WASHINGTON – Yesterday the he U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine the implementation of the Tobacco Control Act, specifically the Government Accountability Office’s (GAO) oversight of regulatory activities of the FDA’s Center for Tobacco Products (CTP) since it was established in 2009 under the Family Smoking Prevention and Tobacco Control Act.

Subcommittee Chairman Joe Pitts opened the hearing by explaining that the Tobacco Control Act gave FDA authority over the regulation of tobacco products, including restricting their sale, distribution, advertising and promotion. He noted that the “sole funding source for CTP is user fees assessed on tobacco manufacturers and importers.”

Pitts continued that the Government Accountability Office’s (GAO) September 2013 report, “New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process,” examines CTP’s review of new tobacco product submissions, responses to meeting requests and the use of its user fees. 

The GAO report found that CTP “lacks basic performance measures ‘like time frames for reviews of...submissions’ and that this ‘limit[s] CTP’s ability to evaluate policies, procedures and staffing resources in relation to CTP’s submission review process and, in turn, limit[s] CTP’s ability to reasonably assure efficient operations and effective results,’” said Pitts, adding that GAO concluded “[a]n entity that is limited in its ability to evaluate its performance will be hard-pressed to determine what adjustments it should make to its operations or how to plan for the future.”

Furthermore, the GAO report “raises troubling concerns about CTP’s performance and its ability to effectively implement the Tobacco Control Act and respond to the thousands of new product submissions it has received in a timely manner,” said Pitts.

Energy and Commerce Committee Chairman Fred Upton also remarked that GAO “has raised a number of concerning issues about the efficiency and consistency of CTP’s regulatory activities to date,” adding that the September 2013 suggests that the Center “had yet to set any performance measures or review timelines to ensure accountability and gauge progress.”

The sole witness at the hearing was Dr. Marcia Crosse, director of health care at the GAO, who has been leading efforts to oversee the TCA’s implementation. The Subcommittee invited the Food and Drug Administration (FDA) to testify, but it refused to do so — a decision met with some sharp criticism by Subcommittee leaders. Combined, CTP and FDA have about 500 employees and nobody was apparently available to participate. 

The bulk of the hearing focused on so-called "substantial equivalence" — the process by which tobacco manufacturers obtain FDA approval for their products. Subcommittee members sharply questioned the efficiency and competency of FDA's system, as designed under the TCA, to bring new products to market.  

The sale of electronic cigarettes also gained some attention, although the topic was not a central issue during the hearing.  Some Democrats raised the specter that e-cigarettes are a "gateway" drug, while U.S. Rep. John Shimkus (R-IL) countered that the products could be helpful in smoking cessation.