In May 2025 the Department of Justice (DOJ) Criminal Division published its enforcement priorities, and the Civil Division has now followed suit with a memorandum of its own (the “Civil Division Memo”)...more
Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...more
4/16/2025
/ Civil Monetary Penalty ,
Customs and Border Protection ,
Department of Justice (DOJ) ,
E-Cigarettes ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
International Trade Commission (ITC) ,
Patent Infringement ,
Patents ,
SCOTUS ,
Tobacco
In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
9/21/2022
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Manufacturers ,
Medicare Part D ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Product Labels ,
Qui Tam ,
Self-Disclosure Requirements ,
Settlement
In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19...more
Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more
12/22/2020
/ Biologics ,
CDRH ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Emergency Use Authorization (EUA) ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry
We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud. These agencies and their respective law enforcement efforts have yet to slow down and appear to have...more
On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) agreed to plead guilty to charges that it distributed contaminated ice cream products that were linked to a 2015 listeriosis outbreak. The Blue Bell outbreak made...more
5/12/2020
/ Blue Bell Creameries ,
Corporate Counsel ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Listeria ,
Settlement Agreements
In case you hadn’t heard about it or didn’t get involved in any of the events hosted by various campaign members, the week of March 6-12 was National Consumer Protection Week. Besides the usual efforts to educate the public...more