"Fit" For Dismissal: SDNY Rejects Class Action Misapplying FDA's "Healthy" Regulation
When is a food “healthy”? And who gets to decide? A recent decision from the Southern District of New York touched on these questions in the context of an implausible consumer class action—though the court ultimately didn’t need to decide them, as it saw “fit” to end the case at the pleadings stage. See Seljak et al. v. Pervine Foods, LLC, No. 1:21-cv-09561, 2023 WL 2354976 (S.D.N.Y. Mar. 3, 2023).
By way of background: since 1994, the FDA has regulated use of the term “healthy” and its lexical variants (e.g., “healthful,” “healthier”) in food labeling. See 59 Fed. Reg. 24232-01 (May 10, 1994); 21 C.F.R. 101.65(d)(2). Under this regulation, manufacturers may use the term if—and only if—a food satisfies particular nutritional conditions that depend on the category of food involved. Foods from all categories must fall below prescribed limits of fat, saturated fat, cholesterol, and sodium. Foods from some categories (e.g., meats), but not others (e.g., produce), must also provide prescribed levels of certain vitamins and minerals.
Fast forward to today. Self-described health enthusiasts Cade Seljak, Jacob Bernardi, and Nancy Taylor bought Pervine Foods’ FITCRUNCH protein bars to support their muscle gain or weight loss goals. The products claimed to be “high [in] protein” and “gluten free,” but made no express claim to be “healthy.”
Our health-minded protagonists later filed suit against Pervine, alleging a theory that only a lawyer could love: the bars didn’t meet the FDA’s regulatory definition of “healthy” because they exceeded that definition’s prescribed limit for fat content. Although the bars didn’t use the term “healthy,” the plaintiffs claimed that the word “FIT” in the product name was synonymous with “healthy,” and therefore triggered the same regulatory requirements. The plaintiffs did not allege that, at the time of their purchases, they were aware that the FDA had a regulatory definition of the term “healthy” at all—let alone how many grams of fat that definition permitted in a protein bar. Nevertheless, the plaintiffs claimed that “[i]f [they] had been aware that the Product[s] did not meet [the FDA’s] definition of ‘Healthy,’ [they] would not have purchased the Product[s] or would have paid significantly less” for them.
Pervine moved to dismiss, and the court granted the motion in its entirety. The court first dismissed the plaintiffs’ claim for injunctive relief, finding no real or immediate threat of future injury. The plaintiffs’ only alleged injury was in the past: they purchased a product they wished they hadn’t purchased. And “there [was] no likelihood that plaintiffs would subject themselves to future injury by repurchasing defendant’s allegedly deceptive products now that they are aware of the true product contents.” The court emphasized that “the fact that unknowing class members might purchase [the] products based on the defendant[’s] allegedly unlawful advertising does not establish standing” on behalf of the named plaintiffs themselves.
Next, the court found that the federal Food, Drug, and Cosmetics Act (FDCA) expressly preempted the plaintiffs’ theory that “fit” is a synonym of “healthy.” The FDCA contains an express preemption clause that blocks state-law food-labeling requirements that are not identical to those imposed by the FDCA. And neither the FDCA nor its implementing regulations state that the term “fit” is interchangeable with “healthy” for regulatory purposes. To the contrary, when the FDA enacted its “healthy” regulation in 1994, it explicitly determined that it would not “extend the definition of ‘healthy’” to purportedly similar terms “like ‘wholesome,’ ‘nutritious,’ [and] ‘good for you,’” because such terms are not “necessarily synonymous with ‘healthy.’” Thus, the court found, it is “clear that the FDA’s definition of ‘healthy’ does not apply to ‘FIT.’” As a result, the plaintiffs’ theory that “fit” triggers the fat limits prescribed in the FDA’s “healthy” regulation would impermissibly diverge from the FDCA’s requirements.
But that was not (yet) the end of the line. In the court’s view, the plaintiffs had at least one non-preempted liability theory: that the FITCRUNCH name violated the FDCA’s general prohibition of “false or misleading” statements in labeling. See 21 U.S.C. § 343(a)(1). This theory, however, flunked on the merits. Pointing to images of unhealthy desserts “such as Oreo cookies” on the bars’ front panel, and the Nutrition Facts panel’s truthful disclosure of the bars’ fat content, the court held that, “as a matter of law, [the] products’ labels are not misleading” to a reasonable consumer. Notably, the court rejected the plaintiffs’ argument that reasonable consumer determinations are inappropriate at the pleadings stage, observing that “courts, at the motion to dismiss stage, have routinely rejected claims that deception [of reasonable consumers] has occurred” (emphasis added). A “fitting” end for an ill-conceived case.
Seljak is helpful to manufacturers in several respects. Most obviously, it rejects the notion that the FDA’s obscure requirements for “healthy” claims apply to other terms that allegedly resemble “healthy,” such as “fit,” “wholesome,” and the like. Seljak also continues two favorable trends we have covered on this blog in the past: dismissing “stop me before I buy again!” claims for injunctive relief on standing grounds, and concluding that reasonable consumers will review the ingredients list or Nutrition Facts panel when specific ingredients or nutrients are a particular concern for them. All of these holdings are most welcome.
But while we’re on the subject, we note that the FDA recently announced its intent to update its definition of “healthy” to make it “consistent with current nutrition science and Federal dietary guidance.” The proposed rule, released last September, differs from the existing one in several respects. Most notably, it “would emphasize healthy dietary patterns by requiring that food products contain a certain amount of food from at least one of the food groups or subgroups recommended by” the USDA and the Department of Health and Human Services’ jointly developed Dietary Guidelines document (fruits, vegetables, dairy, etc.) “in order to be labeled ‘healthy.’” Among other things, the proposed rule would also impose new limitations on added sugars and impose recordkeeping requirements on manufacturers using a “healthy” claim.
Manufacturers would have to remove the term “healthy” from the labels of existing products that do not meet these new requirements. The proposed rule envisions a three-year window for coming into compliance, beginning on the effective date of the (yet-to-be-announced) final rule. Although the comment period closed a month ago, it is unknown if and when the final rule will be announced, or if the FDA will make any changes in response to the hundreds of comments received.
If adopted in final form, the new rule could have a big impact on the food industry. The New York Times reports that “[m]any sugary cereals, granola bars, highly sweetened yogurts and white breads, which might currently qualify as ‘healthy’ under the existing definition, would be eliminated [from eligibility] under the new rule.” At the same time, “[w]ater, avocados, nuts and seeds, fatty fish like salmon, and certain oils – which do not currently qualify as healthy – could earn the distinction under the new guidelines.” The FDA’s proposal has generated considerable pushback from manufacturers, many of whom argue that “the new standards are draconian and will result in most current food products not making the cut, or in unappealing product reformulations.” A well-known food scholar agrees that the proposal, if adopted, would “eliminate vast swaths of the supermarket from being eligible for the healthy [claim].”
Would this proposal result in meaningful public health benefits? The FDA itself doesn’t seem to think so: incredibly, its proposal estimates that only “0 to 0.4 percent of people that try to follow current dietary guidelines...would use the ‘healthy’ implied nutrient content claim to make meaningful, long-lasting food purchasing decisions.” If that’s so, one might ask whether this change is worth the costs and frustration—not to mention the “healthy” increase in class action litigation, like Seljak, that would inevitably follow.