Late last week, the Food and Drug Administration published a long anticipated notice on its potential plans to mandate the reduction of nicotine in cigarettes. The publication, called an Advanced Notice of Proposed Rule Making (ANPRM), seeks industry information on several questions they see as relevant to their regulation process. This includes questions examining if premium cigars should be included or excluded in any nicotine standard pursued by the FDA and how premium cigars should be defined by the FDA. This is part of the agency’s consideration of setting nicotine levels in other combustible tobacco products outside of just cigarettes.
Late last July, the FDA announced its comprehensive plan on tobacco – including a consideration of nicotine reduction in cigarettes, and more importantly, an additional ANPRM on how it treats and defines premium cigars. The premium cigar ANPRM has not been released at this point.
Ken P. Neumann, President of the IPCPR Board of Directors, indicates that IPCPR looks forward to the comment period as a chance to continue providing the FDA and Center for Tobacco Products with an ever-increasing understanding of premium cigars as a distinct product category.
“If the FDA is truly concerned about harm reduction, the agency should not continue to misappropriate its limited personnel and resources by focusing on the regulation of premium cigar products and the retailers who sell them. This current ANPRM and the pending ANPRM relating specifically to premium cigars will provide more opportunities for our association to equip the agency with even more evidence that the current regulatory approach to these products does not work for our industry and undermines the FDA’s mission. This also includes any consideration of a nicotine standard in premium cigars or pipe tobacco products.”
The comment period on the ANPRM is now open to the public for submission and concludes on June 16th. Those wishing to submit those comments can do so at regulations.gov.
For additional questions on the ANPRM and IPCPR’s engagement with the FDA, please contact Daniel Trope, Senior Director of Federal Government Affairs for IPCPR at email@example.com.