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Warning Labels Food and Drug Administration (FDA)

BakerHostetler

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

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On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

Nutter McClennen & Fish LLP

Beverage Breakdown (January 2025)

Welcome to Nutter's Beverage Breakdown, a periodic legal update on developments related to the alcohol beverage industry, including industry news, federal and state updates, and more. We look forward to sharing our insights...more

ArentFox Schiff

US Surgeon General Advises on Link Between Alcohol and Cancer, Recommends Cancer Warnings on Alcohol Labels; Alcohol Beverage...

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On January 3, the US Surgeon General issued an advisory on the association between alcohol and the risk of cancer. The alcohol beverage industry has swiftly responded highlighting conflicting studies and federal guidelines....more

Fishman Haygood LLP

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

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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

DLA Piper

Industrials Regulatory News and Trends - December 2024 #2

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California amends Prop 65 short-form warnings. California’s Office of Environmental Health Hazard Assessment has announced long-expected new amendments to its Prop 65 short-form warning requirements. ...more

Morrison & Foerster LLP

MoFo’s State + Local Government Enforcement Newsletter - October 2024

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Morrison Foerster’s State and Local Government Task Force is pleased to provide our bimonthly newsletter summarizing some of the most important and interesting developments from State Attorneys General across the country and...more

Troutman Pepper Locke

FDA Says Agency Will Enforce the Cigarette Graphic Warning Rule in December 2025, But Pending Litigation Could Still Derail Those...

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In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance...more

Troutman Pepper Locke

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Clark Hill PLC

The Learned Concierge - July 2024, Vol. 10

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....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

Goodwin

FDA Releases Draft Labeling Guidance for Biosimilar Products

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Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues First Untitled Letter of the Year to Xeris Pharmaceuticals

The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more

Foley Hoag LLP

Product Liability Update - April 2023

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MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more

Troutman Pepper Locke

2022 Significant Developments in the Tobacco Industry and What to Expect in 2023 (Part One) - Regulatory Oversight Podcast

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The U.S. tobacco industry is subject to a variety of regulators at the federal and state level. In this first of a two-part series focused on significant regulatory developments in the tobacco industry, Stephen Piepgrass is...more

Vicente LLP

High-THC Hemp Edibles Are Dangerous and Potentially Deadly: A Cautionary Tale in Minnesota

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On December 5, 2022, the Minnesota Board of Pharmacy filed a lawsuit against three affiliated Minnesota hemp companies seeking condemnation and destruction of several million dollars worth of gummy edibles. Ironically named...more

Perkins Coie

Will The New Year Finally Bring FDA Guidance on CBD?

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As 2022 drew to a close, the Wall Street Journal reported that the FDA is finally considering releasing potential guidance regarding cannabidiol (“CBD”) in the coming year. While the exact timeline and scope of the FDA’s...more

Butler Snow LLP

Trust the reProcess? A Practical and Legal Overview of Reprocessing Single-Use Medical Devices in the United States

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Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the tissue and cartilage in his...more

Jenner & Block

New OEHHA Proposition 65 Acrylamide Warning Label Does Little to Resolve Pending First Amendment Challenges - Update

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The California Office of Administrative Law (OAL) recently approved a revised Proposition 65 warning label requirement for the use of acrylamide in food and beverages. California’s Office of Environmental Health Hazard...more

Mintz - Health Care Viewpoints

FDA Announces Review of Opioid Prescribing Regulations and Framework for Preventing Overdose-Related Deaths

The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing...more

Troutman Pepper Locke

FDA Cigarette Graphic Warning Rule Delayed … Again

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In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the...more

Bradley Arant Boult Cummings LLP

COVID and CBD Prove to be a Powder Keg for Federal Regulators

Cannabis operators (from marijuana to hemp-derived products such as CBD) often get the sense they are one of the central targets of the federal government’s reach. But they are not in the same league lately as the COVID-19...more

Lathrop GPM

[Webinar] Exploring PFAS in Food - May 5th, 2:00 pm - 3:00 pm CT

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PFAS – per- and polyfluoroalkyl substances – are a family of human-made chemicals, often referred to as “forever chemicals,” and are found in a wide range of products used by the food supply industry. Because of their...more

King & Spalding

FDA Warns That Most Hair Smoothing or Straightening Products Release Formaldehyde Gas During the Hair Straightening or Smoothing...

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On March 2, 2021, the U.S. Food & Drug Administration (“FDA”) issued a consumer update in the form of a “what you should know” regarding formaldehyde in hair smoothing or straightening products, such as keratin treatments....more

White and Williams LLP

Making Safer Robotic Devices

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...Robots are everywhere – but perhaps just not how everyone imagined them. For decades, the promise of robots brought to mind devices like R2D2 and C3PO, or perhaps Rosie the Robot from The Jetsons – autonomous, intelligent...more

American Conference Institute (ACI)

[Virtual Event] Advanced Legal, Regulatory and Compliance Forum on Over the Counter Drugs - February 26th, 9:00 am - 5:45 pm EST

A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more

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