Two Congressmen Send Letter to FDA Asking About Premium Cigar Regulations

Yesterday, Rep. Troy Carter, D-La., and Dan Meuser, R-Pa., sent a letter to the U.S. Food & Drug Administration (FDA) regarding the agency’s plans for regulating premium cigars.

In a letter sent to Dr. Robert Califf, commissioner of FDA, and Dr. Brian King, director of FDA’s Center for Tobacco Products, the congressmen asked about what the agency has done following the March 2022 report from the National Academy of Sciences, Engineering, and Medicine (NASEM). FDA commissioned NASEM, another government organization, to produce a report looking at “premium cigars” in four specific areas: product characteristics, patterns of use, marketing and perceptions, and health effects. The report made 13 findings, though it spent a lot of time discussing what constitutes a “premium cigar.” The primary conclusion of the report, which scientists authored, was that more work needed to be done to study “premium cigars” given the small body of literature about “premium cigars” as most studies simply look at all cigars, which include mass-market, flavored, machine-made and other cigars that would not meet most working definitions of “premium cigars.”

Carter and Meuser also asked how FDA is ensuring that any regulatory action regarding premium cigars will not “disproportionately impact small businesses.”

Given the ongoing litigation between the cigar industry and FDA, it seems unlikely that the agency would reply to this letter with much substance. Last July, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia ruled against FDA as part of the Cigar Association of America et al. v. United States Food and Drug Administration et al. lawsuit filed by three cigar trade groups in 2016. In his ruling, Metha indicated that the agency failed to follow rules while creating regulations for products, specifically, ignoring comments regarding how “premium cigars” are consumed. Because of this, it is likely that the current set of regulations—many of which have already been overturned or delayed for “premium cigars”—will no longer apply and the agency will need to restart the rulemaking process for premium cigars. Carter and Meuser’s letter seems to be asking about status quo and future regulations, not necessarily considering the potential, if not likely, outcome where Metha rules that FDA must start over.

Update — The original version of this article listed Tyler Menzler as the chief of staff for Rep. Meuser; Tim Costa is the current chief of staff.