Is prominently labeling a juice “Pomegranate Blueberry” when it actually contains less than 1% pomegranate blueberry juice actionable false advertising under the federal Lanham Act or is that claim barred by the Federal Food, Drug, and Cosmetic Act (“FDCA”)? The Supreme Court has granted certiorari in Pom Wonderful, LLC v. Coca-Cola Corp. to answer this question.
The case involves Coca-Cola’s Minute Maid “Pomegranate Blueberry” juice. Despite its label, Coca-Cola’s beverage is 99.4% apple and grape juice. Pom Wonderful makes a juice that contains only pomegranate and blueberry juice. Concerned it was losing sales to Coca-Cola, Pom Wonderful sued Coca-Cola for false advertising under the federal Lanham Act. Both the federal district court and the Ninth Circuit Court of Appeals rejected Pom Wonderful’s claim, finding Coca-Cola’s labeling acceptable under the FDCA.
Now Pom Wonderful’s false advertising claim lives to see another day. The Supreme Court’s decision will be of great interest to the food and beverage industry. It should be carefully watched by all industries regulated under the FDCA.
The Dietary and Nutritional Supplements Industry
As I wrote last month, dietary supplement manufacturers will want to keep tabs on Pom Wonderful’s fate. If the Supreme Court reverses the Ninth Circuit, supplement companies could see more Lanham Act lawsuits. False advertising plaintiffs may be especially interested in airing these claims given recent negative publicity for the supplements industry stemming from research published in the journal Annals of Internal Medicine.
Pom Wonderful’s appeal should matter to drug manufacturers, particularly companies that shoulder the expense of bringing a drug to market through the FDA approval process. Many times these manufacturers and their approved products face competition from drug products that have never been approved by the FDA. Many courts, including the Fourth Circuit Court of Appeals, see, e.g., Mylan Laboratories v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993), have turned back attempts by pharmaceutical companies to use the Lanham Act to mitigate the impact of such unapproved drugs. The Supreme Court’s decision should shed light on the viability of these claims.
Medical Device Industry
Advertisements about “FDA approved” medical devices are legion. Many of those advertisements are inaccurate. The reason is that most medical devices are on the market through the 510(k) clearance process. This means the device manufacturer has shown that its device is “substantially equivalent” to another legally marketed device. A medical device has been “approved” by FDA when the agency approves a manufacturer’s (expensive) premarket approval application (“PMA”). If a device is on the market through a PMA that means the FDA has found the device safe and effective for its intended use.
Medical device manufacturers who have invested resources in the PMA process might be interested in using the Lanham Act to prevent manufacturers of 510(k) devices from using “FDA approved” to market their 510(k) device. For reasons similar to the ones the Ninth Circuit gave in Pom, those claims have failed in the past. Cf. PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010). The Supreme Court may breathe new life into these claims.