PURE Bioscience ‘deeply disappointed’ after FCN withdrawal
The creator of the patented silver dihydrogen citrate (SDC) antimicrobial submitted the FCN in July.
Hank Lambert, CEO of PURE, said it was surprised and deeply disappointed in the need to withdraw the FCN and delay commercialization efforts into the new market for SDC.
“However, going forward we intend to work with the FDA and members of the food processing industry to address the FDA's request for additional data regarding exposure levels and the use of silver in food processing. Our confidence in SDC is not diminished.”
Silver intake level data
The firm took the action after receiving a letter from the FDA, which said data is under review which questions the safety levels of the cumulative dietary intake of silver in the US from food contact uses the agency had previously approved.
As a result, the FDA indicated that it would not approve PURE's FCN absent data or additional information that adequately addresses its new toxicity concerns.
PURE had also submitted an FCN in October for the use of SDC to reduce Salmonella, E. coli and Listeria in the processing of produce.
Because the FDA is unlikely to approve any new uses of silver in food processing at this time, PURE anticipates that it will receive a similar Deficiency Letter.
If it does receive such a notification, it will withdraw that FCN until it can provide the FDA with additional data and information to address the FDA's concerns.
Work with FDA and industry
PURE Bioscience said it will work with the FDA and the food processing industry to collect or develop additional data and information necessary to address the FDA's safety concerns.
It added it cannot provide an exact timeline of when it will be able to resubmit the FCN.
Lambert said it submitted the FCN based on test results demonstrating that the SDC use provided a material significant reduction in Salmonella contamination in raw poultry.
“Given what we have learned from our earlier test results demonstrating SDC's ability to significantly reduce or eliminate pathogen levels in poultry and produce, our dedication does not waiver to drive SDC as a unique food safety solution into the food processing market,” he said.
“While we gather this data, we are continuing to aggressively commercialize our EPA registered PURE Hard Surface disinfectant for use in the food service and food processing industries."
