Cigar Rights of America Challenges FDA’s Proposed TPMP Rule on Premium Cigars

May 18, 2023

WASHINGTON, DC – Today, Cigar Rights of America (CRA) expressed to the Tobacco Products Scientific Advisory Committee (TPSAC), our concerns over the proposed Tobacco Product Manufacturing Practice (TPMP) rule by the U.S. Food and Drug Administration (FDA).

The proposed TPMP rule, which aims to establish corrective and preventative actions to safeguard public health, has raised alarm bells within the premium cigar industry because of a flawed scientific approach that is not supported by evidence.

Given the distinct nature of premium cigars as a tobacco product category, CRA firmly believes that the proposed rule fails to demonstrate that the majority of risks described are applicable to premium cigars or that the suggested mitigations, as applied to premium cigars, would genuinely protect public health.

Moreover, CRA’s believes that FDA’s reliance on pharmaceutical standards within the artisanal agricultural context of premium cigar manufacturing are impractical and unnecessary and are not supported by a scientifically sound rationale. Unsupported policy-making around tobacco is a persistent issue for FDA, as recently found in the Reagan Udall report and Judge Mehta’s holding that FDA’s regulation of premium cigars was arbitrary and capricious. 

To this point, CRA applauds the comment by noted Harvard professor and public health advocate Lisa Robinson, who called upon the FDA during today’s session to “consider an exemption for premium cigars in the spirit of allocating resources to maximize the impact on public health.”  

Ms. Robinson’s statement is a clear indication that FDA is headed in the wrong direction, and that premium cigars should be exempted from TPMP.

CRA urges TPSAC to clearly communicate and emphasize to the agency that the TPMP proposal lacks a scientific justification to apply to premium cigars, and the agency should reverse course and exempt premium cigars from TPMP.

In closing, today’s presentation was an important step in the process and CRA will continue to work to prevent unnecessary requirements from being applied to our industry. CRA intends to submit further comments to the docket on matters of law and policy as the rulemaking proceeds over the course of the summer.