Today (February 10), the U.S. Food and Drug Administration is hosting its much-anticipated “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products.” Center for Tobacco Products (CTP) director Dr. Matthew Farrelly offered his opening remarks, which led into the “product characterization” panel moderated by deputy director Dr. Todd Cecil.
Dr. Matthew Walters, Dr. Karen Coyne, Dr. Lynn Hull, and Dr. Carolina Ramôa rounded out the early sessions for FDA. Industry representatives said that unclear product characterization standards are limiting the long-term viability for smaller ENDS manufacturers, argued that the absence of objective, measurable benchmarks create uncertainty around PMTA compliance, and raised questions about defining testing ranges for open-system products and the ability to update long-pending PMTAs. FDA said it wants to create a dialogue with manufacturers, but statutory requirements constrain its regulatory flexibility.
The afternoon panels were led by Cecil, Dr. Benjamin Apelberg, Dr. Mollie Miller, Dr. Amy Gross, Dr. Mary Irwin, and Dr. Hans Rosenfeldt, and were still being held at the writing of this article. Tobacco Reporter will update the proceedings as the information becomes available.