by: Angela Garrity
CNN reports that the FDA issued final guidance for remitting PMTAs today and gave a clearer path to companies in doing so.
"The final guidance issued today provides companies seeking to market e-cigarette and [electronic nicotine delivery system] products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product," Acting FDA Commissioner Dr. Ned Sharpless said.
Companies must show that their products “would be appropriate for the protection of the public health," the agency says.
The FDA is also taking into consideration how vaping products may change people's behaviors, including the prospect of nonsmokers picking up the e-cig habit, as well as how often e-cig users tend to quit. The guidance also outlines the agency's plans to examine ingredients and additives in vaping products, how they are packaged and labeled, and how these devices are designed and made. This could address ‘known risks of exploding batteries and accidental nicotine poisoning among children’, the agency said.
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