FDA PLANS NEW TOBACCO REGS

US: The FDA has announced plans to reduce nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. It will seek input on potential public health benefits and any possible adverse effects from lowering the levels. To better protect children and encourage smokers to quit, the agency is also revising the timelines for product review applications for newly-regulated tobacco products that were on the market as of 8th August 2016. For combustible products applications would be submitted by 8th August 2021, and 8th August 2022 for non-combustible products, such as e-cigarettes and other electronic nicotine delivery devices. The FDA expects that manufacturers would continue to market their products while it reviews the applications. 

Comment: The FDA will seek public input on a variety of topics, including approaches to regulating appealing flavours in e-cigarettes and cigars. In particular it will 1) be looking for opinions on the role that flavourings (including menthol) have in attracting youth and whether they may play a role in helping some smokers switch to potentially less harmful nicotine delivery methods and 2) be soliciting additional comments and scientific data related to patterns of use and resulting health impacts from premium cigars, which were included in the FDA's 2016 rule. It also plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.