Court Opinion

ID: 4651146
Source: CourtListenerOpinion
Date Created: 2021-01-13 18:00:34.450521+00
Date Added: 2024-06-11T08:01:36.951023
License: Public Domain

FOR PUBLICATION

  UNITED STATES COURT OF APPEALS
       FOR THE NINTH CIRCUIT

TODD GREENBERG, On Behalf of              No. 19-16699
Himself and All Others Similarly
Situated,                                    D.C. No.
                 Plaintiff-Appellant,     3:17-cv-01862-
                                                RS
                 v.

TARGET CORPORATION, a Minnesota             OPINION
Corporation; INTERNATIONAL
VITAMIN CORPORATION, a New
Jersey Corporation; PERRIGO
COMPANY OF SOUTH CAROLINA,
INC.,
              Defendants-Appellees.

      Appeal from the United States District Court
         for the Northern District of California
       Richard Seeborg, District Judge, Presiding

        Argued and Submitted October 16, 2020
                 Pasadena, California

                 Filed January 13, 2021
2                    GREENBERG V. TARGET

    Before: Mary H. Murguia and Kenneth K. Lee, Circuit
       Judges, and Edward R. Korman, * District Judge.

                      Opinion by Judge Lee

                          SUMMARY **

    Federal Food, Drug, and Cosmetic Act / Preemption

    The panel affirmed the district court’s summary
judgment in favor of defendant manufacturer and
distributors, and its ruling that the plaintiff’s state law
claims, challenging the labeling of the dietary supplement
biotin, were preempted by federal law – the Federal Food,
Drug, and Cosmetic Act (“FDCA”).

    Plaintiff bought a bottle of biotin with a label stating that
Biotin “helps support healthy fair and skin.” The Food and
Drug Administration has limited authority under the FDCA
to regulate dietary supplements, and it requires that the label
be truthful and not misleading. 21 U.S.C. § 343(r)(6)(B)
authorizes several categories of statements, including
disease claims and structure/function claims. The FDCA
includes a preemption provision to establish a national and
uniform standard for certain labeling statements.

     *
       The Honorable Edward R. Korman, United States District Judge
for the Eastern District of New York, sitting by designation.
    **
       This summary constitutes no part of the opinion of the court. It
has been prepared by court staff for the convenience of the reader.
                  GREENBERG V. TARGET                      3

    The panel held that the FDCA preempted plaintiff’s state
law claim because the challenged statement was a
permissible structure/function claim. Specifically, the panel
held that if defendants’ biotin statement met the FDCA’s
three requirements for a structure/function claim, then any
state law claims challenging that claim fell to the wayside.
The defendants met the first requirement for its
structure/function claim because it had substantiation that
biotin “helps support healthy hair and skin,” and that
statement was truthful and not misleading. Manufacturers
may make structure/function claims about a nutrients’
general role on the human body without disclosing whether
the product will provide a health benefit to each consumer.
Second, the biotin product label had the appropriate
disclosures. Third, the biotin product label did not claim to
treat diseases. Because the structure/function claim about
biotin met the FDCA’s requirements, plaintiff’s state law
claims amounted to an imposition of different standards
from the FDCA.

                        COUNSEL

Elaine A. Ryan (argued) and Carrie A. Laliberte, Bonnett
Fairbourn Friedman & Balint P.C., Phoenix, Arizona;
Patricia N. Syverson, Bonnett Fairbourn Friedman & Balint
P.C., San Diego, California; for Plaintiff-Appellant.

Matthew R. Orr (argued), William P. Cole, and Samuel G.
Brooks, Call & Jensen ACP, Newport Beach, California, for
Defendants-Appellees.

J. Kathleen Bond, and Jennifer M.S. Adams, Amin Talati
Wasserman LLP, Chicago, Illinois, for Amicus Curiae
Council for Responsible Nutrition.
4                 GREENBERG V. TARGET

                         OPINION

LEE, Circuit Judge:

    Millions of Americans buy dietary supplements each
year. The U.S. Food and Drug Administration (FDA) does
not require pre-approval of labels on these products, but it
insists that the statements be truthful and not misleading.
The FDA also allows the product labels to feature so-called
“structure/function” claims that describe the role of a
nutrient or ingredient on the structure or function of the
human body. So, for example, a vitamin product can tout
that “calcium supports strong bones” because scientific
evidence backs that claim, even if not everyone needs or
benefits from more calcium.

    This case challenges a structure/function claim for a
vitamin called biotin. The label for the biotin product at
issue states that it “helps support healthy hair and skin.”
While the plaintiff agrees that biotin can promote hair and
skin health, he argues that the statement is still misleading
because most people obtain enough biotin from their regular
diets and thus this product provides no health benefit for
them.

    The district court granted summary judgment to the
defendants, ruling that the plaintiff’s state law claims are
preempted by federal law that allows the challenged
structure/function claim. We affirm the district court’s order
because the plain language of the statute makes clear that a
structure/function claim addresses only the nutrient’s role in
the human body, not the product’s health impact on the
general population. The defendants have met all of the
federal requirements for making a structure/function claim,
including having substantiation showing that the biotin
nutrient can promote healthy hair and skin. Federal law thus
                     GREENBERG V. TARGET                            5

allows the defendants to make this structure/function claim
and preempts the plaintiff’s state law causes-of-action.

                        BACKGROUND

    In hopes of battling his hair loss, plaintiff Todd
Greenberg dabbled in a wide variety of treatments and self-
medication for several years. One of his self-cure attempts
included buying a 5000-mcg bottle of Up & Up biotin at a
Target store in 2015 for $8. 1

    The product label states that biotin “helps support
healthy hair and skin.” The label also has an asterisk that
points to a disclaimer below: “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.” As disclosed on the Supplement Facts panel
on the bottle, biotin amount in the product far exceeds the
recommended daily dosage — 333% to 3,333% depending
on the size of the tablet.

    Greenberg claims that he thought this biotin product
would stimulate hair growth. Several weeks later, however,
a friend told him that the supplement does not provide any
benefits. Greenberg then filed this putative class action
lawsuit, alleging that the product labels are deceptive
because most people do not benefit from biotin
supplementation. He brought claims under California’s
Unfair Competition Law, Cal. Bus. & Prof. Code §§ 17200,

    1
     The other two defendants in this case — International Vitamin
Corporation, and Perrigo Company of South Carolina, Inc. —
manufacture the biotin products for Target’s private label brand, Up &
Up.
6                  GREENBERG V. TARGET

et seq., and California’s Consumers Legal Remedies Act,
Cal. Civ. Code §§ 1750, et seq.

    Notably, the parties agree that biotin is a nutrient that
supports healthy hair and skin. Greenberg’s expert,
however, concluded that most people obtain all the biotin
they need from their diets. Thus, according to Greenberg’s
expert, Biotin vitamins are superfluous for all but a tiny
percentage of people who have a biotin deficiency.

    The district court granted summary judgment for the
defendants, ruling that federal law preempts Greenberg’s
state law claims. It held that the defendants’ biotin statement
met the statutory requirements for a structure/function claim:
there was substantiation for the truthful claim, the product
label included the appropriate disclosures, and it did not
suggest that the product could treat diseases. It ruled that
Greenberg was seeking to impose an additional disclosure
requirement by claiming that the product label was
deceptive, even though it complied with the federal
requirements for a structure/function claim.

                STANDARD OF REVIEW

    We review a district court’s summary judgment order de
novo, examining all evidence in the light most favorable to
the non-moving party. Badgley v. United States, 957 F.3d
969, 974 (9th Cir. 2020). We review questions of
preemption de novo. Gingery v. City of Glendale, 831 F.3d
1222, 1226 (9th Cir. 2016) (citation omitted).
                   GREENBERG V. TARGET                        7

                       DISCUSSION

I. Federal law permits companies to make
   structure/function claims for dietary supplements.

    The FDA has limited authority under the Federal Food,
Drug, and Cosmetic Act (FDCA) to regulate dietary
supplements, which include vitamin, botanical, enzyme, and
amino acid products. Unlike with drugs, the FDA does not
pre-approve product labels for dietary supplements. It,
however, requires that the labels be truthful and not
misleading, 21 U.S.C. § 343(r)(6)(B), and authorizes several
categories of statements that can be made on the product if
certain requirements are met. For purposes of this case, the
two relevant types of claims allowed under the FDCA are
disease claims and structure/function claims.

    A disease claim refers to a “statement about a product
[that] claims to diagnose, mitigate, treat, cure, or prevent
disease,” either explicitly or implicitly.          21 C.F.R.
§ 101.93(g)(2) (emphasis added). Put another way, a disease
claim refers to a statement that the product itself can cure or
treat a disease.

     In contrast, a structure/function claim does not purport to
treat a disease or even refer to the product itself. Rather, it
is a much more narrowly focused statement “that describe[s]
the role of a nutrient or dietary ingredient intended to affect
the structure or function in humans or that characterizes the
documented mechanism by which a nutrient or dietary
ingredient acts to maintain such structure or function,
provided that such statements are not disease claims.”
21 C.F.R. § 101.93(f) (emphasis added); see also 21 U.S.C.
§ 343(r)(6)(A) (a structure/function claim “describes the role
of a nutrient or dietary ingredient intended to affect the
8                    GREENBERG V. TARGET

structure or function in humans”) (emphasis added). 2 In
other words, a structure/function claim merely describes the
function or role of an ingredient or nutrient on the human
body.

   To make a structure/function claim, manufacturers must
meet three requirements:

        1. The       manufacturer     must have
           substantiation that the statement is
           truthful and not misleading;

        2. The statement must contain a prominent
           disclaimer that the 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 may not “claim to
           diagnose, mitigate, treat, cure, or
           prevent” disease.

21 U.S.C. § 343(r)(6)(B)–(C).

    In guidance published in the Federal Register, the FDA
has blessed structure/function claims that use general terms
such as “strengthen,” “improve,” and “protect,” so long as
the claims do not suggest disease prevention or treatment.
See Regulations on Statements Made for Dietary
Supplements Concerning the Effect of the Product on the

    2
      The relevant FDA regulation specifies that diseases resulting from
essential nutrient deficiency are not “diseases” for label claims (e.g.,
scurvy). 21 C.F.R. § 101.93(g)(1).
                   GREENBERG V. TARGET                        9

Structure or Function of the Body, 65 Fed. Reg. 1000-01,
1028 (Jan. 6, 2000).

    The guidance also speaks to substantiation. To
substantiate a claim, supplement manufacturers need only
show evidence of an effect on a small aspect of the related
structure/function; they need not provide evidence of an
effect on the disease linked to that structure/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.”). That guidance appears consistent
with the narrow nature of a structure/function claim: it refers
to the ingredient’s general role in the human body, not the
product’s impact on a person’s health.

II. The FDCA preempts Greenberg’s state law claims
    because the challenged statement is a permissible
    structure/function claim.

    To avoid a patchwork quilt of conflicting state labeling
laws, the FDCA includes a preemption provision that
establishes a national and uniform standard for certain
labeling statements. The statute 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).

    The     FDCA’s      preemption       provision   covers
structure/function claims because its requirements appear in
section 343(r)(6), which falls under the preemption
provision’s umbrella. See id. 21 U.S.C. § 343(r)(6) (“For
purposes of paragraph (r)(1)(B), a statement for a dietary
supplement may be made if . . . .”) (emphasis added). This
Court has thus held that “§ 343-1(a)(5) preempts state-law
10                GREENBERG V. TARGET

requirements for claims about dietary supplements that
differ from the FDCA’s requirements.” Dachauer v. NBTY,
Inc., 913 F.3d 844, 848 (9th Cir. 2019).

    Thus, if the defendants’ biotin statement meets the
FDCA’s three requirements for a structure/function claim,
then any state law claims challenging that claim fall to the
wayside. As explained below, the defendants’ biotin
structure/function claim meets all three requirements.

     A. The biotin structure/function           claim    has
        substantiation and is accurate.

    The defendants have met the first requirement for its
structure/function claim because it has substantiation that
biotin “helps support healthy hair and skin,” and that
statement is truthful and not misleading. 21 U.S.C.
§ 343(r)(6)(B).

    Greenberg does not dispute that scientific evidence
exists showing that biotin — the nutrient — supports healthy
hair and skin. Instead, he argues that the structure/function
claim is nevertheless deceptive and runs afoul of the
FDCA’s prohibition against false or misleading statements.
He maintains that a mega-dosage of biotin benefits only a
tiny percentage of the public with biotin deficiency. Thus,
Greenberg reasons, the suggestion that the Up & Up biotin
product helps support hair and skin is misleading for most
people. He implies that the structure/function claim must be
true not only as to the nutrient itself but the product as a
whole.

    But the plain language of the FDCA and its
implementing regulations clarifies that a structure/function
claim addresses only the general role of an
ingredient/nutrient on the human body. It does not purport
                   GREENBERG V. TARGET                       11

to convey the product’s health impact on the general
population, contrary to Greenberg’s assertion. The FDCA
describes a structure/function claim as one that “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.”
21 U.S.C. § 343(r)(6)(A) (emphasis added); see also
21 C.F.R. § 101.93(f). In contrast, a disease claims refers to
the health benefit of a product. 21 C.F.R. § 101.93(g)(2) (“A
statement claims to diagnose, mitigate, treat, cure, or prevent
disease if it claims, explicitly or implicitly, that the product
. . .”) (emphasis added).

    Greenberg’s state law claims challenging the biotin
product’s efficacy are preempted because the statute only
requires substantiation for the ingredient’s function on the
human body, not the health impact of the product as a whole.
Put differently, Congress appears to have created two classes
of claims: (1) a structure/function claim that refers only to
the ingredient or nutrient’s role in the human body, and (2) a
disease claim that speaks to the product’s effect on the
consumer’s disease. Greenberg cannot implicitly import a
disease claim requirement — evidence showing the
product’s impact on the consumer’s health or disease — into
the structure/function claim, given the differences in the
statutory requirements for each. Cf. Dachauer, 913 F.3d at
847 (state law claims preempted where the plaintiff tried to
use evidence about supplement’s inability to prevent disease
to challenge a structure/function claim).

   Greenberg’s reliance on the FDCA’s general prohibition
against false or misleading statements fares no better. Under
Greenberg’s view, the statement that biotin “helps support
healthy hair and skin” is misleading because very few people
12                    GREENBERG V. TARGET

have biotin deficiency and thus would not benefit from the
product. But only a fraction of people suffers a deficiency
of any nutrient. For example, according to Greenberg’s
reasoning, a product that bears the true statement that
“vitamin C boosts immunity” would be misleading because
most people are not vitamin C deficient and would not
benefit from the product. Similarly, the accurate claim that
“calcium helps maintain bones” would be misleading to
most consumers because an extra dosage of calcium would
be superfluous for them. In short, under Greenberg’s logic,
virtually any structure/function claim for dietary
supplements would potentially be misleading to the great
majority of people. Such reasoning conflicts with the
FDCA’s statutory language and the FDA’s stated purpose
for allowing structure/function claims. Cf. Regulations on
Statements Made for Dietary Supplements Concerning the
Effect of the Product on the Structure or Function of the
Body, 65 Fed. Reg. at 1003 (noting that the final
structure/function claim rule “increase[es] the amount of
information available to the consumer without prior FDA
review”).

    Simply put, manufacturers may make structure/function
claims about a nutrient’s general role on the human body
without disclosing whether the product will provide a health
benefit to each consumer. 3

     3
      The plaintiff cites FDA and Federal Trade Commission guidance
to bolster his argument, but they are not on-point and in any event are
not binding on this Court. See, e.g., Guidance for Industry:
Substantiation for Dietary Supplement Claims Made Under Section
403(r)(6) of the Federal Food, Drug, and Cosmetic Act, 74 Fed. Reg.
204-01, 304 (Jan. 5, 2009) (stating that it “does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public”).
                  GREENBERG V. TARGET                     13

   B. The biotin product label has the appropriate
      disclosures.

    To qualify as a structure/function claim, the product
must also contain a prominent disclaimer that the FDA has
not evaluated the statement and that the product “is not
intended to diagnose, treat, cure, or prevent any disease.”
21 U.S.C.§ 343(r)(6)(C). Here, that disclosure appears
twice on the label. The FDCA’s second requirement for
structure/function claims has thus been met.

   C. The biotin product label does not claim to treat
      diseases.

    Finally, the FDCA requires that the statement itself does
not “claim to diagnose, mitigate, treat, cure, or prevent”
disease. Id. The Up & Up biotin product label clearly
disclaims: “This product is not intended to diagnose, treat,
cure, or prevent any disease.” And nowhere does the label
imply otherwise.

                       * * * * *

    In sum, because the structure/function claim about biotin
meets the FDCA’s requirements, Greenberg’s state law
claims amount to an imposition of different standards from
the FDCA. Greenberg essentially seeks to impose an
additional requirement that dietary supplement labels can
make structure/function claims only if consumers are likely
to benefit from the product. But that requirement “is not
identical to the requirement of section 343(r).” 21 U.S.C.
§ 343-1(a)(5). It is thus preempted.

     To be sure, a structure/function claim may be misleading
if it fails to disclose a harmful aspect of the nutrient. For
example, in Dachauer, this Court held that the FDCA did
14                GREENBERG V. TARGET

not preempt the plaintiff’s claim that vitamin E increased the
risk of all-cause mortality. 913 F.3d at 849. There is no such
allegation here.

    Likewise, if a structure/function claim is factually false
or lacks substantiation, then state law claims will not be
preempted. See Kroessler v. CVS Health Corp., 977 F.3d
803, 812 (9th Cir. 2020) (“Kroessler alleges that CVS’s
glucosamine claims are false because scientific studies
directly refute them.”). But that is not the case here.

    We thus hold that the FDCA authorizes the defendants’
structure/function claim about biotin and preempts
Greenberg’s state law claims challenging them.

     AFFIRMED.