Tuesday, February 18, 2020

Tuesday, February 18, 2020

FDA proposes new rule for premarket tobacco product applications


Premarket tobacco product applications (PMTAs) now have new requirements for the content, format and Food and Drug Administration (FDA) review and communication procedures after the FDA issued a proposed rule in their efforts to lessen the number of e-cigarette and other tobacco products on the market.

“Our review of premarket product applications will help evaluate the public health benefits and harms of a tobacco product to ensure that those authorized for marketing are appropriate for the protection of public health,” acting FDA commissioner Ned Sharpless, M.D., said in a press release “This will include understanding the likelihood that those who do not use tobacco products – such as kids – will start using them, as well as the likelihood that tobacco users will stop. And as I’ve said before, responsible manufacturers certainly don’t need to wait to act. We encourage the industry to use available FDA resources as a guide for their submissions to the agency.”

Manufacturers and imports must now prove that the marketing of their product would be good for public health. They may submit a supplemental PMTA, so they do not have to go through the trouble of submitting the standard PMTA.

“This proposed rule follows our announcement last week that we intend to finalize a compliance policy in the coming weeks that would prioritize enforcement to clear the market of unauthorized, non-tobacco-flavored e-cigarette products," Sharpless said in the release. "These important regulatory actions are part of our ongoing oversight of e-cigarettes and other tobacco products that is critical to our public health mission and especially to protecting kids from the dangers of nicotine addiction and tobacco-related disease and death.”

The proposed rule is open for public comment through November 25, 2019.

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U.S. Food and Drug Administration (FDA)

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