CRA Files Comment on FDA's Proposed TPMP Rule

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WASHINGTON, DC (October 6, 2023) – Today, Cigar Rights of America submitted a written comment to the federal docket concerning the U.S. Food & Drug Administration's (FDA) proposed Tobacco Products Manufacturing Practice (TPMP) rule.

On March 10, 2023, FDA announced the proposed TPMP rule. The rule would apply to any premium cigar manufacturer selling products in the United States, regardless of whether the manufacturer's facilities were in the U.S. Although the rule's provisions are vaguely defined, CRA believes that the Agency's proposal would likely require sweeping capital investments and threatens to bankrupt many small manufacturers. For domestic tobacco manufacturers alone, FDA estimates one-time costs of $39 million and $73 million and between $15 million and $56 million in recurring annual costs.

CRA's comment today demonstrates that FDA's proposal is not supported by science. Although the Agency suggests that its burdensome requirements will prevent human illnesses, it identifies almost no illnesses linked to manufacturing issues for any tobacco product - and no illnesses at all associated with premium cigars.

In this action, the FDA failed to adequately analyze the costs to small businesses, as required by the Regulatory Flexibility Act. The Agency also did not attempt to provide basic support to industry for compliance with any final provisions. Specifically, our comment took issue with the proposed rule's lack of guidance for businesses and the fact that the proposed rule sets forth a pharmaceutical-grade production standard, which is unrealistic for artisanal, handmade products grown outdoors using processes that have been established over centuries without contamination issues.

Lastly, our comment points out that the proposed rule lacks a proper environmental impact assessment. In the proposal, FDA implies that they are likely to require significant testing requirements that could impact the environment. Yet, they fail to provide a formal Environmental Assessment or Environmental Impact Statement. The failure to issue a proper environmental analysis and address water, soil, and pest-mitigation measures that FDA implies it will require, will significantly impact foreign manufacturing facilities and create needless technical barriers to trade.

For the foregoing reasons, CRA believes that the proposed TPMP rule does not address all the required aspects of the rulemaking process and should not apply to premium cigars.