Bubak v. Golo, LLC

• Court: Court of Appeals for the Ninth Circuit
• Decided: October 9, 2025
• Docket: 24-492
• Status: Unpublished

Opinion

NOT FOR PUBLICATION FILED UNITED STATES COURT OF APPEALS OCT 9 2025 MOLLY C. DWYER, CLERK U.S. COURT OF APPEALS FOR THE NINTH CIRCUIT

VINCENZZA BUBAK, individually and on No. 24-492 behalf of all others similarly situated, D.C. No. 1:21-cv-00492-DAD-AC Plaintiff - Appellant, MEMORANDUM* v.

GOLO, LLC, a Delaware Limited Liability Company,

Defendant - Appellee.

Appeal from the United States District Court for the Eastern District of California Dale A. Drozd, District Judge, Presiding

Argued and Submitted February 3, 2025 Submission Vacated February 7, 2025 Resubmitted April 24, 2025 Pasadena, California

Before: WARDLAW, CALLAHAN, and HURWITZ, Circuit Judges. Concurrence by Judge CALLAHAN.

Vincenzza Bubak filed a putative class action alleging that Golo, LLC

violated California law through its marketing and distribution of a dietary

* This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3. supplement. Bubak asserted violations of California’s Unfair Competition Law

(“UCL”), which permits suit by private parties who have suffered an injury as a

result of “any unlawful, unfair or fraudulent business act or practice.” Cal. Bus. &

Prof. Code §§ 17200, 17204. Bubak’s UCL claim was premised on Golo’s alleged

violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”), “as

incorporated into California law in the Sherman Food, Drug, and Cosmetic Law,

Cal. Health & Safety Code §§ 110100 et seq.” (“Sherman Law”).

After we decided Nexus Pharmaceuticals, Inc. v. Central Admixture

Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022), the district court dismissed

the complaint. Bubak timely appealed.

We have jurisdiction under 28 U.S.C. § 1291 and review the dismissal de

novo, taking all factual allegations in the complaint as true and construing “the

pleadings in the light most favorable to the nonmoving party.” Est. of Bride v.

Yolo Techs., Inc., 112 F.4th 1168, 1175 (9th Cir. 2024) (internal quotation marks

and citation omitted). We affirm.

1. The FDCA expressly prohibits private enforcement. 21 U.S.C. §

337(a)–(b). In Nexus, the plaintiff sought to avoid this prohibition by bringing

claims under the UCL and other state laws that “incorporate” the FDCA. 48 F.4th

at 1047. We explained, however, that these claims are preempted because they

“rest upon a violation of the FDCA,” id. at 1044, and proceedings to enforce or

2 24-492 restrain violations of the FDCA “must be by and in the name of the United States,

not a private party,” id. at 1049.

Bubak’s claims face the same problem. She asserts that she may sue under

the UCL because the FDCA is “incorporated into” the Sherman Law and Golo

violated § 403(r) of the FDCA by representing that its dietary supplement can

mitigate or prevent a disease. See 21 U.S.C. § 343(r)(6). Bubak’s UCL claim

therefore necessarily requires litigating “the alleged underlying FDCA violation,”

Nexus, 48 F.4th at 1049, and the “plain text of the FDCA leaves that determination

in the first instance to the FDA’s balancing of risks and concerns in its

enforcement process,” id. at 1050.

2. Bubak’s attempts to distinguish Nexus are unpersuasive. Although

Bubak argues that “Nexus did not address the Sherman Law,” the UCL claim in

that case rested on an alleged violation of the Sherman Law. See Case No. 8:20-

cv-01506, Dkt. 13 at ¶ 90; id. ¶ 15 (“Defendants are engaged in unlawful and

unfair business and trade practices because Defendants are compounding and

selling drugs in violation of the Sherman Law”); id. ¶ 46 (“California’s Sherman

Law incorporates the FDCA’s requirement that pharmaceutical manufacturers

must obtain approval before selling a new drug.”).

Bubak also argues that Nexus is distinguishable because it concerned drug

regulations. But Congress’s preemption of a state’s food labeling regulations that

3 24-492 are “not identical to” FDCA requirements mirrors Congress’s preemption of a

state’s drug regulations that are “different from, or in addition to” FDCA

requirements. Compare 21 U.S.C. § 360k, with 21 U.S.C. § 343-1. As the district

court correctly noted, Nexus “did not limit its holding to [the pharmaceutical]

context.”

Finally, Bubak argues that Nexus concerned fraudulent statements made to

the FDA while her claim turns on misrepresentations made to consumers. But

what matters is whether the plaintiff brings a state law claim that exists “solely by

virtue of the FDCA.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353

(2001).

3. Bubak also argues that Davidson v. Sprout Foods, Inc., 106 F.4th 842

(9th Cir. 2024), decided during the pendency of this appeal, requires reversal. The

plaintiffs in Davidson brought a claim under California’s UCL alleging that Sprout

Foods violated the Sherman Law by including nutrition information on baby food

in violation of FDA regulations. See id. at 846. This claim “fundamentally

differs” from the claim in Nexus because it does not “require litigating” questions

that are “reserved for the FDA,” because the violation was plain. Id. at 849. As in

Nexus, further analysis is needed to determine whether Golo’s marketing actually

violated the FDCA.1 Because the FDCA preempts private suits seeking judicial

1 Golo’s motion for initial hearing en banc is DENIED. Dkt. 26.

4 24-492 resolution of such questions, this claim is preempted.

AFFIRMED.

5 24-492 FILED Bubak v. Golo, No. 24-492 OCT 9 2025 MOLLY C. DWYER, CLERK CALLAHAN, Circuit Judge, concurring: U.S. COURT OF APPEALS

I concur in the judgment because Bubak’s state law claims are preempted by

the Federal Food, Drug, and Cosmetic Act (“FDCA”). Although the issue is not

critical to our disposition of this appeal, I write separately to note my disagreement

with the majority’s attempt to reconcile our opinions in Nexus Pharmaceuticals,

Inc. v. Central Admixture Pharmacy Servs., Inc., 48 F.4th 1040 (9th Cir. 2022),

and Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), and to suggest

that in the appropriate case we should overrule Davidson’s limitation on the

FDCA’s prohibition of private actions to enforce the FDCA. Judge Collins in his

dissent got it right: “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.” Davidson, 106 F.4th at 857 (Collins, J., dissenting).

I

The tension between Nexus and Davidson is apparent. In both, plaintiffs

alleged violations of Sherman Law provisions that “incorporate” the FDCA. See

Nexus Compl. ¶ 46, Davidsons’s Compl. ¶ 62. The court in Nexus held these

allegations impliedly preempted because they are simply a roundabout way to

claim violations of the FDCA, which § 337 prohibits. Nexus, 48 F.4th at 1048; id.

at 1050 (“[T]he claim is that a manufacturer is harmed economically because the defendant violated the FDCA. The purported state law violation is of a law that

says in substance ‘comply with the FDCA,’ not a traditional common law tort.”).

The Davidson majority held the opposite. Davidson, 106 F.4th at 851 (“Statutory

causes of action to enforce identical state standards that Congress permitted must

also survive implied preemption.”).

The Davidson majority understandably sought to distinguish its case from

Nexus. They did this by saying the plaintiff in Nexus asserted a Sherman Law

claim that “would require litigating whether . . . an FDCA violation had occurred,”

which is “a task reserved for the FDA,” Davidson, 106 F.4th at 849, and that the

Davidsons were “claiming violations of California law, the Sherman Law, not the

federal FDCA.” Id. This distinction ultimately fails, however, because the

plaintiffs in Davidson also asserted a Sherman Law claim that “would require

litigating whether . . . an FDCA violation had occurred,” id., namely, whether

Sprout Foods made “nutrient content claims” in violation of the FDCA. See, e.g.,

Davidsons’s Compl. ¶ 62 (“Defendant has violated 21 U.S.C. § 343(a), and the

standards set by FDA regulations, including, but not limited to, 21 C.F.R. §§

101.13(b), 101.13(c), which have been incorporated by reference in the Sherman

law, by including impermissible nutrient content claims on the labels of foods

intended for children less than 2 years of age.”).

2 The distinction fails for the additional reason that the plaintiff in Nexus—

like the plaintiffs in Davidson—was “claiming violations of California law, the

Sherman law, not the federal FDCA.” Davidson, 106 F.4th at 849. See, e.g.,

Nexus Compl. ¶ 90 (“Defendants have violated the UCL by engaging in the

unlawful business practice of marketing, selling, and distributing their products in

violation of the California Sherman Law.”).

II

Today’s memorandum disposition doesn’t do any better distinguishing

Nexus and Davidson. Tellingly, the memorandum disposition does not endorse the

Davidson panel’s reasoning, and instead says that in Davidson, the Sherman Law

“violation was plain,” Mem. Dispo. at 4, so did not require litigating questions that

are “reserved for the FDA,” id. (quoting Davidson, 106 F.4th at 849). The

memorandum disposition then goes on to hold that in both this case and in Nexus,

the alleged violation was not “plain” and that “further analysis is needed to

determine whether Golo’s marketing actually violated the FDCA.” Id.

There are a few issues with this approach. For starters, the FDCA does not

carve out a “plain violation” exception to its bar on private enforcement. The

FDCA clearly states that “all such proceedings for the enforcement, or to restrain

violations, of this Act shall be by and in the name of the United States,” 21 U.S.C.

§ 337(a), or “[a] State,” id. § 337(b). See Rotkiske v. Klemm, 589 U.S. 8, 14 (2019)

3 (“It is a fundamental principle of statutory interpretation that absent provisions

cannot be supplied by the courts. To do so is not a construction of a statute, but, in

effect, an enlargement of it by the court.”) (cleaned up).

Second, there is no principled basis for concluding that some FDCA

violations involve litigating questions “reserved for the FDA” while others do not.

Mem. Dispo. at 4. Congress made the FDA “the primary enforcer of the FDCA,”

Kroessler v. CVS Health Corp., 977 F.3d 803, 809 (9th Cir. 2020), so all alleged

violations of the FDCA require litigating questions “reserved for the FDA.”

Finally, even if there were a “plain violation” exception hidden in § 337, this

wouldn’t distinguish the present appeal from Davidson. The alleged FDCA

violation in Davidson required us to look at Sprouts Food packages and to decide

whether Sprouts Food made “nutrient content claims” in violation of federal

regulations. 21 C.F.R. § 101.13(b)(3). Here, the alleged FDCA violation requires

us to look at Golo’s website and decide whether Golo is making “implied disease

claims” in violation of federal regulations. 21 C.F.R. § 101.93(g). There is no

meaningful distinction between the two cases in this respect.

III

4 Notwithstanding the tension between Nexus and Davidson, they are arguably

not irreconcilable, but for different reasons than those in the Davidson opinion and

today’s memorandum disposition.1

Recall that plaintiffs may not allege violations of Sherman Law provisions

that “exist solely by virtue of the FDCA.” Buckman Co. v. Plaintiffs’ Legal

Comm., 531 U.S. 341, 353 (2001). All of the alleged Sherman Law violations in

Nexus fall into this category. The alleged Sherman Law violations in Davidson did

not. In Davidson, the plaintiffs alleged that Sprout Foods violated certain Sherman

Law provisions that “predate the enactment of the Sherman Law.” Davidsons’s

Compl. ¶ 26. For example, plaintiffs alleged that Sprout Foods violated the

“advertising provisions of the Sherman Law.” Id. ¶ 120(ii); see Cal. Health &

Safety Code §§ 110390, 110395, 110398, 110400. These state laws predate, and

thus exist independently of, the federal law at issue in that case. Cf. Buckman, 531

U.S. at 353. See Comm. On Children’s Television, Inc. v. Gen. Foods Corp., 673

P.2d 660, 668 (Cal. 1983) (explaining how, before enactment of the NLEA, the

Sherman Law prohibited “false, unfair, misleading, or deceptive advertising”).

Accordingly, plaintiffs’ Sherman Law claims based on these provisions were not

impliedly preempted. See Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th

1 I therefore join the denial of Golo’s motion for initial hearing en banc. Mem. Dispo. at 4 n.1. 5 Cir. 2015) (Gorsuch, J.) (“[W]e must ask whether [the state claim] exists ‘solely by

virtue’ of the federal statutory scheme (unacceptable) or ‘predates’ the scheme

(acceptable).”); id. at 1352 (Lucero, J., concurring in part) (a state law claim is not

impliedly preempted if it “predate[es] the FDCA, and would exist in the absence of

the Act.”) (citation omitted).

However, the Davidson plaintiffs also alleged that Sprout Foods violated

certain Sherman Law provisions that did not “predate,” or exist independently of,

the FDCA, Caplinger, 784 F.3d at 1340. For example, the plaintiffs alleged that

Sprout Foods violated a Sherman Law provision that “[a]ny food is misbranded if

its labeling does not conform with the requirements for nutrition labeling as set

forth in [the FDCA].” Cal. Health & Safety Code § 11065. This provision

necessarily exists “solely by virtue of the FDCA,” Buckman, 531 U.S. at 353, and

would necessarily “require litigating whether . . . an FDCA violation has

occurred,” Davidson, 106 F.4th at 849. See also, e.g., Davidsons’s Compl. ¶ 3

(alleging that Sprout Foods “misbrands its baby and toddler food products by

making nutrient content claims on the product packages that are strictly prohibited

by the [FDA].”).

Thus, Nexus and Davidson may be reconciled on the ground that at least

some of the Sherman Law provisions alleged in Davidson predate and exist

independently of the FDCA. In Nexus, and here, the opposite is true: all of the

6 alleged Sherman Law violations “exist solely by virtue of the FDCA.” Buckman,

531 U.S. at 353.

IV

The Davidson majority departed from Nexus and created an intra-circuit split

when it held that “[s]tatutory causes of action to enforce identical state standards

that Congress permitted must also survive implied preemption.” Davidson, 106

F.4th at 851. The Nexus court had held just two years earlier that alleging

violations of “identical state standards” to the FDCA unavoidably requires

litigating an alleged violation of the FDCA. Nexus, 48 F.4th at 1048 (explaining

that “a necessary element of Nexus’s [Sherman Law] claim is the alleged violation

of the FDCA”); id. at 1050 (“The purported state law violation is of a law that says

in substance ‘comply with the FDCA’”). I agree with the Nexus panel’s

determination that § 337’s prohibition of private enforcement applies to Sherman

Law provisions that “incorporate” the FDCA, and that state law claims relying on

these provisions are impliedly preempted. Id. at 1050–51.

“’[T]he purpose of Congress is the ultimate touchstone’ in every pre-

emption case.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (quoting Retail

Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)). Congress’s purpose in passing

the FDCA, and especially the twin NLEA and DSHEA amendments, was to

promote national uniformity and standards for the manufacture and distribution of

7 food, drugs, and cosmetics. See, e.g., 21 U.S.C. § 323-1 (“National uniform

nutrition labeling”); 21 U.S.C. § 379r (“National uniformity for nonprescription

drugs”). This court even recognized in Davidson that Congress enacted the NLEA

and DSHEA “to provide nationally uniform standards for nutrition labeling . . . to

displace disparate state standards.” Davidson, 106 F.4th at 845. Permitting private

enforcement of the state laws that “exist solely by virtue of the FDCA,” Buckman,

531 U.S. at 353, frustrates the goal of national uniformity, and raises the prospect

for inconsistent application of the FDCA through the guise of “identical state

standards.” Cf. Davidson, 106 F.4th at 851. These state law claims are therefore

preempted by the FDCA’s bar on private enforcement. 21 U.S.C. § 337.

The enforcement scheme outlined in § 337 reflects Congress’s concern for

national uniformity. Section 337(a) reserves enforcement of the FDCA to the

federal government, and § 337(b)(1) carves out an exception for States to bring

enforcement actions for food-related violations “if the food that is subject of the

proceedings is located in the States.” The exception in subsection (b)(1) is then

limited by subsection (b)(2), which provides that States cannot commence

proceedings until “after the State has given notice to the Secretary [of Health and

Human Services],” id. at § 337(b)(2)(A)-(B), and even after notice is given, cannot

commence proceedings “if the Secretary is diligently prosecuting a proceeding in

court pertaining to such food,” id. § 337(b)(2)(C). This means that even when

8 Congress gave States the power to enforce the FDCA, it limited that power and

made it dependent on coordinating with the federal government. See also 58 Fed.

Reg. 2457, 2460 (Jan. 6, 1993) (“[T]he agency believes that close cooperation

between [the] FDA and the States will ensure that goals of uniformity are met

while still addressing the concerns of citizens of a State.”).

The majority in Davidson believed that § 337 “implicates only enforcement

of the federal, not enforcement of identical state requirements.” Davidson, 106

F.4th at 850. But such a reading ignores that Congress allowed States to enact

standards that are “identical to” certain FDCA standards. See 21 U.S.C. § 341. It

makes little sense to think Congress would so carefully prohibit private

enforcement of the federal standards but not be concerned with private

enforcement of identical state standards. “Federal law does not support such a

strange result.” Cf. Davidson, 106 F.4th at 849. Had Congress intended private

enforcement of state laws that are identical to the FDCA, “it would have said so

expressly, and not left the matter to mere implication.” Palmore v. United States,

411 U.S. 389, 395 (1973). Indeed, it “expressly” permitted States to enforce state

laws that are identical to the FDCA. 21 U.S.C. § 337(b). Congress’s decision to

omit private enforcement of these identical standards should be respected. Cornell

v. Lima Corporate, 988 F.3d 1089, 1099 (9th Cir. 2021) (reading Congress’s

“omission to be intentional”).

9 The Davidson majority did not understand why Congress would allow States

to have food labeling requirements that are “identical to” FDCA requirements, 21

U.S.C. § 341-a, while at the same time not allow individuals in that State to

enforce the identical requirements. Davidson, 106 F.4th at 849 (“There is no reason

we can perceive why Congress would permit states to enact particular legislation

and then deny enforcement by their citizens.”). But there are a number of reasons

why Congress would do this, not the least of which is to ensure consistent

application of FDCA food labeling requirements across the country. Several states

in addition to California have “incorporated” these FDCA requirements into state

law.2 If individual plaintiffs could bring suit, defendant corporations would be

subject to conflicting interpretations of federal law throughout the country; for

instance, a state court in California might find that Golo made “implied disease

claims” while a state court in Florida finds that Golo did not make “implied disease

claims.” Congress sought to prevent such inconsistent application of FDCA

standards through § 337(a)-(b).

There is yet another clue that Congress permitted States to enact parallel

food labeling requirements while not permitting private citizens to enforce those

requirements. It is axiomatic that “Congress legislates against the backdrop of

2 See, e.g., Fla. Stat. Ann. § 499.023; Conn. Gen. Stat. § 21a-110; Ariz. Rev. Stat. § 32-1962; 35 Pa. Stat. Ann. § 780-11. 10 existing law,” McQuiggin v. Perkins, 569 U.S. 383, 398 n.3 (2013), and Congress

passed the NLEA and DSHEA “against the backdrop” of state governments

enforcing their own food labeling laws. For instance, California’s Sherman Law

does not contemplate a private right of action, but instead contemplates

government enforcement of the state’s food labeling requirements. See, e.g., Cal.

Health & Safety Code §§ 111840, 111900. This settled expectation, along with

Congress’s longstanding desire for national uniformity, demonstrates Congress’s

intent to prohibit individuals from enforcing state food labeling laws that are

“identical to” the FDCA.3

V

I concur in the affirmance of the district court’s order of dismissal because

Bubak’s state law claims are preempted by the FDCA. I write separately to draw

attention to contrasting perspectives on the FDCA’s preemption of state laws that

“incorporate” the FDCA and to encourage my colleagues to, in the appropriate

case, reaffirm our holding in Nexus that the FDCA prohibits private enforcement of

any state law that incorporates the FDCA.

3 I do not take issue with California Supreme Court’s holding that “private parties may assert UCL claims based on violations of the Sherman Law,” Farm Raised Salmon Cases, 175 P.3d at 1084 n.5, so long as the alleged Sherman Law violation predates, and exists independently of, the federal law at issue. 11