The US Court of Appeal in Washington DC overturned the US Food and Drug Administration (FDA) rule on cigar, pipe tobacco, and other tobacco warnings on July 7, saying that FDA did not properly consider whether the regulation would have an impact on the number of smokers.
The case – Cigar Associations of America v. United States Food and Drug Administration, filed in 2016 – rose over FDA’s issuance of regulations requiring “extensive health warnings on packaging and in advertising for cigars and pipe tobacco.” FDA issued the rule to communicate health risks associated with smoking.
However, taking into consideration whether a regulation will increase or decrease the number of smokers is a requirement under the US Tobacco Control Act, signed into order in 2009. The court drew particular attention to the fact that FDA stated that “…reliable evidence on the impacts of warning labels . . . on the users of cigars [and] pipe tobacco . . . does not, to our knowledge, exist.”
The court concluded that FDA failed to provide a “reasoned explanation” for requiring such warnings on premium cigars and that, based on “usage patterns and user demographics,” the FDA health warnings were not justified. As a result, the court vacated the health warnings provision, as to premium cigars.
The decision was in a case filed in Texas by Texas manufacturers and retailers, and transferred to Washington DC, where it was consolidated with the industry action pending there. Judge Mehta, who has had that case since it was filed in July 2016, previously upheld the health warning requirements as to all cigars, and the appeal of that decision is still pending in the DC Circuit Court.
Notably, while the health warnings requirement has been vacated as to premium cigars, there is still no FDA definition for “premium” cigar. Accordingly, that definition remains unclear.