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Wolters Kluwer Lecture Series: FDA Food Labeling Litigation

On April 15, 2014, Anthony Nguyen and Danielle Capilla spoke to students and attorneys on the Food and Drug Administration’s recently proposed changes to its food label regulations, and the lawsuits that they precipitated from. The speakers gave a brief background on the FDA’s labeling procedures, the proposed revisions to its labeling regulations, an overview of Pom Wonderful LLC v the Coca Cola Company, 679 F.3d 1170 (9th Cir. 2012) currently pending in the Supreme Court at the time, and the consumer-protecting “food courts” of the Ninth Circuit Court of Appeals.

The FDA has jurisdiction over practically every type of food product, whether they are designed to be eaten directly from the packaging or are components in cooking other foods. [1] The only food-type items that the FDA does not regulate are those covered by the United States Department of Agriculture, such as meat, poultry, and processed egg products. [2] The FDA currently requires that the food labels on the packaging of consumer food items display certain information such as serving size, caloric content, ingredients, and the daily nutritional value. [3] The problem with the current labeling regulations is that some of the standards regulating how this information may be defined and quantified are vague and open-ended; this allows products to display misleading information while still being in compliance with the FDA.

The alleged misleading information can come in the form of ingredients displayed in “friendlier terms,” such as sugar being labeled as “evaporated cane juice” or the liberalized use of “organic,” and “no sugar added” on packaging. Although the Fair Packaging and Labeling Act prohibits false or misleading labels on the containers or wrappers of consumer food products, it grants certain exceptions for “health” and “organics” claims, such as equating whole grains with heart health, or “origin claims” such as “Idaho” potatoes, or hotdogs being “products of the U.S.A.” when some of the meats could have come from overseas.

The FDA’s proposed changes to its labeling regulations seek to emphasize certain nutritional aspects of foods such as the total calories, added sugars, and certain nutrients. [4] The FDA also proposed revisions to its serving size standards, in an attempt to make them more applicable to how consumers actually eat or drink by calculating the total nutrition facts of larger, multi-serving containers. [5] The FDA also plans to remove the “calories from fat” section because studies found that consumers were more conscious of the type of fat rather than the total fat content. [6] The new regulations also require labels to display “added sugars” as well as certain vitamins and minerals like Vitamin D and potassium. [7] Calcium and iron will still be required, but the proposed regulations downgrade Vitamin A and C to being “permitted” on labels, rather than required. [8] The most noticeable proposed revision concerns how the information is displayed: the word “calories” as well as the numerical value will be enlarged and will be displayed as the total amount in the container, as well as calories per serving; the “%DV” will be moved to the left side of the label to better highlight information; and the footnote information regarding the daily caloric denominator for the percentage of daily nutrition value will be removed. [9]

The Northern District Court of California is commonly referred to as the California “Food Court” due to its tendency to take FDA related cases when other courts will not. [10] Several cases are currently in the Ninth Circuit that turn on some of the issues the FDA hopes to resolve through its proposed changes. [11] The Supreme Court is currently reviewing the Ninth Circuit’s ruling in Pom, 679 F.3d 1170, which held that Pom, a maker of pomegranate juice products, could not challenge Coca Cola’s labeling because the FDA has exclusive authority to regulate food labels. [12] Pom alleged that the label on Coca Cola’s “pomegranate and blueberry” juice blend was deceptive because the words “pomegranate and blueberry” were much larger than “apple and grape” and the pictures showed the fruits in equal proportions, even though it was actually 99.4% apple and grape juice. [13] Pom sued under the Lanham Act, which allows private lawsuits for unfair competition based on deceptive labeling or marketing, but the Ninth Circuit held that the action was precluded under the FDA’s exclusive authority to regulate food labeling. [14] Though the FDA’s authority precludes most private claims, suits can be brought in state court if the state has laws allowing such claims. [15] California has created legislation mirroring the FDA so its citizens may bring lawsuits in their state courts.

Though most courts have followed the Ninth Circuit by categorically denying labeling claims as being precluded by the FDA’s authority, some courts have allowed such claims but set future trial dates very far in advance, allowing time for the Supreme Court to make a decision in Pom or for the FDA to enact its new regulations. [16]

The speakers at the lecture series, Danielle Capilla and Anthony Nguyen, are senior writer analysts in the Health law division of Wolters Kluwer Law & Business, a leading global provider of intelligent solutions for legal and business professionals.  They are based in Riverwoods, Illinois.

Editor's Note (August 2014): Since the presentation, the Supreme Court of the United States has issued its opinion in Pom Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014). The Court reversed the Ninth Circuit’s denial of Pom’s claim under the Lanham Act. The Supreme Court held that the Ninth Circuit erred in stating that the FDA’s authority to regulate and enforce labeling procedures precluded the private party Lanham Act claim. The Supreme Court of the United States opined that the structures of the Lanham Act and Federal Food, Drug, and Cosmetic Act (FDCA) were complimentary, and found no indications that Congress intended the FDCA to preclude other private claims.



[1] Anthony H. Nguyen, Food Developments for First Quarter of 2014 Reflect Concerns About Label Content and Health Claims, Wolters Kluwer (Apr. 2, 2014).

[2] Id.

[3] Id.

[4] Id.

[5] Id. at 2.

[6] Id.

[7] Id.

[8] Id. at 3.

[9] Id.

[10] Id. at 4.

[11] Id.

[12] Id.

[13] Id.

[14] Id.

[15] Id. at 5.

[16] Id. at 6.