The creator of the silver dihydrogen citrate (SDC) antimicrobial said it will make a food contact notification (FCN) before the end of June.
The firm withdrew an FCN last year because the US Food and Drug Administration (FDA) said silver intake levels were under review due to toxicity concerns so it would not approve it.
PURE said new test results demonstrate the lowering of residual silver on poultry to below detectable levels as well as the market analysis on overall silver exposure.
FCN and USDA process
The FDA’s FCN review period is 120 days from submission.
If or when the FDA grants the FCN, PURE intends to submit the FCN to the Food Safety and Inspection Service (FSIS) of the USDA for a new technology review.
As part of the FSIS review process, PURE may be required to do in-plant process validation and optimization trials with authorization of the USDA.
PURE also plans to resubmit its produce FCN later this year. It is conducting additional produce testing for silver residue levels for the use of SDC as a processing aid.
For meats, the firm is continuing its product development efforts for SDC as a processing aid/intervention for beef and pork. Pending positive test results, it expects to file the FCN afterwards.
Hank Lambert, CEO of PURE Bioscience, told investors during a conference call that FDA has not shared or indicated any plans for issuing new silver guidelines.
“They also have not indicated anything about issuing the silver toxicity study that was referenced last fall at the time that we withdrew our FCN,” he said.
“So, based on our meeting with them, we believe this will not be an issue.
“We conducted additional testing on poultry and successfully demonstrated that we can reduce silver residues to below detection limits without impacting SDC’s superior efficacy as a processing aid.”
Market penetration
All American Chemical Company became a non-exclusive distributor of PURE products to food and beverage manufacturers and processors in February.
It has gained adoption of PURE in more than half a dozen of its customers and of PURE Hard Surface disinfectant in four poultry processing plants.
In the food processing segment, the firm is selling to more than a dozen manufacturer and processor customers compared with nine last quarter, excluding reach from distributor partners and is in test protocol development with another nine compared with six in Q2.
In an earlier statement, Lambert said while slower than it had hoped, food safety revenues are gaining momentum.
“We are making meaningful strides toward achievement of our goals - gaining commercial traction in food safety, aggressively pursuing FDA/USDA authorizations for direct food contact, and continuing to license SDC distribution and/or technology for non-core applications," he said.
“We would not resubmit the application unless we believe these data adequately address the FDA’s prior issues and meets or exceeds the FDA guidelines.”