Warning Labels

News & Analysis as of

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

Bootstrapped Claim Against the FDA Gets the Boot

We’re pleased to report the demise of a plaintiff’s firm’s attempt to punish the FDA for rejecting the firm’s attempt to force the agency to create evidence helpful to plaintiffs in litigation. The ploy began in 2012, when “a...more

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

Stinson Leonard Street's Emerging Trends Newsletter - Q3

We are thrilled to bring you the third installment of Stinson Leonard Street's Emerging Trends newsletter. We are proud of the depth and breadth of experience and knowledge across our firm's 13 offices nationwide and are...more

WARNING: Prop 65 Can Expose Product Manufacturers to Increased Litigation in California

California's Proposition 65 ("Prop 65") requires product manufacturers and sellers to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone in California to a chemical listed by the...more

Proposition 65: New regulations for "clear and reasonable" warnings

Remember when the warning above was “clear and reasonable” for purposes of Proposition 65? Soon that will no longer be true. Following a two-year rulemaking, the California Office of Environmental Health Hazard Assessment...more

California Prop 65: More Unintended Consequences

Last month, the California Office of Environmental Health Hazard Assessment (“OEHHA”) adopted new Proposition 65 warning regulations. Much of the discussions regarding these new regulations have centered on the warning...more

New Modifications to the Proposition 65 Regulations

The modifications significantly change both the AG’s Regulations and OEHHA’s Clear and Reasonable Warnings provisions. California’s Office of Administrative Law recently approved important changes to two sets of Proposition...more

California Adopts Amendments to Prop 65 “Safe Harbor” Warning Requirements

In September, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) announced that it had adopted amendments to the regulations governing California’s Proposition 65, which requires that businesses provide a...more

Food and Beverage News and Trends - October 2016

FDA seeks public comment on possible revision of its definition of "healthy" on food labels. The FDA has begun an initiative to revisit its legal definition of "healthy" as used by manufacturers on food labels. In a September...more

California Adopts New Regulations For Warnings Under Proposition 65: CAVEAT VENDITOR (Sellers Beware)

Come August 30, 2018, consumer products to be released into the California marketplace must meet new regulations under California’s infamous Proposition 65. On August 30, 2016, the California Office of Administrative Law...more

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

189 Results
View per page
Page: of 8
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.