Statute
FDCA
242 published works
Drug & Device Law
What’s In a Name?
“That which we call a rose by any other name would smell just as sweet.” William Shakespeare uses this line in his play Romeo and Juliet to convey that the naming…
Drug & Device Law
FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations
A few weeks ago, we reported on Chong v. Kind LLC, 2022 WL 464149 (N.D. Cal. 2022), a decision holding that 21 U.S.C. § 337(a) as construed in Buckman v.…
Drug & Device Law
Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law
Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law…
Regulatory Oversight
New Regulations Potentially on the Horizon for Synthetic Nicotine in 2022
By Michael Jordan, Bryan Haynes
On December 15, New Jersey Congresswoman Mikie Sherrill introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration…
Regulatory Oversight
North Carolina AG Opens Investigation Into E-Cigarette Maker Puff Bar
By Michael Jordan, Chris Carlson, Agustin Rodriguez
On November 16, North Carolina Attorney General Josh Stein launched a probe into e-cigarette maker Puff Bar and others, citing concerns of youth-appealing flavors, youth marketing, and poor age verification.…
Drug & Device Law
More Interesting Post-MDL IVC Rulings
By Bexis
Ever since our Bone Screw days, when we used the strategy to great effect, we’ve rooted for defendants undertaking to beat post-MDL remand plaintiffs in guerrilla litigation in numerous courts…
The Daily Intake
AAFCO Releases Position on Hemp in Animal Food
On September 20, 2021, the American Association of Feed Control Officials (AAFCO) released a press statement in which it detailed its updated position on the regulation of hemp and hemp…
Drug & Device Law
No Comparison
By Bexis
We are watching the post-MDL-remand Bard IVC filter litigation with interest. It bears some resemblance to the Bone Screw litigation of the late 1990s/early 2000s (except in Bone Screw, there…
Drug & Device Law
Recent Second Circuit Implied-Preemption Decision Confirms That A ‘Major Change’ Is A Big Deal In Pharmaceutical Litigation
We’ll get to the recent Second Circuit decision, Ignacuinos v. Boehringer Ingelheim Pharms., Inc., --- F.4th ----, 2021 WL 3438355 (2d Cir. 2021), in due course, but first some background.…
Drug & Device Law
Is Something Fishy Going On?
By Bexis
Back in the early days of the blog, when it was a Bexis/Herrmann operation, we wrote about the California Supreme Court decision that opened the floodgates to all that food…