PMTA Update: Nearly 70% of Reviews Completed for 189 Applications, Full Completion Expected by Year-

According to the American Tobacco Retailers Association (NATO), the FDA recently submitted a progress report on the PMTA application for electronic cigarettes to the U.S. District Court in Maryland. The report indicates that there are currently 189 "Covered Applications." The FDA has taken and expects to take the following actions:
- As of June 30, 2023, the FDA has completed 65% of the reviews for the 189 pending covered applications.
- The FDA expects to complete 68% of the reviews for the 189 covered applications by September 30, 2023.
- The FDA expects to complete 100% of the reviews for the 189 covered applications by December 31, 2023.
In this latest progress report, the FDA stated that it has completed the review of the PMTA "covered applications" on time. The so-called "covered applications" refer to electronic cigarette products that were on the market as of August 8, 2016, and for which PMTAs were submitted to the FDA before September 9, 2020. These products accounted for 2% or more of total retail sales in Nielsen's reported retail electronic cigarette sales, including brands such as JUUL, Vuse, NJOY, Logic, Blu, SMOK, suorin, and PUFF Bar.
The requirement for regular progress reports was initially brought to the FDA by several public health organizations, which requested the court to compel the FDA to complete the PMTA reviews by September 9, 2020. The original deadline set by the court was September 9, 2021, but due to the overwhelming number of PMTAs submitted by manufacturers, the FDA was unable to meet this deadline, necessitating regular updates on progress.
Under current U.S. regulations, to legally sell these novel tobacco products, the Family Smoking Prevention and Tobacco Control Act requires the FDA to conduct a substantive review of the PMTA for each new tobacco product and issue a marketing order allowing the sale of the product. In this latest progress report, the FDA stated that it will submit another progress report to the court by October 23, 2023.

It is evident that the FDA is making continuous progress in reviewing PMTAs in line with the goal announced at the beginning of the year to complete the reviews by the end of the year. Previously, Ge Wu Consumer predicted in a tweet titled "Dialogue with Zheng Zhi: PMTA Enters a Critical Period in the Second Half of the Year, Major Changes Expected in the U.S. Market" that all signals point to one point in time—by the end of 2023, the PMTA will officially take effect. Based on the progress announced this time, this prediction is highly likely to become a reality.