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DOJ Criminal Fraud Section’s Annual Health Care Fraud Enforcement Action: “We Are a Target-Rich Environment”

On June 27, 2024, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced...more

Nuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is Deceptive, Misleading

Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all...more

FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines

On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final...more

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more

Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care [Video]

The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done...more

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more

FDA Introduces Dietary Supplement Ingredient Directory

In a March 6, 2023 constituent update, the U.S. Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of...more

Four Years After Enactment – Clinical Laboratories Should Not Forget About EKRA

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and...more

Four Years After EKRA: Reminders for Clinical Laboratories

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and...more

No More Exceptions: What to Do When the California Privacy Exemptions for Employee, Applicant and B2B Data Expire

The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) gives consumers increasingly more control over their personal information when collected by businesses subject to the law. We have...more

One Step Closer to a Revised Standard for the Admissibility of Expert Testimony Under Rule 702

The Judicial Conference of the United States’ Committee on Rules of Practice and Procedure seems poised to advance proposed amendments to Federal Rule of Evidence 702, after the Advisory Committee on Evidence unanimously...more

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