Court orders FDA to move up its review of e-cigarettes.
In another blow to e-cigarettes that could have repercussions for many industries utilizing vaping technologies, a Federal Judge has ruled that the FDA must move its submission date from its announced 2022 to 2021 to expedite its review of e-cigarette products. The recent e-cigarette ruling finds that the FDA failed to comply with the Administrative Procedure Act for comment and notice in issuing the guidance that the FDA ultimately issued that gave rise to this suit taking issue with the pace at which the FDA has been progressing:
Defendants do not state, even generally, when the draft guidance will be finalized; they simply state that “the FDA has given every indication that it plans to finalize the draft guidance as quickly as possible,” after it finishes reviewing the approximately 15,467 comments it received electronically and the additional comments it received via U.S. mail. … Given the pace at which the FDA has implemented the premarket review provisions of the Tobacco Control Act, its notion of “as quickly as possible” must be taken with a grain of salt.
You can read the full opinion here.
This ruling follows on the heels of last September’s federal ruling that the FDA proceed with regs implementing compliance for manufacturers to add graphic warning labels to cigarette packs. Take that with a grain of salt, however, as those pushing for the warnings touted that as a victory that would soon lead to such warnings, and yet, here we are a few months from being a year out and no such warnings are on cigarettes.