United States: Not An Easy Recipe – Courts Struggle With The Intersection Of FDA Food Labeling Regulations And Private Causes Of Action

Last Updated: February 10 2014
Article by Jessie F. Beeber and Sarah J. Abramson

The Federal Food, Drug, and Cosmetic Act and the Nutrition Labeling and Education Act of 1990, along with all of their corresponding regulations, create a complex and uniform system of food labeling requirements.  Neither of these statutes provides for a private right of action, but more and more consumer class action and other claims are being brought, under both federal and state law, based on alleged violations of federal food labeling regulations.

This intersection between federal food labeling regulations and private suits has forced courts to consider complicated questions of preemption and statutory interpretation as well as the proper balance of authority between the federal courts and the FDA.

Two recent opinions provide a glimpse into how the courts are currently grappling with these issues.

Rahman v. Mott's LLP, (N. D. Cal.) Order dated January 29, 2014: In this consumer class action filed in the Northern District of California, the Plaintiff argued that defendant Mott's violated state false advertising and unfair competition laws by failing to label its applesauce and apple juice products in accordance with FDA food labeling regulations.  Plaintiff alleged that labels on these products claiming "no sugar added" were false and misleading because the products in fact contained concentrated fruit juice.  In deciding Mott's motion to dismiss, the Court looked to, credited and applied the FDA's interpretation of its own rule regarding "no sugar added" claims on food labels.  At the time that rule was published, the FDA, in response to public comment, had indicated that the addition of concentrated juice to products for uniformity, and not sweetening, would not in itself preclude a "no sugar added" claim.  The Court observed that "[u]nder plaintiff's interpretation of the regulations, the term 'no sugar added' could never be used if the product contained any amount of concentrated fruit juice, but that is directly contrary to FDA's position, which allows concentrated fruit juice to be used in certain circumstances."  The Court then held that because Mott's applesauce products could fit within this FDA-recognized exception, the Plaintiff's pleading on that issue was insufficient and it dismissed Plaintiff's claims with respect to those products.  The Court did allow some claims involving Mott's apple juice products to proceed.

Koenig v. Boulder Brands, Inc., et al. (S.D.N.Y.) Opinion and Order dated January 31, 2014: In this case, the Court recently denied the Defendants' motion to dismiss a consumer class action involving Smart Balance milk.  Plaintiffs, like the plaintiff in Rahman, brought state law claims arising out of Defendants' alleged violations of FDA requirements for "fat free" labeling on products, because Smart Balance fat-free milks contained one gram of fat as a result of added omega-3 fatty acids.  The Defendants argued that because Smart Balance milk with omega-3 was a "combination product," the Court should follow FDA Compliance Policy Guides for other combination products and allow "fat free" claims for their milk.  Unlike the Rahman Court, the Court in this case rejected the FDA's guidances on the ground that they were advisory opinions that did not concern the product at hand, milk.

Thus, while the Rahman Court accepted the FDA's interpretation of its own regulation as determinative, the Koenig Court rejected the preemptive effect of an arguably applicable guidance from the Agency.  These two different conclusions might be explained by the very particular facts of each of these cases, such that a response to public comments made in the notice and comment rulemaking process, not limited in scope to one product, was found to have more relevance to the issue at hand than guidances that the Court determined were "advisory" and limited to the products they specifically addressed.

It is also worth noting that a recent development in the Ninth Circuit case, Pom Wonderful v. Coca Cola, may have significant bearing on these issues.  On January 10, 2014, the Supreme Court granted Pom's petition for a writ of certiorari on the issue of whether the Circuit Court erred in holding that a private party cannot bring a Lanham Act claim challenging a product label regulated and authorized by the Food, Drug, and Cosmetic Act.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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