Synopsis

The Tobacco Control Act’s premarket authorization pathway does not violate the APA. Additionally, neither the pre-marketing authorization requirement applicable to modified risk products nor the free sample ban violate the First Amendment.

Why It Matters for Public Health

The court upheld the FDA’s regulatory authority over e-cigarettes, hookah, cigars, and all other tobacco products.

Background

The Tobacco Control Act (TCA) requires “new tobacco products,” defined as those that were commercially marketed after February 15, 2007, to go through a premarket review process and receive affirmative marketing orders before being sold in the U.S. With the issuance of FDA’s “deeming rule,” this requirement applied to all tobacco products, including, e-cigarettes and liquid nicotine.

District Court Proceedings

On May 10, 2016, Nicopure Labs, a Florida manufacturer of e-cigarette devices and liquid nicotine, filed suit in the District Court of the District of Columbia, requesting that the court permanently strike down the deeming rule and, in the meantime, prevent enforcement of the rule pending resolution of the litigation. Among other arguments, the e-cigarette companies argued that FDA violated the Tobacco Control Act and the Administrative Procedure Act by not providing an easier premarket review authorization pathway for e-cigarettes. They also claimed that the TCA violated the First Amendment in regulating their claims about modified risk products as restricting the distribution of free samples.  On June 20, 2016, eleven e-cigarette trade groups also filed suit in the District Court of the District of Columbia, similarly requesting that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeded, and asked the court to permanently strike down the rule. These two lawsuits were consolidated, and on July 21, 2017, the court granted the FDA’s motion for summary judgment, finding that the promulgation of the deeming rule did not violate the APA and that the rule did not infringe on any of the plaintiffs’ constitutional rights. The plaintiffs’ motion for summary judgment was dismissed. The plaintiffs filed an appeal to the Court of Appeals for the D.C. Circuit.

Proceedings in the Fourth Circuit Court of Appeals

On September 8, 2017, public health groups (the American Academy of Pediatrics, the American Lung Association, the American Heart Association, the American Cancer Society Cancer Action Network, the Campaign for Tobacco-Free Kids, and the Truth Initiative) filed a motion to intervene as defendants to ensure that the deeming rule was adequately defended, after the government had filed several requests to delay, in addition to its plan to postpone premarket review under the deeming rule. The plaintiffs and the government filed responses to this motion on September 28, 2017, and the potential intervenors filed their reply on October 5, 2017. On March 30, the potential intervenors filed a motion to withdraw their motion to intervene and instead moved to participate as amicus curiae.

The appellants’ brief was filed on February 12, 2018. The FDA filed its brief on May 2, 2018. Four amicus curiae briefs in support of the FDA were filed on May 9, 2018, including a brief filed by the Public Health Law Center. The appellants’ reply was filed on May 16, 2018, and final briefs were filed on June 6, 2018. Oral arguments were held on September 11, 2018.

On December 10, 2019, the A three-judge panel of the D.C. Circuit Court of Appeals upheld the decision of the lower court, noting that “it is entirely rational and nonarbitrary to apply to e-cigarettes the Act’s baseline requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with the public health.”It addressed the industry’s First Amendment arguments in stating that “the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturer has shown that they actually are safer as claimed.” The court also noted that “free samples are not expressive conduct, and in any event, the government’s interest in preventing their distribution is unrelated to the suppression of expression.” In short, the court found that “the [TCA’s] premarket authorization pathway for new products does not violate the APA, and that both the preclearance pathway for modified risk products and the free sample ban are constitutional.”

Litigation Status

No request for rehearing or petition for certiorari to the U.S. Supreme Court was filed, meaning the Court of Appeals’ decision is final.