Labeling

News & Analysis as of

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

Deja Vu All Over Again: Federal GMO Labeling Legislation Re-Introduced

Last week, Sen. Barbara Boxer of California, Richard Blumenthal of Connecticut, and Rep. Peter DeFazio (D-Ore)–joined by chef-lebrity Tom Colicchio–announced the reintroduction of The , a federal bill that would mandate the...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

Proposed Prop 65 Rules Won't Please Calif. Businesses

California’s Proposition 65 warning requirements (Health & Safety Code Sections 25249.6 et seq.) have long been a major concern for businesses that want their products offered for sale in the state’s large marketplace....more

Advertising Law - February 2015 #3

FCC Chair Announces New Net Neutrality Regs - The battle over net neutrality took a new turn when Federal Communications Commission Chairman Tom Wheeler announced his intention to reclassify broadband service as a...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Made in the USA?: Suit Against Nordstorm Alleging Misleading Jeans Labels May Proceed

How much of a product has to be “Made in the USA” for a company to label it as such, and who gets to decide? Those questions are raised by an ongoing action lawsuit before a federal court in the Southern District of...more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Advertising Law - January 2015 #3

President Obama Focuses on Cybersecurity, Privacy, Data Breach Notification - Data security and privacy concerns received special attention in President Obama’s State of the Union address where the President advocated...more

State of the GMO Union

Just how hot is GMO-labeling legislation? On Jan. 6, 2015, a Republican state senator introduced just such a bill - in Indiana, the nation’s breadbasket. Still, federal legislation on both sides of the issue has stalled, the...more

Kimberly-Clark Corporation Wins Motion to Dismiss in Flushable Wipes Case

Judge Phyllis J. Hamilton of the Northern District of California recently granted Kimberly-Clark’s motion to dismiss a case challenging the truthfulness of the defendant’s claims that its wipes are flushable. Davidson v....more

Product labeling requirements aren't all black and white

Your company has created and developed a new, innovative product. You’ve tested your product, you’ve adopted a new trademark, and you’re ready to begin manufacturing. The remaining steps of preparing your product for sale,...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

Vermont Doubles Down: Representative Testifies Before Congress Against Federal GMO Labeling Bill

As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Advocates of GMO labeling vow to continue fight even after electoral...more

Advertising Law - November 2014 #3

NAD Sniffs at Odor Protection Claims - Concerned that a 48 hour antiperspirant/deodorant constitutes an overstated claim of “100% odor protection,” the National Advertising Division recommended...more

Wait for the "Green" Light Before Making Environmentally Friendly Claims

Consumers increasingly pay a premium for environmentally friendly products. As a result, companies are expanding their green marketing claims regarding products and packaging. Those companies may find themselves under...more

Consumer Products Companies Should Take Care to Comply with California “Made in USA” Labeling Law

New cases are being brought by plaintiff attorneys under the California “Made in USA” labeling law, which prohibits use of that claim or similar language if the "merchandise or any article, unit, or part thereof" was made...more

Illinois Supreme Court Agrees to Review Tobacco Verdict Again

Not infrequently, the law calls upon a court to decide what another court would do with a particular issue or case. In the closing days of its September term, the Illinois Supreme Court agreed to take up Price v. Philip...more

A Taste of Things to Come? Whole Foods Feels Sting of “Non-GMO” Litigation

As we’ve explored in past posts, mandatory GMO-labeling legislation has, at best, a spotty track record among state legislatures. Nevertheless, the GMO issue continues to draw the public’s attention, and it is becoming clear...more

OSHA To Provide Enforcement Discretion On June 2015, Deadline For SDS

On October 31, 2014, the Occupational Safety and Health Administration (OSHA) responded to an August 2014 petition from the American Coatings Association (ACA) and other trade associations to extend the June 1, 2015,...more

Making a “Made in the USA” Claim Requires a Reading of Federal and State Law

Given the rise in false advertising claims, manufacturers and retailers that wish to label or advertise their goods as being “Made in the USA” must be aware of federal and state laws that place certain requirements on the...more

Skinnygirl Squeezes Past Class Action For Deceptive Advertising

Amy Langendorf alleged that Skinnygirl Margarita, a pre-mixed alcoholic beverage, contains the non-natural preservative sodium benzoate, rendering the product’s “all natural” label false and misleading. Langendorf filed suit...more

A Quick Summary of New Changes to California Law

Our friends at Legsilative Intent Service (a great resource for digging deep into the history of California legislation) have recently published their list of changes to California law coming in 2015. These legislative...more

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