Warning Labels Manufacturers

News & Analysis as of

California May Collect Certain Information from Businesses to Support Its New Proposition 65 Website

California’s Office of Environmental Health Hazard Assessment (OEHHA) has launched a website, www.P65Warnings.ca.gov, intended to provide both businesses and consumers with information regarding the requirements for...more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

BPA in Plastics Requires a Prop 65 Warning — For Food Containers, California Imposes a Generic Point-of-Sale Warning

Last year the State of California added Bisphenol A (BPA) to its list of chemicals known to cause cancer or reproductive harm under Prop 65 [the Safe Drinking Water and Toxic Enforcement Act of 1986], a law which requires...more

Legal Update: Regulation of E - Cigarettes

On May 5, 2016, the federal Food and Drug Administration (FDA) announced new regulations governing the sale of e-cigarettes, hookahs, dissolvable tobacco, pipe tobacco, cigars and other tobacco products (ENDS). The new rule...more

Trimming Some Fat From Statin Litigation With Daubert and Preemption

In the mythical days of product liability yore, a big drug litigation was spurred by a notable event—like a study describing a new risk appearing in a major journal, a significant labeling change because of new or greater...more

FDA Regulation of E-Cigarettes: The What, When, and Warnings

On May 10, 2016, the Food and Drug Administration (FDA) issued a final rule extending its regulation of "tobacco products" to include electronic cigarettes and similar products, sometimes called Electronic Nicotine Delivery...more

California's Proposition 65: History and Proposed Amendments in 2016

In 1986, California voters passed the Safe Drinking Water and Toxic Enforcement Act, otherwise known by its original name, Proposition 65. Proposition 65 requires the California Office of Environmental Health Hazard...more

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

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

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

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

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

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

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

California Adopts Additional Phthalate Proposition 65 Safe Harbor Limit - Agency Rejects Calls for Higher (and Lower) Limit

California’s Office of Administrative Law has amended the list of regulatory safe harbor levels under Proposition 65 to include the chemical diisononyl phthalate (DINP), setting the limit at 146 micrograms per day...more

Alabama No Longer An Outlier State: Legislature Says “No” To Innovator Liability

I. Introduction - Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic...more

California Issues New Draft of Proposition 65 Warnings Overhaul - Significant Changes Respond to Public Comment

In January 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed the most significant revisions to the Proposition 65 warning regulations since the 1980s. Not surprisingly, OEHHA received...more

After Years of Starts and Stops, OEHHA Commences New Rulemaking to Change the Prop 65 Product Label Requirements

After nearly a year of heavy industry opposition and objections to the proposed draft regulations requiring all manufacturers selling goods in California to change their Prop 65 product label warnings, the California Office...more

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

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