News & Analysis as of

Preemption Food and Drug Administration (FDA)

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

Nutter McClennen & Fish LLP

Product Liability 2023 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...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

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...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

Womble Bond Dickinson

Artificial Intelligence - The Promise of Early Disease Diagnosis and Improved Treatment and the Potential of Liability

Womble Bond Dickinson on

If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more

Nelson Mullins Riley & Scarborough LLP

First Substantial Reform of Cosmetics Law Since FDR Administration

President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), as part of the Consolidated Appropriations Act, 2023. This is the first major reform of cosmetics regulation since the Federal...more

Nutter McClennen & Fish LLP

Product Liability 2022 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...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

Wiley Rein LLP

[Podcast] Cellular Agriculture and the Evolving Legal/Regulatory Landscape: A Conversation with Ahmed Khan

Wiley Rein LLP on

On this episode of “Food for Thought and Thoughts on Food,” Ann Begley and Amaru Sanchez join to discuss regulatory and commercialization challenges facing novel foods today. The pair interview Ahmed Khan, Founder and Editor...more

Manatt, Phelps & Phillips, LLP

FDA Preemption: Implications of Dobbs Decision for Uniform Access to FDA-Approved Drugs in the U.S.

The Big Picture - On June 24, in Dobbs v. Jackson Women’s Health Organization, the Supreme Court held that the “Constitution does not confer a right to abortion. Roe [v. Wade] and Casey [v. Planned Parenthood] must be...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

Morrison & Foerster LLP - Class Dismissed

Till The Cows Come Home: Tenth Circuit’s Affirmation Of Federal Preemption Is A Win For Defendants In Food Labeling Cases

The Tenth Circuit recently held that the Federal Meat Inspection Act (FMIA) gets the final word on what “Product of the U.S.A.” means for labels of beef products. Thornton v. Tyson Foods, Inc., No. 20-2124, 2022 WL 727628...more

Faegre Drinker Biddle & Reath LLP

Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court

We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and...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

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