In what appear to be the first restrictions of their kind, the state of California and the city and county of Denver have adopted bans on flavored tobacco products that cover not only products containing tobacco and nicotine, but also nicotinic alkaloids and nicotine analogs.

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be revived under a future administration, the withdrawal ends both of the current rulemaking processes. The move also strongly indicates shifting FDA priorities under the second Trump administration. Amid these changes, industry may find the agency more receptive to its arguments—particularly those submitted in comments to proposed rulemaking.

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). As we have previously discussed here and here, FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium cigars to the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act (TCA). On January 24, the U.S. Court of Appeals for the District of Columbia Circuit (the D.C. Circuit) issued an opinion agreeing[1] with (i) the district court’s ruling that FDA acted arbitrarily and capriciously when it sought to include premium cigars in its Deeming Rule and (ii) the district court’s vacatur of the Deeming Rule as applied to premium cigars, but it remanded the case to the district court to determine the appropriate definition of “premium cigar.” Now, the district court will reconsider the appropriate definition of “premium cigar,” which will ultimately determine the types of cigars that are not subject to the TCA and FDA’s Deeming Rule. In one potential setback for industry, the D.C. Circuit also stated that it understood the district court’s order as granting relief from user fees prospectively but that it does not read it as permitting the refunding of past user fee payments.

Bryan Haynes and Agustin Rodriguez of the Troutman Pepper Locke Tobacco + Nicotine team will attend the Total Product Expo at the Las Vegas Convention Center, January 29-31, 2025.  TPE features displays from 500 plus exhibitors covering the full spectrum of tobacco and other products, including vape, modern oral nicotine

On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products.

Maximum Nicotine Level

FDA proposes to “make cigarettes and certain other combusted tobacco products minimally addictive or nonaddictive by limiting the nicotine yield of these products.” Specifically, the proposed rule would set a maximum nicotine content level of 0.70 milligrams of nicotine per gram of total tobacco. This would represent a drastic reduction in nicotine content. By comparison, one recent study — which FDA cited in the proposed rule — reported that the average nicotine content in the top 100 cigarette brands of 2017 was 17.2 milligrams of nicotine per gram of total tobacco.

On December 17, 2024, Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint[1] and motion for a preliminary injunction[2] in federal district court against the Iowa Department of Revenue (the Department) challenging Iowa House File 2677 (HF 2677), a law imposing certification and directory requirements on vapor products sold in Iowa. A hearing on the plaintiffs’ motion for a preliminary injunction is scheduled for March 5. If the court rules in the plaintiffs’ favor, it could stay enforcement of the new law until the case is ultimately resolved. While the Department was previously scheduled to publish the vapor products directory on January 2 and begin enforcement on February 3, the Department has not published the directory, and its website indicates that it will not be enforcing the directory. The Department’s website states: “Publication and enforcement of Iowa’s vapor products directory is delayed until further notice. The Department will make an additional announcement before publication and enforcement of the vapor products directory begins. During the delay, manufacturers should continue to submit certification applications.”

Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of which are unauthorized — there is little evidence that these enforcement efforts have reduced illicit sales. Indeed, some observers estimate that flavored ENDS account for more than 80% of all ENDS sales. With a new administration on the horizon, our team highlights two opportunities for FDA to step up its enforcement efforts: (1) focusing enforcement on imports and (2) authorizing premarket tobacco product applications (PMTAs) for flavored products.