UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
MOOSE JOOCE, et al. , Plaintiff s ,

v. FOOD AND DRUG ADMINISTRATION, et al. , Defendant s
. Case No. 18

- cv - 203 ( CRC )

RAVE SALON, INC. d/b/a JOOSIE VAPES, Plaintiff ,

v. FOOD AND DRUG ADMINISTRATION, et al. , Defendant s
. Case No. 18

- cv - 1615 (CRC)

JEN HOBAN d/b/a MASTERPIECE VAPORS, et al. , Plaintiff s,

v. FOOD AND DRUG ADMINISTRATION, et al. , Defendant s
. Case No. 19

- cv - 372 (CRC)

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 to2 regulate electronic cigarettes. 1 It did so by issuing a final rule that deem ed 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

- c igarette manufacturers and retailers challenge the Deeming Rule under the Appointments Clause and the First Amendment of the
U.S. Constitution. First, t hey contend that the rule violates the Appoint ments 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 wer e 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 requir ement 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 . S ince 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 Th is Opinion uses the term “e

- cigarettes” to refer to all e lectronic n icotine d elivery s ystems ( 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 cigarett es, and electronic devices that resemble everyday objects like flash drives.3 substantially similar claim . The Court finds that Nicopure Labs directly controls the question raised here and requires dismissa l 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 tobacc o, 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

. T he FDA Commissioner , in turn, reserved the power to “continue to exercise all delegated authority.” 2012 SMG § 1410.21(1)(G)(1), J.A. 43; i d. § 1410.21(1)(A),
J.A. 40.
In 201 4 , the FDA issued a Notice of Proposed Rulemaking, signed by the A CP , 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 Comm issioner and the Associate Commissioner as those positions had the same relevant responsibility, namely to promulgate rules for the FDA under the Tobacco Control Act.4 under the To bacco Control Act. 80 Fed. Reg. 23,14 1 ( Apr. 25, 2014 ) , J.A. 141

. At least one of the P laintiffs 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 Smoki ng Prevention and Tobacco Control Act (Aug. 6, 2014),
J.A. FDA 125272

– 74. None of the more than 135,000 comment er s challenged the ACP’s authority to sign the proposed or final rule. The f inal Deeming Rule , also signed by the ACP, was issued two years la ter. 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 includ ed studies showing that e cigarettes have the potential ability to help adults quit smok ing conventional cigarettes , as we ll

as studies indicating that young people who vap e are more likely to begin smok ing cigarettes . 81 Fed. Reg. at 29,036

– 41 , J.A. 314

– 1 9

. Balancing all the evidence , the FDA decided that risks of nicotine addiction for non - smoking youth outweighed the pur ported (and disputed) benefits of smoking cessation for adult s
. Id.
T he Deeming Rule subjects e - cigarettes to the Tobacco Control Act and regulates their distribution, marketing, and labeling in two general ways: first, t o reduce youth access, it bans sales to people under 18, requires ID checks for people under 26, and bans vending machine sales except in ad ult

- only facilities , 81 Fed. Reg. at 29,057, J.A. 335 ; second, t o 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

. In5 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 produc t “is safer than other tobacco products” before it may market it as such. The Act requires manufacture r s “to substantiate such claims with evidence of their overall public health effects in advance of marketing, and to show that the proposed product as ma rketed will not mislead consumers as to its safety.” Nicopure Labs , 944 F.3d at 284. Since its issuance, t he 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

— a s a part of a broad agency reorganization. J.A. 144. And a fter this litigation began, Commissioner Scott Gottlieb specifically ratified the Deeming Rule in April 2019. J.A. 23 1. 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, b etween the time of the Rule’s promulgation and the
Co mmissioners’ ratification s , se veral 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 who6 smok e conventional cigarette s
. Id. at 34. Also during th is interim period, the FDA issued guidance do cuments that have adjusted some of the compliance deadlines in the final rule

. Id. Three sets of p laintiffs filed suit against the FDA alleg ing that the ACP was not appointed consistent with the Appointments Clause and , therefore, that her execution of th e notice of proposed rulemaking and the fi nal r ule re quires the court to “set aside” the Deeming Rule. See, e.g. , Moose Jooce Compl. ¶ ¶ 5 0

– 5 2 (quoting APA § 706(2)(A))

. The parties have filed cross

- motions for summary judgment on that issue. The Court h eld a hearing on October
22 , 2019.
P laintiffs 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 t he D.C. Circuit decided that case in early December 2019 , the Court asked the parties whether additional briefing was required. Plaintiffs respond ed that further briefing is necessary beca us e the issue decided by the Circuit is distinguishable from the issues raised here , while the FDA maintain ed that the Circuit’s opinion clearly foreclose s Plaintiffs’ First Amendment claim

. See Joint Status R eport ( “ JSR ” ) (Dec. 17, 2019), EC F 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 violate s the Appointments Clause is a pure question of law that is properly decided by summary judgment. S ee, e.g. , Estes v. U.S. Dep’t of the Treasury , 219 F. Sup p. 3d 17, 38

– 39 (D.D.C. 2016) ; see also 5 U.S.C. § 706(2)(A) (requiring courts to “hold unlawful and7 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 th e [relevant] agency during the rulemaking in order for the court to consider the issu e, ” Tex Tin Corp. v. EPA , 935 F.2d 1321, 1323 (D.C. Cir. 1991) , a nd 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 Car rier 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. Copyrigh t 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.” Freyta g , 501
U.S. at 879 (explaining , in the context of an agency adjudication, that avoiding “t he 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. 530,8 535

– 536 (1962) (Harlan, J., plurality opinion ) ) ). The Court chooses it exercise its discretion here. U nlike the appellant in Intercollegiate I , Plaintiffs ha ve offered a reason to “depart from [the] normal forfeiture rule” and have offered a strong “ justification for its delay

. ” 574 F.3d at
756

. R ulemaking is di fferent from adjudication. S ee Citizens Coal Council v. EPA , 447 F.3d 879, 904 n.25 (6th Cir. 2006) (noting that forfeiture rule s “ should not be applied freely in both ” rulemaking and adjudication contexts , “ given the fundamental differences between the t wo endeavors ”). Even though the forfeiture rule s may appl y 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 la ter 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 esoter ic 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 repr esented 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 , s ee Part III.B., supra
.9 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 the ir 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 ru les . But the Deeming Rule was ratified by two different FDA Commissioners after its publication in May
2016 , and t he D.C. Circuit has repeatedly held that an agency’s ratification of a prior decision or action cures any potential Appointments Clause viola tion 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. 3 d 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 P laintiffs ’ burden to present evidence

— beyond the mere fact of ratification

— “to suggest that the [agency] failed to conduct an independent evaluation of the merit s 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 vi olation. Legi

- Tech , 75 F. 3 d at 7 08

– 09 (refusing to “forc[e] the [agency] to start at the beginning of the administrative process”)

. The test is akin to “harmless10 error” under the APA. Doolin , 139 F.3d at 212

– 13 (explaining that t he test for whether rati fication 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’”). Und er this test, Plaintiffs bear the burden of provid ing 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 rat ification “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

c ourts 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 d egree of prejudice

— if it exists

— requires dismissal.” Legi

- Tech , 75 F.3d at 708; see Intercollegiate III , 796 F.3d at 12 4 ( “ [T] he subsequent proceeding is constitutionally suspect only if there is sufficient continuing taint arising from the first.” ). T he 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 stan dard 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. R ulemakings 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 no11 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 a pplied 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 proc eeding 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 A ppointments 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. T hese courts have consistently h e ld that a rulemaking “that would otherwise be unlawful due to pro cedural 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 17 7, 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 hav e consistently declined to impose formalistic procedural requirements12 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

ra tification 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 Gottl ie b cured any potent i al 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. Commi ssioner 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

. T he Court must therefore take Commissioner Gottlieb’s ratification “at face value.” Legi

- Tech , 75 F. 3 d 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 la cked 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. Pl aintiffs ’ 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 be13 taken “at face value,” unless a plaintiff provides contrary evidence. Legi

- Tech , 75 F. 3 d at 709. That evidence must be something more than the mere fact that the decision is being ratified. As
P laintiffs 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 Cla use 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
in tervening 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. Th is 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
tr ibe wished to conduct gaming ope rations based on a years - old legal opinion by the

3 Citing Legi

- Tech , Plaintiffs assert that a court must find that it is “virtually inconc eivable” 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

- Te ch . 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 “hum an 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 ratific ation. Id. at 708.14 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 d ecision. 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, “ r egardless of the type of admini strative 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 ei ther 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, t he studies cited by Plaintiffs do not gi ve the Court pause about whether a new notice

- and

- comment period would have yield ed different results. See Doolin , 139 F.3d at15 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 . B ut it nevertheless concluded that e - cigarettes “clearly have the potential to increas e tobacco use and net health costs for the public as a whole.” Nicopure Labs , 944 F.3d at 275 (citing 81 Fed. Reg. at 29,03 8). 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 [a lleged] 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 w ere “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 ratification s . It must take them “at face value and
treat [them] as an adequate remedy” for an y 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 t o the industry, that the FDA has extended them says little about whether it would reissue the substantive aspects of the rule.16 b. Ratification is Resolution on the Merits Plaintiffs contend that their Appointments Clause challenge survives even if the ratifications were effective

. They argue that ratification s in actions challenging a rule making 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 notwithstan ding the effectiveness of the r atifications

. Again, Plaintiffs run headlong into D.C. Circuit precedent. T he C ircuit has “repeatedly held that a p roperly 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 ( reaffirm ing that “[r]atification can remedy defects arising from the decisions of improperly appointed officials” ). T hat rule make sense. Whether the FDA issue s 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. Y et to be promulgated rules, that may or may not p ose 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 period s to give the FDA the chance to confront any problems before they materialize

.17 Plaintif fs attempt to distinguish th e 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, pr e - enforcement challenges

. Pls.’ MSJ 37

– 38. That difference, to Plaintiffs, warrants reject ing the general rule and find ing that the ratifications here merely moot their claim. Id. Plaintiffs primarily rely on the Guedes panel ’s discuss ion 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 Ba rr 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 th e ratification was effective , and the Circuit held

— on appeal of a denial of preliminary injuncti ve 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 ratific ation resolved the merits of their pre - enforcement Appointments Clause c hallenge

. 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

-18 and

- suspenders mootness discussion does not hing to alter or undermine its fundame ntal 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 speaker s ( i .e
. , e - cigarette manufa cturers) to prove that their marke ting 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 Nico pure 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 pro ceed: Plaintiffs argued that further briefing is required, while Defendants argued that Nicopure Labs resolved Plaintiffs’ arguments

. The Court concludes that Nicopure Labs foreclose s Plaintiffs’ First Amendment claim. Plaintiffs maintai n that Nicopure Lab s i s 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 th e 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 First19 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

mar keting claim s does not violate the First Amendment

. Bound by that precedent , th e Court holds that the Tobacco Control Act’s premarket review provisions do not impermissibly burden speech.

IV. Conclusion For the foregoing reasons, the C ourt 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 Amendm ent Claim. A separate Order shall acc ompany this memorandum opinion

.

CHRISTOPHER R. COOPER United States District Judge
Date: February 11, 2020