SEI made a supplement, MethylHex 4,2, claiming to provide an
“elevated sense of well-being, improved mood, increased CLEAN energy,
suppressed appetite and heightened focus,” in addition to being “a powerful CNS
stimulant, for added energy, increased clarity and a boost in physical
performance, especially valuable to athletes during calorie restriction or when
a high level of focus is needed.” The supplement lists a substance known as DMAA
as one of its ingredients. While the product label claimed that its DMAA
consisted of “Geranium Extract Leaves and Stem,” but plaintiff alleged that it
was instead synthetic. The FDA sent a warning letter to SEI stating that
synthetic DMAA isn’t a “dietary ingredient” under the DSHEA and thus couldn’t
be used as an active ingredient in a supplement. Also, the FDA has received 42 adverse event
reports on products containing DMAA, some including complaints of cardiac
disorders, nervous system disorders, psychiatric disorders, and death. Plaintiff allegedly bought the product in
reliance on SEI’s misrepresentations about the product’s safety, efficacy and
legality, and asserted the usual California claims.
SEI moved to dismiss (or stay) based on the primary
jurisdiction doctrine. Velasco responded
that, given the warning letter, the FDA had already substantially performed its
regulatory functions, and the issue weren’t within the FDA’s exclusive
jurisdiction. The primary jurisdiction
doctrine should be used only if a claim requires resolution of an issue of
first impression, or if there’s a particularly complicated issue committed to a
regulatory agency and protecting the integrity of a regulatory scheme dictates
preliminary resort to that agency.
The FDA’s warning letter told SEI to immediately cease
distribution of the supplement. SEI
argued that this was only preliminary action, and that the warning letter
specifically contemplated further FDA action.
SEI conceded that it had complied with the FDA’s request to cease
distribution. There was no indication
that the FDA had acted since the warning letter in April 2012, and no evidence
that future action was likely. Nor did SEI
identify an available procedure for the parties to seek an administrative
ruling from the FDA about this matter if the court got rid of the case. Thus,
the court declined to apply the primary jurisdiction doctrine.
Separately, SEI argued that the class allegations should be
dismissed or struck because whether the class members read and relied on the
package statements required individual analysis and wasn’t suitable for class
treatment. Though the parties disputed whether reliance could be presumed on a
classwide basis in a case of this type (spoiler: yes), this was not an appropriate
issue to resolve on a motion to dismiss or strike class allegations, but rather
on a motion for class certification.
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