Nearly six years ago, in 2015, the FDA attempted to slip a change to its “intended use” regulations (21 C.F.R. §§201.128, 801.4) – which had not been updated since the 1950s – through the administrative process by hiding it in a Federal Register notice about electronic cigarettes.  80 Fed. Reg. 57756 (FDA Sept. 25, 2015). 

Today we’re updating our readers on new developments this month relating to three of our prior posts.

First, back in March we reported on an “Advocate’s General’s opinion” in a case before the European Court of Justice (“ECJ”).  See the original post for details, but the plaintiff was asserting the radical claim that EU

How many of us entered law school dreaming of following the paths of Brandeis, Marshall, etc. in the field of constitutional law? How many of us now can go weeks, or even months, without reading a Supreme Court case? Paying off student loans led many of us to work for law firms where there was

Our recent post about the First Amendment decision in American Beverage Ass’n v. City & County of San Francisco, ___ F.3d ___, 2019 WL 387114 (9th Cir. Jan. 31, 2019) (en banc) (“ABevA”), holding unconstitutional a purported product “safety warning” was more than enough to set the old First Amendment juices flowing. 

Not too long ago we read a non-drug/device decision, Hale v. State Farm Mutual Automobile Insurance Co., 2018 WL 3241971 (S.D. Ill. July 3, 2018), which left us shaking our heads.  How this suit could not be a blatant First Amendment violation is beyond us.

But that’s not really the point of this post.