Jooce v. Food & Drug Admin.

MOOSE JOOCE, et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.

RAVE SALON, INC. d/b/a JOOSIE VAPES, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.

JEN HOBAN d/b/a MASTERPIECE VAPORS, et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants.

Case No. 18-cv-203 (CRC)

Case No. 18-cv-1615 (CRC)

Case No. 19-cv-372 (CRC)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

February 11, 2020

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 asubstantially 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 regulationunder 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. Inaddition, 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 whosmoke 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(...