PMTA rule proposed

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September 20, 2019

On Sept. 20, the U.S. Food and Drug Administration (FDA) issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs).

“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,” said Acting FDA Commissioner Ned Sharpless.

The proposed rule follows the FDA’s mid-September vow to
clear the market of unauthorized, non-tobacco-flavored e-cigarette products

In July, a U.S. District Court judge in Maryland issued an
order requiring that manufacturers submit premarket applications by May 12,
2020, for deemed tobacco products, including e-cigarette products, that were on
the market as of Aug. 8, 2016.

The proposed rule will be open for public comments for 60 days through Nov. 25, 2019.

Read the FDA’s full statement announcing the proposed rule here.

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