I made the distinction between getting approval "to sell" cigarettes without VLN designation vs. selling "VLN designated" cigarettes...I indicate that they could and should get approval to sell...but without the VLN designation because FDA is conducting a 4 year study to determine effects of different levels of nicotine and effects on smokers.
How could they grant XXII a designation of VERY LOW NICOTINE cigarettes...without first conducting their study...to determine effects so that they could decide what they should consider VLN? In fact, the length of the study gives FDA a 4 year cover to kick the VLN issue down the road.
IMHO reason FDA contacted XXII was to discuss its proprietary product in order to purchase different nicotine level cigarettes for their study...not because they were trying to decide to grant only XXII VLN status.
I still maintain VLN designation will not occur until the 4 years study is over and results are in.
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