On March 10, 2023, the U.S. District Court for the Southern District of New York dismissed (Law360 subscription required) an amended complaint which alleged that Wegmans’s vanilla cake mix product was falsely and misleadingly labeled as “naturally flavored” and free of artificial flavors.

Per 21 CFR 101.22(i) a product that presents itself as having the characterizing flavor of vanilla may be labeled as “naturally flavored” if it contains natural flavor derived from vanilla bean (the “characterizing ingredient”) and no artificial flavors.

The complaint alleges that the product contains artificial ethyl vanillin, and thus that the representations regarding flavoring are incorrect. Plaintiffs support their assertions by citing to a laboratory analysis which purportedly shows the presence of 3.07 part per billion (ppb) of ethyl vanillin.

The Court held that the viability of Plaintiffs’ claims depended on their ability to plausibility substantiate the claims that ethyl vanillin is present in the product and that ethyl vanillin is an artificial flavor. The Court held that Plaintiffs failed to substantiate either claim, but it focused on the deficiencies regarding the former. Specifically, the Court held that the pleadings failed to substantiate the presence of ethyl vanillin because no information was included regarding “testing methodology, the date, time, or place of the testing, who conducted the testing, and what the exact product tested was.”

The motion to dismiss was granted with prejudice (without leave to amend) because the Court had already put Plaintiffs on notice of the deficiencies in the complaint and given them an opportunity to correct the deficiencies.