News & Analysis as of

Marketing Misbranding

Fishman Haygood LLP

U.S. Eleventh Circuit Rejects FIFRA Preemption in Roundup Case

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As of May 2022, Monsanto, the company that developed the allegedly cancer-causing weed killer Roundup, has settled more than 100,000 lawsuits, and paid nearly $11 billion in settlements. Despite this massive number, 30,000...more

Epstein Becker & Green

Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care

Epstein Becker & Green on

The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done...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

Patterson Belknap Webb & Tyler LLP

Tenth Circuit Reverses, Finds Bakery’s Lanham Act Claim Under-Proofed

A common maxim in the service industry is that the customer always knows best. But a recent decision from the Tenth Circuit suggests that the maxim has its limits when it comes to interpreting ambiguous marketing claims.  In...more

BakerHostetler

AD-ttorneys@law – October 2020 #3

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Puffy Class Action Deflated by $1.9 Million Settlement - Mass-producer of tandoori supermarket breads won’t change packaging (much) - Folklore Fusion - Friend v. FGF Brands (USA), Inc. is a modern-day, South-Asian themed take...more

BakerHostetler

AD-ttorneys@law – October 2020 #1

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First Amendment Rescues Butter Marketing from Regulation’s Hot, Hot Knife - Miyoko’s Kitchen can keep buttering up consumers, but must let the hormones go - Precious?...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

Harris Beach PLLC

FDA and FTC Issue Warnings Concerning e-Cigarette Marketing

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The FDA and FTC jointly issued thirteen (13) warning letters to companies involved in the manufacture, distribution and retail of certain e-liquid products to be used in connection with e-cigarettes which feature packaging...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

Morrison & Foerster LLP - Class Dismissed

Court Dismisses Labeling Claims Against Wholesoy, Deferring to the Authority and Expertise of the FDA

Are judges in the Northern District of California losing their taste for food labeling litigation? In a recent win for Wholesoy & Co., Judge Yvonne Gonzalez Rogers dismissed plaintiff’s “misbranding” claims concerning the...more

Morrison & Foerster LLP - Class Dismissed

“All Natural” Suit Against AriZona Iced Tea: Class Decertified and Suit Tossed

In the world of food misbranding class actions, few cases have yet made it to the merits stage. Companies defending against these claims should accordingly take note of AriZona Iced Tea’s recent win in Ries v. AriZona...more

Saul Ewing LLP

Court Upholds Executive’s Conviction Stemming from Off-Label Drug Promotion

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The U.S. Court of Appeals for the Ninth Circuit has upheld the wire fraud and misbranding convictions and sentence of InterMune Inc. founder W. Scott Harkonen. United States v. Harkonen, No. 11-10209 (9th Cir. March 4, 2013)....more

Holland & Knight LLP

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

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After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

King & Spalding

Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia

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On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce...more

K&L Gates LLP

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

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On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

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