Today, Cigar Rights of America (“CRA”) was back in federal court before Judge Amit P. Mehta reasserting the industry’s challenge to the U.S. Food & Drug Administration’s (“FDA”) rejection of the Option 2 regulatory framework. This challenge is a final push solely by CRA to give our industry permanent relief from the egregious regulation that threatens to destroy our industry.
In 2014, FDA outlined its initial plan to regulate premium cigars and provided two potential pathways for regulation – Option 1, which would regulate premium cigars in the same manner as cigarettes and all other tobacco products, and Option 2, which would have recognized that premium cigars are different and permitted a different regulatory approach. In 2016, FDA rejected the Option 2 framework and imposed a sweeping regulatory scheme on premium cigars.
In today’s hearing, Michael J. Edney of Steptoe & Johnson – lead attorney for CRA – focused the industry’s challenge on FDA’s rejection of Option 2 on the grounds that FDA acted arbitrarily when it addressed the question concerning different patterns of usage for premium cigars.
In 2014, FDA sought comment on how the potential patterns of usage for premium cigars might result in different health impacts. In the final rule, however, FDA stated that despite this request, “no such evidence was presented.”
Crucial to challenging FDA’s conclusions on the topic, was CRA’s administrative comment leading to the 2016 Rule, which cited and discussed a 2014 article by Katherine Corey, an FDA researcher, that addressed the issue concerning patterns of usage and health impacts.
In effect, by ignoring this cited study along with FDA’s failure to rebut data submitted regarding the National Institute of Health’s Monograph 9 – which could not detect a statistically significant increase in tobacco related disease for occasional cigar smokers – FDA acted in an arbitrary and capricious manner by rejecting Option 2.
At the conclusion of today’s hearing, Michael Edney noted that:
“he was grateful for the opportunity provided by the Court for CRA to present its legal concerns that the FDA did not properly consider the evidence in the record before choosing to regulate premium cigars.”