22nd Century Group Inc (XXII)

[rightcoast1]

Once again, here are the FDA’s preliminary conclusions as set out in the pre-TPSAC briefing materials. I didn’t here anything during the TPSAC meeting that would alter these conclusions:

(1) Substantiation: The three proposed claims are substantiated. [The claims are: 1. 95% less nicotine 2. Helps reduce your nicotine consumption 3. Greatly reduces your nicotine consumption.]

(2) Consumer understanding: Consumers understand the addiction risk of using the products relative to normal nicotine content cigarettes, but it is unclear whether they understand the other relative health risks of using the products; they perceive the products to be lower risk than
other cigarettes.

(3) Morbidity and mortality: The proposed modified risk products can substantially reduce dependence among individual tobacco users. The magnitude of the reduction in other morbidities and mortality from reduced dependence remains unclear.

(4) Population health impact: Nonsmokers have low intentions to use the products, and current smokers have moderate intentions to use the products. All smoker groups have higher
intentions to purchase VLN™ cigarettes compared to Marlboro Gold cigarettes.