US: FDA to Shift Tobacco Regulatory Focus

Basing decisions on 'continuum of risk' from different products
 

Federal officials today announced a dramatic shift in tobacco policy, vowing to slash nicotine levels in combustible cigarettes to non-addictive levels while delaying key regulatory action on electronic cigarettes until the summer of 2022.
 

In a Friday morning media call, FDA Commissioner Scott Gottlieb, MD, made it clear that the agency now considers e-cigarettes to be less harmful than conventional cigarettes and a potential tool for smoking cessation, and that it will move forward with regulation of the products with this view in mind.
 

Under the revised timeline for newly deemed tobacco products, applications for newly-regulated combustible tobacco products, such as cigars, pipe tobacco and hookah tobacco, would need to be submitted to the FDA by Aug. 8, 2021, and product applications for e-cigarettes currently on the market would be required by Aug. 8, 2022.
 

The new enforcement policy does not affect provisions of the regulatory rule that are already in place, such as mandatory age and photo-ID checks for e-cigarettes and other newly regulated tobacco products. It will also not affect future deadlines for other provisions of the deeming rule.
 

Gottlieb said the FDA is ready to move forward with efforts to require tobacco companies to reduce nicotine levels on combustible cigarettes to non-addictive levels, but he gave no timeline for this.
He said the evidence shows that the greatest dangers from tobacco come from smoking it. Although nicotine itself is not harmless, Gottlieb said, its most important harm is that it addicts people to smoking.
 

"We believe that in a world where we are rendering combustible cigarettes no longer addictive, we can take a more balanced approach to some of the newer innovations that might have the potential to help current combustible cigarette smokers transition to products that might be less harmful," he said. "And our regulatory process will help determine whether, in fact, those products are less harmful."
 

A press release issued Friday stated that the agency plans to issue an Advance Notice of Proposed Rulemaking (ANPRM) "to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes."
 

During the media call, Mitch Zeller, JD, who directs the FDA's Center for Tobacco Products, said the ongoing debate in public health about whether e-cigarettes are harmful or helpful is a distraction.
"I think all sides would hopefully look at what we are doing as advancing and promoting public health, and acknowledging that there is a continuum of risk, and there are more and less harmful ways for nicotine to be delivered. In a properly regulated marketplace there is an appropriate place for the least harmful forms of nicotine delivery, whether its medicinal nicotine products or electronic cigarettes."
 

"This is an opportunity to re-frame the debate," he added. "Yes, we need to ask some tough questions about the benefits and potential risks of any new technology, but these questions should be asked through re-framing."
 

Where smokeless tobacco products fit into the "continuum of risk" scheme was not addressed directly.
 

Eric Lindblom, JD, former director of the FDA Center for Tobacco Products' Office of Policy, was highly critical of the FDA's action to delay regulatory action on e-cigarettes, calling it "seriously troubling" in a press statement.
"If the FDA were truly concerned about protecting the public health, the agency would not extend the deadlines at all, or it would at least extend the deadlines only for those e-cigarettes and cigars that meet certain minimum standards and only for those smaller tobacco companies that might not have sufficient resources to meet the existing deadlines," he said.
 

Lindblom currently directs the Tobacco Control and Food & Drug Law Program at Georgetown Law's O'Neill Institute for National & Global Health Law in Washington, D.C.
 

He was also highly skeptical of the FDA plan to seek input on the proposed reduction of combustible cigarette nicotine levels through an ANPRM.
 

"FDA Advanced Notices of Proposed Rulemaking have, so far, been where good tobacco control ideas go to die or be delayed," he said, noting that the agency has issued previous ANRPMs on control measures such as banning menthol-flavored cigarettes, with no action being taken.
 

"If FDA were serious about reducing nicotine levels, it could quickly issue a proposed rule now to get all the comments they would need before issuing a final rule and start saving some lives."
 

Gottlieb also vowed to seek public comment through ANPRMs to further explore the role of flavors, including menthol, in attracting kids and teens to tobacco products.
 

The American Thoracic Society applauded the action in a statement issued Friday afternoon, while expressing concern about FDA's role in tobacco regulation moving forward.
 

"While we are encouraged that FDA Commissioner Gottlieb indicated the agency intends to develop new regulations on flavored tobacco products that appeal to children and adolescents and consider banning menthol, we are concerned about the agency's intent on tobacco regulation overall, including the signaling of potential regulatory exemptions for premium cigars. The ATS will continue to monitor the FDA's progress to ensure the best possible outcome for children and adults," the statement read.