Preemption of Structure/Function Claims
Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds strong bones,” “St. John’s Wort supports mood,” and “Vitamin E supports the immune system.”
The FDA defines and regulates structure/function claims, and FDA requirements generally preempt state-law requirements that are “not identical.” 21 U.S.C. § 343-1(a)(5). So, does compliance with FDA regulations for structure/function claims shield food and supplement manufacturers from lawsuits claiming their structure/function claims are false and misleading?
The Ninth Circuit is the only federal Court of Appeals to address this question, in two cases decided in the past two years. The upshot of those cases is that there is some preemption for proper structure/function claims, but it is narrow and likely will not result in dismissal until summary judgment. As a result, structure/function claims continue to be relatively risky because the bar for surviving a motion to dismiss is low.
FDA Regulation of Structure/Function Claims
The FDA imposes a number of requirements for structure/function claims. 21 U.S.C §§ 321(g), 343(r)(1)(A), (r)(6); 21 C.F.R. § 101.93. Two are relevant here: (1) The manufacturer must have substantiation that the statement is truthful and not misleading, and (2) the statement must not claim to “diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.”
The distinction between structure/function and disease claims is extremely important because disease claims require prior approval by the FDA, and making an unauthorized disease claim can render the product a misbranded, unapproved “drug.” See 21 C.F.R. § 101.93(g).
Disease claims can be explicit or implicit. As a result, there is a wide spectrum of conceivable claims, some of which FDA considers to be impermissible disease claims and others it considers to be acceptable structure/function claims. The below chart is just one example from the FDA’s guidance:
|“Protects against bacterial infections”||Explicit disease claim||Prohibited|
|“Supports the body’s ability to resist infection”||Implicit disease claim||Prohibited|
|“Supports the immune system”||Structure/function claim||Allowed|
Dachauer v. NBTY: FDCA Preemption Covers Structure/Function Claims
In Dachauer v. NBTY, Inc., 913 F.3d 844, 847-48 (9th Cir. 2019), the Ninth Circuit was the first federal Court of Appeals to hold that the Nutrition Labeling and Education Act’s express preemption provision applies to structure/function claims.
In Dachauer, the plaintiff claimed that Vitamin E supplements labeled “support cardiovascular health” were misleading because the supplements did not prevent cardiovascular disease.
The Dachauer court found that theory preempted because it ignored “the FDCA’s distinction between disease claims and structure/function claims.” Id. at 848. As explained above, the FDA allows structure/function claims such as “promotes heart health” so long as the claims are substantiated “with evidence that a supplement has some structural or functional effect on a given part of the human body.” Id. The plaintiff was not allowed to demand evidence that the supplement reduced the risk of disease because the FDA does not impose that requirement for structure/function claims.
Kroessler v. CVS Narrows the Scope of Preemption for Structure/Function Claims
Less than two years after Dachauer, the Ninth Circuit addressed structure/function preemption a second time. Kroessler v. CVS Health Corp., 977 F.3d 803 (9th Cir. 2020). This time, the court found no preemption.
In Kroessler, the plaintiff alleged that the statements “supports flexibility” and “helps support and maintain the structure of joints” on glucosamine supplements were false and misleading because glucosamine does not support healthy joint function or relieve symptoms of joint disease. Id. The district court dismissed the claims as preempted because (1) Kroessler’s allegations that some studies disproved glucosamine’s effectiveness did not show that CVS lacked “substantiation” for its claims, which is all that the FDA requires, and (2) the challenged statements were proper structure/function claims and not disease claims. Kroessler v. CVS Health Corp., 387 F. Supp. 3d 1064, 1071-72 (S.D. Cal. 2019).
The Ninth Circuit reversed on both grounds. On the first ground, the court held that the FDA’s substantiation standard did not preempt Kroessler’s claims because Kroessler was permitted to allege that the joint-support claims were false under the same “substantiation” standard that the FDA uses. The court also emphasized that it could not evaluate the quality of the studies that Kroessler claimed disproved glucosamine’s effectiveness on a motion to dismiss.
On the second ground, the Ninth Circuit held that Kroessler should be allowed to amend his complaint to allege that CVS made implied disease claims, finding that “a structure/function claim may also imply a disease claim when considered in context.” The court explained that plaintiffs can allege such context by pointing to not only other statements on the label, but also “product advertisements, the consumer’s experience with the product, and market research showing consumers’ typical uses of the product.”
Preemption for Structure/Function Claims Is a Narrow Defense
The Kroessler decision dramatically narrowed the scope of preemption for structure/function claims, at least in the Ninth Circuit. Using FDA-compliant language is not sufficient. A plaintiff can still attack structure/function claims by arguing either (1) that the structure/function claim is false (i.e., the nutrient does not have the claimed effect) by pointing to studies that contradict the defendant’s substantiation, or (2) that the structure/function claim is, in fact, a prohibited “implied disease claim.”
In sum, structure/function claims continue to be an attractive litigation target because it is relatively easy for plaintiffs to construct a claim that will withstand a motion to dismiss. Preemption will apply only in a narrow set of cases, and as the Kroessler decision demonstrates, most courts will not decide a structure/function preemption defense without a full factual record.