Court Opinion

ID: 4357828
Source: CourtListenerOpinion
Date Created: 2019-01-10 18:01:30.868445+00
Date Added: 2024-06-11T14:46:41.163615
License: Public Domain

FOR PUBLICATION

    UNITED STATES COURT OF APPEALS
         FOR THE NINTH CIRCUIT

 PAUL DACHAUER, On Behalf                        No. 17-16242
 of Himself and All Others
 Similarly Situated,                             D.C. No.
            Plaintiff-Appellant,             3:16-cv-00216-VC

                  v.
                                                   OPINION
 NBTY, INC., a Delaware
 corporation; NATURE’S
 BOUNTY, INC., a Delaware
 corporation,
        Defendants-Appellees.

         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’ immune-
health 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 all-
cause 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 Competition Law,
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 dietary supplements, 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 all-
cause 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.