Warning Labels

News & Analysis as of

Los Angeles Superior Court Issues Important Defense Verdict In Unique Proposition 65 Trial Against Brass-Polish Manufacturer

In a recent trial in Los Angeles Superior Court in the matter AFS Enterprises, LLC, v. Reckitt Benckiser, PLC, Los Angeles Superior Court Case No. BC539678, the plaintiff brought a single claim under Proposition 65 (Safe...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

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

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...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

Be Warned: Prop 65 Emergency Regulation on BPA Takes Effect

A new Proposition 65 requirement takes effect today, May 11, 2016. It requires all California hotel and lodging businesses with 10 or more employees to display a warning for all canned and bottled foods and beverages offered...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

Restaurants and Food Retailers Are Now Required to Post Proposition 65 Warning Signs about BPA in All California Locations

As of May 11, 2016, all businesses that distribute or sell food and beverage products in California that potentially contain bisphenol A (BPA) are required to provide a warning under California’s Proposition 65 to consumers....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

California – New Prop 65 Product Label Requirements Likely to be Adopted

Today, May 17, 2016, OEHHA released a second set of revisions to its proposed regulations to change the warning labeling requirements for Prop 65. This is the first major change to the words required on product labels and...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

Vermont GMO Food Labeling - Is Your Label Ready?

In less than two months, Vermont's genetically modified organism (GMO) food labeling law, Consumer Protection Rule 121, goes into effect. Starting July 1, 2016, food manufacturers producing food containing GMOs to be sold in...more

Yet Another Failure-To-Update Claim Bites the Dust

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts,...more

FDA New e-Cig Rules Raise Issues for Traditional and Digital Ad Platforms

The long awaited FDA regulations “deeming” e-cigarettes a tobacco product have, at last been issued and were published in the Federal Register earlier this week. While they may have answered some questions, they also leave...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

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

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