The U.S. Food and Drug Administration (FDA) recently issued its final guidance on the definition and labeling of medical foods, entitled "Frequently Asked Questions About Medical Foods:...10 June 2016
Ninth Circuit Suggests Flexibility in Type Size for Food Statements of Identity
The issue involved the statement of identity for Coca-Cola’s Pomegranate Blueberry Minute Maid drink, “Pomegranate and Blueberry Flavored in a Blend of 5 Juices.” POM argued all words in the statement of identity needed to be of uniform size and objected to the printing of Pomegranate Blueberry in larger type than the rest of the statement, “flavored in a blend of five juices.” The court noted the statutory and regulatory requirements and said that if FDA wanted to require all words in the statement of identity to be of the same type, the agency could have done so.
This Ninth Circuit opinion provides an instance of a court recognizing that the law requires the information in a statement of identity must be presented in a way that renders it likely to be read and understood, citing section 403(f) of the Federal Food, Drug and Cosmetic Act (FFDCA). The court also recognized that if FDA wanted to mandate the use of a certain type size, the agency could do so (presumably by regulation). FDA takes the position that statements of identity typically should be at least one-half the type size of the largest words on the label. The Ninth Circuit’s decision suggests a more flexible standard may be appropriate under current laws and regulations. While we would not expect this decision to alter FDA’s position, the decision provides another argument supporting a company’s decision to justify a statement of identity that deviates from the FDA policy.
It is encouraging to see the courts recognize the reach of the express preemption provision. Here the preemption argument was fairly straightforward. Coca-Cola labeled the product as a Pomegranate and Blueberry Flavored Blend of 5 juices, consistent with the FDA regulation that specifically addresses the common or usual name that must be used when the named fruit is not the predominant fruit. POM argued that Coca-Cola’s naming and labeling of its Minute Maid “Pomegranate Blueberry” drink was false and deceptive advertising under the Lanham Act given the minor amounts of pomegranate and blueberry juice in the product. The court of appeals held that the FFDCA bars POM’s Lanham Act claim, referring repeatedly to the deference a court owes “to the FDA’s considered judgments,” its “extensive” and “careful” regulation of juice labeling, and its decision not to take action against Coca-Cola. This case should send a clear signal to the class action bar of the difficulties in bringing actions involving provisions that are expressly preempted.