PURE Bioscience reveals launch plans for SDC-based processing aid
The creator of the patented silver dihydrogen citrate (SDC) antimicrobial said it would help accelerate commercialization of SDC as an FDA and USDA approved direct food contact processing aid for raw poultry and fresh produce.
The firm added it would use the financing to pursue regulatory approval for use of SDC as a direct food contact processing aid for raw meats.
PURE Bioscience said the ‘urgent pressure of increasing regulatory requirements’ such as the Food Safety Modernization Act (FSMA) and USDA Salmonella Action Plan will help drive adoption.
Hank Lambert, CEO, said it received the FDA's Acknowledgement Letter for the poultry FCN last month, enabling it to start the USDA review process.
“We already have plans in place for the in-plant trials that are prescribed as part of the USDA process,” he said.
“With anticipated USDA approval for use of SDC on raw poultry, together with anticipated FDA approval for use on fresh produce, we are well along in preparing for commercialization in both markets in calendar Q1 2016.”
PURE Bioscience resubmitted a Food Contact Notification (FCN) for its antimicrobial in raw poultry processing earlier this year after the US FDA prompted a withdrawal last year.
It withdrew an FCN last year because FDA said silver intake levels were under review due to toxicity concerns so it would not approve it.
PURE said test results demonstrate the lowering of residual silver on poultry to below detectable levels as well as the market analysis on overall silver exposure.
The firm said a number of processors in poultry and produce, are already using EPA registered PURE Hard Surface disinfectant on plant equipment so it may be able to achieve accelerated market adoption with a relatively short sales cycle.
It closed the private placement with investor Franchise Brands, it is the second investment it has made in PURE.