Yesterday the U.S. Food and Drug Administration (FDA) announced an Advanced Notice of Proposed Rule Making (ANPRM) concerning setting limits on maximum nicotine levels in tobacco products. This was part of a comprehensive plan by FDA Commissioner Dr. Scott Gottlieb announced last July to reduce nicotine levels down to non-addictive levels. As a part of the program, the question of whether premium cigars should be regulated differently was posed. As a result, the FDA announced it was extending the deadline to August 8, 2021 for when premium cigars would require pre-market approval until it could sort out this question. There are now plans for a separate ANPRM to deal with the regulation of premium cigars. In addition, there is a third ANPRM planned to deal with the impacts of using flavored tobacco. The plans for these additional ANPRMs were announced in remarks made by Dr. Gottlieb as the ANPRM concerning nicotine levels was announced.
“…as we advance our framework to protect public health in the evolving tobacco marketplace, the FDA also plans shortly to issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use, and cessation of tobacco products. A second ANPRM will solicit additional comments and data related to the regulation of premium cigars,” commented Dr. Gottlieb.
The ANPRM around nicotine levels included the question of whether cigars should be exempt or subject to a different set of rules than cigarettes, the tobacco product that the nicotine limits are focused around. While yesterday’s ANPRM was specific to nicotine levels, the forthcoming ANPRM around premium cigars will go broader addressing the overall question on whether or not premium cigars should be exempt or regulated differently other tobacco products.
As for the ANPRM on flavored cigars, how that impacts premium handmade cigars is an unknown at this time. It is also unknown what the timetable is to deliver the two additional ANPRMs. Each ANPRM will be open to public comment which is a part of the rule making process. The ANPRN around nicotine levels officially starts soliciting public comment today (March 16, 2018) and will be open for 90 days, through June 14, 2018.