Compliance, Investigations & White Collar
November 19, 2024 | Stella Lellos | Lindsay M. Brocki | |
WHAT: A filing with FinCEN disclosing information about certain entities and owners.
WHO: Nonexempt entities formed or registered to do business by filing a document with the state and the beneficial owners of such entities.
WHEN: Companies formed prior to January 1, 2024, must file by January 1, 2025.
WHERE: FinCEN’s Beneficial Owner e-filing system here.
Read MoreOctober 29, 2024 | Jeffrey Ehrhardt | |
On October 9, 2024, the United States Attorney’s office in the Eastern District of New York unsealed an indictment alleging that eight defendants defrauded Medicaid of approximately $68 million.[1] The alleged scheme involved two adult day care programs and a home care financial intermediary, all owned and controlled by the same individuals, as well as
Read MoreAugust 20, 2024 | Marc S. Ullman |
Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex processes involved in making a dietary supplement can occur because human beings are not perfect. These events can range from
Read MoreJuly 30, 2024 | Jeffrey P. Rust | | |
On April 23, 2024, the Federal Trade Commission finalized its rule enforcing a noncompete ban for a vast majority of workers. The noncompete ban is set to take effect on September 4, 2024. With limited exceptions, the rule invalidates existing noncompete clauses and bans new noncompete clauses.
On the same day, Ryan, LLC filed suit
Read MoreJuly 9, 2024 | Benjamin P. Malerba | Jeffrey Ehrhardt | |
On June 24, 2024, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a final rule that establishes disincentives for certain health care providers that have committed information blocking, or any activity that is likely to hamper access, exchange, or use of electronic protected health information (PHI). This rule applies
Read MoreJuly 1, 2024 | Steven Shapiro |
Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale?
If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and Drug Administration (FDA) expanded authority to regulate dietary supplements?
“Gas station heroin” is a
Read MoreJune 28, 2024 | Eric D. Fader | |
Eric Fader co-authored the article “OIG Advisory Opinion Cautions Against ‘Surgeon Deals’ in Neuromonitoring” in SpineLine, the magazine of the North American Spine Society (NASS), with Dr, Rich Vogel, Co-Chair of the NASS Section on Intraoperative Neurophysiological Monitoring (IONM).
The article includes a detailed analysis of the U.S. Department of Health and Human Services’ Office
Read MoreJune 24, 2024 | Marc S. Ullman |
Marc Ullman recently authored “The Problem Isn’t DSHEA — It’s FDA Siloing” in Natural Products Insider.
In the article, Marc explains the dangers of the silo effect and how it limits interactions between members of different branches of the FDA. This results in reduced productivity and the issuing of only single-center warning letters on noncompliant
Read MoreMarch 29, 2024 | Marc S. Ullman |
Marc S. Ullman, of counsel to Rivkin Radler, recently authored “FDA sends a message with two warning letters to Amazon” in Natural Products Insider.
In the article, Marc explains the importance of the FDA warning letters on homeopathic “supplements” and products that contain active pharmaceutical ingredients. Ullman writes, “During the last quarter of 2023,
Read MoreJanuary 30, 2024 | Jennifer F. Hillman | Wendy Hoey Sheinberg | | | |
What Happened
Come on, you know what happened, right?
For those denied the joy of Roald Dahl and his take on bad parents, here is an overview.
Willy Wonka, the owner of Wonka’s Chocolates, is a unique and secretive chocolatier. Wonka’s Chocolates has one factory. Unlike other factories, no workers or visitors are seen entering
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