The Presumption of Innocence Podcast: Episode 45 - The Grit, Grace and Gift of Second Chances
The Justice Insiders Podcast - The Ever-Expanding Net: Corporate Compliance in an Era of Increasing Trade Sanctions and Restrictions
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Episode 333 -- The Boeing Proposed Plea Agreement
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
FCPA Survival Guide - Step 8 - Investing in Compliance
Exploring the AI and Crypto Intersection
The Justice Insiders Podcast: Jarkesy’s Implications for the Administrative State
The Presumption of Innocence Podcast: Episode 41 - The Dynamics of Decision-Making: Psychology and the Criminal Justice System
INTERPOL and Child Kidnapping Cases. What are INTERPOL’s Abilities and Limitations?
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
The Justice Insiders Podcast - AI-Washing: Everything Old Is New Again
The CFPB and State AGs Act Jointly Against Online Educational Company
Will the U.S. Have a GDPR? With Rachael Ormiston of Osano
Episode 328 -- Sanctions Enforcement Risks and Redlines
FCPA Survival Guide: Step 3 - Extensive Remediation
Episode 324 -- Third-Party Risks and Sanctions Compliance
Compliance Tip of the Day – Compliance Lessons from the Albemarle FCPA Enforcement Action
The Presumption of Innocence Podcast: Episode 38 - A Blueprint for Compliance: The Fraud Pentagon Theory
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
Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more
On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC)...more
“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more
FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more
In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more
Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...more
On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more
In April 2021, the Federal Trade Commission (“FTC”) emphasized its commitment to protecting consumers from unsubstantiated claims of products advertised to prevent, treat or cure COVID-19. On April 29, 2021, the FTC announced...more
In March, Khloe Kardashian unwittingly joined her sister, Kim Kardashian, as the subject of a Food and Drug Administration (FDA) Warning Letter relating to the reality star’s influencer-marketing activities. ...more
On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more
The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale....more
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more
There are two types of advertisers during a crisis. The first type knocks it out of the park by reaching consumers with empathy and graciousness through ads that generate feelings of hope, togetherness, and kindness. A...more
Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more
From severe shortages in medical masks and ventilation equipment worldwide to the curious “toilet paper desert” in America, COVID-19 is creating temporary and long-term disruptions in the availability of both highly...more
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more
On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by...more
The federal Food and Drug Administration (FDA) just released a report to Congress regarding the agency’s progress toward comprehensive regulation of hemp-derived cannabidiol (CBD). The report echoes the hard-line approach to...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
Social media is ever present in the daily lives of the majority of Americans. It has also become one of the main advertising vehicles for companies in recent years. These advertisements and, more specifically, marketing via...more
Resolve this new year to avoid advertising mistakes that could result in class actions, regulator enforcement, or competitor claims. Five advertising law takeaways for brand and legal teams to consider for 2020 follow....more
Products containing hemp-derived cannabidiol ("CBD") have become incredibly popular in the United States, with new product brands entering the market seemingly every day. Consumer demand and public interest in those products...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more