News & Analysis as of

Product Labels Preemption Food and Drug Administration (FDA)

Mayer Brown

Regulatory and Legal Implications of the Surgeon General’s Call For Cancer Warning On Alcohol Labels

Mayer Brown on

On January 3, 2025, outgoing US Surgeon General Dr. Vivek Murthy released a new advisory outlining the alleged causal link between alcohol consumption and cancer, claiming “numerous high-quality observational studies and...more

Fishman Haygood LLP

U.S. Third Circuit Rejects Claims of Preemption and Allows Fosamax Cases to Proceed

Fishman Haygood LLP on

In 2022, over 500 plaintiffs filed a case alleging that Merck Sharp & Dohme Corp., a drug manufacturing company, failed to provide adequate warnings that one of their drugs increased the risk of atypical femoral fractures....more

King & Spalding

Spotlight on PFAS and Other Substances in Cosmetics Likely to Grow in 2022

King & Spalding on

This year – 2022 – may finally be the year that the effort to modernize safety standards in the U.S. for cosmetics and other personal care products, which has been ongoing since 2013, comes to fruition. If so, the new...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

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

Faegre Drinker Biddle & Reath LLP

Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht

The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 2

Butler Snow LLP on

Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice. The...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin l June 2019

LEGISLATION, REGULATIONS & STANDARDS - FDA Study Finds Sunscreen is Absorbed into Bloodstream - JAMA has published a study conducted by researchers at the U.S. Food and Drug Administration (FDA) Center for Drug...more

Butler Snow LLP

Express Preemption of Consumer Protection Actions: Preventing a Patchwork of State Drug and Device Regulations

Butler Snow LLP on

The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.” Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect. Under...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | September 2017 #3

FDA Announces Final FSMA Produce Safety Rule - The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing...more

Butler Snow LLP

Pro Te: Solutio Vol. 8 No. 2

Butler Snow LLP on

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

Proskauer - Advertising Law

Sun-Blocked: California Court Dismisses Sunscreen Labeling Case

It’s summertime, and for many of us that means buying and applying sunscreen. Lots of it. Indeed, when selecting sunscreen rated at, say, SPF 30, we rely on national standards promulgated by the FDA. It thus comes as no...more

Carlton Fields

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

Carlton Fields on

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

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