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

Product Liability Update - July 2015

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

Inside the Implied Conflict Preemption Box

Federal preemption in the drug and medical device world is a game of categories. Express preemption versus implied. Conflict preemption versus field preemption. Drugs versus devices, generic versus branded, premarket...more

Officer/Director Liability for Violations of the US Federal Food, Drug, and Cosmetic Act

Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more

Food for Thought: Ninth Circuit Holds Cosmetic Labeling Claims Not Preempted by FDCA, Primary Jurisdiction Appropriately Invoked

In April 2015, the Ninth Circuit held in a cosmetic labeling class action that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state causes of action predicated on federal cosmetics labeling laws and that...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

June Trade Legislation Tracker

Sponsor: Marchant (R-Texas) - A bill to amend the Harmonized Tariff Schedule of the United States to exempt from duty residue of bulk cargo contained in instruments of international traffic previously exported from the...more

A “Too Old” OTC Product Does Not A Class Action Make

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy. We volunteered to photograph the event, because the usual photographer was not able to attend. And...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Pumped Up Protein Powder Preemption

While some of us are naturally jacked up—have you seen Bexis in short sleeves?—others turn to supplements to build up their beach bodies. We are not talking about the injectables favored by 1970s East German Olympians or...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

IP/Unfair Comp. Case Applies Buckman

The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race...more

Focus on Tax Controversy and Litigation - Supreme Court Decides Maryland v. Wynne and Rules that Maryland Tax Scheme Is...

In This Issue: - Maryland’s Tax Scheme Ruled Unconstitutional - “FTC Generator” Case Update - FSA Rules that Equitable Disgorgement May be Deductible Expense - District Court Upholds Attorney Client...more

FDA Finally Releases Initial Framework for Food Importation “VQIP”

As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

SG’s Latest Brief On Implied FDCA Preemption Under Buckman

On May 26, 2015, the Solicitor General’s office responded to the United States Supreme Court’s Oct. 14, 2014 invitation for the government’s views on the certiorari petition filed in Athena Cosmetics, Inc. v. Allergan, Inc.,...more

Otsuka Suit Results in Victory for FDA

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

On May 18, 2015, the U.S. Food and Drug Administration (“FDA”) withdrew its 2003 Compliance Policy Guide – Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding...more

Weird "Science" = Preemption

Here at the DDL Blog, we write from time to time on food litigation. You might think it’s out of left field, and sometimes we even justify our food posts by pointing out that the “F” in FDCA stands for “Food.” But we need...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

Are Cosmetics Gaining Higher Congressional and FDA Scrutiny?

Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting. Senators Dianne Feinstein (D-CA) and Susan...more

Law Review Articles That Caught Our Eye

Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.” Here are a couple of recent ones that looked interesting to us....more

FDA Issues Guidance for Mobile Medical Apps

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act...more

Will Your No-Smoking Policy Get Vaporized?

Wondering what your employee is smoking in the break room, likely in violation of your “no-smoking” policy? Chances are it is an electronic smoking device, such as an e-cigarette or vaporizer. What should you do about it?...more

Going The Distance To Limit Preemption

Anybody who watched the Mayweather-Pacquiao fight knows that a long fight does not necessarily make for an exciting fight. Thirty-six minutes of “action” can actually contain very little action. The exceedingly long...more

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