Post Foods, LLC v. The Superior Court of Los Angeles, Richard Sowinski, Real Party in Interest

Petitioners Post Foods, LLC, General Mills, Inc., General

Mills Sales, Inc., and Kellogg USA, Inc. petition for a writ of

mandate directing the superior court to vacate its June 26, 2017

order denying their motion for summary judgment and issue an

order granting the motion. We issued a stay pending this Court’s

resolution of the petition and an order to show cause why a writ

of mandate should not issue.

Real party in interest Dr. Richard Sowinski’s complaint

alleges that Petitioners’ breakfast cereals were required by

California’s Proposition 65 to display cancer and reproductive

harm warnings because they contain acrylamide. Petitioners

contend such warnings on cereals are preempted by federal law

because they would pose an obstacle to federal policy objectives to

increase Americans’ consumption of whole grains. In support,

Petitioners cite to numerous federal statutes establishing that

policy, and Food and Drug Administration (FDA) letters to

California regulators cautioning against Proposition 65 warnings

on cereals because they could mislead consumers and cause them

to avoid whole grains, resulting in health detriments. Because

we agree that Dr. Sowinski’s Proposition 65 claim is preempted

by federal law, we grant the petition and direct the superior court

to vacate its order denying Petitioners’ motion and enter a new

and different order granting the motion.

FACTUAL AND PROCEDURAL BACKGROUND

Acrylamide has been produced artificially since the 1950’s

for industrial purposes, including the manufacture of various

polymers, cement, and for waste water treatment. Acrylamide

has been known to pose health risks for some time. It was added

to Proposition 65’s list of chemicals known to cause cancer in

1990, and later was determined to cause reproductive harm in

animal test subjects.

2

In April 2002, Swedish researchers discovered that

acrylamide is generated naturally when carbohydrate-rich foods

are baked, roasted, fried, or deep fried. In particular, French

fries, potato chips, crackers, pretzel-like snacks, cereals, and

brown breads “tend to have the highest levels of [acrylamide].” A

2010 Environmental Protection Agency study noted, however,

that “since [acrylamide] appears to form from standard cooking

methods like baking, frying, and roasting, it has been in the

human diet for many thousands of years.”

Dr. Sowinski’s complaint alleges that 59 breakfast cereals

manufactured by Petitioners and sold in California contain

acrylamide, and therefore are required to include cancer and

reproductive toxicity warnings. He alleges that Petitioners’

failure to include such warnings violated the Safe Drinking

Water and Toxic Enforcement Act that Proposition 65 enacted.

At the outset of the case, the parties agreed to stay expert

discovery pending resolution of the Petitioners’ motion for

summary judgment on the threshold issue of whether Dr.

Sowinski’s claim is preempted by federal law.

Petitioners’ summary judgment papers included extensive

evidence that federal agencies have been studying the health

risks of acrylamide in food since it was discovered there in 2002.

The FDA has coordinated its studies with other federal agencies

and international science communities and is waiting until

scientifically sound risk assessments have been completed before

it determines what, if any, warnings are needed for acrylamide.

A. The FDA’s Guidance Regarding Acrylamide and

Proposition 65 Warnings

Beginning in 2003, the FDA corresponded with California’s

health agencies to advise against a Proposition 65 acrylamide

warning on food products because of its potential to confuse and

mislead consumers, and because a warning was likely to cause

3

consumers to avoid whole grain foods like breakfast cereals,

leading to health detriments. The FDA explained that its usual

approach is to disseminate advice regarding ingredients carrying

health risks, require that the labels of food products containing

such ingredients identify the amounts, and require package

warnings only in exceptional cases. The FDA cautioned

California authorities that a Proposition 65 warning on foods

would conflict with FDA’s ongoing efforts to provide consumers

with effective, scientifically-based risk information, would

confuse and mislead consumers due to the lack of context, and

might be preempted because such warnings would frustrate

federal objectives and conflict with federal law.

Specifically, on July 14, 2003, FDA Deputy Commissioner

Lester Crawford wrote to Joan E. Denton, director of California’s

Office of Environmental Health Hazard Assessment (OEHHA),

Proposition 65 Implementation. Noting that California

“currently has a no significant risk level (NSRL) for acrylamide of

.2 micrograms per day,” Crawford stated, “We understand that

California intends to announce a revised approach to acrylamide

in the near future. FDA believes it is premature to set a level of

acrylamide in food, and that California’s current NSRL and

future actions may frustrate federal purposes or even conflict

with federal law.” Crawford summarized the FDA’s “Action Plan”

to study acrylamide, and the work being done in coordination

with the World Health Organization and an international

committee of experts.

The FDA noted that California’s 0.2 microgram/day

standard would require many foods to be labeled. “FDA is

concerned that premature labeling of many foods with warnings

about dangerous levels of acrylamide would confuse and could

potentially mislead consumers, both because the labeling would

be so broad as to be meaningless and because the risk of

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consumption of acrylamide in food is not yet clear. [¶]

Furthermore, consumers may be misled into thinking that

acrylamide is only a hazard in store-bought food. In fact,

consumer exposure may be greater through home cooking. . . . In

addition, a requirement for warning labels on food might deter

consumers from eating foods with such labels. Consumers who

avoid eating some of these foods, such as breads and cereals, may

encounter greater risks because they would have less fiber and

other beneficial nutrients in their diets. For these reasons,

premature labeling requirements would conflict with FDA’s

ongoing efforts to provide consumers with effective scientifically

based risk communication to prevent disease and promote

health.”

After identifying some other potential unintended negative

consequences of Proposition 65 labeling of foods, the letter

continued, “FDA believes that California should not require

warning labels for foods under Proposition 65 before completion

of scientific studies adequate to assess the potential risk to

consumers . . . and until FDA determines appropriate risk

management based on FDA’s risk assessment. This approach

will avoid confusing consumers and will assure that advice to

consumers is scientifically founded.” The FDA also addressed

federal preemption, stating, “FDA believes that California’s

current requirements for acrylamide under Proposition 65 and

some actions that California may propose may be preempted by

federal law to the extent that they frustrate federal purposes or

create conflicts with federal law. For example, as discussed

above, warning labels based on the presence of acrylamide in food

might be misleading.”

Subsequently, in March 2006, following discussions

between the FDA and the OEHHA and the Attorney General’s

staff regarding acrylamide and Proposition 65, FDA Director

5

Terry Troxell of the FDA’s Office of Plant and Dairy Foods,

Center for Food Safety and Applied Nutrition, wrote to Edward

Weil, Deputy Attorney General of California, to “summarize

recent and ongoing FDA activities.” After describing the FDA’s

progress and future plans in its study of acrylamide, Troxell

noted, “FDA previously wrote to OEHHA that [Proposition 65]

warning language might have the following adverse effects,

among others: [¶] [*] Create unnecessary and unjustified public

alarm about the safety of the food supply; [¶] [*] Dilute overall

messages about healthy eating; and [¶] [*] Mislead consumers

into thinking that acrylamide is only a hazard in store-bought

food. [¶] FDA also stated that California should not require

acrylamide warning labels for foods under Proposition 65 before

completion of scientific studies adequate to assess the potential

risk of acrylamide to consumers and until FDA determines, based

on our risk assessment, that risk management measures (beyond

our current advice to eat a balanced diet) are needed. [¶] In

summary, FDA has been and remains very active in the

acrylamide field, and continues to believe that California should

not require acrylamide warning labels for foods under Proposition

65.” On the same date, the FDA wrote in similar terms to Joan

Denton, chief counsel of OEHHA.

Notably, the OEHHA heeded the FDA’s advice letters and

deferred to the FDA’s approach to acrylamide. Rather than

require a Proposition 65 warning, on its own webpages OEHHA

summarized the current FDA guidance for acrylamide: “The U.S.

Food and Drug Administration (FDA) and other health and

scientific organizations continue to study the prevalence of

acrylamide in food, its formation during cooking, its effect on

health, and cooking methods that can reduce acrylamide levels in

foods. The FDA has not advised the public to stop eating foods

that contain acrylamide. This research may form the basis for

6

more specific dietary advice or federal regulation of specific food

products in the future. [¶] In the interest of promoting overall

good health, the FDA recommends eating a balanced diet that

includes foods high in dietary fiber, like fruits, beans, vegetables,

and whole grains.”

In March 2016, the FDA issued its Guidance for Industry,

Acrylamide in Foods, in which it outlined ways that growing

conditions of crops and industrial food processing can be modified

to reduce the production of acrylamide. In the section concerning

cereal-based food, including “breakfast cereals,” the report states,

“Reducing whole grain content may also reduce acrylamide

[citations], but FDA does not recommend this approach given the

benefits of whole grains [citations].”

Similarly, the OEHHA Web site FAQ’s on acrylamide and

Proposition 65 provides guidance on cooking methods that reduce

the production of acrylamide during cooking. The FAQ’s

summarize cooking recommendations offered by the U.S.

National Toxicology Program and provides links to the FDA’s

2010 dietary guidelines for further reading.

1

B. Petitioners’ Motion for Summary Judgment

Petitioners moved for summary judgment on two distinct

grounds. First, they contended that Dr. Sowinski’s claim seeking

to require Proposition 65 acrylamide warning labels on their

cereals is expressly preempted by the Nutritional Labeling and

Education Act (NLEA), title 21 United States Code section

343-1(a), because such warnings are not identical to the FDA’s

regulations authorizing certain health claims on cereals. Second,

Petitioners contended that Dr. Sowinski’s claim is preempted

because a Proposition 65 warning would pose an obstacle to

1 See

(as of June 1, 2018).

7

Congress’ nutrition policies and programs aimed to increase

Americans’ consumption of whole grain cereals containing fiber

and important vitamins and minerals. Petitioners’ obstacle

preemption argument is based on the FDA’s advice letters to

California regulators and several federal statutes and regulations

establishing policies to promote the consumption of whole grains

and the vitamins and minerals they contain to improve public

health.

C. The Trial Court’s Summary Judgment Ruling

The court denied Petitioners’ motion for summary

judgment on both grounds. First, the court ruled that Petitioners

“have not satisfied their burden [of showing] that the Proposition

65 claim in this case is expressly preempted by federal law.”

Second, the court ruled that Petitioners failed to satisfy their

burden of showing that “conflict preemption applies.” Petitioners

challenge only the trial court’s ruling on conflict preemption.

The trial court began its analysis of conflict preemption by

stating, “The question thus becomes whether Proposition 65’s

acrylamide warning requirement either renders it impossible for

the Defendants to comply with both state and federal

requirements, or otherwise stands as an obstacle to the

accomplishment and execution of the full purposes and objectives

o[f] Congress.”

The trial court judicially noticed and extensively quoted

from the FDA’s guidance concerning acrylamide, and the

OEHHA’s incorporation of FDA guidance. The court considered

obstacle preemption in light of that evidence and concluded,

“California’s Proposition 65 acrylamide warning requirement, as

set forth in the operative complaint, would not stand as an

obstacle to the accomplishment and full purposes and objectives

of the federal government in encouraging the consumption of

whole grains (pursuant to the statutes referenced supra). This is

8

because there has been no acrylamide warning requirement at

the federal level. None of the items for which Defendants seek

judicial notice prohibit California from requiring such a warning

under Proposition 65. Importantly, the fact that the FDA itself

has recognized that research is ongoing reveals that no current

federal standard is in place.”

Next, the trial court concluded, “Nor would it be impossible

for Defendants to comply with both state and federal

requirements. It is apparent the documents for which

Defendants seek judicial notice reveal an important national

policy of increasing consumers’ intake of whole grains (which

would include breakfast cereal). The FDA advises consumers to

‘[c]onsume at least half of your total grain choices as whole

grains’ because they ‘are a source of important vitamins and

minerals and are typically high in dietary fiber, too.’ The FDA

has assisted HHS [U.S. Departments of Health and Human

Services] in articulating a national health goal of doubling the

average intake of whole grains by Americans. Again, though, it

would not be impossible for Defendants to comply with

Proposition 65 and the federal policies encouraging consumption

of whole grains. Proposition 65 is a warning requirement on the

presence of acrylamide; it does not purport to establish any

nutritional guidelines. The acknowledgment by the FDA itself

that it is waiting for new research results before considering

whether new advice on acrylamide is needed shows that there is

no conflict preemption at this time. [¶] Further, the fact that the

FDA has commented that breakfast cereals, among other foods,

‘are larger sources of acrylamide in the diet,’ and that reducing

consumption of such foods is one way to reduce acrylamide

intake, at the very least, shows that the research is unresolved.

In any event, though, this also illustrates that it is not

‘impossible’ for Defendants to comply with state and federal

9

requirements. At best, this is an ‘ambiguous case,’ such that the

Court is ‘reluctant to infer preemption[.]’ ” (Fns. omitted.)

We pause to note that the court’s paraphrasing of the

FDA’s advice is misleadingly incomplete. The cited FDA

document states, “Some foods are larger sources of acrylamide in

the diet, including certain potato products (especially French fries

and potato chips), coffee, and foods made of grains (such as

breakfast cereal, cookies, and toast). These foods are all part of a

regular diet. However, if you want to lower acrylamide intake,

reducing consumption of these foods is one way to do so, keeping

in mind that its best to limit intake of foods that are high in

saturated fats, trans fats, cholesterol, salt (sodium), and added

sugars. FDA does not recommend reducing intake of healthful

grain products (e.g., whole grain cereals) that are a good source of

whole grains and fiber.” (Second italics added.)

At oral argument, Dr. Sowinski’s counsel contended the

FDA’s use of the adjective “healthful” was intended to distinguish

between healthful and unhealthful whole grains. We disagree.

The parenthetical that follows, “(e.g., whole grain cereals)”

undercuts the interpretation Dr. Sowinski urges. Viewing the

document as a whole, the FDA advises consumers to reduce their

consumption of foods like potato chips, french fries and coffee, but

not cereals rich in whole grains or fiber. Indeed, the two pages

(of the three-page document) that immediately follow the quote

describe how toast should be prepared to a “light brown” instead

of “dark brown,” and french fries should be baked rather than

fried and prepared to a “golden yellow” rather than “brown.”

There is no discussion of whole grain cereals, let alone any

distinction made between healthful and unhealthful whole grain

cereals.

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D. Petition for Writ of Mandate

As noted, Petitioners challenge only the trial court’s ruling

on obstacle preemption. They contend the court mistakenly

applied only the impossibility test for conflict preemption, even

when it purported to apply the obstacle preemption test. As a

result, Petitioners contend, the trial court failed to consider the

FDA’s balancing of the federal statutory goal of promoting the

consumption of whole grains with the goal of protecting

consumers’ health, FDA’s nuanced approach to accomplishing the

purposes and objectives of Congress, and the obstacle Proposition

65 warnings would pose to that scheme.

E. Real Party Dr. Sowinski’s Return

In his return to our order to show cause, Dr. Sowinski

asserts that Petitioners’ summary judgment motion “was brought

on the sole ground of federal preemption pursuant to Nutritional

Labeling and Education Act of 1990.” That is incorrect.

Petitioners based their express preemption argument on the

NLEA, but based their obstacle preemption ground for summary

judgment on federal statutes and regulations the trial court

found to have established an important national policy of

increasing consumers’ intake of whole grains. We highlight this

distinction because Dr. Sowinski contends the NLEA’s savings

clause precludes preemption of Proposition 65 warnings by that

statute.2 Dr. Sowinski also asserts that Proposition 65 warnings

2 In support, Dr. Sowinski quotes the trial court’s tentative

order that framed Petitioners’ obstacle preemption argument as

presenting the issue of whether a Proposition 65 warning would

pose “an obstacle to the accomplishment and execution of the full

purposes and objectives o[f] Congress in enacting the NLEA.”

(Italics added.) In its finalized order, the trial court corrected

this error by deleting the italicized reference to the NLEA.

Moreover, the portions of the trial court’s order Dr. Sowinski

11

cannot conflict with the NLEA because the Act “ ‘does not in any

way regulate carcinogens or other, non-nutritive substances in

foods,’ ” quoting Sciortino v. Pepsico, Inc. (N.D.Cal. 2015) 108

F.Supp.3d 780, 806 (Sciortino).3

Dr. Sowinski also contends the trial court correctly held

that obstacle preemption was not triggered because it would not

be impossible for Petitioners to comply with both state and

federal labeling requirements. In addition, Dr. Sowinski

contends that even if conflict preemption applies, disputed issues

of material fact precluded summary judgment because not all of

Petitioners’ 59 cereals at issue contain whole grains or are

eligible for a “health claim.”

At oral argument, Dr. Sowinski’s counsel suggested there

could be no conflict between a Proposition 65 warning and federal

law because only some whole grain cereals contain acrylamide,

and consumers should be able to determine which ones do not.

4



relies upon are drawn from the court’s ruling that NLEA did not

expressly preempt a Proposition 65 warning for acrylamide, and

are not relevant to Petitioners’ conflict preemption contentions.

3 Even if the NLEA were at issue, Sciortino does not

support Dr. Sowinski’s contention. Sciortino held that a

Proposition 65 warning claim based on a color additive in soda

was not preempted because it did not pose an obstacle to federal

rules establishing unsafe levels for that color additive. (108

F.Supp.3d at p. 810.) Not surprisingly, no federal laws or policies

promoting the consumption of soda were identified for the court.

4 Dr. Sowinski’s counsel did not identify any whole grain

cereals that do not contain acrylamide, but the FDA’s digest of

several studies lists only a few common breakfast foods that

contain nondetectable amounts of acrylamide, including oatmeal,

white enriched bread, hominy (corn) grits, and cream of wheat.

12



This ignores the FDA’s expertise on consumer behavior. The

FDA explained, “[A] requirement for warning labels on food

might deter consumers from eating foods with such labels.

Consumers who avoid eating some of these foods, such as breads

and cereals, may encounter greater risks because they would

have less fiber and other beneficial nutrients in their diets. For

these reasons, premature labeling requirements would conflict

with FDA’s ongoing efforts to provide consumers with effective

scientifically based risk communication to prevent disease and

promote health.”5

At oral argument, Dr. Sowinski’s counsel also suggested

that a Proposition 65 warning would encourage cereal producers

to reformulate their cereals to reduce the amounts of acrylamide

they contain. In its letters to California regulators, the FDA

expressly stated it wanted to avoid premature efforts at

reformulation: “In addition, any warning label requirements

imposed under Proposition 65 might encourage manufacturers to

take premature steps to remove acrylamide from food by

introducing additives or changing cooking processes. Such steps

(See [as of June 1, 2018].)

5 Neither party addressed whether a Proposition 65

warning on whole grain cereals would lead to labels on other

foods, but this presents a concern. Proposition 65 warnings on

foods containing acrylamide above California’s nonsignificant

risk levels would cause many otherwise healthy foods to appear

to consumers to be unhealthful and vice versa. Peanut butter,

rye bread, whole wheat bread, sunflower seeds, sweet potatoes,

and prune juice would bear Proposition 65 warnings. But hot

dogs, bologna, salami, pork sausage, canned refried beans, frozen

chicken pot pie, and macaroni and cheese would not. (See

[as of June 1, 2018].)

13



could have unforeseen adverse consequences on public health if

the consequences of these changes o[r] the introduction of other

health hazards are not scientifically and thoughtfully considered.

Currently, not enough is known about acrylamide formation to

identify safe, effective, and practical modifications to food

processing techniques that will clearly prevent or reduce

formation. Studies on formation and methods to reduce

acrylamide are currently underway in many labs around the

world including the FDA’s National Center for Food Safety and

Technology.”

These studies are ongoing. The FDA published its

Guidance for Industry, Acrylamide in Foods in March 2016 and

invited comments. The guidance, which draws from dozens of

studies from around the world, explains, “Acrylamide reduction is

an area of ongoing research, and some approaches discussed may

still be at a research stage, rather than in general use.” The

guidance “provides information to help growers, manufacturers,

and food service operators reduce acrylamide levels in certain

foods.” The eight-page section devoted to cereal-based foods,

including breakfast cereals, discusses possible changes to

ingredients and cooking techniques, but some of these involve

trade-offs. For example, the FDA noted that in breakfast cereals,

sodium chloride can reduce acrylamide formation, but cautioned

that “Sodium chloride also may mitigate acrylamide in breakfast

cereals [citation], but avoidance of excess dietary sodium also

should be considered.”6 The FDA states it “will update this

6 With respect to wheat, the FDA concluded (based on a

British study) that soil with adequate sulfates and without

excessive nitrogen fertilization produces less asparagine, from

which acrylamide is formed, and “may help reduce acrylamide in

cereal-based foods.” Other studies show some varieties of wheat

produce less asperagine. The FDA guidance discusses one of the

14

guidance as needed to reflect new developments in the field of

acrylamide reduction.” Notably, in its 2003 letter to California

regulators, the FDA expressed concern that a warning “might

discourage manufacturers from sharing data with FDA or with

the Joint Institute for Food Safety and Applied Nutrition

(JIFSAN), which is running the Acrylamide InfoNet for

FAO/WHO. Such data would be helpful to FDA in its exposure

and risk assessments for acrylamide.”

DISCUSSION

I. Standard of Review

“Since a motion for summary judgment or summary

adjudication ‘involves pure matters of law,’ we review a ruling on

the motion de novo to determine whether the moving and

opposing papers show a triable issue of material fact.” (Travelers

Casualty & Surety Co. v. Superior Court (1998) 63 Cal.App.4th

1440, 1450.) Under Code of Civil Procedure section 437c, a

defendant may move for summary judgment on the grounds that

there is a complete or affirmative defense to the action. (Code

Civ. Proc., § 437c, subd. (o)(2).) Once a defendant meets the

burden of establishing the elements of the affirmative defense,

the burden shifts to the plaintiff to show that there are triable

issues of one or more material facts regarding the affirmative

defense. To survive summary judgment, the plaintiff must

adduce admissible evidence showing the existence of such

material issues of fact. (Code Civ. Proc., § 437c, subd. (c).)

“most effective practices adopted by manufacturers” of cookies,

chips and pretzels that involves treating dough with

asparaginase, which reduced acrylamide by 35 to 90 percent.

However, the method is ineffective on whole grains because of

“limited penetration of asparaginase into the product.”

15



II. Federal Preemption

Federal preemption of state law under the supremacy

clause of the United States Constitution, article VI, clause 2,

“ ‘may be either express or implied, and “is compelled whether

Congress’ command is explicitly stated in the statute’s language

or implicitly contained in its structure and purpose.” ’ ” (Shaw v.

Delta Air Lines, Inc. (1983) 463 U.S. 85, 95.)

“ ‘In determining whether federal law preempts state law, a

court’s task is to discern congressional intent. [Citation.]

Congress’s express intent in this regard will be found when

Congress explicitly states that it is preempting state authority.

[Citation.] Congress’s implied intent to preempt is found (i) when

it is clear that Congress intended, by comprehensive legislation,

to occupy the entire field of regulation, leaving no room for the

states to supplement federal law [citation]; (ii) when compliance

with both federal and state regulations is an impossibility

[citation]; or (iii) when state law “stands as an obstacle to the

accomplishment and execution of the full purposes and objectives

of Congress.” ’ ” (Eckler v. Neutrogena Corp. (2015) 238

Cal.App.4th 433, 447.)

Petitioners challenge only the trial court’s ruling on

obstacle preemption. Whether state law poses an obstacle to

accomplishing the purposes of federal law “is a matter of

judgment,” “informed by examining the federal statute as a whole

and identifying its purpose and intended effects.” (Crosby v.

National Foreign Trade Council (2000) 530 U.S. 363, 373

(Crosby).) If, after examining the “entire scheme” of the federal

law, the court determines that its purpose and operation are

frustrated by the state law, then the state law is preempted.

(Ibid.) Even if a state statute “attempts to achieve one of the

same goals as federal law,” it may still be preempted because “a

‘[c]onflict in technique can be fully as disruptive to the system

16

Congress erected as conflict in overt policy.’ ” (Arizona v. United

States (2012) 567 U.S. 387, 406, quoting Motor Coach Employees

v. Lockridge (1971) 403 U.S. 274, 287.) “Where a comprehensive

federal scheme intentionally leaves a portion of the regulated

field without controls, then the pre-emptive inference can be

drawn—not from federal inaction alone, but from inaction joined

with action.” (Puerto Rico Dept. of Consumer Affairs v. Isla

Petroleum Corp. (1988) 485 U.S. 495, 503.)

When evaluating conflict preemption, courts have

recognized that administrative agencies possess “a unique

understanding of the statutes they administer and an attendant

ability to make informed determinations about how state

requirements may pose an ‘obstacle to the accomplishment and

execution of the full purposes and objectives of Congress.’ ”

(Wyeth v. Levine (2009) 555 U.S. 555, 577.) For that reason,

courts give weight to the determinations of the agency charged

with administering the federal statutory and regulatory scheme,

especially when “the subject matter is technical; and the relevant

history and background are complex and extensive.” (Geier v.

American Honda Motor Co. (2000) 529 U.S. 861, 883 (Geier).)7

7 In Geier, the Supreme Court held that state tort claims

premised on Honda’s failure to install airbags conflicted with a

federal regulation that did not require airbags for all cars. The

Department of Transportation had promulgated a rule that

provided car manufacturers with a range of choices among

passive restraint devices. (Geier, supra, 529 U.S. at p. 875.)

Rejecting an “ ‘all airbag’ ” standard, the agency had called for a

gradual phase-in of a mix of passive restraints in order to spur

technological development and win consumer acceptance. (Id. at

p. 879.) Because the plaintiff’s claim was that car manufacturers

had a duty to install airbags in all vehicles, it presented an

obstacle to achieving “the variety and mix of devices that the

federal regulation sought.” (Id. at p. 881.)

17

III. Proposition 65

“Passed in 1986 by California voters to protect the health

and safety of Californians, Proposition 65 requires California to

create and maintain a list of chemicals ‘known to the state to

cause cancer or reproductive toxicity.’ [Citation.] The statute

provides: ‘[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,’ unless a specified exemption applies. [Citation.]”

(Physicians Committee For Responsible Medicine v. McDonald’s

Corp. (2010) 187 Cal.App.4th 554, 566.) The Proposition 65 list

identifies acrylamide as a chemical known to cause cancer and

reproductive harm.

IV. Nutrition Labeling and Education Act of 1990

“The purpose of the NLEA was to create uniform national

standards regarding the labeling of food and to prevent states

from adopting inconsistent requirements with respect to the

labeling of nutrients. [Citation.] To that end, the NLEA included

an explicit preemption provision in the form of section 343–1(a)

[citation], which provides that ‘no State or political subdivision of

a State may directly or indirectly establish under any authority

or continue in effect as to any food in interstate commerce—[¶]

. . . [¶] (3) any requirement for the labeling of food of the type

required by section . . . 343(k) of this title that is not identical to

the requirement of such section . . . .’ [Citation.]” (Farm Raised

Salmon Cases (2008) 42 Cal.4th 1077, 1086.)

Dr. Sowinski contends that Proposition 65 warning labels

are exempted from preemption by the NLEA’s savings clause.

NLEA section 6(c)(2), states that NLEA’s preemption clause

“shall not be construed to apply to any requirement respecting a

statement in the labeling of food that provides for a warning

18

concerning the safety of the food or component of the food.”

(Pub.L. No. 101-535 (Nov. 8, 1990) 104 Stat. 2353, § 6(c)(2).) At

oral argument, Dr. Sowinksi’s counsel urged us to read section

6(c)(2) broadly to cover “any form of preemption” and conclude

that “Proposition 65 is exempt as it relates to food.” Dr. Sowinski

ignores the next paragraph of section 6(c), which states that

paragraph “(2) of this subsection shall not be construed to affect

preemption, express or implied, of any such requirement of a

State or political subdivision, which may arise under the

Constitution, any provision of the Federal Food, Drug, and

Cosmetic Act not amended by subsection (a), any other Federal

law, or any Federal regulation, order, or other final agency

action. . . .” (Pub.L. No. 101–535, § 6(c)(3) (Nov. 8, 1990) 104

Stat. 2364, italics added.) “[T]he phrase ‘any such requirement’

in NLEA section 6(c)(3) refers to the ‘requirement’ discussed in

NLEA section 6(c)(2)” exempting state food safety warnings from

preemption. (Farm Raised Salmon Cases, supra, 42 Cal.4th at p.

1093.) Because Petitioners’ obstacle preemption affirmative

defense is based not on the NLEA but on a host of other federal

laws and regulations promoting the consumption of whole grains,

the savings clause in NLEA section 6(c)(2) does not “affect

preemption, express or implied” of state laws by those other

federal laws and regulations.

8

V. Trial Court’s Obstacle Preemption Ruling

The trial court judicially noticed and summarized the

federal statutory directives promoting whole grains in Americans’

8 Sciortino, the federal district court case cited by Dr.

Sowinski, also read NLEA’s section 6(c)(2) and (c)(3) to mean that

the “safety warning assertedly required under California law

may be subject to implied preemption by a federal law that predates

(and was left unamended by) the NLEA.” (Sciortino, supra,

108 F.Supp.3d at p. 808.)

19

diets that Petitioners rely on: “Defendants reference, among

others, the following federal policies promoting consumption of

whole grains: 7 U.S.C. §5341 (authorizing the establishment of

‘Dietary Guidelines for Americans,’ one such guideline

encourages Americans to eat at least 48 grams of whole grains

per day); 42 U.S.C. §300u(a)(l)-(4), (10)-(11) (part of the Healthy

People Initiative, which establishes a national health goal of

nearly doubling the average whole grains intake by Americans);

42 U.S.C. §300u-3 ([creating] the FDA to establish consumer

education, pursuant to which the FDA encourages Americans to

‘[s]tart [the] day with a bowl of whole grain breakfast cereal . . .

that is high in dietary fiber and low in added sugars’); and 42

U.S.C. §1786 and 7 C.F.R. §246.l0 (the Special supplemental

nutrition program for women, infants, and children (‘WIC’))

(setting guidelines of less than 6 grams of sucrose and other

sugars per dry ounce of cereal; and mandating that at least half

of the cereals authorized on a State Agency’s food list have at

least 51% whole grain, be low in saturated fat and cholesterol,

bear quantitative trans fat labeling, and contain less than 6.5

grams of total fat and 0.5 grams or 6 less of trans fat).” The trial

court concluded it is “apparent the documents for which

Defendants seek judicial notice reveal an important national

policy of increasing consumers’ intake of whole grains (which

would include breakfast cereal).”

The trial court also concluded, however, that a Proposition

65 warning “would not stand as an obstacle to the

accomplishment and full purposes and objectives of the federal

government in encouraging the consumption of whole grains

(pursuant to the statutes referenced supra). This is because

there has been no acrylamide warning requirement at the federal

level. None of the items for which Defendants seek judicial notice

prohibit California from requiring such a warning under

20

Proposition 65. Importantly, the fact that the FDA itself has

recognized that research is ongoing reveals that no current

federal standard is in place.”

The trial court correctly articulated the rule that, “ ‘Conflict

preemption exists: (1) where it is impossible for a private party

to comply with both state and federal requirements; or (2) where

state law stands as an obstacle to the accomplishment and

execution of the full purposes and objectives of Congress.’ ” But

by requiring Petitioners to identify a conflicting federal

acrylamide warning or a formal prohibition on a Proposition 65

warning for acrylamide, the court applied only the impossibility

strand of conflict preemption and failed to consider obstacle

preemption. Having determined that Congress enacted several

laws establishing an “important national policy of increasing

consumers’ intake of whole grains (which would include breakfast

cereal),” the court’s next task was to determine whether the

purpose and operation of those laws would be “frustrated” by a

Proposition 65 warning. (Crosby, supra, 530 U.S. at p. 373.)

We agree with the parties and the trial court that the

California Supreme Court’s ruling in Dowhal v. SmithKline

Beecham Consumer Healthcare (2004) 32 Cal.4th 910 (Dowhal)

guides our decision here. In Dowhal, the FDA rejected a

proposed Proposition 65 warning label on nicotine patches used

to stop smoking, concerned that it might “lead pregnant women

to believe that [the] products were as dangerous as smoking,” and

discourage them from quitting. (Dowhal, supra, at p. 929.) In a

one-page advice letter the FDA approved language that

encouraged pregnant women to stop smoking, indicated nicotine

patches are believed to be safer than smoking, and stated their

risks were not fully known. (Id. at p. 922.) Dowhal held that this

determination, made in a short FDA advisory letter, had

preemptive effect because a Proposition 65 warning would pose

21

an obstacle to the FDA’s objective of encouraging smoking

cessation. (Dowhal, supra, at p. 935.) The Court noted, “The

mere existence of the risk . . . is not necessarily enough to justify

a warning; the risk of harm may be so remote that it is

outweighed by the greater risk that a warning will scare

consumers into foregoing use of a product that in most cases will

be to their benefit.” (Id. at p. 934.)

Dr. Sowinski contends Dowhal “very specifically” held that

due to the savings clause in the Food and Drug Administration

Modernization Act of 1997 (21 U.S.C. § 379r(d)(2) (Modernization

Act)), conflict preemption “could only arise as to Proposition 65 if

the FDA had adopted a specific warning and the Proposition 65

warning actually conflicted with it.” (Bold omitted.) Dr.

Sowinski misreads Dowhal. In its discussion of the effect of the

Modernization Act’s savings clause on conflict preemption, the

Supreme Court concluded “that Geier is not a narrow holding

limited to automobile safety standards; instead it established a

general rule upholding conflict preemption even if the applicable

federal law contains a savings clause.” (Dowhal, supra, 32

Cal.4th at p. 926.) Then, based on the language and legislative

history of the Modernization Act’s savings clause, the Court held

that it precludes conflict preemption only when the federal policy

of uniform labeling forms the basis of the purported conflict.

Dowhal explained, “The language of the Modernization Act’s

savings clause does not express an intention to preclude all

conflict preemption. The legislative history suggests an intent to

preclude conflict preemption in pursuit of national uniform

labeling.” (Dowhal, supra, at p. 926.) In support, Dowhal quotes

Senator Barbara Boxer’s statement during floor debate on the

Act, that the savings clause was intended to ensure “that

California’s proposition 65 will not be preempted by the

uniformity provisions of this bill . . . .” (Id. at p. 926, fn. 6.) The

22

Court concluded that while “a Proposition 65 warning cannot be

preempted solely because it is not identical with the federal

requirement,” it could be preempted “on a basis relevant to

consumer health.” (Id. at p. 926.)

Significant for our decision here, Dowhal gave substantial

deference to the FDA’s deliberate risk-benefit balancing. The

Court noted the FDA’s concern that a Proposition 65 warning on

nicotine patches might be misleading and cause an unintended

negative effect on consumers’ choices: “Whether a label is

potentially misleading or incomprehensible is essentially a

judgment of how the consumer will respond to the language of

the label. As we have noted, a truthful warning of an uncertain

or remote danger may mislead the consumer into misjudging the

dangers stemming from use of the product, and consequently

making a medically unwise decision. The authority of the FDA,

we conclude, extends to barring warnings that are misleading in

this fashion.” (Dowhal, supra, 32 Cal.4th at p. 934.)

Here, the FDA’s policy, described in its advisory letters to

California’s regulators and Attorney General, is that no

Proposition 65 warning for acrylamide should be placed on foods,

including breakfast cereals, unless and until the science supports

such a warning. Even then, the FDA may, as it does with trans

fats, require producers to identify foods that contain acrylamide

and the amount, and educate the public about the risks and

benefits of various types of breakfast cereals based on quantities

consumed.

The trial court did not ignore the FDA’s letters, but it also

appears not to have given them much, if any, weight. In Dowhal,

the Court rejected the plaintiff’s argument that the FDA’s letter

responding to a citizen petition was too informal to prohibit the

defendants from complying with Proposition 65. The Court

concluded “that the FDA’s . . . letter established a federal policy

23

prohibiting defendants from giving consumers any warning other

than the one approved by the FDA in that letter, and that the use

of a Proposition 65 warning would conflict with that policy.”

(Dowhal, supra, 32 Cal.4th at p. 929.) Thus, the Court found that

the FDA’s letter was sufficient to articulate a policy that it found

to have a preemptive effect. (Ibid.)

The trial court was entitled to ignore the FDA’s legal

conclusion that Proposition 65 as applied to acrylamide is

preempted by its regulatory scheme. (See Wyeth v. Levine, supra,

555 U.S. at p. 576 [“we have not deferred to an agency’s

conclusion that state law is pre-empted”].) But it should have

given weight to the FDA’s analysis and concerns regarding a

Proposition 65 warning and the obstacles it would pose to the

fulfillment of its statutorily-driven dietary goals. Courts are to

focus on “an agency’s explanation of how state law affects the

regulatory scheme. While agencies have no special authority to

pronounce on pre-emption absent delegation by Congress, they do

have a unique understanding of the statutes they administer and

an attendant ability to make informed determinations about how

state requirements may pose an ‘obstacle to the accomplishment

and execution of the full purposes and objectives of Congress.’ ”

(Wyeth v. Levine, supra, at pp. 576-577.) “The weight we accord

the agency’s explanation of state law’s impact on the federal

scheme depends on its thoroughness, consistency, and

persuasiveness.” (Id. at p. 577.)

Here, the FDA’s July 2003 and March 2006 letters were

thorough, consistent, and contained persuasive reasoning why

Proposition 65 acrylamide warnings on whole grain cereals would

mislead consumers and lead to health detriments. Dr. Sowinski

characterizes them as “old letters,” but California regulators

complied with them, so the FDA had no reason to issue further

advice letters regarding Proposition 65 warnings for acrylamide.

24

Indeed, to this day, the OEHHA’s Proposition 65 web page

dedicated to acrylamide quotes from and refers to the FDA’s

advice providing a balanced approach. And the FDA’s March

2016 Guidance for Industry, Acrylamide in Foods shows that

acrylamide research is ongoing. The FDA quotes the conclusion

of the World Health Organization/FDA Joint Expert Committee

on Food Additives “that acrylamide may be ‘a human health

concern’ ” and states that the “FDA is not suggesting maximum

recommended levels for acrylamide in various products at this

time.” This shows that the FDA continues to execute on the

strategy outlined in its advice letters and has not endorsed

California’s 0.2 microgram/day standard that would require

many foods to be labeled.

Petitioners offer as a parallel example a case concerning

mercury in tuna, in which California regulators disregarded the

FDA’s advice and sued tuna canneries to require Proposition 65

warnings. Two excerpts from the FDA’s advice letters illustrate

the problem with placing Proposition 65 warnings on otherwise

healthy foods that contain a chemical that poses health risks.

First, the FDA explained, “The warnings that would be required

on the defendants’ products if the lawsuit is successful are some

derivation of the following: ‘WARNING: This product contains a

chemical known to the State of California to cause cancer,’ and

‘WARNING: This product contains a chemical known to the

State of California to cause birth defects or other reproductive

harm.’ [¶] FDA believes that such warnings are preempted

under federal law. They frustrate the carefully considered

federal approach to advising consumers of both the benefits and

possible risks of eating fish and shellfish; accordingly, federal law

preempts these Proposition 65 warnings concerning mercury and

mercury compounds in tuna.”

25

After detailing for several pages the studies the FDA had

conducted and the balancing it had undertaken before

determining its approach, the letter states, “the Proposition 65

warnings purport to convey factual information, namely that

methylmercury is known to cause cancer and reproductive harm.

However, it is done without any scientific basis as to the possible

harm caused by the particular food in question, or as to the

amounts of such foods that would be required to cause this harm.

Stated differently, these warnings omit facts which are necessary

to place the information in its proper context. As a result, FDA

believes that the Proposition 65 warnings are misleading under

section 403 of the Act, causing tuna products with such warnings

to be misbranded under federal law.”

Following a bench trial, the superior court found that

mercury was naturally occurring in tuna and thus exempt from

Proposition 65. The court also ruled that “any Proposition 65

compliant warning would frustrate the purpose and objectives of

the FDA’s carefully considered federal approach to advising

consumers of both the benefits and possible risks of eating fish

. . . and thus Proposition 65 as applied to the Tuna Companies . . .

was preempted by federal law.” (People ex rel. Brown v. TriUnion

Seafoods, LLC (2009) 171 Cal.App.4th 1549, 1559–1560

(Tri-Union).) The trial court relied on the FDA’s advisory letter,

explaining that “requiring Proposition 65 warnings would

frustrate the agency’s carefully nuanced approach ‘to advising

consumers of both the benefits and possible risks of eating fish

and shellfish; accordingly federal law preempts these Proposition

65 warnings concerning mercury and mercury compounds in

tuna.’ ” (Id. at p. 1560.) “The trial court’s preemption ruling also

leaned heavily on [Dowhal’s conclusion] that the FDA’s approach

to warnings on nicotine replacement therapy products embodied

a nuanced goal that was in conflict with California’s single26

minded goal of informing consumers of the products’ risks.”

(Ibid.)

9

Here, the trial court found the federal statutes cited by

Petitioners’ evidence “an important national policy of increasing

consumers’ intake of whole grains (which would include breakfast

cereal).” But then the court failed to determine whether a

Proposition 65 warning for acrylamide on breakfast cereals would

frustrate that policy, and failed to give weight to the FDA’s

advice letters describing how a Proposition 65 warning would

mislead consumers and undermine federal objectives. We

conclude that Petitioners’ summary judgment motion papers

established that a Proposition 65 warning for acrylamide on

breakfast cereals would pose an obstacle to the federal scheme

and therefore is preempted by federal law.

We are left to address Dr. Sowinski’s contention that even

if conflict preemption applies, disputed issues of material fact

precluded summary judgment because not all of Petitioners’ 59

cereals at issue contain whole grains or are eligible for a health

claim. Dr. Sowinski is correct that 10 of Petitioners’ breakfast

cereals do not contain whole grains, but each of these cereals

carries another ingredient that qualifies it for a health claim.

Seven cereals, Frosted Flakes, Kellogg’s Corn Flakes, Cocoa

Pebbles, Fruity Pebbles, Rice Krispies, Crispix, and Special K

qualify for health claims because they contain lipids and folic

acid. The other three, All-Bran, All-Bran Buds, and Corn Pops

contain dietary fiber, lipids, and folic acid.

9 The Court of Appeal did not address the issue of federal

preemption. Instead, it affirmed the judgment solely on the

ground that substantial evidence supported the trial court’s

finding that methylmercury in tuna is naturally occurring and

thus exempt from Proposition 65 warning requirements. (TriUnion,

supra, 171 Cal.App.4th at p. 1576.)

27

The FDA advisory letters identified whole grain cereals as

its chief concern, but also expressed concern for cereals with fiber

and other nutrients: “Consumers who avoid eating some of these

foods, such as breads and cereals, may encounter greater risks

because they would have less fiber and other beneficial nutrients

in their diets. For these reasons, premature labeling

requirements would conflict with FDA’s ongoing efforts to provide

consumers with effective scientifically based risk communication

to prevent disease and promote health.” (Italics added.) Notably,

the trial court judicially noticed several FDA nutritional

guidelines that identify folic acid and dietary lipids as qualifying

for health claims, and stated: “The FDA has issued certain

health claims regarding food with nutrients that may reduce the

risk of cancer and neural tube birth defects. As Defendants point

out, the FDA allows health claims associating low fat diets with a

reduced risk of cancer (see 21 C.F.R. §101.73(e)(2), addressing

health claims on the relationship between dietary lipids and

cancer); . . . and health claims involving folate and neural tube

defects (see 21 C.F.R. §101.79).”

If Dr. Sowinski believed disputed material facts precluded

summary judgment on Petitioners’ affirmative defense of federal

preemption, it was his burden to raise them in the trial court.

Instead, in opposing summary judgment Dr. Sowinski contended

in his response to Petitioners’ separate statement that none of

the health claims identified above was a material fact because

the “presence of ‘nutrients’ in some cereals is not an issue in this

litigation.” “When a defendant moves for summary judgment on

the ground there is an affirmative defense to the action, the

burden shifts to the plaintiff to show there is one or more triable

issues of material fact regarding the defense after the defendant

meets the burden of establishing all the elements of the

28

affirmative defense.” (Jessen v. Mentor Corp. (2008) 158

Cal.App.4th 1480, 1484.) Dr. Sowinski did not carry that burden.

The petition for writ of mandate is granted. Let a peremptory writ of mandate issue, directing the trial court to vacate its June 27, 2017 order denying Petitioners’ motion for summary judgment and to issue a new and different order granting same. Petitioners are entitled to recover costs on appeal.