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Advancing Harm Reduction for Adults Who Smoke 

Silver microphone on a black stand with an out of focus blue background
In June 2024, Dr. Vergara presented at the Next Generation Nicotine Delivery USA conference where she highlighted the importance of non-combustible products, specifically NJOY ACE®, in helping adults who smoke transition to reduced harm alternatives.
Dr. Vergara shared research showing that certain harmful and potentially harmful constituents in NJOY ACE Classic Tobacco 5%, for example, are not detected or significantly reduced when compared to combustible cigarettes.
Powerpoint slide titled “HPHCs in NJOY ACE® Classic Tobacco 5% are Not Detected or Substantially Reduced Compared to Cigarettes.”
She also showed how biomarkers of exposure are significantly reduced in individuals who completely switched from combustible cigarettes to the NJOY ACE.
Powerpoint slide titled “Biomarkers of Exposure are Significantly Reduced Among Switchers Based on Real World Evidence” with a bar chart.
Our data illustrates how nicotine delivery for NJOY ACE is similar to the nicotine delivery that one would experience when smoking a combustible cigarette. This highlights how the NJOY ACE product can help adults who smoke switch to a less harmful option. 
Powerpoint slide titled “Nicotine PK indicates NJOY ACE® Abuse Liability Not Likely to be Higher Than Cigarettes” with a line chart.
Dr. Vergara described how our longitudinal cohort study demonstrated the switching potential for NJOY ACE. The study assessed the relationship between the frequency of combustible cigarette smoking, switching from combustible cigarettes to ENDS, and the purchasing and use of NJOY ENDS products. The study demonstrated switching success with NJOY ACE. 
Powerpoint slide titled “Real World Evidence Demonstrates Switching Success with NJOY ACE®.”
The study also showed flavored products played a significant role in switching showing that Menthol, Blueberry and Watermelon were more effective in promoting complete switching than classic tobacco flavors. 
Powerpoint slide titled “Flavored NJOY® Products More Effective in Promoting Complete Switching Relative to Tobacco-Flavored.”
Looking at individual switch rates, the population impact modeling showed over a 60-year period that tobacco flavored NJOY ACE and flavored NJOY ACE products would result in lives saved.
Powerpoint slide titled “Population Impact Model” with a line chart showing over a 60-year period that switching to NJOY ACE products would result in lives saved.
Regarding youth prevalence, data from the National Youth Tobacco Survey showed that NJOY ACE use by youth was too low to determine statistical reliable estimates. 
Powerpoint slide titled “NJOY ACE® ENDS Youth Prevalence is rare.”

Dr. Vergara told the audience we submitted all this research to FDA as part of the PMTAs for the NJOY ACE products. In 2022, FDA issued a marketing granted orders for the tobacco flavored NJOY products. And, soon after Dr. Vergara’s presentation, FDA also issued marketing granted orders for four NJOY menthol products.

Dr. Vergara also shared that we recently submitted PMTAs for Watermelon and Blueberry NJOY ACE 2.0, which feature Bluetooth®-enabled access restriction technology.

View Dr. Vergara's presentation “Advancing Harm Reduction for Adults Who Smoke”.