BROOMFIELD, Colo. – Where the FDA’s daunting and onerous deeming regulations were seemingly set in stone and poised to strike a massive blow to the entire e-cigarette and vaping category, the agency’s sudden turnaround appears to come largely from its new commissioner, Dr. Scott Gottlieb.
Speaking at a tobacco-retail seminar in the Denver area on Aug. 23, Mitch Zeller, director of the Center for Tobacco Products (CTP), Rockville, Md., an agency within the U.S. Food and Drug Administration, flatly said that the change of heart—and policy—came directly from Gottlieb.
“We spent time briefing [Gottlieb] on every aspect of the CTP,” Zeller told the group of about 75 attendees at the seminar sponsored by Minneapolis-based NATO. “He then pivoted to policy decisions … [to] reframe the debate, [moving] forward together with the new focus of nicotine addiction.”
In a media event held July 28, Gottlieb announced changes to FDA policy that reopened discussion on a number of topics, including regulating nicotine levels in cigarettes, revisiting the issue of flavored tobacco (including menthol) and examining the value of persuading smokers to choose less harmful ways to inhale nicotine. The review process would include public input and evaluation periods based on scientific evidence.
As a part of that new policy track, the FDA postponed deadlines for manufacturers to submit new-product applications for approval by four or five years.
“The debate for the last decade has been remarkably unproductive,” Zeller said. “A harm-reduction dialogue [may offer] common ground.”
Though regulating nicotine levels and reevaluating flavored-tobacco products had many retailers expressing concern, Zeller said the agency would definitely encourage public comment and thoroughly review all aspects of any final standard. These troublesome issues could include how to consistently manipulate nicotine levels, as well as unintended consequences such as people smoking more to get the nicotine levels they want.
As an agency that conducts a large amount of research, the FDA is vested in hard data, Zeller said. He mentioned, for instance, a recent study that showed smokers in markets banning flavored cigarettes simply switch to flavored cigars or cigarillos. “It’s like a game of whack-a-mole,” he said, where users find alternatives instead of quitting.