1

Filed 3/9/23

CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

FIRST APPELLATE DISTRICT

DIVISION ONE

CENTER FOR ENVIRONMENTAL 

HEALTH,

Plaintiff and Appellant,

v.

PERRIGO COMPANY et al.,

Defendants and Respondents.

 A163682

 (Alameda County

 Super. Ct. No. RG20-054985)

Appellant Center for Environmental Health (CEH) sued respondents, 

various manufacturers and retailers of generic over-the-counter (OTC)

antacids, claiming they failed to warn consumers that the products contained 

a known carcinogen under Proposition 65, the Safe Drinking Water and Toxic 

Enforcement Act of 1986, Health and Safety Code section 25249.5 et sequitur

(Proposition 65).

1 CEH also sued two manufacturers of Zantac, the brandname version of respondents’ products.2

1 Respondents are Dr. Reddy’s Laboratories, Inc., and Dr. Reddy’s 

Laboratories Louisiana, LLC (collectively, Dr. Reddy’s), Perrigo Company, 

Target Corporation, Apotex Corp., Granules USA, Inc., and 7-Eleven, Inc. All 

further statutory references are to the Health and Safety Code unless 

otherwise noted.

2 The brand-name manufacturers sued are Sanofi-Aventis U.S. LLC 

and Chattem Inc. Although they are not parties to this appeal, we discuss 

issues related to them to provide relevant context.
2

Respondents, whom we will refer to as the generic-drug defendants,

demurred to the complaint on the basis that the federal Food, Drug, and 

Cosmetic Act, 21 United States Code section 301 et sequitur (FDCA),

preempted CEH’s claim. The remaining defendants, whom we will refer to as 

the brand-name defendants, demurred on the same basis. The trial court 

sustained the generic-drug defendants’ demurrers without leave to amend

and entered judgment in their favor. But the court sustained the brandname defendants’ demurrers with leave to amend, and CEH’s action against 

them is proceeding below. 

On appeal, CEH contends the trial court erred by ruling that conflict

preemption bars CEH’s claim against the generic-drug defendants on the 

basis that it would be impossible for them to comply with both state and 

federal law.

3 The court determined that the generic-drug defendants cannot 

give a Proposition 65 warning about the products without violating the 

federal duty of sameness, which requires the generic version of a drug to have 

the same “labeling” as the brand-name version. (See PLIVA, Inc. v. Mensing

(2011) 564 U.S. 604, 612–613 (Mensing).) Given the broad definition of 

“labeling” under the FDCA, the court concluded there was no permissible

method of giving a Proposition 65 warning without the manufacturer of the 

brand-name equivalent doing so first.

We affirm the dismissal of the action against the generic-drug 

defendants. Due to the unusual interplay between an express preemption 

provision governing OTC drugs and Proposition 65, the viability of CEH’s 

suit against the generic-drug defendants turns on whether federal law 

governs warning in a manner that preempts state law governing warning. 

3 The Attorney General filed an amicus curiae brief in support of CEH, 

as authorized under California Rules of Court, rule 8.200(c)(7).
3

We conclude that it does. Although we do not hold that all methods of 

publicly communicating a warning about a drug necessarily qualify as 

“labeling,” CEH fails to identify any method by which the generic-drug 

defendants could provide a warning about their consumer products that

would satisfy both Proposition 65 and the federal duty of sameness. As a 

result, until brand-name manufacturers give a Proposition 65 warning on 

their products’ labeling, the generic-drug defendants cannot be required to do 

so.

I.

FACTUAL AND PROCEDURAL

BACKGROUND

This lawsuit concerns OTC antacids with the active ingredient 

ranitidine. The following facts are taken from CEH’s second amended 

complaint (SAC), and we accept them as true in reviewing whether the 

generic-drug defendants’ demurrers were properly sustained. (See Ace 

American Ins. Co. v. Fireman’s Fund Ins. Co. (2016) 2 Cal.App.5th 159, 164.)

The generic-drug defendants either manufacture or sell generic 

versions of ranitidine-containing antacids, which are also sold under the 

brand name Zantac. The chemical n-nitrosodimethylamine (NDMA), a 

known carcinogen that “is used in laboratory research to induce tumors in 

experimental animals[,] . . . can . . . form during the manufacturing process of 

certain drug products, such as those containing ranitidine.”

In September 2019, after an independent laboratory found “significant 

quantities of NDMA” in ranitidine-containing antacids, the United States 

Food and Drug Administration (FDA) issued a public alert. Some 
4

manufacturers voluntarily recalled their products.4 A subsequent FDA 

analysis “determined that NDMA formation can occur in ranitidine through 

the use of contaminated materials and ingredients, the application of inferior 

drug manufacturing processes, and improper drug storage after 

manufacture.” FDA testing also confirmed the presence of NDMA at varying 

levels in the generic-drug defendants’ ranitidine products. 

In April 2020, the FDA “request[ed that] manufacturers withdraw all 

prescription and [OTC] ranitidine drugs from the market immediately.” CEH 

alleges that despite “the publicity and recalls,” the generic-drug defendants

“continued to expose individuals to NDMA without prior clear and reasonable 

warnings regarding the carcinogenic hazards of NDMA,” and that this failure 

to warn is ongoing.5

CEH, as a nonprofit corporation acting in the public interest, originally 

sued Perrigo and Target in February 2020.6 (See § 25249.7, subd. (d).) The 

remaining respondents, as well as the brand-name defendants, were 

subsequently added as defendants. The brand-name defendants manufacture 

and sell Zantac; Perrigo, Apotex, Granules, and Dr. Reddy’s manufacture 

generic versions of Zantac; and 7-Eleven and Target sell generic versions of 

Zantac.

4 CEH filed a request for judicial notice of announcements by four 

companies, three of whom are generic-drug defendants, of voluntary recalls of 

ranitidine products. We deny the request as unnecessary to our decision.

5 At oral argument, CEH’s counsel stated that respondents stopped 

selling contaminated products several years ago.

6 The presence of NDMA in Zantac and generic ranitidine products is 

also the subject of a multidistrict litigation in federal court. (See In re Zantac 

(Ranitidine) Products Liability Litigation (S.D. Fla. 2021) 548 F.Supp.3d 

1225, 1228–1229.)
5

In January 2021, CEH filed the SAC, which alleged a cause of action 

for injunctive relief under Proposition 65 to prevent the defendants from 

selling the products “without providing prior clear and reasonable warnings” 

about “the carcinogenicity of NDMA.” CEH also sought civil penalties and 

attorney’s fees and costs.

All the defendants demurred to the SAC on the basis that CEH’s claim 

was preempted by federal law. The brand-name defendants contended that it 

was impossible for them to add Proposition 65 warnings to their labeling 

unilaterally without violating federal law. Similarly, the generic-drug 

defendants contended that it was impossible to satisfy Proposition 65 without 

violating federal law governing labeling for generic drugs, which must always 

be the same as the labeling for the drugs’ brand-name equivalents.

7

In May 2021, the trial court issued an order sustaining the brand-name 

defendants’ demurrers with leave to amend and the generic-drug defendants’ 

demurrers without leave to amend. The following month, CEH filed a third 

amended complaint against the brand-name defendants only. A judgment 

dismissing the complaint against the generic-drug defendants was entered in 

August 2021, from which CEH appealed. 

II.

DISCUSSION

A. General Legal Standards

1. Federal preemption and standard of review

“The Supremacy Clause provides that the laws and treaties of the 

United States ‘shall be the supreme Law of the Land . . . any Thing in the 

Constitution or Laws of any state to the Contrary notwithstanding.’ ” (Mut. 

7 Apotex also unsuccessfully argued that CEH’s claim was moot and 

failed due to field preemption. Apotex does not challenge the trial court’s 

rejection of these arguments.
6

Pharm. Co. v. Bartlett (2013) 570 U.S. 472, 479 (Bartlett), quoting U.S. 

Const., art. VI, cl. 2.) Thus, “[w]hen a state statute, administrative rule, or 

common-law cause of action conflicts with a federal statute, it is axiomatic 

that the state law is without effect.” (Geier v. American Honda Motor Co., 

Inc. (2000) 529 U.S. 861, 894.) “Similarly, federal agencies, acting pursuant 

to authorization from Congress, can issue regulations that override state 

requirements.” (Quesada v. Herb Thyme Farms, Inc. (2015) 62 Cal.4th 298, 

308.) 

Express preemption occurs when Congress provides by statute that

state law is preempted. (Crosby v. National Foreign Trade Council (2000) 

530 U.S. 363, 372.) There are also various forms of implied preemption. 

Field preemption occurs “[w]hen Congress intends federal law to ‘occupy the 

field.’ ” (Ibid.) And conflict preemption occurs in two main situations: 

(1) “where it is impossible for a private party to comply with both state and 

federal law” and (2) “where ‘under the circumstances of [a] particular case, 

[the challenged state law] stands as an obstacle to the accomplishment and 

execution of the full purposes and objectives of Congress.’ ” (Id. at pp. 372–

373.) Here, we are concerned only with the first type of conflict preemption, 

which we will refer to as impossibility preemption. 

“Consideration of issues arising under the Supremacy Clause ‘starts 

with the assumption that the historic police powers of the States [are] not to 

be superseded by . . . Federal Act unless that [is] the clear and manifest 

purpose of Congress.’ ” (Cipollone v. Liggett Group (1992) 505 U.S. 504, 516.) 

Since “ ‘ “[c]ourts are reluctant to infer preemption, . . . it is the burden of the 

party claiming that Congress intended to preempt state law to prove it.” ’ ” 

(Viva! Internat. Voice for Animals v. Adidas Promotional Retail Operations, 
7

Inc. (2007) 41 Cal.4th 929, 936.) Congressional intent “ ‘ “is the ultimate 

touchstone” ’ of pre[]emption analysis.” (Cipollone, at p. 516.) 

We review de novo an order sustaining a demurrer. (T.H. v. Novartis 

Pharmaceuticals Corp. (2017) 4 Cal.5th 145, 162 (T.H.).) Likewise, whether 

state law is federally preempted is “a pure question of law” that we 

independently review. (Farm Raised Salmon Cases (2008) 42 Cal.4th 1077, 

1089, fn. 10.) In deciding whether a demurrer was properly sustained, “[w]e 

are not bound by the trial court’s stated reasons, if any, supporting its ruling; 

we review the ruling, not its rationale.” (Mendoza v. Town of Ross (2005) 

128 Cal.App.4th 625, 631.)

2. Proposition 65

“Proposition 65, which was passed as a ballot initiative in 1986, 

requires the state to develop and maintain a list of chemicals ‘known to the 

state to cause cancer or reproductive toxicity.’ ” (American Meat Institute v. 

Leeman (2009) 180 Cal.App.4th 728, 735 (Leeman), quoting § 25249.8, 

subd. (a).) NDMA is listed as a known carcinogen. (Cal. Code Regs., tit. 27, 

§ 27001, subd. (b).)8 

Proposition 65 provides that “[n]o person in the course of doing 

business shall knowingly and intentionally expose any individual to a 

chemical known to the state to cause cancer or reproductive toxicity without 

first giving clear and reasonable warning to such individual, except as 

provided in Section 25249.10.” (§ 25249.6.) In turn, section 25249.10 

provides that section 25249.6 does not apply to “[a]n exposure for which the 

person responsible can show that the exposure poses no significant risk 

assuming lifetime exposure at the level in question for substances known to 

8 All further references to “Regulations” are to title 27 of the California 

Code of Regulations.
8

the state to cause cancer.” (§ 25249.10, subd. (c).) Nor does section 25249.6 

apply to “[a]n exposure for which federal law governs warning in a manner 

that preempts state authority.” (§ 25249.10, subd. (a).)

The required warning under section 25249.6 “need not be provided 

separately to each exposed individual and may be provided by general 

methods such as labels on consumer products, . . . posting of notices, placing 

notices in public news media, and the like, provided that the warning 

accomplished is clear and reasonable.” (§ 25249.11, subd. (f).) Regulations 

implementing Proposition 65 “describe optional ‘safe harbor’ warnings that 

are deemed to be clear and reasonable.” (Dowhal v. SmithKline Beecham 

Consumer Healthcare (2004) 32 Cal.4th 910, 918 (Dowhal); see Regs., § 25600 

et seq.) The safe-harbor warning for carcinogens reads, “This product can 

expose you to chemicals including [name of one or more chemicals], which is 

[are] known to the State of California to cause cancer. For more information 

go to www.P65Warnings.ca.gov.” (Regs., § 25603, subd. (a)(2)(A).)

An action under Proposition 65 “fundamentally seeks a form of 

declaratory relief—that the product requires a warning.” (DiPirro v. Bondo 

Corp. (2007) 153 Cal.App.4th 150, 182 (DiPirro).) Other remedies include 

injunctive relief and civil penalties. (§ 25249.7, subds. (a) & (b).)

3. The FDCA

The FDCA “ ‘regulates the manufacture, use, or sale of drugs.’ ” (Merck 

KGaA v. Integra Lifesciences I, Ltd. (2005) 545 U.S. 193, 196.) Under the 

FDCA, “a manufacturer seeking federal approval to market a new drug must 

prove that it is safe and effective and that the proposed label[ing] is accurate 

and adequate. [Citations.] Meeting those requirements involves costly and 

lengthy clinical testing.” (Mensing, supra, 564 U.S. at p. 612, fn. omitted; 

21 U.S.C. § 355(b)(1), (d).) A new drug application (NDA) “will be refused if 
9

the FDA determines that the labeling is false or misleading in any particular, 

if the application contains an untrue statement of a material fact, or if the 

proposed labeling does not comply with . . . [applicable] regulations.” 

(Kanter v. Warner-Lambert Co. (2002) 99 Cal.App.4th 780, 785, citing 

21 U.S.C. § 355(d)(7) & 21 C.F.R. § 314.125(b)(6)–(8); see 21 U.S.C. 

§ 352(a)(1) [drug is considered misbranded “[i]f its labeling is false or 

misleading in any particular”].)

The 1984 Drug Price Competition and Patent Term Restoration Act, 

98 Stat. 1585 (21 U.S.C. § 355(j)), also known as the Hatch-Waxman Act, 

authorizes “a prospective generic drug manufacturer to file an abbreviated 

new drug application (ANDA) asserting the generic drug’s bioequivalence to 

an existing listed drug that has already been approved by the FDA. . . . The 

streamlined application relieves the generic manufacturer of the need to 

duplicate the clinical trials previously submitted for the equivalent brandname drug.” (T.H., supra, 4 Cal.5th at p. 157; Mensing, supra, 564 U.S. at 

p. 612.) Thus, manufacturers can develop generic drugs more cheaply and 

pass those savings to consumers. (See Mensing, at p. 612; Andrx

Pharmaceuticals, Inc. v. Biovail Corp. (Fed. Cir. 2002) 276 F.3d 1368, 1370–

1371.)

In addition to asserting bioequivalence, an ANDA “must also ‘show that 

the [safety and efficacy] labeling proposed . . . is the same as the labeling 

approved for the [brand-name] drug.’ ” (Mensing, supra, 564 U.S. at pp. 612–

613, quoting 21 U.S.C. § 355(j)(2)(A)(v).) The FDCA defines “labeling” as “all 

labels and other written, printed, or graphic matters (1) upon any article or 

any of its containers or wrappers, or (2) accompanying such article.” 

(21 U.S.C. § 321(m).) While the brand-name manufacturer “bears 

responsibility for the accuracy and the adequacy of its label ‘as long as the 
10

drug is on the market,’ ” a generic manufacturer “is responsible only for ‘an 

ongoing federal duty of “sameness.” ’ ” (T.H., supra, 4 Cal.5th at p. 157; 

Mensing, at p. 613.) The duty of sameness requires a generic manufacturer 

to ensure that its labeling is the same as the brand-name manufacturer’s, 

both when its labeling is approved and thereafter. (Mensing, at p. 613; T.H., 

at p. 157.) Otherwise, a labeling difference could “inaccurately imply a 

therapeutic difference between the brand and generic drugs and thus could 

be impermissibly ‘misleading.’ ” (Mensing, at p. 615.)

In certain circumstances, the manufacturer of a brand-name drug can 

change the drug’s labeling without FDA approval. “Generally speaking, a 

manufacturer may only change a drug label after the FDA approves a 

supplemental application.” (Wyeth v. Levine (2009) 555 U.S. 555, 568;

21 C.F.R. § 314.70.) But under “the FDA’s ‘changes-being-effected’ (CBE) 

process,” a manufacturer can make certain changes to a drug’s labeling

without needing to “wait for preapproval by the FDA.” (Mensing, supra, 

564 U.S. at p. 614; 21 C.F.R. § 314.7(c)(6).) These include any “[c]hange[] in 

the labeling to reflect newly acquired information” that will “add or 

strengthen a contraindication, warning, precaution, or adverse reaction.” 

(21 C.F.R. § 314.70(c)(6)(iii)(A).) Although the manufacturer of a generic 

drug can use the CBE process to “change[] its label to match an updated 

brand-name label or to follow the FDA’s instructions,” unlike a brand-name 

manufacturer it cannot use the process “to unilaterally strengthen [its] 

warning label[].” (Mensing, at p. 614.)

The FDCA contains a provision expressly preempting state law 

regarding OTC drugs. 21 United States Code section 379r (section 379r), 

titled “National uniformity for nonprescription drugs,” provides that “no 

State or political subdivision of a State may establish or continue in effect 
11

any requirement . . . [¶] (1) that relates to the regulation of a 

[nonprescription] drug . . . and [¶] (2) that is different from or in addition to, 

or that is otherwise not identical with, a requirement under this Act.” 

(§ 379r(a).) For purposes of section 379r(a), “a requirement that relates to 

the regulation of a drug shall be deemed to include any requirement relating 

to public information or any other form of public communication relating to a 

warning of any kind for a drug.” (§ 379r(c)(2).)

Proposition 65 is exempted from express preemption under section 379r 

by “a savings clause designed specifically to preserve [it].” (Dowhal, supra, 

32 Cal.4th at p. 919.) Under the savings clause, section 379r does “not apply 

to a State requirement adopted by a State public initiative or referendum 

enacted prior to September 1, 1997.” (§ 379r(d)(2).)9 “Proposition 65 is the 

only state enactment that falls within the savings clause.” (Dowhal, at 

p. 919.)

B. The Limited Nature of Our Holding

Before we analyze CEH’s claims of error, we mention two aspects of 

this case that distinguish it from cases involving similar issues and that limit 

our holding and its practical effect. First, NDMA is a contaminant, not an 

intended ingredient of the drugs at issue. The SAC alleges that the products 

have been subject to recalls, but it also alleges that the generic-drug 

defendants continue to sell products containing NDMA. Although for 

9 Section 379r also contains a second savings clause, under which 

nothing in the statute “shall be construed to modify or otherwise affect any 

action or the liability of any person under the product liability law of any 

State.” (21 U.S.C. § 379r(e).) It is undisputed that this savings clause does 

not apply because CEH’s claim does not involve California product-liability 

law, under which “injury to the plaintiff from a defective product is an 

essential element of a cause of action.” (Kanter v. Warner-Lambert Co., 

supra, 99 Cal.App.4th at p. 790.)
12

purposes of our review we must accept the allegation that contaminated

drugs continue to be sold, our record does not reveal how the generic-drug 

defendants could continue to sell them without running afoul of the FDA. A 

lawsuit seeking to require warnings that the products contain NDMA—

which, again, is not supposed to be in them at all—seems a poor way to 

address the potential danger to consumer health. Consumers would likely be 

better protected by removing the contaminated drugs from the market than 

by allowing the drugs’ sale, even with a warning, in a contaminated state.

Proposition 65 is intended “to regulate toxic substances [that] are 

deliberately added or put into the environment by human activity.” (NicolleWagner v. Deukmejian (1991) 230 Cal.App.3d 652, 659, italics added.) Thus, 

regardless of preemption issues, a Proposition 65 warning about NDMA 

would only be required if it became acceptable for the drugs to contain the 

contaminant and the generic-drug defendants continued selling contaminated

products. As a result, resolving whether CEH’s claim is preempted because it 

seeks to impose a state-law “labeling” requirement is something of a 

theoretical exercise; as a practical matter, no such labeling is likely to result 

from this litigation.

Second, this appeal concerns only the generic-drug defendants. As we 

have said, CEH’s claim against the brand-name defendants is proceeding 

below, based on the possibility that they could unilaterally add a 

Proposition 65 warning to their products through the CBE process. Putting 

aside the contamination issue, if CEH were to prevail and the brand-name 

defendants were required to provide a Proposition 65 warning on their

products’ labeling, then the generic-drug defendants would have to do so as 

well to comply with the federal duty of sameness. Thus, our holding that 

CEH’s claim against the generic-drug defendants is preempted does not 
13

foreclose the possibility that a Proposition 65 warning could be required for 

their products, so long as such a warning was first required of manufacturers 

of brand-name equivalents.

C. The Effect of the Statutory Preemption Provisions

We now turn to the preemption-related provisions of the FDCA and 

Proposition 65. It is undisputed that if not for the savings clause of 

section 379r, that statute would preempt CEH’s claim because the claim

seeks to establish a “requirement relating to public information or any other 

form of public communication relating to a warning of any kind for [an OTC] 

drug” that “is different from or in addition to, or . . . otherwise not identical 

with, a requirement under [the FDCA].” (21 U.S.C. § 379r(a)(2), (c)(2).) But 

because the savings clause of section 379r provides that the statute does not 

apply to Proposition 65 (21 U.S.C. § 379r(d)(2)), federal law does not 

expressly preempt suits under Proposition 65 involving OTC drugs.

Dowhal held that although section 379r’s savings clause excludes 

Proposition 65 from express preemption, the clause “does not entirely exclude 

conflict preemption,” that is, impossibility or obstacle preemption. (Dowhal, 

supra, 32 Cal.4th at pp. 923–924, 926.) Dowhal determined that Geier v. 

American Honda Motor Co., Inc., supra, 529 U.S. 861 “established a general 

rule upholding conflict preemption even if the applicable federal law contains 

a savings clause” exempting a state requirement from express preemption. 

(Dowhal, at pp. 925–926.) Thus, if a Proposition 65 requirement is “in direct 

conflict with . . . or frustrate[s] the purpose of” an FDA requirement, the state 

requirement is preempted. (Id. at pp. 924, 926.) 

Dowhal quoted, but did not discuss the effect of, Proposition 65’s 

provision that section 25249.6 does not apply to “[a]n exposure for which 

federal law governs warning in a manner that preempts state authority.” 
14

(§ 25249.10, subd. (a); Dowhal, supra, 32 Cal.4th at p. 918.) Referring to this 

provision as Proposition 65’s “self-exception,” the trial court here concluded 

that it “does more than state the obvious, which is that federal law preempts 

state law.” The court interpreted it to mean “that if federal law on warning 

preempts state law on warning, then there is no liability for an exposure 

under [section] 25249.6,” regardless of the basis for that liability, “and thus 

the court cannot order any non-warning injunctive relief or award any 

penalties.” Later in the order, the court also indicated that even if “the 

FDCA might not prevent the [manufacturers] from voluntarily putting 

Proposition 65 warnings in advertisements for the [p]roducts, the FDCA’s 

regulation of warnings on labels and in label[]ing means that ‘federal law 

governs warning in a manner that preempts state authority,’ which means 

that [Proposition 65’s] self-exception applies.” 

CEH claims the trial court erred by interpreting Proposition 65’s selfexception to “compel[] preemption even in circumstances where the federal 

Constitution does not, e.g., where the violations could be rectified by means 

other than providing a warning (such as reformulation), or where certain 

types of warnings may be precluded but others are not (e.g., a label warning 

versus an advertisement warning).” In other words, CEH contends the court 

interpreted Proposition 65’s self-exception “to mean that where federal law 

preempts any aspect of state authority under Proposition 65, Proposition 65 

is wholly preempted.” 

We review issues of statutory interpretation de novo. (Lopez v. 

Ledesma (2022) 12 Cal.5th 848, 857.) Under “ ‘the ordinary rules and canons 

of statutory construction,’ ” which also apply to initiative measures, “ ‘[w]e 

look first to the language of the statute, giving the words their ordinary 

meaning, and construing the statutory language in the context of the statute 
15

as a whole and the overall statutory scheme.’ . . . ‘ “We give the language its 

usual and ordinary meaning, and ‘[i]f there is no ambiguity, then we presume 

the lawmakers meant what they said, and the plain meaning of the language 

governs.’ . . . Ultimately we choose the construction that comports most 

closely with the apparent intent of the lawmakers, with a view to promoting

rather than defeating the general purpose of the statute.” ’ ” (DiPirro, supra,

153 Cal.App.4th at pp. 190–191.) As “ ‘a remedial law, designed to protect 

the public,’ ” Proposition 65 must be “ ‘construe[d] . . . broadly to accomplish 

that protective purpose.’ ” (Lee v. Amazon.com, Inc. (2022) 76 Cal.App.5th 

200, 226.)

It is not clear that the trial court interpreted Proposition 65’s selfexception as broadly as CEH claims it did. In any event, the generic-drug

defendants disclaim any interpretation under which Proposition 65 is wholly 

preempted if even one method of satisfying it is preempted. We agree with 

the parties that the self-exception does not mean that section 25249.6 would 

be inapplicable if federal law were to preempt a single type of warning that 

would otherwise be required under Proposition 65 but not other types of 

Proposition 65 warnings. For example, there is no dispute that federal law 

bars the manufacturer of a generic OTC drug from unilaterally putting a 

Proposition 65 warning on its product’s container. Even though federal law 

thus governs warning in a manner that preempts some state authority, we

decline to conclude that Proposition 65’s self-exception therefore establishes a 

manufacturer cannot be liable for failing to warn in a manner that federal 

law would allow. Such a reading is inconsistent not only with the principle 

that Proposition 65 be interpreted in a manner that effectuates its remedial 

purpose but also with section 379r’s savings clause, which expresses a 

congressional intent to permit Proposition 65 warnings involving OTC drugs. 
16

The true dispute on appeal is whether Proposition 65’s self-exception 

means, as CEH claims, that “compliance with Proposition 65 by any means

must be completely impossible for Proposition 65 to be entirely preempted,”

or, as the generic-drug defendants claim, that a defendant is not liable under 

section 25249.6 if all possible warnings are preempted by federal law. We 

conclude that the generic-drug defendants have the better argument. 

To begin with, the parties disagree about the potential methods of 

complying with section 25249.6. CEH claims that “a defendant may avoid 

Proposition 65 liability” for exposing consumers to consumer products that 

contain carcinogens “either by (a) providing a clear and reasonable warning, 

or (b) taking any number of steps to eliminate or reduce the levels of the 

listed chemical to below the level requiring a warning.”10 Similarly, the trial 

court indicated that a defendant can “avoid liability by either providing a 

warning or ensuring that its products have chemical exposure below the ‘no 

significant risk’ level.”11 The generic-drug defendants, however, reject this

“novel ‘dual compliance’ construction of Proposition 65,” arguing that “a duty 

to warn is the only duty imposed by [section 25249.6].” Likewise, in his 

10 CEH identifies numerous examples of how manufacturers could 

reduce the amount of NDMA in the products at issue, including by “adopting 

better drug manufacturing practices,” “storing the [p]roducts at lower 

temperatures,” or “spot-testing [p]roducts . . . and not selling those that are 

found to contain high NDMA levels.” For the sake of simplicity, we will refer 

to any action that would result in the products no longer containing an 

amount of NDMA requiring a warning as “reformulation.”

11 Elsewhere in the order, the trial court stated that “liability for an 

exposure under [section] 25249.6” may be “based on either lack of warning or 

knowing exposure to chemicals.” This statement is puzzling, since “knowing 

exposure to chemicals” is not enough to establish liability. To the contrary, 

an entity is free to “knowingly and intentionally expose” consumers to 

carcinogens so long as it “first giv[es] clear and reasonable warning” it is 

doing so. (§ 25249.6.)
17

amicus curiae brief the Attorney General argues that “reformulation is not a 

statutory duty or requirement” under Proposition 65.12

In our view, the parties’ positions on this issue do not substantively 

conflict. Section 25249.6 does “not apply” to an exposure to a low-enough 

level of a carcinogen (§ 25249.10), meaning CEH is correct that reformulation 

is one way to avoid liability under Proposition 65. But the generic-drug 

defendants and the Attorney General are correct that section 25249.6 itself 

does not impose a duty to reformulate, because exposures below a certain 

level are exempted from that statute’s reach.

This is significant because even if reformulation is a potential remedy 

for a violation of section 25249.6, a suit under that provision fundamentally 

seeks to impose a state-law warning requirement, not a reformulation 

requirement. (See DiPirro, supra, 153 Cal.App.4th at p. 182.) In turn, 

Proposition 65’s self-exception provides that section 25249.6 is inapplicable to 

an exposure if “federal law governs warning in a manner that preempts state 

authority.” (§ 25249.10, subd. (a), italics added.) Thus, the most reasonable 

interpretation of Proposition 65’s self-exception is that if federal law governs 

warning in a manner that preempts state law authority governing warning, 

there is no liability for exposing consumers to a regulated substance—

meaning that no remedy, including reformulation, is available. CEH’s 

interpretation, in contrast, would mean that even if it were impossible to 

comply with both federal and state warning requirements, a suit under 

12 CEH also filed a request for judicial notice of the Attorney General’s 

amicus curiae brief filed in another Proposition 65 appeal. CEH claims the 

brief shows that the Attorney General agrees that Proposition 65 “plainly 

contemplates two methods of compliance: providing a clear and reasonable 

warning or not exposing persons to listed chemicals.” We deny the request,

because whatever the Attorney General’s position on this issue may be in a 

different case is not relevant to our decision.
18

section 25249.6 would never be preempted by the self-exception because 

federal law would never “govern[] warning” in a manner that preempted

reformulation.

In sum, we conclude that Proposition 65’s self-exception applies, and 

CEH’s action against the generic-drug defendants cannot go forward, if 

federal law governs warning in a manner that preempts state law governing 

warning. Thus, the determinative issue is whether it is possible for the 

generic-drug defendants to provide warnings about their products that satisfy 

both Proposition 65 and federal law. If it is possible, then federal law 

governing warning does not preempt state authority governing warning, 

Proposition 65’s self-exception does not apply, and CEH’s suit may proceed. 

If it is not possible, then federal law governing warning preempts state 

authority governing warning despite section 379r’s savings clause,

Proposition 65’s self-exception does apply, and CEH’s suit against the 

generic-drug defendants may not proceed. Therefore, we turn to whether the 

generic-drug defendants could give warnings about their products that 

comply with both Proposition 65 and federal law.

D. CEH Identifies No Method by Which the Generic-drug Defendants

Could Both Comply With the Federal Duty of Sameness and Give

Warnings that Satisfy Proposition 65.

1. The generic-drug defendants’ duties under state and 

federal law

Impossibility preemption exists “where ‘compliance with both federal 

and state regulations is a physical impossibility.’ ” (Arizona v. United States

(2012) 567 U.S. 387, 399.) The first step in determining whether this form of 

preemption applies is to identify a defendant’s duty under state law. 

(Bartlett, supra, 570 U.S. at p. 480; Trejo v. Johnson & Johnson (2017) 

13 Cal.App.5th 110, 153.) As noted above, Proposition 65 requires a company
19

to “giv[e] clear and reasonable warning” before “knowingly and intentionally 

expos[ing] any individual” to a carcinogen. (§ 25249.6.) The required 

warning “need not be provided separately to each exposed individual and may 

be provided by general methods such as labels on consumer products, . . .

posting of notices, placing notices in public news media, and the like, 

provided that the warning accomplished is clear and reasonable.”13 

(§ 25249.11, subd. (f).) 

Regulations implementing Proposition 65 identify acceptable methods 

of providing warnings, although a party may “provid[e] a warning using . . .

methods other than those specified . . . that nevertheless complies with 

[s]ection 25249.6.” (Regs., § 25600, subd. (f).) For consumer products, 

“exposure warnings must be prominently displayed on a label, labeling, or 

sign, and must be displayed with such conspicuousness as compared with 

other words, statements, designs[,] or devices on the label, labeling, or sign, 

as to render the warning likely to be seen, read, and understood by an 

ordinary individual under customary conditions of purchase or use.” (Id., 

§ 25601, subd. (c).) In addition to being placed “on the label,” a warning may 

be conveyed “on a posted sign, shelf tag, or shelf sign, for the consumer 

13 The potential liability for failure to give a Proposition 65 warning is

more limited for retailers of consumer products than it is for manufacturers

of those products. (See § 25249.11, subd. (f); Regs., § 25600.2; Lee v. 

Amazon.com, Inc., supra, 76 Cal.App.5th at p. 231.) The parties do not 

address this distinction, and we therefore do not differentiate between the 

manufacturer respondents and the retailer respondents in our discussion of 

state-law duties. Likewise, although retailers of generic OTC drugs are not

subject to FDA oversight, we follow the parties’ lead and focus on the federallaw duties of manufacturers of those drugs. Ultimately, because we conclude 

that CEH’s claim is preempted as to the manufacturer respondents, we need 

not determine whether there are additional reasons the claim fails as to the

retailer respondents. 
20

product at each point of display of the product”; or by “any electronic device or 

process that automatically provides the warning to the purchaser prior to or 

during the purchase of the consumer product, without requiring the 

purchaser to seek out the warning.” (Id., § 25602, subd. (a)(1)–(4).) If a 

product is sold by internet or catalog, a warning must also be provided 

through the website or in the catalog. (Id., § 25602, subds. (b)–(c).)

Next, we address a generic manufacturer’s duty to warn under federal 

law. (See Bartlett, supra, 570 U.S. at p. 486.) As Mensing discussed at 

length, a generic manufacturer has an ongoing duty to “ensur[e] that its 

warning label is the same as the brand name’s.” (Mensing, supra, 564 U.S. at 

p. 613.) We note that Mensing concerned generic prescription drugs, not OTC 

drugs. (Id. at p. 610.) But as another court observed in applying Mensing to 

OTC drugs, “[t]he key distinction in the relevant regulatory structure and 

case law is not between prescription and non-prescription drugs but between 

NDA holders and ANDA holders. The distinction makes a difference because 

of the [CBE] regulation, which permits NDA holders—but not ANDA 

holders—to ‘add or strengthen’ a warning on the product’s label [citation], 

without waiting for preapproval from the FDA.” (Greager v. McNeil-PPC, 

Inc. (N.D.Ill. 2019) 414 F.Supp.3d 1137, 1142.) Thus, we agree with the 

generic-drug defendants that the duty of sameness also applies to 

manufacturers of generic OTC drugs. 

To be approved, an ANDA must include, with exceptions that are not 

relevant here, “information to show that the labeling proposed for the new 

drug is the same as the labeling approved for the [brand-name] drug.” 

(21 U.S.C. § 355(j)(2)(A)(v); 21 C.F.R. § 314.94(a)(8)(iv).) An OTC drug’s label 

must have a “Warning” or “Warnings” section that includes all applicable 

warnings from a specified list. (21 C.F.R. § 201.66(c)(5).) That list includes 
21

warnings about particular side effects, contraindications for the product’s 

use, and the need to consult a medical professional before taking the product. 

(Ibid.) Unlike a brand-name manufacturer, a generic manufacturer cannot

“use[] the CBE process to unilaterally strengthen [its] warning labels.” 

(Mensing, supra, 564 U.S. at p. 614.) Thus, a generic manufacturer can list 

on its labeling only warnings that are identical to the warnings listed on the 

brand-name manufacturer’s labeling.14

Mensing concerned state-law tort claims that manufacturers of generic 

prescription drugs “fail[ed] to provide adequate warning labels” about the 

risk of a particular side effect. (Mensing, supra, 564 U.S. at pp. 608–610.) 

After explaining a generic manufacturer’s ongoing duty of sameness, the 

Supreme Court concluded the manufacturers could not “use a different, 

stronger label than the label they actually used” without violating federal 

law, which “prevented [them] from independently changing their generic 

drugs’ safety labels.” (Id. at pp. 617–618.) Therefore, impossibility 

preemption barred the consumers’ claims. (Id. at p. 618.) 

In reaching this holding, Mensing rejected the consumers’ arguments 

that the manufacturers could have complied with both state and federal law 

by (1) using the CBE process to change their labels, (2) using “ ‘Dear Doctor’ 

letters to send additional warnings to prescribing physicians and other

14 As a result, a lawsuit may be preempted merely because it concerns a 

generic version instead of a brand-name version of the same drug. (See 

Mensing, supra, 564 U.S. at p. 625.) Here, the trial court relied on this 

distinction when it dismissed the suit against the brand-name manufacturers 

without prejudice and gave CEH leave to amend for it to allege, if possible, 

that the NDMA exposure was serious enough that the brand-name 

manufacturers could unilaterally add a Proposition 65-compliant warning to 

their labeling through the CBE process. (See 21 C.F.R. §§ 201.57(c)(6)(i), 

314.70(c)(6)(iii)(A).)
22

healthcare professionals,” or (3) “ask[ing] the FDA for help in strengthening 

the corresponding brand-name label.”15 (Mensing, supra, 564 U.S. at 

pp. 614–616, 619–620.) The Supreme Court determined that the first two 

methods were not available to the manufacturers. (Id. at pp. 614–615.) 

Specifically, deferring to the FDA’s interpretation of its regulations, the 

Court concluded that generic manufacturers cannot use the CBE process to 

change warning labels unilaterally, and “Dear Doctor” letters qualify as 

“labeling” under the FDCA and its regulations. (Ibid.) 

As for the third method, asking the FDA to change the labeling,

Mensing concluded that it was insufficient to avoid impossibility preemption. 

(Mensing, supra, 564 U.S. at p. 621.) Even assuming the FDA was correct 

that generic manufacturers had a duty to propose “stronger warning labels to 

the agency if they believed such warnings were needed,” preemption was not 

avoided based on the mere “possib[ility] that, had the [m]anufacturers asked 

the FDA for help, they might have eventually been able to strengthen their 

warning label.” (Id. at pp. 616, 620.) The Supreme Court concluded that 

“[t]he question for ‘impossibility’ is whether the private party could 

independently do under federal law what state law requires of it,” not 

whether “a third party or the Federal Government might do something that 

makes it lawful for a private party to accomplish under federal law what 

state law requires of it.” (Id. at p. 620, some italics added.) The consumers’ 

claims were preempted because state law required the generic manufacturers 

to strengthen their labels and federal law prevented them from doing so 

unilaterally. (Id. at pp. 623–624.)

15 “Dear Doctor” letters are mailings that drug manufacturers may be 

required to send to medical professionals conveying “important information 

about their products.” (Teva Pharmaceuticals USA, Inc. v. Superior Court

(2013) 217 Cal.App.4th 96, 104; see 21 C.F.R. § 200.5.) 
23

Two years later, Bartlett applied Mensing to hold that “state-law 

design-defect claims that turn on the adequacy of a drug’s warnings are preempted by federal law.” (Bartlett, supra, 570 U.S. at p. 476.) The plaintiff 

sued the manufacturer of a generic prescription drug after she became 

“severely disfigured” by using it. (Id. at p. 478.) The First Circuit Court of 

Appeals held that her claim was not preempted, because “generic 

manufacturers facing design-defect claims could simply ‘choose not to make 

the drug at all’ and thus comply with both federal and state law.” (Id. at 

p. 479.) 

The Supreme Court reversed, concluding the manufacturer could not 

comply with both its state-law duty to ensure its product was not 

“ ‘unreasonably dangerous’ ” and its federal-law duty not to change its 

product’s label unilaterally. (Bartlett, supra, 570 U.S. at pp. 480, 482.) The 

state-law duty could be satisfied only by redesigning the drug or changing its 

labeling. (Id. at p. 482.) Redesigning the drug was impossible because of the 

federal duty of sameness and because any altered composition “would be a 

new drug that would require its own NDA to be marketed in interstate 

commerce.” (Id. at p. 484.) As a result, “the only way for [the manufacturer] 

to ameliorate the drug’s ‘risk-utility’ profile,” and thereby avoid liability 

under state law, “was to strengthen ‘the presence and efficacy of [the drug’s] 

warning’ in such a way that the warning ‘avoid[ed] an unreasonable risk of 

harm from hidden dangers or from foreseeable uses.’ ” (Ibid.) But that was 

impossible under Mensing, because the manufacturer could not unilaterally 

change its labeling to differ from the brand-name version’s labeling. 

(Bartlett, at p. 486.) Finally, the Supreme Court rejected the “ ‘stop-selling’ 

rationale” for finding no impossibility preemption as “incompatible with [the 

Court’s] pre-emption jurisprudence.” (Id. at p. 488.)
24

2. The effect of Dowhal

Before considering whether it is possible for the generic-drug 

defendants to give warnings that comply with both Proposition 65 and the 

federal duty of sameness, we address the Attorney General’s argument that

Dowhal, supra, 32 Cal.4th 910 provides the proper “framework for analyzing 

the preemption question in this case.” According to the Attorney General, 

under Dowhal, section 379r’s savings clause “preserves Proposition 65 from 

preemption in this case because [the] addition of a Proposition 65 warning for 

NDMA does not present any conflict with FDA requirements relevant to 

consumer health.” Dowhal cannot sustain the weight the Attorney General 

places on it.

Dowhal addressed whether the FDCA preempted a claim that 

manufacturers of OTC “products containing nicotine sold . . . as aids to stop 

smoking” were required to place Proposition 65 warnings on the products. 

(Dowhal, supra, 32 Cal.4th at pp. 917–918.) Since “California listed nicotine 

as a chemical known to cause reproductive toxicity,” Proposition 65 required 

the manufacturers to warn of the danger of reproductive harm. (Id. at 

p. 918.) The FDA, however, refused to permit the manufacturers to put such 

a warning on their products, because it did not want to discourage pregnant 

women from using the products to quit smoking. (Id. at pp. 918–919.) The 

FDA informed the manufacturers that they could warn only that nicotine 

might increase a baby’s heart rate and advise pregnant women to seek 

professional advice before using the products. (Id. at p. 920.)

Dowhal held that the FDA’s labeling policy preempted Proposition 65’s 

warning requirement. (Dowhal, supra, 32 Cal.4th at p. 918.) The Supreme 

Court recognized that section 379r’s savings clause still permits impossibility 

or obstacle preemption of Proposition 65. (Dowhal, at p. 924.) If a 
25

Proposition 65 requirement is “in direct conflict with . . . or frustrate[s] the 

purpose of” an FDA requirement, the state law is preempted. (Id. at pp. 924, 

926.) Since the FDA had “established a federal policy prohibiting [the] 

defendants from giving consumers any warning [about use during pregnancy] 

other than the one approved by the FDA . . . , the use of a Proposition 65 

warning would conflict with that policy,” and the suit was therefore 

preempted. (Id. at p. 929.) 

Dowhal was careful to note that “a Proposition 65 warning cannot be 

preempted solely because it is not identical with [a] federal requirement,” 

since section 379r’s legislative history revealed that the provision’s savings 

clause was intended to allow Proposition 65 warnings even if they resulted in 

different labeling in California. (Dowhal, supra, 32 Cal.4th at p. 926.) Thus, 

an FDA requirement can preempt a Proposition 65 warning only “on a basis 

relevant to consumer health, and not because the [warning] would frustrate 

the FDA’s policy favoring national uniformity.” (Ibid.)

The Attorney General claims that under Dowhal, Proposition 65 cannot 

be preempted in this case unless there is “a conflict, relevant to consumer 

health, between providing a Proposition 65 cancer warning for NDMA 

exposure . . . and the FDA’s regulation of the[] products under the FDCA.” 

He argues that the federal duty of sameness “serves the FDCA’s national 

uniformity policy,” not consumer health, and therefore “cannot be used to 

evade the savings clause” of section 379r. 

We do not agree with the Attorney General’s characterization of the 

federal duty of sameness. The duty of sameness “ensures that generic drugs 

are of the same safety and effectiveness as their branded counterparts.” 

(Fulgenzi v. PLIVA, Inc. (6th Cir. 2013) 711 F.3d 578, 585, italics added.) By 

making it easier to obtain FDA approval for generic drugs, the Hatch-
26

Waxman Act “recognized that conducting new human clinical trials for 

generic drugs was ‘unnecessary and wasteful’ where demonstrating sameness 

was enough to show the drug to be ‘safe and effective.’ [Citation.] The 

Hatch-Waxman Act’s cost savings, therefore, were accomplished without 

[compromising] the FDCA’s core safety policies.” (Fulgenzi, at p. 586.) Thus, 

the duty of sameness is meant to ensure consumer safety, not merely

uniformity in labeling.

Moreover, Dowhal’s conclusion that “a Proposition 65 warning cannot 

be preempted solely because it is not identical with [a] federal requirement”

was based on the need to give effect to section 379r’s savings clause. 

(Dowhal, supra, 32 Cal.4th at p. 926.) Our state Supreme Court rejected the 

argument that “any nonidentical state warning would constitute 

misbranding,” as that “would nullify the savings clause . . . , which plainly 

permits Proposition 65 warnings that differ from the FDA warnings.” (Id. at 

p. 934.) But here, a determination that the federal duty of sameness 

prevents the generic-drug defendants from unilaterally adding Proposition 65 

warnings to their labeling would not nullify section 379r’s savings clause. 

Rather, the clause preserves the ability of brand-name manufacturers to use 

the CBE process to add a Proposition 65 warning that is not identical to 

federal requirements.16 In turn, if brand-name manufacturers added

16 CEH claims it would be “a surprising result” if section 379r’s savings 

clause preserved Proposition 65 claims against brand-name manufacturers

only, since nothing in the legislative history of section 379r suggests Congress 

thought the savings clause “would be wholly inoperative for generic OTC 

drugs unless the brand[-]name manufacturers provided such warnings.” But 

section 379r was enacted several years before Mensing made clear that even 

if it may seem arbitrary, due to the federal duty of sameness a claim against 

a generic manufacturer may be preempted where the identical claim against 

a brand-name manufacturer is not preempted. (See Mensing, supra, 564 U.S. 

at p. 625.)
27

Proposition 65 warnings to their ranitidine products, the generic

manufacturers would have to do so as well.

It is also significant that Dowhal was decided several years before 

Mensing and Bartlett clarified that impossibility preemption bars a claim if a 

defendant cannot independently comply with state law without violating 

federal law. In Dowhal, the manufacturers sought approval from the FDA to 

add a Proposition 65 warning, but the FDA denied the requests, offering the 

policy justification on which our state Supreme Court relied to find conflict 

preemption. (Dowhal, supra, 32 Cal.4th at pp. 920–921, 922, 929.) Thus, 

Dowhal had no reason to address whether the suit was preempted for the 

separate reason that the manufacturers could not add a Proposition 65 

warning without first obtaining FDA approval. But here, even if the mere 

lack of identity between a Proposition 65 warning about NDMA and federally 

required labeling does not suffice to establish preemption under Dowhal, 

CEH’s claim is still preempted if it would require the generic-drug defendants

to obtain FDA approval before giving such a warning.

In short, we do not agree that Dowhal is determinative. Therefore, we 

proceed to address whether it is impossible for the generic-drug defendants to 

comply with their federal-law duties and Proposition 65’s warning

requirement.

3. CEH’s claim is preempted.

The generic-drug defendants argue that CEH’s claim is preempted 

under Mensing and Bartlett because those cases, and subsequent decisions 

applying them, stand for the proposition that “any state-law claim that 

imposes a legal duty to issue some other type of warning that is not on the 

brand-name label conflicts with federal law and is preempted.” We need not 

decide whether Mensing and its progeny establish such a sweeping principle
28

or whether, as CEH claims, the trial court incorrectly determined that “any 

and all communications involving a warning are properly characterized as 

‘labeling’ that require FDA approval.” Rather, because CEH fails to identify 

a method by which the generic-drug defendants could give a Proposition 65 

warning that would not constitute “labeling” under the FDCA, we conclude 

that the federal duty of sameness renders it impossible for the generic-drug 

defendants to comply with both state and federal law under Mensing.

17

Our determination rests on the broad definition of “labeling” under the 

FDCA. We begin by discussing two decisions that are crucial to our analysis, 

Kordel v. United States (1948) 335 U.S. 345 (Kordel) and Leeman, supra, 

180 Cal.App.4th 728. We then explain why the two primary methods CEH 

proposes in which the generic-drug defendants could give Proposition 65 

warnings without violating the duty of sameness—point-of-sale displays and 

“public advertising”—do not avoid preemption. 

a. Kordel and Leeman

As noted above, the FDCA defines “labeling” as “all labels and other 

written, printed, or graphic matters (1) upon any article or any of its 

containers or wrappers, or (2) accompanying such article.” (21 U.S.C. 

17 In reaching this conclusion, we reject CEH’s argument that the duty 

of sameness does not apply because this case involves the generic-drug 

defendants’ “undisclosed contamination of the [p]roducts with NDMA.” The 

fact that the generic-drug defendants may have violated the duty of sameness

by selling products that contained different amounts of NDMA than did the 

brand-name versions does not mean that the duty is inapplicable to 

Proposition 65 warnings about NDMA. Rather, because CEH’s suit seeks to 

impose a warning requirement, we must consider whether the generic-drug 

defendants could give a Proposition 65 warning while complying with the 

duty of sameness, even though reformulation is the more realistic response to 

contamination. For the same reason, the possibility of reformulation cannot 

save CEH’s claim from preemption if all possible methods of giving 

Proposition 65 warnings would conflict with federal law. 
29

§ 321(m).) In Kordel, the United States Supreme Court addressed this 

definition in the context of a criminal case. (Kordel, supra, 335 U.S. at 

pp. 346–348.) The defendant was found guilty of introducing misbranded 

drugs into interstate commerce, which required a finding that the drugs’ 

“ ‘labeling [was] false or misleading in any particular’ ” or did not “bear[] 

‘adequate directions for use.’ ” (Id. at pp. 346–347.) “The alleged 

misbranding consist[ed] of statements in circulars or pamphlets” about the 

products’ efficacy. (Id. at p. 346.) The defendant provided the materials to 

vendors, who in turn “distributed [them] to consumers” through means 

including displaying them in stores, giving them away with the sale of the 

products, or mailing them. (Id. at pp. 346–347.) The issue was whether the 

fact that some of this “literature . . . was shipped separately from the drugs 

and at different times . . . saved the drugs from being misbranded” because 

the literature did not “accompany[] such article” and was therefore not 

“labeling” under the statutory definition. (Id. at pp. 347–349.) 

Kordel held “that the phrase ‘accompanying such article’ is not 

restricted to labels that are on or in the article or package that is 

transported.” (Kordel, supra, 335 U.S. at p. 349.) The Supreme Court 

reasoned that the phrase did not by its terms require labeling to be on or in 

the same package or container as the drugs: “One article or thing is 

accompanied by another when it supplements or explains it, in the manner 

that a committee report of the Congress accompanies a bill. No physical 

attachment [of] one to the other is necessary.” (Ibid.) Since “[t]he false and 

misleading literature . . . was designed for use in the distribution and sale of 

the drug[s]” as part of “an integrated distribution program,” it qualified as 

“labeling.” (Ibid.) 
30

In Leeman, the Fourth District Court of Appeal relied on Kordel in 

holding that the Federal Meat Inspection Act (FMIA) “expressly preempts 

point of sale warning requirements imposed by Proposition 65 with respect to 

meat.” (Leeman, supra, 180 Cal.App.4th at pp. 735, 752–753.) The FMIA’s 

preemption statute provides in relevant part that “ ‘labeling . . . requirements 

in addition to, or different than, those made under this chapter may not be 

imposed by any State.’ ” (Leeman, at pp. 748–749, quoting 21 U.S.C. § 678.) 

The Leeman plaintiff did not “dispute that a Proposition 65 warning is in 

addition to, or different than, any requirement set forth in the FMIA,” nor 

“that a Proposition 65 warning affixed directly to a package containing meat 

would constitute ‘labeling’ within the meaning of the FMIA’s preemption 

provision.” (Leeman, at p. 749, italics omitted.) Rather, she argued that 

“point of sale warnings do not constitute ‘labeling,’ and thus, Proposition 65 

does not create ‘labeling . . . requirements in addition to, or different than, 

those made under [the FMIA].’ ” (Ibid., italics omitted.)

Leeman rejected the plaintiff’s position, holding that point-of-sale 

warnings qualify as “labeling requirements” under the FMIA’s preemption 

provision. The definition of “labeling” under the FMIA was taken from the 

FDCA, and likewise provides that the term means “ ‘all labels and other 

written, printed, or graphic matter (1) upon any article or any of its 

containers or wrappers, or (2) accompanying such article.’ ” (Leeman, supra, 

180 Cal.App.4th at p. 752 & fn. 27, quoting § 21 U.S.C. § 601(p).) The Fourth 

District determined that in importing the FDCA’s definition to the FMIA, 

Congress intended that Kordel’s interpretation of “labeling”—to refer to 

“material that accompanies a product in the sense that it ‘supplements or 

explains it,’ but is not necessarily physically attached”—applies to the FMIA 

as well. (Leeman, at p. 757.) Leeman then concluded that under 
31

Proposition 65 “a properly designed point of sale warning will ‘supplement[] 

or explain[]’ the meat offered for sale in that it will give consumers additional 

information about the product” and “will necessarily be ‘designed for use in 

the distribution and sale’ of the product,” meaning a point-of-sale warning 

qualifies as “labeling” under Kordel. (Leeman, at p. 761, quoting Kordel, 

supra, 335 U.S. at p. 350.)

b. Point-of-sale warnings

We agree with Leeman that “labeling,” as interpreted by Kordel, 

includes point-of-sale warnings under Proposition 65. A point-of-sale 

warning is “designed for use in the distribution and sale of the drug” and 

“supplements or explains” the drug. (Kordel, supra, 335 U.S. at p. 350.) 

Indeed, some of the material that Kordel found to be “labeling” under the 

FDCA was “literature . . . displayed in stores in which the [defendant’s]

products were on sale.” (Id. at p. 346.) In turn, since the manufacturer of a 

generic drug cannot deviate from the labeling of the brand-name version of 

the drug, it would be impossible for the generic-drug defendants to give a 

Proposition 65 point-of-sale warning without violating the federal duty of 

sameness. 

CEH attempts to distinguish Leeman from this case but does not 

explain why the identified distinctions suggest Leeman’s interpretation of 

“labeling” to include point-of-sale warnings is inapplicable. For example, it is 

not apparent why it matters that “the FDA has never stated that it believes 

Proposition 65 warnings for NDMA on [the generic-drug defendants’ 

products] would be inappropriate.” As Mensing makes clear, the duty of 

sameness makes it “impossible” for a generic manufacturer to change its 

labeling unilaterally even if the FDA has no specific objection to the change. 

Nor is it apparent why the fact that the FMIA has no express savings clause 
32

matters. As Dowhal makes clear, a Proposition 65 claim involving OTC 

drugs may be preempted despite section 379r’s savings clause. 

CEH also states that “Leeman failed to note the . . . observation in 

Dowhal that ‘point-of-sale signs’ are not ‘product labeling.’ ” In the cited 

portion of Dowhal, however, our state Supreme Court was not addressing the 

FDCA’s definition of “labeling” but merely summarizing the content of a

former Proposition 65 regulation as providing that a “warning may be 

communicated through product labeling, point-of-sale signs, or public 

advertising.” (Dowhal, supra, 32 Cal.4th at p. 918.) The fact that the Court 

differentiated between these three categories sheds no light on the definition 

of “labeling” under the FDCA. In any case, to the extent Dowhal could be 

read to suggest that point-of-sale signs are not “labeling,” that would conflict 

with Kordel’s conclusion that materials displayed in stores are “labeling.” 

(See Kordel, supra, 335 U.S. at pp. 346, 350.)

CEH also points out that the Ninth Circuit Court of Appeals rejected a 

“broad reading of Kordel” and suggests we do the same. In Chemical 

Specialties Mfrs. Ass’n, Inc. v. Allenby (9th Cir. 1992) 958 F.2d 941 (Allenby), 

the Ninth Circuit addressed an action in which the plaintiff trade association 

sought a declaratory judgment that the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) preempted Proposition 65 warning requirements. 

(Allenby, at pp. 942, 945.) FIFRA defines “labeling” in relevant part as “all 

labels and all other written, printed, or graphic matter—[¶]

(A) accompanying the pesticide or device at any time; or [¶] (B) to which 

reference is made on the label or in literature accompanying the pesticide or 

device.” (7 U.S.C. § 136(p)(2).) Thus, like the FDCA, FIFRA includes 

material “accompanying” the product in its definition of “labeling.” (7 U.S.C. 

§ 136(p)(2); 21 U.S.C. § 321(m).) 
33

The trade association argued that Proposition 65 was preempted 

because “FIFRA expressly prohibits states from imposing labeling 

requirements that differ from those registered with the [Environmental 

Protection Agency (EPA)],” and “the warnings required under Proposition 65 

fall squarely within FIFRA’s definition of ‘labeling.’ ” (Allenby, supra, 

958 F.2d at p. 945.) The Ninth Circuit disagreed, concluding that point-ofsale warnings are not “labeling” under FIFRA. (Id. at pp. 946–947.) Allenby

determined that “FIFRA’s definition of labeling cannot encompass every type 

of written material accompanying the pesticide at any time. If this were true, 

then price stickers affixed to shelves, sheets indicating that a product is on 

sale, and even the logo on the exterminator’s hat would all constitute 

impermissible labeling.” (Id. at p. 946.) Rather, relying on a Second Circuit 

Court of Appeals decision that interpreted “labeling” under FIFRA, Allenby

held that point-of-sale signs did not qualify because they were “not attached 

to the immediate container of a product and [would] not accompany the 

product during the period of use.” (Allenby, at p. 946; New York State 

Pesticide Coalition, Inc. v. Jorling (2d Cir. 1989) 874 F.2d 115, 119 [signs 

posted on site where pesticides used not “labeling” because “FIFRA ‘labeling’ 

is designed to be read and followed by the end user”].)

In reaching its holding, Allenby declined to adopt Kordel’s definition of 

“labeling,” finding that decision distinguishable. (Allenby, supra, 958 F.2d at 

p. 946.) The Ninth Circuit explained: “First, the written materials in Kordel

were aimed at the ultimate user of the drug, not the purchaser that is 

targeted by Proposition 65. [Citation.] Second, the materials at issue in 

Kordel contained directions for use, which the EPA had clearly stated must 

be on the label. [Citation.] Finally, the context of the manufacturer’s 
34

mailings in that case suggested that the manufacturer was attempting to 

circumvent the [FDCA] rather than supplement it.” (Id. at pp. 946–947.)

We agree with Leeman that “Allenby’s attempt to distinguish Kordel [is 

not] . . . persuasive” (Leeman, supra, 180 Cal.App.4th at p. 758, fn. 36), and 

we decline to follow a Ninth Circuit decision interpreting a different statute 

instead of binding United States Supreme Court precedent interpreting the 

FDCA. Although Allenby’s focus on materials accompanying a pesticide 

during use may have been appropriate under FIFRA, “we see no basis for 

importing that focus into the [FDCA].” (Leeman, at p. 758.) Rather, similar 

to the FMIA, the FDCA’s primary purpose is to protect consumers from 

harmful products. (See Wyeth v. Levine, supra, 555 U.S. at p. 574; Leeman, 

at p. 758.) Consistent with this purpose, Kordel focused on whether the 

materials at issue there—which, again, included in-store displays—were

“designed for use in the distribution and sale of the drug[s].” (Kordel, supra, 

335 U.S. at pp. 346, 350; Leeman, at p. 758, fn. 36.) 

Our conclusion is not altered by CEH’s argument that “an allencompassing definition of ‘labeling’ ” cannot be reconciled with section 379r’s 

savings clause. In CEH’s view, since section 379r preempts state-law

requirements “relating to public information or any other form of public 

communication relating to a warning of any kind for a drug” (§ 379r(c)(2)),

the term “labeling” must have a narrower meaning than that phrase or else 

Congress would have simply stated that all “labeling” requirements are

preempted. As we have said, we need not decide whether “labeling” includes 

all forms of public communication related to drug warnings but only whether 

the term includes all valid methods of conveying a Proposition 65 warning

involving generic OTC drugs. And we perceive nothing in section 379r 

suggesting an intent to reject Kordel’s interpretation of “labeling” which, 
35

while broad, is not equivalent to any public communication about any drug 

warning. Because point-of-sale warnings qualify as “labeling” under Kordel, 

we conclude that the generic-drug defendants cannot unilaterally provide 

them without violating the federal duty of sameness.

c. Public advertising

Finally, we turn to whether the generic-drug defendants could comply 

with federal and state law by conveying Proposition 65 warnings in 

advertising or similar communications to the public.

18 We conclude they 

cannot, and CEH’s claim is therefore preempted.

Initially, it is not obvious to us that public advertising can ever be a 

sufficient method of providing a Proposition 65 warning about a consumer 

product. True, as CEH observes, Proposition 65 provides that a warning 

“need not be provided separately to each exposed individual and may be 

provided by general methods such as labels on consumer products, . . . 

posting of notices, placing notices in public news media, and the like, 

provided that the warning accomplished is clear and reasonable.” 

(§ 25249.11, subd. (f).) Although this provision is broad enough to include

public advertising, a Proposition 65 regulation pertaining to consumer 

products in particular requires that the warning be delivered so “as to render 

[it] likely to be seen, read, and understood by an ordinary individual under 

customary conditions of purchase or use.” (Regs., § 25601, subd. (c), italics 

added.) Unlike the safe-harbor methods of providing consumer-product 

warnings, which require that the warning be on the product’s label, displayed 

at the point of sale, or “automatically provide[d] . . . to the purchaser prior to 

18 CEH also identifies “postings on websites or over social media” as 

possible methods of conveying Proposition 65 warnings. Our discussion of 

“public advertising” includes such means of communicating with the general 

public.
36

or during the purchase” (Regs., § 25602, subd. (a)), advertising is not

necessarily likely to be seen during purchase or use of the product.

19 But the 

parties do not address this issue, so we will assume for the sake of argument 

that public advertising could be a valid method of conveying a Proposition 65 

warning about the generic-drug defendants’ products. 

The question, therefore, is whether a Proposition 65 warning 

transmitted through public advertising constitutes “labeling” under the 

FDCA. Kordel addressed the relationship between advertising and labeling, 

stating that advertising qualifies as labeling “where the advertising performs 

the function of labeling.” (Kordel, supra, 335 U.S. at p. 350.) The Supreme 

Court recognized that the Federal Trade Commission (FTC) had 

responsibility for false advertising of drugs under legislation that created the 

commission.20 (Kordel, at p. 351; 52 Stat. 111 (1938).) But the Court found 

nothing in the legislative history suggesting that Congress thereby “had the 

19 We recognize that Dowhal referred to advertising as a permissible 

method of giving a Proposition 65 warning. (See Dowhal, supra, 32 Cal.4th 

at p. 918.) But when Dowhal was decided, former California Code of 

Regulations, title 22, section 12601, subdivision (b)(1)(C), provided that a 

Proposition 65 warning could be given through “[a] system of signs, public 

advertising identifying the system and toll-free information services, or any 

other system that provides clear and reasonable warnings.” Now, the 

regulations no longer identify advertising as part of a suitable method of 

conveying a warning and focus on whether a consumer will see the warning 

before or during purchase or use. Thus, CEH is simply incorrect that “almost 

any form of public communication can serve as [a] proper warning method 

under Proposition 65.” 

20 Under the Federal Trade Commission Act, it is “unlawful for any 

person, partnership, or corporation to disseminate, or cause to be

disseminated, any false advertisement” meant to “induc[e] . . . the purchase

. . . of foods, drugs, devices, services, or cosmetics.” (15 U.S.C. § 52(a).) “The 

term ‘false advertisement’ means an advertisement, other than labeling, 

which is misleading in a material respect.” (Id., § 55(a)(1).)
37

purpose to eliminate from the [FDCA] advertising [that] performs the 

function of labeling. Every labeling is in a sense an advertisement. The 

advertising which we have here performs the same function as it would if it 

were on the article or on the containers or wrappers.” (Kordel, at p. 351.) 

In 1971, “[t]o resolve issues of enforcement resulting from [the] 

concurrent jurisdiction” of the FDA and the FTC over the marketing of OTC 

drugs, the agencies “agreed to a division of regulatory authority: the FDA 

regulates the labeling of OTC drugs while the FTC monitors the advertising 

for these drugs.” (Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc. 

(3d Cir. 1990) 902 F.2d 222, 226–227.) Under the agencies’ memorandum of 

understanding, the FTC “has primary responsibility with respect to the 

regulation of the truth or falsity of all advertising (other than labeling)” of 

OTC drugs, whereas the FDA “has primary responsibility for preventing 

misbranding” of OTC drugs and “will exercise primary jurisdiction over all 

matters regulating [their] labeling.” (36 Fed. Reg. 18539 (1971).) In contrast, 

the FDA retains primary responsibility for regulating the advertising of 

prescription drugs. (Ibid.; see 21 U.S.C. § 352(n); 21 C.F.R. § 202.1.)

As both Kordel and the 1971 memorandum of understanding

demonstrate, there is no firm dividing line between “labeling” and 

“advertising,” and materials normally thought of as advertising can 

constitute “labeling” under the FDCA. Under Kordel, the touchstone is 

whether the material is “designed for use in the distribution and sale of the 

drug” and “part[] of an integrated distribution program.”21 (Kordel, supra, 

21 We reject CEH’s claim that Kordel held that the “function of labeling” 

is providing “directions for drug use.” The material at issue in Kordel related 

to the drugs’ usage (Kordel, supra, 335 U.S. at p. 348), but the Supreme 

Court never suggested that the only function of drug labeling is to provide 

directions for use. Clearly, it is not. 
38

335 U.S. at p. 350.) In our view, any public advertising containing a 

Proposition 65 warning that is “likely to be seen, read, and understood by an 

ordinary individual under customary conditions of purchase or use” (Regs., 

§ 25601, subd. (c)) would qualify as “advertising [that] performs the function 

of labeling” under Kordel. (Kordel, at p. 351.)

CEH focuses on disproving the notion that “any and all warning 

statements are ‘labeling.’ ” Again, even if some advertising that contains 

warnings does not constitute “labeling” under federal law, CEH’s claim is still 

preempted if all advertising that would comply with Proposition 65 qualifies 

as “labeling.” Thus, CEH’s arguments based on (1) the differentiation 

between “advertising” and “labeling” in the FDCA and its regulations and 

(2) cases involving the FDCA’s preemptive effect on other state laws miss the 

mark. Likewise, CEH’s observation that some of the generic-drug defendants

issued press releases warning about NDMA in their products without first 

obtaining FDA approval is irrelevant. Even assuming such press releases 

complied with federal law, CEH does not argue that the generic-drug 

defendants could lawfully issue Proposition 65 warnings by the same method.

In short, CEH fails to demonstrate that the generic-drug defendants

could give Proposition 65 warnings by any method that would not constitute 

“labeling” under the FDCA. Accordingly, it would be impossible for the 

generic-drug defendants to give such warnings without violating the federal 

duty of sameness, and CEH’s claim is preempted. 

III.

DISPOSITION

The judgment is affirmed. Respondents are awarded their costs on 

appeal.
39

_________________________

Humes, P.J.

WE CONCUR:

_________________________

Banke, J.

_________________________

Swope, J.*

*Judge of the Superior Court of the County of San Mateo, assigned by 

the Chief Justice pursuant to article VI, section 6 of the California 

Constitution.

Center For Environmental Health v. Perrigo Company et al., A163682
40

Trial Court:

Superior Court of the County of Alameda

Trial Judge:

Hon. Winifred Y. Smith

Counsel: 

Lexington Law Group, Mark N. Todzo, Joseph Mann, for Plaintiff and 

Appellant

Steptoe & Johnson LLP, Dennis Raglin; Goodell, DeVries, Leech & 

Dann LLP, Richard M. Barnes, Derek M. Stikeleather, Sean L. Gugerty; 

Norton, Rose, Fulbright US LLP, Jeffrey B. Margulies, Lauren A. Shoor; 

Lewis Brisbois Bisgaard & Smith LLP, Paul A. Desrochers; Arnold & Porter 

Kaye Scholer LLP, Trenton H. Norris, Willis M. Wagner; Blank Rome LLP, 

Cheryl S. Chang, Jessica A. McElroy, Terry M. Henry; Gordon Rees Scully 

Mansukhani LLP, Brian M. Ledger, for Defendants and Respondents

Rob Bonta, Attorney General, Edward H. Ochoa, Senior Assistant 

Attorney General, Laura J. Zuckerman, Supervising Deputy Attorney 

General, Raissa S. Lerner, Deputy Attorney General, for Amicus Curiae in 

support of Plaintiff and Appellant

Center For Environmental Health v. Perrigo Company et al., A163682