[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
On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
On February 6, a bipartisan group of 51 attorney general (AG) sent a warning letter to Life Corporation (Life Corp.) for allegedly engaging in an illegal robocall campaign that they claim was intended to deter New Hampshire...more
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more
In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products....more
Advertisers likely recall that back in 2021, the Federal Trade Commission (FTC) created quite the stir when it sent to more than 700 companies warning letters that threatened penalties if companies engaged in deceptive...more
LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...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
Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping...more
On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate...more
On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products....more
On March 21, 2022, the Federal Trade Commission (FTC) announced a final administrative complaint and decision and order that finalizes a settlement with a California online fashion retailer to settle allegations that the...more
In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more
Environmental regulators have recently taken significant enforcement actions against cannabis companies who violate fundamental environmental laws. What can other cannabis and hemp operators learn from these cases? Watch...more
As the saying goes, “the only thing for certain, is nothing is certain.” With a rash of changes since Chairperson Lina Kahn took command, the FTC is certainly proving that maxim true. Seeking to transform the historically...more
An old adage is that an “ounce of prevention is worth a pound of cure.” Perhaps no setting is a more appropriate example of this than a company whose business centers on food products regulated by the Federal Food and Drug...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
The Centers for Medicare and Medicaid Services (CMS) has confirmed that the agency began sending warning letters to hospitals it deems out of compliance with the Hospital Price Transparency Rule in April 2021. This represents...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
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Good riddance to 2020 for so many reasons. But, as the AGG Year in Review of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek...more
In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year....more