Appeal in Tobacco Enforcement Deadline Case Dismissed

The Fourth Circuit filed an opinion dismissing the appeal in a tobacco regulation case, saying newly released guidance superseding a compliance deadline moots an appeal from the parties known as Vapor Appellants because the appeal concerns now-outdated Food and Drug Administration (FDA) guidance. The case addresses the deadline for cigars and e-cigarettes to be approved through the FDA’s Premarket Tobacco Application (PMTA) process. The 2020 guidance accelerated the PMTA compliance deadline dramatically, setting the deadline to May 12.

The FDA and health organizations argued that the 2020 guidance moots the appeal by the vapor appellants. “Any ruling by this court as to the procedural or substantive reasonableness of the August 2017 guidance would amount to nothing more than an advisory opinion,” the court said. The opinion says intervention by the “Cigar Appellants” was delayed and they “decline to disturb the district court’s ruling.” 

New tobacco products are required to submit an application and receive authorization from the Food and Drug Administration (FDA) before the products are marketed unless it is ‘substantially equivalent’ to a commercially marketed product. This includes information about the ingredients, manufacturing, labeling, and health risks. Cigars, pipe tobacco, and electronic nicotine delivery systems like e-cigarettes were not subject to this rule until May 2016.

“The FDA explained that, during that time, it did not intend to seek to administratively or judicially enforce the statutory premarket review requirements for products with submitted Premarket Tobacco Applications (PMTA) during the initial compliance period,” the opinion states. This system meant they had staggered enforcement periods and did not intend to enforce requirements until 2018.

In May 2017, the FDA issued a new deadline for all items which had been deemed ‘tobacco products’ to come into compliance with the regulations, saying it would be three months beyond the initial staggered compliance dates. Later in August, they extended the deadline to August 2021 for cigars and August 2022 for vapor products.  The case opened because of a complaint that this new deadline was issued without notice or the opportunity for public input.

Six public-health organizations and five pediatricians, each represented by Democracy Forward Foundation, filed an appeal in 2018 alleging that a new compliance deadline issued in August of 2017 for additional tobacco companies to follow regulations applying to other tobacco products did not follow correct administrative procedure. A district court ruled in favor of these appellees, saying it was a “legislative, rather than interpretive” rule and required public comment.

In January 2020 the FDA issued a separate guidance that superseded the initial deadline, setting it to May 2020. The court opinion states that this latest guidance “moots the merits of their appeal.” A draft of the 2020 guidance was provided in March of 2019 and according to the opinion received over 15,000 comments.