News & Analysis as of

Preemption Federal Food Drug and Cosmetic Act (FFDCA)

Morrison & Foerster LLP - Class Dismissed

Passing On Preemption: Ninth Circuit Holds That California’s Sherman Law Is Not Impliedly Preempted

While it rarely rules on questions of preemption, the Ninth Circuit took an even rarer step on July 1, 2024 when it took up the question of whether private parties can seek to enforce the provisions of California’s Sherman...more

Troutman Pepper

Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer

Troutman Pepper on

In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River)...more

Holland & Knight LLP

Ninth Circuit Holds That California Food-Labeling Law Is Not Preempted by Federal Law

Holland & Knight LLP on

In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more

Harris Beach PLLC

California Microplastics Mislabeling Case Dismissed on Preemption Grounds

Harris Beach PLLC on

A nationwide class action lawsuit accusing a bottled water company of misleading customers by selling water allegedly containing microplastics has been dismissed on preemption grounds. The court’s decision looms large in...more

Polsinelli

FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

Polsinelli on

Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more

Sheppard Mullin Richter & Hampton LLP

FDCA Preemption: A Powerful Tool for Defending Class Actions

Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs,...more

Faegre Drinker Biddle & Reath LLP

California Appellate Court Upholds Federal Preemption of Negligent Undertaking Claim Under the Medical Device Amendments of 1976

Federal preemption can be a very powerful defense. For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et...more

Proskauer - Minding Your Business

Ozempic Gains Popularity, Its Maker Loses First Legal Fight

With Hollywood celebrities speaking out both in favor of and against the use of drugs like Ozempic and Wegovy for weight loss, it was only a matter of time before demand outpaced supply. Although most might believe that...more

Holland & Knight LLP

FDA, PFAS and Food Packaging: More to Come?

Holland & Knight LLP on

The U.S. Environmental Protection Agency (EPA) is not the only federal agency that regulates per- and polyfluoroalkyl substances (PFAS). And states aren't the only ones scrutinizing PFAS in food packaging products. PFAS,...more

Ervin Cohen & Jessup LLP

Ninth Circuit Finds Protein False Labeling Cases Are Preempted

On August 14, 2023, a panel of judges for the United State Court of Appeals for the Ninth Circuit issued a published opinion affirming dismissal of two complaints alleging that food product labels advertising the amount of...more

Hogan Lovells

Modernization of U.S. cosmetics regulation will be phased in over time - A detailed overview and preliminary analysis of the new...

Hogan Lovells on

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more

Mintz - Health Care Viewpoints

Cosmetic Regulatory Reform Finally Becomes Law

As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA),...more

Foley & Lardner LLP

Ninth Circuit Holds that Implied Preemption Bars State Law Claims Based on a Violation of the FDCA

Foley & Lardner LLP on

In Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040, 1041 (9th Cir. 2022), the Ninth Circuit recently held that the implied preemption doctrine barred state law claims because they were...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Implied FDCA Preemption

This week, the Ninth Circuit addresses the statutory prohibition on private enforcement actions under the Food, Drug, and Cosmetic Act. The Court holds that a drug manufacturer’s suit against a compounding pharmacy for...more

Faegre Drinker Biddle & Reath LLP

Blurry Vision in Two Courts Leads to Denial of Preemption in Intraocular Lens Implant Case

A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues. In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Hogan Lovells

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2021

Harris Beach PLLC on

From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more

Patterson Belknap Webb & Tyler LLP

In Hair Supplement Case, Ninth Circuit Rejects Bald Attempt to Escape Preemption

Federal law expressly authorizes manufacturers of dietary supplements to make “structure/function” claims—that is, claims about the effect of particular nutrients on the structure or function of the human body.  (Think:...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Habeas and Hair Loss

This week, the Ninth Circuit declines to extend a recent Supreme Court decision on retaliatory arrest to the immigration bond revocation context, and resolves a particularly hairy preemption question about state-law...more

Faegre Drinker Biddle & Reath LLP

Preemption of Structure/Function Claims

Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds...more

Patterson Belknap Webb & Tyler LLP

In Butter-Flavored Spray Case, Federal Labeling Preemption Sticks In the End

Federal food-labeling laws preempt state laws that impose requirements different from or in addition to those established by federal law. In some cases, the FDA has spoken directly to a labeling issue by regulation, and if...more

Haug Partners LLP

Clarifying the Scope of the Parallel Claim Exception to Federal Regulatory Preemption of Medical Devices

Haug Partners LLP on

Medical device manufacturers who seek to dispose of meritless claims at the initial pleading stage have long relied upon the doctrine of federal regulatory preemption. This doctrine is embodied by 21 U.S.C. § 360k(a), the...more

Patterson Belknap Webb & Tyler LLP

Federal Court Wipes Away Challenge to Nivea Lotion on Preemption Grounds

What distinguishes a “cosmetic” from a “drug” under the Federal Food, Drug, and Cosmetic Act (FDCA)? The FDA has struggled to offer clear guidance on the distinction, but the classification as one or the other (or both)...more

Proskauer - Advertising Law

Gin Manufacturer Bacardi Avoids Lawsuit for Its Use of “Grains of Paradise”

A federal judge in the Southern District of Florida recently dismissed an action alleging that Bacardi’s use of a botanical called “grains of paradise” in its gin was “harmful and illegal,” holding that the statute on which...more

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