By Rend Al-Mondhiry, Senior Counsel with Amin Talati Upadhye, and Megan Olsen, the Assistant General Counsel of the Council for Responsible Nutrition, a trade association representing the dietary supplement industry.
The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), permits dietary supplement manufacturers to make truthful statements about the benefits of a product or its ingredients on a structure or function of the body, known as “structure/function claims.”<note>21 U.S.C. § 343 (r)(6).</note> The law clearly distinguishes between these statements and “disease claims”—claims that a product can prevent, treat, or cure disease—which can only be made for drugs approved by the U.S. Food and Drug Administration (FDA). A recent U.S. Court of Appeals for the Ninth Circuit decision not only recognizes this distinction, but in a rare move by the court also affirms that the FDCA preempts state laws governing such claims.
In Dachauer v. NBTY, Inc.,1 the Plaintiff alleged that the Defendant’s vitamin E supplements—which included the claims “support cardiovascular health,” “promote immune function,” and similar statements—violated California’s false advertising laws because the supplements do not prevent cardiovascular disease and could increase the risk of mortality. The appellate panel affirmed the district court’s summary judgment in favor of the Defendant, holding that the FDCA preempts the majority of the Plaintiff’s claims. The court also found that the Plaintiff failed to demonstrate that the vitamin E supplements pose any actual harm, and therefore there was no genuine issue of material fact as to whether the immune health claim was misleading.
The court’s ruling essentially upholds the regulatory framework Congress approved nearly 25 years ago under DSHEA and acknowledges the strength of FDCA preemption provisions as they apply to dietary supplements. The authors of DSHEA recognized an increased need for “information linking nutrition and long-term good health” and sought to remove “unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.”2 Under the law, structure/function claims cannot claim to prevent or treat disease and must be substantiated with an appropriate level of scientific evidence, among other requirements.3 Thus, when lawfully made, these claims should not require drug-level proof of efficacy—which is exactly what the Plaintiff sought to impose in this case. Although not without its critics, the framework has worked well for both the industry and consumers. It allows dietary supplement manufacturers to communicate the value of their products while also providing reasonable protections for consumers against deceptive or false claims.
In Dachauer, the Plaintiff attempted to impose a different (and higher) evidentiary standard for dietary supplement structure/function claims under California law, which the court soundly rejected. A different outcome would also fundamentally undermine the federal regulatory structure put in place by Congress under DSHEA, take away the ability of dietary supplement manufacturers to convey truthful information about their products, and run counter to the preemption language in the FDCA. The very nature of structure/function language permitted under the law is clearly distinguished from drug claims. Further, no precedent supports the notion that the claim “supports heart health” means the same thing, or requires the same level of evidence, as “prevents cardiovascular disease.” These claims are separate and distinct under DSHEA, and each require a level of evidence that is appropriate for the claim. And as the court wisely noted, the Plaintiff essentially “disagrees with the federal statutory scheme for dietary supplements, but we cannot accept his invitation to upend it.”4
Notably the court rejected the Plaintiff’s argument regarding the level of substantiation needed for its heart-health claims because of the FDCA’s preemption language. Dietary supplements are regulated as foods under the FDCA, and thus, preemption language that applies to the labeling for foods also applies to dietary supplements. The FDCA expressly preempts any state law for food that establishes “any requirement respecting any claim of the type described in section [403(r)(1) of the FDCA] made in the label or labeling of food that is not identical” to FDCA requirements.5 FDCA § 403(r)(6) establishes requirements for structure/function claims, and as the court noted, falls under the umbrella of subsection (r)(1). The FDCA’s food preemption language in this section covers state laws that not only contradict FDCA provisions, but that are not identical to these provisions.
If the Plaintiff’s argument had prevailed, the court would have imposed non-identical requirements on supplements that claim to promote heart health in the form of the substantiation accepted to support such a claim. The court reasoned that “FDA allows manufacturers of supplements to make general claims—such as ‘promotes heart health’ and to substantiate them with evidence that a supplement has some structural or functional effect on a given part of the human body.”6 To also require a defendant to possess evidence that the product treats or prevents a disease would eviscerate the FDCA’s distinction between disease and structure/function claims and violate the express preemption language. The court appropriately rejected this argument and, in doing so, created a bright-line rule regarding structure/function claims and their preemption under federal law.
This case, however, also serves as a reminder that the FDCA does not preempt state-law claims where statements at issue could be considered misleading both under federal and state law. In Dachauer, the Plaintiff argued that the supplements could increase the risk of mortality. The court held that under both federal and California law, failing to reveal material facts about product harm, if true, would be a misleading labeling practice.7 The Ninth Circuit examined the Plaintiff’s evidence under the standard in California that private plaintiffs are not permitted to demand substantiation—rather, they must produce evidence proving that a challenged statement is actually false or misleading.8 The court went on to hold that summary judgement was appropriate on this claim because “no reasonable jury could conclude that Defendants misleadingly” failed to disclose product harm based on the Plaintiff’s evidence.9
Thus, this case is important to industry for a number of reasons. First, it preserves the important distinction between structure/function claims and diseases claims, and the level of substantiation needed to support these claims. Second, it sets important precedent about FDA preemption and dietary supplement/food labeling. And third, it appropriately upholds the plaintiffs’ evidentiary burden for false advertising claims, particularly in light of recent Ninth Circuit decisions that have confused the standards for private claims and summary judgement requirements.10
- Dachauer v. NBTY, Inc., No. 17-16242, 2019 WL 150016 (9th Cir. Jan. 10, 2019).
- Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103–417, 108 Stat. 4325 (1994), § 2.
- 21 U.S.C. § 343 (r)(6)(A)-(C). In addition, structure/function claims must be accompanied by the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
- Dachauer at 9.
- 21 U.S.C. § 343-1(a)(5) (emphasis added).
- Dachauer at 8-9.
- See 21 C.F.R. § 1.21(a)(2) (stating that a food label “shall be deemed to be misleading if it fails to reveal facts” that are “[m]aterial with respect to consequences which may result from use of the article”) and Williams v. Gerber Prods. Co., 552 F.3d 934, 938 (9th Cir. 2008) (quoting Kasky v. Nike, Inc., 45 P.3d 243, 250 (Cal. 2002) (finding that an undisclosed product harm could have “a capacity, likelihood or tendency to deceive or confuse the public”).
- Nat’l Council Against Health Fraud, Inc. v. Kin Bio Pharm., Inc., 133 Cal. Rptr. 2d 207 (Ct. App. 2003).
- Dachauer at 11.
- See Sonner v. Schwabe North America, Inc., No. 17-55621 (9th Cir. Dec., 26, 2018).