Category Archives: FDA

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9th Circuit Delivers Sweet Victory to Soft Drink Advertisers

San Francisco found itself in a sticky situation after the Ninth Circuit struck down a city ordinance that would have required soda companies and other makers of sugar-sweetened beverages to place the following warning on their ads: WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from … Continue Reading

Springtime for Food Marketers? Two Big Wins in California in Recent Days

The coming of spring has been accompanied by good news for two food marketers—ConAgra and Bumble Bee Foods—in their respective court fights in California. In the Northern District of California, a federal judge dismissed a putative class action against ConAgra alleging that the marketer’s Crunch N’ Munch product violated California’s unfair competition law since it … Continue Reading

FTC, New York AG File Complaint Against Marketers of Dietary Supplement Prevagen

Have you seen an ad like this (we have, more times than we can remember): “Ever walk into a room and forget why? Spend extra time looking for your car keys or purse? Have trouble remembering names or faces?” If the answer is yes, the dietary supplement Prevagen may be just what the doctor ordered. … Continue Reading

Slack-Fill Consumer Class Action Challenge Not Enough Muscle to Survive

Last week, the Southern District of New York dismissed with prejudice a putative consumer class action alleging that containers for Muscle Milk protein powder violated New York consumer protection laws because they were approximately one-third empty at the time of purchase. More specifically, the plaintiff’s Amended Complaint contended that “Defendant CytoSport, Inc. intentionally packaged its … Continue Reading

The FTC Weighs in Further on All Natural Claims

At last year’s Kennedy Center Honors, Aretha Franklin brought down the house and brought President Obama to tears with her rendition of Natural Woman. Marketers relying on “all natural” claims also may feel like crying these days. We’ve blogged frequently about natural claims; see this recent post. Much of the misery in this area results … Continue Reading

Ninth Circuit Decides Not To Stay Natural Case, But Read the Fine Print

When courts decide to stay actions to await FDA guidance in an area, it’s only natural that our ears perk up. Which has been going on a lot, with cases such as Kane v. Chobani and Swearingen v. Santa Cruz Natural, Inc. Last week, however, the Ninth Circuit Court of Appeals, which had previously opted … Continue Reading

Class Action Labeling Claims Partially Evaporated, But What’s Left May Signal a Revival of “Evaporated Cane Juice” Claims

Earlier this year, we discussed the Ninth Circuit’s decision staying a consumer class action against Chobani challenging its listing of “evaporated cane juice” as an ingredient on its yogurt labels. According to the plaintiffs in that case, “evaporated cane juice” was simply code for sugar, and Chobani therefore allegedly misled them about the healthiness of … Continue Reading

Major Changes Coming to Nutrition Facts and Supplement Facts Labels Near You

FDA finalizes rule to revise Nutrition Facts panels for foods and Supplement Facts panels for Dietary Supplements On May 20, 2016, the U.S. Food and Drug Administration (FDA or the Agency) issued a final rule (Rule) that overhauls the design and content of nutrition labeling for foods and dietary supplements (known as the Nutrition Facts … Continue Reading

FDA Reverses Stance on Kind Snack Bar Labels and Re-Evaluates Its “Healthy” Standard

The U.S. Food and Drug Administration announced this week that Kind LLC may label its snack bars as “healthy,” sort of. In 2015, the FDA warned Kind that several of its products were misbranded as “healthy,” and that such labeling falsely claimed that the snacks were low-fat or rich in anti-oxidants, among other things. The … Continue Reading

It’s Not Nice to Fool Mother Nature: FTC Takes Aim at “All Natural” Claims

While the Food and Drug Administration (FDA) is still considering whether to issue guidance over the use of the term “natural” in food products, the Federal Trade Commission (FTC) is steamrolling ahead this week with a flurry of settlements and a complaint over deceptive use of the terms “all natural” and “100% natural” in the … Continue Reading

Ninth Circuit Stays Class Action Food Labeling Lawsuit Until the FDA Completes Review

The pitter patter of class action footsteps that food companies hear may have gotten a bit quieter, at least for now, based upon a Ninth Circuit decision in Kane v. Chobani this week.  The lawsuit centers on Chobani’s use of the terms “evaporated cane juice” and “only natural ingredients” on its yogurt labels.  According to … Continue Reading

FTC Considers Advertising of Homeopathic Drugs

On Monday, September 21st the Federal Trade Commission (“FTC”) held a workshop entitled Homeopathic Medicine & Advertising (“workshop”). The workshop consisted of three panels: one discussing the homeopathic industry parameters generally, one discussing the science of homeopathic medicine, and the last discussing the legal and regulatory issues surrounding the marketing of homeopathic medicines. … Continue Reading

FDA Warns About Celebrity Social Media

Kim Kardashian is everywhere. But there were some bumps in the road when she took to social media on behalf of the drug company Duchesnay, Inc. to promote its morning sickness drug Diclegis. On Instagram, Ms. Kardashian breathlessly told her followers “OMG. My morning sickness has been bad. My doctor prescribed me Diclegis, and I … Continue Reading

First Amendment Protects Certain Truthful, Non-Misleading Statements about Off-Label Drug Uses

The Food and Drug Administration (FDA), along with other federal authorities, has been zealous in prohibiting drug companies from making promotional statements about their drugs with respect to uses (indications) for which FDA has not granted approval. FDA’s long-held view has been that “off-label” promotion is unlawful, even if the statements are truthful and non-misleading. … Continue Reading

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
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