December 11, 2023

Reducing the rate of smoking is, by far, the best and most impactful way to address lingering, preventable, and inequitable death and disease caused by tobacco and improve public health in the United States.

As such, we are disappointed FDA is not yet positioned to promulgate its final regulation for a product standard for menthol in cigarettes.

Just prior to the delay announcement, Juul Labs representatives met with officials in the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) and FDA regarding the proposed product standard (find our meeting script and slides on the OIRA website). In our meeting with OIRA and FDA, we reiterated our support for the proposed menthol ban if FDA determines, based on the science and evidence, that banning menthol as a characterizing flavor in cigarettes is appropriate for the protection of public health.

We also discussed with OIRA and FDA the federally-funded analysis that suggests adult smokers should have access to a robust marketplace of potentially less harmful alternatives to fully realize the public health impact of the proposed product standard. JLI presented literature citing national survey data that demonstrate menthol smokers overwhelmingly prefer menthol-flavored ENDS. 

FDA’s proposed product standard to ban menthol cigarettes relies on population modeling that anticipates significant switching to Electronic Nicotine Delivery Systems (ENDS) and other non-combusted products. Over a 40 year period, the model predicts the proposed rule will avert as many as 654,000 deaths. The public health benefit this model contemplates will not be fully realized if adult menthol smokers do not have access to authorized ENDS alternatives.  

We urge FDA to act on the evidence by advancing the proposed policy, creating a clear pathway for evidence-based alternatives like Juul products, and stepping up enforcement against illicit disposable vapor products that continue to flood the U.S. market. According to the science and evidence, this will create the real world conditions in which the agency can successfully implement a menthol cigarette product standard that has the potential to save hundreds of thousands of lives.

For additional background, see our August 2022 public comment on the proposed regulation.