News & Analysis as of

Food and Drug Administration (FDA) Advertising Marketing

Saul Ewing LLP

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

Saul Ewing LLP on

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

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

Holland & Knight LLP on

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

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

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

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

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

Alston & Bird on

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

Cozen O'Connor

New York Lawsuit Hits Big Against E-Cigarettes

Cozen O'Connor on

New York AG Letitia James has filed a lawsuit against 13 e-cigarette companies alleging violations of state and federal laws stemming from the manufacture, distribution, and sale of flavored vape products....more

American Conference Institute (ACI)

[Event] 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products - March 27th - 28th, New York,...

Attend ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to stay ahead of the latest environmental and sustainability developments impacting cosmetics and personal care products...more

Ice Miller

FDA Final Rule for “Healthy” Nutrient Content Claims Effective Date Looms but Rule’s Future Is Uncertain

Ice Miller on

After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food...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

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

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On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

King & Spalding on

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Kohrman Jackson & Krantz LLP

Three Legal Mistakes Influencers Make and How to Avoid Them

In the rapidly evolving world of social media marketing, content creators are an invaluable asset for brands seeking to reach a larger audience. Influencers effectively assist brands in showcasing brand values, gaining...more

Alston & Bird

FDA’s Final Rule for “Healthy” Claim Requirements: What Industry Should Know

Alston & Bird on

Our Food, Beverage & Agribusiness Team unpacks what companies need to know about the Food and Drug Administration’s final rule on “healthy” food labeling....more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - December 2024

The U.S. Food and Drug Administration (FDA) has announced a final rule updating the definition of the nutrient content claim “healthy.” To qualify as “healthy” under the updated definition, food products must contain a...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin - December 2024

BBB National Programs’ National Advertising Division (NAD) has found claims by skincare company Drunk Elephant, LLC that its products are “safe for kids and tweens to use” to be supported but recommended the company modify...more

Husch Blackwell LLP

Navigating Legal Waters: Ensuring Success in the Functional Beverage Industry

Husch Blackwell LLP on

To succeed in the growing functional beverage industry, understanding key legal issues is crucial. As new functional beverage brands continue to emerge, business owners need to consider a variety of legal issues, including...more

Arnall Golden Gregory LLP

It Cuts You Up: OPDP Issues an NOV to a Dermatologic Drug Company

Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation....more

Arnall Golden Gregory LLP

Rock You Like a Migraine: OPDP Issues Notice of Violation for Misleading Representations in TV Ad That Promoted Popular Migraine...

In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.” Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company...more

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