The FDA issued a press release that announced comprehensive regulatory plan to shift trajectory of tobacco-related disease, death and to pursue lowering nicotine in cigarettes to non-addictive levels and create more predictability in tobacco regulation.
The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
However, it’s not all good news as some regulation dates will remain in effect.
Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., “light,” “low,” or “mild,” or similar descriptors.
The entire press release can be read at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm
