PURE Bioscience, Inc., creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that the FDA has completed its review of the safety and efficacy of the proposed use of silver dihydrogen citrate (SDC) as a raw poultry processing aid and declared PURE Bioscience’s food contact notification (FCN) to be effective as of December 18, 2015.

Dramatic SDC test results show consistent reductions in pathogen levels -- including the potential to reduce Salmonella on raw poultry to below detection levels. A breakthrough technology, SDC is a non-toxic food safety solution (safe for both people and the environment) – delivering superior efficacy when compared with other processing aids used in the market today.

USDA Approval Process Proceeding

The final step in the regulatory approval process for commercialization of SDC-based PURE Control® in poultry processing is to obtain USDA approval. With receipt of the FDA’s approval, PURE is engaged in the review and approval process with the Food Safety and Inspection Service of the USDA. This process will involve plant trials under the authorization of the USDA. The Company is working with partner processors and laboratories, has developed protocols, and is designing the equipment necessary for the trials.

The USDA trials are expected to take 45-60 days and following completion and USDA review, PURE expects the USDA to issue a “Letter of No Objection” and list SDC as an approved poultry processing aid in Attachment 1, of the FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat, Poultry and Egg Products.

By early calendar Q2 2016, PURE anticipates having both of the necessary regulatory approvals to begin commercializing PURE Control as a poultry processing aid to reduce Salmonella and other pathogens to prevent foodborne illness.

Hank R. Lambert, CEO of PURE said, “Attaining FDA approval as a direct food contact processing aid for poultry is a truly important and catalytic milestone for PURE. It marks the first FDA approval for our powerful SDC antimicrobial technology – and brings us just one step away (USDA approval) from bringing PURE Control to the US poultry processing market as a much needed, effective and non-toxic food safety solution.

“Each year, one in six Americans is sickened by foodborne illness, according to the CDC. We believe that PURE Control will be an important breakthrough to help make food safer for consumers, beginning with raw poultry processors, as they combat prevalent contaminants that have persisted through processing, including Salmonella and Campylobacter,” concluded Lambert.

Poultry Processing - $350+ Million Annual US Market Opportunity

  • In the US, poultry processing aids and interventions represents a $350+ million annual market. The average US poultry processing plant spends $1+ million annually in processing aids and intervention chemistries. PURE Control will be marketed to replace the toxic chemicals presently used during online reprocessing as well as in other intervention steps. The Company believes it can capture a significant share of this market based on PURE Control’s proven superior efficacy and lower toxicity compared to interventions currently in use.
  • EPA approved PURE Hard Surface® disinfectant (applied on surfaces that come into contact with food but not directly on the food itself) has already been adopted for use on equipment and plant surfaces at a growing number of poultry processing plants. PURE will leverage this especially relevant foothold for its direct food contact initiative with PURE Control.

Additional information on PURE is available at www.purebio.com.