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
FTC Issues Largest Fine in Made in USA Enforcement — but Seeks to Collect Much Less
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
The Growing Causal Divide: But-For Causation in AKS/FCA Actions
In United States v. Regeneron, the District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to prevail in Anti-Kickback Statute (AKS) and False Claims Act (FCA) actions. The District Court’s ruling
HHS Rescheduling, SAFER Banking Act May Change the Marijuana Landscape
In late August, the Department of Health and Human Services recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substance Act. Meanwhile Congress is weighing a bill that would create federal safe harbors for financial institutions to accept deposits from state-sanctioned marijuana business operators. Read on for details
What Businesses Should Know About the NLRB’s Broad Standard for Joint Employment Status
On Oct. 26, 2023, the National Labor Relations Board issued a final rule that significantly broadens the definition of “joint employment” under the National Labor Relations Act, marking the fifth change to the board’s joint employer standard since 2015. Read on to learn more about how this rule affects employers.
FDA Proposes Brominated Vegetable Oil Ban
The Food and Drug Administration has proposed revoking the regulation that authorizes the use of brominated vegetable oil (BVO) in food because the agency no longer considers it safe. Public comments on the proposed rule are due Jan. 17, 2024. Read on to learn what California and New York are doing related to BVO and
Beneficial Ownership Reporting Requirements under the Corporate Transparency Act
Corporate Transparency Act Beneficial Ownership Reporting Requirements to Take Effect
In 2021, the Corporate Transparency Act (“CTA”) was enacted as part of the Anti-Money Laundering Act of 2020, requiring certain business entities (“Reporting Companies”) to report beneficial ownership information (“BOI”) to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”). FinCEN issued the final
HHS Advisory Opinion Approves Profit-Based Bonus Plan for Bona Fide Physician Employees
On Oct. 13, the U.S. Department of Health and Human Services Office of Inspector General issued an advisory opinion approving a physician practice’s proposal to pay bonuses to each of its employed physicians based on net profits derived from the facility fee generated by procedures the physician performed at the practice’s ambulatory surgery center.
Economic Crime and Corporate Transparency Act Becomes Law: What Companies Need to Know
On 26 October 2023, the Economic Crime and Corporate Transparency Act received royal assent. The new law is designed to fight corruption, money laundering and fraud, and has major implications for businesses, including:
California Bans Four Common Food Additives and 26 Chemicals Used in Cosmetics
Gov. Gavin Newsom recently signed into law the California Food Safety Act and amendments to the 2020 Toxic-Free Cosmetics Act. Together, they ban four additives commonly used in popular snacks and beverages, and an additional 26 chemicals found in many personal care products.
Read on for details about these developments impacting food and personal care