FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

GILLIAN DAVIDSON; SAMUEL 

DAVIDSON, as individuals, on behalf 

of themselves, the general public, and 

those similarly situated, 

Plaintiffs-Appellants, 

 v. 

SPROUT FOODS, INC., 

Defendant-Appellee.

No. 22-16656 

D.C. No.

3:22-cv-01050-RS 

OPINION

Appeal from the United States District Court

for the Northern District of California

Richard Seeborg, Chief District Judge, Presiding

Argued and Submitted November 9, 2023

Phoenix, Arizona

Filed June 28, 2024

Before: Mary M. Schroeder, Daniel P. Collins, and 

Roopali H. Desai, Circuit Judges.

Opinion by Judge Schroeder;

Partial Concurrence and Partial Dissent by Judge Collins
2 DAVIDSON V. SPROUT FOODS, INC. 

SUMMARY*

Food Labeling 

The panel affirmed the district court’s dismissal of 

plaintiffs’ fraud-based claims, and reversed the district court’s 

dismissal of plaintiffs’ California Sherman Law claim and 

unjust enrichment claim, in a putative class action challenging 

the labels on Sprout Foods, Inc.’s baby food pouches. 

The Sherman Law, California’s analog to the federal Food 

Drug and Cosmetic Act (FDCA), incorporates by reference 

all federal food labeling standards, including a prohibition 

against labeling the front of baby food containers with the 

product’s nutrient content. Sprout produced pouches of baby 

food with labels on the front stating the amount of nutrients 

the pouches contained. Plaintiffs seek to represent a class of 

consumers who purchased Sprout’s products. 

The panel held that federal law did not preempt private 

enforcement of the Sherman Law’s labeling requirements, 

and reversed the district court’s dismissal of plaintiffs’ 

Sherman Law claims. Although the FDCA provides, with 

limited exceptions, that the law can only be enforced by the 

federal government, the federal food labeling statute—the 

Nutrition Labeling and Education Act—permits states to 

enact labeling standards so long as they are identical to the 

federal standards. California has done that. Because plaintiffs 

were seeking to enforce the parallel state law that Congress 

intended states to enact, the district court should not have 

relied on authority preempting private enforcement of the 

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

been prepared by court staff for the convenience of the reader.
DAVIDSON V. SPROUT FOODS, INC. 3

federal law. 

The panel affirmed the district court’s dismissal of 

plaintiffs’ fraud-based claims because the claims were subject 

to the heightened pleading requirements of Fed. R. Civ. P. 9, 

and the allegations failed to allege with particularity why the 

products were harmful. 

In light of the reversal on the Sherman Law claim, the 

panel held that an additional unjust enrichment claim 

survived, and the panel reversed the district court’s dismissal 

of that claim. 

Concurring in part and dissenting in part, Judge Collins 

would affirm the district court’s judgment dismissing the 

entire action. He agreed with the majority that plaintiffs’ 

fraud-based claims were properly dismissed as inadequately 

pleaded. He would further hold that plaintiffs’ remaining 

substantive claim—which attempted to use California state 

law to enforce a specific federal regulation concerning the 

labeling of toddler food products—was impliedly preempted 

because the relevant federal statute barred private 

enforcement of its provisions. He dissented to the extent that 

the majority reached a contrary conclusion and allowed the 

claim, and the related unjust enrichment claim, to proceed.
4 DAVIDSON V. SPROUT FOODS, INC. 

COUNSEL

Matthew T. McCrary (argued), Gutride Safier LLP, Boulder, 

Colorado; Seth A. Safier, Gutride Safier LLP, San Francisco, 

California; for Plaintiff-Appellant. 

Chad R. Fears (argued), Joshua D. Cools, Haley E. LaMorte, 

Evans Fears Schuttert McNulty & Mickus LLP, Las Vegas, 

Nevada; Elizabeth V. McNulty and Joshua D. Cools, Evans 

Fears Schuttert McNulty & Mickus LLP, Irvine, California; 

for Defendant-Appellee.

OPINION

SCHROEDER, Circuit Judge: 

INTRODUCTION

California’s analog to the federal Food Drug and 

Cosmetic Act (FDCA) is known as the Sherman Law. It 

incorporates by reference all federal food labeling standards. 

These include a prohibition against labeling the front of baby 

food containers with the product’s nutrient content. Sprout 

Foods, Inc. (Sprout), the Defendant-Appellee, nevertheless 

produced pouches of baby food with labels on the front of 

the package conspicuously stating the amount of nutrients 

the pouches contained. Gillian and Samuel Davidson, the 

plaintiff-appellants, purchased some of the pouches. 

The Davidsons filed this putative class action in federal 

court claiming violation of California’s Unfair Competition 

Law, and alleging the pouch labels violate the Sherman 
DAVIDSON V. SPROUT FOODS, INC. 5

Law.1 The amended complaint also contained state law 

claims of false advertising, fraud, and deception, alleging 

that the nutrient content labels misled consumers into 

believing the products were good for babies when they were 

actually harmful.

The district court dismissed the complaint for failure to 

state a claim. It held that the Sherman Law claim was 

impliedly preempted because the Sherman Law is derived 

from the FDCA, and the federal law calls for federal 

government enforcement. The federal law, however, 

expressly permits states to enact standards identical to the 

federal standards and in this case, plaintiffs are attempting to 

enforce identical standards set forth in a state statute, the 

Sherman Law. The federal law does not limit the manner in 

which the state statute is enforced, and private enforcement 

of that statute does not conflict with federal enforcement of 

the FDCA. We therefore conclude that the federal law does 

not preempt private enforcement of the Sherman Law’s 

labeling requirements, and we reverse the district court’s 

dismissal of the Sherman Law claim.

The district court also dismissed the fraud-based claims 

for failure to plausibly allege the products were misleading. 

We affirm the district court’s dismissal of these claims, 

because they do not meet the elevated pleading standards of 

Federal Rule of Civil Procedure 9(b).

1 For consistency, because the Davidsons’ Unfair Competition Law 

claim is premised on alleged violations of the Sherman Law, we refer to 

the Davidsons’ claim as the “Sherman Law claim.”
6 DAVIDSON V. SPROUT FOODS, INC.

FACTUAL AND PROCEDURAL BACKGROUND

This case is about the relationship between the federal 

labeling requirements for baby food and the identical 

California labeling requirements. The umbrella federal 

statute, the FDCA, provides, with limited exceptions, that 

the law can be enforced only by the federal government. 

Nevertheless, the federal food labeling statute, the Nutrition 

Labeling and Education Act (NLEA), permits states to enact 

labeling standards so long as they are identical to the federal 

standards. California has done that. Plaintiffs therefore 

claim that Sprout has violated the California requirements.

The principal legal question in the case is whether the 

California requirements can be privately enforced or 

whether the federal limitation, effectively preventing private 

enforcement of the federal law, preempts private 

enforcement of the state standards. The regulatory 

background is therefore important to understanding the 

relationship between the federal and state labeling standards.

Food labeling has traditionally been the province of the 

states, and California has made the false or misleading 

labeling of food unlawful at least since 1939. See Cal. 

Health & Safety Code § 110660, previously codified as Cal. 

Health & Safety Code § 26490. In 1970, California enacted 

more modern and comprehensive provisions, known as the 

Sherman Law. See 1970 Cal Stat. ch. 1573.

Congress in 1990 amended the FDCA by enacting the 

NLEA in order to provide nationally uniform standards for 

nutrition labeling. The law was intended to displace 

disparate state standards. See 21 U.S.C. § 343-1. It contains 

an express preemption provision that allows states to enact 

only standards identical to federal law. Id. California then 

amended the Sherman Law to incorporate all federal 
DAVIDSON V. SPROUT FOODS, INC. 7

standards, thereby ensuring that California standards will be 

the same as the federal standards and not be preempted. Cal. 

Health & Safety Code § 110100(a).

The relevant federal regulation prohibits “nutrient 

content claims . . . on food intended for use by infants and 

children less than 2 years of age.” 21 C.F.R. § 101.13(b)(3). 

California law incorporates the same prohibition. See Cal. 

Health & Safety Code § 110100(a).

In setting out its reason for the prohibition, the FDA 

essentially explained that what is good for adults may not be 

so good for babies. See Food Labeling: Nutrient Content 

Claims, General Principles, Petitions, Definition of Terms, 

56 Fed. Reg. 60421, 60424 (Nov. 27, 1991). The agency 

pointed to a general agreement among associations of health 

professionals that fat and cholesterol should not be restricted 

in the diets of infants. Id. The agency also said that it lacked 

evidence that restricting nutrients like sodium or increasing 

intake of nutrients such as fiber would be beneficial for 

infants and toddlers. Id. It therefore concluded that until it 

had such evidence, it was prohibiting nutrient content claims 

on food products intended for babies under two. Id. The 

agency was clearly concerned that such labeling could lead 

consumers to believe that a product was good for babies 

when the agency had no basis for such conclusions.

Sprout sells baby and toddler food products under its 

label, including pouches of pureed food intended for babies 

under two. The front of the pouches have labels that 

prominently feature statements of the nutrient content of the 

food inside. The example alleged in the amended complaint 

and cited by the district court was “3g of Protein, 5g of Fiber 

and 300mg Omega-3 from Chia ALA.” These types of 

claims on the labels of the Sprout pouches appear to be what 
8 DAVIDSON V. SPROUT FOODS, INC.

the FDA regulation and, by extension, the Sherman Law 

prohibit.

This is an example:

The parties agree that the federal statute does not 

expressly preempt private enforcement of the state 

standards. It expressly preempts only state standards that 

deviate from the federal. 21 U.S.C. § 343-1(a). Still, the 

Supreme Court has recognized that preemption of state law 

may be implied where preemption “was the clear and 

manifest purpose of Congress.” Altria Grp., Inc. v. Good, 

555 U.S. 70, 77 (2008) (quoting Rice v. Santa Fe Elevator 

Corp., 331 U.S. 218, 230 (1947)). We have, for example, 

said state law is impliedly preempted when it stands in the 

way of fulfilling a Congressional objective. See McClellan 

v. I-Flow Corp., 776 F.3d 1035, 1039 (9th Cir. 2015). There 

have been a number of cases filed in federal district courts in 

California where private parties sought to enforce the 

provisions of the California Sherman Law that parallel the 

federal law, but this is the first to reach this court.
DAVIDSON V. SPROUT FOODS, INC. 9

The plaintiffs in this case, Gillian and Samuel Davidson, 

filed this diversity action in district court seeking to 

represent a class of consumers who purchased Sprout’s 

products, beginning in 2018. Plaintiffs asserted a claim that 

Sprout’s conduct was “unlawful” under California’s Unfair 

Competition Law (UCL) because the Sprout pouches were 

labeled in violation of California’s Sherman Law. See Cal. 

Bus. & Prof. Code § 17200 (UCL). Plaintiffs also invoked 

the California False Advertising Law (FAL), the California 

Consumer Legal Remedies Act (CLRA), the UCL, and 

common law fraud to contend that the labeling was 

fraudulent and misleading in that the labeling led purchasers 

to believe the products were good for babies when they were 

actually harmful. See Cal. Bus. & Prof. Code § 17500,

(FAL); Cal. Civ. Code § 1770 (CLRA).

Sprout moved to dismiss the First Amended Complaint 

under Rule 12(b)(6) for failure to state a claim. The district 

court granted the motion in its entirety. The court dismissed 

the Sherman Law claim as impliedly preempted by the 

federal statute, reasoning that because the Sherman Law 

depends upon and “adopts the FDCA and regulations as state 

law,” the claim was essentially governed by the federal law 

that barred private enforcement.

The district court also dismissed the claims sounding in 

fraud. The district court accepted for purposes of surviving 

a motion to dismiss, that plaintiffs had plausibly alleged the 

nutrient content labels imply health benefits. But it ruled 

plaintiffs had failed to plausibly allege that this implied 

message was misleading because they did not sufficiently 

allege that the products caused harm. The court dismissed 

under Rule 9 with further leave to amend, but plaintiffs 

chose to stand on their First Amended Complaint and appeal.
10 DAVIDSON V. SPROUT FOODS, INC. 

In this appeal, they first argue that the district court erred 

in holding their Sherman Law claim was impliedly 

preempted. Plaintiffs contend that because they are seeking 

to enforce the parallel state law that Congress intended states 

to enact, the district court should not have relied on authority 

preempting private enforcement of the federal law. We 

agree with plaintiffs in this regard.

Plaintiffs also contend the district court erred in 

dismissing their fraud-based claims. Here we affirm the 

district court, because the claims were subject to the 

heightened pleading requirements of Rule 9, and the 

allegations failed to allege with particularity why the 

products were harmful.

DISCUSSION

I. Sherman Law Claim

The primary legal issue in this case is whether the FDCA 

provision, granting the federal government virtually 

exclusive authority to enforce the federal law, preempts 

private enforcement of California’s Sherman Law, even 

though the FDCA does not preempt the Sherman Law itself. 

The plaintiffs seek such private enforcement through the 

state’s UCL. The district court correctly recognized that the 

success of this claim turns on the relationship between 

federal and state law. It is therefore helpful to review the 

relevant statutory and regulatory provisions: 

• 21 U.S.C. § 337(a) (FDCA § 310(a)) - This provision 

dictates that the FDCA shall only be enforced by the 

United States, except as described in § 337(b). 
DAVIDSON V. SPROUT FOODS, INC. 11

• 21 U.S.C. § 337(b) (FDCA § 310(b)) - This 

provision permits states to enforce the FDCA in 

limited circumstances.

• 21 U.S.C. § 343-1 (NLEA § 403A) - This is the 

NLEA’s express preemption provision, which 

prevents states from enacting labeling requirements 

that are “not identical to” federal standards.

• 21 C.F.R. § 101.13(b)(3) - This FDA regulation 

promulgated under the NLEA prohibits “nutrient 

content claims” on “food intended specifically for 

use by infants and children less than 2 years of age.” 

• Cal. Health & Safety Code § 110100(a) - This section 

of California’s Sherman Law incorporates by 

reference food labeling regulations adopted under 

the NLEA.

Because the Sherman Law incorporates all the federal 

food labeling requirements, it is “identical” to federal 

standards and not expressly preempted. It is expressly 

permitted. See 21 U.S.C. § 343-1 (NLEA § 403A). In 

preempting state laws that differ from the federal standards, 

and thereby permitting parallel state laws, the FDCA did not 

even purport to limit enforcement of such parallel state laws 

in any way. The express preemption provision simply states, 

“no State . . . may directly or indirectly establish . . . or 

continue in effect . . . any requirement for nutrition labeling 

of food that is not identical to the [NLEA] requirement[s].” 

21 U.S.C. § 343-1(a)(4) (NLEA § 403A(a)(4)). 

The district court nevertheless held that enforcement of 

the state standards under state law was impliedly preempted. 

It reasoned that because federal law prohibited private 

enforcement of the federal standards, and the substance of 
12 DAVIDSON V. SPROUT FOODS, INC.

the state law was the same as the federal law, Congress 

impliedly preempted private enforcement of the state 

standards as well. The district court adopted reasoning from 

its own prior decision finding that the FDCA impliedly 

preempted a similar Sherman Law claim. See Chong v. 

Kind, LLC, 585 F. Supp. 3d 1215, 1219-20 (N.D. Cal. 2022). 

That decision, in turn, relied upon the leading Supreme 

Court case holding that the FDCA impliedly preempts state 

law claims premised on FDCA violations. See Buckman Co. 

v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). It is 

therefore important to understand what Buckman was and 

was not about.

Buckman did not involve any violation of duties owed 

under a state consumer protection statute. Plaintiffs there 

were attempting to use causes of action available under state 

law to claim damages for violations of duties owed under the 

federal FDCA. Plaintiffs had been injured by faulty medical 

devices that required FDA approval and attempted to sue the 

manufacturer under state tort law for violating duties owed 

to the FDA under federal law. Id. at 343. They claimed the 

defendant had misrepresented the uses of the devices to the 

FDA in order to receive pre-market approval. Id. The 

Supreme Court held the claims were impliedly preempted by 

the FDCA because the duties allegedly violated were duties 

owed to the federal agency, and the claim was in essence a 

claim of violation of federal law. Id. at 348, 353. The Court 

explained that the claims existed “solely by virtue of FDCA 

. . . requirements” to make disclosures to the FDA during the 

pre-market approval process. Id. at 353. The Court further 

explained that such claims are impliedly preempted because 

they “inevitably conflict” with the federal government’s 

exclusive enforcement authority over the FDCA’s 
DAVIDSON V. SPROUT FOODS, INC. 13

regulatory scheme for medical devices. Id. at 348-50 (citing 

21 U.S.C. § 337(a) (FDCA § 310(a))).

Our court has reached the same conclusion where 

plaintiffs attempted to use state causes of action to claim 

violations of FDCA duties. For example, in Perez, this court 

considered a common law fraud-by-omission claim that 

medical device manufacturers failed to disclose that a laser 

system was not FDA-approved to treat farsightedness. See 

Perez v. Nidek Co., 711 F.3d 1109, 1117 (9th Cir. 2013). 

This claim rested “solely [upon a] failure to disclose lack of 

FDA approval,” a disclosure that the FDCA requires. Id. at 

1119-20. Like the claim in Buckman, this claim “exist[ed] 

solely by virtue of the FDCA . . . requirements” rather than 

a state law duty. Id. at 1119 (quoting Buckman, 531 U.S. at 

353). We therefore held the claim was impliedly preempted 

because it “amount[ed] to an attempt to privately enforce the 

FDCA,” which is barred by the enforcement limitation in 

§ 337 (FDCA § 310). Id. at 1117, 1119.

In a more recent case, we followed Buckman and Perez

in concluding that a state law claim premised on violation of 

FDCA duties was impliedly preempted. Nexus Pharms., Inc. 

v. Cent. Admixture Pharmacy Servs. Inc., 48 F.4th 1040, 

1050-51 (9th Cir. 2022). There, the plaintiffs claimed that 

drug-compounding facilities violated state statutes 

prohibiting the sale of drugs not approved by the FDA. Id. 

at 1044. Such a claim would require litigating whether the 

facilities qualified for an exception to FDA approval, i.e., 

whether an FDCA violation had occurred. Id. at 1049. 

Because this was a task reserved for the FDA, we held that 

the claim was impliedly preempted under § 337 (FDCA 

§ 310) as an attempt to privately enforce the FDCA’s 

requirements for compounding facilities. Id. at 1050-51.
14 DAVIDSON V. SPROUT FOODS, INC.

This case fundamentally differs from Buckman, Perez, 

and Nexus. In this case, plaintiffs are claiming violations of 

California law, the Sherman Law, not the federal FDCA. It 

is true that the Sherman Law standards are identical to the 

federal standards, but Congress said such standards are not 

preempted and hence permitted states to adopt them. See 21 

U.S.C. § 343-1(a) (NLEA § 403A(a)). There is no reason 

we can perceive why Congress would permit states to enact 

particular legislation and then deny enforcement by their 

citizens.

Federal law does not support such a strange result. In 

cases where private plaintiffs claimed violations of state law, 

as opposed to federal standards, the Supreme Court and our 

court have held the claims are not preempted. In the leading 

Supreme Court case, the Court held that the FDCA did not 

preempt state common law claims that a medical device 

manufacturer had failed to warn of the known dangers of a 

pacemaker. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 474, 

481, 495 (1996). The Court interpreted a preemption 

provision, similar to § 343-1 (NLEA § 403A) in this case, as 

permitting states to enact requirements identical to those 

imposed by the federal law. Id. at 496-97. The Court 

reasoned that “[n]othing . . . denied [the state] the right to 

provide a traditional damages remedy for violations of 

common-law duties when those duties parallel federal 

requirements.” Id. at 495. The claims were not preempted 

because plaintiffs claimed violations of parallel state law 

duties, not the violation of duties owed under federal law.

Our court followed Lohr in Stengel, holding that the 

FDCA did not preempt a state law negligence claim for 

violation of duties that paralleled duties owed under federal 

requirements. Stengel v. Medtronic Inc., 704 F.3d 1224, 

1233 (9th Cir. 2013) (en banc). There, citing Lohr and 
DAVIDSON V. SPROUT FOODS, INC. 15

Buckman, we described the Supreme Court’s preemption 

jurisprudence as establishing a rule that the FDCA “does not 

preempt a state-law claim for violating a state-law duty that 

parallels a federal-law duty” under the FDCA. Id. at 1228-

29. The claim at issue was that a medical device 

manufacturer was negligent in failing to report known risks 

of a medical pump to the FDA, an FDCA requirement. Id. 

at 1226. Because state law also contemplated a duty to warn 

a third party such as the FDA, we concluded that the claim 

“rest[ed] on a state-law duty that parallel[ed] a federal-law 

duty” and was thus not preempted by the FDCA. Id. at 1233.

In a recent case even more analogous to the present one, 

our court reaffirmed that the FDCA does not preempt claims 

for violations of parallel state law duties. See Kroessler v. 

CVS Health Corp., 977 F.3d 803 (9th Cir. 2020). Kroessler

involved dietary supplement labels, which, like food labels, 

are governed by the NLEA. Id. at 808. Accordingly, as in 

this case, the express preemption provision of § 343-1 

(NLEA § 403A), and the federal enforcement limitations in 

§ 337 (FDCA § 310) both applied. We interpreted those 

provisions to permit private enforcement of state standards 

so long as they were identical to the federal standards. We 

said that “private plaintiffs may bring only actions to enforce 

violations of ‘state laws imposing requirements identical to 

those contained in the FDCA.’” Id. at 808 (quoting the 

California Supreme Court in Farm Raised Salmon Cases, 

175 P.3d 1170, 1177 (2008) (emphasis in the original)). The 

plaintiffs in Kroessler had brought claims under California 

statutes, alleging that a retailer made false and misleading 

representations on dietary supplement labels without 

meeting a substantiation standard that was identical to the 

one found in the FDCA. Id. at 809-10. Because the claims 

were brought under state law and the state standard was 
16 DAVIDSON V. SPROUT FOODS, INC.

identical to the federal, we again concluded that the claims 

were not preempted. Id. at 813-14.

The reasoning of this line of cases, involving claimed 

violations of parallel state law, controls our decision in this 

case. We therefore hold that the FDCA does not impliedly 

preempt plaintiffs’ Sherman Law claims. Because the 

Sherman Law incorporates federal standards, the state 

requirements at issue are identical to their federal 

counterparts, and thus permitted by § 343-1 (NLEA 

§ 403A). Plaintiffs’ claim is that Sprout violated these 

parallel state requirements. Because the FDCA places no 

limitations on enforcement of these state parallels, plaintiffs’ 

Sherman Law claim is not preempted.

In contending that enforcement of the Sherman Law is 

preempted, Sprout can do no more than point to the federal 

origin and content of the state’s labeling standards. Sprout 

ignores that Congress permitted identical state laws and 

offers no explanation for why Congress would want states to 

enact laws that its citizens cannot enforce. The dissent 

makes the same mistakes. The anomaly of their position has 

been observed by the California Supreme Court. It said “[i]f 

Congress intended to permit states to enact identical laws on 

the one hand, but preclude states from providing private 

remedies for violations of those laws on the other hand, ‘its 

failure even to hint at it is spectacularly odd.’” Farm Raised 

Salmon, 175 P.3d at 1178 (quoting Lohr, 518 U.S. at 491 

(Stevens, J., concurring)).

Sprout looks to the prohibition of private enforcement in 

§ 337(a) (FDCA § 310(a)) as evidence of Congress’s intent 

to preempt private enforcement of the state law. Indeed, 

Sprout takes the position that, except for the limited 

enforcement powers granted to the states in § 337(b) (FDCA 
DAVIDSON V. SPROUT FOODS, INC. 17

§ 310(b)), the enforcement power of the United States is 

exclusive, and there is no entity within the states that can 

enforce the state law. Yet, by its terms, § 337(a) (FDCA 

§ 310(a)) implicates only enforcement of the federal law, not 

enforcement of identical state requirements. 

The dissent does not go so far as to suggest that only the 

federal government can enforce the state law. The dissent 

speculates that the state might vest enforcement power in a 

state agency. Nevertheless, like Sprout, the dissent assumes 

that because § 337(a) (FDCA § 310(a)) prohibits private 

enforcement of the federal law, Congress must have 

intended to prohibit the private enforcement of parallel state 

laws as well. Yet, we are offered no basis for such an 

assumption. The dissent never comes to grip with the fact 

that the text of § 337(a) (FDCA § 310(a)) addresses only 

enforcement of the federal law. Nor does the dissent explain 

how private enforcement of identical state standards would 

conflict with federal enforcement of the federal law.

Sprout also seeks support from § 337(b) (FDCA 

§ 310(b)), which permits states to enforce certain provisions 

of the federal law. Sprout points out that Congress provided 

this limited enforcement authority to the states, not to private 

parties, and contends Congress must therefore have intended 

to prohibit any private enforcement of parallel state laws. 

The dissent agrees. But again, both read too much into the 

text of § 337(b) (FDCA § 310(b)), which relates only to the 

enforcement of the federal law. It does not limit 

enforcement of state law.

The dissent would fashion a rule found in none of the 

cases but that it contends follows from them: to avoid 

preemption, the state law’s substance must be identical to the 

federal standards but derive from a source “independent” of 
18 DAVIDSON V. SPROUT FOODS, INC. 

the federal law. The dissent borrows the term “independent” 

from Stengel where it was used to differentiate a claim 

premised on the violation of state law from a claim premised 

on the violation of the federal law, as in Buckman. See 

Stengel, 704 F.3d at 1233. The claims here seek to enforce 

state standards that are similarly “independent” of the federal 

law, as they arise from a state statute. Still, the dissent would 

hold that a cause of action is “independent” only if it is 

grounded in the common law and predates the FDCA. While 

Buckman indicated that such claims survive implied 

preemption, see Buckman, 531 U.S. at 353, neither the 

Supreme Court nor our court has said that these are the only 

claims that do so. Statutory causes of action to enforce 

identical state standards that Congress permitted must also 

survive implied preemption. 

The dissent views Kroessler as our leading example of a 

case where the FDCA did not preempt state-law claims. Yet 

as we have seen, the claims there escaped preemption 

because they were based on a state standard identical to the 

federal. See Kroessler, 977 F.3d at 810, 813-14. Kroessler 

did not make that standard’s enforceability depend on 

whether its content had an origin “independent” of the 

federal law. Rather, the claims were not preempted because 

they sought to enforce an identical state standard that the 

federal law expressly spared from preemption. Id. The same 

result should obtain here. 

Section 343-1 (NLEA § 403A) is not unique in 

providing that states may only adopt provisions identical to 

the federal law. Other statutory schemes have similar 

provisions that the Supreme Court has interpreted to permit 

private enforcement of parallel state requirements. See, e.g., 

21 U.S.C. § 360k(a) (prohibiting states from establishing 

requirements “different from, or in addition to” any 
DAVIDSON V. SPROUT FOODS, INC. 19

requirements in the Medical Device Amendments (MDA) to 

the FDCA); Riegel v. Medtronic, Inc., 552 U.S. 312, 330 

(2008) (holding that § 360k(a) does not prevent states from 

providing a damages remedy for claims premised on 

violations of the MDA’s implementing regulations); see also

7 U.S.C. § 136v(b) (prohibiting states from imposing 

requirements “in addition to or different from” the 

requirements in the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA)); Bates v. Dow Agrosciences, 544 

U.S. 431, 432 (2005) (holding that nothing in § 136v(b) 

prevents states from providing a damages remedy for state 

requirements equivalent to federal requirements). Sprout’s 

position conflicts with all of this authority.

While this is the first case to reach our court involving 

the Sherman Law and food labels, the district courts in this 

circuit are in near unanimous agreement that the FDCA does 

not preempt Sherman Law food labeling claims. Most agree 

that § 337 (FDCA § 310) does not limit states’ authority to 

provide private remedies for identical state laws that are 

expressly permitted by § 343-1 (NLEA § 403A). See, e.g.,

Hesano v. Iovate Health Scis., Inc., No. 13CV1960-WQHJMA, 2014 WL 197719, at *7 (S.D. Cal. Jan. 15, 2014). One 

district court collected the cases and concluded that 

“[d]istrict courts have routinely rejected arguments that . . . 

food-labeling claims . . . under the Sherman Law are 

impliedly preempted under § 337(a) and Buckman.” Corbett 

v. PharmaCare U.S., Inc., 567 F. Supp. 3d 1172, 1193 (S.D. 

Cal. 2021) (quoting Sandoval v. PharmaCare US, Inc., 145 

F. Supp. 3d 986, 995 (S.D. Cal. 2015)).

Finally, even if we were to conclude that there is some 

doubt as to whether § 337 (FDCA § 310) permits private 

enforcement of state laws, we would still have to reverse the 

district court and hold the plaintiffs’ claim is not preempted. 
20 DAVIDSON V. SPROUT FOODS, INC.

This is because of the longstanding presumption against 

preemption that our court recognizes. In implied preemption 

cases, “we start with the assumption that the historic police 

powers of the States are not preempted unless that was the 

clear and manifest purpose of Congress.” R.J. Reynolds 

Tobacco Co. v. County of Los Angeles, 29 F.4th 542, 561 

(9th Cir. 2022) (quoting In re Volkswagen “Clean Diesel” 

Mktg., Sales Pracs., & Prod. Liab. Litig., 959 F.3d 1201, 

1212 (9th Cir. 2020)). When we are faced with “plausible 

alternative reading[s]” of a statute’s preemptive effect, we 

apply this presumption and “have a duty to accept the 

reading disfavoring pre-emption.” Bates, 544 U.S. at 432. 

Thus, even if Sprout’s interpretation of § 337 (FDCA § 310) 

were equally plausible, we would be bound to accept the 

interpretation that we ultimately adopt: the FDCA does not 

impliedly preempt private enforcement of the Sherman Law.

II. Fraud Claims

The essence of plaintiffs’ fraud-based claims is that 

Sprout’s labels misled consumers into believing the products 

provided health benefits to children under two when the 

products were in fact nutritionally and developmentally 

harmful. In the First Amended Complaint, plaintiffs pleaded 

these claims as common law fraud and as violating 

California’s FAL, CLRA, and UCL.

Because all these claims are grounded in fraud, 

plaintiffs’ First Amended Complaint needed to satisfy not 

only Rule 12(b)(6)’s plausibility pleading standard but also 

the heightened pleading requirements of Rule 9(b). See 

Davidson v. Kimberly-Clark Corp., 889 F.3d 956, 964 (9th 

Cir. 2018). Rule 9(b) requires that a party plead fraud with 

particularity. This means the complaint must “identify the 

who, what, when, where, and how of the misconduct 
DAVIDSON V. SPROUT FOODS, INC. 21

charged, as well as what is false or misleading about the 

purportedly fraudulent statement, and why it is false.” Id.

(quoting Cafasso, U.S. ex rel. v. Gen. Dynamics C4 Sys., 

Inc., 637 F.3d 1047, 1055 (9th Cir. 2011)).

The district court held that plaintiffs failed to do this. 

The court first noted that plaintiffs had sufficiently alleged 

what the misstatement was, i.e., that the nutrient content 

claims imply that the products provide health benefits for 

babies. But the court ultimately found that plaintiffs had 

failed to sufficiently allege why this implied message was 

false, i.e., that the products were in fact harmful. Because 

this was a core component of their theory of fraud, the 

district court held that plaintiffs failed to plausibly allege the 

claims sounding in fraud.

In support of their contention that Sprout’s products are 

harmful, plaintiffs offer two sets of allegations in the First 

Amended Complaint. The first allegation is that Sprout’s 

products contain high amounts of sugar and that sugars in 

pureed, pouch-based foods can lead to health issues such as 

tooth decay. Second, the complaint cites to several articles 

and reports suggesting that pouch-based foods may lead to 

long-term health risks and hinder babies’ development.

Plaintiffs’ allegations regarding harm are largely 

unspecific to Sprout’s products. The exception is their 

allegation that the products “contain high amounts of free 

sugars” accompanied by a list of the grams of sugar in some 

of the products. But as the district court rightly noted, this 

allegation lacks context. Plaintiffs do not explain at what 

level sugars become harmful or why the levels of sugar in 

these products, in particular, could cause harm.

The rest of plaintiffs’ harm-related allegations offer 

explanations for how pouch-based foods in general may be 
22 DAVIDSON V. SPROUT FOODS, INC.

unhealthy for children, nutritionally and developmentally. 

These allegations are largely speculative. For example, 

plaintiffs allege that “consumption of pouches may lead to 

long term health risks”; that if babies are “overly dependent 

on pouches,” there are “noted delays in [their] motor 

development”; and that pouches “can be a gateway to bad 

long-term snacking habits and routine overeating.” The 

district court correctly observed that each of these 

allegations of harm relies on hypotheticals and contingencies 

outside the scope of this case. Moreover, plaintiffs never 

actually alleged that Sprout’s products cause any of these 

harms.

The district court identified the deficiencies before 

dismissing plaintiffs’ fraud claims and gave plaintiffs a 

second opportunity to amend. But plaintiffs chose to stand 

on their First Amended Complaint. We agree with the 

district court that this complaint failed to allege fraud with 

particularity as required by Rule 9(b).

III. Unjust Enrichment

The district court dismissed the unjust enrichment claim 

because, after dismissing all other claims, there was no 

underlying basis for recovery. In light of our reversal on the 

Sherman Law claim, an additional claim survives. We thus 

reverse the district court’s dismissal of the unjust enrichment 

claim.

CONCLUSION

Because the FDCA does not preempt private 

enforcement of the Sherman Law, we reverse the district 

court’s dismissal of plaintiffs’ Sherman Law claim and 

remand for further proceedings consistent with this opinion. 

We also reverse the district court’s dismissal of the unjust 
DAVIDSON V. SPROUT FOODS, INC. 23

enrichment claim. We affirm the district court’s dismissal 

of plaintiffs’ fraud-based claims.

AFFIRMED IN PART, REVERSED IN PART, AND 

REMANDED.

COLLINS, Circuit Judge, concurring in part and dissenting 

in part: 

I would affirm the district court’s judgment dismissing 

this action, in which Plaintiffs challenge the lawfulness of 

the nutrition claims made by the defendant on certain food 

pouches that it markets for toddlers. As the majority 

explains, Plaintiffs’ fraud-based claims were properly 

dismissed as inadequately pleaded. In my view, Plaintiffs’ 

remaining substantive claim—which attempts to use state 

law to enforce a specific federal regulation concerning the 

labeling of toddler food products—is impliedly preempted 

because the relevant federal statute bars private enforcement 

of its provisions. To the extent that the majority reaches a 

contrary conclusion and allows this claim (and a related 

unjust enrichment claim) to proceed, I respectfully dissent. 

I 

Federal regulations issued by the Food and Drug 

Administration (“FDA”) under § 403(q) of the Federal Food, 

Drug, and Cosmetic Act (“FDCA”) require manufacturers of 

food products to disclose specified nutritional information in 

the familiar standardized box that is typically placed on the 

back of the package. See 21 U.S.C. § 343(q); 21 C.F.R. 
24 DAVIDSON V. SPROUT FOODS, INC.

§ 101.9(d).1 A separate federal regulation, adopted under 

§ 403(r) of the FDCA, imposes an additional special rule on 

foods that are intended specifically for children under the 

age of two. 21 C.F.R. § 101.13(b)(3); see also 58 Fed. Reg. 

2302, 2303–04 (Jan. 6, 1993); 56 Fed. Reg. 60421, 60423–

24 (Nov. 27, 1991). Under that rule, manufacturers may not 

make any other nutritional claims on the package, including 

on the front, unless specifically authorized by the relevant 

federal regulations. 21 C.F.R. § 101.13(b)(3). Contending 

that Defendant Sprout Foods, Inc. (“Sprout”) violated this 

regulation in the packaging of a variety of its baby and 

toddler food products, Plaintiffs Gillian and Samuel 

Davidson filed this putative class action seeking equitable 

relief for those violations.2

In seeking such relief, however, Plaintiffs did not and 

could not rely directly on § 101.13(b)(3) itself. That is 

because, under FDCA § 310, FDA regulations, including 

§ 101.13(b)(3), can only be enforced in suits brought by the 

federal Government or by a State, and not by a private party. 

See 21 U.S.C. § 337(a) (providing that suits to enforce the 

FDCA generally must be brought “by and in the name of the 

United States”); id. § 337(b) (allowing a “State” to “bring in 

its own name” a suit to enforce specified provisions of the 

FDCA, including § 403(q) and § 403(r)). Instead, Plaintiffs 

1 The FDCA has been classified as chapter 9 of the unenacted title 21 of 

the U.S. Code. Its current text can be found at the website of the 

Government Publishing Office at 

https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS973.pdf.

2 As this suit comes to us, the parties have assumed that Sprout’s conduct 

violated § 101.13(b)(3) and that the prohibition contained in that 

regulation is valid. I therefore take those points as true, without 

expressing any view as to their correctness. 
DAVIDSON V. SPROUT FOODS, INC. 25

rested this aspect of their suit on a California statute that 

automatically incorporates all federal food-labeling 

regulations into California law, including § 101.13(b)(3). 

Specifically, § 110100(a) of the California Health and Safety 

Code expressly adopts, as “the food labeling regulations” of 

California, all “food labeling regulations” that have been 

“adopted pursuant to the federal act,” i.e., the FDCA. See

CAL. HEALTH & SAFETY CODE § 110100(a); id. § 109930 

(defining the “federal act” as the FDCA).3 Plaintiffs sought 

enforcement of that state statute under the private right of 

action conferred by California’s Unfair Competition Law 

(“UCL”). See CAL. BUS. & PROF. CODE § 17204 

(authorizing a private right of action for equitable relief by 

those who have “lost money or property as a result of . . . 

unfair competition”); id. § 17200 (defining “unfair 

competition” to include, inter alia, any practice that is 

“unlawful” under other law).

Plaintiffs also asserted additional state-law claims 

alleging that Sprout’s front-label nutritional claims were 

misleading in violation of the UCL, see CAL. BUS. & PROF.

CODE § 17200 (defining “unfair competition” to also include 

any practice that is “fraudulent”); California’s False 

Advertising Law (“FAL”), see id. § 17500 (generally 

prohibiting “untrue or misleading” advertising); the 

California Consumer Legal Remedies Act (“CLRA”), see

CAL. CIV. CODE § 1770(a) (prohibiting a variety of specified 

“deceptive acts or practices”); and the California common 

law of fraud. For these claims, Plaintiffs sought 

3 Section 110100 is contained in Part 5 of Division 104 of the Health and 

Safety Code, and that Part, which encompasses §§ 109875–111929.4, is 

“known as the Sherman Food, Drug, and Cosmetic Law.” See CAL.

HEALTH & SAFETY CODE § 109875. I will refer to that Part by its more 

colloquial name of the “Sherman Law.”
26 DAVIDSON V. SPROUT FOODS, INC.

compensatory, statutory, treble, and punitive damages. 

Finally, Plaintiffs also asserted an unjust enrichment claim 

that was predicated on the unlawful nature of Sprout’s 

conduct as alleged in the other claims. 

On October 21, 2022, the district court dismissed without 

leave to amend the Sherman-Law-based UCL claim on the 

ground that it was impliedly preempted by the FDCA’s 

prohibition on private enforcement of its provisions. As to 

the fraud-based claims under the UCL, the FAL, the CLRA, 

and the common law, the court held that Plaintiffs had failed 

to allege sufficient facts, in accordance with the heightened 

pleading standards of Federal Rule of Civil Procedure 9(b), 

to plausibly infer that the challenged statements were 

misleading. Because all predicate causes of action had thus 

been dismissed, the district court also dismissed Plaintiffs’ 

derivative claim for unjust enrichment. The district court, 

however, granted leave to amend as to the fraud-based 

claims and as to the unjust enrichment claim. 

Rather than amend their complaint, Plaintiffs filed a 

notice of appeal four days later. Because the district court 

subsequently entered a final judgment dismissing the action, 

Plaintiffs’ premature notice of appeal is effective to invoke 

our appellate jurisdiction. See Weston Family P’ship LLLP 

v. Twitter, Inc., 29 F.4th 611, 618–19 (9th Cir. 2022) (holding 

that, although “orders dismissing claims with leave to amend 

are considered not final and thus not appealable as of right,” 

a district court “effectively cure[s] [a] premature notice of 

appeal when it later issue[s] a final order”).

II

In addressing whether Plaintiffs’ UCL claim based on 

§ 110100 is impliedly preempted, I begin by setting forth the 

basic statutory and legal framework concerning the FDCA’s 
DAVIDSON V. SPROUT FOODS, INC. 27

preemptive scope. I will then explain why I think that 

Plaintiffs’ claim is impliedly preempted and then discuss 

why the majority’s reasons for its contrary conclusion are 

flawed.

A

Under the Constitution’s Supremacy Clause, all “Laws 

of the United States which shall be made in Pursuance” of 

the Constitution “shall be the supreme Law of the Land.” 

U.S. CONST. art. VI, cl. 2. The resulting “pre-emption” of 

state law by federal statutes “may be either expressed or 

implied, and ‘is compelled whether Congress’ command is 

explicitly stated in the statute’s language or implicitly 

contained in its structure and purpose.’” Gade v. National 

Solid Waste Mgmt. Ass’n, 505 U.S. 88, 98 (1992) (citation 

omitted). Here, the relevant provisions of the FDCA 

implicate both express and implied preemption.

Section 403A of the FDCA contains an express 

preemption provision that addresses FDCA § 403(q) and 

§ 403(r), which are the two key provisions concerning food 

labeling that provide the asserted statutory basis for the 

regulation at issue here, 21 C.F.R. § 101.13(b)(3). See 56 

Fed. Reg. at 60423–24. Section 403A generally provides 

that “no State or political subdivision of a State may directly 

or indirectly establish under any authority[,] or continue in 

effect[,] as to any food in interstate commerce[,]” either 

(1) “any requirement for nutritional labeling of food that is 

not identical to the requirement” of section 403(q); or 

(2) “any requirement respecting” any “nutrient” content 

claim that is “made in the label or labeling of food that is not 

identical to the requirement” of § 403(r). 21 U.S.C. § 343-

1(a)(4), (5) (emphasis added). Because, as explained earlier, 

the California statute here expressly adopts, as “the food 
28 DAVIDSON V. SPROUT FOODS, INC.

labeling regulations” of California, all “food labeling 

regulations” that have been “adopted pursuant to” the 

FDCA, see CAL. HEALTH & SAFETY CODE § 110100(a), the 

relevant substantive prohibition set forth in 21 C.F.R. 

§ 101.13(b)(3) is incorporated by reference into California 

law as a “food labeling regulation” under California law. 

And because that incorporated-by-reference regulation was 

adopted under § 403(q) and § 403(r) of the FDCA, the 

resulting California-law obligation derived from 

§ 101.13(b)(3) is “identical” to the requirements of § 403(q) 

and § 403(r). It therefore is not expressly preempted by 

§ 403A(a)(4) or § 403A(a)(5). The parties do not contest 

these points for purposes of this appeal.

The Supreme Court has held, however, that a statute with 

an express preemption provision also may have an additional 

implied preemptive effect. See Buckman Co. v. Plaintiffs’ 

Legal Comm., 531 U.S. 341, 352 (2001); Freightliner Corp. 

v. Myrick, 514 U.S. 280, 287–89 (1995). Implied preemption 

occurs when “the scope of a statute indicates that Congress 

intended federal law to occupy a field exclusively . . . or 

when state law is in actual conflict with federal law.” 

Freightliner, 514 U.S. at 287 (citation omitted). Here, 

Sprout relies only on “conflict” preemption, not “field” 

preemption. Specifically, Sprout notes that § 310 of the 

FDCA generally provides that “all such proceedings for the 

enforcement, or to restrain violations, of [the FDCA] shall 

be by and in the name of the United States.” 21 U.S.C. 

§ 337(a). The only exception is that certain suits—including 

specifically suits to enforce § 403(q) and § 403(r)—may also 

be brought by a State “in its own name and within its 

jurisdiction . . . if the food that is the subject of the 

proceedings is located in the State.” Id. § 337(b)(1). Sprout 

contends that allowing Plaintiffs to indirectly enforce 
DAVIDSON V. SPROUT FOODS, INC. 29

§ 101.13(b)(3) through a UCL action based on § 110100 

would undermine the FDCA’s exclusive reservation of 

enforcement jurisdiction to the federal Government and the 

State of California. In other words, Sprout asserts that to the 

extent the UCL provides a private right of action to indirectly 

enforce § 101.13(b)(3), it “stands as an obstacle to the 

accomplishment and execution of the full purposes and 

objectives of Congress” as expressed in § 310. Freightliner, 

514 U.S. at 287 (citation omitted). 

B

Against this backdrop, the central legal question 

presented in this case is how to determine when private 

enforcement of a non-expressly-preempted state law that 

draws on the FDCA’s provisions is nonetheless impliedly

preempted on the ground that it amounts to impermissible 

indirect private enforcement of the FDCA itself. 

Fortunately, we are not writing on a clean slate, and our 

caselaw provides what I ultimately believe is a relatively 

clear line. Expressed in general terms, the rule that emerges 

from our precedent is that a private cause of action based on 

state law with independent substantive content that parallels

the FDCA’s applicable requirements in a given case (such as, 

for example, a negligence claim predicated on a duty to warn 

that matches the FDCA’s requirements) is not impliedly 

preempted, but a private claim based on state law that has no 

substantive content other than a parasitic copying of the 

FDCA’s requirements is impliedly preempted. Here, 

Plaintiffs’ § 110100-based UCL claim falls on the latter, 

preempted side of the line.

1

The seminal Supreme Court decision addressing implied 

preemption in light of FDCA § 310’s prohibition of private 
30 DAVIDSON V. SPROUT FOODS, INC.

enforcement is Buckman Co., 531 U.S. 341. Accordingly, a 

careful review of that decision is critical to any assessment 

of implied preemption in this area.

In Buckman, the defendant, Buckman Co., was a 

“consulting company that assisted” AcroMed Corporation, a 

manufacturer of “orthopedic bone screws,” “in navigating 

the federal regulatory process” for those devices. 531 U.S. 

at 343. Under FDCA § 515(b), “Class III” devices (such as 

AcroMed’s bone screws) are exempt from the FDCA’s 

otherwise-applicable pre-market approval if they are “shown 

to be ‘substantially equivalent’” to a device on the market at 

the time the pre-market approval provisions of the FDCA 

were enacted in 1976. Id. at 345 (quoting 21 U.S.C. 

§ 360e(b)(1)(B)); see also id. at 344–46. “Demonstrating 

that a device qualifies for this exception is known as the 

‘§ 510(k) process,’” which refers to the section of the FDCA 

under which such an exception request is submitted. Id. at 

345. The plaintiffs alleged that Buckman Co. “made 

fraudulent representations to the FDA” in successfully 

applying for a § 510(k) exemption for AcroMed’s bone 

screws. Id. at 347. The plaintiffs, “who claim[ed] injuries 

resulting from the use” of the bone screws, alleged that these 

fraudulent statements violated state-law duties against fraud 

and that Buckman was therefore liable in damages “under 

state tort law.” Id. at 343. The Third Circuit held that these 

state-law “fraud claims were neither expressly nor impliedly 

pre-empted,” but the Supreme Court reversed. Id. at 347.

The Buckman Court explicitly declined to address the 

question of express preemption, and its decision therefore 

necessarily proceeded on the assumption that the state-law 

fraud claims might not be expressly preempted by FDCA 

§ 521, which is the FDCA’s express preemption provision 

applicable to medical devices. 531 U.S. at 348 & n.2; see 21 
DAVIDSON V. SPROUT FOODS, INC. 31

U.S.C. § 360k. The Court first held that, because “[p]olicing 

fraud against federal agencies is hardly ‘a field which the 

States have traditionally occupied,’” there was no “warrant” 

for applying “a presumption against finding federal preemption of a state-law cause of action.” Buckman, 531 U.S. 

at 347. “Given this analytical framework,” the Court held 

that the plaintiffs’ state-law fraud claims “conflict[ed]” with 

the FDCA and were therefore “impliedly pre-empted.” Id. 

at 348. The Court held that allowing the state common law 

of fraud to regulate the quality of the required disclosures 

made in connection with the § 510(k) application process 

would interfere both with the FDA’s exercise of its 

“statutorily required judgment as to whether the device 

qualifies” for an exception and with the FDA’s “flexibility” 

in developing a “measured response to suspected fraud” on 

the FDA. Id. at 348–51. Citing FDCA § 310, the Court 

emphasized that the FDCA provided “clear evidence that 

Congress intended” that the statute’s medical-device 

provisions “be enforced exclusively by the Federal 

Government.” Id. at 352.

In reaching these conclusions, the Court specifically 

rejected the plaintiffs’ argument that the Court’s decision in 

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had already 

broadly held that state-law tort claims could be based on 

“violations of FDCA requirements” and still escape 

preemption. Buckman, 531 U.S. at 352. Because Buckman’s 

distinguishing of Medtronic is critical to the issue before us, 

I will first briefly summarize the relevant portions of 

Medtronic before returning to Buckman’s discussion of that 

case.

In Medtronic, the plaintiff, Lohr, was injured by the 

failure of her Medtronic pacemaker, which had been 

exempted from pre-market approval pursuant to the § 510(k) 
32 DAVIDSON V. SPROUT FOODS, INC.

exemption process. 518 U.S. at 480–81. As relevant here, 

Lohr asserted state common law claims for negligent 

manufacture and negligent failure to warn. Id. at 481–84. 

The Court held that these claims were not expressly 

preempted by FDCA § 521, which preempts any state-law 

requirement that is “different from, or in addition to, any 

requirement” of the FDCA that is “applicable . . . to the 

device” and that “relates to the safety or effectiveness of the 

device or to any other matter included in a requirement 

applicable to the device under” the FDCA. Id. at 481–82 

(quoting 21 U.S.C. § 360k(a)); id. at 503. The Medtronic

Court noted that Lohr’s state-law negligent manufacturing 

and failure-to-warn claims included “claims that Medtronic 

ha[d], to the extent that they exist[ed], violated FDA 

regulations” concerning those matters. Id. at 495. The Court 

held that, because these claims rested on “violations of 

common-law duties” that “parallel federal requirements,” 

they were not expressly preempted by § 521. Id. 

In reaching this conclusion, the Court acknowledged that 

the applicable state law would require Lohr to prove the 

additional elements of her common law claims, including 

that the regulatory violations “were the result of negligent 

conduct” or that the pacemaker “created an unreasonable 

hazard for users of the product.” Medtronic, 518 U.S. at 495. 

Although these further elements were arguably literally 

“different from, or in addition to,” the FDCA’s requirements, 

the Court held that these additional elements made the “state 

requirements narrower, not broader, than the federal 

requirement[s].” Id. In effect, the Court held that the state 

requirements thereby reached a subset of the situations that 

the federal requirements did and that, within that 

overlapping subset, the relevant requirements were identical. 

The Court further held that “[t]he presence of a damages 
DAVIDSON V. SPROUT FOODS, INC. 33

remedy does not amount to the additional or different 

‘requirement’” that gives rise to preemption under § 521; 

rather, the Medtronic Court explained, “it merely provides 

another reason for manufacturers to comply with identical 

existing ‘requirements’ under federal law.” Id. 

In Buckman, the plaintiffs argued that, because 

Medtronic had held that a common law negligence claim 

based on an alleged violation of the FDCA was not 

preempted, a common law fraud claim “arising from 

violations of FDCA requirements” was likewise not 

expressly or impliedly preempted. Buckman, 531 U.S. at 

352. The Buckman Court rejected the plaintiffs’ contention 

that Medtronic stood for “the proposition that any violation 

of the FDCA will support a state-law claim.” Id. at 353. 

While noting that “Medtronic did not squarely address the 

question of implied preemption,” the Court appeared to 

accept the Buckman plaintiffs’ assertion that the claims at 

issue in Medtronic were neither expressly nor impliedly 

preempted. Id. Nonetheless, the Court held that the claims 

in Buckman were distinguishable in a way that made a 

difference to the implied-preemption inquiry. “[I]t is clear,” 

the Court stated, “that the Medtronic claims arose from the 

manufacturer’s alleged failure to use reasonable care in the 

production of the product, not solely from the violation of 

FDCA requirements.” Id. (emphasis added). By contrast, 

the Buckman plaintiffs’ “fraud claims exist[ed] solely by 

virtue of the FDCA disclosure requirements” connected to 

the § 510(k) exemption process. Id. at 352–53. Thus, 

“although Medtronic can be read to allow certain state-law 

causes of action that parallel federal safety requirements,” 

the Buckman plaintiffs’ fraud claims did not “rely[] on 

traditional state tort law which had predated the federal

enactments in question[].” Id. at 353 (emphasis added). 
34 DAVIDSON V. SPROUT FOODS, INC.

The line that follows from Buckman is that a state-law 

cause of action that aligns with the content of the FDCA’s 

requirements, and thus escapes express preemption, will also 

escape implied preemption if the state-law rule has 

independent content—such as the preexisting “reasonable 

care” standard—that supports a parallel result. The 

negligence claims in Medtronic met that standard, because 

the deficiencies in the pacemaker could be independently 

established under the reasonable-care standard in a way that 

paralleled the applicable requirements of the FDCA. By 

contrast, the duties imposed by the state-law fraud claims in 

Buckman vis-à-vis communications with the FDA simply 

could not be defined independently of the very specific 

“disclosure requirements” applicable to the § 510(k) process 

under the FDCA. 531 U.S. at 353. Those fraud claims thus 

“exist[ed] solely by virtue of the FDCA disclosure 

requirements.” Id. (emphasis added). 

2

Our caselaw construing Buckman similarly confirms 

that, to escape implied preemption under § 310, a state-law 

cause of action must rest on a duty that has sufficient 

independent existence apart from the FDCA. 

Our decision in Kroessler v. CVS Health Corp., 977 F.3d 

803 (9th Cir. 2020), provides a paradigmatic case of a statelaw claim that falls on the non-preempted side of the line 

drawn in Buckman. The plaintiff in Kroessler asserted 

claims under California’s UCL and CLRA, as well as a 

common law claim for breach of express warranty. Id. at 

806. As relevant here, the gravamen of these claims was that 

CVS’s “glucosamine-based supplements” were advertised as 

supporting “joint health,” but that the supplements “did not 

provide the advertised benefits.” Id. As we explained, 
DAVIDSON V. SPROUT FOODS, INC. 35

“Kroessler allege[d] that CVS’s glucosamine claims [were] 

false because scientific studies directly refute[d] them.” Id. 

at 812. We held that Kroessler’s claim that he could 

affirmatively refute CVS’s representations rested on the 

same “‘substantiation’ standard” as applicable under the 

FDCA and its regulations. Id. at 813. Specifically, § 403(r) 

of the FDCA contains a provision governing dietary 

supplements, and it states that, with respect to claims that a 

dietary supplement “acts to maintain [a] structure or 

function” “in humans,” the manufacturer must “ha[ve] 

substantiation that such statement is truthful and not 

misleading.” 21 U.S.C. § 343(r)(6)(A), (B); see Kroessler, 

977 F.3d at 809. Because the obligation on which 

Kroessler’s California-law claims were based thus involved 

an obligation that was “identical” to one imposed under 

FDCA § 403(r), it was not expressly preempted under 

§ 403A(a)(5). See Kroessler, 977 F.3d at 808. Moreover, 

because the substantiation standard invoked by Kroessler 

under California law obviously had sufficient content that 

existed independent of the FDCA, it could not be said to 

“exist solely by virtue of the FDCA.” Buckman, 531 U.S. at 

353. Kroessler’s claim therefore rested on a “parallel” duty 

that was not impliedly preempted. Kroessler, 977 F.3d at 

814.

Similarly, in Stengel v. Medtronic, Inc., 704 F.3d 1224 

(9th Cir. 2013) (en banc), we held that the Arizona “statelaw failure-to-warn claim” asserted by the plaintiffs was 

neither expressly nor impliedly preempted, because it had 

sufficient independent content that paralleled FDCA 

requirements. See id. at 1233. One of the plaintiffs, Richard 

Stengel, had been rendered paraplegic by Medtronic’s 

device, which had been given pre-market approval by the 

FDA. Id. at 1227. The plaintiffs alleged that Medtronic was 
36 DAVIDSON V. SPROUT FOODS, INC.

liable under Arizona tort law requiring that warnings be 

provided to third parties “if, given the nature of the warning 

and the relationship of the third party, there is ‘reasonable 

assurance that the information will reach those whose safety 

depends on their having it.’” Id. at 1233 (citation omitted). 

Specifically, the plaintiffs invoked this Arizona duty to warn 

third parties in alleging that Medtronic had a duty “to warn 

the FDA” of any product risks of which Medtronic later 

became aware and that Medtronic had breached that duty to 

Stengel’s detriment. Id. at 1232. This state-law duty 

paralleled Medtronic’s obligation, under the FDCA’s 

regulations, not to “conceal[] known risks.” Id. at 1227. We 

held that this state-law claim was “independent of the FDA’s 

pre-market approval process that was at issue in Buckman,” 

and that the claim “rest[ed] on a state-law duty that parallels

a federal-law duty under the [FDCA], as in [Medtronic v.] 

Lohr.” Id. at 1233 (emphasis added). As such, it was “not 

preempted, either expressly or impliedly.” Id.; see also id. 

at 1235 (Watford, J., concurring) (“It is sufficient here that, 

in contrast to Buckman, [the plaintiffs’] claim is grounded in 

a traditional category of state law failure-to-warn claims that 

predated the federal enactments in question, and that the 

claim therefore does not exist solely by virtue of those 

enactments.”).4

By contrast, we have repeatedly held that FDCA § 310 

impliedly preempts state-law causes of action that have no 

independent substance apart from an explicit parasitic 

reliance on the FDCA’s provisions. For example, in Perez v. 

Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013), we addressed 

a state common law fraud claim in which the plaintiffs 

4 Judge Watford’s concurrence was joined by six other members of the 

en banc panel.
DAVIDSON V. SPROUT FOODS, INC. 37

alleged that the defendant, a manufacturer of a laser that had 

received FDA pre-market approval for “treating 

nearsightedness,” had “fail[ed] to disclose” to patients “that 

the Laser was not FDA approved” for “correct[ing] 

farsightedness.” Id. at 1112, 1117. We held that this claim 

was impliedly preempted by § 310 under Buckman. We 

explained that, “[l]ike the fraud-on-the-FDA claims in 

Buckman, [the plaintiffs’] fraud by omission claim exists 

solely by virtue of the FDCA requirements with respect to 

approved use of the Laser” and “the existence of these 

federal enactments is a critical element in their case.” Id. at 

1119 (simplified). We reasoned that, although other fraud 

claims might not be barred, the FDCA impliedly preempted 

“a claim that rests solely on the non-disclosure to patients of 

facts tied to the scope” of pre-market approval. Id. We 

concluded by stating that the Eighth Circuit had “aptly 

described the ‘narrow gap’ through which a state-law claim 

must fit to escape preemption by the FDCA: ‘The plaintiff 

must be suing for conduct that violates the FDCA (or else his 

claim is expressly preempted by § 360k(a) [FDCA 

§ 521(a)]), but the plaintiff must not be suing because the 

conduct violates the FDCA (such a claim would be impliedly

preempted under Buckman).’” Id. at 1120 (quoting Bryant 

v. Medtronic, Inc. (In re Medtronic, Inc., Sprint Fidelis Leads 

Prods. Liab. Litig.), 623 F.3d 1200, 1204 (8th Cir. 2010)).

In Nexus Pharmaceuticals, Inc. v. Central Admixture 

Pharmacy Services, Inc, 48 F.4th 1040 (9th Cir. 2022), we 

applied similar reasoning in holding that state statutory 

causes of action that parasitically borrowed from the FDCA 

were impliedly preempted by § 310. The plaintiff was a drug 

manufacturer who alleged that the defendants’ compounded 

drug was “essentially a copy” of plaintiff’s drug and was 

therefore required under FDCA § 503B to be approved by 
38 DAVIDSON V. SPROUT FOODS, INC.

the FDA pursuant to the approval process for new drugs 

under FDCA § 505. Nexus, 48 F.4th at 1043–44; see also 21 

U.S.C. §§ 353b(a)(5), 355. The plaintiff alleged that, 

because the defendants’ products lacked the required FDA 

approval, their sale was unlawful under the statutes of five 

States that specifically “prohibit[ed] the sale of drugs not 

approved by the FDA.” Id. at 1044. One of those statutes 

was a provision of California’s Sherman Law that prohibited 

the sale of any “new drug” unless “a new drug application 

has been approved for it and that approval has not been 

withdrawn, terminated, or suspended under Section 505 of 

the federal act.” CAL. HEALTH & SAFETY CODE 

§ 111550(a)(1) (citing 21 U.S.C. § 355). 

In evaluating whether these claims were impliedly 

preempted, we exhaustively reviewed many of the same 

precedents I have summarized above, and we held that “a 

clear distinction reveals itself when one reads them all 

together.” Nexus, 48 F.4th at 1050. That distinction, we 

explained, was between “a traditional common law tort 

action” alleging “harm to a patient,” which “might” provide 

a private cause of action that “escape[s] preemption,” and a 

claim that a plaintiff “is harmed economically because the 

defendant violated the FDCA.” Id. We stated that the Nexus

plaintiffs’ claims fell on the preempted side of that line 

because the “purported state law violation is of a law that 

says in substance ‘comply with the FDCA,’ not a traditional 

common law tort.” Id. We therefore held that the plaintiffs’ 

claims, which “relie[d] on a state statute which itself relies 

on the federal statute, not traditional tort law theory,” were 

impliedly preempted by § 310’s prohibition on private 

enforcement of the FDCA. Id. at 1046, 1050–51; see also 

id. at 1047 (noting that the plaintiffs’ claims were “based on 
DAVIDSON V. SPROUT FOODS, INC. 39

state laws that incorporate federal law, rather than on 

traditional tort law”). 

Notably, Nexus explicitly rejected the Federal Circuit’s 

contrary conclusion in Allergan, Inc. v. Athena Cosmetics, 

Inc., 738 F.3d 1350 (Fed. Cir. 2013). Relying on the 

presumption against preemption, and the “the historic 

primacy of state regulation of matters of health and safety,” 

the Federal Circuit held in Allergan that the very same 

California statute at issue in Nexus was not impliedly 

preempted. Id. at 1353–56. Buckman was distinguishable, 

the Federal Circuit concluded, because the Court there had 

held that the subject involved (fraud on a federal agency) 

was “hardly a field which the States have traditionally 

occupied.” Id. at 1356 (citing Buckman, 531 U.S. at 347). 

The Federal Circuit held that implied preemption was 

unwarranted, despite the California statute’s reliance on the 

content of the FDCA, because the statute still “implicate[s] 

an historic state power” of a sort “that may be vindicated 

under state law tort principles.” Id. at 1355. We held in 

Nexus that, in reaching this conclusion, the Federal Circuit 

failed adequately to consider “the FDCA’s prohibition of 

private enforcement.” 48 F.4th at 1050. Taking that 

prohibition into account, we held, “required a contrary 

result” from Allergan. Id. As we explained, the private 

cause of action allowed in Allergan was impliedly 

preempted by § 310’s ban on private enforcement of the 

FDCA, because the “California law merely incorporated 

FDCA requirements.” Id. at 1049.

3

Under this caselaw, the answer in this case is clear: 

Plaintiffs’ UCL claim based on § 110100 is impliedly 

preempted. 
40 DAVIDSON V. SPROUT FOODS, INC.

Here, as in Nexus, the California statute at issue “merely 

incorporate[s] FDCA requirements” and “says in substance 

‘comply with the FDCA.” 48 F.4th at 1049–50. And, like 

the common law claims in Buckman and in Perez, the 

statutory claim here is ultimately parasitic of the FDCA and 

“exist[s] solely by virtue of the FDCA . . . requirements” that 

it borrows. Perez, 711 F.3d at 1119 (quoting Buckman, 531 

U.S. at 353 (emphasis added)). Because the substance of the 

asserted violation of § 110100 is defined entirely by a federal 

regulation adopted under the FDCA, the “existence of [that] 

federal enactment[] is a critical element in [Plaintiffs’] case.” 

Id. (citation omitted). As a result, and in contrast to the 

statutory and common law claims at issue in Kroessler and 

the common law claim in Stengel, the private state statutory 

cause of action here has no independent substance that 

“parallel[s]” the requirements of the FDCA. Kroessler, 977 

F.3d at 814; Stengel, 704 F.3d at 1233. Accordingly, the 

district court correctly held that Plaintiffs’ § 110100-based 

UCL private cause of action is impliedly preempted.

C

In reaching a contrary conclusion, the majority relies on 

several arguments, all of which are legally erroneous.

1

The majority’s primary rationale for its no-preemption 

holding rests on a broad and seemingly simple syllogism that 

is, on closer inspection, clearly wrong.

The majority emphasizes that, “by its terms,” FDCA 

§ 310’s prohibition of private enforcement “implicates only 

enforcement of the federal law.” See Opin. at 17 (emphasis 

added). According to the majority, it does not matter that 

§ 110100 parasitically incorporates the FCDA’s food-
DAVIDSON V. SPROUT FOODS, INC. 41

labeling requirements in toto, so that the resulting state law 

has an entirely “federal origin and content.” See Opin. at 16. 

The FDCA’s relevant express preemption provision, the 

majority concludes, clearly “permitted states to adopt” 

identical food-labeling requirements, and “[t]here is no 

reason we can perceive why Congress would permit states to 

enact particular legislation and then deny enforcement by 

their citizens.” See Opin. at 14. In the majority’s view, it 

would be “strange,” and an “anomaly” to conclude that 

“Congress would want states to enact laws that [their] 

citizens cannot enforce.” See Opin. at 14, 16. The majority 

therefore broadly concludes that “the FDCA does not 

preempt [private] claims for violations of parallel state law 

duties.” See Opin. at 15. For multiple reasons, the 

majority’s reasoning is deeply flawed. 

First, the majority’s reasoning wrongly equates the scope 

of the FDCA’s express preemption with the scope of its 

implied preemption. According to the majority, because 

§ 110100(a)’s wholesale incorporation of the FDCA’s foodlabeling regulations is not expressly preempted—and 

California is thus “permitted” to adopt such a law—there are 

no implied limitations on the enforcement of that state law. 

See Opin. at 11, 14, 16, 18–19. This holding is flatly 

contrary to Buckman. As I have explained, the Court there 

explicitly held that the plaintiffs’ fraud-on-the-FDA claims 

were impliedly preempted without regard to whether the 

alleged state-law duty on which they rested was expressly

preempted by the FDCA. See 531 U.S. at 348 n.2 (stating 

that, having concluded that the claims were impliedly 

preempted, the Court “express[ed] no view on whether [they 

were] subject to express pre-emption under [FDCA § 521]” 

(emphasis added)). By stating that it was irrelevant whether 

the fraud claims there were expressly preempted, the Court 
42 DAVIDSON V. SPROUT FOODS, INC.

effectively assumed that they might not be. Buckman thus 

holds that the mere fact that a state law is not expressly 

preempted—and is thus “permitted” by the express 

preemption provision—does not preclude a finding that 

private enforcement of that law conflicts with § 310, thereby 

leading to implied conflict preemption. 

Likewise, in Nexus, we found that a private state 

statutory cause of action that “relie[d] on a state statute 

which itself relies on the [FDCA]” was impliedly preempted 

by § 310 even though “no applicable express preemption 

clause applied” at all. 48 F.4th at 1046. Like the provision 

at issue here, the state statute in Nexus “merely incorporated 

FDCA requirements.” Id. at 1049. Specifically, the state 

statute in Nexus, which was another provision of the 

Sherman Law, prohibited “the sale of drugs not approved by 

the FDA.” Id. at 1044. We held that the private cause of 

action was impliedly preempted because the “purported state 

law violation is of a law that says in substance ‘comply with 

the FDCA,’ not a traditional common law tort,” and the law’s 

features impermissibly invaded the federal Government’s 

exclusive authority to enforce the FDCA. Id. at 1050. Under 

Buckman and Nexus, it is thus not enough that a state statute 

is not expressly preempted and is in that sense “permitted.” 

The crucial question remains whether private enforcement 

of the non-expressly-preempted state statute is impliedly 

preempted due to the fact that the state cause of action, as in 

Buckman and Nexus, parasitically relies on the FDCA. By 

wrongly equating express preemption and implied 

preemption here, the majority’s opinion simply begs that 

critical question and thus provides no answer to it.

Second, the majority’s rhetorical question—why would 

Congress “permit states to enact particular legislation and 

then deny enforcement by their citizens[?]”—has an obvious 
DAVIDSON V. SPROUT FOODS, INC. 43

answer. See Opin. at 14. By mirroring the FDCA itself—

which expressly permits state enforcement of § 403(q) and 

§ 403(r)—the “identical” state law could likewise provide 

for enforcement by state authorities and could perhaps allow 

those authorities, in such a public suit in state court, to obtain 

additional remedies (monetary or otherwise) that are not 

afforded by the FDCA. Cf. Medtronic, 518 U.S. at 495. It 

can hardly be thought to be “strange” to limit States to using, 

for the “permitted” identical state laws, only the same public 

enforcement mechanisms that are permitted by the very 

federal law they are copying. If that public-enforcementonly policy is sensible for the FDCA, it cannot be dismissed 

as strange and anomalous for state laws whose substantive 

provisions must be identical to the FDCA. The unstated (and 

untenable) premise of the majority’s opinion is that the 

FDCA’s prohibition on private enforcement is itself 

“strange” and “anomal[ous].” See Opin. at 14, 16.

Third, the dispositive weight that the majority attaches to 

the express preemption provision in FDCA § 403A(a) is 

directly contrary to the statutory rule of construction that 

applies to § 403A(a). Section 403A was added to the FDCA 

by § 6(a) of the Nutritional Labeling and Education Act 

(“NLEA”), Pub. L. No. 101-535, 104 Stat. 2353, 2362 

(1990). Section 6(c) of the NLEA contains certain rules of 

construction for this new preemption provision in § 403A, 

which was added to the FDCA at the same time as § 403(q) 

and § 403(r). Section 6(c)(1) generally states that the 

NLEA—as opposed to the entire FDCA—“shall not be 

construed to preempt any provision of State law, unless such 

provision is expressly preempted under section 403A of the 

Federal Food, Drug, and Cosmetic Act.” Id. § 6(c)(1), 104 

Stat. at 2364 (reproduced as a note to 21 U.S.C. § 343-1). 

That general rule, if applicable here, would perhaps have 
44 DAVIDSON V. SPROUT FOODS, INC.

supported the majority’s complete equation of express and 

implied preemption. But § 6(c)(3) goes on to state that 

§ 6(a) “shall not be construed to affect preemption, express 

or implied, of any such requirement of a State or political 

subdivision, which may arise under,” inter alia, “any 

provision of the Federal Food, Drug, and Cosmetic Act not 

amended by subsection (a).” Id. § 6(c)(3), 104 Stat. at 2364. 

Section 310 of the FDCA is a “provision of the Federal, 

Food, Drug, and Cosmetic Act not amended by subsection 

(a)” of § 6 of the NLEA, inasmuch as § 6(a) only adds 

§ 403A to the FDCA. See 104 Stat. at 2362–63. 

Accordingly, § 6(c)(3) of the NLEA explicitly states that the 

enactment of the express preemption provision in § 403A 

does not detract from the implied preemptive force of § 310 

of the FDCA. The majority’s rationale is directly contrary 

to this statutory command.

Fourth, the majority’s reasoning is difficult to square 

with the fact that, in adding the relevant regulatory 

provisions (§ 403(q) and § 403(r)) and the relevant express 

preemption provision (§ 403A) to the FDCA, the NLEA 

simultaneously amended § 310 of the FDCA (which was 

then called § 307)5 by adding the provision allowing state 

authorities to enforce § 403(q) and § 403(r). See NLEA § 4, 

104 Stat. at 2362. Had it wanted to do so, Congress could 

have added private enforcement authority to the new foodlabeling provisions, but it did not. However, under the 

majority’s reading, simply by enacting a single sentence that 

indiscriminately incorporates into state law all of the foodlabeling regulations adopted under the NLEA’s amendments 

to the FDCA, California has succeeded in adding precisely 

5 Section 307 was renumbered as § 310 in 1992. See Pub. L. No. 102-

282, § 2, 106 Stat. 149, 150 (1992).
DAVIDSON V. SPROUT FOODS, INC. 45

the private enforcement remedy that Congress deliberately 

withheld when it enacted the NLEA. This direct reversal of 

Congress’s intent that the food-labeling provisions “be 

enforced exclusively by the Federal Government” and state 

authorities confirms that the private right of action the 

majority allows is impliedly preempted. Buckman, 531 U.S. 

at 352.

The majority is thus wrong in broadly concluding that, 

merely because the FDCA does not expressly preempt 

§ 110100, a private cause of action enforcing an FDA 

regulation incorporated into § 110100 is not impliedly 

preempted.

2

The majority’s additional arguments in support of its 

holding fare no better.

The majority’s effort to distinguish Buckman, Perez, and 

Nexus on their specific facts is unavailing. According to the 

majority, the instant case “fundamentally differs” from those 

three cases in that, here, “plaintiffs are claiming violations of 

California law, the Sherman Law, not the federal FDCA.” 

See Opin. at 14. This assertion is simply false. Indeed, the 

plaintiff in Nexus—who invoked a different provision of the 

Sherman Law that incorporated different provisions of the 

FDCA—quite literally “claim[ed] violations of California 

law, the Sherman Law, not the federal FDCA.” The 

plaintiffs in Buckman and Perez likewise relied on state 

common law causes of action whose state-law content 

lacked relevant independent substance apart from the 

borrowing of FDCA requirements. The majority attempts to 

distinguish Buckman on the basis that it “did not involve any 

violation of duties owed under a state consumer protection 

statute,” but this is a distinction without a difference. See
46 DAVIDSON V. SPROUT FOODS, INC.

Opin. at 12. The claim in Buckman rested on the “state-law” 

tort duty against “fraudulent representations,” with the 

substance of that duty being defined “solely” by reference to 

the relevant “FDCA disclosure requirements.” Buckman, 

531 U.S. at 346–47, 352–53. Because Buckman, Perez, and 

Nexus all similarly involved a borrowing of FDCA standards 

into the substance of state law, the majority’s effort to 

distinguish those cases on that basis fails.

Finally, the majority relies on the presumption against 

preemption as justifying its holding here. See Opin. at 19–

20. But this invocation of the presumption cannot be 

squared with Nexus. There, we expressly rejected the 

Federal Circuit’s decision in Allergan, which had 

extensively relied on the presumption against preemption in 

holding that another provision of the Sherman Law that 

similarly borrowed from the FDCA was not impliedly 

preempted. See Allergan, 738 F.3d at 1355–56. In rejecting 

Allergan, we held that what mattered was that, because the 

“California law merely incorporated FDCA requirements,” 

it ran afoul of “the FDCA’s prohibition of private 

enforcement.” Nexus, 48 F.4th at 1049–50. Moreover, the 

States’s historic police powers are amply preserved by the 

line drawn in our caselaw, which allows private causes of 

action that rest on traditional state-law causes of action with 

independent substantive content that parallels federal law.6 

6 This case itself illustrates the point—Plaintiffs here have asserted 

fraud-based claims alleging that, by singling out particular nutrients, 

Sprout’s front-label claims falsely suggest that increased intake of those 

nutrients is beneficial for toddlers. Those claims fail here because they 

are inadequately pleaded, but they clearly fall on the non-preempted side 

of the line: they rest on traditional state common law with independent 

substantive content that, on the facts of this case, matches the applicable 

provisions of the FDCA and its pertinent regulations.
DAVIDSON V. SPROUT FOODS, INC. 47

By contrast, parasitically copying publicly enforced federal 

statutes and attaching new privately enforceable remedies to 

them can hardly be thought of as a traditional state power 

that is protected by the presumption against preemption.

For the foregoing reasons, I would hold that Plaintiffs’ 

UCL cause of action based on § 110100 is impliedly 

preempted. 

III

I concur in Section II of the majority opinion, which 

affirms the dismissal of Plaintiffs’ fraud-based claims for 

failure to comply with the heightened pleading standards of 

Federal Rule of Civil Procedure 9(b). Because, in my view, 

no predicate claim thus remained that could support an 

unjust enrichment claim, that cause of action was properly 

dismissed as well. 

* * *

For the foregoing reasons, I would affirm the district 

court’s judgment dismissing all of Plaintiffs’ claims with 

prejudice. To the extent that the majority does otherwise, I 

respectfully dissent.