Tobacco Product Standard for Nicotine Level of Combustible Cigarettes

The federal strategy to regulate VLN cigarettes is referred to as The Tobacco Product Standard for Nicotine Level of Combustible Cigarettes policy.¹ It was included in the Comprehensive Plan for Tobacco and Nicotine Regulation of the United States that the Food and Drug Administration (FDA) announced in July 2017. It is intended to lower nicotine in cigarettes to a minimally or non-addictive level (entailing over 90% nicotine reduction) with the aim of decreasing smoking initiation among future generations while making smoking cessation easier for current smokers. 

In March 2018, the FDA published an Advance Notice of Proposed Rulemaking seeking public comment on a tobacco product standard for nicotine levels in combustible cigarettes. Such a rule could require all cigarettes sold in the U.S. to lower its nicotine content. In June 2022, the plan to develop a proposed product standard establishing a maximum nicotine level was published in the Unified Agenda of Regulatory and Deregulatory Actions.

In December 2021, the FDA authorized for retail sale of two brands (menthol and non-menthol) of Very Low Nicotine (VLN) cigarettes through its premarket review authority and granted applications to permit reduced exposure claims. While these products show it is feasible for tobacco manufacturers to lower the nicotine content in products, the public health benefit of non-addictive cigarettes can only be achieved with a product standard requiring all cigarettes to be non-addictive.