Cigar Rights of America (CRA) has been at the vanguard of the fight against the Food & Drug Administration’s (FDA) efforts to regulate premium cigars under the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009. Those efforts came to a head with the issuance of the FDA’s Deeming Rule in 2016, which brought cigars specifically under the FDA’s regulatory jurisdiction.

The FDA’s deeming regulation, proposed in 2014 (later edited by the Office of Information and Regulatory Affairs), established two options for how the FDA was to have considered regulating cigars. The two regulatory alternatives were: uniform regulation for all types of tobacco products included in the deeming regulation (Option 1) and another that would have exempted hand-rolled premium cigars (Option 2). CRA was a strong advocate for Option 2 and presented an abundance of scientific data in support of premium cigar exemption. When the FDA rejected that approach and announced its intention to regulate all cigars as one class, CRA and others challenged the FDA in federal court. 

In an earlier decision by U.S. District Court Judge Amit P. Mehta, a definition of a premium cigar, that was supported by CRA, was established. In his final ruling in the case, Judge Mehta agreed with CRA’s position, admonished the FDA’s lax approach to the rule-making process, and vacated the FDA’s regulatory authority over premium cigars while relying heavily on the science provided by CRA during the Option 2 discussions. While the decision is being appealed by the FDA, Representative Donalds’ proposed bill offers a permanent solution and the only avenue that allows industry certainty.

While the matter was pending before the courts, several member-companies of CRA advocated before Congress to pass legislation that would resolve the issue conclusivelyby denying FDA jurisdiction over premium cigars. This would be achieved by removing premium cigars from the definition of “tobacco product” in the Federal Food, Drug, and Cosmetic Act (the Act), which is the law that serves as the basis of FDA’s jurisdiction under the TCA.

Representative Byron Donalds (R-FL), a long-time friend of the premium cigar industry, agreed to serve as the leader of the effort to resolve the issue permanently. He has drafted legislation that would amend the Act to (1) establish a federal definition of premium cigars (using the definition adopted by Judge Mehta) and (2) state that a premium cigar is not a tobacco product for the purposes of the Act. If enacted, FDA would have no jurisdiction over premium cigars and, accordingly, exempt premium cigars from all aspects of the TCA. Fellow House Member and cigar enthusiast Steven Horsford (D-NV) agreed to sign on as the lead Democratic Co-Sponsor of the bill, in a display of bi-partisan agreement on this common-sense issue.

The bill relies largely on the FDA’s own commissioned study by the National Academies of Sciences, Engineering, and Medicine (NASEM). The NASEM study found numerous instances wherein premium cigars were found to pose significantly lower, or undetectable, health consequences for adult consumers compared to other tobacco products. It also found that there was no detectable usage of premium cigars by youth, a significant policy goal for the FDA.  Moreover, the FDA has publicly declared that premium cigars are their lowest enforcement priority.

Cigar Rights of America is proud to endorse Representative Byron Donald’s (R-FL) Legislation to Exempt Premium Cigars from Food & Drug Administration Regulation and thanks Representative Steven Horsford for his support as lead Democratic Co-Sponsor.