FDA Publishes Nicotine Rule

January 20, 2025 By Matthew Tabacco
FDA Updates

Last week, the U.S. Food & Drug Administration (FDA) published its proposed rule to establish a maximum nicotine level for cigarettes and certain other combustible tobacco products. This dramatic action targeting nearly all combustible tobacco products aims to reduce the nicotine in those products to “non-addictive” levels. Vaping products and other non-combusibles would not be affected.

Importantly, premium cigars are explicitly excluded from this proposed rule—a decision directly resulting from the lawsuit led by Cigar Rights of America (CRA), which successfully overturned the FDA’s regulatory oversight of premium cigars. It is important to note that the FDA is currently appealing this ruling.

FDA’s proposal also reflects the agency’s recognition of the distinct nature and usage patterns of premium cigars, which differ significantly from those of cigarettes and other combustible tobacco products.

“CRA welcomes the FDA’s decision to exclude premium cigars from this proposed rule, and we strongly believe premium cigars should remain exempt from all FDA regulation,” said Mike Copperman, Executive Director of CRA. “This distinction underscores the need for a nuanced approach to tobacco regulation that acknowledges the differences between product categories and respects the cultural and artisanal heritage of premium cigars.” 

Notably, this last-minute act by the Biden Administration will not go into effect immediately. It will be reviewed by the incoming Trump Administration, which will decide whether to move forward with the policy by crafting a final rule.

Cigar Rights of America says it is carefully reviewing the proposed rule and assessing its potential long-term implications for the broader tobacco regulatory landscape. While premium cigars are notably excluded from this rule, CRA says it remains committed to safeguarding their unique characteristics and ensuring they are respected in future regulatory actions.

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