On October 14th, 2011, Senators Lautenberg (NJ), Blumenthal (CT) and Brown (IL) wrote to FDA Commissioner Hamburg to request FDA’s action to regulate additional tobacco products under the Tobacco Control Act.
The Tobacco Control Act requires FDA to regulate certain tobacco products, including cigarettes, roll-your-own and smokeless, and permits FDA to regulate others, such as pipe tobacco, cigars and electronic cigarettes. FDA must promulgate regulations in order to assert authority over these tobacco products.
In April 2011, in the aftermath of the courts’ rejection of FDA’s effort to regulate electronic cigarettes as drugs and/or medical devices, FDA signaled its intent to promulgate regulations to assert authority over electronic cigarettes and all other tobacco products. In July, FDA advised interested parties that it anticipated issuing regulations in October. To date, however, FDA has not published proposed regulations.
Apparently growing impatient with FDA’s efforts in this regard, Senators Lautenberg, Blumenthal and Brown requested that FDA “move swiftly” to regulate all tobacco products under the Tobacco Control Act. They requested that FDA update its progress on the regulations and its timeline for releasing the proposed regulations. They also requested a meeting with Commissioner Hamburg to discuss the matter in more detail.
Based on FDA’s prior commitment to issue the regulations in October, we expect that the proposed regulations will be issued shortly. The proposed regulations would be followed by a period of notice and comment, during which stakeholders will have an opportunity to shape how FDA will regulate these products. When the proposed regulations are issued, the Troutman Sanders Tobacco Team will be prepared to advise stakeholders on the appropriate response.
For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.