News & Analysis as of

Food and Drug Administration (FDA) Advertising

Loeb & Loeb LLP

Illuminating the Risks: FDA Clearance Does Not Fully Shield Health & Wellness Devices from Advertising Scrutiny

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The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and...more

Saul Ewing LLP

Marketing Risk in the Age of Wellness: When Are Food Claims Misbranding?

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On October 1, 2024, the U.S. Food and Drug Administration (FDA or the Agency) implemented its unified Human Foods Program (HFP). The Agency established the HFP – which represented the single largest reorganization in FDA’s...more

Fitch, Even, Tabin & Flannery LLP

The Federal Circuit takes on Kisses, Sunlight, and Soft Drinks

An application for a US trademark may be rejected if it is likely, when used on or in connection with the goods of the applicant, to cause confusion with another registered mark. On July 23, in Sunkist Growers, Inc. v....more

Husch Blackwell LLP

Chocolate Therapy: The Legal Limits of Mood and Sleep Claims in Functional Foods

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Functional foods designed to promote relaxation, better sleep, and improved mood have exploded in popularity, and chocolate is increasingly the delivery method of choice. Calming confections featuring ingredients like...more

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

Holland & Knight LLP

Red Flags Over Red 40: Heightened Regulatory Scrutiny on Use of Artificial Food Dyes

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The regulatory landscape for consumer-packaged goods (CPG) brands is shifting, with artificial food dyes emerging as a central focus of both state and federal scrutiny. Recent actions by the federal and state governments,...more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

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On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

Brownstein Hyatt Farber Schreck

The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads

Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more

Kelley Drye & Warren LLP

2025 AGA Annual Meeting Wrap-Up: Day 2

In part two of this three-part series on the Attorney General Alliance (AGA) 2025 Annual Meeting, we highlight panelists’ discussions on the safety and regulation of GLP-1 medications and the role of attorneys general in...more

Akin Gump Strauss Hauer & Feld LLP

HHS to Launch Campaign Promoting Wearable Devices

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more

American Conference Institute (ACI)

[Virtual Conference] Food Law and Regulation Boot Camp - July 22nd - 23rd, 8:15 am - 2:00 pm CST

Food laws and regulations are evolving rapidly — you and your team must prepare now to navigate the changes and anticipate what’s next on the horizon. ACI's virtual Food Law and Regulation Boot Camp will equip you with the...more

Foley & Lardner LLP

Direct-to-Consumer Drug Ads Are Under Attack – Pharmaceutical Companies Beware

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On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in...more

Sheppard Mullin Richter & Hampton LLP

FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter

The U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently posted a warning letter (the “Letter”, issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO,...more

Arnall Golden Gregory LLP

Not a Second Time: FDA’s Office of Prescription Drug Promotion Issues a Warning Letter to a Company for Unlawful Promotion

The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more

BakerHostetler

NAD Jurisdiction: Can NAD Hear a Case if the Advertising Is Under Investigation by a Government Agency?

BakerHostetler on

We won’t bury the lede. The short but surprising answer here is yes. And this may be a rule ripe for reconsideration by the National Advertising Division (NAD)....more

Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

Gardner Law on

FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

Stradling Yocca Carlson & Rauth

Vegan Collagen and the Law: Clean Beauty Claims Face Legal Scrutiny, but Courts Urge Common Sense

Clean Beauty Legal Risks Clean beauty claims have become the current "flavor of the month" for consumer class action lawsuits, particularly in California, New York, Florida, and Texas, where plaintiff's bar activity is...more

Arnall Golden Gregory LLP

Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more

Ervin Cohen & Jessup LLP

FDA Webinar on the Updated Criteria for Making a “Healthy” Claim

On April 10, 2025, the FDA held a public webinar on the updated criteria for companies to use the “healthy” nutrient content claim. This webinar tracked the final rule issued on December 27, 2024....more

ArentFox Schiff

Non-Cannabis Brands Capitalizing on Cannabis Culture: Marketing Opportunities for 4/20 and Beyond

ArentFox Schiff on

As 4/20 approaches, the cannabis industry is aflame with trends and opportunities that extend beyond traditional boundaries. Recent insights reveal a dynamic shift in consumer behavior and consumption methods, offering an...more

Alston & Bird

For Your Consumption – March 2025: Always Reading the Tea Leaves

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In the March edition of For Your Consumption, our food & beverage digest of court cases and litigation trends affecting the food, beverage, agribusiness, and cosmetics industries, there’s nothing natural about beavers’ anal...more

Arnall Golden Gregory LLP

Haven’t Got Time for the Panel: OPDP Issues Its First Notice of Violation of 2025

This (bad) pun of the 1974 Carly Simon song, “Haven’t Got Time for the Pain,” came to mind when we read the Food and Drug Administration’s Office of Prescription Drug Promotion’s (“OPDP”) first Notice of Violation of 2025....more

Foley & Lardner LLP

Telehealth Companies and Social Media Influencers May Face New FDA Laws

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On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes”...more

Kelley Drye & Warren LLP

Two Class Actions Take a ShOt at Substantiation for Lemme’s GLP-1 Daily Supplement

Two new class action complaints, both captioned Robins v. Lemme Inc., were filed in in California Superior Court and the Southern District of New York on February 19 and March 9, respectively....more

Gardner Law

Exercise Caution: Celebrity Endorsements of Medical Products

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Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more

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