public as a whole.” Nicopure Labs, 944 F.3d at 275 (citing 81 Fed. Reg.
at 29,038). It is that ultimate conclusion which led the FDA to deem e-cigarettes subject to the
Tobacco Control Act. Though the new studies Plaintiffs raise here may add to the quantum of
evidence, there is no indication whatsoever that they alone would have upset the balance struck
by the agency.
Finally, Plaintiffs have failed to show any “‘continuing prejudice’ from the [alleged]
violations.” Wilkes-Barre, 857 F.3d at 372 (quoting Legi-Tech, 75 F.3d at 708–09). The Court
will not presume that any taint from the alleged Appointments Clause violation continued after
the rule was ratified. Legi-Tech, 75 F.3d at 708. And there is no indication that either of the
ratifiers were “biased” by the alleged improper promulgation of the rule. See Legi-Tech, 75 F.3d
at 709; Wilkes-Barre, 857 F.3d at 372. Without such a showing, the Court may not look behind
the decision-making process that led to the ratifications. It must take them “at face value and
treat [them] as an adequate remedy” for any potential Appointments Clause violation. Legi-
Tech, 75 F.3d at 709.
The Court therefore finds the ratifications effective.
4
Plaintiffs also cite the FDA’s adjustment of compliance dates as evidence that a new
rulemaking would yield a different result. Pls.’ Reply/Opp’n 26–27. But while the Court does
not discount the importance of compliance deadlines to the industry, that the FDA has extended
them says little about whether it would reissue the substantive aspects of the rule.
15
b. Ratification is Resolution on the Merits
Plaintiffs contend that their Appointments Clause challenge survives even if the
ratifications were effective. They argue that ratifications in actions challenging a rulemaking
merely moot the case (rather than operate as a decision on the merits) and that the voluntary-
cessation exception to mootness applies to the ratifications here. Pls.’ MSJ 37–40. Plaintiffs
maintain that because there is no guarantee that the FDA will not simply continue its purportedly
illegal practice of having the ACP sign final rules, the Court retains jurisdiction notwithstanding
the effectiveness of the ratifications.
Again, Plaintiffs run headlong into D.C. Circuit precedent. The Circuit has “repeatedly
held that a properly appointed official’s ratification of an allegedly improper official’s prior
action, rather than mooting a claim, resolves the claim on the merits by remedying the defect (if
any) from the initial appointment.” Guedes v. Bureau of Alcohol, Tobacco, Firearms and
Explosives, 920 F.3d 1, 13 (D.C. Cir. 2019) (cleaned up); see e.g., Wilkes-Barre, 857 F.3d at 371
(reaffirming that “[r]atification can remedy defects arising from the decisions of improperly
appointed officials”). That rule make sense. Whether the FDA issues future rules through an
improperly appointed officer is irrelevant to whether the Deeming Rule—the only rule
challenged here—is valid. It is valid because it was ratified. Yet to be promulgated rules, that
may or may not pose Appointments Clause concerns and may or may not affect these Plaintiffs,
must await a different case. A challenge to them is too speculative in nature to be considered in
this suit. Plaintiffs can (and should) raise potential Appointments Clause violations to the
agency during such future rules’ notice-and-comment periods to give the FDA the chance to
confront any problems before they materialize.
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Plaintiffs attempt to distinguish the well-established principle that ratification resolves
Appointments Clause issues on the merits by highlighting that the relevant D.C. Circuit opinions
all involved defenses to enforcement actions as opposed to independent, pre-enforcement
challenges. Pls.’ MSJ 37–38. That difference, to Plaintiffs, warrants rejecting the general rule
and finding that the ratifications here merely moot their claim. Id. Plaintiffs primarily rely on
the Guedes panel’s discussion of ratification and mootness, id. (quoting Guedes, 920 F.3d at 12–
17), but they read Guedes too far. That case involved President Trump’s appointment of Acting
Attorney General Whitaker under the Federal Vacancies Reform Act, after Attorney General
Sessions resigned and before Attorney General Barr was nominated and confirmed. Guedes, 920
F.3d at 9. Although most of the rulemaking process at issue took place under General Sessions,
it was Acting General Whitaker who signed the final rule. After General Barr was confirmed, he
announced—similar to Commissioner Gottlieb here—that he had “independently reevaluate[d]”
the rule and the “underlying rulemaking record” and that he “personally c[a]me to the conclusion
that it is appropriate to ratify and affirm the final rule.” Id. at 9. The Guedes plaintiffs conceded
that the ratification was effective, and the Circuit held—on appeal of a denial of preliminary
injunctive relief—that “with th[e] act of ratification and the concession, [the plaintiff’s]
likelihood of success on the merits of his challenge to the rule based on Acting Attorney General
Whitaker’s role in its promulgation reduces to zero.” Id. at 12 (emphasis added). The
ratification meant that the plaintiffs would be unable to succeed on the merits because the
ratification resolved the merits of their pre-enforcement Appointments Clause challenge. Full
stop. Admittedly, the panel went on to address in dicta why the claim still lacked a likelihood of
success even if they were to adopt the proposed analytical approach that ratification merely
moots a claim. Id. at 14–17. But the panel assuredly did not adopt that approach, and its belt-
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and-suspenders mootness discussion does nothing to alter or undermine its fundamental holding,
which this Court is bound to apply: Ratification resolves potential Appointments Clause errors
on the merits. Id. at 13.
B. The First Amendment
Plaintiffs also challenge the rule under the First Amendment. E.g. Moose Jooce Compl.
¶¶ 54–57. They argue that the FDA’s premarket review of e-cigarettes that purport to reduce
harm or the risk of disease is an impermissible restriction on commercial speech because it puts
the burden on speakers (i.e., e-cigarette manufacturers) to prove that their marketing materials
are truthful and not misleading. E.g. Moose Jooce Compl. ¶¶ 55–56. The Court stayed the
briefing on the First Amendment arguments pending the D.C. Circuits ruling in a case raising
almost identically arguments. Once the Circuit issued that ruling in early December 2019, see
Nicopure Labs, 944 F.3d 267 (D.C. Cir. 2019), the Court sought the views of the parties on
whether Plaintiffs’ arguments were now foreclosed or required further briefing. The parties
disagreed on how to proceed: Plaintiffs argued that further briefing is required, while
Defendants argued that Nicopure Labs resolved Plaintiffs’ arguments.
The Court concludes that Nicopure Labs forecloses Plaintiffs’ First Amendment claim.
Plaintiffs maintain that Nicopure Labs is distinguishable because it merely “give[s] FDA the
power to prohibit truthful, non-misleading speech if such speech is determined not to
significantly reduce harm or to benefit the general public health” but does not “address[] at all
the constitutionality of the Act’s placement of the burden of proof entirely on the manufacturer-
speaker, which is the focus of Plaintiffs’ First Amendment claim.” JSR, at 5. The Court
disagrees. The Circuit expressly held that “[p]lacing an obligation on a manufacturer to
demonstrate that an e-cigarette is in fact safer before it may market it as such easily” passes First
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Amendment scrutiny. Nicopure Labs, 944 F.3d at 284; see also id. at 288 (rejecting several
industry arguments that it claimed FDA did not adequately considered because “[e]ach of those
suggestions seeks to place the onus on the government, rather than the manufacturers”). The
Circuit quite clearly held that placing the burden on manufacturers to substantiate their
marketing claims does not violate the First Amendment. Bound by that precedent, the Court
holds that the Tobacco Control Act’s premarket review provisions do not impermissibly burden
speech.
IV. Conclusion
For the foregoing reasons, the Court will deny Plaintiff’s Motion for Partial Summary
Judgement and grant the FDA’s Cross-Motion for Partial Summary Judgment on the
Appointments Clause claim. The Court will also, sua sponte, grant Summary Judgment for the
FDA on Plaintiffs’ First Amendment Claim. A separate Order shall accompany this
memorandum opinion.
CHRISTOPHER R. COOPER
United States District Judge
Date: February 11, 2020
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