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Defendants do not state, even generally, when  the draft guidance will be finalized; they  simply state that “the FDA has given every indication  that it plans to finalize the draft guidance as quickly  as possible,” after it finishes reviewing the approximately  15,467 comments it received electronically and the additional  comments it received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.   

Ashley Brandt

Hi there! I’m happy you’re here. My name is Ashley Brandt and I’m an attorney in Chicago representing clients in the Food and Beverage, Advertising, Media, and Real Estate industries. A while back I kept getting calls and questions from industry professionals and attorneys looking for advice and information on a fun and unique area of law that I’m lucky enough to practice in. These calls represented a serious lack of, and need for, some answers, news, and information on the legal aspects of marketing and media. I've got this deep seeded belief that information should be readily available and that the greatest benefit from the information age is open access to knowledge... so ... this blog seemed like the best way to accomplish that. I enjoy being an attorney and it’s given me some amazing opportunities, wonderful experiences, and an appreciation and love for this work. I live in Chicago and work at an exceptional law firm, Goldstein & McClintock, with some truly brilliant people. Feel free to contact me at any time with any issues, comments, concerns… frankly, after reading this far, I hope you take the time to at least let me know what you think about the blog and how I can make it a better resource.

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