On January 15, 2025, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register titled “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.” The proposal sought to establish a maximum nicotine level of 0.70 milligrams per gram of total tobacco in cigarettes and certain other combusted tobacco products. According to the FDA, the intent of the rule was to reduce the addictiveness of cigarettes and other combusted tobacco products—a move that would have far-reaching implications for tobacco growers, manufacturers, and retailers nationwide. In reality, it would be impossible for most manufacturers to meet this standard, and it was clearly intended to drive all combustible tobacco out of the marketplace.

While premium cigars were exempted from the scope of the proposed rule—due to Cigar Rights of America’s (CRA) successful litigation resulting in premium cigars being vacated from FDA’s regulatory authority—CRA raised serious concerns about the broader policy implications and continued regulatory overreach. CRA’s comments cautioned that the proposal represented a thinly veiled attempt to eliminate combustible tobacco products entirely, setting a dangerous precedent for future regulation.

SBA’s Comment Highly Critical of Proposed Rule

CRA has long maintained a strong working relationship with the U.S. Small Business Administration’s Office of Advocacy (SBA Advocacy) to ensure that the interests of the premium cigar industry and small businesses across the tobacco sector are represented. In the case of the proposed Nicotine Rule, CRA met directly with SBA Advocacy to outline its concerns, which were well received.

In its formal comment submission, SBA Advocacy echoed a lot of the concerns that CRA expressed and went further in criticizing FDA’s underlying analysis. SBA found that FDA’s Regulatory Flexibility Act (RFA) review failed to adequately assess the economic impacts on small entities, and that the agency had not meaningfully considered less burdensome regulatory alternatives as required by law. SBA also highlighted the technical and financial infeasibility of compliance for small manufacturers, citing the prohibitive costs of retooling equipment, testing products, and validating new formulations. The comments further warned of severe ripple effects across the supply chain, from small tobacco farms and processors to distributors, retailers, and rural communities. SBA further cautioned that FDA’s assumptions on market behavior, including illicit trade and product substitution, were speculative and incomplete.

Ultimately, SBA Advocacy urged FDA to withdraw the proposed rule in its current form and, if the agency wished to revisit the issue, to do so only after conducting a new and thorough analysis that considers phased implementation, extended compliance timelines, and exemptions for small entities.

Future of the Nicotine Rule

With the publication of the most recent Unified Agenda, the proposed nicotine limit rule has now been removed from active consideration, signaling that the action is officially off the table for the remainder of the Trump Administration. CRA views this as a positive development for small businesses and premium cigar stakeholders who continue to face the threat of overbroad regulatory initiatives.

CRA will continue to monitor federal regulatory activity closely and engage with policymakers to ensure that premium cigars remain recognized as the distinct, artisanal products they are—not swept into one-size-fits-all tobacco policies.

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