Food, Drug and Cosmetic Act

The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set... more +
The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set standards for food and drug safety, and to conduct factory inspections.  The FDCA was amended in 1962 to strengthen drug safety policies and implement new efficacy requirements. In 1976, Congress further amended the FDCA to apply safety and efficacy standards to new medical devices. less -
News & Analysis as of

Lanham Act Claims Are Not Precluded by Compliance with the FDCA

In POM Wonderful LLC v. Coca-Cola Co., decided last month, the U.S. Supreme Court confirmed that companies can bring unfair competition actions under the Lanham Act even when their competitors have complied with the Federal...more

Lanham Act Claims Are Not Precluded by Compliance with the FDCA

POM Wonderful LLC (“POM”) produces and sells a pomegranate-blueberry juice blend. POM brought a Lanham Act suit against Coca-Cola for allegedly marketing one of its juices in such a way that it misled consumers into thinking...more

FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings

On July 23, 2014, the Food and Drug Administration (FDA) issued its response to two citizen petitions submitted by AbbVie Inc. (AbbVie) and Auxilium Pharmaceuticals, Inc. (Auxilium) requesting that FDA initiate...more

Pin the Blame on the Corporate Officer: Senators Introduce Hide No Harm Act

Three Senate Democrats recently introduced a bill that seeks to hold company executives of a product maker or seller criminally liable for knowingly "failing to inform and warn of serious dangers" associated with a product....more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Labeling Laws for the Food and Beverage Industry – Unfair Competition and Mislabeled Products

In a recent unanimous U.S. Supreme Court ruling, the court opened the door for private parties, including competitors, to bring false advertising and misrepresentation claims under the Lanham Act even if the product labels...more

Food Safety Whistleblower Regulations on the Way

Otto von Bismarck once said, “Laws are like sausages, it is better not to see them being made.” Fortunately, the government that makes the laws does want to see the sausage being made and, as such, has instituted new...more

False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback...more

Advertising Law - July 2014

Online Reviews Not Sufficient To Support Ad Claim, NAD Rules - While recognizing the benefits of using new sources of information, the National Advertising Division (NAD) decided that an advertiser’s use of aggregated...more

Supreme Court: FDCA Compliance Does Not Bar Lanham Act Claims

POM Wonderful LLC v. Coca-Cola Co. - In a unanimous decision, the Supreme Court of the United States reversed the U.S. Court of Appeals for the Ninth Circuit ruling that the Food, Drug, and Cosmetic Act (FDCA) and its...more

Pom v. Coke Will Impact Financial Services Too

Law 360, New York (June 23, 2014, 11:22 AM ET)--Legal and compliance departments, take note: the U.S. Supreme Court’s recent decision in Pom Wonderful LLC v.Coca-Cola Co. confirms that even i fan institution’s conduct meets...more

POM Wonderful Decision: Companies Cannot Rely on FDCA for Protection from False Advertising Liability

The US Supreme Court allows private parties to bring Lanham Act claims challenging product labels that otherwise satisfy the Food, Drug, and Cosmetic Act. In a battle of the beverages, the Supreme Court recently...more

POM v. Coca-Cola Further Dilutes Consumer Class Action Claims for Deceptive Labeling

The Supreme Court's recent decision in POM Wonderful LLC v. Coca-Cola Company could have redefined the consumer class action landscape with respect to claims for the deceptive labeling of food products. Instead, the decision...more

Supreme Court Opens Door to Food and Beverage Label Challenges Under Lanham Act

The United States Supreme Court paved the way on June 12 for competitors to challenge FDA-regulated food and beverage labels under the Lanham Act. The Court's opinion in POM Wonderful LLC v. The Coca-Cola Co, is the latest...more

Advertising and Food Alert: The Food, Drug, and Cosmetic Act Does Not Shelter a Beverage Company from Claims of Deceptive and...

On June 12, 2014, the Supreme Court, in an 8-0 ruling, held in POM Wonderful LLC v. Coca-Cola Co. that a competitor may sue another under the Lanham Act for unfair competition because of false or misleading food and beverage...more

The Juicy Truth – Supreme Court Rules that POM May Bring False Advertising Claim Based on Coke’s Misleading Juice Label

On June 12, 2014, the Supreme Court issued an opinion holding that the Federal Food, Drug and Cosmetic Act (FFDCA) does not presumptively bar Lanham Act claims that challenge food and beverage labels. This decision comes at a...more

Supreme Court Rules Compliance with FDA Labeling Guidelines Does Not Bar Lanham Act False Advertising Suits – POM Wonderful v....

In a highly anticipated decision, the Supreme Court on June 12 announced that compliance with food labeling guidelines promulgated by the Food and Drug Administration will not operate as a bar against false advertising claims...more

Supreme Court Rules That Food and Beverage Mislabeling Claims Do Not Foreclose Competitor's Unfair Competition Claims Under §43(a)...

On Thursday, June 12, 2014, Justice Anthony Kennedy delivered an opinion for a unanimous United States Supreme Court in POM Wonderful LLC v. The Coca-Cola Co., No. 12-761, in which the Court ruled that the Federal Food, Drug,...more

POM Wonderful™ News for Prescription Drug and Device Manufacturers?

Last week, the Supreme Court decided that POM Wonderful™, maker of pomegranate juice, could sue Coca-Cola Company, maker of a blended juice product that included pomegranate and blueberry juices, under the Lanham Act for...more

Supreme Court Paves The Way For Lanham Act Claims Against FDA-Regulated Competitors

The Supreme Court issued a unanimous decision last week in Pom Wonderful LLC v. Coca-Cola Co., a case pitting the false advertising provisions of the Lanham Act against the beverage labeling standards of the federal Food Drug...more

Food Labeling and Marketing after POM LLC v. Coca-Cola Co.: Why Compliance with FDA Regulations May Not Be Enough

On June 12, 2014, the United States Supreme Court issued a unanimous decision in POM Wonderful LLC v. Coca-Cola Co., holding that competitors may bring Lanham Act claims challenging food and beverage labels regulated by the...more

Supreme Court Rules Competitors Can Bring Suit Against FDA-Regulated Labels

On June 12, 2014, a unanimous Supreme Court of the United States ruled that competitors may bring federal false advertising and unfair competition claims against beverage labels that are regulated by the Food and Drug...more

Recent Supreme Court Decision Gives Competitor False Advertising Claims Added Juice

The U.S. Supreme Court recently issued an opinion that could have important consequences for lawsuits between competitors in the food and beverage industry and for manufacturers’ evaluation of their product labels, but the...more

POM Wonderful: U.S. Supreme Court Holds Lanham Act False Advertising Claims Not Precluded by FDA Statute

On June 12, 2014, the United States Supreme Court issued its decision in POM Wonderful LLC v. Coca-Cola Co., No. 12-761, which confirms that federal false advertising claims can be brought against false or misleading...more

Lanham Act Claims for Misleading Product Description Can Coexist with FDCA Labeling Regulations, Court Find

A unanimous Supreme Court (8-0, Justice Breyer recusing) ruled on June 12, 2014 in POM Wonderful v. Coca-Cola that one competitor may sue another for unfair competition under the Lanham Act for allegedly false or misleading...more

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