WASHINGTON – Today the U.S. House of Representatives Energy
and Commerce Committee’s Subcommittee on Health is holding 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.
The CTP is responsible for reviewing the marketing of new
tobacco product submissions, enforcing prohibitions on the sale of certain
tobacco products, developing regulations and guidance and handling other
regulatory activities. Under current law, tobacco manufacturers and importers
are assessed user fees, which provide the sole source of funding for the CTP’s
regulatory activities.
GAO has conducted extensive analysis on the implementation
of the Tobacco Control Act, including a September 2013 report, “New Tobacco Products: FDA Needs
to Set Time Frames for Its Review Process,” which examined the status of
the CTP’s review of new tobacco product submissions, responses to meeting
requests and use of resources. GAO also has conducted work on trade in tobacco
products and issued a report in April 2012, which in part describes market
shifts and differences in FDA’s regulation of various types of tobacco
products. GAO currently is working on a report concerning “the adequacy of
[FDA’s] authority and resources” as well as “any recommendations for
strengthening that authority” that will be issued later this year.
The Subcommittee also will discuss H.R. 389, the
“Transparency in Tobacco User Fees Act of 2013,” which was introduced by Rep.
Brett Guthrie (R-KY-02) on January 23, 2013. This bill would require FDA to
submit annual reports to Congress on the use of tobacco user fees assessed and
collected under the Tobacco Control Act.
The hearing begins today at 10:15 am EST. Check NACS Daily
tomorrow for an in-depth update on the hearing.