American Journal of Law & Medicine

Inappropriate Referral: The Use of Primary Jurisdiction in Food-Labeling Litigation


Food system regulation must negotiate intensely individual and hyper-local preferences with the national and collective implications of food production and consumption. The regulatory scheme permits the coincidence of multiple sets of regulators, and there is an active interchange between federal and state authorities. This kind of "dynamic" or "polyphonic" federalism entails "the interaction of multiple independent voices" and "the dynamic interaction among states and the national government." (1)

The productive interaction among multiple sets of regulators is brought into sharp focus in the area of food labeling. The Food and Drug Administration (FDA) regulates food labeling in the United States under a comprehensive federal regulatory scheme that leaves room for the continued vitality of state law requirements. (2) For example, even the express preemption provision written into the Nutrition Labeling and Education Act of 1990 (NLEA) is narrowly drawn. (3)

The coexistence of state law requirements in food labeling and federal regulation may have uniformity and efficiency costs. Think, for example, of the concern that various state labeling requirements for genetically engineered ingredients will result in a patchwork of regulation, or the concern that state law litigation about food labels will result in conflicting rulings on what is acceptable. These costs, however, are outweighed by the benefits of this dynamic and multivalent regulatory system, and thus Congress and the courts should resist the further federalization of food labeling regulation. (4)

Having multiple sets of regulators, however, leads invariably to some difficulty in determining the ultimate authority in the context of challenges to food regulation. We see this struggle in legal challenges to food labels, which have increased greatly in the last few years. (5) Courts presented with state law claims about food labeling issues have to figure out if the claim is preempted, either expressly or impliedly, and if not, whether the claim is one better left to agency determination. (6) Advocates defending against food labeling challenges have used the doctrine of primary jurisdiction, which provides a mechanism for courts to delay resolving a case while an agency decides an issue that the court has determined is more appropriately within the agency's competence, and has been increasingly accepted by courts in this context. (7)

Certain commentators have suggested that the use of this doctrine may lead to increased and beneficial dialogue between agencies and courts. (8) In this Article, I argue that this is not the case. The ill-defined doctrine of primary jurisdiction has already led to inconsistent outcomes in food labeling cases. (9) Use of the doctrine will also delay any determination of these issues. Furthermore, referring these cases to FDA thwarts the will of Congress, which preserved a dual regulatory system, and interferes with agency decision-making.

In Part II, I sketch the outline of the food-labeling regulatory scheme. I focus here on the general parameters of authority and a light history of the maintenance of dual regulatory authority. In Part III, I discuss the recent increase in food labeling litigation, centered in the Northern District of California, and the adjudication of threshold doctrines, including preemption, primary jurisdiction, standing, and class certification in this context. Next, in Part IV, I describe the doctrine of primary jurisdiction and its use in food litigation, and in Part V, I explain why this doctrine is being misused, as a matter of both law and policy. (10)


FDA regulates food labels under the Food, Drug, and Cosmetic Act (FDCA). (11) The FDCA defines "labels" as "display[s] of written, printed, or graphic matter upon the immediate container of any article," (12) and "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." (13) When it was passed in 1938, the FDCA "[wa]s a catalogue of definitions elaborating two basic concepts: 'adulteration' and 'misbranding,'" (14) which served to protect the consumer and to maintain a fair marketplace. (15)

Section 403 of the FDCA prohibits the "misbranding" of food and includes a list of labeling practices that constitute misbranding. (16) For example,

[a] food shall be deemed to be misbranded--(a) ... If ... its labeling is false or misleading in any particular ... (b) ... If it is offered for sale under the name of another food, (c) ... If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated. (17)

In 1990, Congress amended the FDCA with the Nutrition Labeling and Education Act (NLEA), and added two [provisions] ... to Section 403, (q) and (r). (18) Section (q) is straightforward and adds specific labeling requirements for foods. (19) It requires foods intended for human consumption to be labeled with a serving size, the number of servings in a container, the total calories in each serving size, the calories derived from fat in each serving size, and the "[t]otal fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size." (20) This provision led to the creation of the nutrition facts box--the highly recognizable chart on the labels of packaged foods. (21)

Section (r) is a bit more complicated and creates standards and requirements for nutrient content claims and health claims. (22) Nutrient content claims and health claims are involved in much of the food-labeling litigation discussed below. (23) discuss this and the NLEA's express preemption clause as background to my discussion of food labeling litigation, and follow that with a section on two specific hot-button labeling issues: the labeling of genetically engineered foods (GEs) (24) and of food termed "all-natural." (25)


One of the main impetuses behind the passage of the NLEA was a perceived need to regulate the landscape of nutrient content claims and health claims being made by food manufacturers about their products. (26) A nutrient content claim is a claim that "expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling," (27) for example, "low in sodium." (28) A "[h]ealth claim means any claim made on the label or in labeling of a food ... that expressly or by implication, including 'third party' references, written statements (e.g., a brand name including a term such as 'heart'), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition." (29) Health claims include statements like "heart healthy." (30)

FDA regulations prescribe how manufacturers can characterize the nutrient content of foods, including the use of the terms, "light," "good source," "high," "more," and "high potency," and the characterization of calorie, sodium, fat, and cholesterol content in foods. (31)

As to health claims, FDA currently allows two types: health claims for which it has promulgated specific regulations and "qualified health claims." (32) To promulgate a regulation authorizing a health claim, FDA must determine that "there is significant scientific agreement, among experts able by scientific training and experience to evaluate such claims, that the claim is supported by such evidence." (33) In 1999, however, as a result of a D.C. Circuit decision, FDA also began to allow "qualified health claims" for claims that do not meet the significant scientific agreement standard. (34) A disclaimer statement to explain the level of scientific evidence that supports the claim must accompany these claims. (35) As of 2011, FDA had authorized twelve health claims based on significant scientific agreement and had issued sixteen letters allowing various qualified health claims. (36)


The NLEA increased the transparency of nutritional information and created a regulatory regime intended to rationalize the use of health and nutrient content claims by food manufacturers. (37) The NLEA also contains an express preemption provision designed to prevent state law intrusion into these areas and to foster uniformity in food labeling, the inclusion of which helped to gamer support of the food industry for the NLEA. (38) There are two reasons why an express preemption provision was important to food manufacturers. (39) First, the FDCA does not contain a sweeping preemption provision that applies to food, drugs, and cosmetics. (40) Specific areas, like medical devices and radiation emissions are covered by discrete preemption clauses. (41) An express preemption clause in the NLEA was important to ensure the preemption of state law on matters of food labeling. (42)

Second, the FDCA provides no private right of action. (43) Private parties cannot sue alleged violators of the FDCA. An express preemption provision, which eliminates some suits under state law, provides a measure of insulation for manufacturers. (44) The NLEA's express preemption provision prohibits the establishment of any state or local requirements that are not identical to the NLEA's provisions regarding label requirements and the listing of product ingredients. (45) It also prohibits state and local requirements that are not identical to the NLEA's on nutrient content and health claims. (46) The provision does not prohibit the establishment of state and local requirements that are identical to those in the NLEA. (47) Courts have rejected allegations that actions brought under state law with requirements identical to those of the FDCA are attempts to circumvent the FDCA's prohibition on private actions. (48)

The applicability of the express preemption provision and the identicality of the state law requirements are issues when the challenge fits squarely within the parameters of the NLEA. …

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