FDA’s Tobacco Products Scientific Advisory Committee Says Ban on Menthol Cigarettes Would Benefit Public Health
As we previously reported, with the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA has been mandated by Congress to study the impact of the use of menthol in cigarettes on public health. On March 17 and 18, the Tobacco Products Scientific Advisory Committee (“Tobacco Advisory Committee”) in advance of the release of its full report and recommendations, met to announce its recommendations to the FDA.
Over the past year, the Tobacco Advisory Committee has met ten times to consider the public health effect of menthol cigarettes, evaluate how menthol cigarettes are marketed, discuss the appeal of menthol cigarettes to young people, and study their physiological effects on smokers. During its most recent meeting on March 17, the Tobacco Advisory Committee announced its recommendation that the “removal of menthol cigarettes from the marketplace would benefit public heath in the United States.” However, the committee stopped short of recommending that the FDA take any specific action such as restricting the amount of menthol in cigarettes or even a full ban on the use of menthol. As a result of the committees findings but lack of an outright call for a menthol ban, the FDA may consider alternatives to banning menthol cigarettes, such as limits and restrictions on marketing and increased labeling regulation. A copy of the Tobacco Advisory Committees draft report is available here.
On March 23, 2011, the Tobacco Advisory Committee will release its full report and recommendations. However, the FDAs receipt of the final report and recommendations does not have a direct and immediate effect on the availability of menthol products in the marketplace. The FDA will consider the report and recommendations of the Committee, the industry perspective document, and continue to review all of the available science concerning menthol cigarettes prior to acting. The FDA will then make a determination about what future regulatory action(s), if any, are warranted.
The Tobacco Control Act does not set a required deadline or timeline for the FDA to act on the recommendations provided by the Committee in the report. Any future action(s) taken by the FDA to regulate the sale or distribution of menthol cigarettes or establish a tobacco product standard for menthol cigarettes will require rule making that includes public notice and the opportunity for public comment. However, the FDA intends to provide its first progress report on the review of the science in approximately 90 days from the Tobacco Advisory Committee report due date.
An overview of the effect of the Tobacco Advisory Committees recommendation is available at FDA’s website here. Fuerst Ittleman will continue to watch the developments on menthol cigarettes with a keen eye. If you have questions pertaining to the FDCA or the Tobacco Act or how to ensure that your business maintains regulatory compliance at both the state and federal levels, contact Fuerst Ittleman PL at email@example.com.