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Bryan Haynes serves clients by developing and implementing creative solutions for complex issues. Specializing 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.

In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River) from the state tobacco directory based on Grand River’s alleged violations of the Federal Food, Drug, and Cosmetics Act (FDCA). The FDCA preempts state law actions based solely on FDCA violations if the U.S. Food and Drug Administration (FDA) has not already found that such violations exist, the court explained.Continue Reading Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer

In the first half of 2024, the U.S. Food and Drug Administration (FDA) continued ramping up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened enforcement against sellers of unauthorized ENDS in 2023 and predicted that this pattern of enforcement would continue. A year-to-date review of 2024 shows that FDA is placing a high priority on action against unauthorized ENDS. Continue Reading FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

We have previously reported on the proliferation of tobacco product flavor bans imposed by localities and subsequent legal challenges throughout the U.S. See Oregon Court Upholds Local Tobacco Product Flavor BanTroutman Pepper Tobacco Team Featured in Vapor Voice Post on Ninth Circuit’s Holding that L.A. County’s Flavor Ban Is Not Preempted

The Food and Drug Law Institute’s 2024 Annual Conference is happening May 15-16, 2024! Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine team will be participating in a panel discussion on “State Regulation of Nicotine Products: Evaluating Flavor Bans and Registration Lists.” Agustin’s panel will discuss actions being taken at the state and local

In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and Cosmetic Act (FDCA), known as the “Deeming Rule.” This decision exempted premium cigars from FDA’s tobacco product authorities. In September 2023, however, FDA appealed, and the U.S. Circuit Court of Appeals for the D.C. Circuit is currently weighing the matter. So, what would it take for FDA to succeed on appeal, and what is at stake for the premium cigar industry?Continue Reading What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco product including product names, company names, categories (e.g., cigarette, roll-your-own, e-cigarette, cigar, heated tobacco product), sub-categories (e.g., e- components, filler, leaf wrap), source of U.S. marketing authority (e.g., marketing granted order, substantially equivalent order, found exempt order), and the date of FDA’s action on the tobacco products. FDA indicates that it plans to update the database on a monthly basis. This database is helpful to industry members seeking more transparency from FDA about which products are authorized for sale in the U.S. The database is not, however, without limitations.Continue Reading FDA Launches Legally Marketed Tobacco Products Database

Mark your calendars for the TMA 2024 Annual Meeting and Conference! The Troutman Pepper Tobacco + Nicotine team will be in attendance, with our very own Bryan Haynes participating in a panel discussion, “Taking Stock: Discussions on Legal Challenges and What Comes Next.” Bryan will discuss court actions challenging the Center for Tobacco Products’ decisions

On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its already-proposed rule banning menthol as a characterizing flavor in combustible cigarettes. The case comes as FDA has missed several internal deadlines for promulgating a final rule on the topic.Continue Reading Advocacy Organizations Sue FDA Over Delay in Menthol Cigarette Ban

The Massachusetts Supreme Judicial Court (SJC) recently upheld, in a unanimous decision, the town of Brookline’s ordinance banning the sale of tobacco and e-cigarette products to anyone born after Jan. 1, 2000 (the Tobacco Sales Ban). Brookline is the first U.S. locality to impose a tobacco sales ban based on a specific date.Continue Reading Massachusetts High Court Upholds Local Tobacco Sales Ban