Congressman Byron Donalds has announced the introduction of legislation to protect small and family-owned cigar businesses in the U.S. from overly-burdensome federal regulation.
The legislation would accomplish the goals of clarifying the ambiguity surrounding premium cigars by “enshrining case law rulings into statute.” It would also ensure that the U.S. Food and Drug Administration “focuses on its mission with regard to tobacco rather than imposing a regulatory regime on a credible industry that is globally respected.”
H.R. 2111 – “Cutting the Invasive Government’s Arbitrary Regulations (CIGAR) Act” is the 9th piece of legislation introduced by Congressman Donalds during the 119th Congress. The bill has received bipartisan support from Representatives Mario Díaz-Balart, Nick Langworthy, Dina Titus, and Jimmy Panetta.
For years, the FDA struggled to determine whether there should be two categories of cigars subject to the 2009 “Family Smoking Prevention and Tobacco Control Act” (TCA): one for premium cigars and one for the rest of the cigar industry.
This has prompted discussion around how a premium cigar should be defined. Being subject to the TCA requires the small, family-owned businesses that produce premium cigars to pay significant FDA user fees (up to 5 cents per cigar sold) in addition to excise taxes, while also undergoing the time-consuming, paper-work heavy and expensive Premarket Tobacco Application process (PMTA) that FDA estimates could cost up to $400,000 per cigar style.
Premium cigar manufacturers produce thousands of styles. For example, a handcrafted 5-inch Robusto and a handcrafted 6-inch Robusto would be two different styles, yet the only difference would be the length of the cigar.
Currently, the FDA’s definition—introduced in 2020—requires a cigar to meet eight criteria to qualify:
- Wrapped in whole tobacco leaf
- Contains a 100% leaf tobacco binder
- Has at least 50% long-filler tobacco by weight
- Handmade or hand-rolled with no machinery, apart from simple tools
- Lacks a filter, nontobacco tip, or nontobacco mouthpiece
- Contains no characterizing flavor other than tobacco
- Made only with tobacco, water, and vegetable gum
- Weighs more than 6 pounds per 1,000 units
Under this definition, nearly every cigar sold in a humidor qualifies—except flavored cigars, which remain regulated.
This definition was initially proposed while the FDA was navigating two federal lawsuits. In January, an appeals court ruling rejected the government’s arguments in Cigar Association of America et al. v. United States Food and Drug Administration et al., a lawsuit that began in 2016 and continues to shape the regulatory landscape for premium cigars.
However, the ruling also sent the case back to Judge Amit P. Mehta to finalize the definition of “premium cigar.”
In addition to the premium cigar case, the agency had recently lost a lawsuit in Maryland that accused it of delaying regulations announced in 2016. In response, the FDA temporarily exempted premium cigars while it conducted further research, a move intended to satisfy both legal challenges. As a result, parts of the premium cigar lawsuit continued, while others were paused.
Though first introduced by the FDA, some industry insiders have referred to this as the “Mehta definition” due to Judge Mehta’s involvement. The FDA originally deferred enforcement on products meeting these criteria, prioritizing efforts on regulating flavored e-cigarettes and vaping products. While this definition was meant to be temporary, the government’s legal losses have made it more permanent.
