Warning Labels

News & Analysis as of

WARNING: California’s Proposition 65 Warning Requirements are Changing

California’s Office of Environmental Health Hazard Assessment (“OEHHA”) recently finalized substantial amendments to the regulations governing the provision of warnings required by “Proposition 65” (a/k/a the “Safe Drinking...more

Proposition 65: OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations

On August 28, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering "clear and reasonable warnings"...more

Prop. 65 Conference Focuses on Compliance With New Warning and Settlement Regulations

The Prop. 65 Clearinghouse held its annual conference in San Francisco recently, and the speakers and panelists had a number of recommendations for both retailers and manufacturers following the adoption of Proposition 65’s...more

OEHHA Issues Notice of Intent to List PFOA and PFOS

On September 16, 2016, the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of intent to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate...more

New Proposition 65 Regulation Amendments Modify Clear and Reasonable Warning Requirements and Private Enforcement Settlement...

The California Office of Environmental Health Hazard Assessment (OEHHA) and the California Attorney General each adopted regulatory amendments to the Proposition 65 regulations at the close of August 2016. The OEHHA...more

EU Retail News – September 2016

UK retailers, like all businesses, are facing several years of uncertainty following the Brexit vote. This uncertainty will not be alleviated until the terms of the UK’s withdrawal from the European Union are defined and...more

WARNING: OEHHA amends California Proposition 65 requirements for "clear and reasonable warnings": next steps

The California Office of Environmental Health Hazard Assessment (OEHHA) has introduced the final amendments to the "clear and reasonable warnings" required by Proposition 65. This unique California law, in relevant part,...more

Another Make Work Project In New Jersey – Duty To Update Claims

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the...more

California Adopts New "Clear and Reasonable Warning Requirements" for Proposition 65

If you're modifying packaging or introducing a new product, it may be a good time to update your Proposition 65 warnings. On August 30, 2016, California’s Office of Administrative Law approved the adoption of amendments to...more

California Adopts New Prop. 65 Warning Regulations

California’s Office of Environmental Health Hazard Assessment (OEHHA) has adopted new Proposition 65 warning regulations. The new regulations will take effect in two years, on August 30, 2018. In the interim, businesses may...more

WARNING: California Adopts New Proposition 65 “How to Warn” Rules

Last Friday, the state published the first major changes to the Proposition 65 regulations in more than a decade. The sweeping changes rewrite the “safe harbor” warning regulations and, in doing so, create a new set of...more

Prop 65 Warning Regulations Adopted

Today, September 2, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) published its notice of adoption of amendments to Prop 65 – essentially overhauling Title 27 of the California Code of...more

The Do’s and Don’ts of Growler Labeling

With growler sales getting more popular in Pennsylvania, we decided to examine the relevant federal and state laws with regard to the refilling of growlers if they do not bear the labeling of your licensed business. To...more

FDA Regulatory and Compliance Monthly Recap — August 2016

FDA issues draft guidance on use of real-world data in medical device decision-making - The Food and Drug Administration’s draft guidance provides an overview of how the agency will determine the quality and reliability...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison...more

Update: Unraveling the Toxic Substances Control Act Reform Bill

In June, the U.S. Senate and House of Representatives passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals. The bill...more

EPA Issues Final Rule on Formaldehyde Emission Standards for Composite Wood Products

On Wednesday, July 27, 2016, the Environmental Protection Agency (“EPA”) released a prepublication version of its final rule on Formaldehyde Emission Standards for Composite Wood Products. The authority for the rule comes...more

Summary Judgment for All Pending Cases in The Mirena MDL

We often lament, in our curmudgeonly way, that plaintiffs in obviously lacking cases get chance after chance to keep going, all the while imposing costs and risks on the defendants and a burdens on court dockets. Plaintiffs...more

E-Cigarette Makers Contending with New CPSC and FDA Regulations

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other...more

Food and Beverage News and Trends Series - August 2016

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. USDA publishes final rules to improve quality of food served in schools. On...more

“Auto-Pilot” May Not Be Perfect, But It May Be Better

Virtually every day there are media reports regarding the introduction of driverless cars to mainstream consumers. As driverless cars rapidly accelerate from concept to commercialization, it is becoming increasingly apparent...more

Warning Labels Suit Not Suitable for Preliminary Injunction

In American Beverage Association v. City and County of San Francisco, No. 3:15-cv-03415-EMC, decided on May 17, 2016, Northern District Judge Edward Chen denied a preliminary injunction against enforcement of a San Francisco...more

California Agency’s Continued Tinkering with Prop 65 Rule Revisions Receives Mixed Reviews from Stakeholders

In the July 2015 issue, we reported on food and beverage companies’ views on the overhaul of warning regulations under the Safe Drinking Water and Toxic Enforcement Act (colloquially known as Prop 65) proposed by the Office...more

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