Pom sued Coca-Cola over its “Pomegranate Blueberry” or
“Pomegranate Blueberry Flavored Blend of 5 Juices” product. (Coca-Cola argued that the latter was the
product’s name, as if any consumer in the entire world would call it
that.) Pomegranate Blueberry contains about
99.4% apple and grape juices, 0.3% pomegranate juice, 0.2% blueberry juice, and
0.1% raspberry juice.
The front label displays the product’s name and a vignette depicting each of those fruits:
The district court ruled that the Lanham Act claim against
the name and fruit vignette was barred by FDA regulations, though Pom could
challenge other advertising and marketing of the product. Also, Pom’s state law claims were preempted
to the extent they would impose requirements not identical to federal ones on
Coca-Cola. Also, the court held that Pom
lacked statutory standing to pursue its state law claims because it hadn’t not
shown that it was entitled to restitution.
Pom appealed, and the court of appeals largely affirmed. “[T]he Lanham Act may not be used as a vehicle
to usurp, preempt, or undermine FDA authority. That teaching, however, operates
as a presumption or a general principle—not as an automatic trump or a firm
rule.” Courts must attempt to give as
much effect to both statutes as possible.
Here, the naming aspect of Pom’s claim was barred “because, as
best we can tell, FDA regulations authorize the name Coca-Cola has chosen.” Under the regs, a manufacturer can name a
beverage using a name of a flavoring juice that is not predominant by
volume. For example, a raspberry-and-cranberry-flavored product whose
predominant juice is not raspberry or cranberry can be called “‘Raspcranberry’;
raspberry and cranberry flavored juice drink.” If the juices provide the characterizing
flavor, and if Coca-Cola states that the juices aren’t predominant, then the
name is ok. Thus, allowing Pom’s claim
to proceed would conflict with the FDA’s apparent authorization of names like “Pomegranate
Blueberry Flavored Blend of 5 Juices.” The same went for the labeling component of
Pom’s claim, which focused on the presentation
of the words on the label (Pom didn’t spend meaningful time on the fruit
vignette on appeal). Pom apparently
sought to make Coca-Cola change the size of the words on its labeling so that
the words “Pomegranate Blueberry” no longer
appeared in larger, more conspicuous type on Coca-Cola’s label than “Flavored
Blend of 5 Juices.” But that too would
undermine the FDA’s regulations, which specify what words must or may be
included on labels and how prominently and conspicuously they must appear: in such a way “as to render
[them] likely to be read and understood by the ordinary individual.” Despite this, the FDA hasn’t required that all
words in a juice blend’s name appear on the label in particular sizes; if the
FDA thought that such a regulation were necessary, “it could have said so. If
the FDA believes that more should be done to prevent deception, or that Coca-Cola’s
label misleads consumers, it can act.”
But here, to act when the FDA hasn’t would risk undercutting its
expertise and authority.
Previous district court decisions allowing similar Lanham
Act claims to proceed, on the ground that the claims didn’t require the court
to interpret or apply FDA regulations, couldn’t be harmonized with governing 9th
Circuit precedent. “Although these
courts were right to recognize that a Lanham Act claim is barred when it would
require a court to interpret ambiguous FDA regulations, that is not the only
circumstance in which such a claim is barred…. [C]ourts must generally prevent private
parties from undermining, through private litigation, the FDA’s considered
judgments.”
How do we know when the FDA has made a considered judgment,
as opposed to not making a judgment?
Good question, to which you will not find a great answer here! The court reiterated that the FDA could
determine that Coca-Cola’s label is misleading, but that it hasn’t to date done
so, “even though it has acted extensively and carefully in this field. (The FDA
has not established a general mechanism to review juice beverage labels before
they reach consumers, but the agency may act if it believes that a label in the
market is deceptive.) As best we can
tell, Coca-Cola’s label abides by the requirements the FDA has established.” However, “mere compliance with the FDCA or
with FDA regulations will [not] always (or will [not] even generally) insulate
a defendant from Lanham Act liability.”
Compliance with FDA’s regulations alone was not enough, but rather the
court found compelling “Congress’s decision to entrust matters of juice beverage
labeling to the FDA and by the FDA’s comprehensive regulation of that labeling.” The FDA apparently didn’t impose the
requirements Pom wants, and the court lacked the FDA’s expertise in guarding
against deception in the context of juice beverage labeling. (Does the FDA have expertise in assessing
likely deception, as opposed to scientific evidence on safety and
efficacy? I don’t think the D.C. Circuit
thinks it does.)
Turning to the state law claims, the district court
dismissed on standing grounds: it found that Pom hadn’t lost money or property
because it wasn’t entitled to restitution directly from Coca-Cola. But the California Supreme Court has made
clear that standing doesn’t depend on eligibility for restitution, so the court
remanded for further proceedings, which would restart the preemption issue and
also raise the question whether California’s safe-harbor doctrine for
regulatory compliance insulated Coca-Cola from liability. So it seems unlikely that Pom can get much
traction on state-law claims either.
No comments:
Post a Comment