“A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA said in a statement.
The submitted proposal, which has been on CTPs agenda since 2018, does not mean that there will be any immediate changes. The OMB’s approval process can take months, including a mandatory public comment period. It is also likely that the proposed regulation would be challenged legally by the industry. Finally, it is also not clear how this proposal may be affected once Trump becomes President in January.
Posted in FDA and USDA Regulatory Update, Tobacco.