See 21 C.F.R. § 101.22(i) (regulating "representations with respect to the primary recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, or other means" (emphasis added)). Given that the FDA regulations on flavors permit primary recognizable flavors to be identified by "word, vignette, . . . or other means" and specify that the "common or usual name of the characterizing flavor" shall accompany the name of a food where that flavoring product is the source of the flavor, see id., the Court concludes that, where honey is a flavor as well as a sweetener, Plaintiffs have not plausibly alleged that Post's use of the word "honey" and the images of a sun, bee, and honey dipper is "false or misleading in any particular" within the meaning of 21 U.S.C. § 343(a), contra Red v. Kraft Foods, Inc., 754 F. Supp. 2d 1137, 1143 (C.D. Cal. 2010) (declining to construe use of word honey and a prominent image of flowing honey "as mere representations of 'characterizing flavor'"). Although the Amended Complaint asserts that "[t]he branding and packaging of 'Honey Bunches of Oats' cereals is not accurate or justifiable on the basis that honey is the primary or characterizing flavor," Am. Compl. ¶ 32, that mixed assertion of law and fact incorrectly presumes that a food can have only one primary recognizable flavor and does not explicitly contend that the cereal does not taste like honey.
Reading additional requirements into § 101.54 would violate the express preemption provision of the FDCA. See Red v. Kraft Foods, Inc., 754 F. Supp. 2d 1137, 1144 (C.D. Cal. 2010). The label at issue fulfills each of the labeling requirements for antioxidant claims.
Defendants' use of “healthy” is not an implied nutrient claim and is not expressly preempted. See Red v. Kraft Foods, Inc., 754 F.Supp.2d 1137, 1142 (C.D. Cal. 2010) (recognizing that if claims “are not implied nutrient claims within the regulatory meaning . . . then there would be no obvious argument for express preemption.”).
In short, it is plausible from the allegations in the Complaint that the "made with real honey" representation is a representation solely about the ingredients in the Product, and not about the Product's flavor. See Hoffmann v. Kashi Sales, L.L.C., 646 F.Supp.3d 550, 559-60 (S.D.N.Y. 2022) ("Defendant's use of the words 'Made with' presents honey as an ingredient, not a flavor."); Red v. Kraft Foods, Inc., 754 F. Supp. 2d 1137, 1143 (C.D. Cal. 2010) ("[T]the phrase 'Made With Real Vegetables' appears to refer to the products' supposed constituent ingredients and not to flavor."); cf. Warren v. Stop & Shop Supermarket, LLC, 592 F. Supp. 3d 268, 279 (S.D.N.Y. 2022) (concluding that "the label's use of the word 'honey' by itself"—and because "the Product's label does not use language such as [inter alia] 'made with' "—"merely represents that the Product is honey flavored, not that honey is an ingredient—much less, the predominant sweetening ingredient"). By prohibiting Defendant from marketing the Product as "made with real honey," New York would not be prohibiting Defendant from using a label that federal law demands or imposing a requirement inconsistent with federal requirements.
See Ivie v. Kraft Foods Global, Inc., No. 12-cv-2554 RMW, 2013 WL 685372, at *10 (N.D. Cal. Feb. 25, 2013) ("[T]he factual determinations of whether [the ingredients are] used as a sweetener and/or . . . a flavoring agent in this particular product, and whether a reasonable consumer would have thus been misled by the 'no artificial sweeteners or preservatives' label, are inappropriate for determination on a motion to dismiss."); Engurasoff v. Coca-Cola Co., No. C 13-03990 JSW, 2014 WL 4145409, at *3-4 (N.D. Cal. Aug. 21, 2014) (court "cannot make a factual determination upon a motion to dismiss as to whether phosphoric acid qualifies as an artificial flavor"); Gitson v. Trader Joe's Co., No. 13-CV-01333-WHO, 2014 WL 1048640, at *4 (N.D. Cal. Mar. 14, 2014) ("[W]hether sodium citrate, citric acid, and tocopherol function as artificial flavors, chemical preservatives, or both, is inappropriate to determine at this stage of the litigation.").Red v. Kraft Foods, Inc., 754 F. Supp. 2d 1137 (C.D. Cal. 2010) is in accord. There, consumers alleged that the labeling of "Honey Maid Graham Crackers" caused them to believe the product was sweetened primarily with honey, when in fact, its predominant sweeteners were sugar and high fructose corn syrup.
See id. at 538 ("Where federal requirements address the subject matter that is being challenged through state law claims, such state law claims are preempted to the extent they do not impose identical requirements.").Red v. Kraft Foods, Inc., 754 F. Supp. 2d 1137, 1141 (C.D. Cal. 2010), distinguished PepsiCo. There, the court held that claims concerning statements that a product was "healthy" were "premised on misrepresentations concerning subject matter that the FDA has not endeavored to regulate," and thus were not preempted.
Therefore, read in context, the allegations do not implicate the NLEA preemption provisions regarding nutrient content. See, e.g., Red v. Kraft Foods, Inc., 754 F.Supp.2d 1137, 1142 (C.D. Cal. 2010) (finding that state law claims regarding the use of the phrases "made with real vegetables" and "made with real ginger and molasses" on defendants' packages were not covered by the NLEA preemption provisions because they did not suggest that a specific nutrient was absent or present in certain amounts); In re 5-hour Energy Marketing and Sales Practices Litigation, 2014 WL 5311272, *13-14 (C.D. Cal. 2014) (claims based upon defendants' alleged "false and misleading" "attempts to attribute 5-hour ENERGY's effects to B-vitamins and amino acids" were not covered by the NLEA preemption provision). The cases upon which MPC relies, (see Motion at 10), do not compel a different conclusion.
As it stands, however, the FDA has issued a monograph directly on point but declined, in spite of that, to indicate—either in the monograph itself or in advisory interpretations of the monograph—that “Restores Enamel” is misleading. If successful, this litigation would do exactly what Congress, in passing section 379r of the FDCA, sought to forbid: using state law causes of action to bootstrap labeling requirements that are “not identical with” federal regulation.See, e.g., Red v. Kraft Foods, 754 F.Supp.2d 1137, 1141 (C.D.Cal.2010) (holding that the logic of In re PepsiCo. does not apply to “state law claims [that are] premised on misrepresentations concerning subject matter that the FDA has not endeavored to regulate”) (internal citation omitted).In the alternative, plaintiffs argue that even if the state law causes of action are preempted, their misbranding claim can proceed because it arises independently under federal law. For support, plaintiffs point to the “misbranding” provision of the FDCA, which provides that “ ‘[a drug] shall be deemed to be misbranded [if] its labeling is false or misleading in any particular.’ ” According to plaintiffs, if their central allegation is correct—that “the loss of [ ] enamel is permanent” —it follows that the label “Restores Enamel” is “false or misleading.”
By contrast, in Red v. Kraft Foods, Inc., 754 F.Supp. 2d 1137 (C.D. Cal., 2010), the court held that state law claims regarding the use of the phrases "made with real vegetables" and "made with real ginger and molasses" on the defendants' packages of crackers and cookies were not preempted because they did not suggest that a specific nutrient was absent or present in certain amounts. Id. at 1142.
Several recent District Court decisions have held that claims based on statements concerning nutrient content, or using terms that the FDA has defined or permitted, are preempted by the federal regulatory statute. See Red v. Kraft Foods, Inc., ___ F.Supp.2d ___, 2010 WL 5000717 (C.D. Cal. Nov. 18, 2010) (discussing earlier ruling that labeling claims of "no cholesterol" and specific quantities of "whole" grain were preempted); Chacanaca v. The Quaker Oats Co., ___ F.Supp.2d ___, 2010 WL 4055954 (N.D. Cal. Oct. 14, 2010); Red v. The Kroger Co., 2010 WL 4262037, *4-5 and n. 4 (C.D. Cal. Sept. 2, 2010) (state law claims preempted where it was undisputed that the phrase "0g Trans Fat" was a nutrient content claim subject to 21 U.S.C. § 343(r)). In Chacanaca, Judge Seeborg considered state law claims based on "0 Grams Trans Fat" statements on the labeling for granola bars.