FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PAUL DACHAUER, On Behalf

of Himself and All Others

Similarly Situated,

Plaintiff-Appellant,

v.

NBTY, INC., a Delaware

corporation; NATURE’S

BOUNTY, INC., a Delaware

corporation, 

Defendants-Appellees.

No. 17-16242

D.C. No. 

3:16-cv-00216-VC

OPINION

Appeal from the United States District Court

for the Northern District of California

Vince Chhabria, District Judge, Presiding

Argued and Submitted November 13, 2018

San Francisco, California

Filed January 10, 2019

Before: Sidney R. Thomas, Chief Judge, Susan P. Graber,

Circuit Judge, and Leslie E. Kobayashi,* District Judge.

Opinion by Judge Graber

* The Honorable Leslie E. Kobayashi, United States District Judge for

the District of Hawaii, sitting by designation.
2 DACHAUER V. NBTY, INC.

SUMMARY**

California Law / Federal Preemption

The panel affirmed the district court’s summary judgment

in favor of makers of vitamin E supplements in a

plaintiff/consumer’s action alleging that the labels on the

supplements violated California laws against false

advertising.

For dietary supplements, the Federal Food, Drug, and

Cosmetic Act (“FDCA”) distinguishes between “disease

claims” and “structure/function claims” that manufacturers

make about their products. A structure/function claim

describes the role of a dietary ingredient, but may not claim

to mitigate a specific disease. 21 U.S.C. § 343(r)(6). 

Although the FDCA requires manufacturers to have

substantiation for their structure/function claims, California

law does not allow private plaintiffs to demand substantiation

for advertising claims.

The panel held that § 343-1(a)(5) of the FDCA expressly

preempts state-law requirements for claims about dietary

supplements that differ from the FDCA’s requirements. The

panel further held that, as applied here, § 343-1(a)(5)

preempted most of plaintiff’s claims. Specifically, the panel

held that § 343-1(a)(5) preempted plaintiff’s claims to the

extent that he argued that defendants’ structure/function

claims were false or misleading because their supplements

did not prevent cardiovascular disease. The panel also held

** This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.
DACHAUER V. NBTY, INC. 3

that because the FDCA and California law have the same

labeling requirement with respect to failing to disclose an

increased risk of death, § 343-1(a)(5) did not preempt this

particular aspect of plaintiff’s case.

The panel held that the record lacked evidence that

vitamin E supplements are actually harmful, as opposed to

simply useless at reducing all-cause mortality (which they do

not claim to reduce). The panel concluded that, on this

record, plaintiff failed to meet his burden to create a genuine

issue of material fact as to whether defendants’ immunehealth structure/function claim was misleading. 

COUNSEL

Stewart Weltman (argued), SIPRUT PC, Chicago, Illinois;

Max A. Stein and Nada Djordjevic, Boodell & Domanskis,

LLC, Chicago, Illinois; Patricia N. Syverson and Manfred

Muecke, Bonnett, Fairbourn, Friedman & Balint, P.C., San

Diego, California; Elaine Ryan, Bonnett, Fairbourn, Friedman

& Balint, P.C., Phoenix, Arizona; for Plaintiff-Appellant.

Robert Andalman (argued) and Rachael Blackburn, A&G

Law, LLC, Chicago, Illinois; William A. Delgado, Willenken

Wilson Loh & Delgado LLP, Los Angeles, California; for

Defendants-Appellees.
4 DACHAUER V. NBTY, INC.

OPINION

GRABER, Circuit Judge:

Defendants NBTY, Inc., and Nature’s Bounty, Inc., make

vitamin E supplements that claim, on their labels, to “support

cardiovascular health” and to “promote[] immune function,”

“immune health,” “heart health,” and “circulatory health.”1

Plaintiff Paul Dachauer purchased one bottle of the

supplements for health reasons. He claims that the labels’

statements violate two California laws against false

advertising, because the supplements do not prevent

cardiovascular disease and might increase the risk of allcause mortality. The district court disagreed and granted

Defendants’ motion for summary judgment. Reviewing de

novo, and viewing the evidence in the light most favorable to

Plaintiff, Albino v. Baca, 747 F.3d 1162, 1168 (9th Cir. 2014)

(en banc), we affirm.

A. Relevant Statutes and Regulations

Plaintiff sued under California’s Unfair CompetitionLaw,

Cal. Bus. & Prof. Code § 17200, and Consumers Legal

Remedies Act, Cal. Civ. Code § 1770. Both statutes prohibit: 

(1) false advertising; and (2) advertising that is literally true,

but which is “actually misleading or which has a capacity,

likelihood or tendency to deceive or confuse the public.” 

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)). Our analysis, however, centers on the Federal Food,

Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301–399i,

and its implementing regulations.

1

 The Appendix includes two examples of the labels.
DACHAUER V. NBTY, INC. 5

For dietarysupplements, the FDCA distinguishes between

“disease claims” and “structure/function claims” that

manufacturers make about their products. A

structure/function claim “describes the role of a nutrient or

dietary ingredient intended to affect the structure or function

in humans” or “characterizes the documented mechanism by

which a nutrient or dietary ingredient acts to maintain such

structure or function,” but “may not claim to diagnose,

mitigate, treat, cure, or prevent a specific disease or class of

diseases.” 21 U.S.C. § 343(r)(6) (emphasis added). A

disease claim, conversely, “claims to diagnose, mitigate,

treat, cure, or prevent disease,” either explicitly or implicitly

(such as by claiming that a product treats a disease’s

“characteristic signs or symptoms”). 21 C.F.R.

§ 101.93(g)(2)(ii). Structure/function claims must meet three

requirements: (1) the manufacturer has substantiation that the

statement is truthful and not misleading; (2) the statement

contains a prominent disclaimer that the Food and Drug

Administration (“FDA”) has not evaluated the statement and

that the product “is not intended to diagnose, treat, cure, or

prevent any disease”; and (3) the statement itself does not

“claim to diagnose, mitigate, treat, cure, or prevent” disease. 

21 U.S.C. § 343(r)(6). 

The FDA has published guidance in the Federal Register

discussing, among other things, acceptable structure/function

claims. Regulations on Statements Made for Dietary

Supplements Concerning the Effect of the Product on the

Structure or Function of the Body, 65 Fed. Reg. 1000-01 (Jan.

6, 2000). The guidance recognizes that structure/function

claims may use general terms such as “strengthen,”

“improve,” and “protect,” as long as the claims “do not

suggest disease prevention or treatment.” Id. at 1028. For

example, the guidance identifies the phrase “helps maintain
6 DACHAUER V. NBTY, INC.

cardiovascular function and a healthy circulatory system” as

a permissible structure/function claim. Id. at 1012; see also

id. at 1029 (The “FDA does not agree that . . . ‘supports the

immune system’” implies disease prevention.). The guidance

further explains that manufacturers of supplements can

substantiate structure/function claims with evidence of an

effect on a small aspect of the related structure/function,

rather than with evidence of an effect on the main disease that

consumers might associate with a given bodily structure or

function. See id. at 1012 (“For example, to substantiate the

claim ‘supports mood,’ it is not necessary to study the effects

of a substance on clinical depression. Instead, it is quite

possible to assess the effects of a substance on mood changes

that do not constitute clinical depression.”).

Although the FDCA requires manufacturers to have

substantiation for their structure/function claims, California

law does not allow private plaintiffs to demand substantiation

for advertising claims. Nat’l Council Against Health Fraud,

Inc. v. King Bio Pharm., Inc., 133 Cal. Rptr. 2d 207, 213–14

(Ct. App. 2003). Instead, a private plaintiff bears the burden

of producing evidence to prove that the challenged statement

is false or misleading. Id.

B. Preemption

The FDCA expressly preempts any state law that

establishes “any requirement respecting any claim of the type

described in section 343(r)(1) of this title made in the label or

labeling of food that is not identical to the requirement of

section 343(r) of this title.” 21 U.S.C. § 343-1(a)(5). 

Defendants argue that § 343-1(a)(5) preempts Plaintiff’s

claims because he seeks to impose labeling requirements

under California law that differ from the FDCA’s
DACHAUER V. NBTY, INC. 7

requirements. Although the district court did not reach the

issue of preemption, we may affirm on that ground because

Defendants raised the issue below, and it is a threshold legal

issue. Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, 757

(9th Cir. 2015).

The preemption provision governs claims “of the type

described in section 343(r)(1).” 21 U.S.C. § 343-1(a)(5). 

Section 343(r)(6), which establishes the requirements for

structure/function claims, falls under subsection (r)(1)’s

umbrella. See id. § 343(r)(6) (“For purposes of paragraph

(r)(1)(B), a statement for a dietary supplement may be made

if . . . .” (emphasis added)). So, a structure/function claim

made under § 343(r)(6) is a “claim of the type described in

section 343(r)(1).” Also, the FDCA classifies dietary

supplements as food; indeed, § 343-1 (“National uniform

nutrition labeling”) and § 343 (“Misbranded food”) fall under

the FDCA’s “Food” subchapter. Thus, a structure/function

claim also constitutes a claim “made in the label or labeling

of food.” Id. § 343-1(a)(5). Accordingly, we hold that § 343-

1(a)(5) preempts state-law requirements for claims about

dietary supplements that differ from the FDCA’s

requirements.

As applied here, § 343-1(a)(5) preempts most of

Plaintiff’s claims. We first address Defendants’

structure/function claims that their supplements promote and

support cardiovascular, circulatory, and heart health. Plaintiff

argues that those claims are false because the supplements do

not prevent cardiovascular disease.

Plaintiff’s expert witness, Edgar Miller, Ph.D., M.D.,

offered ample evidence that vitamin E supplements, taken in

the doses that Defendants sell, fail to prevent cardiovascular
8 DACHAUER V. NBTY, INC.

disease. In Dr. Miller’s view, no metric except the absence or

presence of cardiovascular disease can measure heart health

(and, accordingly, no other metric can demonstrate whether

a supplement promotes or supports heart health). In essence,

Dr. Miller rejects the discrete categories of claims that the

FDCA establishes; by definition, structure/function claims do

not and may not claim to treat or prevent disease. Id.

§ 343(r)(6); 21 C.F.R. § 101.93(g)(2). And Defendants’

labels do not claim that their vitamin E supplements treat or

prevent cardiovascular disease. Yet Plaintiff seeks to impose

a requirement under California law that structure/function

claims—at least those related to cardiovascular, circulatory,

and heart health—made on a supplement’s label require proof

that the supplement treats or prevents cardiovascular disease.2

That requirement “is not identical to the requirement of

section 343(r).” 21 U.S.C.§ 343-1(a)(5).

On appeal, Plaintiff argues that it does not matter whether

he categorizes Defendants’ claims as structure/function

claims or as disease claims, because he addressed the falsity

of the labels’ text. To the contrary, it matters very much. 

Plaintiff’s argument would vitiate the FDCA’s distinction

between disease claims and structure/function claims. The

FDA allows manufacturers of supplements to make general

claims—such as “promotes heart health”—and to substantiate

2 Plaintiff suggests that we should grant him leave to amend his

complaint to allege that Defendants make false implied-disease claims

instead of structure/function claims. But Plaintiff had a chance to raise

implied-disease claims, and he expressly told the district court that he had

no such claims. Moreover, Plaintiff never requested leave from the

district court to amend his complaint, so his request on appeal comes too

late. See Ventura Packers, Inc. v. F/V Jeanine Kathleen, 305 F.3d 913,

917 n.1 (9th Cir. 2002) (declining the plaintiff’s request, made for the first

time on appeal, for leave to amend its complaint).
DACHAUER V. NBTY, INC. 9

them with evidence that a supplement has some structural or

functional effect on a given part of the human body. 65 Fed.

Reg. at 1012. Manufacturers need not also have evidence that

those structural or functional effects reduce the risk of

developing a certain disease. See Kaufman v. CVS Caremark

Corp., 836 F.3d 88, 95 (1st Cir. 2016) (rejecting the

plaintiff’s argument that “evidence showing a supplement

does not reduce heart disease necessarily implies that the

nutrient itself has no function in maintaining heart health”). 

Plaintiff disagrees with the federal statutory scheme for

dietary supplements, but we cannot accept his invitation to

upend it. We hold that § 343-1(a)(5) preempts Plaintiff’s

claims to the extent that he argues that Defendants’

structure/function claims are false or misleading because their

supplements do not prevent cardiovascular disease.

As for Defendants’ structure/function claim that their

supplements promote immune health, Plaintiff argues that the

claim is false and misleading, either because the supplements

fail to reduce all-cause mortality or because the supplements

increase the risk of all-cause mortality. The FDCA does not

require that manufacturers substantiate structure/function

claims about immune health with proof that their supplements

reduce the risk of all-cause mortality. 21 U.S.C. § 343(r)(6). 

(Nor do Defendants claim that their supplements reduce that

risk.) Because any such requirement under California law

would differ from the FDCA’s labeling requirements, the

FDCA preempts Plaintiff’s claim to the extent that he argues

that Defendants make a false structure/function claim because

their supplements fail to reduce the risk of all-cause

mortality.

But the FDCA does not preempt Plaintiff’s claim that

Defendants’ structure/function claim about immune health is
10 DACHAUER V. NBTY, INC.

misleading because their supplements increase the risk of allcause mortality. FDCA regulations state 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” under normal conditions of use

or the conditions of use that the label prescribes. 21 C.F.R.

§ 1.21(a)(2). In other words, if a supplement’s label

recommends taking one capsule per day, and that dose

actually causes an increased risk of death—a material fact

“with respect to consequences which may result from use of

the article”—the FDCA would deem it misleading not to

reveal that fact on the label. Id.; see also Kaufman, 836 F.3d

at 96 (noting that a structure/function claim would be

misleading if it “fail[ed] to disclose the harmful aspects of the

nutrient’s structure/function”).

Likewise, a label that omitted that fact would be

misleading under California law. The associated

structure/function claim would have “a capacity, likelihood

or tendency to deceive or confuse the public,” because a

reasonable consumer would not expect to suffer an increased

risk of death from taking the product. Williams, 552 F.3d at

938 (quoting Kasky, 45 P.3d at 250). Because the FDCA and

California law have the same labeling requirement with

respect to failing to disclose an increased risk of death, § 343-

1(a)(5) does not preempt this particular aspect of Plaintiff’s

case. Thus, we address whether Plaintiff created a genuine

issue of material fact as to whether the immune-health claim

is misleading.
DACHAUER V. NBTY, INC. 11

C. Defendants’ Immune-Health Claim 

Conceivably, evidence that a supplement endangered

users by increasing their risk of death could prove that a

structure/function claim that omitted the risk was misleading. 

But the record lacks evidence that vitamin E supplements are

actually harmful, as opposed to simply useless at reducing

all-cause mortality (which they do not claim to reduce).

At best, the record reveals, in Dr. Miller’s words, a

“small” correlation between high-dose vitamin E

supplements (which Defendants sell) and an increased risk of

all-cause mortality. Miller cited four meta-analyses3

for this

point, but none of them concluded that vitamin E supplements

caused an increased risk of all-cause mortality. See, e.g.,

Goran Bjelakovic et al., Mortality in Randomized Trials of

Antioxidant Supplements for Primary and Secondary

Prevention, 297 J. Am. Med. Ass’n 842, 842, 854 (2007)4

(concluding that “vitamin E may increase mortality,” but also

stating that “[w]e are not able to determine the cause of the

increased mortality” (emphasis added)). And, as the term

“all-cause mortality” suggests, the record contains no

evidence about the actual cause of death for any of those

included in the studies. Those causes could include many

things unrelated to vitamin E supplements or immune

function, such as suicide or a car accident. Without more, no

reasonable jury could conclude that Defendants misleadingly

“fail[ed] to disclose the harmful aspects of the nutrient’s

structure/function.” Kaufman, 836 F.3d at 96. In summary,

3 A meta-analysis combines results from multiple clinical trials to

draw broader conclusions about the subject under study.

4 Available at: http://dcscience.net/bjelakovic-supplements-07.pdf. 
12 DACHAUER V. NBTY, INC.

we hold that, on this record, Plaintiff failed to meet his

burden to create a genuine issue of material fact as to whether

Defendants’ immune-health structure/function claim is

misleading.

AFFIRMED.
DACHAUER V. NBTY, INC. 13

APPENDIX 
14 DACHAUER V. NBTY, INC.