Category Archives: FDA

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FDA Gives Food Industry Three Years to Cut Out Trans Fat

The debate over the use of trans fats has been ongoing for years.  Despite claims that trans fats are unhealthy, the Food and Drug Administration historically considered them safe for use in food.  Many of our favorite foods contain the ingredient, including Popeyes fried chicken and Betty Crocker frosting and cake mix. On June 16, … Continue Reading

Distributors Beware: Don’t Get Caught with Your Hand in the Cookie Jar

The reasonable consumer couldn’t possibly believe that every Danish cookie, must, as a matter of law, be made in Denmark.  Yet, a recent NAD decision may suggest that this reasonable consumer is not as cookie-cutter as one might expect. In today’s global economy, it is common for U.S. distributors to sell products manufactured and packaged … Continue Reading

The Ninth Circuit Reaffirms The Application Of The Primary Jurisdiction Doctrine To FDCA / Lanham Claims In The Post-POM Wonderful Era

In 2014, the Supreme Court decided POM Wonderful LLC v. The Coca-Cola Company, 134 S.Ct. 2228, which we have discussed in detail here, and here, and here.  In POM Wonderful the Supreme Court held that “Congress did not intend the [Food, Drug and Cosmetic Act] FDCA to preclude Lanham Act suits like POM’s.”  Since that … Continue Reading

3D Printing Series: 3D Printing of Medical Devices

3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive … Continue Reading

3D Printing Series: Be Right Down — Printing My Makeup

Since we are now fully comfortable with “smart” everything, it should be no surprise that 3D printing has taken center stage in the tech world. It’s easy to imagine 3D-printed machine parts, prototype models, or even toys, but it might be harder to accept 3D-printed foods, implantable medical devices, cosmetics, drugs, and even human tissue.  … Continue Reading

3D Printing Series: No One Goes into Space for the Food – Yet

As expected, NASA recently successfully completed the first hot-fire tests on an advanced rocket engine thrust chamber assembly using copper alloy materials.  This was the first time a series of rigorous tests confirmed that 3D manufactured copper parts could withstand the heat and pressure required of combustion engines used in space launches. In all, 19 hot-fire … 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

We 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, … Continue Reading

FDA Labeling Requirements for Restaurants and Vending Machines

“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 … Continue Reading

A Whole New Lanham Act? A Look at Lexmark and POM Wonderful in Action

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 … Continue Reading

Supreme Court Opens Door to Food and Beverage Label Challenges Under Lanham Act

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 … Continue Reading

Absence of Federal Standard Greases Way for Another “Natural” Class Action

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 … Continue Reading

Upcoming Advertising Symposium

We try not to use this space for shameless self-promotion but we have an upcoming event in New York City that we’re so excited about that we just can’t help ourselves. Venable is sponsoring a day long advertising symposium on Tuesday March 11th at the Vanderbilt Club in New York City.  Now listening to us talk … Continue Reading

Not an Easy Recipe – Courts Struggle with the Intersection of FDA Food Labeling Regulations and Private Causes of Action

The Federal Food, Drug, and Cosmetic Act and the Nutrition Labeling and Education Act of 1990, along with all of their corresponding regulations, create a complex and uniform system of food labeling requirements.  Neither of these statutes provides for a private right of action, but more and more consumer class action and other claims are … Continue Reading

FDA Bursts Bubble on Antibacterial Soaps

With worries over antibiotic-resistant “super bugs” on the rise, many consumers may assume that antibacterial soaps would help protect against unwanted bugs: not so fast, says the FDA.  Amongst growing concerns that the active ingredient in many of these soaps, triclosan, could be linked to hormonal effects and bacterial resistance, on December 17th, FDA published … Continue Reading

FDA’s Message to Medical Device Company: Stop

The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious diseases,” including diabetes, coronary heart disease, and breast cancer.  This all sounds good.  As an FDA Warning Letter issued on November 22, 2013, makes … Continue Reading

NAD Keeps It Regular with Whole Grain and Fiber Claims Review

A recent NAD decision once again illustrates how the NAD is often at the forefront of opining on many currently trending claims.  The holy grail for any pasta loving carb avoider ‎is a great tasting but healthier spaghetti. And as companies increase their whole grains and overall nutritional profile, comparative claims and challenges are sure … Continue Reading

If You Don’t Eat Your Medicine, You Can’t Have Any Pudding!

On August 13th, the Food and Drug Administration (FDA) released a second version of its draft guidance on medical foods.  The draft guidance, “Frequently Asked Questions About Medical Foods; Second Edition,” amends and expands upon the original draft guidance published in 2007 by incorporating 15 new questions and answers. Specifically, the FDA addresses medical food … Continue Reading

USDA Releases Draft Guidance on the Definition of Natural vs. Synthetic

On April 2, 2013, USDA released Draft Guidance here, here, and here addressing an issue that has plagued the National Organic Standards Board (NOSB”) for years: how to determine whether a substance is agricultural or non-agricultural and synthetic or non-synthetic. These determinations are paramount when considering whether a substance may be used in “organic” or “made … Continue Reading

FDA Warning Letter Makes Shout-Out to Facebook

This week, FDA finally published a December 2012 warning letter on its website, showcasing its first-ever enforcement action based on a company’s social media activity.  In the letter, FDA interprets a dietary supplement company “liking” a consumer testimonial posted to its Facebook website as an implied endorsement of the underlying claim content. The offending post, … Continue Reading

The Scope of Liability for False Advertising Claims

The crisp autumn breezes and reemergence of everything pumpkin-flavored makes us think that it’s the perfect time for an All About Advertising Law seasonal refresher.  Today’s topic: how far liability can extend in false advertising actions.  Exactly who can be held responsible for a particular advertisement?  These days it seems like practically everyone, except perhaps … Continue Reading
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