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FDA’s New Approach to Nicotine Regulation – What’s In and What’s Out

FDA’s New Approach to Nicotine Regulation – What’s In and What’s Out

On Friday, July 28th, FDA Commissioner Dr. Scott Gottlieb announced the agency’s new vision for tobacco regulations. As stated, the central driving force behind the proposed shift in policy is the commitment to reduce the harms caused by combustible tobacco use. The most immediately significant part of Commissioner Gottlieb’s announcement is a proposal to extend the deadline for pre-market tobacco approval applications (PMTA) for newly-deemed tobacco products to August 8th, 2022. FDA will issue guidance on the matter soon.

 

  • Proposed new deadline for submission of PMTA applications is August 8, 2022
  • Compliance deadlines that have already passed are not affected.
  • Future compliance deadlines (here) for warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituents (HPHC) reports, and the removal of modified risk claims are not affected.

 

Although Friday’s announcement is a clear signal that the FDA is granting the vapor industry a four-year stay of execution, it bears repeating that this is simply a delay. Commissioner Gottlieb included several pressing issues that concern the vaping community, future vapor consumers, and tobacco harm reduction (THR) advocates, all of which will need to be addressed in short order so that 2022 isn’t just another cliff edge.

Proposed regulation of nicotine content in cigarettes

The proposed policy shift for the FDA centers around refocusing the agency’s regulatory efforts to address the “astonishingly addictive” nature of nicotine. Specifically, the FDA is targeting nicotine delivered via smoking and will be considering a rule that would mandate lower nicotine levels in cigarettes. By forcing manufacturers to produce cigarettes that are, in theory, less or non-addictive, FDA speculates that young people who are at risk for initiating smoking will quickly lose interest or, if they go on to become regular smokers, will have an easier time of quitting.

Very low nicotine content (VLNC) cigarettes are not a new idea and this raises questions that stakeholders and public health advocates will need to tackle. Probably the most immediate concern is how consumers will react to lower nicotine levels: Does such a mandate create an underground market for full-strength cigarettes and will smokers just end up smoking more? Appropriately, these questions will be addressed during the rulemaking process.

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