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As the Clark-Esposito Law Firm, P.C. previously reported to our partners in the premium cigar industry, we have been monitoring the important Cigar Association of America v. FDA case, as well as a subsequent appeal, challenging FDA on a number of provisions relating to the regulation of premium cigars and pipe tobacco. Unfortunately, late last month the US Court of Appeals in Washington DC struck a difficult blow to the cigar and pipe tobacco industry in the case.
The appeal centered around technical features of administrative law and FDA’s ability to subject cigars and pipe tobacco to the 2007 predicate date (or grandfather date) for what is termed an FDA Substantial Equivalence marketing pathway, among other points of appeal. The DC Appeals Court wasted little time in unanimously striking down all six points of appeal by the Cigar Association on July 20.
In short, Cigar Association of America had hoped to, at a minimum, buy the cigar and pipe tobacco industry time, before full compliance with FDA’s regulatory threshold dates and enforcement would apply to these products.
What does the Appeals Court rejection of Cigar Association of America’s arguments mean for the premium cigar and pipe tobacco industry? While the decision does not necessarily trigger anything with immediate effect, it does mean that the premium cigar and pipe tobacco industry should begin monitoring and preparing for FDA to issue a new effective date. And for market participants with predicate products, e.g., cigars in the US tobacco market prior to the 2007 grandfather date, the time for restarting your substantial equivalence preparations to obtain marketing orders is now.
The Appeals Court decision represents a green light for FDA to begin setting application deadlines and effective dates for SE product applicants (as well as enforcement dates for product makers who allow these deadlines to come and go without taking action).
The Clark-Esposito Law Firm, P.C. will continue to monitor FDA’s response to the agency’s win in the Appeals Court, as well as the announcement of updated deadlines and effective dates for the premium cigar and pipe tobacco industry.
If you have questions about the outlook for FDA regulation of the tobacco industry, or how to begin preparing substantial equivalence applications for affected products, please contact us at contact@clarkespositolaw.com.