Warning Labels

News & Analysis as of

Major New Wave of California Proposition 65 Lawsuits About to B(PA)reak

May 11, 2016. A day that may live in California Proposition 65 infamy. The date marks the one –year anniversary of the listing of Bisphenol A (BPA) as a reproductive toxicant under Proposition 65, and the expiration of the...more

UPDATE Regarding California Prop. 65: Revised Warning Requirements for BPA in Canned Foods Effective May 11, 2016

The Proposition 65 warning requirement for Bisphenol-A (“BPA”) takes effect on May 11, 2016, but a recent emergency regulation has revised the warning requirements for food and beverage products only. Pursuant to an...more

Mark Your Calendars: BPA Prop 65 Warnings Required as of May 11, 2016; Styrene Also Added to the Prop 65 List

Earlier this month, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Emergency Action to allow temporary use of a standard point-of-sale warning message for bisphenol A (“BPA”)...more

Lawsuits Involving Fluoroquinolones Piling Up Against Manufacturers

Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated...more

Turmoil for Food Brands: New Prop 65 Warning Requirement for BPA in Packaging

Just three weeks before new Proposition 65 warning requirements for BPA kick in, OEHHA has adopted emergency regulations that specify responsibilities for food manufacturers, retailers and others offering canned and bottled...more

Efforts to rein in Proposition 65 abuse have gone awry

The lofty goal of Proposition 65 was to incentivize manufacturers, importers, distributors, wholesalers and retailers to reformulate their products so that consumers were not needlessly exposed to "listed chemicals" (the term...more

OEHHA Proposes New Prop. 65 Warning Regulations

California’s Office of Environmental Health Hazard Assessment (OEHHA) has released another draft of its proposed amendments to the Proposition 65 warning regulations. This is the third draft OEHHA has released for public...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Grace Period Ends Soon for California Companies with Products Containing BPA

On May 11, 2016 products that contain Bisphenol A (BPA) manufactured, sold or distributed in California, without a proper warning, will be fair game for a Notice of Intent to Sue issued under the state’s Safe Drinking Water...more

FDA Releases Naming Guidance

The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA...more

Prop. 65 Warning Requirement for BPA Takes Effect May 11

The California Proposition 65 warning requirement for Bisphenol-A (BPA) takes effect on May 11, 2016. After May 10, products that contain BPA sold in California without a Prop. 65 warning could subject retailers,...more

Proposition 65: OEHHA Proposes Revisions to Its Proposed Proposition 65 Warning Regulations

On March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) modified its November 27, 2015, proposed rule that would repeal and replace the Proposition 65 (Prop 65) Article 6 regulations...more

I See a Prop 65 Label On This Product, But What Does It Mean? New California Website to Explain

At the beginning of 2016, the State of California (OEHHA) adopted a new regulation to give itself authority to create and operate a website to provide information about the Prop 65 labels the public sees on everyday products...more

OEHHA Issues Additional Modifications to Proposition 65 Article 6: Clear and Reasonable Warning Requirements

On March 25, 2016, the California Office of Environmental Health and Hazard Assessment (“OEHHA”) released a Notice of Modification to Text of the Proposed Repeal and Adoption of a New Article 6 Clear and Reasonable Warning...more

FDA Takes Further Steps to Curb Opioid Abuse

Required Black Box Warnings on Immediate Release Opioids - Closely following on recent efforts undertaken by states and the Centers for Disease Control to curb opioid abuse (review further here and here), the U.S. Food...more

A Proposition 65 Violation May Be Lurking in Your Cash Register Receipt

Many consumer-facing businesses have learned to identify high-risk Prop 65 targets: soft, flexible plastics; faux and colored leathers; and any kind of brass or metal that may contain lead or other heavy metals. But...more

Short Comment Period for Revised Prop 65 Warning Regulations

On Friday, March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) released another set of proposed revisions to the Prop 65 warning label regulations. The comment period is very short – only...more

California Proposes Emergency Regulation to Ease the Prop 65 Warning Burden on Canned and Bottled Food and Beverage Products

California’s Office of Environmental Health Hazard Assessment (“OEHHA”) added Bisphenol A (“BPA”) to the Proposition 65 (“Prop 65”) list as a chemical known to cause reproductive toxicity, on May 11, 2015. Prop 65 provides...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

Important Developments for Prop 65 Application to BPA

California’s Office of Environmental Health Hazard Assessment takes action to address BPA exposures and upcoming warning requirements under Proposition 65. On March 17, California’s Office of Environmental Health Hazard...more

Prop 65 Regulatory Activity Raises New Compliance Questions for Industry

Summary: This post explores recent developments in California under Prop 65, including programmatic changes, new chemical listings, and related litigation. Companies that operate in California should be aware of these...more

Deadline Approaching for Prop 65 Compliance for Bisphenol A

Effective May 11, 2016, manufacturers that make products containing Bisphenol A (“BPA”) will be required to comply with California’s Safe Drinking Water and Toxic Enforcement Act of 1986, also known as “Prop 65.” More...more

Health Canada Assesses Monetary Penalties against Company under Canadian Product Safety Act for First Time

On March 11, Health Canada announced that it had assessed administrative monetary penalties under the Canada Consumer Product Safety Act (CCPSA) against company Orange TKO Industries (Orange TKO or the Company) of Calgary. ...more

Product Liability: 2015 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2015. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

2015 Year in Review: OPDP and APLB Warning and Untitled Letter

The drought in enforcement by the Office of Prescription Drug Promotion (OPDP) continued in 2015, as OPDP issued a total of only nine enforcement letters. Two of the nine letters were Warning Letters and seven were Untitled...more

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