PolicyBrief
H.R. 2111
119th CongressMar 14th 2025
To amend the Federal Food, Drug, and Cosmetic Act to exempt the premium cigar industry from certain regulations.
IN COMMITTEE

This bill exempts qualifying premium cigars, defined by strict manufacturing and ingredient standards, from certain regulations under the Federal Food, Drug, and Cosmetic Act.

Byron Donalds
R

Byron Donalds

Representative

FL-19

LEGISLATION

Premium Cigars Get a Federal Pass: Bill Exempts Hand-Rolled Tobacco from FDA Regulation

This legislation is all about carving out a specific type of tobacco product—the “premium cigar”—and pulling it entirely out of the FDA’s regulatory sandbox. Essentially, it amends the Federal Food, Drug, and Cosmetic Act to say that if a cigar meets a very specific checklist, it is no longer considered a standard “tobacco product” subject to federal oversight.

The VIP List for Cigars: What Gets a Pass?

This isn’t a blanket exemption for all cigars; the bill creates an incredibly strict, eight-point definition of what qualifies as a “premium cigar.” Think of it like a velvet rope list for tobacco products. To qualify, a cigar must be wrapped entirely in natural tobacco leaf, use 100% leaf tobacco for the binder, be hand-rolled with simple tools (no complex machinery allowed), and contain no flavors other than the natural taste of tobacco. If you’re a manufacturer, meeting this list means you skip the FDA’s compliance checks, which can be costly and time-consuming. The bill explicitly states that this exemption is based on findings that premium cigars make up a small market (about 1%) and that youth usage is rare, suggesting that the health risks are lower because users tend not to inhale or smoke them daily.

Why This Matters for Public Health and Your Wallet

Removing a product from federal regulation is a big deal, even if it’s a niche item. For the small, family-owned businesses that make these specific cigars, this is a massive win, cutting down on their compliance costs (Economic_Burden). The potential benefit is that the FDA can focus its resources on higher-use products like e-cigarettes or mass-market cigars, while the premium cigar market gets a break. However, the flip side is that federal consumer protection is completely removed for this product category (Protection_Removal). If you’re a consumer, you lose the assurance of federal oversight regarding product safety, manufacturing standards, and marketing practices.

The Regulatory Gap: Who’s Watching Now?

The bill essentially creates a regulatory vacuum at the federal level, relying on the idea that state-level regulations can handle any necessary oversight. This means that if you live in a state with weak tobacco laws, there might be very little scrutiny on these specific products. For the general public, this is concerning because it sets a precedent: if an industry can demonstrate low youth usage and small market share, they might be able to argue for an exemption from federal health regulations. While the definition is specific—no artificial tips, no added flavors, etc.—it still involves removing federal oversight for a product that contains tobacco, a known health hazard. This shift means that the responsibility for monitoring potential long-term health risks and ensuring product quality falls entirely off the federal radar, leaving consumers and public health agencies with fewer tools to track and manage these products.