The Food, Drug, and Cosmetic Act (FDCA) promotes nationwide uniformity in food labeling by establishing a comprehensive federal labeling scheme and preempting state law that imposes different requirements.  21 U.S.C. § 343-1(a).  Over the years, the FDA has issued regulations directed to specific labeling issues, including representations of a food product’s “primary recognizable flavor.”  21 C.F.R. §§ 101.22(a)(3), 170.3(o)(12).  So long as a label’s representation of a “primary recognizable flavor” complies with the FDA’s flavoring regulation, the label is not misleading, and any state law that supposedly says otherwise is preempted. 

This should mean that, to state a claim, a false advertising plaintiff must credibly allege that the labeling statement is not a representation as to a “primary recognizable flavor,” and thus falls outside the regulation’s preemptive sweep.  As a recent pair of conflicting decisions shows, however, courts are inconsistent in their application of this principle. 

In Tucker v. Post Consumer Brands, LLC, the Northern District of California considered a claim that images of honey on the box of Post’s “Honey Bunches of Oats” cereal misleadingly convey that honey is a primary “sweetener” and is one of the top three ingredients, when in fact the main sweeteners are sugars and syrups.  2020 WL 1929368 (Apr. 21, 2020).  Tucker relied on an unidentified 2019 survey of 400 consumers which supposedly found that 68% believed the cereal is primarily sweetened with honey and 80% believed honey is one of its three main ingredients.  Id. 

Post moved to dismiss, arguing that Tucker’s claims were preempted by the FDA’s flavoring regulation, 21 C.F.R. § 101.22(i), because honey is undisputedly a “primary recognizable flavor” of Honey Bunches of Oats and is represented on the packaging in accordance with the regulation.  Therefore, Post argued, the plaintiff was using state law to challenge a representation about “primary recognizable flavor” that the FDA regulations authorized—exactly what FDCA preemption prohibits. 

The district court denied the motion, concluding that “the crux of [Tucker’s] claims is that Honey Bunches of Oats’ labeling is deceptive as to the use of honey as a sweetener.”  Tucker at *3.  So according to the court, even though the FDA permits Post’s representations about honey in its capacity as a “primary recognizable flavor,” plaintiffs can nevertheless use state law to challenge those same representations on the ground that they misrepresent the product’s primary “sweetener.” 

Another recent case, however, viewed this same claim with a more (appropriately) skeptical eye.  Lima v. Post Consumer Brands, LLC, 2019 WL 3802885 (D. Mass. Aug. 13, 2019), reconsideration denied, 2019 WL 4889599 (Oct. 2, 2019).[1]  In Lima, the plaintiffs also challenged Post’s labeling branding of Honey Bunches of Oats on the ground that they expected it to contain more honey.  However, the court in that case granted Post’s motion to dismiss, reasoning that “to the extent the use of the word ‘honey’ and the packaging’s graphics can be understood to be a reference to a flavor of the cereal,” 21 C.F.R. § 101.22 set forth the FDA’s specific requirements for how a product’s “‘primary recognizable flavor(s)’ may be identified,” and Post was in compliance with that regulation.  Lima at *5.  Moreover, to the extent the plaintiffs challenged the use of “honey” as a sweetener, they had not identified any FDA regulation specific to “sweeteners” that Post had violated.  And Post had satisfied the FDA’s general regulation concerning misbranding of food, 21 C.F.R. § 101.18, because there was no dispute that Honey Bunches of Oats contains some honey, and any reasonable consumer who “cared about how the cereal was sweetened” “would then have checked the ingredient list and discovered that honey, although a sweetener, was not the most prominent,” Lima at *7. 

The Tucker court ostensibly did not disagree with that analysis.  Instead, it distinguished Lima because the plaintiffs there had “implicitly acknowledged that honey has a distinctive flavor that is responsible for the honey taste of Honey Bunches of Oats.”  Tucker at *3.  By contrast, Tucker had “explicitly reject[ed] the contention that honey is the ‘primary recognizable flavor’ in Honey Bunches of Oats” by alleging that “in fact other ingredients, ‘such as molasses, brown sugar, nuts, and dried fruit,’ have more prominent flavor characteristics.”  Id. at *3-4.  Because the court was purportedly required to credit that allegation at the pleadings stage, it could not determine as a matter of law that “the labeling at issue is permitted under [the FDA’s flavoring regulation,] section 101.22(i) and [that] plaintiff’s claims are [therefore] preempted.”  Id. at *4.

Tucker’s analysis is suspect on a number of levels.  First, recall that the plaintiff’s actual theory of deception was that the cereal overstated the quantity of honey in the product relative to other sweeteners, such as corn syrup, that are present in greater quantities.  The “primary recognizable flavor” issue came up only because Post pointed out that its representations about honey were permitted by the FDA’s flavoring regulation.  But redressing the “primary recognizable flavor” issue would not address the plaintiff’s purported theory of deception, because the “primary recognizable flavor” is a function of the product’s flavor profile, not its ingredients or their amount.  Indeed, although the plaintiff in Tucker suggested that “brown sugar” was the primary recognizable flavor of Honey Bunches of Oats, brown sugar is not even an ingredient in the cereal, according to its publicly available ingredient list.  So if the plaintiff proved his “brown sugar” theory, and the court ordered Post to replace the picture of honey with a picture of brown sugar, that would not resolve the plaintiff’s purported confusion about the predominant sweetener in the product.  In fact, that outcome would only worsen the plaintiff’s confusion—which was the sole basis of his claim to have been injured by Post’s alleged mislabeling. Accordingly, even assuming the plaintiff alleged a regulatory violation, he did not allege that he relied on or was injured by that violation. 

Second, the FDA’s flavoring regulation is not limited to a product’s single or most recognizable flavor; it applies to representations concerning any of a product’s “primary recognizable flavor(s).”  21 C.F.R. § 101.22(i) (emphasis added).  By focusing on Tucker’s “explicit rejection” that honey is “the ‘primary recognizable flavor’ in Honey Bunches of Oats,” Tucker at *3 (emphasis added), the court allowed Tucker to evade preemption simply by alleging that there are more prominent flavors than honey.  As the Lima court recognized, however, alleging that Honey Bunches of Oats has “other ingredients with more distinctive flavor characteristics than honey . . . stops short of claiming that honey is not among [its] primary recognizable flavors,” as would be necessary to avoid preemption.  Lima at *6.  It is questionable, to say the least, whether Tucker could have alleged, plausibly and in good faith, that honey—even if not the single dominant flavor—is not among the primary recognizable flavors of Honey Bunches of Oats.

Third, as Post observed in seeking dismissal, the FDA’s consumer guidance on flavoring specifically uses the example of “Maple Flakes made with real Maple Syrup,” with a picture of maple-flavored cereal, and instructs consumers to look at the ingredient list if they want to know whether such a product contains actual maple syrup.  FDA, “What’s in a Name? What Every Consumer Should Know About Foods and Flavors,” https://www.fda.gov/consumers/consumer-updates/whats-name-what-every-consumer-should-know-about-foods-and-flavors. 

The Tucker court apparently distinguished this guidance, and a related case concerning maple, because “maple appear[s] on the FDA’s list of ‘flavoring substances,’” whereas honey does not.  Tucker at *4 n.4.  But it is far from clear that should matter for purposes of determining the applicability of the “primary recognizable flavor” regulation: the same FDA guidance referred to “lemon” and “strawberry” flavored products, neither of which appear on the FDA’s list of flavorings.  See 21 C.F.R. § 172.510.  And even if that distinction did matter, it does not support the district court’s determination that the plaintiffs stated a valid consumer protection claim.  The “Maple Syrup” guidance underscores that reasonable consumers cannot expect “flavor” representations, such as product names and images on front panels, to tell them everything they need to know about the product’s ingredients.  If a reasonable consumer buying a “maple” product must check the ingredient list to determine whether it contains real maple syrup, a reasonable consumer buying Honey Bunches of Oats can also be expected to check the ingredient list to determine what sweeteners, other than honey, the cereal contains, and in what amounts.

Fourth, the court gave short shrift to whether Tucker’s claims were preempted insofar as he was challenging honey as a sweetener, stating that it could not address preemption further because “[w]hether honey is a ‘primary recognizable flavor,’ sweetener, or both is a factual determination.”  Tucker at *4.  But as the Lima court concluded, Post did not make any representations on its packaging regarding honey “as a sweetener.”  None of the challenged representations identified any objective amount of honey or said anything about how the product was sweetened, and a “reasonable consumer who presumed honey to be a sweetener” “would then have checked the ingredient list and discovered that honey, although a sweetener, was not the most prominent.”  Lima at *7. 

Finally, and perhaps most problematically, the court seemed to accept that if the plaintiff is unclear about whether something is—or is challenged in its capacity as—a flavor, sweetener, or otherwise, the plaintiff should get a free pass on preemption.  See Tucker at *4 n.3 (noting the “difficulty of analyzing preemption” in this context and asking “[w]ho gets to decide whether a product labeling claim is a ‘characterizing flavor’ claim or a claim about the product’s ingredients[?]”) (quoting Red v. Kraft Foods, Inc., 754 F. Supp. 2d 1137, 1143 (C.D. Cal. 2010).  As the Supreme Court recently stressed, however, it is the court’s responsibility—and not that of the factfinder—to decide the nature of the plaintiff’s claim and whether it is preempted.  See Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1676 (2019) (“We here decide that a judge, not the jury, must decide the pre-emption question.”).  Crucially, this includes not just the ultimate legal question of preemption, but also any “subsidiary factual disputes” that are “part and parcel of th[at] broader legal question.”  Id. at 1680.  Thus, the Tucker court had an obligation to resolve any “contested” questions relevant to the preemption analysis, such as the actual nature of the product claim at issue.  Id.  As Lima demonstrates, that analysis may be complicated by artful and ambiguous allegations, but it can and should be done. 

At the end of the day, Tucker sought to challenge Post’s branding and labeling based on its representations as to the relative amount of honey in its product, and whether framed in terms of flavoring, sweetener, or otherwise, Post made a compelling case for why it complied with the FDA’s applicable regulations.  Those regulations are intended to provide some comfort that a label that conforms with federal labeling requirements will not be a source of state-law liability.  They cannot serve that function, and the federal government’s interest in uniformity in labeling, if courts are unwilling to carefully scrutinize plaintiffs’ allegations and determine whether their substance is the subject of federal labeling law.