In a March 25 order staying the Odwalla case*, judge Yvonne Gonzalez-Rogers said the FDA’s recent decision to re-open comments on its 2009 draft guidance on ECJ could have a direct bearing on the lawsuit.
She added: “The FDA’s action clearly indicates that the agency is exercising its authority in this area… Any final pronouncement by the FDA in connection with that process almost certainly would have an effect on the issues in litigation here.
“Accordingly, [Odwalla's] Motion to Dismiss is granted in part on the grounds of primary jurisdiction. This action is stayed.”
Attorney: It's conceivable judge will lift the stay based on arguments about the length of time it will take FDA to come to grips with this matter
But what does this mean for other food and beverage firms facing legal action over ECJ (which plaintiffs argue is just plain old sugar and should be described as such on food labels), plus the thousands of others who fear they could be targeted?
Will other judges follow Gonzalez-Rogers lead, meaning for the time being at least, scores of ECJ-related cases effectively go away? Or will they decide to leave the FDA out of it and come to their own conclusions based on where things stand now?
Arnold Friede, senior food and drug law attorney with Sandler, Travis & Rosenberg, P.A in Miami, told FoodNavigator-USA that the length of time that it could take the FDA to issue finalized guidance on ECJ could be a key factor in determining how these class actions play out in the courts.
It could take months, but it could also take years, he added: “The judge has set a status conference for August in which she will consider what happens next.
"It is entirely conceivable that she will lift the stay based on arguments about the length of time it will take FDA to come to grips with this matter.”
Re-opening comments supports idea that the ECJ labeling matter remains ‘unsettled’
But what prompted FDA’s March 4 decision to re-open comments on its draft guidance in the first place?
The move, speculates Friede, was likely based on pressure from industry given the recent tidal wave of lawsuits that have been filed over ECJ claims.
While pushing the FDA to clarify its position on ECJ might seem odd given that food manufacturers already know the FDA doesn’t like the term (its 2009 guidance tells firms not to use it), it could work in their favor, says Friede.
“Re-opening the comments seems to provide further support for the idea, advanced by industry, that the ECJ labeling matter remains ‘unsettled’ at FDA.”
And this means defendants in ECJ lawsuits can argue - as Odwalla has - that this is not a matter for the courts, says Friede.
And if other judges follow Gonzalez-Rogers’ lead, he observes, “then the ECJ cases effectively go away.
“However, if other judges look at the practicalities of the situation, and the lengthy delay that will inevitably ensue, then they may not dismiss these cases on primary jurisdiction grounds and they may give some deference to FDA’s 2009 guidance or, perhaps, independently determine the ECJ labeling question.
“Who really knows what will happen?”
Justin Prochnow: The FDA has been reluctant to decide issues based on referrals from judges
Justin Prochnow, attorney in the Denver office of Greenberg Traurig, notes that judge Gonzalez-Rogers recently stayed a case over 'all-natural' claims in the hope (which was later dashed) that the FDA would weigh in.
And she may be disappointed again, predicted Prochnow. "The FDA has been very reticent to decide issues based on referrals from judges."
But he adds: "We have a little bit of a different situation because the FDA did indicate it was reopening the comment period. However, it is unclear when, if ever, the reopening of comments will produce a revised draft guidance or final guidance."
Optimistic timetable
It's also worth noting that even if FDA issues final guidance, "it would not definitively decide the issue", given that guidance is just that, guidance, he says.
"Most importantly, Judge Gonzalez-Rogers has stayed the case until August which would mean the FDA would need to review any comments after the closing period in May, and draft a revised draft guidance or final guidance in less than 90 days", a timetable which seems somewhat "optimistic", he says.
*The case is Reese v. Odwalla Inc., et al., Case No. 4:13-cv-00947, in the U.S. District Court for the Northern District of California.
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