Washington, D.C. -Today, Rep. Raja Krishnamoorthi and Rep. Michael Cloud, Chairman and Ranking Member of the Subcommittee on Economic and Consumer Policy, sent a letter to the Food and Drug Administration (FDA) requesting information about the agency’s progress in reviewing the premarket tobacco product applications (PMTAs) from e-cigarette manufacturers. The request is the most recent effort by the Subcommittee to ensure FDA is exercising its full authority to protect children from harmful e-cigarette products after it missed a court-ordered deadline to rule on all PMTA applications.
“Despite the September 9, 2021, court-ordered deadline for FDA to rule on all PMTA applications, FDA has yet to complete its review or issue rulings on the most significant applications," the Members wrote. “We are concerned that FDA may not be making adequate progress on its commitment to prioritize the review of the e-cigarette manufacturers with the largest market share. Four out of the five manufacturers with the highest market share have yet to receive a decision, and the fifth, R.J. Reynolds, has only had part of its application ruled upon."
On Sept. 10, 2021, Chairman Krishnamoorthi sent a letter to FDA requesting that it provide weekly briefings to the Subcommittee addressing why the agency failed to meet the court’s deadline and the progress it has made on outstanding PMTAs. While FDA has provided briefings, it has not shared any information about its progress or made decisions on PMTAs from four of the five major manufacturers.
In today’s letter, the Members requested that FDA provide progress-report timelines for each of the outstanding applications, showing which steps have been completed and when. The Members requested this information be provided by Dec. 20, 2021.
