On Dec. 14, 2017, the Scott Gottlieb of the U.S. Food and Drug Administration (FDA) revealed some of his agency’s major policy goals for 2018. For the tobacco industry, two topics on the FDA’s agenda will be of great interest: nicotine addiction and the regulation of premium cigars.
Gottlieb and the FDA will continue to zero in on combustible tobacco products and make new proposals on how the agency can best reduce their addictive appeal. Flavored tobacco products and premium cigars will also be major focuses of the agency next year. Here’s what Gottlieb wrote on the FDA’s blog about these topics:
“To reduce the morbidity and mortality associated with combusting tobacco, we are proposing meaningful actions to advance our new, comprehensive approach to nicotine and the regulation of combustible cigarettes. These efforts include an Advance Notice of Proposed Rulemaking asking critical questions related to our pursuit of regulation that would result in a targeted reduction of the nicotine levels in combustible cigarettes to eliminate or dramatically reduce their addictive value. At the same time, FDA is taking new steps to facilitate innovation in products that can deliver satisfying levels of nicotine to adults who want or need such access without the same health risks associated with combustible tobacco.
As part of this plan, FDA will also be issuing an Advanced Notice of Proposed Rulemaking to look at how to best regulate flavors in tobacco products to limit their appeal to youth, while considering the potential role that some flavors may play in helping users transition away from combustible products. Further, FDA will be issuing an Advance Notice of Proposed Rulemaking to solicit information that may inform regulatory actions FDA might take with respect to premium cigars, asking certain questions related to how we might define and regulate “premium cigars,” taking into consideration the health effects of these products and their patterns of use.”
These proposals will come in the form of an Advance Notice of Proposed Rulemaking (ANPRM), a document that an agency publishes that seeks public and industry-specific comments in regards to proposed regulation changes. This document is published in the Federal Register and is an early action that could lead to more changes in the government’s policy. Whether this will lead to to positive changes or negative is unknown at this time.