Atlanta, GA

What the US should learn from the UK’s wisdom on e-cigarettes – Sally Satel

This is one of the better articles to come out recently discussing the data needed to submit for approval through the PMTA pathway the FDA has laid out in the current deeming regs. Very much worth the read.

From the article….

“…Added to this onus is the so-called “public health or population impact.” According to the FDA, “Manufacturers must, for each product, quantify the likelihood that nonsmokers will start using the product, the likelihood that former smokers will relapse back to nicotine use by using the product, the likelihood that nonsmokers who do start using the product will progress to cigarette smoking, the likelihood that former smokers who relapse back to nicotine use will then progress to smoking, the likelihood that consumers will use the product in conjunction with other tobacco products, and the likelihood that smokers who start using the product would otherwise have quit smoking.”

 

Link to article –  Click Here

 

gsfa

 

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