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Volume XI, Number 268

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Malic Acid Flavoring Case Allowed to Proceed Sans Injunctive Relief

  • Malic acid is a compound that is used as a food ingredient in a variety of ways, including as a flavor enhancer, flavoring agent and adjuvant, and as a pH control agent. See 21 CFR 184.1069 (“Malic acid”). L-malic acid occurs naturally in some foods, including many fruits. In contrast, DL-malic acid is commercially manufactured and considered by some to be artificial.  Plaintiffs have frequent targeted the use of DL-malic acid in foods that are advertised as naturally flavored and free of artificial flavors. They have argued that DL-malic acid is artificial and imparts flavor to the food, and therefore that food products which contain DL-malic must be labeled as artificially flavored. In contrast, Defendants have generally argued they are not using DL-malic acid as a flavoring agent, and therefore it is not misleading to label their products as naturally flavored and/or free of artificial flavors.

  • Following this pattern, in Hayes v. General Mills, CA No. 19-cv-05626, Plaintiff had brought a proposed class action against General Mills alleging that the company had falsely and intentionally mislead consumers with claims that various fruit flavored snacks (sold under the brands names “Fruit by the Foot,” “Gushers,” and “Fruit Roll-ups”) were free of artificial flavors when they in fact contained DL-malic acid which contributed to the flavor of the products. General Mills had moved to dismiss the complaint on the grounds that DL-malic acid was not used as a flavor and therefore that the flavor statement was not deceptive. Specifically, the company argued that they use DL-malic acid in the food snack products as a flavor enhancer and not a flavor, and thus the products cannot be artificially flavored by DL-malic acid. While a “flavor” imparts flavor, a “flavor enhancer” is added “to supplement, enhance, or modify the original taste and/or aroma of a food, without imparting a characteristic taste or aroma of its own.” See 21 CFR 101.22 (a)(1) (defining “ artificial flavor”) and  21 CFR 170.3(o)(11) (defining “flavor enhancer”). In other words, both parties agreed that DL-malic acid impacts the taste, but they disagreed as to whether the change in taste constituted a flavor.

  • The Court held that the distinction between a “flavor” and a “flavor enhancer” was a factual dispute that could not be resolved on a motion to dismiss, and thus allowed Plaintiff’s deceptive advertising claims to proceed. However, the Court denied Plaintiff’s request for injunctive relief because there was no immediate threat of future violation of Plaintiff’s rights. While Plaintiff may have been deceived into purchasing the product at issue, there was no such present risk where Plaintiff was aware of the alleged deception and was suing the company for it. The Court also rejected the argument that there was imminent harm to other unaware consumers and held that Plaintiff could not rely on prospective harm to other consumers to demonstrate that injunctive relief was appropriate.

  • The case demonstrates the difficulty of making natural flavor or free of artificial flavoring claims with products containing DL-malic acid and/or other ingredients that may serve multiple functions, including as flavoring agents (citric acid is another ingredient that is frequently invoked in flavor litigation). Even if a defendant ultimately prevails, it may find it difficult to avoid much of the cost of litigation since the pivotal question on the role of a substance in a food (i.e., flavoring agent or not) are factual and cannot be determined at the motion to dismiss stage.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 215
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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