The U.S. Food and Drug Administration issued a new guidance last week citing handmade cigars as the agency’s “lowest priority,” indicating that a bit of regulatory relief could be on the way for the handmade cigar industry.
Issued last Thursday by the government agency in charge of tobacco regulation, the document describes the FDA’s plans to enforce its rules for newly deemed tobacco products that have not yet been approved by the agency, including cigars. The deadline for these premarket applications was extended two years ago by the FDA to August 2021.
Last July, however, a Maryland judge shortened the deadline and ordered applications for premarket products to be filed by May 12, 2020.
As the May deadline looms, the FDA guidance centered largely on vaping and e-cigarette regulations. Flavored cigars and handmade cigars were also addressed.
“After May 12, 2020, FDA will make enforcement decisions on a case-by-case basis, recognizing that it is unable, as a practical matter, to take enforcement action against every illegally marketed tobacco product, and that it needs to make the best use of agency resources. FDA intends to prioritize enforcement based on the likelihood of youth use or initiation to make the most efficient use of its resources,” the FDA wrote. “FDA’s lowest priority among these products will include relatively expensive, large hand-rolled cigars that do not have flavors (e.g., fruit, candy, or mint), given what FDA understands to be their comparatively lower youth usage rates.”
In other words, the agency recognizes that handmade cigars are not popular with teenagers, and so it may turn a blind eye towards enforcing its own rules.
"We appreciate the recognition of being on the lower end of risk," said J. Glynn Loope, executive director of Cigar Rights of America, in an article posted on CNBC.com. "But we'd like to not be subject to this regulation at all."
Drew Newman, general counsel for J.C. Newman Cigar Co., echoed Loope’s sentiments.
“Although we appreciate hearing that premium cigars are FDA’s ‘lowest priority’ and that the agency may or may not choose to enforce the regulation of premium cigars, the announcement provides little certainty or relief,” Newman said. “Importantly, it does not change the accelerated May 12 deadline for cigarmakers to submit Substantial Equivalency reports. Not only is this process very costly and cumbersome, but FDA does not expect to finalize the instructions for Substantial Equivalency until April. We hope that the courts and Trump administration will recognize the undue harm caused by this arbitrary deadline and will delay until the process can be tailored for premium cigars, which FDA has now acknowledged are different.”