Background
Jason and Abigail Franco filed a class-action lawsuit against Chobani, LLC, alleging deceptive marketing. The suit centered on Chobani’s “Zero Sugar” yogurt, which contains four grams per serving of allulose, a naturally occurring sweetener. Federal regulations require products labeled “sugar free” to contain less than 0.5 grams of “sugars.” The core of the dispute was whether allulose qualifies as a “sugar” under the FDA’s definition, which states “Total sugars” are “the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose).”
Chobani argued the Francos’ state-law consumer protection claims were preempted by the federal Food, Drug, and Cosmetic Act (FDCA). Chobani pointed to FDA guidance from 2020 (the “Allulose Guidance”) stating the agency would exercise “enforcement discretion” for manufacturers who excluded allulose from the “Total Sugars” count on nutrition labels. The district court agreed with Chobani, deferring to the FDA’s guidance and finding the lawsuit was preempted. It dismissed the case for failure to state a claim.
The Court’s Holding
The Seventh Circuit reversed the district court’s dismissal. The appellate court held that the FDA’s regulation defining “Total Sugars” is unambiguous. Since allulose is a monosaccharide, it falls squarely within the regulation’s definition of a sugar. The court found that the parenthetical list “(such as glucose, fructose, lactose, and sucrose)” provides non-exhaustive examples and does not limit the definition to only those sugars with certain physiological characteristics.
The court found the district court erred by deferring to the FDA’s Allulose Guidance. It reasoned that deference was inappropriate because the regulation itself was not ambiguous. Furthermore, the guidance was merely an announcement of enforcement policy, not a formal interpretation of the regulation’s meaning, and did not immunize Chobani from state-law claims. The court was persuaded by an amicus brief filed by the FDA itself, which argued that allulose is unambiguously a sugar under the plain text of the regulation. Because the Francos’ state-law claims sought to enforce standards identical to the federal requirements, they were not preempted by the FDCA.
Finally, the court held that the Francos had plausibly alleged consumer deception. It found that a reasonable consumer could be misled by a “sugar free” claim on a product that contains four grams of a substance legally defined as a sugar. The question of how consumers actually interpret the label was deemed a matter of fact to be resolved later in the litigation, not on a motion to dismiss.
Key Takeaways
- Under the plain text of current FDA regulations (21 C.F.R. § 101.9(c)(6)(ii)), allulose is legally defined as a “sugar” for food labeling purposes because it is a monosaccharide.
- Informal agency guidance announcing “enforcement discretion” does not alter the legal meaning of a regulation and may not shield companies from private consumer protection lawsuits based on state law.
- State-law consumer protection claims are not preempted by the FDCA if they seek to enforce requirements that are identical to those imposed by federal law.
- A product label making an absolute claim like “sugar free” can be plausibly misleading to consumers if the product contains an ingredient that, while a low-calorie sweetener, is chemically and legally defined as a sugar.
Why It Matters
This ruling clarifies that the chemical definition of “sugar” in federal food labeling regulations is what governs, not necessarily a substance’s metabolic effects or caloric content. It puts food manufacturers on notice that they cannot rely on informal agency non-enforcement policies as a shield against private litigation. Even if the FDA chooses not to pursue action against a particular labeling practice, manufacturers may still face liability under state consumer protection laws if their labels violate the plain text of federal regulations.
The decision reinforces the power of private lawsuits to enforce food labeling standards and underscores the distinction between an agency’s enforcement priorities and the binding legal requirements of its regulations. For companies using novel ingredients like allulose, this case highlights the risk of making absolute marketing claims like “sugar free” before regulations are formally amended to account for the unique properties of these substances.