What the Rule Said
On May 10, 2016, the U.S. Food and Drug Administration published its final deeming rule in the Federal Register under docket FDA-2014-N-0189 , formally titled "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act." The rule took effect August 8, 2016. Its operative mechanism was to exercise the authority granted to the FDA under the Family Smoking Prevention and Tobacco Control Act of 2009, which permits the agency to "deem" additional tobacco products subject to Chapter IX of that statute — the chapter governing manufacturer registration, product listing, ingredient reporting, and the premarket review framework.
Four product categories came in under the rule: electronic cigarettes and e-liquids, cigars (both premium and machine-made), hookah tobacco (also marketed as waterpipe tobacco), and pipe tobacco. Cigarettes, smokeless tobacco, and roll-your-own tobacco had been covered since the 2009 act itself. The deeming rule's addition of e-cigarettes was the provision drawing the most immediate attention; by 2016 the domestic e-cigarette market had grown substantially, and no product in the category had yet undergone premarket tobacco product application — PMTA — review.
The proposed standard reaches the number only after hundreds of pages of preamble.
Photo: Mikhail Nilov / Pexels
The rule also carried several immediate prohibitions: manufacturers of newly deemed products could no longer distribute free samples, could not sell the products to anyone under 18, and were barred from making modified-risk claims without FDA authorisation. Vending-machine sales of the newly covered products were restricted to adult-only facilities.
Compliance Deadlines and Their Revisions
The August 2016 effective date did not mean immediate PMTA filings. The FDA established a compliance period during which manufacturers could continue selling existing products while applications were prepared. The original deadline for PMTA submissions for products on the market before August 8, 2016, was set at two years — August 2018. That deadline was extended administratively to August 2021, a shift formalised through guidance documents and subsequently contested in federal court.
In May 2019, the U.S. District Court for the District of Maryland, in American Academy of Pediatrics v. FDA, ordered the FDA to comply with a PMTA submission deadline of May 12, 2020 , for e-cigarettes specifically, ruling that the agency's unilateral extension exceeded its discretion. The FDA ultimately accepted applications by September 9, 2020, under a further negotiated extension also ratified by the court, and began issuing marketing denial orders and authorisations through 2022 and 2023. JUUL Labs received a marketing denial order in June 2022 — subsequently stayed pending review — while IQOS had already received authorisation in a separate pathway in 2019.
Key dates
- May 10, 2016deeming rule published in Federal Register, docket FDA-2014-N-0189
- August 8, 2016rule takes effect; four product categories newly subject to Chapter IX
- August 2018original PMTA submission deadline for pre-market products
- May 2019American Academy of Pediatrics v. FDA (D. Md.) orders accelerated deadline
- September 9, 2020FDA's final extended PMTA submission deadline for e-cigarettes
- June 2022JUUL Labs marketing denial order issued, then stayed
The Litigation Landscape
Industry challenges to the deeming rule concentrated on scope and burden. Cigar manufacturers, arguing that large premium cigars posed different risks from cigarettes, filed suits seeking categorical exemption. The FDA had considered but declined to exempt premium cigars in 2016, a decision plaintiffs challenged in Cigar Association of America v. FDA, which produced multiple rounds of briefing in the D.C. Circuit through the late 2010s and into the 2020s.
The deeming rule also intersected with state and local regulation. Several municipalities had enacted e-cigarette restrictions before 2016; after the rule, the question of federal preemption of more stringent local rules arose in various proceedings, though the Tobacco Control Act's preemption clause is limited to requirements that differ from, rather than are identical to or stricter than, federal standards — a distinction courts have interpreted narrowly.
By the time the FDA's Center for Tobacco Products was processing thousands of PMTA submissions in 2021 and 2022, the deeming rule had become less a discrete regulatory event than the foundation layer of an ongoing and heavily litigated federal oversight system.
