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FDA’s Progress on Tobacco Product Application Review and Related Enforcement
On Sept. 9, 2020, FDA faced the unprecedented task of reviewing applications for over 6.5 million “deemed” new tobacco products – many of which were already on the market. In just one year, the agency has made significant progress and taken action on over 90% of the total timely-submitted applications, including issuing marketing denial orders (MDOs) for over one million flavored e-cigarette products.
Earlier this month, CTP Director Mitch Zeller published a perspective piece discussing the progress that the agency has made on the premarket applications submitted to FDA by the Sept. 9, 2020 application deadline and what to expect after Sept. 9, 2021.
The piece covers several important topics, including:
- An update on FDA’s review of applications for deemed tobacco products
- A summary of the marketing decisions taken
- FDA’s plans on compliance and enforcement
Joint Statement with Acting Commissioner Woodcock
In addition to CTP’s perspective piece, Acting FDA Commissioner Janet Woodcock and Director Zeller jointly released a statement marking the significant progress made over the past year on reviewing tobacco product applications.
In Case You Missed It: Recent CTP News
This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.
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