FDA Proposes Rule to Limit Nicotine Levels in Combustible Tobacco Products, Excludes Premium Cigars

On Thursday, January 16, 2025, the U.S. Food and Drug Administration (FDA) proposed a groundbreaking rule that would limit nicotine levels in all combustible tobacco products—except premium cigars and hookah tobacco—to 0.7 mg of nicotine per gram of product, a threshold considered “non-addictive.” This rule, which excludes vapes and other non-combustible products, marks a significant step in the FDA’s efforts to reduce nicotine addiction among smokers.

What the Rule Requires

The proposed rule targets cigarettes, cigars (excluding premium cigars), and other combustible tobacco products, imposing strict nicotine limits to make them less addictive. Premium cigars and hookah tobacco are explicitly exempted, with the FDA excluding them from all scientific and economic analyses associated with the rule.

Timeline and Next Steps

• The rule is currently in the proposal stage and cannot take effect until the FDA reviews public comments and issues a final rule.
• The comment period for the rule is 240 days, an unusually long timeframe, potentially to allow new appointees in the Trump Administration time to influence the decision or to coincide with the conclusion of FDA’s appeal of the vacatur ruling, which limits its regulatory reach over premium cigars.
• If the rule advances to a final version, it would go into effect two years after publication, with no phase-in period for gradually lowering nicotine levels.

Political Context and Future Risks

While it is anticipated that the Trump Administration may shelve the rule, this outcome is not guaranteed. President Trump has expressed anti-smoking sentiments in the past, and the views of his appointees on this specific issue remain unclear. If the rule is not implemented during this administration, it could be revived under a future Democratic administration and potentially proceed directly to a final rule without restarting the notice-and-comment process.

Implications for Premium Cigars

The rule represents a significant victory for the premium cigar industry, as it offers the most straightforward exemption ever granted by the FDA. Unlike previous regulatory efforts, the FDA does not include premium cigars in its analysis, does not seek public comment on their exclusion, and makes no argument for their inclusion in future regulations.

This omission is atypical and provides fewer legal pathways for the FDA to regulate premium cigars should it revisit the issue. For example, while hookah tobacco is also excluded, the FDA explicitly requests feedback on whether that decision is appropriate, leaving the door open for future action.

If, however, the FDA’s appeal of the vacatur ruling succeeds or the agency decides to revisit its authority over premium cigars, it would be legally required to issue a new proposed rule specific to premium cigars before imposing any regulations.

A Hard-Earned Victory

The exclusion of premium cigars from this rule underscores the impact of relentless advocacy and the weight of evidence differentiating premium cigars from other tobacco products. This demonstrates that including premium cigars in such sweeping regulations would create unnecessary challenges and delay efforts targeting other products.

While this is a significant win for the premium cigar industry, vigilance remains essential. The FDA could still revisit its position on premium cigars in the future, but for now, the industry has avoided being swept into broader restrictions on combustible products.

Cigar Rights of America (CRA) will continue to monitor developments and provide updates on this critical issue throughout the process.