A lawsuit challenging a 2016 decision by the U.S. Food and Drug Administration (FDA) expanding its power has been delayed again.
The court’s decision also postpones compliance deadlines set by the controversial “deeming rule” regulation, thus slowing down the phasing-in of the rules.
In August 2016, FDA declared regulatory powers granted by federal law in 2009 to restrict cigarette sales extend to other products, such as e-cigarettes and cigars.
Lawyers for Cigar Rights of America (CRA), a nonprofit public advocacy organization representing cigar smokers’ interests, were originally scheduled to present their case before Judge Amit P. Mehta in the U.S. District Court for the District of Columbia, but Mehta ordered new deadlines for the trial in May, pushing back the court date by approximately three months.
Mehta’s order notes FDA agreed with the judge’s decision to extend the deeming rule’s submission deadlines for paperwork, such as lists of products sold and documentation of product advertising plans.
No official court date has been set. Mehta is scheduled to consider motions in the case on December 8.
‘Unprecedented’ Regulation
Glynn Loope, executive director of Cigar Rights of America, says FDA exceeded its regulatory authority by redefining cigars and e-cigarettes as “cigarettes.”
“On May 10, 2016, the FDA issued its Final Rule for the regulation of cigars, in addition to other products, and for the first time in history, brought premium handmade cigars under the domain of federal regulatory authority,” Loope said. “Within those 499 pages, roughly 30 of them attacked the premium cigar industry in an unprecedented manner. The regulations impose draconian new reporting, testing, pre-market review requirements, user fees, bans on samples, and new warning labels that defy any basis in scientific review. It is what I would characterize as Velcro rulemaking: ‘Let’s throw everything at them, and see what sticks.'”
‘A Turning Point’
Loope says he’s optimistic about CRA’s chances in court.
“With the agenda on both ends of Pennsylvania Avenue seemingly pressing against regulatory overreach, and within a federal courthouse in between the two, we are hoping that 2017 represents a turning point in this case study in regulatory extremism,” Loope said.
Paperwork Overload
Lindsey Stroud, a government relations coordinator for The Heartland Institute, which publishes Budget & Tax News, says the deeming rule amounts to death by paperwork for cigar manufacturers.
“The new rules mean cigar manufacturers would be subjected to an array of new regulations, including reporting and paying user fees; registering and submitting a list of products, including labeling and advertisements, as well as ingredient listings; submitting tobacco health documents; applying for the ability to market the ‘new’ tobacco product; submitting warning plans for cigars; and submitting documentation of quantities of harmful and potentially harmful constituents.”
Different Products, Different Rules
Stroud says cigars and cigarettes are different products that are consumed in various ways. Thus, they should be regulated differently.
“Though technically a tobacco product, the risk of harm associated with cigars is nowhere near the equivalent to that of tobacco cigarettes,” Stroud said. “Most cigars smokers use the product very infrequently, not ritually. Think of celebrations, or teeing off on the 10th hole, versus on-the-hour smoke breaks for the people who smoke cigarettes. In addition to the point that the harm from cigars and cigarettes is not comparable, the ruling by FDA’s own estimate could wipe out 10–50 percent of cigar products, to comply with the new regulations.”
