To amend the Federal Food, Drug, and Cosmetic Act to exempt the premium cigar industry from certain regulations.

Bill Number

H.R. 2111

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-03-14: Referred to the House Committee on Energy and Commerce.

Last Updated

2025-11-13T09:05:22Z

AI-Generated Summary

Purpose of the Legislation

This bill, H.R. 2111, seeks to exempt premium cigars from being classified as "tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The goal is to remove certain federal regulations imposed by the Food and Drug Administration (FDA) on these products, based on findings that premium cigars pose lower health risks and are used primarily by adults in limited quantities.

Key Provisions

• Findings Section: Congress outlines 16 facts supporting the exemption, drawing from a 2022 National Academies of Sciences, Engineering, and Medicine (NASEM) report. These include:
• Premium cigars represent only 1% of U.S. cigar sales and are produced by small, family-owned businesses.
• They are sold in age-restricted venues like tobacco shops or cigar bars.
• Usage is low (1% of adults), rare among youth (0.6% under 18), and less common among women, non-Hispanic Black individuals, and those with lower education.
• Users smoke them less frequently and intensely than other tobacco products, with lower inhalation and health risks compared to cigarettes or other cigars.
• The NASEM report suggests premium cigars have fewer health consequences overall due to occasional use and adult exclusivity.
• References a federal court ruling that premium cigars' limited risks can be handled by state regulations.
• Exemption and Definition Section: Amends the FD&C Act (Section 201(rr)) to exclude "premium cigars" from the definition of "tobacco product." A premium cigar is defined as one that:
• Is wrapped in whole tobacco leaf.
• Has a 100% leaf tobacco binder.
• Contains at least 50% long filler tobacco (whole leaves running the cigar's length, by filler weight).
• Is handmade or hand-rolled (using only simple tools like scissors, no machinery).
• Lacks a filter, non-tobacco tip, or non-tobacco mouthpiece.
• Has no added flavors beyond tobacco.
• Contains only tobacco, water, and vegetable gum (no other additives).
• Weighs more than 6 pounds per 1,000 units.

Significant Changes to Existing Law

• Currently, the FD&C Act regulates most tobacco products, including cigars, under FDA authority (established by the 2009 Family Smoking Prevention and Tobacco Control Act). This bill introduces a new exemption, carving out premium cigars from federal oversight.
• It adopts a narrower definition of premium cigars than the NASEM report's broader one, aligning with a recent U.S. District Court decision (by Judge Amit P. Mehta) that struck down an FDA attempt to regulate them.
• This shifts regulation of premium cigars primarily to states, as noted in the court's findings, rather than federal mandates like premarket approval, warning labels, or marketing restrictions.

Potential Impacts

• On Government Agencies: Reduces the FDA's regulatory burden by excluding premium cigars from tobacco product reviews, enforcement, and compliance monitoring, potentially freeing resources for other products. States may need to develop or strengthen their own rules on sales, taxes, and health warnings.
• On Citizens: Adult consumers of premium cigars could face fewer federal restrictions on access and sales, but youth and non-users might see minimal change since usage is already low. Health advocates worry about reduced federal protections, though the bill emphasizes lower risks.
• On International Relations: No direct impacts, as the bill focuses on domestic U.S. sales and production; it does not address imports or exports explicitly.

Main Stakeholders Affected

• Premium Cigar Manufacturers and Retailers: Primarily small, family-owned businesses and specialty shops, who benefit from reduced federal compliance costs and regulatory hurdles.
• Consumers: Adult users (mostly occasional smokers) gain easier access; youth and vulnerable groups (e.g., women, minorities) are indirectly affected through potential state-level protections.
• Government Entities: FDA faces diminished authority; state health departments may take on more responsibility.
• Public Health Organizations: Groups like the NASEM or anti-tobacco advocates could oppose the exemption, citing any remaining health risks from cigar use.

Notable Legal, Constitutional, or Political Implications

• Legal: Reinforces a federal court ruling by codifying the exemption, potentially limiting future FDA challenges to premium cigar regulation. It clarifies the FD&C Act's scope, reducing ambiguity in product definitions.
• Constitutional: Touches on federalism (division of powers between federal and state governments) by deferring to states for regulation, aligning with the court's view that federal overreach is unnecessary for low-risk products.
• Political: Bipartisan support (sponsors from both parties) highlights a niche industry focus; it could spark debates on tobacco control consistency, especially amid broader efforts to curb youth vaping and smoking. No major constitutional challenges are evident, but it may invite lawsuits from health groups arguing insufficient public health safeguards.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Donalds, Byron [R-FL-19]

Cosponsors (16)

Rep. Langworthy, Nicholas A. [R-NY-23], Rep. Titus, Dina [D-NV-1], Rep. Panetta, Jimmy [D-CA-19], Rep. Diaz-Balart, Mario [R-FL-26], Rep. Calvert, Ken [R-CA-41], Rep. Horsford, Steven [D-NV-4], Rep. Carter, Troy A. [D-LA-2], Rep. Tenney, Claudia [R-NY-24], Rep. Franklin, Scott [R-FL-18], Rep. Cuellar, Henry [D-TX-28], Rep. Boyle, Brendan F. [D-PA-2], Rep. Figures, Shomari [D-AL-2], Rep. Espaillat, Adriano [D-NY-13], Rep. Jackson, Ronny [R-TX-13], Rep. Vasquez, Gabe [D-NM-2], Rep. Jackson, Jonathan L. [D-IL-1]

Recent Actions

• 2025-03-14: Referred to the House Committee on Energy and Commerce.
• 2025-03-14: Introduced in House
• 2025-03-14: Introduced in House

Bill Versions

• To amend the Federal Food, Drug, and Cosmetic Act to exempt the premium cigar industry from certain regulations. — issued 2025-03-14 — PDF (5 pages)