James Kroessler v. Cvs Health Corporation ( 2020 )

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
JAMES KROESSLER, individually, and No. 19-55671
on behalf of all others similarly
situated, D.C. No.
Plaintiff-Appellant, 3:19-cv-00277-
CAB-JLB
v.
CVS HEALTH CORPORATION, OPINION
Defendant-Appellee.
Appeal from the United States District Court
for the Southern District of California
Cathy Ann Bencivengo, District Judge, Presiding
Argued and Submitted July 8, 2020
Pasadena, California
Filed October 9, 2020
Before: Richard A. Paez and Bridget S. Bade, Circuit
Judges, and Eric F. Melgren, * District Judge.
Opinion by Judge Melgren
*
The Honorable Eric F. Melgren, United States District Judge for
the District of Kansas, sitting by designation.
2 KROESSLER V. CVS HEALTH CORP.
SUMMARY **
Federal Food, Drug, and Cosmetic Act / Preemption
The panel reversed the district court’s dismissal of a
putative class action brought against CVS Corporation, and
remanded for further proceedings. The district court
dismissed based on Federal Food, Drug, and Cosmetic Act
(“FDCA”) preemption of California state law claims
Plaintiff, a California consumer representing a putative
class, sued CVS Corporation under California law, alleging
that CVS glucosamine-based supplements did not provide
the advertised benefits. Plaintiff alleged that CVS violated
California Unfair Competition Law and Consumer Legal
Remedies Act, and breach of express warranty through the
use of false and misleading labels on the supplements. So
long as California laws impose requirements identical to the
FDCA, the FDCA will not preempt plaintiff’s state law
causes of action.
The FDCA requires manufacturers of dietary
supplements to ensure that the labels on their products are
not “false or misleading in any particular.” 21 U.S.C.
§ 343(a). The FDCA distinguishes between “disease
claims” and “structure/function claims” that manufacturers
make about their products. Plaintiff alleged that CVS lacked
substantiation for its structure/function claims.
**
This summary constitutes no part of the opinion of the court. It
has been prepared by court staff for the convenience of the reader.
KROESSLER V. CVS HEALTH CORP. 3
The panel held that the district court erred in holding that
CVS’s glucosamine labels presented proper
structure/function claims under the FDCA, and in
concluding that plaintiff’s state law causes of action were
preempted. Specifically, first, the panel held that the district
court erred in applying Dachauer v. NBTY, Inc., 913 F.3d
844 (9th Cir. 2019), to the present case. Because plaintiff
“matched” his evidence with CVS’s structure/function
claims, and he did not otherwise allege effects on the risk of
all-cause mortality, his case presented a scenario that
Dachauer did not explicitly address. Second, this case was
distinguished from Dachauer by its procedural posture.
Third, the district court erred by greatly expanding the
present state of federal preemption jurisprudence under the
FDCA, contrary to public policy.
The panel held that the district court erred in holding that
any amendment by plaintiff attempting to state an “implied
disease” claim would be futile. The panel held that the
FDCA allows courts examining implied disease claims to
consider extra-label evidence. The district court should have
given plaintiff the chance to present such evidence and
allegations. The panel further held that the district court
correctly concluded that CVS’s glucosamine-based
supplements did not present implied disease claims on the
face of the label alone.
COUNSEL
Leslie E. Hurst (argued) and Timothy G. Blood, Blood Hurst
& O’Reardon LLP, San Diego, California; Todd D.
Carpenter, Carlson Lynch LLP, San Diego, California; for
Plaintiff-Appellant.
4 KROESSLER V. CVS HEALTH CORP.
Jean-Claude André (argued) and Adriane Peralta, Sidley
Austin LLP, Los Angeles, California; Amy P. Lally, Sidley
Austin LLP, Los Angeles, California; for Defendant-
Appellee.
J. Kathleen Bond and Jennifer M.S. Adams, Amin Talati
Wasserman LLP, Chicago, Illinois, for Amicus Curiae
Council for Responsible Nutrition.
OPINION
MELGREN, District Judge:
Appellant James Kroessler purchased one of CVS’s
glucosamine-based supplements in 2017, believing it would
provide the advertised joint health benefits. He sued CVS
under California law, alleging that the supplement he
purchased, and five additional CVS glucosamine-based
supplements, did not provide the advertised benefits. He
sought to certify a class of similarly situated consumers who
purchased CVS’s glucosamine-based supplements during
the relevant limitations period. The district court dismissed
the case without leave to amend, holding that federal law
preempted Kroessler’s California claims. For the following
reasons, we reverse and remand for further proceedings.
BACKGROUND
Kroessler is a California consumer who represents a
putative class that asserts claims against CVS Health
Corporation (“CVS”), alleging violations of the California
Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code
§§ 17200–17210, and the California Consumer Legal
Remedies Act (“CLRA”), Cal. Civ. Code §§ 1750–1759, as
well as a common-law breach of express warranty claim.
KROESSLER V. CVS HEALTH CORP. 5
CVS sells a line of glucosamine-based supplements.
Kroessler alleges that CVS markets these supplements to
consumers using express and implied messages. The
express marketing message—which CVS concedes—states
that CVS’s glucosamine-based supplements maintain or
support joint health. Kroessler alleges that the implied
marketing message—which CVS contests—states that the
supplements ameliorate the cardinal symptoms of arthritis,
namely joint pain, discomfort, stiffness, and lack of mobility
or flexibility. Kroessler alleges that the supplements do not
provide the advertised benefits.
The complaint identifies six CVS glucosamine-based
supplements: glucosamine maximum strength tablets,
glucosamine MSM caplets, glucosamine chondroitin with
MSM tablets, glucosamine chondroitin with vitamin D
caplets, and glucosamine chondroitin, available in both
tablets and capsules. In marketing these supplements, CVS
makes various claims on the products’ labels. One label
states that the supplement “[s]upports flexibility & range of
motion,” “help[s] support and maintain the structure of
joints,” and “work[s] to support joint comfort while helping
to promote joint mobility.” The message includes the
disclaimer that it is a “DIETARY SUPPLEMENT” that “is
not intended to diagnose, treat, cure, or prevent any disease”
and that “[i]ndividual results may vary.” Another states that
the supplement “[n]ourishes cartilage and promotes
comfortable joint movement” and “[s]upports cartilage
health & joint comfort.”
Kroessler alleges that glucosamine neither supports
healthy joint function nor ameliorates joint pain, discomfort,
stiffness, or other symptoms of joint disease. He claims that
CVS’s glucosamine-based supplements “[have] been
extensively studied in large, well-conducted and published
6 KROESSLER V. CVS HEALTH CORP.
studies involving persons with and without diagnosed
arthritis and [have] been proven to be ineffective at
supporting or benefiting joint health, including by positively
impacting the signs and symptoms of arthritis.” 1 His
complaint summarizes four clinical trials conducted on
persons without diagnosed arthritis, or on a mix of subjects
with and without osteoarthritis, that allegedly support those
contentions. He also cites numerous articles and other
clinical trials concluding that glucosamine is no more
effective than a placebo in preventing osteoarthritis.
Kroessler alleges these studies also show that glucosamine
is no more effective than a placebo at reducing joint pain,
relieving joint stiffness, improving joint function, impacting
joint swelling or space width loss, rebuilding joint cartilage,
or relieving the symptoms of osteoarthritis or slowing their
progression.
CVS moved to dismiss the complaint under Federal
Rules of Civil Procedure 12(b)(1) and 12(b)(6), arguing in
pertinent part that federal law preempted Kroessler’s state-
law causes of action. The district court granted CVS’s
motion to dismiss and denied Kroessler leave to amend.
JURISDICTION AND STANDARDS OF REVIEW
The district court entered final judgment on May 16,
2019, after granting CVS’s motion to dismiss Kroessler’s
claims. Kroessler timely filed a notice of appeal on June 12,
2019, under the Class Action Fairness Act. 2 28 U.S.C.
1
These studies are not part of the record. Kroessler merely
referenced them in his complaint. Accordingly, the district court did not
consider the contents of the studies.
2
Kroessler appeals only the dismissal of his claims pertaining to the
label of the product he purchased. The district court resolved the motion
KROESSLER V. CVS HEALTH CORP. 7
§ 1332(d)(2). Accordingly, this Court has jurisdiction to
review the final judgment. 28 U.S.C. § 1291.
We review de novo a district court’s dismissal of a case
under Rule 12(b)(6) for failure to state a claim. Marder v.
Lopez, 450 F.3d 445, 448 (9th Cir. 2006). Likewise, we
review de novo a district court’s determination that a federal
statute preempts state law claims. Niehaus v. Greyhound
Lines, Inc., 173 F.3d 1207, 1211 (9th Cir. 1999). On review,
we accept the plaintiff’s allegations as true and construe
them in the light most favorable to the plaintiff. Gompper v.
VISX, Inc., 298 F.3d 893, 895 (9th Cir. 2002). A district
court properly dismisses a complaint if the complaint fails to
“plead ‘enough facts to state a claim to relief that is plausible
on its face.’” Weber v. Dep’t of Veterans Affairs, 521 F.3d
1061, 1065 (9th Cir. 2008) (quoting Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 570 (2007)).
Ordinarily, we review a district court’s decision to deny
a party leave to amend its complaint for an abuse of
discretion. Cervantes v. Countrywide Home Loans, Inc.,
656 F.3d 1034, 1041 (9th Cir. 2011). However, if a district
court denies leave to amend based on the futility of the
amendment or inability to allege a valid cause of action, we
review the decision de novo. See Leadsinger, Inc. v. BMG
Music Publ’g, 512 F.3d 522, 532 (9th Cir. 2008).
DISCUSSION
We address two issues in this appeal. First, whether the
district court erred in holding that the Federal Food, Drug,
to dismiss solely on preemption grounds without addressing CVS’s other
arguments, including that Kroessler lacked standing to challenge the
claims made on the labels on the five products that he did not purchase.
We limit our review accordingly.
8 KROESSLER V. CVS HEALTH CORP.
and Cosmetic Act (“FDCA”) preempts Kroessler’s
California state-law causes of action. Second, whether the
district court erred in dismissing Kroessler’s complaint
without granting him leave to amend.
I. FDCA Preemption
Congress enacted the FDCA to “promote the public
health” by ensuring that “foods are safe, wholesome,
sanitary, and properly labeled.” 21 U.S.C. § 393(b)(2)(A).
In 1990, Congress amended the FDCA with the Nutrition
Labeling and Education Act (“NLEA”), 21 U.S.C. § 343 et
seq., and established new requirements governing the
labeling of food, including dietary supplements. In 1994,
Congress further amended the FDCA with the Dietary
Supplement Health and Education Act (“DSHEA”), Pub. L.
No. 103-417, 108 Stat. 4325. 3 The NLEA and DSHEA
together established a new category of food products—
specifically, dietary supplements—that have unique safety,
labeling, manufacturing, and other related standards.
All proceedings “for the enforcement, or to restrain
violations, of” the FDCA must “be by and in the name of the
United States.” 21 U.S.C. § 337(a). Private plaintiffs may
not bring actions to enforce violations of the FDCA. See
POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 109
(2014) (citing 21 U.S.C. § 337(a)). Instead, private plaintiffs
may bring analogous state law claims as long as the FDCA
does not preempt those claims. See Farm Raised Salmon
Cases, 175 P.3d 1170, 1177 (Cal. 2008).
3
We refer to the FDCA, NLEA, and DSHEA collectively as “the
FDCA.”
KROESSLER V. CVS HEALTH CORP. 9
Federal preemption can be either express or implied. See
Fid. Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141,
152–53 (1982). Express preemption exists when a statute
explicitly addresses preemption. Chicanos Por La Causa,
Inc. v. Napolitano, 558 F.3d 856, 863 (9th Cir. 2009).
“When a federal statute contains an explicit preemption
provision, we are to identify the domain expressly pre-
empted by that language.” Id. (internal quotations omitted).
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). The phrase
“not identical to” means “that the State requirement directly
or indirectly imposes obligations or contains provisions
concerning the composition or labeling of food [that] . . .
[a]re not imposed by or contained in the applicable [federal
regulation] . . . or [d]iffer from those specifically imposed by
or contained in the applicable [federal regulation].”
21 C.F.R. § 100.1(c)(4). Furthermore, “§ 343-1(a)(5)
preempts state-law 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).
Therefore, private plaintiffs may bring only actions to
enforce violations of “state laws imposing requirements
identical to those contained in the FDCA.” Farm Raised
Salmon Cases, 175 P.3d at 1177 (citing 21 U.S.C. §§ 337,
343-1).
A.
In the present case, Kroessler brings claims for violations
of the California UCL and CLRA, as well as breach of
express warranty. The UCL prohibits unfair competition,
defined as any “unlawful, unfair or fraudulent business act
10 KROESSLER V. CVS HEALTH CORP.
or practice,” as well as any “unfair, deceptive, untrue or
misleading advertising.” Cal. Bus. & Prof. Code § 17200.
Similarly, the CLRA declares unlawful various anti-
competitive, unfair, or deceptive acts, including
misrepresenting that goods have characteristics, uses, or
benefits that they do not possess. Cal. Civ. Code § 1770(a).
Kroessler alleges that CVS violated California law by selling
glucosamine-based supplements with false and misleading
labels. So long as California laws impose requirements
identical to the FDCA, the FDCA will not preempt
Kroessler’s state law causes of action. Accordingly, it is
necessary to consider the FDCA’s requirements.
B.
The FDCA requires manufacturers of dietary
supplements to ensure that the labels on their products are
not “false or misleading in any particular.” 21 U.S.C.
§ 343(a). The Food and Drug Administration (“FDA”)—the
primary enforcer of the FDCA—specifies that a
supplement’s label is misleading if, among other things, it
fails to reveal facts that are: (1) Material in
light of other representations made or
suggested by statement, word, design, device
or any combination thereof; or (2) Material
with respect to consequences which may
result from use of the article under: (i) The
conditions prescribed in such labeling or (ii)
such conditions of use as are customary or
usual.
21 C.F.R. § 1.21(a). To these ends, the FDCA distinguishes
between “disease claims” and “structure/function claims”
that manufacturers make about their products, applying
different regulatory standards to each. A structure/function
KROESSLER V. CVS HEALTH CORP. 11
claim, among other things, “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)(A), (C). 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); see also 21 U.S.C. § 343(r)(6).
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 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)(C). A dietary
supplement manufacturer making only structure/function
claims regarding its supplement must notify the Office of
Nutritional Products, Labeling, and Dietary Supplements in
the FDA. 21 C.F.R. § 101.93(a). Notably, as long as a
dietary supplement manufacturer meets these requirements,
it may assert structure/function claims without pre-approval
from a federal agency. See id.
The FDA has published regulations defining acceptable
structure/function claims. See 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 (Jan. 6, 2000) (codified at 21 C.F.R. pt. 101). The
guidance recognizes that structure/function claims may use
12 KROESSLER V. CVS HEALTH CORP.
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 FDA
states that “ ‘joint pain’ is characteristic of arthritis . . . [but]
[t]he claim ‘helps support cartilage and joint function,’ on
the other hand, would be a permissible structure/function
claim, because it relates to maintaining normal function
rather than treating joint pain.” Id. at 1016–17. 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.”). As the
main enforcer of the FDCA, the FDA would look to these
guidelines and requirements when pursuing actions against
supplement manufacturers. 4 Because private plaintiffs
cannot enforce these provisions, plaintiffs may only seek to
enforce those standards through state law causes of action
when those state laws hold supplement manufacturers to
identical standards.
To briefly refocus on this appeal: Kroessler sues CVS for
making false and misleading representations on its
glucosamine-based supplement labels, alleging that CVS
lacks substantiation for its structure/function claims. He can
do so as long as his California causes of action seek to hold
4
See 21 U.S.C. § 393.
KROESSLER V. CVS HEALTH CORP. 13
CVS to standards identical to the FDCA’s and the FDA’s
implementing regulations and guidelines.
C.
Although the FDCA requires manufacturers to have
substantiation for their structure/function claims, California
law prohibits private plaintiffs from demanding that
advertisers substantiate their claims. Nat’l Council Against
Health Fraud, Inc. v. King Bio Pharm., Inc., 133 Cal. Rptr.
2d 207, 213 (Cal. Ct. App. 2003). Rather, the onus is on
plaintiffs to prove that advertisers’ claims are false. Id. In
Dachauer, we addressed issues similar to those Kroessler
raises in the present case. There, a consumer brought a
putative class action against manufacturers of vitamin E
supplements, alleging that labels on the supplements
“violate[d] two California laws against false advertising,
because the supplements d[id] not prevent cardiovascular
disease and might increase the risk of all-cause mortality.”
Dachauer, 913 F.3d at 846. The district court granted
summary judgment to the manufacturers because the
plaintiff’s claims were preempted by federal law. Id.
The consumer appealed, and we affirmed. First, we held
that the FDCA preempted the consumer’s claims. The
consumer alleged that the supplement did not prevent
cardiovascular disease (a disease claim), but the supplement
advertised support for cardiovascular health (facially a
structure/function claim). Id. at 848. We implied that the
plaintiff had mismatched his evidence, presenting studies
alleging that vitamin E did not prevent cardiovascular
disease when, based on his claims, he should have presented
studies alleging that vitamin E did not support
cardiovascular health—the supplement’s actual claim. See
id.
14 KROESSLER V. CVS HEALTH CORP.
Second, stemming from the supplement label’s claim to
promote immune health, the consumer alleged that the
supplement did not reduce the risk of all-cause mortality. Id.
at 849. We held that the FDCA preempted that claim
because reducing mortality is a disease claim. Id. Third and
finally, stemming from the supplement label’s claim to
promote immune health, the consumer alleged that the
supplement increased the risk of all-cause mortality. Id. We
held that the FDCA did not preempt that claim. 5 Id. (stating
“the FDCA and California laws have the same labeling
requirement with respect to failing to disclose an increased
risk of death.”). Because the FDCA would not preempt a
claim of that nature, we examined the record to see if any
evidence existed to create a genuine issue of material fact.
Id. at 849–50. “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).” Id. at 849. Thus, in Dachauer we
affirmed the district court’s grant of summary judgment
because the plaintiff failed to meet his burden to create a
genuine issue of material fact that the defendant’s
structure/function claim was misleading. Id. at 850.
In Dachauer, we stated that “[a]lthough the FDCA
requires manufacturers to have substantiation for their
structure/function claims, California law does not allow
5
In the present case, neither Kroessler nor CVS allege that the
glucosamine-based supplements present mortality claims in addition to
their joint health claims. Therefore, Dachauer’s holdings concerning the
increased or decreased risks of all-cause mortality have little bearing on
this case.
KROESSLER V. CVS HEALTH CORP. 15
private plaintiffs to demand substantiation for advertising
claims.” Id. at 847. But just because California law
prohibits private plaintiffs from forcing defendants to
substantiate their advertising claims, that does not mean
California law prohibits those plaintiffs from attacking
defendants’ substantiation. The California case governing
this issue—King Bio Pharmaceuticals, Inc.—held that
California state law prohibits private plaintiffs from shifting
the burden of production to defendants to substantiate their
advertising claims. King Bio Pharm., 133 Cal. Rptr. 2d at
213–14. But it did not hold that plaintiffs cannot challenge
a defendant-advertiser’s purported substantiation. In fact,
that case went to trial but ended with a directed verdict after
the plaintiff failed to provide any evidence rebutting the
defendant’s substantiation. Id. at 210. Therefore, under
California law, a plaintiff retains the burden of production
and the burden of proof but can nevertheless challenge a
defendant’s substantiation. So, Dachauer’s conclusion that
a plaintiff cannot demand substantiation did not encompass
a challenge to an already substantiated claim. On the
contrary, Dachauer implicitly supports a plaintiff’s ability to
challenge both a defendant’s initial substantiation and its
substantiation produced in rebuttal to a plaintiff’s attack, as
revealed by the district court allowing the case to proceed to
summary judgment rather than granting outright dismissal as
a matter of law on the pleadings. Dachauer, 913 F.3d at 846.
By permitting discovery and proceeding to summary
judgment, the district court in Dachauer confirmed that
plaintiffs can challenge defendants’ substantiation by
pointing to “matching evidence” contradicting those
claims. 6 That distinction provides the key to understanding
6
The FDA’s guidelines also support this proposition. To meet the
FDCA’s requirement for “dietary supplement manufacturers to have
16 KROESSLER V. CVS HEALTH CORP.
Dachauer’s previously quoted juxtaposition between the
FDCA and California law. Dachauer dealt with a
“mismatch” of evidence—the plaintiff attempted to dispute
the defendant’s substantiation that the supplement promoted
heart health by citing studies showing that the supplement
did not prevent heart disease. See id. at 848. Had we
permitted the plaintiff’s claims to proceed, we would have
forced the defendant to substantiate that the supplement also
prevented heart disease. That would have held the defendant
to burdens of production and proof different than those
required for structure/function claims under the FDCA.
Therefore, the FDCA preempted the plaintiff’s claim.
Importantly, however, Dachauer did not hold that the FDCA
preempts state law causes of action when a plaintiff attempts
substantiation that structure/function . . . claims on a dietary supplement
product’s labeling are truthful and not misleading” the FDA recommends
that manufacturers possess adequate substantiation for
each reasonable interpretation of the claims. We
intend to apply a standard that is consistent with the
FTC standard of “competent and reliable scientific
evidence” to substantiate a claim. We consider the
following factors important to establish whether
information would constitute “competent and reliable
scientific evidence”: . . . [] If multiple studies exist, do
the studies that have the most reliable methodologies
suggest a particular outcome? If multiple studies exist,
what do most studies suggest or find? Does the totality
of the evidence agree with the claim(s)?
Guidance for Industry: Substantiation for Dietary Supplement Claims
Made Under Section 403(R) (6) of the Federal Food, Drug, and
Cosmetic Act, 2008 WL 10889843, at *15 (emphasis added). This
implies that a defendant’s substantiation may be evaluated and
challenged.
KROESSLER V. CVS HEALTH CORP. 17
to hold a defendant to the same substantiation standard
required by the FDCA.
D.
Here, the district court interpreted Dachauer as holding
that the FDCA preempts any state-law cause of action
seeking to challenge the substantiation of a
structure/function claim—including those where the
allegations and evidence “match” the structure/function
claims—so long as the manufacturer’s claims are proper
structure/function claims. Because the court concluded that
CVS’s glucosamine labels presented proper
structure/function claims under the FDCA, it held that
Kroessler’s causes of action were preempted. It stated that
Kroessler’s citations to studies alleging that glucosamine is
“ineffective at supporting or benefiting joint health”
ultimately do not matter because CVS is merely required to
substantiate its structure/function claims, not defend against
a private plaintiff’s contradicting evidence. According to the
district court, if it permitted Kroessler’s state law causes of
action then the distinction between structure/function claims
and disease claims would be blurred since Kroessler would
seek to hold CVS’s structure/function claims to the higher
standard for disease claims.
The district court erred in so holding. First, the court
erred in applying Dachauer to the present case because this
case does not fit within Dachauer’s ruling. Kroessler does
not allege that CVS’s structure/function claims are false
either because the supplements do not prevent osteoarthritis
or because they do not reduce the risk of all-cause
mortality—allegations Dachauer clearly proscribed. Nor
does he allege that the claims are false because the
supplements increase the risk of all-cause mortality—an
allegation Dachauer clearly permitted. Although he is
18 KROESSLER V. CVS HEALTH CORP.
occasionally inconsistent throughout the complaint and
briefings, Kroessler alleges that CVS’s glucosamine claims
are false because scientific studies directly refute them. The
supplement labels claim, using various terms, to support and
maintain joint health, but the scientific studies allegedly
conclude that glucosamine is useless for such ends.
Therefore, Dachauer did not address the scenario in the
present case.
Kroessler cited multiple scientific studies in his
complaint but he was not able to pursue discovery to obtain
evidence that might bolster or rebut them. To be sure,
Kroessler’s synopses of the studies generally allege that
glucosamine is no more effective than a placebo at reducing
joint pain, relieving joint stiffness, improving joint function,
impacting joint swelling or space width loss, rebuilding joint
cartilage, or relieving the symptoms of osteoarthritis or
slowing their progression. These allegations do not match
the labels containing CVS’s structure/function claims, which
state that the products maintain and support general joint
health. Indeed, many of the studies’ titles themselves
suggest that they narrowly address glucosamine’s effects on
osteoarthritis, rather than its wider efficacy in supporting or
maintaining joint health.
However, as previously noted, Kroessler also alleges that
the contents of the studies support the conclusion that
glucosamine is “ineffective” at “supporting, maintaining, or
benefiting the health of human joints.” Taken as true, those
allegations directly refute CVS’s claims. Therefore, unlike
the plaintiff in Dachauer, Kroessler’s factual allegations,
taken as true, support his claim that CVS violated California
law.
The FDCA does not preempt California false advertising
causes of action simply because the challenged label
KROESSLER V. CVS HEALTH CORP. 19
contains a proper structure/function claim; instead,
preemption applies only if the plaintiff’s legal claims and
factual allegations would hold a defendant to a different
“substantiation” standard than the FDCA. Dachauer held
that the FDCA only preempted causes of action where the
evidence to rebut a supplement’s structure/function claims
did not “match” such claims, but instead related to a disease
claim or showed a decreased risk of all-cause mortality.7
Dachauer, 913 F.3d at 848. Thus, Dachauer is
distinguishable, and applying its analysis here does not lead
to the conclusion that the FDCA preempted Kroessler’s state
law causes of action. Because Kroessler “matched” his
evidence with CVS’s structure/function claims and he does
not otherwise allege effects on the risk of all-cause mortality,
his case presents a scenario that Dachauer did not explicitly
address.
Second, this case is distinguished from Dachauer by its
procedural posture. Dachauer was an appeal from a grant of
summary judgment, while this case is an appeal from
dismissal on the pleadings. See id. at 846. The quality of
the evidence in the record—namely, what the scientific
studies and expert testimony claimed to prove or disprove—
was crucial to our holding in Dachauer. There, we noted
that the record lacked evidence showing that the supplement
increased the risk of all-cause mortality and therefore the
plaintiff failed to meet his burden to show a genuine issue of
material fact. Id. at 850. This court in Dachauer, and many
other courts, have permitted state-law claims for false
7
However, Dachauer did not hold that only cases with
“mismatched” evidence are preempted.
20 KROESSLER V. CVS HEALTH CORP.
advertising to proceed well past the pleading stage. 8 Thus,
Dachauer implicitly supported the proposition that private
plaintiffs should be allowed to sue dietary supplement
manufacturers, so long as the state law causes of action
impose identical standards as the FDCA, unless the court
ultimately determines that the plaintiffs’ evidence does not
support their claims. Such an evidentiary analysis is not
appropriate at the early procedural stage presented in this
case.
CVS unsuccessfully attempts to fit Kroessler’s factual
scenario into the confines of Dachauer. It argues that
Kroessler’s cited scientific studies attempt to prove
glucosamine’s inefficacy at treating arthritis, while the
supplement’s labels merely claim to support and maintain
normal joint function. Thus, CVS’s argument attacks the
evidence Kroessler eventually intends to present in this case.
At this early stage in the proceedings, however, we will not
consider the studies’ substance because they are not attached
to the pleadings or otherwise part of the record. CVS may
attack the sufficiency of Kroessler’s evidence at summary
judgment or trial—and it may well succeed at those stages.
But at this stage, FDCA preemption does not prevent
Kroessler’s state law claims from proceeding.
8
See, e.g., Hazlin v. Botanical Labs., Inc., No. 13cv0618 DMS
(JMA), 2013 WL 12076470, at *4 (S.D. Cal. Aug 8, 2013); Vasic v.
Patent Health, LLC., No. 13cv849 AJB (MDD), 2014 WL 940323, at *7
(S.D. Cal. Mar. 10, 2014); Zakaria v. Gerber Prods. Co., No. LA CV15-
00200 JAK (Ex), 2015 WL 4379743, at *3 (C.D. Cal. July 14, 2015); In
re Clorox Consumer Litig., 894 F. Supp. 2d 1224, 1228 (N.D. Cal. 2012);
Fraker v. Bayer Corp., No. CV F 08-1564 AWI GSA, 2009 WL
5865687, at *8–9 (E.D. Cal. Oct. 6, 2009); Stanley v. Bayer Healthcare
LLC, No. 11cv862-IEG (BLM), 2012 WL 1132920, at *3 (S.D. Cal. Apr.
3, 2012).
KROESSLER V. CVS HEALTH CORP. 21
Third and finally, the district court erred by greatly
expanding the present state of federal preemption
jurisprudence under the FDCA, contrary to public policy.
No other circuit has held that the FDCA preempts any state
law cause of action seeking to challenge the substantiation
of a structure/function claim—where the allegations and
evidence “match” the structure/function claims—so long as
the manufacturer’s claims are proper structure/function
claims. Rather, it is well established that “supplement
makers can be sued for false claims, and no federal
preemption exists under the FDCA either by statute or by
implication, since the FDA does not occupy the field and its
controls are unaffected by private false advertising suits
against supplement makers.” 1 James T. O’Reilly, Food and
Drug Administration § 10:112 (Katharine A. Van Tassel, 4th
ed. 2020). Adopting the district court’s interpretation of
Dachauer would permit an unprecedented broadening of
FDCA preemption, barring nearly all private rights of action
under state law against supplement manufacturers.
Furthermore, since the FDCA does not create a private
right of action for plaintiffs to sue dietary supplement
manufacturers, affirming the district court’s ruling would
leave federal regulators as the sole enforcers of the FDCA
within the Ninth Circuit. Id. This contradicts the FDCA’s
stated purpose of promoting public policy by retaining
parallel avenues for private and public enforcement actions
against false or misleading statements. 2 James T. O’Reilly,
Food and Drug Administration § 25:21 (Katharine A. Van
Tassel, 4th ed. 2020). Even CVS does not directly argue that
the FDCA preempts Kroessler’s California claims simply
because its glucosamine-based supplements present
structure/function claims. It likely understands that such a
position would greatly expand the preemption doctrine. The
22 KROESSLER V. CVS HEALTH CORP.
district court’s ruling mistakenly broadened the FDCA
preemption doctrine beyond acceptable public policy limits.
II. Leave to Amend the Complaint
The district court dismissed Kroessler’s complaint with
prejudice, stating in a footnote that any amendment to the
complaint would be futile because, as a matter of law, the
FDCA would preempt any state law cause of action.
Kroessler disagrees, asserting that an amendment would not
be futile because he could bolster his “implied disease”
claim with further allegations.
In assessing whether leave to amend is proper, courts
consider “the presence or absence of undue delay, bad faith,
dilatory motive, repeated failure to cure deficiencies by
previous amendments, undue prejudice to the opposing party
and futility of the proposed amendment.” Moore v. Kayport
Package Exp., Inc., 885 F.2d 531, 538 (9th Cir. 1989).
“Futility of amendment can, by itself, justify the denial of a
motion for leave to amend.” Bonin v. Calderon, 59 F.3d 815,
845 (9th Cir. 1995). If no amendment would allow the
complaint to withstand dismissal as a matter of law, courts
consider amendment futile. See Moore, 885 F.2d at 538–39.
Here, the district court concluded that any amendment
attempting to state an “implied disease” claim would be
futile. As we explain next, this conclusion was in error.
A.
The FDA recognizes that products marketed as
supplements may nevertheless implicitly claim to impact a
disease or the signs of symptoms of a disease. See 65 Fed.
Reg. at 1012. Differentiating between structure/function and
disease claims, the FDA specifies the criteria it uses to
classify a supplement’s statements as disease claims.
KROESSLER V. CVS HEALTH CORP. 23
21 C.F.R. § 101.93(g)(2). However, the “criteria are not
intended to classify as disease claims statements that refer to
the ability of a product to maintain healthy structure or
function, unless the statement implies disease prevention or
treatment.” Id. (emphasis added). “In determining whether
a statement is a disease claim under these criteria, [the] FDA
will consider the context in which the claim is presented.”
Id. Therefore, a structure/function claim may also imply a
disease claim when considered in context.
The first factor the FDA looks to when considering “the
context in which the claim is presented” is the actual label
on the supplement. Regarding a supplement’s objective
representations, the FDA’s guidance states that a label
claiming the product “reduces the pain and stiffness
associated with arthritis” would be a clear disease claim
because it explicitly mentions arthritis. 65 Fed. Reg. at 1012.
“Implied disease claims do not mention the name of a
specific disease, but refer to identifiable characteristics of a
disease from which the disease itself may be inferred.” Id.
Implied disease claims need not consist of words alone;
“images of people suffering from the disease” are another
way to imply a disease claim. Id. at 1012. The FDA admits
that “[t]he distinction between implied and express disease
claims is thus, in many cases, a semantic one . . . .” Id.
at 1013.
A supplement label’s objective representations are not
the only factors the FDA will consider when determining
“the context in which the claim is presented” for purposes of
identifying implied disease claims. 21 C.F.R.
§ 101.93(g)(2). “[I]n appropriate circumstances, [the] FDA
may find that a dietary supplement for which only
structure/function claims are made in labeling may
nevertheless [claim to treat disease] if there is other evidence
24 KROESSLER V. CVS HEALTH CORP.
of intended use to prevent or treat disease.” 65 Fed. Reg.
at 1006 (emphasis added). We need not delineate what types
of evidence courts may consider when evaluating implied
disease claims. It is sufficient to state that many other courts
have considered extra-label material when identifying
implied disease claims and that those considerations are best
made by district courts on a case-by-case basis. 9
B.
In this case, the district court considered only the
objective representations on the label of the glucosamine-
based supplement that Kroessler purchased, which is similar
to the labels on CVS’s other glucosamine-based
supplements identified in the complaint. It concluded that
CVS’s representations did not make disease claims since
they did not purport to reduce or improve anything or
otherwise mention joint pain. The district court concluded
that they were proper structure/function claims that were
consistent with federal requirements. The court appears to
have foreclosed Kroessler from asserting an implied disease
claim based on its incorrect determination that the presence
of a structure/function claim causes the FDCA to preempt
California causes of action. In a footnote at the end of its
order, the court stated that “[it] does not find that any
amendment to this claim could possibly cure the deficiency.”
The footnote is attached to a sentence concluding that the
9
District courts within this circuit have considered factors such as
the product’s advertisements, the consumer’s experience with the
product, and market research showing consumer’s typical uses of the
product. See, e.g., Mullins v. Premier Nutrition Corp., 178 F. Supp. 3d
867, 899 (N.D. Cal. 2016). District courts in other circuits have similarly
considered various extra-label factors. See United States v. Kasz Enters.,
Inc., 855 F. Supp. 534, 540–44, amended, 862 F. Supp. 717 (D.R.I.
1994).
KROESSLER V. CVS HEALTH CORP. 25
FDCA preempts all of Kroessler’s claims. By denying
Kroessler leave to amend his complaint to include
allegations of extra-label evidence supporting an implied
disease claim, the court concluded that only a supplement’s
label can imply disease claims.
The court erred in denying Kroessler leave to amend his
complaint on the grounds of futility. It attached its
preemption holding to Kroessler’s implied disease claim and
considered only the labels on CVS’s glucosamine-based
supplements, concluding that they present structure/function
claims that necessarily trigger the FDCA’s preemption of
Kroessler’s California causes of action. But even if the
district court’s preemption reasoning is disentangled from its
denial of leave to amend, it still erred in denying leave. The
current state of FDCA law, as clarified by the FDA’s
guidance and various courts’ rulings, both cited above,
allows courts examining implied disease claims to consider
extra-label evidence. The district court should have given
Kroessler the chance to present such evidence and
allegations.
C.
The district court correctly concluded, however, that
CVS’s glucosamine-based supplements do not present
implied disease claims on the face of the label alone. None
of the words on the labels fit within the FDA’s guidance on
telltale implied disease claims. On the contrary, most of the
labels’ representations perfectly match the FDA’s examples
of proper structure/function claims. Furthermore, as
Kroessler himself notes, the images on the labels show an
elderly couple leisurely walking along a beach, far from
suffering with the symptoms of arthritis. The labels do not
present these pictures as “before and after” comparisons,
implying the healing of arthritic patients. Therefore, based
26 KROESSLER V. CVS HEALTH CORP.
on the FDCA, enabling regulations, and the FDA’s
accompanying guidance, CVS’s glucosamine-based
supplements do not present implied disease claims on the
face of the labels alone.
Because Kroessler may have been able to “bolster” his
complaint with allegations of extra-label evidence showing
that CVS’s glucosamine-based supplements present implied
disease claims, the court erred by denying him leave to
amend his complaint based on futility.
CONCLUSION
The district court erred in concluding that the FDCA
preempts Kroessler’s state law causes of action simply
because CVS’s glucosamine-based supplements present
only structure/function claims, and erred in dismissing the
complaint without granting Kroessler leave to amend to add
allegations regarding an implied disease claim.
REVERSED and REMANDED.