As the September 9 deadline for cigar manufacturers to submit their premarket applications to the FDA nears, the agency in charge of overseeing all tobacco products has asked a Maryland court to consider a plan that would postpone enforcement of the requirement for premium cigar manufacturers. Additionally, the agency indicated in its filing that it plans to begin new research on the impact of premium cigars on public health.
“The FDA intends to exercise its retained discretion by deferring enforcement of the premarket authorization requirement for premium cigar manufacturers and importers on a case-by-case basis,” wrote the U.S. Justice Department, which represents the FDA, in its filing. “The deferrals are intended to help prioritize the use of the FDA’s limited enforcement resources while the agency undertakes a new research effort to evaluate the public health impact of premium cigars.”
In its filing, the FDA acknowledged that e-cigarettes and vaping, not premium cigars, are the products that are of the most concern, given their usage among youth. “The FDA’s top priority for premarket review of deemed products remains products that pose the greatest risk for initiation or use by underage persons, such as flavored, cartridge-based e-cigarette products targeted to or easily accessible to youth. Because the FDA’s current information indicates that youth smoke premium cigars comparatively less than most other deemed tobacco products, like e-cigarettes, premium cigars remain the FDA’s lowest priority for premarket review.”
The FDA’s letter was submitted to Judge Paul Grimm, of U.S. District Court for the District of Maryland. In 2019, Judge Grimm shortened the deadline as part of his ruling in the case of American Academy of Pediatrics v. FDA. While the FDA may not necessarily need Judge Grimm’s approval to carry out its new plan, the plaintiffs in that case may disagree and could file motions to reject it. In other words, the FDA is seeking Judge Grimm’s approval before it officially implements the plan.
Whether or not the plan can be approved in time for the September 9 deadline is still not known. The plaintiffs in the Maryland court case have until August 17 to reply to the letter. Should they not object to the FDA’s plan, the agency would then have only a few weeks to offer guidance to cigar manufacturers on how to apply for a deferment.
“This is an important indication by the FDA that they do not have the capacity or resources to regulate premium cigars for premarket review,” said Scott Pierce, executive director of the PCA. “However, the industry needs further clarity and is hopeful that the Trump Administration will take definitive action in support of the small businesses across the country and go a step further. We cannot operate businesses in regulatory uncertainty and the FDA’s action further complicates the situation especially without their definitive release of guidance on the topic.”
