In January, the Food and Drug Administration withdrew its proposed rules to ban menthol cigarettes and flavored cigars. The announcement came on President Donald Trump’s second day in office and convenience-store retailers were instrumental in these efforts.
This insight comes from Executive Director David Spross with the National Association of Tobacco Outlets (NATO), who told a room full of c-store tobacco category managers and operators on Sept. 17, at CSP’s Tobacco Plus Forum in Schaumburg, Illinois, that they should be credited with their engagement on this issue.
“There’s no better example of the engagement of all of you in the industry,” Spross said. “Excellent work by everybody in this room to engage on this.”
Another proposed rule, which is not getting as much attention, is the concept of very low nicotine in combustible cigarettes and other combustible products, Spross said.
The proposed rule was entered Dec. 10, into the Office of Management and Budget’s (OMB) Regulatory Information Service Center (ROCIS) system, which is part of the standard OMB review of regulatory documents. The OMB's approval process generally takes months.
“This rule has not been withdrawn, but conventional wisdom is this rule is not going anywhere,” Spross said.
Spross told attendees at the forum that NATO filed public comments to the agency.
“We put together a detailed economics study by congressional district of what this rule would do,” Spross said.
He said based on how the rule is written, it would ban 99% of all combustible cigarettes.
“It would have a detrimental impact,” Spross said.
On Sept. 15, a group of Democratic senators sent a letter to Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Tobacco Products Acting Director Bret Koplow urging the agency to move “swiftly” to finalize the proposed rule that would establish maximum nicotine levels in cigarettes and other combusted tobacco products.
Turning to the Trump administration, Spross highlighted Department of Health and Human Services (HHS) Secretary Robert F. Kennedy’s position on topics surrounding the tobacco category.
“He’s been very active and engaged in the tobacco and nicotine space, which I think is very much a positive,” Spross said.
Turning to the FDA’s CTP, Spross recognized the frustration surrounding the premarket tobacco product application (PMTA) process but remains hopeful.
“I see more authorizations coming,” Spross said.
A pilot program that aims to ease the review process for premarket tobacco product applications (PMTAs) for nicotine pouch products launched this month.
Calling it a “significant” step forward, details of the program include real-time communication between the FDA and applicants and shorter review timeframes, the agency said.
“This is a very good sign that I think the White House and the administration realizes that action needs to happen quickly,” Spross said.
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