Earlier this month, the FDA announced that it would reopen the comment period on its draft guidance for the industry concerning use of the term “evaporated cane juice” (ECJ). Draft Guidance for Industry on Ingredients Declared as Evaporated Cane Juice; Reopening of Comment Period; Request for Comments, Data, and Information, 79 Fed. Reg. 12,507 (Mar. 5, 2014).
Back in 2009, the FDA issued draft guidance suggesting that the term “evaporated cane juice” should not be used on food labels to declare the presence of sweeteners derived from sugar cane syrup because such sweeteners did not fit the definition of “juice” as defined in 21 C.F.R. 120.1(a). Draft Guidance for Industry: Ingredients Declared as Evaporated Cane Juice; Availability, 74 Fed. Reg. 51, 610 (Oct. 7, 2009).
The FDA explained it is now reopening the comment period to “better understand” evaporated cane juice, how it is manufactured and how it compares to other sweeteners derived from sugar cane.
The announcement states that, after review of the received comments, the FDA “intend[s] to revise the draft guidance, if appropriate, and issue it in final form, in accordance with FDA’s good guidance practice regulations in 21 CFR 10.115.”
The FDA’s move may help defendants bolster their arguments that plaintiffs’ ECJ claims are either preempted or fall under the primary jurisdiction doctrine.
While some courts have already dismissed ECJ “misbranding” claims on these bases (see our post on Hood v. Wholesoy), the trend did not catch on. The new announcement has the potential to revive the argument that this issue remains firmly within the FDA’s decision-making realm.
However, the FDA makes clear that it is only reopening the comment period, and may or may not make revisions or issue final guidance. Accordingly, at least one court has hesitated to weigh in at this stage, explaining that “[i]t remains unclear when or if the FDA will conclusively resolve this issue.” Order, Morgan v. Wallaby Yogurt Co., Inc., No. 13-cv-00296-WHO (N.D. Cal. Mar. 13, 2014), ECF No. 49 at 6 n.2 (“Lacking definitive guidance, this case will proceed apace.”).
Counsel representing clients defending ECJ claims should stay tuned.