Last Thursday, the Premium Cigar Association (PCA) filed public comments opposing the U.S. Food and Drug Administration’s (FDA’s) proposed rule entitled “Tobacco Product Standard for Characterizing Flavors in Cigars.”
The proposed rule would prohibit the manufacture, distribution, and sale of cigars, or any of their components or parts, with a characterizing flavor other than tobacco. However, the evidence on which FDA relied in issuing the proposed rule does not demonstrate that use of flavored cigar products inherently poses an increased health risk relative to use of cigars without non-tobacco “characterizing flavors.” Further, FDA erroneously claimed that banning such products will improve health equity, particularly among certain subpopulations.
Greg Zimmerman, President of the Premium Cigar Association, stated: “There is something inherently wrong about targeting communities for additional regulation based on race. Our retailers are part of the social fabric of the communities where they operate. They have a right to support their consumers’ product choices, whether they are premium cigars or flavored cigars.”
In its comments, PCA raised specific concern over the proposed rule’s impact on an advertiser’s or retailer’s ability to describe the flavor profile of any cigar. The comments also criticized the fact that FDA failed to clearly define “characterizing flavor.” Rather, FDA identified non-binding factors that, if present, would indicate the presence of a characterizing flavor. These non-binding factors appear so vague and subjective in nature so as to render the rule, at worst, unconstitutionally vague and, at best, exceedingly difficult for industry to implement and for FDA to enforce consistently.
PCA’s comment also calls out FDA’s failure to adequately conduct an economic impact assessment on minority-owned small businesses. In addition, FDA failed to consider the broad international impact that the product standard would have on commerce, immigration, and economic stability for U.S. allies in tobacco- and cigar-producing countries.
Scott Pearce, Executive Director of the Premium Cigar Association, remarked: “FDA has a mechanism to prevent youth access to tobacco. Yet, instead of working to fulfill the statutory requirements of T-21, the agency is speeding recklessly toward product bans with questionable legal authority.”