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In discussing these efforts, Commissioner Gottlieb noted, this work is aimed at creating a more flexible framework that enables the development of safe and effective product innovations that have the potential to be helpful in assisting smokers quit combustible cigarettes and improve their health. 29 Future Considerations As it currently stands, the PMTA process presents a significant barrier to market entry for ENDS deemed as tobacco products

Smoking while you are pregnant can lead to miscarriage, premature birth, stillbirth, and illness, and it increases the risk of cot death by at least 25%

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