Today we have the pleasure to have a distinguished guest contributor on Foodlawlatest.com: Arnold L. Friede, Of Counsel and Senior Food and Drug Law Attorney with c, P.A.. Prior to joining ST&R, Mr. Friede ran his own law firm specializing in FDA-related legal and regulatory matters. Earlier in his career he served as associate chief counsel in the FDA’s Chief Counsel’s Office, representing the agency in a wide array of significant judicial and administrative proceedings while also serving as counsel to the then-Bureau of Radiological Health, now part of FDA’s Center for Devices and Radiological Health. He has held a number of senior in-house legal positions with major corporations in FDA-regulated industries and has served as adjunct professor of food and drug law at the University of Miami (FL) School of Law.
Arnie offers us today his comments about the following judicial case, Figy v. Lifeway Foods, Case No. 13-CV-04828-THE (May 5, 2014) in the Northern District of California.
Plaintiff brings this suit on behalf of himself and a putative class of consumers who, within the last four years, purchased certain of Defendant’s food products that he contends Defendant misbranded by deceptively referring to the added sugar contained in each product as “evaporated cane juice” (“ECJ”).
The focal point of the opinion is whether the primary jurisdiction doctrine is applicable or not in similar situations. The primary jurisdiction doctrine basically allows courts to stay proceedings or to dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency.
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Courts continue to be divided on whether lawsuits challenging use of the term “evaporated cane juice” in food labeling should be stayed or dismissed under the Doctrine of Primary Jurisdiction in light of FDA’s March 2014 Notice announcing that the agency is now reopening the comment period on its 2009 Draft Guidance on the subject. In that Draft Guidance, FDA concluded that ECJ was not an appropriate common or usual name of any type of sweetener, including those derived from dried cane syrup.
As I’ve previously observed, FDA’s March 2014 Notice announcing that it was reopening the 2009 Draft ECJ Guidance for additional comment was undoubtedly issued, in large part, in response to food industry pressure to do so. No matter what one’s view of the underlying the merits of the ECJ controversy, it seems reasonably clear that industry believed that if FDA were to reopen the Draft ECJ Guidance for comment, courts would more readily conclude that the agency had not yet spoken with finality on the matter. As a result, courts would be more willing to apply the Primary Jurisdiction Doctrine to stay or dismiss these ECJ cases until FDA finalizes its views on the subject. As a practical matter, then, the thought must have been that these ECJ cases would simply disappear. And that’s pretty much what Judge Henderson did in this case, at least for a while.
In what might accurately be characterized by some as wishful thinking, the Court held that, because the comment period on the March 2014 FDA Notice expires in early May, and because FDA is actively considering the matter and may well resolve it soon, it is appropriate to stay the case on Primary Jurisdiction Grounds until the agency acts. It is not entirely apparent how Judge Henderson squared his conclusion that FDA’s active current consideration of the matter suggests that a decision is forthcoming soon when FDA had not issued a final guidance on ECJ labeling in the 5 years since the Draft Guidance was announced. The Judge did set a status conference for November 3 to determine if the case should remain stayed in light of intervening action—or, possibly, inaction–by FDA. Decisions in other recent ECJ cases come out on opposite sides of the Primary Jurisdiction Question. It seems reasonable to believe that the U.S. Court of Appeals for the Ninth Circuit will soon be asked to decide whether, given where FDA stands on the matter, the Doctrine of Primary Jurisdiciton is properly invoked to stay or dismiss these ECJ case.
One point not addressed by the Court has to do with the actual finality of FDA Draft Guidances. Even though called Draft, and even though they contain limiting language suggesting that they are not currently operative, are they really “draft” in terms of FDA’s compliance policy in the interim? Or, are Draft Guidances effectively “final” until modified by FDA in the actual Final Guidance? Many FDA Draft Guidances remain in place for years before they are finalized. The status of Draft FDA Guidances is itself a controversial topic. As one prominent food and drug law blog noted today, the U.S. Senate Health Education and Labor Committee sent a letter to FDA Commissioner Margaret Hamburg earlier this week asking about the agency’s policy on use of Draft Guidances as authoritative and effectively final in their own right. So the foundation for Judge Henderson’s conclusion, that FDA’s Draft Guidance on ECJ is just a draft, is open to debate. It is a point that will undoubtedly be raised when the Primary Jurisdiction question in these ECJ cases is before the Ninth Circuit.
Arnold I. Friede
Of Counsel, Senior Food and Drug Law Attorney