News & Analysis as of

Enforcement Food and Drug Administration (FDA)

Mintz - Health Care Viewpoints

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

Vicente LLP

Texas Cannabis Legalization: What the SB 3 Veto Means for Hemp Businesses - UPDATED

Vicente LLP on

What is Texas Senate Bill 3? As it stands, current Texas law permits hemp-derived products with less than 0.3% THC content, which are widely available at more than 8,000 locations throughout the state. In comparison to a...more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Wiley Rein LLP

FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations

Wiley Rein LLP on

The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): •Standardized test methods to detect...more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Foley Hoag LLP

Health Care Fraud Enforcement in 2025

Foley Hoag LLP on

We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more

ArentFox Schiff

Death Knell Sounds for PFAS-Containing Food Packaging Materials

ArentFox Schiff on

On January 6, the US Food and Drug Administration (FDA) published in the Federal Register a notice announcing its determination that 35 previously authorized Food Contact Notifications (FCNs) for food contact substances...more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

ArentFox Schiff

FDA Issues New Cosmetics Proposed Rule: Let’s Talk About Talc

ArentFox Schiff on

Two years after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) has published the long-awaited proposed rule on talc-containing cosmetics....more

Foley & Lardner LLP

GLP-1 Drugs: FDA “Re-Confirms” Decision Removing Tirzepatide from the Drug Shortage List

Foley & Lardner LLP on

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more

King & Spalding

The Trifecta: What to Expect from a Second Trump Administration and a Republican Congress

King & Spalding on

Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more

ArentFox Schiff

As the (Customs and Trade) World Turns: November 2024

ArentFox Schiff on

Welcome to the November 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

Foley & Lardner LLP

Health Policy: Expected Movements in the Lame Duck Session – November/December 2024

Foley & Lardner LLP on

Congress returned to Washington this week with just five weeks left in this year’s legislative calendar. With a Continuing Resolution (CR) that expires December 20, 2024, either a year-end spending package or a new Continuing...more

Fuerst Ittleman David & Joseph

Compounded GLP-1 Drugs: is the Party Over? These Are the Legal and Regulatory Issues for Game Changing Weight Loss Products and...

Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

ArentFox Schiff on

Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more

Gardner Law

FDA Compliance: Conducting a Recall

Gardner Law on

Conducting a recall is a time-sensitive process that requires an informed, strategic, and measured approach. When conducting recalls, companies must take the necessary steps to protect patients or consumers and comply with...more

Foley Hoag LLP - Cannabis and the Law

Senate Wades Into the Muddy Waters of Intoxicating Hemp

With the persisting uncertainty surrounding the next iteration of the Farm Bill and its treatment of hemp-derived consumable products, perhaps it should come as no surprise that legislators on Capitol Hill have proposed...more

Knobbe Martens

FDA and FTC Crack Down on Delta-8 THC Copycat Products

Knobbe Martens on

In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more

Foley & Lardner LLP

2024 CPSC and FDA Enforcement Trends

Foley & Lardner LLP on

The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more

Foley & Lardner LLP

Yes, You Can Patent Food Products!

Foley & Lardner LLP on

Companies in the food and beverage industry might overlook significant advantages by not patenting their innovations. While there’s a common belief that “recipes” cannot be patented, unique formulations and other aspects of...more

Perkins Coie

FDA and AAFCO Updates for Animal Food Ingredient Oversight

Perkins Coie on

FDA’s Center for Veterinary Medicine (CVM) recently announced the upcoming expiration of its longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO). This MOU—which has...more

Fenwick & West LLP

Disclosure Trend: Risk Factors Post-Chevron

Fenwick & West LLP on

Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more

Gardner Law

FDA Drafts Guidance on Correcting “Misinformation”

Gardner Law on

The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more

Akin Gump Strauss Hauer & Feld LLP

The Top 10 Takeaways for Businesses from the Supreme Court’s Three Big Administrative Law Decisions in 2024

Now that the dust has settled following the Supreme Court’s overhaul of administrative law through three late-term decisions, Akin litigators and policy advisors offer the most significant takeaways for businesses and...more

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