FDA Cigar Regulations

The relationship between the cigar industry and the U.S. Food and Drug Administration (FDA) has been one of the most contentious topics in tobacco regulation over the past two decades. While cigarettes and smokeless tobacco have long been subject to federal oversight, premium cigars remained largely untouched—until 2016. That year marked a turning point, as the FDA extended its regulatory authority to include all tobacco products, including premium cigars, under the “Deeming Rule.” What followed was a clash between bureaucratic policy and centuries-old tradition.

At the heart of the debate lies a fundamental question: Should handcrafted cigars—often produced in small batches, enjoyed occasionally, and marketed to adults—be treated the same as mass-produced, flavored, youth-targeted tobacco products?

The FDA believed so, at least initially.

How It Started: The Deeming Rule

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, giving the FDA the power to regulate cigarettes, smokeless tobacco, and roll-your-own products. But it wasn’t until May 2016 that the FDA officially “deemed” other tobacco products—including cigars—subject to the same regulations.

The Deeming Rule classified cigars into the same regulatory category as e-cigarettes and flavored cigarillos. It imposed restrictions on manufacturing practices, required ingredient disclosures, mandated health warnings on packaging, and forced companies to obtain pre-market authorization for any cigar not commercially sold before February 15, 2007. This retroactive cutoff date created massive hurdles for manufacturers, especially boutique and premium brands that often thrive on innovation and limited releases.

For many in the cigar industry, this was seen not as reasonable oversight—but as existential overreach.

The Impact on the Premium Cigar Industry

Unlike mass-produced tobacco products, premium cigars are handmade using natural, whole-leaf tobacco, typically with no additives or flavorings. They are not marketed to children, rarely inhaled, and are generally enjoyed in moderation. Despite this, the FDA’s regulations threatened to stifle the very essence of premium cigar craftsmanship.

The most damaging requirement was the pre-market tobacco application (PMTA). This process, designed for industrial products like cigarettes, demanded scientific testing and costly documentation that small cigar companies could neither afford nor feasibly conduct. Brands faced the possibility of pulling beloved cigars from the market simply because they were introduced after 2007.

Moreover, the proposed warning label mandate would have required health disclaimers covering 30% of every cigar box and advertisement—dramatically altering the branding of products often praised for their elegance and tradition.

Boutique cigar makers, known for releasing small-batch, seasonal blends, feared they would be forced to shutter operations altogether. Large manufacturers also faced uncertainty around product continuity, compliance costs, and legal risk.

Industry Pushback and Legal Battles

The backlash was swift and coordinated. Trade groups such as the Cigar Rights of America (CRA), Premium Cigar Association (PCA), and Cigar Association of America (CAA) mounted aggressive legal challenges. Their central argument was that premium cigars are fundamentally different from other tobacco products and should not be regulated the same way.

For years, the industry fought to carve out an exemption—one that would acknowledge the low-risk profile and adult-only appeal of premium cigars. The fight culminated in a major legal victory in August 2023, when a U.S. District Court judge ruled that the FDA had acted “arbitrarily and capriciously” in applying its regulations to premium cigars without considering the evidence that they posed significantly fewer public health risks.

This ruling effectively struck down the FDA’s authority to enforce many of its original requirements on premium cigars, including pre-market approvals and extensive warning labels. It was a turning point—one that signaled a shift in how lawmakers and regulators viewed premium tobacco.

Where Things Stand Today

As of 2025, the FDA’s regulatory grip on premium cigars has loosened considerably. Thanks to legal victories and growing bipartisan support for premium cigar exemptions, many of the burdensome requirements have been delayed, paused, or overturned. However, this does not mean the industry is entirely free from regulation.

Retailers and manufacturers still must comply with minimum age restrictions, labeling accuracy, and truth-in-advertising laws. Flavored cigars—particularly those appealing to youth—remain under scrutiny, though these rules tend to target mass-market products, not premium hand-rolled cigars.

Ongoing litigation, shifting political winds, and FDA appeals may still impact the long-term regulatory landscape. While premium cigars have gained temporary relief, their future depends on continued advocacy, research, and public education to distinguish them from high-risk tobacco products.

Cultural Significance of the Fight

This struggle between regulators and the cigar world has become about more than just policy—it’s about cultural identity. For generations, cigar making has been an artisanal craft passed down through families in Cuba, Nicaragua, the Dominican Republic, and beyond. To treat these products like industrial cigarettes not only ignores their unique role in adult leisure and celebration, but also undermines the very fabric of the communities that produce them.

The industry’s resistance was not a rebellion against safety—it was a call for nuance, fairness, and respect.

Conclusion

The FDA cigar regulations saga reflects a broader tension in public health policy: how to balance regulation with freedom, safety with tradition, and mass-market abuse with niche, adult-focused enjoyment. While the fight is not entirely over, the premium cigar industry has carved out breathing room—and with it, a renewed sense of purpose.

For cigar lovers in the U.S., the stakes have never been higher. Protecting access to handcrafted cigars means staying informed, supporting advocacy efforts, and continuing to highlight the difference between premium cigars and everything else.