The FDA on Friday announced new tobacco-regulation efforts focused on nicotine and “the issue of addiction.” In particular, the agency intends to “begin a public dialogue” on reducing nicotine levels in combustible cigarettes to nonaddictive levels.
In addition, the FDA plans to extend the deadlines for some post-marketing product review applications — those for electronic cigarettes and for newly regulated combustible products (e.g., cigars, hookah tobacco) — in an effort to achieve “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” Under this plan:
the makers of e-cigarettes would need to get their product review applications in by August 2022, rather than next year;
the deadline for the makers of newly regulated combustible products would be August 2021;
these products would be allowed to remain on the market while the FDA reviews the applications.
The New York Times reports that in an interview, FDA commissioner Dr. Scott Gottlieb “sounded notably more open to e-cigarettes than many other federal public health officials.”
Gottlieb cited the “potential opportunity for e-cigarettes to be a lower-risk alternative to smokers who want to quit combustible cigarettes.”