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

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

Food for Thought: 2014 Litigation Annual Review

Food for Thought reports on significant court decisions affecting the food industry. The focus of this edition is on several food-related cases pertaining to class certification; particularly, on district court decisions...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

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more

FDA Finalizes Chain Restaurant Menu Labeling Rules

It may surprise some to learn that the Affordable Care Act of 2010, a.k.a. “ObamaCare,” among other things, amended the US Food, Drug and Cosmetic Act to require chain restaurants and similar retail food business to provide...more

Protecting Trademarks and the Likelihood of Confusion Factor

A few years ago, I wrote a column addressing a case in which Pom Wonderful LLC sued Coca Cola Company in connection with the marketing of one of its pomegranate-blueberry juice products. That case dealt with whether one of...more

Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more

(Baby) Food for Thought: In Alleging Unlawful and Misleading Product Labeling, Plaintiff Needed More Than One Gerber Baby

Last month, Judge Lucy H. Koh of the Northern District of California granted summary judgment in favor of Gerber because the plaintiff failed to satisfy the “reasonable consumer standard” in backing up her allegations that...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 Update: Forecasting FDA Regulation of Laboratory Developed Tests (LDTs) in 2015

2015 is proving to be a landmark year for FDA’s regulation of laboratory developed tests. As we have previously discussed (see our blog here), the U.S. Food and Drug Administration (FDA) has been expressing its intention to...more

Dole Defeats “All Natural Claims” for Sweet Victory

On December 8, 2014, U.S. District Court Judge Lucy Koh of the U.S. District Court for the Northern District of California granted defendant Dole’s motion for summary judgment of the plaintiff’s false labeling claims in...more

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

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

Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals

Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food, drug and...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

For Whom the Whistle Blows

In This Issue: - Applicability and Protected Activity - Procedure Governing Section 402 Claims - Five Steps to Compliance - For More Information - Excerpt from Applicability and Protected...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

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

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