PURE ‘confident’ of success with FCN for produce
The firm believes the resubmission has addressed the Food and Drug Administration’s (FDA's) issues regarding the FCN originally submitted in October 2014 and withdrawn in January 2015.
It follows the June 2015 resubmission of its FCN for poultry processing and discussions with the FDA regarding results of Silver Dihydrogen Citrate (SDC) testing on produce including lettuce, spinach and spring mix.
The FCN review period is 120 days, after which, if there are no concerns from the FDA, the FCN automatically becomes effective.
With an effective FCN for produce, PURE can begin to commercialize SDC as a food safety tool into the market.
Processing aids or interventions commonly used are highly toxic chemistries, said the firm, and pathogens can become increasingly resistant and render interventions less efficacious.
Hank Lambert, CEO of PURE, said it feels confident to make the resubmission because the new test results included have addressed the FDA's concerns.
"Also, we are already working with a number of major produce and fruit processors who are using our SDC-based PURE Hard Surface disinfectant,” he said.
“We believe our test results will be compelling to the FDA, and we are optimistic that the agency will view these results as a breakthrough in the industry's ability to dramatically reduce the pathogen risk that persists through produce processing - thus opening an important and significant new market for SDC as a food safety solution.”
