The Washington, D.C., office of Troutman Pepper Locke is proud to host and sponsor the upcoming Food and Drug Law Institute Tobacco and Nicotine Products Regulatory Science Symposium on October 8. Bryan Haynes and Agustin Rodriguez of the Troutman Pepper Locke Tobacco + Nicotine team will attend.

This symposium will…

Bryan Haynes, Agustin Rodriguez, Michael Jordan, and Zie Alere of the Troutman Pepper Locke Tobacco + Nicotine team will sponsor and attend the Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference in Washington, D.C., on October 6 and 7.

This is a key annual conference on regulating tobacco and nicotine products in the United States. It will feature influential stakeholders from a diverse range of backgrounds—public health leaders, researchers, manufacturers, attorneys, consumer advocates, entrepreneurs, and federal and state regulators.

The U.S. Court of Appeals for the Fifth Circuit recently ruled in NicQuid, L.L.C. v. FDA, No. 24-60272 (5th Cir. Aug. 19, 2026), that the U.S. Food and Drug Administration’s (FDA) “comparative efficacy standard” is a substantive rule that was adopted in violation of the Administrative Procedure Act’s (APA) notice-and-comment rulemaking requirements.

The NicQuid decision notably creates a circuit split with the Ninth Circuit, which recently held in Drip More LLC v. FDA, No. 21-71380 (9th Cir. Aug. 10, 2026) that the comparative efficacy standard is not a substantive rule under the APA’s notice-and-comment requirements. We assume that FDA will appeal its loss in NicQuid—either to an en banc panel of the Fifth Circuit or to the U.S. Supreme Court.

On September 2, 2026, a group of tobacco product manufacturers and retailers filed a complaint in federal court, the U.S. District Court for the Northern District of Texas, challenging the U.S. Food and Drug Administration’s (FDA) 2021 premarket tobacco product application (PMTA) rule. Plaintiffs take aim at a regulation they say has made it virtually impossible for the FDA to authorize new tobacco products within the timeline Congress set more than 15 years ago. The case raises fundamental questions about whether a federal agency can adopt a regulatory process that, by design, cannot meet its own statutory deadlines.

This article was originally published on Law360 and is republished here with permission as it originally appeared on August 21, 2026.

On July 30, two federal appeals courts permitted the enforcement of state laws in Iowa and North Carolina conditioning the sale of electronic nicotine delivery systems, or ENDS, on a manufacturer’s certification of compliance with U.S. Food and Drug Administration premarket review requirements.[1]

Our team recently attended, and presented at, the 100th Annual Meeting of the Federation of Tax Administrators (FTA) Tobacco Tax Section in Washington, D.C., which brought together state tobacco tax administrators, excise tax professionals, attorneys general, compliance officers, tax filing solution providers, and other industry stakeholders. Despite the challenge of navigating our Nation’s Capital in light of preparation for the Freedom 250 Grand Prix, we are glad we had the opportunity to attend and connect with colleagues to advance thought leadership in the tobacco and nicotine industry. The meeting included a line-up of speakers who discussed topics highly relevant to industry, and we wanted to highlight a few themes that emerged related to state vapor and nicotine product directories, nicotine analogues, enforcement, and destruction of illicit vapor products.

The U.S. Food and Drug Administration (FDA) cigarette graphic health warning saga continues. On August 18, 2026, the U.S. Court of Appeals for the Fifth Circuit issued a decision in R.J. Reynolds Tobacco Co. v. FDA, No. 25-40137, affirming the Eastern District of Texas’ order postponing the effective date of FDA’s 2020 cigarette graphic health warning rule pending a final decision on the merits. The decision delivers another significant setback for FDA’s long-running effort to require graphic images on cigarette packaging and advertisements — and provides clarity on the statutory limits of the agency’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by the 2009 Family Smoking Prevention and Tobacco Control Act (TCA).

As our Tobacco + Nicotine team previously reported, FDA’s May 8, 2026 guidance (the 2026 Guidance or the Guidance) on enforcement priorities for certain unauthorized ENDS and nicotine pouch products created a path for products with pending premarket tobacco product applications (PMTAs) to remain on the market. That Guidance is now being challenged in federal court by advocacy organizations, threatening the viability of FDA’s enforcement discretion.

In June, the U.S. District Court for the Middle District of Florida made public an order that stayed a Food and Drug Administration (FDA) refuse to file (RTF) determination, finding that the FDA likely violated the Regulatory Flexibility Act (RFA) and the Administrative Procedure Act (APA) when it promulgated its 2021 PMTA rule based on a small-business certification that the court described as “facially false.” The RTF letter is stayed pending final judgment.

On June 29, 2026, the U.S. Food and Drug Administration (FDA) published a notice of proposed rulemaking (NPRM) titled “Establishment Registration and Product Listing for Tobacco Products,” which would, for the first time, require foreign tobacco product manufacturers to register their manufacturing establishments and list their products with the agency. Domestic manufacturers are already subject to these registration and listing requirements; foreign manufacturers are not. This regulation, if finalized, would close that gap.