F OR P UBLICATION



### UNIT E D ST AT E S CO URT O F APPE AL S FO R T H E NINT H CIRCUIT

P A U L D A C H A

U E R , On B ehalf of Himself and All Others Similarly Situated, Plaintiff-Appellant
,

v.

NB TY, I

N C ., a Delaware corporation; N A T U R

E ’ S B O U N T Y , I N C ., a Delaware corporation, Defendants-Appellees. No. 17-16242

D.C. No. 3:16-cv-00216-VC

OPI N I ON

A ppeal from the United States District Court for the Northern District of California Vince Chhabria, District J udg e, Presiding

A rg ued and Submitted November 13, 2018 San F rancisco, California

F iled J anuary

10, 2019

B efore: Sidney

R. Thomas, Chief J udg e, Susan P. Graber, Circuit J udg e, and L eslie E. Kobay ashi, * District J u dg e.

Opinion by

J udg e Graber

* T h e Ho n o rab le L eslie E. Ko b ay ash i
, Un ited States District J u d g e f or th e District o f

Haw aii, sittin g b y

d esig n atio n

.D A C H A U E R V

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SUMMARY * *

Calif ornia Law / F e deral P reem ption

The panel affirmed the district c ourt’s summary judg ment in favor of makers of vitamin E supplement s in a plaintiff/consumer’s ac t i o n alleg ing that the labels on the

s u p p l em e n t s v i olated California laws ag ainst f al s e advertising

.

F or dietary supplements, the F e deral F ood, Dru g, a nd Cosm e tic Act (“F DCA”) disting uishes between “ disease claims” a nd “ structure/function claims” that manufa c turers make about their products. A structure/function claim describes the role of a d ietary ing redient, but may not claim
to mitig ate a specific disease. 2 1 U .S

. C

. § 343(r)(6). Althoug h th e FDCA requires manufacturers to have substant i a t ion 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 F DCA ex pressly
preem p t s state-law requirements for claims about dietary supplements that differ from the F D CA’s requirements. The panel further held that, as a p p l ied here, § 343-1(a)(5) preempted most of plaintiff’s claims. Specifically
, the panel held that § 343-1(a)(5 ) p r eempted plaintiff’s claims to the

e x tent that he arg ued that defendants’ structure/functi o n claims were f

alse or misleading because their supplement s did not prevent cardiovascular disease. The p a nel als o h eld

** T h is su m m ary co n stitu

t es n o p art o f th e o p in io n o f th e co u rt. It h as b een p rep ared b y

co urt staf

f f o r th e co n v en i en ce o f

th e read er.D A C H A U E R V

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that because the F D CA and Cal i fo r n ia 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 pan el held that the record lacked evidence that vitamin E supplements are actually harmful, as o pposed to simply useless at reducing all-cause mortality (which they do
not claim t o r e d uce). The panel concluded that, on this record, plaintiff failed to meet his burden to create a g enuine issue of materi a l f

act as to whether defendants’ immunehealth structure/function claim was misleading

.

COUNSEL

Stewart Weltman (arg

ued), SI PRUT PC, Ch i c a go, I llinois; Max A. Stein and Nada Djordjevic, B oodell & D om a n s k i s , L L C, Chicag o , I llinois; Patricia N. Sy verson a n d M a nfred Muecke, B onnett, F airbourn, F riedman & B alint, P. C
., San D i e g o , California; Elaine Ry an, B onnett, F ai r b o u r n , F r i e d m a n & B alint, P.C., Phoenix , Ariz ona; for Plaintiff-Appellant.

Robert Andalman (arg

ued) and Rachael B lackbu rn , A& G L aw, L L C, Chicag o, I llinois; W illiam A. Delg ado, W illenken W ilson L oh & D elg ado L L P, L os A ng eles, California ; for Defendants-Appellees.D A C H A U E R V

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OP INION

GRAB ER, Circuit J udg e:

Defendants NB TY, I n c., and Nature’s B ounty , I nc., make vitamin E supplements that claim, on their labels, to “support cardiovascular health” and to “promote[ ] immune function,” “immune h ealth,” “heart health,” and “circulatory health.” 1 Plaintiff Paul Dachauer purchased one bottle of the supplement s f

o r health reasons. H e claims that the labels’
statements violate two California laws ag ainst false advertising
, because the supplements do not prevent cardiovascular disease and mig ht increase the r i sk of allcause mortality

. The district court d isag re ed and g ranted Defendants’ motion f

o r s ummary judg ment. Reviewing de
novo, and viewing the evidence in the lig ht most favorable to Plaintiff, Albino v. Baca
, 747 F .3d 1162, 1168 ( 9th Cir. 2 014) (en banc), we affirm.

A. R elevant Statutes and Regulations

P l aintiff sued under California’s Unfair C o m p e t i t i o n L a

w , Cal. B us. & Prof. Code § 1 7 2 00, and Consumers L eg al Remedies Act, Cal. Civ. Code § 1 770. B oth statutes p r ohibit: (1) false advertising ; and ( 2) advertising that is literally true, but which is “actually misleadin g or which has a capacity
, likelihood o r tendency to deceive or confuse t h e public.” W illiams v. Gerber Prods. Co.
, 5 5 2 F. 3 d 934, 9 38 (9th Cir. 2008) (quoting Kasky v. Nike, I n c. , 45 P.3d 243, 250 (Cal. 2002)). Our analy sis, however, centers on the F e deral F ood, Drug
, and Cosmetic Act (“F D CA”), 21 U.S.C. §§ 301–399i, and its implementing reg ulations.

1 T h e A p p en d ix in clu d es tw o ex am p les o f th e lab els.D A C H A U E R V

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F or die t a r y s u p p l e m e n t s , t

h e F DCA disting uishes b etween “disease c laims” and “ structure/function claims” that

m a n u f a c t u r e r s m a k e a b o u t t h e i r p r o d u c t s

. A structure/function claim “describes t h e r o l e of a nutrient o r dietary ing redient intended to affect the structure or function in humans” or “characteriz es the d o cumented mechanism b y which a nutrient or d ietary ing redient a cts to m a i ntain such
structure o r function,” b ut “ may not claim t o diag nose, mitig ate, treat, cure, o r p re v ent a specific disease or class o f diseases.” 21 U.S.C. § 343(r)(6) (emp h a s i s added). A disease claim, conversely
, “cl a i ms to diag nose, mitig ate, treat, cure, or p revent disease,” either ex plicitly o r implicitly (such a s by claiming that a product treats a disease’s

“ c h a ra c t e r i s t i c s i gn s o r s y m p t o m s ” )

. 2 1 C

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. § 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) th e statement contains a prominent disclaimer that the Food and Drug Administration (“F DA”) has not evaluated the statement a nd that the p roduct “is not intended to diag nose, treat, c ure, o r prevent any disease”; a

n d (3) the statement itself does not “claim to diag nose, mitig ate, treat, cure, or prevent” disease. 21 U.S.C. § 343(r)(6).

The F DA has published g uidance in the F ederal Reg ister discussing
, among other thing s, acceptable structure/function claims. Reg ulations on S t a t e ments Made for Dietary Supplements Concerning the Effec t of the Product o n the Structure or F unction of the B ody
, 65 F ed. Reg

. 1000-01 (J an. 6, 2000). T he g uidance reco g niz es that structure/function claims may use g e n e ral terms such as “streng then,”

“ i m p r ove,” and “protect,” as long as the claims “do n o t sug g est disease prevention or treatme n t

. ” Id. at 1028. F o r

ex a mple, the g uidance identifies the phrase “helps maintainD A C H A U E R V

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cardiovascular function and a healthy circulatory sy stem” as

a permissible structure/functi o n claim. Id. at 1012; see also id. at 1029 (The “F DA does not ag ree that

. . . ‘ s u p p o r ts the immune sy stem’” implies disease p revention.). The g uidance further ex plains that manufacturers of supplements can substantiate structure/function c laims with evidence of an effect o n a small a spect of the related structure/function, rather than with evidence of a n effect on the main disease that

consumers mig ht associate with a g iven bodily str u c t ure o r f u n ction. See id. at 1 012 (“F or e x ample, to substantiat e t h e claim ‘supports mood,’ it is not n ecessary to study the effects of a substance on clin i c a l d epression. I nstead, it is quite possible to assess the effects of a substance on mood chang e s that do not constitute clinical depression.”).

Althoug h the FD C A requires manufacturers to have substantiation for t h eir structure/function claims, California law does not allow private plaintiffs to demand substantiation for advertising claims. Nat’l Council A g ainst H ealth Fraud, Inc. v. King Bio Pharm., Inc.
, 133 Cal. Rptr. 2d 207, 213–14 (Ct. A pp. 2003). I nstead, a private plaintiff bears the burden of producing e vidence to prove that the challeng ed statement is false or misleading

. Id.

B

. P reemption

The F DCA ex pressly pr eempts any state law that establishes “any requirement respecting any claim of the ty pe described in section 343(r)(1) of this title made in the label o r l abeling of food that is not identical to the requir em e n t o f section 3 43(r) of t h i s t i tle.” 21 U .S.C. § 343-1(a)(5). Defendants arg ue that § 343-1(a)(5) preempts Plaintiff’s cl a i m s because he seeks to impose labeling requirements under California law t h at differ f rom the F DCA’sD A C H A U E R V

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requirements. Althoug h the district court did not reach the issue of p reemption, w e may affirm on that g round because Defendants raised the issue below, and it is a threshold leg al issue. Astiana v. Hain Celestial G rp., Inc.
, 783 F .3d 753, 757 (9th Cir. 2015).

The preemption provision g overns cl a ims “ of the ty pe described in section 343(r)(1).” 21 U.S.C. § 343- 1 ( a ) ( 5 ). Section 3 4 3(r)(6), which est a b l ishes the r equirements for structure/function claims, f alls under subsectio n (r)(1)’s umbrella. See id. § 3 43(r)(6) (“ For purposes of

paragraph ( r) ( 1) ( B)
, a statement for a dietary supplement may b e made if

. . . . ” (emphasis a dded)). So, a structure/functio n claim made under § 343(r)(6) is a “claim of the ty pe described in section 343(r)(1).” Also, the F DCA classifies dietary supplements as food; indeed
, § 343-1 (“National u niform nutrition labeling ”) and § 343 (“Misbranded food”) fall under the F DCA’s “F ood” subchapter. Thus, a structure/function claim also constitutes a c laim “made in the label or l a b e l ing of food.” Id. § 343-1(a)(5). According ly
, we hold that § 343- 1(a)(5) preempts state-law r equirements for c l a ims about dietary suppl ements that differ from the F DCA’s requirements.

As applied here, § 343-1(a)(5 ) p r e empts most o f P l a i ntiff’s claims. We f i r s t ad d r e s s D e f

en d a n t s ’ structure/function claims that their supplements promote a nd support cardiovascular, circulat o r y , and h eart health. Plaintiff
arg ues that those claims a

re false because the supplements do not prevent cardiovascular disease.

Plaintiff’s ex pert witness, Ed ga r Miller, Ph.D., M.D., offered ample evidence that vitamin E supplements, taken in the doses that Defendants sell, fail to prevent cardiovascularD A C H A U E R V

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disease. I n Dr. Miller’s view, no metric except the absence o r presence of cardiovascular d isease c a n measure heart health (and, according ly
, no other metric can demonstrate whet h e r

a supplement promotes o r supports heart health). I n essence, Dr. Miller r ejects the discret e categ ories of claims that the F DCA establishes; by definition, structure/function claims do
not and m ay not claim to treat or pre v e n t disease. Id. § 343(r)(6); 21 C.F .R. § 101.93(g )(2). An d Defendants’ labels do not claim that their vitamin E supplements treat o r prevent cardiovascular disease. Y et Plaintiff seeks to impose

a requirement under California law that structu r e/ function claims—at least those r elated to cardiovas c ular, 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 id e n tical to the requirement o f section 343(r).” 21 U.S.C.§ 343-1(a)(5).

On appeal, Plaintiff a

rg ues that it does not matter whether he categ o riz e s Defendants’ claims as struc t ure/function claims or as disease claims, because he addressed the f alsity of the labels’ tex t. To the contrary , i t m a t t e rs very much. Plaintiff’s arg ument would vitiate the F D CA’s distinction between disease claims and structure/function claims. The F DA allows m a n u f

acturers o f supplements to make g eneral claims—such as “promotes heart he a l t h ”

— a n d t o s u b stantiate

2 P lain tif

f su g g ests th at w e s ho u l d g ran t h im leav e to am en d h is

c o m p lain t to alleg e th at Def

en d an ts m ak e f

alse im p lied

- d i s ease clai m s i n s t ead of stru ctu re/f

un ctio n claim s. Bu t P lain tif f h ad a ch an ce to r a i se im p lied

- d isease claim s, an d h e ex p ressly to ld th e d istrict co u rt th at h e h ad

n o su ch claim s. Mo reo v er, P lain tif f n ev er req u ested leav e f ro m th e d istrict co urt t o am en d h is co m p lain t, so h i s req u est o n ap peal co m es t o o late. S ee Ven tu ra Pa ckers, In c. v. F/V Jea n in e Ka th leen
, 3 0 5 F. 3 d 9 1 3
, 9 1 7 n .1 (9 th Cir. 20 0 2 ) (d eclin in g th e p l ain tif f ’ s req u est, m ad e f

o r th e f irst tim e o n ap p eal, f o r leav e to am en d its co m p lain t).D A C H A U E R V

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them with evidence that a supplement has some structural o r functional effect on a g iven part of the h u man body

. 65 F ed. Reg

. at 1 012. Manufacturers need n ot also have evidence that those structural or f

un c t i o n a l effects reduce the risk o f developing a certain disease. See Kaufman v. CVS Caremark Corp.
, 836 F .3d 88, 95 (1st Cir. 2016) (rej ecting the pla i n t i ff’s arg u ment that “evidence showing a supplement does not reduce heart disease necessarily implies t hat the nutrient itself has no functi o n i n maintaining heart h ealth”). Plaintiff disag rees w ith the federal statutory scheme for dietary supplements, b u t we cannot accept his invitation to upend it. W e hold that § 343-1(a)(5) preempts Plaintiff’s claims to the ex tent that h e arg ues that Defendan t s’
str u c t ure/function c laims are f

alse or misleading because their supplements do not prevent cardiovascular disease.

As for Defendants’ structure/func tion claim that their supplements promote immune h ealth, Plaintiff arg ues 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 F DCA does not require that manufacturers substantiate structure/function claims about immune health w i th proof that their supplements reduce the risk of a ll-cause mortality

. 21 U.S.C. § 343(r)(6). (Nor do Defendants claim that their supplements reduce that risk.) B ecause any such requirement under Ca l i fo r n ia law would differ f

rom the F DCA’ s l a b eling requirements, the F DCA preempts Plaintiff’s claim to the ex tent that he arg ues that Defendants make a false structure/functi o n c laim because their supplement s f

ail to reduce the risk of all-cause mortality

.

B u t the FD C A does not preempt Plaintiff’s claim that Defendants’ structure/function claim about immune health isD A C H A U E R V

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misleading because their supplements increase the risk of allc ause mortality

. F DCA reg ulations state that a food lab el “shall be deemed to b e misleading if it fails to reveal facts” that are “[ m] aterial with r espect to consequences which may result from use of the article” under n ormal conditions o f use

or the conditions of use that the label prescribes. 2 1 C

. F. R

. § 1.21(a)(2). I n o t h e r words, if a supplement’s label recommends taking o n e capsule p er day
, and tha t d ose actually causes an increased risk of death—a material fact “with respect to consequences which may result from use of the article”—the F DCA would deem it m isleading n ot to reveal that fact on the label. Id. ; see also Kaufman
, 836 F .3d
at 96 ( n o t ing that a structure/function c laim would be misleading if it “fail[ ed] to d isclose the harmful aspects o f the nutrient’s structure/function”).

L ikewise, a label t h a t omitted that fact would be misl e ading under California law. The associated structure/function claim would have “a cap a city
, likelihood

or tendency to deceive o r confuse the publ i c , ” b ecause a reasonable c onsumer would not e x pect to suffer an increased risk of death from taking

the product. W

illiams , 552 F .3d at 938 ( quoting Kasky
, 45 P.3d at 250). B ecause the F DCA a nd California law have the same l a b eling requirement with respect to failing to disclose an increased risk of death, § 343- 1 ( a)(5) does n ot preempt this p articular aspect of Plaintiff’s

case. Thus, we a d d r es s w hether Plaintiff created a g enuine issue of material fact as to whether the immune-health claim is misleading

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C. D efendants’ Immune-Health Claim

Conceivably
, e vidence that a supplement endang ered

users by increasing their r isk of death could prove th a t a structure/function c laim that omitted the risk was misleading

. B ut the record lacks evidence that vitamin E supplements a re actually harmful, as opposed to simply useless at r e d u c i n g all-cause mortality

(which they

do not claim to reduce).

At b est, the record reveal s , i n Dr. Miller’s words, a

“ s m a l l ” co r r e l a t i o n b e t we e n h i gh

- d o s e v i t a m i n E supplements (which D efendants sell) a nd an increased risk o f all-cause mortality

. Miller cited four meta-analy ses 3 for this point, but none of them concluded that v itamin E supplements caused a n increased risk of all-cause mortality

. S ee, e.g. , Goran B jelakovic et al., Mortality in Rand omized Trials of Antioxidant Supplem e nts for P rimary and S econdary Prevention
, 297 J

. Am. Med. Ass’n 842
, 8 42, 854 (2007) 4 (concluding that “vitamin E may increase mortality ,” but also stating that “[ w] e a

re n ot able to determine th e c a u s e o f the increased mortality ” (emphasis added)). And, as the term “all-cause mor t ality ” sug g ests, the record contains no evidence about the actual cause of death f o r any of those included in the studies. Those causes coul d i n c l u de many t hing s unrelated to v itamin E supplements or immun e function, such as suicide o r a car accident. W ithout more, no reasonable jury could conclude that Defendants misleading ly “fail[ ed] to di s c lose the harmful aspects of the nutrient’s structure/function.” Kaufman , 836 F

. 3d at 96. I n summary ,

3 A m eta- an aly sis co m

b i n es resu lts f

ro m m u ltip le clin ical trials to d raw b ro ad er co n clu sio n s ab o u t th e su bj ect u n d er stu d y

.

4 A v ailab le at: h t tp : //d cscien ce.n et/b j elak o v ic- sup p l em en ts- 07 .p d f

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w e hold that, on this record, Plaintiff failed to meet hi s burden to create a g enuine issue o f material fact a s to whether Defendants’ immu ne-health structure/function claim is misleading

.

AF F IRMED.D A C H A U E R V

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APPENDI XD A C H A U E R V

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