On Dec. 6, the Federal Trade Commission issued a proposed order against ExotoUSA LLC and its owner to resolve allegations that they improperly marketed products online using unqualified Made in USA claims and other false or misleading claims. Read on for details about this case and takeaways for companies that label and market their products
Corporate & Commercial
A Failed Constitutional Challenge to the AKS Safe Harbor Provision – More to come?
This past summer, in United States v. Booker, a North Carolina district court ruled against a challenge to the constitutionality of Congress’s delegation of authority to promulgate safe harbors to the Anti-Kickback Statute (AKS). In filing a motion for acquittal, Defendant Donald Booker argued the AKS “Safe Harbor Provision,” which grants the Secretary of…
Life Sciences Companies Face Continuing Compliance Challenges in Developing Value-Based and Value-Added Models
The U.S. Department of Health and Human Services Office of Inspector General recently issued Advisory Opinion 23-08, continuing its long-held position that the provision of value-added items and services implicates fraud and abuse laws, including the Federal Anti-Kickback Statute and the Beneficiary Inducement Civil Monetary Penalty law.
Read on to learn how manufacturers, distributors, and…
OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers
On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued its General Compliance Program Guidance for healthcare providers and other industry stakeholders. The guidance follows OIG’s previous announcement about a modernization initiative and signifies a major update to OIG’s prior approach to providing guidance on effective compliance…
1st Circuit Rejects Convicted Former Medical Device Executives’ Off-Label “Free Speech” Theory
A federal appeals court recently upheld misdemeanor convictions of two former Acclarent Inc. executives for commercially distributing an adulterated and misbranded medical device by misleading the U.S. Food and Drug Administration regarding the device’s intended use.
Read on for details about the decision, which rejected claims that their off-label promotion amounted to constitutionally protected commercial…
Off-Label “Free Speech” Theory Does Not Fly for Convicted Former Medical Device Executives in 1st Circuit
A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by misleading the FDA regarding the intended use of the device. In United States v. Facteau (89 F.4th 1 (1st Cir. 2023)) the First Circuit Court of…
The Foreign Extortion Prevention Act: Another Tool to Fight Foreign Corruption
In recent years, the Biden Administration has been vocal that combatting foreign public corruption is a key pillar of its national security efforts.[1] Consistent with those policy goals, on December 22, 2023, Congress passed the Foreign Extortion Prevention Act (FEPA), a long-awaited complement to the Foreign Corrupt Practices Act (FCPA). Where the FCPA…
New York LLC Transparency Act Beneficial Ownership Reporting Requirements to Take Effect
On December 23, 2023, New York Governor Kathy Hochul signed the New York LLC Transparency Act (“NYLTA”), which requires LLCs to disclose beneficial ownership information (“BOI”) to the New York Department of State. Effective December 21, 2024, the NYLTA will impose separate BOI reporting requirements on New York LLCs, which are also subject to the…
Recent Sanctions Enforcement Actions Demonstrate Importance of Incorporating All Available Data into Screening
For U.S. businesses, sanctions compliance has never been more challenging or more important. The U.S. has responded to Russia’s invasion of Ukraine with a broad range of sanctions targeting the Russian government, its officials, oligarchs and Russia’s financial and energy industries, among others. Indeed, since the invasion of Ukraine, the agency that administers sanctions, the…
Illinois Jumps on the Food Ingredient ‘Banned’ Wagon
Illinois legislators recently joined California and New York in proposing bans on several food additives that a growing number of studies have shown to be harmful to human health. Read on for details and comparison of the three state bills and an update on related federal-level activity.