The U.S. Food and Drug Administration (FDA) has updated its Unified Regulatory Agenda on two areas that are of interest to premium cigar enthusiasts: if/how premium cigars should be regulated and if/how flavored tobacco products should be regulated. The Unified Regulatory Agenda is published twice a year and provides a status of upcoming regulations. While no final proposals on rulemaking have been made, some initial comments by the FDA should be of concern to cigar enthusiasts.

Earlier this year, the three ANPRMs (Advanced Notice of Public Rulemaking) were issued on three areas related to cigar enthusiasts. The questions on if/how premium cigars should be regulated and if/how flavored tobacco should be regulated were each addressed in their own ANPRM.  There was also a third ANPRM on controlling nicotine levels. The Unified Regulatory Agenda comments represent an initial look into the FDA’s thinking.

In regards to if/how premium cigars should be regulated, while the FDA is still in the process of re-evaluating. It was less than impressed with the comments on the ANPRM as they noted there still was a lack of scientific evidence in the comments provided.

The notice requests information on how premium cigars should be defined, the health effects of these products, and their patterns of use. In the proposed deeming rule, FDA had requested scientific information that would support consideration of exempting premium cigars from regulation. FDA received comments claiming that the health risks associated with cigar use generally, or with the use of premium cigars in particular, are not significant because of the way these products are used. Specifically, commenters claimed that these products are not used by youth and young adults, they are not used frequently, and they are not always inhaled. However, the information in the comments did not provide an adequate scientific basis or public health rationale to support excluding these products from regulation

The lack of scientific comments was something we noted could be a potential issue with the ANPRM responses. While this author has seen scientific-based comments in the ANPRM response, there were a large number of comments that were outside the scope of what the FDA was asking for and is concerned the extraneous comments may be overshadowing the scientific comments.

Ironically, one of the studies referenced frequently in the ANPRM comments was one conducted by the New England Journal of Medicine which showed that only 2.3% of youth from age 12 to 17 have ever smoked a premium cigar. The irony of this study is that it was funded by the FDA itself.

Meanwhile the FDA has put out a statement in a prerule that proposes a tobacco product standard banning on what it terms characterizing flavors in all cigars.

Evidence shows that flavored tobacco products, especially those that are sweet or are described with terms attractive to kids, appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Characterizing flavors in cigars, such as strawberry, grape, orange, and cocoa, enhance taste and make them easier to use. Nearly one million youth in the United States use flavored cigars, placing these youth at risk for cigar-related disease and death. This proposed rule is a tobacco product standard that would ban characterizing flavors in all cigars. We are taking this action to reduce the tobacco-related death associated with cigars.

Prerules are often ones that appear the first time in the Unified Regulatory Agenda. They are typically used to mark the opening of a rulemaking record. Once it is published to the Federal Register, it moves into a proposed-rule status where it will then go through a public comment period.