The United States Food and Drug Administration False Advertising

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Food Litigation Newsletter - August 2015

This Newsletter Aims to keep those in the food industry up to speed on developments in food labeling and nutritional content litigation. RECENT SIGNIFICANT RULINGS - Class Certification Denied In Popcorners “All...more

Advertising Law - August 2015 #2

FDA Wants to Pour Some Sugar on the Nutrition Label - Adding to the proposed changes to the Nutrition Facts label—the first tweaks in 20 years—the Food and Drug Administration has suggested yet another: adding the...more

Sun-Blocked: California Court Dismisses Sunscreen Labeling Case

It’s summertime, and for many of us that means buying and applying sunscreen. Lots of it. Indeed, when selecting sunscreen rated at, say, SPF 30, we rely on national standards promulgated by the FDA. It thus comes as no...more

Advertising Law - July 2015 #5

Place Your Bets: Yahoo to Host Fantasy Sports Games - In a new business venture that adds to an ever expanding field, Yahoo announced that it will host daily and weeklong pay-to-play fantasy sports games for cash prizes....more

Feel The Burn: Court of Appeal Strikes Down State Law Claims Regarding Mislabeled Sunscreen Products Under Finding of Federal...

In Eckler v. Neutrogena (certified for publication 7/1/15, Case No. B2536910), the California Court of Appeal, Second Appellate District, upheld the trial court’s determination that plaintiffs’ claims of mislabeling sunscreen...more

Fun Fun Fun: Cal Court Dismisses Sunscreen Cases on Preemption

During a recent Surfin’ Safari we must have told the DDL Son at least five times to slather on more sunscreen. Naturally, he engaged in the usual noncompliance-defiance and, naturally, now has a face adorned with a scarlet...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

“Age Defying” Make-up Case Only Partially Defies Preemption

Coco Chanel said that nature gives you your face at 20, but you earn your face at 50. Perhaps that is not so different from Mark Twain’s theory that one’s wrinkles should merely be monuments to smiles. Those platitudes do...more

Food and Beverage News and Trends

Judge rejects consumer claim concerning evaporated cane juice - On March 12, a US district judge in the Northern District of Illinois dismissed with prejudice a consumer lawsuit against the manufacturer of Healthy Grains...more

Ninth Circuit Upholds FDA’s Primary Jurisdiction Over “Natural” Labeling On Cosmetics But Orders Stay Rather Than Dismissal

Plaintiffs’ lawyers love to challenge products labeled as “natural,” with hundreds of false advertising class actions filed in just the last few years. Recently, in Astiana v. Hain Celestial (pdf), the Ninth Circuit reversed...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

Court Finds that Class Action Plaintiffs’ False Advertising Claims are Stripped Bayer Based on Federal Preemption

In the recent case of Gallagher v. Bayer AG, Case No. 14-cv-04601-WHO (N.D. Cal. March 10, 2015), the plaintiffs asserted that the defendants Bayer AG and related entities (collectively, “Bayer”) engaged in false advertising...more

Food and Beverage News and Trends Series

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Nestle Purina hit by lawsuit over allegedly poisonous dog food. A lawsuit...more

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

POM Wonderful: The New Prescription for False Advertising

The ability of private parties to pursue mislabelling claims depends on whether allowing such claims to proceed would conflict with the purpose and intent of federal labelling laws and implementing regulations, such as those...more

Intellectual Property 2014 Year in Review

The year 2014 saw some important developments in the area of intellectual property law. A number of intellectual property-related issues even made national headlines. Who can forget the public debate over the rightful...more

Gingko, Roses, or Just Filler? The New York Attorney General's Attack on Supplements

We all know that a rose by any other name would smell as sweet. But what if the roses you give to your sweetheart are actually painted daisies or thorns without flowers? Or worse, if they do not contain flowers at all but...more

Plaintiff’s Mislabeling Claims Against Honest Tea Survive Motion to Dismiss

On January 5, 2015 Judge Kimberly Mueller of the Eastern District of California denied Honest Tea’s motion to dismiss a case involving accusations that the company misled consumers about the antioxidant content of one of its...more

Preemption and Primary Jurisdiction After Pom Wonderful

After the U.S. Supreme Court decision in Pom Wonderful LLC v. The Coca-Cola Co., __ U.S. __, 134 S.Ct. 2228 (2014), fear arose among national marketers that the decision would produce a wave of class actions challenging food,...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

Advertising Law - November 2014 #3

NAD Sniffs at Odor Protection Claims - Concerned that a 48 hour antiperspirant/deodorant constitutes an overstated claim of “100% odor protection,” the National Advertising Division recommended...more

Pom Wonderful Drops Ninth Circuit Appeal of State Claims Filed Against Coca-Cola

On September 19, 2014, Pom Wonderful, LLC dropped its Ninth Circuit appeal of a ruling that dismissed its state deceptive advertising and unfair competition claims against Coca-Cola, a sibling case to a recent Supreme Court...more

California Court Has a Bone to Pick with Male Enhancement Pill Maker

We try to avoid puns in this blog but sometimes, well, we just can’t help it. The makers of “Rockhard Weekend,” a male sex enhancement pill, have successfully sidestepped a claim that they violated federal drug...more

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