Following oral arguments conducted on May 23rd, 2022 in the United States District Court for the District of Columbia in the case of Cigar Association of America et al. v. FDA, PCA prepared the following notes to outline topics covered by the cigar industry and the Food & Drug Administration. These notes were prepared to give PCA membership a better understanding of the crux of the case.
- The FDA’s justification for the sweeping regulatory scheme imposed by the “Deeming Rule” is “arbitrary and capricious,” in violation of the Administrative Procedures Act.
- The FDA claims that all cigars are dangerous, despite convincing evidence to the contrary. The question is not whether premium cigars can be dangerous, but rather whether they are used in a dangerous way (they are not).
- The FDA’s claim, in the rule, that “there were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks,” is patently false. There are many open questions about patterns of use and the health effects of premium cigars.
- A 2014 study cited by the FDA finds that there is no statistically significant increase in “all-cause” mortality for cigar smokers who smoke 1-2 cigars a day. 97% of premium cigar smokers are nondaily smokers.
- The FDA appropriately handled the issue of inhalation and its risks in the rule but failed to respond to comments and evidence submitted by industry groups about frequency of use.
- The FDA failed to sufficiently consider how the regulation would actually affect the behavior of the small minority of premium cigar smokers that smoke frequently.
- The definition of “premium cigar” provided by Judge Mehta in 2020 guards against concerns about adulteration, chemical manipulation, and youth access.
- The number of underage smokers of premium cigars is statistically insignificant and essentially indistinguishable from zero.
- The right result is to vacate the “Deeming Rule.”
Food & Drug Administration
- Premium cigars are not so unique or so inherently different from other cigars as to absolve them of the need for regulation
- Health risks still exist even for infrequent users
- There is no public health justification for allowing premium cigars to go completely unregulated, which is what would happen if the “Deeming Rule” is vacated
- Without the “Deeming Rule,” the FDA can’t prevent youth access or ensure faithful labeling, etc.
- The FDA did address arguments about frequency of use, insofar as it discussed the question of lower exposure to cigar smoke
- While the increase in “all-cause mortality” for 1-2/day cigar smokers may not be statistically significant, it is still higher, and the risk of other causes of death – cancers of the mouth and throat, for instance, which are increased by a statistically significant margin
- As established in the 1964 Surgeon General’s report, no amount of smoking is safe