S. Food and Drug Administration (FDA) may smooth the path for food manufacturers to continue to declare sweeteners derived from cane syrup (such as sugar) as “Evaporated Cane Juice” (ECJ) on food labels, at least for the foreseeable future.Last month, FDA announced that it was reopening comments for 60 days on its 2009 draft guidance for declaring ECJ as an ingredient. The announcement states that FDA reopened comments to obtain more information on ECJ and to better understand the difference between ECJ and other sweeteners.
FDA’s announcement comes amid controversies over the use of ECJ in place of sugar on food labels. In Northern California, for instance, class-action plaintiffs sued food manufacturers, alleging that ECJ is another name for sugar. And, while food companies may want to use the term ECJ rather than sugar to make their products seem healthier, FDA regulations require food labels to reflect common or usual names of ingredients.
Reopened Commenting May Stall or Dismiss ECJ Lawsuits
So far, the most important issue in the ECJ lawsuits has been the relationship between FDA’s draft guidance and primary jurisdiction. Primary jurisdiction allows courts to dismiss a case without prejudice, e.g., without declaring one side a winner, when the issue is within the special competence of an administrative agency and the agency is taking steps to address an issue. Put differently, a court can dismiss a case on primary jurisdiction grounds and defer to an agency working on the issue.
Prior to FDA reopening the commenting period, it was unclear whether courts should dismiss the ECJ cases on primary jurisdiction. On one hand, class-action plaintiffs argued that FDA has already resolved the ECJ labeling issue because it has clearly and continually held that sweeteners derived from cane syrup should not be labeled as ECJ. On the other hand, industry argued that a 2009 draft guidance, which is not binding on industry, is not a final resolution of the issue.
The reopened commenting period may put a fork in the class-action plaintiffs’ arguments. In Swearingen v. Santa Cruz Natural Inc., for example, a case out of the federal District Court for the Northern District of California, Judge Susan Illston held:
“In light of the March 5, 2014 [notice of reopened commenting], the Court finds it appropriate to apply the doctrine of primary jurisdiction. The notice states that the FDA has not resolved the issue of whether ECJ is the common or usual name of the ingredient at issue and that the FDA is engaged in active rulemaking on the issue.”
But not all district court judges are following Judge Illston’s reasoning, according to Arnold (Arnie) I. Friede, a food and drug law attorney with Sandler Travis & Rosenberg and a former associate chief counsel in FDA’s Chief Counsel’s Office.
“Given the divergence of views by different district court judges on whether ECJ cases should be dismissed on primary jurisdiction grounds, it seems reasonable to believe that the matter will be up before the U.S. Court of Appeals for the Ninth Circuit in the not-too-distant future,” Friede said.
No Changes to ECJ Regulations are Likely in the Near Future
FDA reopened the draft guidance for 60 days, but it is unclear what the agency’s actions on the ECJ issue will be after comments close.
“The agency expects to issue final guidance, although I cannot predict a date at this time,” said Arthur Whitmore with FDA’s Office of Foods and Veterinary Medicine.
Given FDA’s long to-do list, some are skeptical of whether the agency will take action to resolve the ECJ issue anytime soon.
“As a practical matter, and now that it has reopened the comment period on the draft ECJ guidance, it is probable that FDA will not get to this for a very long time, if ever, particularly given other competing priorities in the food arena,” Friede said.
So courts are dismissing ECJ cases on primary jurisdiction grounds, thanks to the reopened commenting period. Yet it seems that FDA will not likely resolve the ECJ issue on its own, at least for now.
“As a practical matter, if courts dismiss these ECJ cases on primary jurisdiction grounds until FDA resolves the issue, the cases pretty much disappear,” Friede explained. “Depending on one’s perspective, that may or may not be a good thing.”
