CA’s Prop 65 warning unconstitutional for acrylamide warnings for being scientifically overcertain

California Chamber of Commerce v. Becerra, 2021 WL 1193829, No.
2:19-cv-02019-KJM-EFB (E.D. Cal. Mar. 30, 2021)

California allegedly compelled businesses to display
misleading warnings about the dangers of acrylamide, a carcinogen. The Council
for Education and Research on Toxics (CERT) intervened because it often files
lawsuits against businesses that do not display warnings about acrylamide.

The court granted an injunction against the law because genuine
scientific dispute over the harms to humans of acrylamide meant that the
disclosure was not “purely factual and uncontroversial,” so not ok under Zauderer,
and the state didn’t meet its burden under any higher standard.

Acrylamide is a toxic chemical first
detected in food in 2002, but not newly there. It often forms as a result of a
reaction between sugars and the amino acid asparagine, which naturally occur in
many foods. Roasting, baking, frying, or otherwise cooking food at a high
temperature appears to cause acrylamide to form, whether at home or at
industrial scale. According to the U.S. Food & Drug Administration (FDA),
the foods that contribute the most acrylamide to the American diet are baked
and fried starchy foods like french fries, chips, crackers, donuts, pancakes,
and toast. Coffee also contains acrylamide, as do almonds, olives, and asparagus.

It’s well established that acrylamide increases cancer in
animals; more acrylamide means more cancer. The studies do use very high doses,
not real-world doses. “[M]any public health authorities have concluded that
exposure to acrylamide probably increases the risk of cancer in people.” Some
researchers—some with ties to the food/beverage industries—think that rats and
mice react differently to acrylamide. And for obvious ethical reasons, there
aren’t clinical human studies, though in vitro human cell studies suggest that
acrylamide causes DNA changes that are known to cause breaks and mutations in
chromosomes, which can in turn cause cancer; in the International Agency for
Research on Cancer (IARC) database of 1,600 human tumor genomes, about one
third of the tumor genomes could be connected to acrylamide. “This may mean
that a large portion of human cancer is connected to acrylamide exposure.”
However, dozens of epidemiological studies have failed to find a connection. This
may simply be because food diary studies are unreliable, especially given the ubiquity
and uniformity of acrylamide exposure—plus, the effects may not surface for decades,
so a short-term study won’t be helpful.

It is thus unsurprising that, despite their conclusions
about “probable” or “likely” links to cancer, government authorities haven’t
urged people to avoid acrylamide-containing foods, though the FDA has offered
guidance to reduce consumption. “At the end of the day, however, because
acrylamide is found in so many foods, it is probably impossible to avoid it
completely. The FDA advises Americans not to attempt removing fried, roasted,
and baked foods from their diets.” California public health authorities specifically
decided not to warn against acrylamide exposure in coffee; the State found
“inverse associations—decreasing risk with increasing coffee consumption—for
[some] human cancers.”

But non-coffee sources remain subject to the warning
requirements of California’s Safe Drinking Water and Toxic Enforcement Act of
1986, more commonly known as “Proposition 65.” Businesses must not knowingly or
intentionally expose people to chemicals “known to the state to cause cancer or
reproductive toxicity” without a “prior clear and reasonable warning.”   A chemical “must be listed even if it is
known to be carcinogenic or a reproductive toxin only in animals.”

Regulations require warnings to name the chemical and to be
displayed “prominently,” “with such conspicuousness” that they are “likely to
be seen, read, and understood by an ordinary individual.” A warning may include
more information than this, but only if the addition “identifies the source of
the exposure or provides information on how to avoid or reduce exposure.” There
is a safe harbor warning: “Consuming this product can expose you to [name of
one or more chemicals], which is [are] known to the State of California to
cause cancer. For more information go to http://www.P65warnings.ca.gov/food.”

California has settled cases by allowing more nuanced
warnings: in potato chip litigation, it allowed the warning to say the chips
“contain acrylamide, a substance identified as causing cancer under
California’s Proposition 65.” The warning further explained that foods other
than chips contain acrylamide and that acrylamide is not added to these foods,
but rather is “created when these and certain other foods are browned,” and
that the “FDA has not advised people to stop eating potato crisps and/or potato
chips…or any foods containing acrylamide as a result of cooking.”

Proposition 65 allows for exceptions, as with coffee; under
the regulations, 0.2 micrograms/day poses no significant risk and needs no warning,
and higher levels of exposure are permitted when “chemicals in food are
produced by cooking necessary to render the food palatable or to avoid
microbial contamination”; and the law grants businesses an affirmative defense
if they can prove the alleged exposure “poses no significant risk assuming
lifetime exposure at the level in question,” but the court concluded that these
paths were too risky to be a defense to the First Amendment claim.

Here, the only safe path—the safe-harbor warning—would be:
“Consuming this product can expose you to acrylamide, which is …known to the
State of California to cause cancer. For more information go to
http://www.P65warnings.ca.gov/food.” First, by “asserting vaguely” that consumption
could expose the consumer to acrylamide, a chemical most people have likely
never heard of, “the warning implies incorrectly that acrylamide is an additive
or ingredient.” And the warning required consumers to make several leaps—that
it meant that animals get cancer more often when they consume doses hundreds of
times larger than the amounts in the food, that scientists presume (absent
other evidence) this means cancer in people, and that therefore the chemical is
“known” to cause cancer in humans. (Necessary implication!) “People who
read the safe harbor warning will probably believe that eating the food
increases their personal risk of cancer.” There was indeed some evidence for
that, but the epidemiological studies didn’t find it, and “California has also
decided that coffee, one of the most common sources of acrylamide, actually
reduces the risk of some cancers.”

Thus: “the safe harbor warning is controversial because it
elevates one side of a legitimately unresolved scientific debate about whether
eating foods and drinks containing acrylamide increases the risk of cancer.”

The state couldn’t adopt private definitions of what it
means for California to “know” that acrylamide causes cancer, “or by showing
the warning contains no affirmative falsehoods. Statements are not necessarily
factual and uncontroversial just because they are technically true.”

The court commented that these problems could have been
avoided by allowing businesses to explain that acrylamide forms naturally when
some foods are prepared; that California has listed acrylamide as a chemical
that “probably” causes cancer or is a “likely” carcinogen or that the chemical
causes cancer in laboratory animals; and that acrylamide is commonly found in
many foods and that neither the federal government nor California has advised
people to cut acrylamide from their diets. Although this was okayed in the
potato chip litigation, it wasn’t obviously available to others without
litigation, based on the statute and the regulations. On the current record,
the court agreed that “only the safe harbor warning is actually useable in
practice,” and the state couldn’t “ ‘put the burden on commercial speakers to
draft a warning that both protects their right not to speak and complies with
Proposition 65.’ If the seas beyond the safe harbor are so perilous that no one
risks a voyage, then the State has either compelled speech that is not purely
factual, or its regulations impose an undue burden.”

This case was distinguishable from the earlier CTIA cellphone
radiation warning case in three ways: First, the CTIA warning only “hinted”
at potential dangers, for example by referring vaguely to “safety,” but “its
text was a purely factual summary of federal regulation about radio frequency
radiation.” This wasn’t even argued to be “controversial as a result of
disagreement about whether radio-frequency radiation can be dangerous to cell
phone users.” But the truth of whether acrylamide is “known to cause cancer” is
“the subject of controversy,” even if it wasn’t a political or moral
controversy.

Second, CTIA involved an unchallenged federal mandatory
disclosure of the same information; the ordinance at issue just required more
prominence. Here, “[n]o regulatory or public health authority has advised
against consuming foods with acrylamide.” [… That’s not what this disclosure
says either.]

Third, the ordinance in CTIA allowed businesses to
add information, whereas “Proposition 65 does not permit businesses to add
information to the required warning at their discretion, and thus prevents them
from explaining their views on the true dangers of acrylamide in food.”

Since Zauderer didn’t apply, it also flunked Central
Hudson
and any higher standard of scrutiny. “There is no question that
protecting the health and safety of consumers is a substantial government
interest.”   But at this stage of the
litigation, the required warning likely does not “directly advance” that
interest and is “more extensive than necessary” because it misleadingly implied
that the science about the risks of food-borne acrylamide was settled. The
state could also fund scientific research and pursue public awareness campaigns
to further its interest. “Regulators could also modify safe harbor warnings to
eliminate inaccuracies and controversial statements.”

The court cautioned that it was not invalidating “existing
consent decrees, settlements, or other agreements. For example, this order does
not permit businesses that have already agreed to display a certain warning do
take those warnings down, and businesses that have agreed to reformulate their
products to reduce acrylamide content are not permitted by this order to breach
those agreements.” And the court noted the risk of misinterpretation or misuse
of this injunction to attack warnings about other carcinogens and reproductive
toxins. “California has a substantial and likely compelling interest in
protecting people from exposure to dangerous chemicals, including chemicals
that have been shown to cause cancer or reproductive harm in experimental
animals, even if epidemiological evidence is inconclusive.” But at this stage,
the court granted the preliminary injunction.

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