claims for ab exercise device going beyond FDA clearance are actionable

Loomis v. Slendertone Distrib., Inc., 2019 WL 5790136, No.
3:19-cv-854 – MMA (KSC) (S.D. Cal. Nov. 6, 2019)
Loomis brought the usual California claims based on ads for
the Flex Belt, a purported ab-exercise device. While denying standing for
injunctive relief and finding a bunch of the challenged claims to be puffery,
there was still enough to continue, and the court also rejected an FDA
preemption argument.
Preemption: Slendertone argued that the Flex Belt had been
FDA cleared [NB: not approved] “for Toning, Firming and Strengthening
the stomach muscles,” and thus the claims were preempted. States can adopt FDCA
rules for their own law, but parallel state “consumer protection laws, such as
the UCL, FAL, and CRLA, are nonetheless preempted if they seek to impose
requirements that contravene the requirements set forth by federal law.” But
Loomis didn’t challenge whether the FDA should have cleared the Flex Belt or
whether the specific FDA-cleared statement is misleading, and this was a case
involving a Class II medical device, not FDA approval.
Actionable statements: because the FDA cleared the Flex Belt
as an EMS device for toning, firming, and strengthening abdominal muscles, “such
representations cannot be deceptive to a reasonable person.” But it would be
deceptive to market an EMS device as cleared by the FDA “for weight loss, girth
reduction, or for obtaining ‘rock hard’ abs.” Much of the advertising Loomis
cited was puffery, such as the testimonials:
With my schedule I can’t do an ab
workout every day, but with The Flex Belt® I’ll put it on every day because I’m
doing things at the same time. So it’s really just being smart. It’s easy, I
wear it every day and my abs are there to show for it! My abs feel like I’ve
had the most amazing workout and I just wore The Flex Belt® around the house
for 30 minutes.
The Flex Belt® tightens, tones, and
strengthens my stomach without me even having to think about it. It has taken
my abs to a whole new level… it does all the work, and I get the results.
These statements were “highly subjective to the individuals
giving the statements,” although I think they’re misleading. There was nothing
actionable about the claims on Amazon to “stimulate all your major stomach
muscles at the same time providing you with the perfect abdominal contraction
….You don’t have to worry about your form or come up with the time to get it
done.” That didn’t claim that the Flex belt alone will result in weight loss,
girth reduction, or an attractive appearance. [I don’t think it’s “alone”
that’s the problem. I think the problem is that the Flex belt doesn’t produce a
marginal effect on any of these, and the implication is that it
does.]  “GREAT ABS START HERE,” “Maximum
Core Strength,” and “Ultimate Toning Technology” were also puffery.  [But if it doesn’t work at all, then it’s not
exaggeration, it’s just … not true.]
In the ads, “any reference to fat loss is accompanied by
disclaiming language that the Flex Belt is insufficient to achieve weight loss
and that a more attractive abdominal area requires proper diet and exercise,” e.g.,
the “Flex Belt does not remove inches of fat but it tones, tightens, and
strengthens your stomach muscles. Using The Flex Belt in conjunction with your
dedication to Diet, Nutrition and Exercise can help you achieve your goals of a
more attractive stomach as well!”
Still, there were specific statements, in context, that were
plausibly deceptive to a reasonable person. 
E.g., “Who Should Use the Flex Belt®?…Anyone that wants more
attractive abs, regardless of current fitness levels”; “With The Flex Belt®, it
doesn’t matter what your current exercise status is because there will always
be time to build firmer, stronger abs. This product is perfect for … anyone
that wants more attractive abs, regardless of current fitness levels”; and
touting the product “[f]or those looking for a convenient way to tone,
strengthen and flatten the abdominal area.”
These claims made it “probable that a significant portion of
the general consuming public or of targeted consumers, acting reasonably in the
circumstances, could be misled” to believe the Flex Belt could help consumers
achieve more attractive abdominal muscles. It was contradictory to make misleading
statements as to improved abdominal appearance while simultaneously disclaiming
that “The Flex Belt does not remove inches of fat.” In addition, although the
testimonials and pictures of six-pack abdominal muscles were puffery, they
“contribute[d] ‘to the deceptive context of the packaging as a whole.”
UCL unlawful and unfair claims also survived, as did claims
for breach of express warranty, despite a limited warranty addressing product
BY [Slendertone].”
Under California law, “[w]ords or conduct relevant to the
creation of an express warranty and words or conduct tending to negate or limit
warranty shall be construed wherever reasonable as consistent with each other.”
Limitation of warranties are allowed “only by means of [w]ords that clearly
communicate that a particular risk falls on the buyer.” Further, disclaimers or
modifications “must be strictly construed against the seller.” “Noting the
presumption of construing warranties as consistent with one another, the burden
against the seller, and the fact the limited warranty was included in the
packaging for the Flex Belt after Plaintiff purchased it, the Court finds that
the limited warranty does not upset Plaintiff’s alleged express warranty cause
of action.”

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