In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance document. Although a federal district court previously found the rule unconstitutional, an appeals court reversed that decision and the final rule is now in effect. In its guidance, FDA says that it will not begin enforcing until December 2025 at the earliest, but we believe it likely that the rule might yet again be postponed or vacated, as it remains the subject of ongoing litigation.
Bryan Haynes
Bryan serves clients by developing and implementing creative solutions for complex issues. Focusing in tobacco industry regulatory compliance and enforcement matters, Bryan efficiently assists clients in complying with regulatory obligations and managing risk, consistent with clients' business objectives.
State AGs File Amicus Curae Brief in US Supreme Court Case Involving Flavored E-Cigarettes
Earlier this month, 20 Democratic state attorneys general (AG) filed an amicus brief supporting the U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) of premarket tobacco applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS or e-cigarettes) currently under review by the U.S. Supreme Court. The brief not only demonstrates which side these states support, but also identifies specific enforcement priorities for these states.
FDA Proposes Submission Tracking Number Requirement for ENDS Imports
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN) to U.S. Customs and Border Protection (CBP) for imports of such products. This rule could result in the denial of entry for ENDS imports for which the manufacturer has not submitted a premarket tobacco product application (PMTA) to FDA.
Troutman Pepper Tobacco + Nicotine Team to Attend GTNF 2024
Bryan Haynes of the Troutman Pepper Tobacco + Nicotine Team will attend the Global Tobacco & Nicotine Forum (GTNF) in Athens, Greece on September 24-26, 2024. GTNF is the world’s leading annual conference discussing the future of the tobacco and nicotine industries.
The theme of GTNF 2024 is advancing responsible…
Troutman Pepper Tobacco + Nicotine Team to Attend InterTabac Trade Show
Bryan Haynes of the Troutman Pepper Tobacco + Nicotine Team will attend the InterTabac trade show in Dortmund, Germany on September 20-21.
InterTabac is known as the world’s largest trade fair for tobacco products and smoking accessories, with hundreds of exhibitors from more than fifty countries around the world. InterTabac…
Tobacco Team to Attend the Tobacco Science Research Conference
Agustin Rodriguez and Bryan Haynes will be attending the upcoming Tobacco Science Research Conference in Atlanta, GA, from September 8 to 11.
This year’s conference is focused on “Tobacco Harm Reduction: What Have We Learned and How Do We Move Forward?”
Agustin will be participating in a panel discussion on…
New Jersey Issues Notice of Violations and Fines to Retailers Allegedly in Violation of the State’s Flavor Ban
On August 27, the New Jersey Attorney General (AG) and the Division of Consumer Affairs announced that the state had issued notices of violation and $4,500 civil penalty demands to 19 retailers across New Jersey for allegedly selling banned flavored vapor products. This is New Jersey’s first public enforcement of the state’s 2020 flavor ban, and New Jersey joins a number of other state AGs taking similar action across the U.S.
Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings
In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration (FDA) from requiring graphic warnings on cigarette packs. As we noted in prior coverage, the March 2020 FDA rule at issue would require new textual, health warning statements alongside color, photorealistic images displayed on the top 50% of the front and rear panels of cigarette packs and the top 20% of cigarette advertisements.
ATF Rift With California Tribe Could Expand State Authority Over Tribal Tobacco Sales
In June, the Bureau of Alcohol, Tobacco and Firearms (ATF) argued in federal court that the federal Prevent All Cigarette Trafficking (PACT) Act requires tribal retailers to obtain state licenses to sell cigarettes on their own reservations. If accepted, ATF’s position would greatly expand the scope of state authority over tribal tobacco sales.
Eighth Circuit Decides Case Involving State’s Authority to Regulate Tribal Cigarette Sales
On August 2, the U.S. Court of Appeals for the Eighth Circuit decided a case addressing Nebraska’s authority to require tribal cigarette manufacturers that are not parties to the Master Settlement Agreement (MSA) to comply with the state’s escrow statute with respect to cigarettes sold in Indian country. See HCI Distrib., Inc. v. Peterson, No. 23-2311 (8th Cir., Aug. 2, 2024).