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

International Food Law Gazette - January 2016

FDA Approves First Genetically Modified Food-Producing Animal - On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of...more

Food Litigation Newsletter

RECENT SIGNIFICANT FILINGS - Courts Lift Stays After FDA Stalls in Giving Guidance on ECJ - Perera v. Pac. Foods of Or., Inc., No. 3:14-cv-2074 (N.D. Cal.): In this putative class action alleging violations of...more

Retail and Consumer Products Law Roundup - January 2016

Eye on the Courts: IP Cases for Retailers to Note - Why it matters - Retail companies have closely monitored a series of cases from the U.S. Supreme Court on down, which have focused on IP matters covering induced...more

FDA Extends Comment Period on “Natural” Food Labeling by 90 Days

In November we reported that the federal Food and Drug Administration (FDA) announced that it was seeking public comments on the use of the term “natural” on food labeling, including foods that are genetically engineered or...more

Three Recent Cases Highlight Risks of Using Claims Of “Fresh” In Advertising

In this post, we take a look at three recent decisions in which food industry defendants were accused of falsely advertising their food products as “fresh”. As discussed in our prior post, a clear-cut, consensus definition...more

Off-Label Promotion and Product Liability: Are Industry’s Recent Court Wins in One Space a Win in the Other?

The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., off-label, so long as the...more

Advertising Law - December 2015 #2

Game's Over: Jordan, Grocers Settle Publicity Rights Suits - To avoid a second trial in litigation initiated by Michael Jordan challenging the use of his likeness in a commemorative issue of Sports Illustrated, the...more

FDA Regulatory and Compliance Monthly Recap — November 2015

Bill that refines marketing exclusivity for DEA scheduled drugs becomes law - The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639) was passed in the House of Representatives and was sent to...more

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants. The final...more

Food and Beverage Law Update: October 2015

Labor and Employment - Plaintiff Wage and Hour Lawsuits Continue to Climb - Wage and hour litigation has become what some call the new "workplace revolution." Data from the Federal Judicial Center indicates that...more

FTC Announces Red Light on Unqualified “Green Approved” Seals

Updated to clarify that this post is not about Green Seal, Inc. but the environmental seals or certifications warned against in a recent FTC update. Manufacturers of consumer products labeled with unspecified environmental...more

Ruling Allows Gerber False Advertising Suit to Crawl Onward

For plaintiffs concerned that the Fourth Circuit Court of Appeals’ June 19, 2015 decision in Brown v. GNC Corp. signaled the muscling in of a stricter new pleading standard for false advertising class actions nationwide, a...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Guest Post - The Sweet Smell of Preemption Overcomes Plaintiffs’ Stinky Consumer Fraud Claims

The ingenuity of our friends in the plaintiffs’ bar is never-ending and always fascinating, like Cyrano de Bergerac’s prodigious proboscis. For example, this post is about a case brought by some resourceful lawyers who did ...more

California Federal Court Is Unpersuaded By A Recent Fourth Circuit False Advertising Decision In Reconsidering Its Ruling On A...

The Honorable John A. Kronstadt for United States Federal District for the Central District of California, denied a Defendant’s motion to reconsider his previous ruling on a motion to dismiss based upon a subsequent Fourth...more

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

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