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March 29, 2016 - FDA

The (Not So) Sweet Sound of FDA’s Silence: Judge Seeks Answers from FDA on ECJ Draft Guidance

We recently reported on developments in evaporated cane juice (ECJ) stays pending the FDA’s finalized guidance on the ingredient. (See Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims.) In March 2014, FDA announced that it would revise its ECJ draft guidance, and many courts in the Northern District stayed ECJ claims as a result. FDA has not yet completed this process. In our recent post, we noted that, while the majority of courts to stay ECJ cases have maintained stays despite this two year lapse, some courts are becoming impatient with FDA’s review and have consequently lifted stays.

Recently, Judge Chen joined the latter camp, but took a different approach. Rather than lift stays in two ECJ cases before him, he asked FDA whether it planned to issue further ECJ guidance within the next six months, noting that the parties have been waiting since May 2014 for FDA’s final position.

This is Judge Chen’s second request to FDA for updates on its draft guidance. In May 2015, he asked the agency the same question. FDA responded in July 2015, noting it “anticipated” finalizing its guidance by the end of 2016.

We will update readers with FDA’s response to Judge Chen’s latest request.