On Dec. 6, the U.S. Food and Drug Administration sent a warning letter to the owners of online hemp, tetrahydrocannabinol and cannabidiol retailer Hemp-xr.com for introducing adulterated foods into interstate commerce. FDA took issue with certain cookies, edibles, gummies and honey containing delta-8 THC and CBD because they “bear or contain an unsafe food additive.”
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
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
BIS Continues Enforcement Policy Ramp-Up
On January 16, 2024, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) issued new guidance to incentivize voluntary self-disclosure (“VSD”) of possible violations of the Export Administration Regulations (“EAR”). This new guidance—which was announced in conjunction with a speech by BIS’s top enforcement official indicating the EAR enforcement is an increasingly important priority
Disruptive Technology Strike Force Continues Focus on Trade Secret Theft, Export Control Enforcement
During a summit celebrating its one-year anniversary, the Disruptive Technology Strike Force provided updates on its efforts to prevent authoritarian regimes and hostile nation-states from acquiring critical technologies.
Read on for details about a new expansion of the effort, recent prosecutions and the group’s continued focus on cases involving theft of trade secrets and export
Bank Secrecy Act’s Anti-Money Laundering and Counter Terrorism Financing Requirements to Apply to Investment Advisers
The Bank Secrecy Act (“BSA”) establishes program, recordkeeping, and reporting requirements for certain financial institutions to combat and detect money laundering, terrorist financing, and other illicit activities. On February 13, 2024, FinCEN proposed new rules which expand the scope of the BSA to include certain investment advisers, which currently are not subject to any federal
FinCEN Issues Access Rule Compliance Guide for Beneficial Ownership Information
Rule Regarding Access to Beneficial Ownership Information Takes Effect
On February 21, 2024, FinCEN published a Small Entity Compliance Guide to aid in compliance with the Corporate Transparency Act’s (“CTA”) Beneficial Ownership Information (“BOI”) Access and Safeguards Rule (“Access Rule”). The Compliance Guide is called the Small Entity Compliance Guide only because federal law requires