By Jeffrey H. Brochin, J.D.
FDA’s Deeming Rule that deemed e-cigarettes to be tobacco products and subject to the Tobacco Control Act was not unlawful merely because it was signed by an unappointed official.
A federal district court in the District of Columbia has ruled that the Food and Drug Administration’s (FDA’s) "Deeming Rule," which included e-cigarettes within the definition of "tobacco products," remained valid notwithstanding the fact that it was signed by an FDA official who was neither a Senate-confirmed "principal officer" nor a duly appointed and supervised "inferior officer." Because the rule was subsequently ratified by two Senate-confirmed FDA Commissioners, those ratifications were effective and cured any potential Appointments Clause defect in the rule’s issuance (Jooce Moose v. Food and Drug Administration, February 11, 2020, Cooper, C.).
2016 Deeming Rule. In response to the public health risks posed by dramatic increases in e-cigarette use ("vaping"), especially among teens, in 2016, the FDA issued a final rule that deemed e-cigarettes to be "tobacco products" subject to regulation under the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31) (Tobacco Control Act). As a result of the Deeming Rule, e-cigarettes became 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 court challenges to the rule, e-cigarette manufacturers and retailers filed lawsuits against the FDA claiming that the rule violated the Appointments Clause and the First Amendment of the U.S. Constitution. They contended that the rule violated 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." They further challenged the Tobacco Control Act’s pre-clearance provision claiming that it violated their First Amendment rights because it placed the burden on a manufacture to show that a tobacco product "is safer than other tobacco products" before they could market it as such. Their cases were consolidated into the instant case, in which the court rejected their claims for the reasons cited below.
Ratification after publication. 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. Furthermore, the manufacturers needed to establish that the alleged violation of the Appointments Clause subjected them to continuing prejudice from the conduct of the FDA.
No need to re-do notice and comment. The manufacturers contended that agency rulemakings should be treated differently because the APA’s procedural rulemaking requirements—including notice and opportunity for comment—continue until the moment of ratification. The court, however, was not persuaded by that argument, and applied the aforementioned precedent that a rulemaking that would otherwise be unlawful due to procedural or technical defects can be cured through a subsequent ratification. Because the manufacturers did not meet their burden to show that any Appointments Clause violation was prejudicial and that redoing the administrative process would yield a different result, the Deeming Rule was upheld and their Appointments Clause claim dismissed.
First Amendment claim. In support of their First Amendment violation claim, the manufacturers argued that the FDA’s premarket review of e-cigarettes that purported to reduce harm or the risk of disease placed an impermissible restriction on commercial speech because it put the burden on the e-cigarette manufacturers to prove that their marketing materials were truthful and not misleading. Again, the court disagreed, ruling that placing 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 Amendment scrutiny based on the Circuit’s decision in Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019), which resolved that very argument when it ruled that placing the burden on manufacturers to substantiate their marketing claims does not violate the First Amendment.
For the foregoing reasons, the court dismissed both the Appointments Clause claim and the First Amendment claim.
The case is No. 1:18-cv-00203-CRC.
Attorneys: Damien M. Schiff (Pacific Legal Foundation) for Moose Jooce. Garrett Joseph Coyle, U.S. Department of Justice, for Food and Drug Administration.
Companies: Food and Drug Administration
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