CTP Statement on Premarket Authorization Requirements for Premium Cigars
August 26, 2020
On June 11, 2021, FDA announced the withdrawal of the Unified Agenda entry pertaining to the ANPRM for premium cigars as well as a related request for information (RFI) and posted a web statement about this action. FDA expects to update the public in Spring 2022.
On Aug. 19, 2020, the U.S. District Court for the District of Columbia issued a ruling, in part, to prohibit FDA enforcement of the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the agency considers developing a streamlined substantial equivalence process specifically for premium cigars. FDA will provide further updates on this topic as appropriate.
Accordingly, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline. For purposes of the Court’s order, a premium cigar is defined as a cigar that meets all of the following eight criteria:
- Is wrapped in whole tobacco leaf;
- Contains a 100 percent leaf tobacco binder;
- 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);
- Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
- Has no filter, nontobacco tip, or nontobacco mouthpiece;
- Does not have a characterizing flavor other than tobacco;
- Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and
- Weighs more than 6 pounds per 1,000 units.
Earlier this month, FDA submitted a filing with the U.S. District Court of Maryland on the topic of a potential process for case-by-case deferral of the deadline for submission of premarket applications for premium cigars, including the proposed definition of “premium cigars” being used in the U.S. District Court for the District of Columbia’s order. Following the U.S. District Court for the District of Columbia’s decision, FDA has withdrawn its letter. However, as stated in that letter, the agency intends to undertake a research effort specific to premium cigars and their health effects, patterns of use (such as frequency of use and usage patterns among underage persons), and other factors. The results of this research will inform the FDA’s regulatory policy with respect to the premarket review of premium cigars.
For more information about the upcoming Sept. 9 deadline, please visit FDA’s web hub on the topic.