[Webinar] EHS in the Cannabis Industry: What Happens When the E stands for Enforcement?
#WorkforceWednesday: OSHA ETS Coming Soon, OSHA Cracks Down on States, and EEOC Updates Guidance - Employment Law This Week®
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Subro Sense Podcast - Unpacking Product Claims Against Amazon
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Taking Notice of Notice Letters
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more
The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more
The federal banking agencies have jointly issued a final rule that will modify how examiners assess compliance with the Community Reinvestment Act (CRA). Among other changes to the CRA regulations announced on October 24, the...more
A proposed FTC settlement that involves alleged false Made in USA representations and alleged deceptive COVID claims was recently filed by the Department of Justice on the FTC’s behalf against an individual and the two...more
Federal agencies don’t publish official Second Request transaction numbers until late the following year. But recent trends suggest a high volume of activity for 2021 and 2022, as well as a stricter regulatory and political...more
The Federal Trade Commission (FTC) was busy in its first year under the Biden administration. Over the past year, the FTC announced several important policy and process changes that may have significant implications for US...more
Antitrust activity increased significantly in 2021. This past year brought numerous changes in merger and non-merger enforcement policies and priorities that signal increased scrutiny in industry transactions. The “Biden...more
On Tuesday, August 3, 2021, the Federal Trade Commission announced a new approach for merger investigations that the FTC does not complete during the Hart-Scott-Rodino Act (HSR) waiting period—the FTC may advise merging...more
On February 4, 2021, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) announced that the agencies would temporarily suspend the practice of granting early termination of the 30 day waiting period in...more
The Federal Trade Commission (FTC) and the Department of Justice (DOJ) have filed the first case under the COVID-19 Consumer Protection Act, a law passed by Congress in December 2020 that imposes financial penalties on...more
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
On August 18, 2020, the Financial Crimes Enforcement Network (FinCEN), which is the primary regulator and administrator of the Bank Secrecy Act (BSA), issued a statement on enforcement of the BSA. The requirements of the BSA...more
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products,...more
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
The rapidly evolving COVID-19 (coronavirus) situation is impacting local and global companies, disrupting supply chains, creating volatility in the stock market, and causing great concern in local communities. As part of the...more
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more
We are pleased to share with you the first issue of Manatt's Retail and Consumer Products Law Roundup. The newsletter will be published on a monthly basis and will survey topics of critical importance to the retail,...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more