Summary
The United States District Court for the Southern District of California partially granted and partially denied defendants’ motion to dismiss claims challenging labeling of Enfagrow toddler nutritional drinks. The court dismissed fraud-based claims for failure to satisfy Federal Rule of Civil Procedure 9(b), dismissed a former-price advertising claim and the request for injunctive relief, but allowed claims based on alleged unlawful nutrient-content and fortification-policy violations to proceed. Plaintiffs were granted leave to amend by August 1, 2025.
Topics
Practice areas
Questions Presented
- Whether plaintiffs pleaded fraud-based UCL, FAL, CLRA, and common-law fraud claims with the particularity required by Federal Rule of Civil Procedure 9(b).
- Whether the challenged product-label statements plausibly constituted implied nutrient-content claims.
- Whether plaintiffs plausibly alleged that the products were intended specifically or primarily for children under two.
- Whether plaintiffs plausibly alleged that the product labels made relative or fortification claims violating 21 C.F.R. §§ 101.54(e)(1) and 104.20.
- Whether applying the FDA labeling regulations to the alleged claims violated the First Amendment.
- Whether the complaint adequately pleaded a claim under California Business and Professions Code § 17501.
- Whether plaintiffs had standing to seek injunctive relief.
Holdings
- Fraud-based claims under the UCL, FAL, and CLRA must satisfy Rule 9(b), including allegations explaining what is false or misleading about the challenged statements and why. Plaintiffs' generalized assertion that the products harmed children under two did not satisfy that requirement.
- Statements that couple the existence of listed nutrients with assertions that the nutrients support immune health, brain development, or growth plausibly constitute implied nutrient-content claims.
- Allegations that the products were marketed to toddlers and children one year and older, and were placed in grocery-store baby-food aisles near infant formula, plausibly suggested that the products were specifically or primarily intended for children under two.
- The allegation that the label stated the product had Omega-3 DHA and iron to help nourish brain development, plus prebiotics and vitamins to support immune health, plausibly alleged a fortification claim subject to the FDA fortification policy.
- The First Amendment challenge was not suitable for resolution on a Rule 12(b)(6) motion because the complaint plausibly alleged unlawful labeling and deception, and the substantiality and tailoring of the governmental interest required assessment of additional facts.
- The claim under California Business and Professions Code § 17501 was dismissed because plaintiffs conceded that the citation to section 17501 was a scrivener's error and that the intended provision was section 17500.
- Plaintiffs lacked standing to seek injunctive relief because they alleged only past purchases and did not allege facts showing a likelihood of future harm or future purchase of the products.
Key quotations
“Plaintiffs must explain how the statements would be false or misleading to a reasonable consumer, but they do not.” (Section III.B)
“Thus, the statements are all implied nutrient content claims.” (Section III.C.1)
“Because Plaintiffs fail to allege any facts that support likelihood of future harm, the Court grants the Motion to Dismiss Plaintiffs’ request for injunctive relief for lack of standing.” (Section III.E)
Factual background
Plaintiffs alleged that defendants used labels on Enfagrow PREMIUM Toddler Nutritional Drink and Enfagrow NeuroPro Toddler Nutritional Drink stating, among other things, “IMMUNE HEALTH,” “Supports BRAIN DEVELOPMENT,” and “22 NUTRIENTS to help support growth.” They alleged that these statements misled consumers into believing the products provided physical health benefits for children under two, although the products were allegedly nutritionally and developmentally harmful. Plaintiffs also alleged that the labels made nutrient-content and fortification claims that violated federal FDA regulations.
Procedural history
Plaintiffs filed a complaint asserting claims under the California Consumer Legal Remedies Act, California Unfair Competition Law, California False Advertising Law, common-law fraud, deceit or misrepresentation, and unjust enrichment. Defendants moved to dismiss. The court granted the motion in part, denied it in part, and granted leave to amend by August 1, 2025.