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FDCA
242 published works
Drug & Device Law
FDCA Preemption Delivers Sweet Win for Sugar Substitute Manufacturer
When we first read what the claims were in Cohen v. Saraya USA Inc., (E.D.N.Y. Jan. 20, 2025), we thought of the old Catskills joke about the elderly couple at…
Regulatory Oversight
FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products
By Bryan Haynes, Agustin Rodriguez, Zie Alere
On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products.…
Drug & Device Law
Brain Worms and Roadkill – The Ten Worst Prescription Drug/Medical Device Decisions Of 2024
By Bexis
We warned everyone, but there is no sense beating a dead horse (or bear, or whale). So we’re getting right to the unpleasant business of discussing the bottom ten worst…
Marler Blog
Rizo Lopez Foods Inc. enjoined from manufacturing food that kills people
By Bill Marler
A federal court yesterday enjoined a California company from manufacturing and distributing adulterated food products following a listeria outbreak linked to multiple hospitalizations and two deaths. In a civil complaint…
Consumer products law blog
Pet food regulations in the United States: Federal regulation
By S. Jamal Faleel (US), Will Troutman (US), Andy Crowder (US), Mark Faccenda (US), Lauren Shoor (US)
Today’s post in our pet food series focuses on federal oversight of pet food. At the federal level, the Food and Drug Administration (FDA) regulates pet food similar to that…
Drug & Device Law
It’s Hip To Be Preempted, Again
We are celebrating an anniversary today: We wrote our first blogpost on July 26, 2013. Eleven years and hundreds of posts later, we have two observations. First, we seriously need…
Regulatory Oversight
Federal Court Rules Montana AG Preempted From De-Listing Cigarette Manufacturer
By Agustin Rodriguez, Bryan Haynes, Zie Alere
In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River…
Tobacco Law Blog
Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer
By Troutman Pepper Locke Tobacco Practice, Agustin Rodriguez, Bryan Haynes, Zie Alere
In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River…
Regulatory Oversight
What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?
By Michael Jordan, Bryan Haynes, Agustin Rodriguez
In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had "deemed" premium…
The Daily Intake
Supreme Court Declines to Review FDA Labeling Preemption for State Claims
The Supreme Court declined to review (Law360 subscription required) a First Circuit decision affirming dismissal of false advertising and consumer protection claims alleging that McNeil Nutritionals LLC misbranded Lactaid drug…