A federal judge on Wednesday ruled that the U.S. Food and Drug Administration must review its procedures on how to regulate premium cigars, handing the industry a lifeline as it battles to distinguish itself from other tobacco products.
The ruling from Judge Amit P. Mehta in the U.S. District Court for the District of Columbia undoes the FDA’s plan to classify premium cigars with cigarettes, flavored tobaccos and smokeless tobacco in terms of regulation that would include restrictions on sales, promotion and distribution.
Instead, it requires the FDA to construct a plan to evaluate premium cigars for safety issues rather than lumping them in with other tobacco products.
In 2016, Congress expanded the FDA’s authority to regulate all tobacco products, including premium cigars.
In doing so, FDA decided that any cigar first sold after 2007 must be approved by FDA using the same, regulation laden process developed for cigarettes.
In the latest ruling, Judge Mehta delays the FDA’s enforcement – specifically its premarket approval process – for premium cigars .
“From the beginning, the premarket review process has never worked for premium cigars,” Drew Newman, general counsel for J.C. Newman Cigar in Tampa, said in a statement. “Just as sunlight, wind, and rain cause grapes used to make fine wine to vary from year to year, the same is true with premium cigar tobacco. Like wines, premium cigars also change and get better with age. It would have been impossible to demonstrate that a cigar rolled today is the same as one from 2007.”
The judge also has struck down the September 9 deadline for cigar makers to file premarket review applications for premium cigars.
The ruling applies to most cigars other than flavored and infused.
The FDA’s projected review process was based on an assumption that the agency can scientifically compare a premium cigar rolled today with one made 13 years ago to determine if they are “substantially equivalent,” or have the same properties.
The cigar industry’s lawsuit against the FDA is led by Cigar Association of America, Cigar Rights of America and the Premium Cigar Association. They insist that because premium cigars are handcrafted, rolled in small batches, and subject to inherent natural variation, the same, expensive process used for evaluating and regulating other tobacco products, most of which are made via automation, does not work for premium cigars.