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Warning Labels

Non-News: Warnings Claims For A Generic Drug Preempted (Still)

by Reed Smith on

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it...more

Proposition 65: What Businesses Selling Products in California Need to Know

by Hodgson Russ LLP on

When selling products in the United States, it is important to note that some states have stricter regulations than others. California is the quintessential example, where its Proposition 65 requires businesses to provide...more

Prop 65 – Version 2.0: New Rules for Prop 65 Warnings Shake Things Up

by Davis Wright Tremaine LLP on

California’s old Proposition 65 warnings, which have been in place since 1986 are about to get a facelift – under newly adopted regulations by the Office of Environmental Health Hazard Assessment (OEHHA), what was once “clear...more

The EHS Manager's Guide to the Pitfalls of HAZMAT Shipping: Cathy Webb (Harbor Environmental) Arkansas Environmental Federation...

Ms. Cathy Webb, MS, CQA, CQE undertook a presentation at the Arkansas Environmental Federation Convention and Tradeshow titled: The EHS Manager’s Guide to: The Pitfalls of HAZMAT Shipping (“Presentation”) ...more

New Proposition 65 Warning Regulations Take Effect in 2018

by Downey Brand LLP on

In less than a year, on August 30, 2018, the new Proposition 65 warning regulations will go into effect. Proposition 65 (Safe Drinking Water and Toxic Enforcement Act) requires businesses to provide Californians with a clear...more

Selling Products In California: Navigating Product Regulations

Big Picture: Product Liability in California - California applies its strict product liability laws to all products put into the stream of commerce and sold to the public, and those laws govern a wide array of products. ...more

Staying The Course In A Mississippi Drug Case

by Reed Smith on

Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense...more

Proposition 65: OEHHA Releases Q&A Regarding Proposition 65 Regulations for Clear and Reasonable Warnings

by Bergeson & Campbell, P.C. on

In August 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document related to its August 28, 2016, adopted revisions to its Proposition 65...more

Proposition 65 Legislative Changes Likely “Lack Merit”

by Morrison & Foerster LLP on

On October 5, 2017, California Governor Jerry Brown signed Assembly Bill 1583 into law. It was promoted as a means of reducing frivolous Proposition 65 (Prop 65) lawsuits, but, as discussed below, it is doubtful that it will...more

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

California Enacts Legislation in an Attempt to Level the Playing Field in Proposition 65 Enforcement Actions

by Downey Brand LLP on

On October, 5, 2017, Governor Brown announced that he signed AB 1583 into law. AB 1583, authored by Assemblymember Ed Chau, a democrat from Monterey Park, is intended to promote transparency in Proposition 65 private...more

Under What Circumstances Can a Private Qui Tam Plaintiff Overrule Government Agency Experts' Use of Administrative Discretion to...

• How have appellate courts applied the Supreme Court’s ruling in Escobar? • If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more

Proposition 65 Warning Required for Furfuryl Alcohol as of September 30, 2017

by Downey Brand LLP on

On and after September 30, 2017, a Proposition 65 warning is required for products containing furfuryl alcohol (CAS No. 98-00-0). California’s Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of...more

Cannabis Prop 65 Liability: Lessons Learned from the Dietary Supplement Industry

by Wilson Elser on

The cannabis industry appears to be next on the liability “hit list” under California’s notorious Proposition 65 statute. In June 2017, more than 700 Prop 65 notices were served on California cannabis businesses. Companies in...more

Implementation of Revisions to Proposition 65's Warning Language Requirements is One Year Out

by Clark Hill PLC on

Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires consumer warnings for products that contain one or more of numerous listed chemicals that are known by the State of...more

Government-Mandated Health Warnings in Sweetened Beverage Advertising Found Likely to Chill Protected Free Speech

by Kelley Drye & Warren LLP on

On September 20, the Ninth Circuit blocked the City and County of San Francisco from implementing an ordinance that would have required health warnings on advertisements for beverages that contain one or more added sweeteners...more

When Plaintiff Conduct Matters

by Reed Smith on

We previously addressed the in pari delicto doctrine, whereby a plaintiff injured in the course of his or her criminal conduct cannot recover for those injuries. We specifically examined this doctrine’s most common...more

Food & Beverage Litigation Update | September 2017 #2

FDA Seeks Comment on Regulation Changes for "Meaningful Burden Reduction" - Implementing an executive order titled "Reducing Regulation and Controlling Regulatory Costs," the U.S. Food and Drug Administration (FDA) has...more

WARNING! Prop 65 regulations are a year away in California. Is Your Product’s Warning Label Compliant?

by Wilson Elser on

After many years of debate, consideration and public input, California’s new regulations go into effect on August 30, 2018, under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 - commonly known as Prop 65....more

OEHHA Attempts to Clarify New Proposition 65 Clear and Reasonable Warning Regulations by Issuing Guidance and Proposed Amendments

by Beveridge & Diamond PC on

On August 30, 2016, the California Office of Environmental Health Hazard Assessment (“OEHHA”) repealed and readopted Article 6 of Title 27 of the California Code of Regulations, which sets forth the method and content deemed...more

Is Your Company Ready for the New Prop 65?

by Polsinelli on

One year from now, companies that do business in California will have to comply with new warning regulations under the state’s Safe Drinking Water and Toxic Enforcement Act (“Proposition 65”)....more

Good Risperdal Times, Part Three: Summary Judgment for Janssen in Philadelphia

by Reed Smith on

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday...more

A Rose by Any Other Name: Drug Claims Make Your Cosmetic a Drug

by Arnall Golden Gregory LLP on

Last month, FDA district offices issued Warning Letters to two cosmetic companies for making claims that established their products as drugs. In finding that the products were new drugs requiring premarket approval, FDA...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

Proposition 65: New “Naturally Occurring” Level Proposed for Rice

by Morrison & Foerster LLP on

The California Office of Environmental Health Hazard Assessment (OEHHA) recently proposed levels of inorganic arsenic in rice that would be deemed “naturally occurring” and thus exempt from the Proposition 65 warning...more

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