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Enforcement › Warning Letters › 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

Mintz - Health Care Viewpoints on

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

Sheppard Mullin Richter & Hampton LLP

FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

Sheppard Mullin Richter & Hampton LLP on

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated...more

King & Spalding

2022 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement

King & Spalding on

In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices.  A summary of the noteworthy...more

Bradley Arant Boult Cummings LLP

Warning Sign? A New Round of FDA Warning Letters Over CBD Consumer Confusion May Signal a Shift in Government Enforcement

Bradley Arant Boult Cummings LLP on

FDA warning letters are nothing new in the cannabis industry. In fact, we here at Budding Trends have covered this topic a number of times (here, here, and here). Not resigned to playing the hits, however, the FDA issued a...more

Vicente LLP

Recent FDA Enforcement Letters Signal Increased FDA Scrutiny of Hemp Products

Vicente LLP on

On November 21, 2022, the FDA issued five warning letters to companies selling CBD, Delta-8, and other hemp products for humans and pets. These letters are notable for the following five reasons (see additional details...more

Husch Blackwell LLP

FDA Issues Warning Letters On Marketing And Sale Of OTC CBD Products

Husch Blackwell LLP on

The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug...

Arnall Golden Gregory LLP on

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick give an overview of FDA’s Office of Prescription Drug Promotion's (OPDP) enforcement of unlawful advertising in 2020. Each...more

King & Spalding

FDA Regulation of Cannabis

King & Spalding on

Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds - On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more

King & Spalding

2017 Year in Review: FDA Office of Prescription Drug Promotion Warning and Untitled Letters

King & Spalding on

In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription...more

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