Pom Wonderful v. Coca-Cola: Will the Supreme Court’s Decision Have Implications Beyond “Pomegranate Blueberry Flavored Blend of 5 Juices”?

By Kate Greenwood

Cross-Posted at Health Reform Watch

On April 21st, the Supreme Court will hear oral argument in Pom Wonderful v. The Coca-Cola Company, a case in which Pom sued Coke under Section 43(a) of the Lanham Act arguing that Coke’s product “Pomegranate Blueberry Flavored Blend of 5 Juices” was misleadingly named.  Coke countered that the suit should be dismissed because the name was specifically authorized by the Food and Drug Administration’s regulations governing flavored juice blends, and both the District Court and the Ninth Circuit Court of Appeals agreed.

In its opening brief filed last week, Pom argues that neither the provisions of the Food, Drug and Cosmetic Act governing food and beverage labeling generally, nor the regulations that specifically address juice blends, precludes the application of the Lanham Act to Coke’s misleading juice label.  This conclusion, per Pom,

“follows inexorably from this Court’s holding in Wyeth v. Levine … that FDA’s approval of a drug label does not displace state failure-to-warn suits challenging the adequacy of the warning. … Following Wyeth, there can be no serious argument that the provisions of the FDCA are in ‘irreconcilable conflict’ with the Lanham Act.  FDA does not even generally review—much less approve—particular food labels; nothing even arguably prevented Coca-Cola from designing its label to avoid misleading consumers; and FDA has given no indication that its juice-naming rules set the outer bounds of labeling regulation.” 

In its brief opposing Pom’s petition for certiorari, Coke distinguished Wyeth, noting that the provisions of the FDCA governing drug labeling do not expressly preempt state regulation.  The provisions of the FDCA governing food and beverage labels, by contrast, “expressly supplant State laws—including those that imposed more ‘stringent’ requirements[.]”  This, Coke argued, shows that the food and beverage statutory provisions and their implementing regulations “were not intended as a ‘floor’ but rather as the exclusive body of regulation to which food and beverage labels would be subject.”

In her latest article, The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, Diana Winters decries the time and money courts deciding food and beverage labeling cases must spend “negotiating the interaction between federal and state law, with inconsistent outcomes”.  A similar complaint could be made about the two federal laws at issue in Pom.  Winters argues that “[t]he federal government should get out of the business of trying to regulate the truth of [nutrient content claims and health claims],” in part because this would allow litigants and courts to move past the “confusion regarding whether or not these claims are even litigable” and “focus on the substance of food labeling.” 

Notably, Winters does not argue that the federal government should get out of the business of food and beverage labeling altogether.  Even if her proposal were adopted, courts would still need to evaluate whether cases like Pom’s—which focuses not on oftentimes complex nutrient content or health claims but rather on relatively straightforward pomegranate and blueberry juice content claims—can proceed.  The Supreme Court’s decision in Pom has the potential to clear up lingering confusion about the overlap of the FDCA and the Lanham Act, reducing inconsistencies and, depending on which way the Court comes out, enabling lower courts to “focus on the substance.”

 As the debate between Pom and Coke over Wyeth v. Levine suggests, the Supreme Court’s decision may have implications beyond juice.  In a recent post at the FDA Law Blog, James Ellison makes note of the Generic Pharmaceutical Association’s amicus brief in which it exhorts the Court to “be cognizant of the differences” in the regulation of foods and beverages, on the one hand, and drugs and devices, on the other.  Should the Court permit Pom’s claim to proceed, the GPhA writes, it should be “precise” in its decision about “which portion of the FDCA, and what aspects of that portion inform the preclusion analysis.”  

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