PURE Bioscience to resubmit FCN after FDA talks

The creator of the silver dihydrogen citrate (SDC) antimicrobial said after discussions with the FDA, it will make an FCN for its use in raw poultry processing before the end of June.

It will provide additional information about the re-submission, including timing and the potential approval process, during its fiscal Q3 results conference call this Thursday (11 June).

The firm withdrew an FCN last year because FDA said silver intake levels were under review because of toxicity concerns so it would not approve it.

At the time, Hank Lambert, CEO, said it was surprised and deeply disappointed in the need to withdraw the FCN and delay commercialization efforts. 

Data indicates the use of an SDC antimicrobial solution in poultry processing has the potential to enable plants to achieve non-detectable Salmonella levels after the chilling process, said the firm. 

Lambert said: "The results of recent testing indicate a significant reduction of silver residues on poultry treated with SDC to nearly non-detectable levels. We believe this data adequately addresses the FDA's prior issues.”​