Court Opinion

ID: 4304222
Source: CourtListenerOpinion
Date Created: 2018-08-15 23:02:03.072478+00
Date Added: 2024-06-11T14:34:25.992822
License: Public Domain

Filed 8/15/18 (unmodified opn. attached)
                  CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

                   SECOND APPELLATE DISTRICT

                               DIVISION ONE

POST FOODS, LLC, et al.,                   B284057

       Petitioners,                        (Los Angeles County
                                           Super. Ct. No. BC516747)
       v.

THE SUPERIOR COURT OF                      ORDER MODIFYING
LOS ANGELES COUNTY,                        OPINION, GRANTING
                                           JUDICIAL NOTICE, AND
       Respondent;                         DENYING REHEARING

RICHARD SOWINSKI,                          [NO CHANGE IN JUDGMENT]

       Real Party in Interest.

THE COURT:
      It is ordered that the opinion filed herein on July 16, 2018,
be modified as follows:
      1. In section A of the FACTUAL AND PROCEDURAL
BACKGROUND, on page 6, the first sentence of the last
paragraph, which reads:
      Notably, the OEHHA heeded the FDA’s advice letters and
deferred to the FDA’s approach to acrylamide.
       Is modified to read as follows:
       Notably, the California authorities heeded the FDA’s advice
letters and deferred to the FDA’s approach to acrylamide.
       2. In section E of the FACTUAL AND PROCEDURAL
BACKGROUND, on page 13, the first two sentences of footnote 5,
which read:
       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.
       Are modified to read as follows:
       Neither party addressed whether a Proposition 65 warning
on whole grain cereals would lead to labels on other otherwise
healthful foods, but this presents a concern. Proposition 65
warnings on foods containing acrylamide above California’s
nonsignificant risk levels would cause many such foods to appear
to consumers to be unhealthful and vice versa.
       3. In section V of the DISCUSSION, on page 24, the last
sentence on that page, which reads:
       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.
       Is modified to read as follows:
       Dr. Sowinski characterizes them as “old letters,” but
California regulators heeded them, so the FDA had no reason to
issue further advice letters regarding Proposition 65 warnings for
acrylamide.

                                2
       4. In section V of the DISCUSSION, on page 24, at the end
of the last sentence on that page:
       Insert a new footnote number 9, which will require
renumbering of all subsequent footnotes, that reads as follows:
       Notably, it is not the FDA’s letters that preempt the
proposed Proposition 65 acrylamide warnings here, but the
numerous federal statutes enacted by Congress to increase
Americans’ consumption of whole grains, whose policy objectives
would be obstructed by such a warning. For this reason, Reid v.
Johnson & Johnson (2015) 780 F.3d 952, in which the Ninth
Circuit held that a particular FDA letter lacked any preemptive
effect, is inapposite. Moreover, Reid merely held the FDA letter
at issue lacked the force of law necessary to preempt state law,
largely due to its “equivocal language” regarding the FDA’s
intentions. That letter was “couched in tentative and non-
committal terms” and did “not promise that the FDA will not
enforce its … regulation” but instead provided “that the FDA
‘intends to consider the exercise of enforcement discretion’ in
certain circumstances.” (Id. at p. 965, italics added.) By contrast,
the FDA letters here were unequivocal. The 2003 FDA letter
stated, “[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.” In its 2006 letter, the FDA stated, “California should not
require acrylamide warning labels for foods under Proposition 65

                                 3
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.”
      5. In section V of the DISCUSSION, on page 25, the last
sentence of the partial paragraph, which reads:
      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.
      Is modified to read as follows:
      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
whole grain cereals to be labeled.
      There is no change in the judgment.
      Real party in interest’s request for judicial notice is
granted.
      Real party in interest’s petition for rehearing is denied.
      CERTIFIED FOR PUBLICATION

____________________________________________________________
ROTHSCHILD, P. J.           CHANEY, J.          JOHNSON, J.

                               4
Filed 7/16/18 (unmodified version)
                  CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

                   SECOND APPELLATE DISTRICT

                                DIVISION ONE

POST FOODS, LLC, et al.,                   B284057

       Petitioners,                        (Los Angeles County
                                           Super. Ct. No. BC516747)
       v.

THE SUPERIOR COURT OF
LOS ANGELES COUNTY,

       Respondent;

RICHARD SOWINSKI,

       Real Party in Interest.

      ORIGINAL PROCEEDING; petition for writ of mandate.
Kenneth R. Freeman, Judge. Petition granted.
      Arnold & Porter Kaye Scholer, Trenton H. Norris; Perkins
Coie, David T. Biderman and Eric D. Miller for Petitioners.
      No appearance for Respondent.
      Graham & Martin and Anthony G. Graham for 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

                                4
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
                                             1
2010 dietary guidelines for further reading.
      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.

                                10
      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
          2
statute. 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
                               3
F. Supp. 3d 780, 806 (Sciortino).
       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,
                                                               4
and consumers should be able to determine which ones do not.

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
                 5
promote health.”
       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
                      6
should be considered.” 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.
                                                              7
American Honda Motor Co. (2000) 529 U.S. 861, 883 (Geier).)

      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
                                8
federal laws and regulations.
      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 pre-
dates (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. Tri-
Union 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 single-

                                26
minded goal of informing consumers of the products’ risks.”
      9
(Ibid.)
       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. (Tri-
Union, 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.

                         DISPOSITION
      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.
      CERTIFIED FOR PUBLICATION

                                          CHANEY, J.

We concur:

             ROTHSCHILD, P. J.

             JOHNSON, J.

                                29