Singo v. Ricola USA, Inc.

Background

Lonise Singo filed a proposed class action against Ricola USA, Inc. concerning Ricola’s over-the-counter throat drops labeled “Green Tea with Echinacea” and “Cough Suppressant — Throat Drops.” The product’s Drug Facts listed 4.1 milligrams of menthol as the active ingredient for cough suppression and oral anesthesia. Green tea and echinacea were listed as inactive ingredients.

Singo alleged that the product’s name, prominent echinacea image, and other label features would lead reasonable consumers to believe that green tea and echinacea provided the product’s therapeutic benefits. She also alleged that the label should identify menthol on the front of the package, using wording such as “Menthol Lozenge – Cough Suppressant – 4.1 mg.”

Singo originally asserted New York consumer-protection claims under New York General Business Law §§ 349 and 350, claims under consumer-fraud laws of several other states, express- and implied-warranty claims, a claim under the Magnuson-Moss Warranty Act, and unjust enrichment. She withdrew the implied-warranty, Magnuson-Moss, and unjust-enrichment claims, as well as the claims for the proposed multistate consumer-fraud class. The remaining claims were the New York General Business Law claims and a breach-of-express-warranty claim for the proposed New York class.

Defendant’s Arguments

Ricola moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which permits dismissal when a complaint does not plausibly state a legal claim. Ricola argued that the remaining state-law claims were expressly preempted—meaning federal law barred the state from imposing the proposed labeling requirement—under the Food, Drug, and Cosmetic Act (FDCA). Ricola alternatively argued that its packaging was not misleading to a reasonable consumer.

Singo responded that she was not challenging the use of “cough suppressant” or “oral anesthetic.” She argued instead that Ricola failed to follow Food and Drug Administration recommendations concerning the placement of the active ingredient’s strength and that she sought to prevent misleading representations about which ingredient supplied the product’s therapeutic benefits.

Court’s Analysis

The court explained that the FDCA contains an express-preemption provision for certain over-the-counter drugs. That provision bars states from imposing labeling requirements that differ from, add to, or are not identical to federal requirements. A state-law rule requiring a manufacturer to label or package a product in a particular way can qualify as a labeling requirement.

The court concluded that Singo’s claims were based on her contention that the product’s front label misleadingly suggested that echinacea and green tea, rather than menthol, provided the product’s therapeutic effects. The court found that the requested relief would require Ricola to place menthol on the front of the package. Because Ricola complied with the federal labeling requirements identified by the court, requiring that additional front-label disclosure would impose a requirement beyond the FDCA. The court therefore held that Singo’s New York consumer-protection and express-warranty claims were preempted.

The court also found that Singo’s separate allegation concerning a “soothing relief” representation was conclusory and insufficient to preserve her claims. Because it dismissed the claims as preempted, the court did not reach Ricola’s alternative argument that no reasonable consumer would be misled.

Disposition

Judge Roman granted Ricola’s motion to dismiss. Singo’s claims were dismissed without prejudice, and the court granted her leave to file an amended complaint by February 16, 2024. The court stated that an amended complaint would replace, rather than supplement, the original complaint. It further stated that failure to amend on time would cause the claims previously dismissed without prejudice to be deemed dismissed with prejudice. The clerk was directed to terminate Ricola’s motion.