Warning Labels Manufacturers

News & Analysis as of

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.”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

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

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

The Toxic Substances Control Act Amendments May Do Little to Relieve California Headaches for Businesses

Business groups largely supported the Toxic Substances Control Act (TSCA) Amendments?recently signed into law by President Obama—in order to address concerns about the emergence of varying state-by-state requirements that...more

California Adds Group of Herbicides to Proposition 65 List

Following a failed legal challenge by Syngenta Crop Protection, California’s Office of Environmental Health Hazard (OEHHA) has announced that it has added a group of broadleaf herbicides to the list of chemicals under...more

California Lists Sedaxane, Styrene Under Prop. 65

Sedaxane and styrene are among the latest chemicals to be listed by California as requiring a Prop. 65 warning. Sedaxane is a seed treatment fungicide. It was listed under Prop. 65 as a carcinogen on July 1, and the warning...more

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Another Prescription Drug Warnings Preemption Decision

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up...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

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

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