News & Analysis as of

Advertising Regulatory Requirements Food and Drug Administration (FDA)

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

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

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

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

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

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?

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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

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

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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

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

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

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

Polsinelli

Monday Morning (Advertising) Quarterback – Unprecedented Hims & Hers Super Bowl Ad Has Legislators Concerned

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The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more

Husch Blackwell LLP

THC Beverage Makers and Distributors: Top 5 Concerns for 2025

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In the past couple of weeks, I have been contacted by a few major news outlets about the legality of “THC beverages“. While it sounds like you can only find these products in a state-licensed cannabis dispensary, reporters...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)

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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

Gardner Law

Latest Untitled Letter from FDA’s OPDP Underscores Need for Careful Approach to Drug Advertising

Gardner Law on

Late last month, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued its fourth Untitled Letter of the year to AbbVie, Inc. OPDP uses Untitled Letters to inform drug companies and...more

Venable LLP

The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the...

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On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more

American Conference Institute (ACI)

[Event] 8th Advanced Summit on Food Law - April 30th - May 1st, Chicago, IL

Attend ACI’s 8th Advanced Summit on Food Law – Regulation, Compliance and Litigation and obtain the tools and techniques you need to meet the legal and regulatory challenges which the food industry is now facing as well as...more

Venable LLP

[Event] 10th Advertising Law Symposium - March 21st, Washington, DC

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It’s that time of year again—Ad Law Symposium is back! Please join us in DC for this highly anticipated event focused on providing you with the information you need to promote your brand with confidence. Combining the...more

Foley & Lardner LLP

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

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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

American Conference Institute (ACI)

[Event] West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products - September 28th - 29th, Santa...

The American Conference Institute is hosting its first West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in Santa Monica on September 28-29, 2023! This conference comes just in time to...more

Perkins Coie

Congress Passes Major Update to Federal Cosmetics Regulation

Perkins Coie on

Buried within the thousands of pages of the Consolidated Appropriations Act of 2023 is the most significant statutory expansion to the U.S. Food and Drug Administration’s (FDA) authority over cosmetics since 1938...more

Bodman

The ABCs of CBD and Hemp: A Primer

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Hemp and marijuana both come from the cannabis sativa plant but as a result of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), cannabis sativa with a THC content of less than 0.3% was removed from the federal...more

Hanzo

FDA Regulatory Compliance: Can You Prove What Your Website Said?

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If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. More accurately, the FDA has its eye on your website and social media, checking to see what you’re claiming...more

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