Also this week, the FDA released a second advanced notice of proposed rule-making seeking public input on “…data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars.”  Specifically, the FDA is looking for comments on:

• Definition of premium cigars
• Use patterns of premium cigars 
• Public health considerations associated with premium cigars.

The ATS will respond to the FDA’s request for comment and will urge the administration to reject any proposal to exempt premium cigars from regulations.  

It should be noted that the questions FDA is seeking public input on are not new or novel.  In 2013, the FDA issued an advanced notice of proposed rule-making seeking public input on menthol flavorings in tobacco products.  The FDA also requested and received two independent expert reports on menthol flavorings (the tobacco industry sued in court to have one of the reports blocked).  In 2013, the ATS, joined by the majority of medical and public health groups, strongly recommended that FDA take immediate action to ban menthol flavorings in tobacco products. 

Further, as part of the 2016 FDA Deeming rule extending FDA tobacco regulatory authority over cigars, e-cigarettes and other tobacco products, the administration asked for and received significant public comment on how to address flavoring agents in tobacco products and how to address regulation of cigars. 

The ATS is concerned that the FDA, by revisiting questions that are already well addressed in both public comments and in the scientific literature, is delaying needed regulatory action on cigars and e-cigarettes.  Further regulatory delay by the FDA will only extend the addiction, disease and death caused by tobacco use in the U.S.