News & Analysis as of

Enforcement Food and Drug Administration (FDA) Advertising

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

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

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

King & Spalding

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

King & Spalding on

On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more

Venable LLP

Mitigating Class Action Exposure: An Excerpt from the Advertising Law Tool Kit

Venable LLP on

When it comes to mitigating the risk of class action lawsuits, the best offense is a good defense. Companies can take many steps to reduce their exposure to class action litigation before it happens, including the tactics...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Husch Blackwell LLP

The Future of Functional Foods

Husch Blackwell LLP on

Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more

ArentFox Schiff

10 Legal Challenges for the Cannabis Industry in 2023

ArentFox Schiff on

1. Cannabis Entering the Metaverse - As we discuss in greater detail here, the Metaverse provides expansive marketing and sales opportunities for cannabis companies due to its decentralized nature and the varied regulatory...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

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...

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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

Mintz - Consumer Product Safety Viewpoints

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

McNees Wallace & Nurick LLC

McNees 2016 In Review – Advertising Law

Advertising and marketing laws affect all businesses that expose consumers to their goods and services. In 2016, highlights of advertising and marketing law issues included disclosures and celebrity endorsements, “Made in...more

Morgan Lewis

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

Morgan Lewis on

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

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