U.S. Sen. Dick Durbin (D-IL) recently sent a letter to FDA Commissioner Stephen Hahn urging the Food and Drug Administration to enforce its own regulations regarding e-cigarettes and youth.
In January, the FDA committed to removing all new tobacco products that did not submit premarket tobacco product applications (PMTAs) by Sept. 9.
The FDA stated it would publicly make available a list of the new products on the market as of Aug. 8, 2016, and submitted a PMTA by the deadline. Any e-cigarette company wanting to keep or put a device or flavor product onto the market was required to submit an application.
Durbin said he was concerned more than a month had passed, yet the FDA had yet to publish its list.
“Thousands of the products that FDA will begin regulating have been on the market for years, including those responsible for fueling the current epidemic of youth e-cigarette use—which has resulted in nearly four million children vaping, including one in five high school students. Many of these products were illegally introduced to the market after August 8, 2016, without an FDA marketing order,” Durbin said. “For years, I have been troubled by FDA’s inadequate enforcement of this deeming rule requirement, stemming from the fact that the agency never maintained a list of which products were on the market by August 8, 2016.”