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Warning Letters 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

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

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

FDA Imposes Its Weight and Puts the Load on a Drug Company for Unlawful Promotion

We pay tribute in this Bulletin to the late Robbie Robertson of The Band, who penned the 1968 classic, “The Weight,” and the harmonic lyric, “You put the load right on me.” The Food and Drug Administration’s Office of...more

BakerHostetler

AD-ttorneys@law - January 2023 #2

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Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...more

King & Spalding

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

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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

Kaufman & Canoles

FDA Increases Warning Letter Campaign Against CBD Companies

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In November the Food and Drug Administration (FDA) issued letters to various companies selling products contained cannabidiol (CBD), citing concerns that certain products may appeal to children. These CBD infused foods...more

Perkins Coie

FDA Issues New Warning Letters For Delta-8 and CBD Products

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Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2021

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

Womble Bond Dickinson

Can hashtags get you in trouble?

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They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc. FDA has specific labeling requirements for products and they look at hashtags related to products the same...more

Arnall Golden Gregory LLP

A Drug Company Finds Itself with a Headache and Over Its Head With Unlawful Promotional Messaging

In keeping with family tradition, another Kardashian made headlines again in our food and drug world for the wrong reasons. And FDA’s Office of Prescription Drug Promotion (OPDP) was not likely amused to issue its third...more

Arnall Golden Gregory LLP

Déjà Vu, We Have All Been Here Before: OPDP Issues Its Second Warning Letter in 2021

Well, that was fast. Fresh off issuing its first Warning Letter of 2021,1 the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) struck again. OPDP sent the Warning Letter to the drug company a day...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - February 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...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

A Year in Review: FDA Enforcement in the Prescription Drug Advertising and Promotion World

Good riddance to 2020 for so many reasons. But, as the AGG Year in Review of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek...more

Hogan Lovells

2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

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In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more

Womble Bond Dickinson

Should Mass Torts Plaintiffs’ Lawyers Be Allowed to Use PPP Money to Increase Their TV Advertising Spend?

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Plaintiffs’ lawyers spent $67M between January and May on mass tort TV advertising, a 6.6% increase from the same time last year. As many of us work from home, learn from home, or are otherwise stuck at home due to the...more

Dorsey & Whitney LLP

FTC Works to Thwart Coronavirus Scams

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As the collective consciousness coalesces around coronavirus fears, scammers are capitalizing on the opportunity to exploit the concerned. In recent months, the Federal Trade Commission (“FTC”) has noted the emergence of...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letters to 15 Companies, Consumer Update on CBD Safety

On November 25, 2019, FDA issued Warning Letters to 15 companies illegally marketing cannabidiol (CBD) products. On the same day, U.S. Food & Drug Administration (FDA) published a revised consumer update, “What You Need to...more

Bradley Arant Boult Cummings LLP

The FTC Issues Three New Warning Letters to CBD Companies Regarding Health Claims in Advertising - Cannabis Industry News Alert

On Tuesday, the Federal Trade Commission (FTC) sent warning letters to three companies that sell cannabidiol (CBD) products regarding the health claims found in the companies’ advertisements. The FTC did not make the letters...more

BakerHostetler

AD-ttorneys@law

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Oh, (No) Snap! CARU Praises Snapchat for Safeguarding the Underaged - Company’s response is more than just an age-gate and an indifferent shrug - Singing Praises - The Children’s Advertising Review Unit’s (CARU) paean...more

Davis Wright Tremaine LLP

CBD and Cannabis Related Advertising – Trends and Takeaways

The Food and Drug Administration’s (FDA) recent enforcement action against cannabis and CBD producer Curaleaf exemplifies the need for awareness and understanding of the federal and state laws applicable to advertising these...more

Foley Hoag LLP - Cannabis and the Law

Recent FTC and FDA Warning Letters May Hold Lessons For Cannabis Advertisers

Last month the Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) sent joint warning letters to four companies that manufacture and advertise flavored liquids used in vaping (“e-liquids”). While...more

Neal, Gerber & Eisenberg LLP

Client Alert: FTC and FDA Team Up to Send Warning Letters About Social Media Influencer Posts

Recently, the Federal Trade Commission (“FTC”) and the U.S. Food & Drug Administration (“FDA”) issued joint warning letters to four sellers of e-liquids, the nicotine “juice” used in vaping regarding their use of social media...more

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