Warning Labels

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New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.”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

Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison...more

Update: Unraveling the Toxic Substances Control Act Reform Bill

In June, the U.S. Senate and House of Representatives passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals. The bill...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

Summary Judgment for All Pending Cases in The Mirena MDL

We often lament, in our curmudgeonly way, that plaintiffs in obviously lacking cases get chance after chance to keep going, all the while imposing costs and risks on the defendants and a burdens on court dockets. Plaintiffs...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

Food and Beverage News and Trends Series - August 2016

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. USDA publishes final rules to improve quality of food served in schools. On...more

“Auto-Pilot” May Not Be Perfect, But It May Be Better

Virtually every day there are media reports regarding the introduction of driverless cars to mainstream consumers. As driverless cars rapidly accelerate from concept to commercialization, it is becoming increasingly apparent...more

Warning Labels Suit Not Suitable for Preliminary Injunction

In American Beverage Association v. City and County of San Francisco, No. 3:15-cv-03415-EMC, decided on May 17, 2016, Northern District Judge Edward Chen denied a preliminary injunction against enforcement of a San Francisco...more

California Agency’s Continued Tinkering with Prop 65 Rule Revisions Receives Mixed Reviews from Stakeholders

In the July 2015 issue, we reported on food and beverage companies’ views on the overhaul of warning regulations under the Safe Drinking Water and Toxic Enforcement Act (colloquially known as Prop 65) proposed by the Office...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

Middle District of Louisiana Gets it Wrong: A Different Product is not an “Alternative Design”

Over the Fourth of July weekend, we in the Philadelphia area learned that 120 of the “new, state-of-the-art” trains in our regional commuter rail system were being pulled out of service. Someone noticed that the trains were...more

Prop. 65 Notices Allege BPA in Receipts, Water Cooler Jugs

Although the Prop. 65 warning requirement for bisphenol-A (BPA) took effect on May 11, only two 60-day notices have been served alleging harmful exposure to the chemical without providing a warning. Those notices, both served...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

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

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