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
Episode 323 - Carlos Villagran Discusses Rebuilding a Corporate Culture After a Crisis
A private equity firm and its investment advisor are facing trial over claims they participated in a price-fixing conspiracy for canned tuna carried out at their portfolio company, Bumble Bee tuna. The judge overseeing the...more
The U.S. Food and Drug Administration (FDA) released a public inventory on July 12, 2023, of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally...more
The Justice Department has a long-record of criminal prosecutions of companies for manufacturing food products under unsanitary conditions. In recent years, DOJ has prosecuted Blue Bell Ice Cream, Chipotle, ConAgra Grocery,...more
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
While the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) only makes a minor change to add sesame as a major food allergen, it signals the government’s intent to closely examine food allergen...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
They may not realize it, but the manufacturers of many of America's favorite foods (beer, bread, coffee, jerky, salsa, salad dressing, etc.) are subject to a multitude of environmental regulations for food and beverage...more
The U.S. Food and Drug Administration (FDA) recently issued a fifth Warning Letter related to allergen labeling, continuing a series of Warning letters in the past six months that cite companies for failing to “identify and...more
Historically, neither food companies nor the plaintiffs’ bar have lost sleep over “recyclable” or “recycled content” claims. Over the past year, however, there has been increasing attention to and scrutiny of recyclable...more
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
Fed Chair Powell was far from the main attraction on the Hill yesterday, but hey, let’s keep it on topic here and note his belief that the U.S. economy is performing well even as certain risks—including “sluggish growth...more
The deadline to comply with the Food and Drug Administration’s (FDA) Nutrition Facts and Supplement Facts label final rules is quickly approaching. Per the new rules, companies with annual sales totaling $10 million or more...more
Today, the U.S. Food and Drug Administration (FDA) updated its “Industry Resources on the Changes to the Nutrition Facts Label” webpage questions and answers, stating that the agency does not intend to take enforcement...more
The Commodity Futures Trading Commission received a short delay of the hearing date to determine if it should be subject to a contempt determination, sanctions and other relief for publishing a press release, a formal...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letter to CBD Co. for Unsubstantiated Claims - The U.S. Food and Drug Administration (FDA) has issued a warning letter to Curaleaf Inc. for “illegally selling...more
Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Food Safety and Inspection Service (FSIS) announced a formal agreement, in the form of a memorandum of understanding (MOU), to jointly regulate the...more
Last month, the Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to clarify Proposition 65 reproductive toxicity sampling requirements for food products. California’s Proposition 65, also known as...more
The United States Environmental Protection Agency (“EPA”) and Kerry Biofunctional Ingredients, Inc. d/b/a Kerry Bio Sciences (“Kerry”) entered into an April 10th Consent Agreement (“CA”) addressing alleged violations of...more
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more
Companies operating ammonia refrigeration systems are easy targets for EPA under a number of environmental programs. Recent history suggests release reporting under Section 112(r) of the Clean Air Act (CAA) and under the...more
This quarter’s issue includes summaries and associated court opinions of selected cases principally decided between February 2017 and April 2017. The cases address developing trends in class actions, ERISA, fiduciary duties,...more
The first FCPA enforcement action for 2017 landed with very little fanfare. The SEC reached a settlement with Mondelez International for $13 million. The facts surround the hiring of an agent in India and the failure of...more
In almost every Foreign Corrupt Practices Act (FCPA) enforcement action, there are nuggets to be gleaned for any Chief Compliance Officer (CCO) or compliance practitioner. All one has to do is look for them. Back in 2012,...more