Howard v. Hain Celestial Group, Inc.

Background

Hain Celestial sells infant and toddler food under the Earth’s Best brand. Its labels include quantitative nutrient statements, such as “4g PROTEIN per serving,” and qualitative statements, such as “Excellent Source of Calcium, Vitamins C & D.” The plaintiffs allege that these statements violate a Food and Drug Administration regulation generally prohibiting nutrient-content claims on food intended specifically for infants and children under two.

The plaintiffs do not directly enforce the FDA regulations because the relevant federal law provides no private right of action for doing so. Instead, they bring state-law claims. The Nutrition Labeling and Education Act preempts, or bars, state-law requirements that are not identical to federal requirements. The parties therefore disputed whether the FDA regulations allow the “excellent source” statements. If they did, the plaintiffs’ claims would be preempted; if they did not, the claims could proceed.

In an earlier ruling, the court held that it was plausible to assume from the complaint that the products were intended for children under two, but dismissed claims based on the “excellent source” statements. The plaintiffs filed an amended complaint. They alleged that several products did not satisfy the FDA’s standards for an “excellent source” and asked the court to reconsider its earlier conclusion that such statements were permitted at all. Hain Celestial again moved to dismiss. The court also granted Hain Celestial’s request for judicial notice of the product packaging and specified website pages.

Legal analysis

The FDA regulations prohibit most nutrient-content claims on food intended specifically for infants and children under two. They create an exception for statements that describe the percentage of a vitamin or mineral in relation to the applicable reference daily intake—the amount the FDA recommends for daily consumption of that vitamin or mineral.

The court concluded that “excellent source” statements do not fall within that exception. It distinguished statements that “characterize” a nutrient level from statements that “describe” the percentage of a vitamin or mineral. In the court’s view, the exception covers an explicitly quantitative statement such as “28% of the reference daily intake for vitamin C.” A qualitative statement such as “excellent source of vitamin C” does not explicitly state a percentage, even though FDA regulations define “excellent source” as a food containing at least 20 percent of the relevant reference daily intake.

The court relied on the statutory distinction between “characterize” and “describe,” the structure of the Nutrition Labeling and Education Act, the different regulatory treatment of quantitative and qualitative statements, the history of the FDA’s regulations, and FDA warning letters stating that “excellent source” statements are not allowed on products specifically intended for infants and children under two.

Disposition

The court held that the plaintiffs plausibly alleged that Hain Celestial’s “excellent source” statements violate the FDA’s regulations. Because the statements were not authorized by the FDA regulation, the court held that the plaintiffs’ state-law claims were not preempted at the pleading stage. The court denied Hain Celestial’s motion to dismiss.

The court did not reach whether Hain Celestial’s products satisfied the FDA’s requirements for what constitutes an “excellent source,” because it concluded that the statements were not authorized for the relevant products in the first place. The ruling addressed the sufficiency of the amended complaint and did not finally determine liability.