Congressional Bill Aims To Exempt Premium Cigars From FDA Regulations

[JohnS]

Congressional Bill Aims To Exempt Premium Cigars From FDA Regulations

New legislation looks to further nullify any FDA oversight regarding handmade cigars

Mar 14, 2025 - By Garrett Rutledge

A bill introduced on the Congressional House floor today seeks to exempt premium, handmade cigars from FDA regulation, as established by the Federal Food, Drug and Cosmetic Act. The legislation, being brought forth by Republican Rep. Byron Donalds of Florida’s 19th district, would exclude cigars from its broader “tobacco product” categorization defined by the act.

The Federal Food, Drug and Cosmetic Act essentially authorizes the U.S. Food and Drug Administration to regulate food, drugs, medical devices and cosmetics. These broad categories ultimately include “tobacco products,” which are broadly defined in the Act as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption…” The goal of today's proposal is to amend this portion of the Act, adding that premium cigars do not fall under this one-size-fits-all categorization of “tobacco products.”

Under the new bill, premium cigars would follow the same definition Judge Amit P. Mehta recently established in the cigar industry’s lawsuit battle with the FDA. This definition of a premium cigar would include the following parameters:

• 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 (whole tobacco leaves that run the length of the cigar)  
• Is handmade or hand rolled, meaning 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  
• Weighs more than six pounds per 1,000 units.

Back in January, the cigar industry notched yet another big victory against the FDA in the longstanding battle over regulating cigars. The United States Court of Appeals for the District of Columbia shot down the FDA’s appeal, which sought to overturn the 2023 ruling by Judge Mehta that ruled against the FDA’s application of the Deeming Rule on the cigar industry. The ruling spared the industry from a number of draconian regulations, but it did not fully remove the FDA’s ability to regulate premium cigars. Today’s legislation aims to take that next step in excluding premium cigars from FDA regulation. 

Rep. Donalds introduced similar legislation during the previous Congressional session, and while it gained 13 co-sponsors, it stalled in the committee stage largely due to the election. The original co-sponsors of today’s legislation are Congresswoman Dina Titus (D-NV), Congressman Nick Langworthy (R-NY) and Congressman Jimmy Panetta (D-CA). 

“Congressman Donalds’ leadership in introducing this bill is a victory for premium cigar manufacturers, small businesses and the countless American consumers who appreciate these handcrafted products,” says Mike Copperman, executive director of Cigar Rights of America. “This legislation is not just about regulation, it’s about preserving an industry and ensuring that premium cigars are treated fairly.”

Source: https://www.cigaraficionado.com/article/congressional-bill-aims-to-exempt-premium-cigars-from-fda-regulations

[JohnS]

Another Bill Introduced to Exempt Premium Cigars from FDA Regulation

March 14, 2025 - Charlie Minato

Rep. Byron Donalds, R-Fla., has once again introduced legislation that would exempt premium cigars from regulation by the U.S. Food & Drug Administration (FDA).

In short, Donalds’ bill would preserve the status quo where hand-rolled and unflavored cigars are not regulated by the FDA, while all other cigars are. The bill is very similar to the Joint Resolution that Donalds introduced two years ago. Unfortunately, like that bill—which gained just 13 co-sponsors—it’s unlikely that the bill will ever pass.

To qualify as a “premium cigar,” a tobacco product must meet the following requirements:

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 prior to 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;
8. and weighs more than 6 pounds per 1,000 units.

This is the same definition established in Cigar Association of America et al. v. United States Food and Drug Administration et al., a nearly eight-year-old federal lawsuit filed by three cigar trade groups that has successfully exempted “premium cigars” from regulation by the FDA. That said, it’s unclear whether that definition will remain in use.

In January, a federal appeals court sent the issue of the definition back to a lower court. Earlier this week, an attorney representing the Cigar Rights of America and Premium Cigar Association of America—two of the three plaintiffs in the lawsuit—asked the appeals court to reconsider its decision, in effect, keeping the current definition. An attorney from the Cigar Association of America, the third plaintiff, told the court that that organization would like the issue decided by a lower court.

Avoiding regulation by the FDA means that it is much easier for cigar companies to introduce new products because they do not have to go through a premarket product approval process. In addition, the cigars are not subject to user fees, marketing restrictions and other rules.

While premium cigars are currently exempt from the FDA’s deeming regulations thanks to the court rulings, that is temporary. At any point, the FDA could decide to restart the regulatory process for premium cigars. While it would likely take a year or two, the court rulings don’t stop the agency from regulating premium cigars. That’s the advantage to Donalds’ bill: if it were to pass and become law, the legislation would prevent the FDA from regulating premium cigars in a much more permanent way.

This is the latest in a long list of bills that have been introduced to exempt premium cigars from regulation by the FDA. So far, none of them have been close to passing. Cigar trade groups and advocates have long argued that bills like this are helpful so that the industry can engage with members of Congress about premium cigar regulation.

Source: https://halfwheel.com/another-bill-introduced-to-exempt-premium-cigars-from-fda-regulation/448265/

[BrightonCorgi]

Rep. Byron Donalds knows how important the cigar & tobacco industry is to his district and state. He wants to run for governor as well.

[VeguerosMAN]

5 hours ago, BrightonCorgi said:

Rep. Byron Donalds knows how important the cigar & tobacco industry is to his district and state. He wants to run for governor as well.

Also, Marco Rubio is a fan of Padrons, growing up in Miami.