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3DPrinterWe agree – the Jetsons era has indeed arrived. Beyond the days of “smart” everything, now 3D printing has taken center stage in the tech world. While it is not so farfetched to imagine 3D-printed machine parts, prototype models, or even toys, it is might be harder to watch it printing foods, implantable medical devices, cosmetics, drugs and even human tissue. All too futuristic? Not really. The technology of 3D-print FDA-regulated products is, in large part, already here and rapidly progressing.

Yet, as technology continues to develop, questions arise as to whether, and how, the U.S. Food and Drug Administration’s (“FDA”) regulatory framework will keep pace to impose the same safety, quality and efficacy standards to 3D-printed foods, drugs, cosmetics, and medical devices that currently apply to traditionally manufactured goods. How FDA chooses to deal with 3D-printed products will significantly impact not only barriers to market entry, but also post-marketing enforcement risks. Similarly, even assuming an FDA-regulated 3D-printed product is successfully brought to market in accordance with FDA standards, manufacturers must still assess options and potential challenges associated with protecting their intellectual property.

Through this multi-part blog series, we will explore these questions, considerations and challenges for 3D printing that are likely to be regulated by FDA, with particular focus on foods (consumed on earth and in space), cosmetics and medical devices. While, at this stage, FDA issues may raise more questions than clear answers, this blog series will explore and discuss the topics that are at the forefront of FDA’s agenda regarding 3D printing and, therefore, require careful consideration by any company that contemplates involvement in the 3D-printed foods, cosmetics or devices industries. 
Continue Reading 3D Printing Series: Before You Click “Print” On Your Pizza, Palette or Prosthetic: FDA and IP Considerations With 3D-Printed Foods, Cosmetics And Medical Devices

“How Much is that Doughnut in the Window?”

America has a thoroughly documented problem of too many overweight and obese people, with consequences for them and their health, the overall health of the nation, and the cost of health care.  The premise of the requirement in the Affordable Care Act that the Food and Drug Administration (FDA) adopt regulations requiring the disclosure of calories of food purchased in certain restaurants and from vending machines is that knowing the number of calories will positively influence eating behavior and, over time, help to address the nation’s overweight and obesity problem.  The validity of that premise is about to be tested.

On November 25, 2014, FDA finalized two rules requiring calorie information be listed on menus and menu boards in chain restaurants, similar retail food establishments and vending machines with 20 or more locations.Continue Reading FDA Labeling Requirements for Restaurants and Vending Machines

As we previously reported here on March 25, 2014 the United States Supreme Court issued its much-anticipated decision in Lexmark Int’l Inc. v. Static Control Components, Inc.  The decision resolved a three-way Circuit split, rejected the test in the Seventh, Ninth and Tenth Circuits that the plaintiff and defendant had to be direct competitors, and articulated a new test for standing to bring a Lanham Act false advertising claim – a plaintiff must be in the “zone of interest” and must have injuries proximately caused by the defendant’s false advertising.

The other recent landmark Supreme Court decision in this area is of course POM Wonderful LLC v. Coca-Cola Co., which we also previously reported on here.  That case held that competitors could bring suits under the Lanham Act challenging food and beverage labels that were regulated by the Federal, Food, Drug, and Cosmetic Act (“FDCA”) and complied with those regulations—in other words, the FDCA does not preclude claims under the Lanham Act, at least in the area of food and beverage labeling.

Lower courts are already recognizing that Lexmark and POM Wonderful have broadened the scope of Lanham Act litigation between competitors, and in fact are applying Lexmark and POM Wonderful beyond the realm of false advertising. 
Continue Reading A Whole New Lanham Act? A Look at Lexmark and POM Wonderful in Action

The United States Supreme Court paved the way today for competitors to challenge FDA-regulated food and beverage labels under the Lanham Act.  The Court’s opinion in POM Wonderful LLC v. The Coca-Cola Co. is the latest chapter in a long-running feud between POM Wonderful and Coca-Cola, which arose in 2008 when POM accused Coke of mislabeling one of its fruit juice blend products by prominently displaying the words “pomegranate blueberry” despite the product consisting mostly of less expensive apple and grape juices.  To date, Coke had successfully persuaded a California district court and the Ninth Circuit that POM’s Lanham Act claims were precluded by the Federal Food, Drug, and Cosmetic Act and attendant FDA regulations specifically addressing the labeling of fruit juice blends. 
Continue Reading Supreme Court Opens Door to Food and Beverage Label Challenges Under Lanham Act

Another consumer class action over allegedly false and misleading “natural” claims survived a motion to dismiss in the Southern District of New York on May 15, 2014.  At issue in Ault v. J.M. Smucker Co. is whether “All Natural” claims made on labels of Smucker’s Crisco branded vegetable oils are false and misleading.  The plaintiffs allege in their complaint that the claim is misleading for two reasons: 1) the oils are derived from genetically modified vegetables which are not natural, and 2) the oils are so heavily processed that they bear no chemical resemblance to the ingredients from which they are derived.   

In response to the complaint, Smucker’s filed a motion to dismiss on the grounds that FDA policies and regulations preempt the plaintiffs’ state false advertising claims, and argued that the Court should decline to enter that “All Natural” debate and defer to the FDA as it has primary jurisdiction.  On May 15, 2014, Judge Crotty of the Southern District of New York denied the motion to dismiss.
Continue Reading Absence of Federal Standard Greases Way for Another “Natural” Class Action