CHICAGO — To protect public health and enforce regulations on tobacco products, the U.S. Food and Drug Administration (FDA) needs to immediately publish a comprehensive list of submitted premarket tobacco applications (PMTAs), U.S. Sen. Dick Durbin (D.-Ill.) said.
In an Oct. 16 letter, Durbin urged FDA Commissioner Stephen Hahn to publish a list of product applications—something the FDA has already promised to do but has given no timeline for. Before making the list public, the FDA will need to ensure the publishing of any information complies with federal disclosure laws and regulations, it has said. It was expecting thousands of applications by the Sept. 9 deadline from deemed tobacco and e-cigarette products on the market as of Aug. 8, 2016.
There are three pathways for new tobacco products to obtain premarket authorization: PMTAs, SE Reports or Requests for Exemption from Demonstrating Substantial Equivalence. Deemed new tobacco products still on the market that did not submit premarket applications by Sept. 9 are subject to FDA compliance and enforcement actions.
It has now been more than a month since the PMTA deadline, and delays in publishing the list of products that have submitted applications allows tobacco products that remain out of compliance and illegally on the market to proliferate, Durbin said.
“While I appreciate the sheer volume of applications submitted to FDA, and the agency’s intention to prioritize review of those with the greatest market share and public health impact, we know from recent years that youth shift patterns of e-cigarette use based upon what products are available to them,” Durbin said in the letter. “Therefore, it is imperative that FDA publicize its list and incorporate the totality of products that have submitted PMTAs, so thorough enforcement can quickly follow.”
Durbin said he’s pleased e-cigarette manufactures were required to submit PMTAs to the FDA because it will help address gaps in tobacco product oversight and enforcement and bring sensible regulation to “addictive and kid-friendly e-cigarettes.”
“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,” Durbin said. “Many of these products were illegally introduced to the market after Aug. 8, 2016, without an FDA marketing order. 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 Aug. 8, 2016.”