Today, December 14, 2017, FDA published a summary of its “major policy goals for 2018.” Since the administration change, and since the addition Scott Gottlieb as FDA commissioner, in 2017, regulated agencies have seen a change in the direction of regulatory reform. This is due in part to the reinvigoration of the Congressional Review Act, but also can be attributed to Executive Orders 13771 and 13777, which call for review and elimination of ineffective, outdated, and unnecessary regulations. The various federal agencies went to work, developing task forces to review regulations for their efficacy, and to identify for review those that were ripe for elimination. FDA, specifically, published numerous requests for comments from the public and industry seeking analysis and recommendations of regulations that should be reviewed.
Seemingly as part of this regulatory review process, FDA pushed back one of the major Deeming Rule deadlines (the PMTA submission) to afford it time to inform itself on the industry and to better consider the cost-benefit of ENDS products. FDA has also published requests for comment and requests for industry participation in a dialogue on ENDS products, all apparently in an effort to learn more about the industry.
FDA’s stated focus for 2018 with regard to the tobacco industry is “Addressing the Nicotine Addiction Crisis”, which coincides with the upcoming public hearing in January 2018, to address Nicotine Replacement Therapies.
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.
Also to be expected in 2018 is a discussion of good manufacturing practices for ENDS manufacturers, and the issue of flavored tobacco products:
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.
In addition to these developing topics, two major Deeming Rule deadlines are set to come due in 2018: ingredient listing submission (May 8, 2018); and, compliant warning labels must be on all deemed product packaging and advertisements (August 10, 2018). For more information about the agenda, or for more details about compliance with the Deeming Rule, please contact Lindsey Streicher or Tom Norby.
This article is provided as general information only. This is not legal advice, and nothing about this article creates a legal relationship between the reader and Brownson • Norby, PLLC. Consult your own professional, or contact us, if you have specific questions or concerns about the impact of this new rule on your operation. We expressly disclaim all liability relating to actions taken or not taken based on the contents of this article.