Premium cigars will be exempt from the proposed nicotine regulations by the U.S. Food and Drug Administration (FDA). These proposed rules are being issued in the final days of President Joe Biden’s administration. The FDA is a part of the Department of Health and Human Services (HHS).

Today, the FDA announced its proposed rules for limiting nicotine in tobacco products. The proposed limit is 0.70 milligrams per gram of tobacco. The average nicotine content for the top 100 cigarette brands in 2017 was 17.2 mg per gram of tobacco. This proposed limit is well below the nicotine levels contained by premium cigars.

Premium cigars were temporarily exempt due to the August 9, 2023, ruling of the U.S. District Court of the District of Columbia, which vacated the deeming rule. The ruling is currently being appealed, and once the deemed status is resolved, the FDA says it will consider any impacts and take additional steps in the future.

The proposed rules were published in the Federal Register on Thursday, January 16, 2025. As with all proposed regulations, they are subject to a 240-day public comment period. After the comment period closes, the FDA will work on a final rule.

Donald Trump will become the 47th President of the United States on January 20th, 2025. It is unknown what priority these proposed regulations will have in the new Trump Administration.

The details in the proposed rules that exempt premium cigars from the FDA’s proposed nicotine limits are:

On August 9, 2023, the U.S. District Court for the District of Columbia issued an order vacatingFDA’s rule deeming tobacco products to be subject to FDA’s tobacco product authorities “insofar as it applies to premium cigars.”13 Cigar Ass’n of Am. v. FDA, No. 16-cv- 01460, 2023 WL 5094869 (D.D.C. Aug. 9, 2023), appeal docketed, No. 23-5220 (D.C. Cir. argued Sept. 13, 2024). The government has appealed this decision. When the deemed status of premium cigars is resolved, FDA will consider any impacts with respect to this proposed rule and take additional steps as warranted, including, for example, by reopening the comment period and/or issuing a supplemental notice of proposed rulemaking. References to premium cigars in this document serve merely to clarify the current proposed scope of products covered, evaluate the scientific evidence related to non-premium cigars, and describe FDA’s approach to modeling the projected public health impacts of this proposed standard.

The definition of a premium cigar being considered follows:

For purposes of its ruling, the court specified that a premium cigar is a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco before rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units.