The plaintiffs sued under California law alleging that Splenda
Essentials with Antioxidants, Splenda Essentials with Fiber, and Splenda
Essentials with B Vitamins were deceptively advertised. They objected to the
name “Essentials”; the label on Splenda with Fiber, which includes the
statement “1 gram of fiber in each packet” and “healthy fiber” placed next to a
photo of fruit and whole-grain cereal; the label on Splenda with Antioxidants,
which includes the statement “20% of the daily value of antioxidant vitamins C
and E, like those found in fruits and vegetables” placed near a picture of
berries; and the label on Splenda Essentials with B Vitamins, which includes
the statement “helps support a healthy metabolism.” The court partially granted J&J’s motion
to dismiss.
Plaintiffs alleged that Splenda Essentials costs 25% more
than regular Splenda, and that they paid this extra based on J&J’s
misrepresentations. The versions with
antioxidants and B vitamins were discontinued, but that didn’t affect
plaintiffs’ claims for damages.
The plaintiffs claimed that they bought the products in
reliance on the labels, but didn’t allege that they relied on any website or
print marketing, so they didn’t have standing for anything but claims based on the labels. Though they aren’t required to plead exposure
with an unrealistic degree of specificity under In re Tobacco II, that case dealt with an extensive and longterm ad
campaign, whereas the campaign here began in 2012.
Preemption: As for Splenda Essentials with Antioxidants, the
statement that the product contains “20% of the daily value of antioxidant
vitamins C and E” was an express nutrient content claim. The regulations allow
nutrient content claims for antioxidants when: (1) an RDI (recommended daily
intake) has been established for each of the nutrients; (2) the nutrients that
are the subject of the claim have recognized antioxidant activity; (3) the
level of each nutrient is at least 10% of the RDI for vitamins; and (4) the
names of each nutrient are included on the label. Any additional requirements would
be preempted. The label here met each
requirement. Because the FDA doesn’t require a distinction between synthetically
derived antioxidants and those derived from fruit, claims that the label was
misleading for failing to do so were preempted.
However, there was no preemption with regard to the statement
“like those found in fruits and vegetables” placed next to a photograph of
antioxidant rich foods like strawberries, raspberries, blueberries, and
blackberries. J&J argued that “the
FDA affirmatively prohibits manufacturers from labeling products in any manner
that suggests that ‘a natural vitamin in a food is superior to an added or
synthetic vitamin.’” But plaintiffs
weren’t arguing that the label led consumers to think that vitamins in fruit
were better. Instead, they argued that
J&J misleadingly suggested that the product’s antioxidants were actually
derived from fruits and vegetables, or that they produce the same health benefits
as fruits and vegetables.
Turning to Splenda Essentials with Fiber, plaintiffs alleged
that the label was misleading because J&J didn’t differentiate between the
health benefits of fiber found in whole grains, etc., versus refined
fiber. But that claim was preempted
since the FDCA and NLEA specifically addressed the labeling of dietary fiber on
a package. The FDA rejected a proposal
to distinguish between intact plant fiber and synthetically manufactured fiber. Federal law required no more than what
J&J did.
For Splenda Essentials with B Vitamins, plaintiffs
challenged the statement that it would “help support a healthy metabolism.” J&J
argued that this was a structure/function claim specifically permitted by FDA
regulations, but preemption for structure/function claims was limited to
dietary supplements, not food. J&J
argued that the preemption provisions should be read broadly since the DSHEA’s
goal was to bring dietary supplement labeling in line with food labeling. But the specific language of the preemption
provision applied to dietary supplements, not food, and preemption statutes are
to be construed narrowly. Nor was the
claim impliedly preempted; J&J didn’t show that these claims would upend a
carefully calculated scheme. The FDA hasn’t promulgated nuanced regulatory
guidelines on food structure/function statements. Even if structure/function claims are
permitted by the FDA, FDA regulations bar misleading statements, and plaintiffs
alleged misleadingness.
J&J argued that plaintiffs were bringing a mere lack of
substantiation claim, and the court agreed in part. “A claim can survive a lack of substantiation
challenge by, for example, alleging studies showing that a defendant's
statement is false. In contrast, a plaintiff's reliance on a lack of scientific
evidence or inconclusive, rather than contradictory, evidence is not sufficient
to state a claim.” With respect to B vitamins and fiber, plaintiffs alleged
only lack of substantiation--“no reliable studies have shown” that Splenda
Essentials with B Vitamins promotes weight loss, that “there is no scientific
consensus that refined fibers function like intact fibers”, and that “research is inconclusive about the
physiological benefits of refined, processed fiber.” They didn’t cite any source stating that B
vitamins don’t contribute to weight
loss or that the effect of refined fiber is actually different than intact
fiber. However, plaintiffs did allege falsity with respect to some claims, “which
further confirms that Plaintiffs' claims lacking such allegations rest on mere
lack of substantiation theories.” They couldn’t rely on FTC substantiation
standards for health claims, since private citizens under California law can’t
bring lack of substantiation claims.
However, their claims based on Splenda Essentials with
Antioxidants were “adequately, if tenuously, pled.” The allegations that the label misleadingly
suggested that the antioxidants in the product, vitamins C and E, were derived
from fruits and vegetables, when they are actually ascorbic acid and
synthetically created vitamin E, survived.
And they alleged the existence of at least one source stating that the
vast majority of antioxidant benefits from fruit come from the entire fruit,
and not just the vitamin C. This
properly alleged misleadingness as to the source of the vitamins and as to
whether Splenda’s benefits were the same as benefits from fruit.
The court noted that federal law expressly permitted certain
statements. It was therefore unclear how
much a court could rely on preempted statements when considering what a
reasonable consumer would think of the whole label. Still, because the Antioxidants label might
be misleading to a reasonable consumer regardless of the preempted statements,
the court didn’t need to resolve the question.
The statement “20% of the daily value of antioxidant
vitamins C & E, like those found in fruits and vegetables,” when viewed in
the context of the photos of multiple berries, could create the misleading
impression that the vitamins “are derived from fruit or provide [ ] the same
benefits as real fruit, even though they do not provide any notable health
benefits.” A reasonable consumer could think that the antioxidants were derived
from berries, rather than ascorbic acid and synthetically created vitamins, and
might also incorrectly believe that Splenda Essentials has the same health
benefits as consuming real fruit.
However, putting “Essentials” in the name wasn’t misleading,
despite plaintiffs’ arguments that it “cue[d] customers to think this product
is a necessity” and suggested that the nutrients included are necessary to be
healthy. “Essentials” was mere puffery.
Because the consumer law claims survived, so did the breach
of implied warranty of merchantability claim.
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