News & Analysis as of

Marketing Food and Drug Administration (FDA) Enforcement Actions

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

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues First Untitled Letter of the Year to Xeris Pharmaceuticals

The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

Gardner Law

Back on the Case: FDA Issues Fresh Enforcement Letters

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After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more

Arnall Golden Gregory LLP

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

Arnall Golden Gregory LLP

Out of Touch: FDA Takes Exception With Drug Company’s Promotion for Topical Drug Product

Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Arnall Golden Gregory LLP

Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post

Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more

Arnall Golden Gregory LLP

You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward

Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product....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

Arnall Golden Gregory LLP

FDA is (Once Again) Keeping Up with the Kardashians: A Cautionary Tale Involving Endorsements, Testimonials and Influencer...

In March, Khloe Kardashian unwittingly joined her sister, Kim Kardashian, as the subject of a Food and Drug Administration (FDA) Warning Letter relating to the reality star’s influencer-marketing activities. ...more

Hogan Lovells

FDA signals uptick in enforcement with market sweep on depression claims

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On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...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

Akin Gump Strauss Hauer & Feld LLP

FDA Submits Progress Report on Policy Development Related to CBD Products

Thursday, March 5th, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on FDA action to develop an enforcement discretion policy and evaluate potential regulatory pathways for consumer...more

Ward and Smith, P.A.

Class is in Session: CBD Class Action Lawsuits are Trending Up

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Products containing hemp-derived cannabidiol ("CBD") have become incredibly popular in the United States, with new product brands entering the market seemingly every day. Consumer demand and public interest in those products...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

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Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Ward and Smith, P.A.

FDA Issues Warnings to 15 Companies for Illegally Selling Products Containing CBD

Ward and Smith, P.A. on

On November 25, 2019, the U.S. Food & Drug Administration ("FDA") published a press release, published a revised Consumer Update, and announced the issuance of new warning letters to 15 companies for illegally selling and...more

Furia Rubel Communications, Inc.

Truth in Advertising, Cannabis, and the Importance of a Crisis Plan and Social Media Policy

If you’ve ever wondered whether Big Brother is watching you online, the answer is yes. I’m not just referring to the big data and privacy breaches such as Equifax’s recent $700 million settlement which has been reported in...more

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Bass, Berry & Sims PLC on

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | November 2018 #3

LEGISLATION, REGULATIONS & STANDARDS - California Passes Cage-Free Eggs Mandate - California residents voted to pass a measure that will require by 2022 that all eggs sold in the state come from cage-free hens. ...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | August 2018

LEGISLATION, REGULATIONS & STANDARDS - FDA Warns About Color Additives, Manufacturing Practices - The U.S. Food and Drug Administration (FDA) has warned three dietary-supplement manufacturers about their marketing and...more

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