The United States Food and Drug Administration Food, Drug and Cosmetic Act

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

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

D.C. Circuit Rejects FDA’s Claim of Inherent Authority to Reclassify a Device by Rescinding a 510(k) Substantial Equivalence Order

On September 26, 2014, the D.C. Circuit issued an opinion holding that the Food and Drug Administration (“FDA”) failed to follow the appropriate statutory procedure for reclassifying a device when the Agency relied on its...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

Advertising Law - October 2014 #3

Permanent Ban From Prize Promotion Business After Sweepstakes Scam - A sweepstakes operator agreed to a permanent ban from the prize promotion business pursuant to a settlement with the Federal Trade Commission after...more

FDA Holds Webinar Discussing Final Guidance on Custom Device Exemptions - Restrictions Loosened but Exemption Remains Narrow

On October 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) held a webinar for industry to explain the guidance document, Custom Device Exemption: Guidance for Industry and Food and Drug Administration...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Commentator says “food addiction” is a misleading term that should not be...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

What’s In a Name? The Value of Pharmaceutical & Biologic Branding

September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch- Waxman strove to offer consumers the benefits of “rapid...more

Supreme Court Allows POM Wonderful to Sue Coke for False Advertising, Despite Its Apparent Compliance with FDA Regulations

In a unanimous decision, the Supreme Court in POM Wonderful LLC v. The Coca Cola Co. (June 12, 2014) held that the Food, Drug, and Cosmetic Act (FDCA) does not preclude a private party from bringing a Lanham Act claim...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

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 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

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

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