According to the rule, any substance that functions to alter flavor may qualify as an artificial flavor. In citric acid litigation, disputes hinge on this concept of “function”—specifically, whether the citric acid in the product actually affects its flavor and to what extent it does so. Because this is ultimately a matter of degree, it constitutes a question of fact rather than a question of law. Juries determine questions of fact. Plaintiffs’ firms capitalize on this by advancing the broadest interpretation of a complex regulation, then frame the issue as one for the jury to decide. This strategy often enables cases to survive a motion for summary judgment.
To defend a citric acid lawsuit, start with a clear reading of 21 CFR 101.22. This is the “characterizing flavor rule”. This rule tells brands when to place the statements “naturally flavored” or “artificially flavored” on the front of the package. The trigger is the characterizing flavor—the taste a shopper expects from the product name, images, or marketing. Lemon. Vanilla. Apple-cinnamon. If a label suggests that flavor, the rule applies.
How 21 CFR 101.22 Works
Essentially the rule is a disclosure requirement that is intended to tell the consumer how the product is flavored. Customers make the assumption when they see a “blueberry muffin” that it is filled with delicate and expensive blueberries. For products flavored from another source, the disclosure requirement kicks in to let the customer know not to expect blueberries. If natural flavoring substances deliver the flavor, a product must disclose “naturally flavored.” If artificial flavoring substances deliver the flavor, the product must disclose “artificially flavored.”
Placing the disclosure statement on the front of the pack gives the manufacturer safe harbor. This helps shoppers understand where the taste comes from and prevents confusion about whether real fruit, dairy, or chemical additives supply the flavor. Customers can allege they intended to buy more of a valuable thing and were substituted with something cheaper and less valuable for every instance in which the rule is violated. This is why almost all citric acid cases derive from state consumer protection laws, essentially fraud.
Where Citric Acid Fits Under 21 CFR 101.22
Here’s the direct quote from the regulation: “The term artificial flavor or artificial flavoring means any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof.”
Defend a Citric Acid Lawsuit at Trial
Although often vexatious, the strategy is undeniably clever. Once a plaintiff’s firm identifies a product likely to reach trial, the bargaining power shifts decisively against the manufacturer. At that point, in order to defend a citric acid lawsuit, the manufacturer must make a business decision: litigate through trial or settle on acceptable terms. The next article in this series outlines a practical framework for making that choice.
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