Sumary of FDA misses deadline for decision on e-cigarettes:
- The agency has acted on about 93% of 6.5 million applications for “deemed” new tobacco products that were submitted for review, with a court-ordered deadline of Sept.
- 9, according to a joint statement from Janet Woodcock, MD, acting FDA commissioner, and Mitch Zeller, MD, director of the Center for Tobacco Products.
- Manufacturers had a court-ordered deadline to submit applications by Sept.
- Photo source: Adobe Stock The FDA said it requires additional time to process the remaining applications.
- “We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept.
- 9, 2020, deadline, many of which are in the final stages of review,” Woodcock and Zeller said in the statement.
- Most of the applications were for electronic nicotine delivery systems (ENDS) products like e-cigarettes and e-liquids.
- 9, 2021], the agency has taken action on applications for over 6 million ENDS products, including refusing to file one company’s applications for approximately 4.5 million products because required contents were missing, as well as issuing 132 marketing denial orders for more than 946,000 flavored ENDS products,” Woodcock and Zeller said.