SAN DIEGO, CA--(Marketwired - Jul 14, 2014) - PURE Bioscience, Inc. (
FDA and USDA Approval Process
The FDA's FCN Program ensures the safety of Food Contact Substances (FCS) used in food processing and packaging.
- The FCN review period is 120 days, after which, if there are no concerns from the FDA, the FCN automatically becomes effective.
- An FCN is considered to be proprietary as it applies only to the specific product and manufacturer or supplier identified in the FCN.
- Upon the FDA's granting of the FCN, PURE will immediately 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 will conduct three in-plant process validation and optimization trials with the authorization of the USDA.
- After completion of the three in-plant validation trials, PURE expects the USDA to issue a "Letter of No Objection" and list SDC as an OLR poultry processing aid in Attachment 1 of FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat and Poultry Products.
- Subject to receipt of both FDA and USDA approval PURE will begin commercialization of SDC in Q1 2015 for use in poultry processing.
Data submitted as part of the Company's FCN showed that SDC achieved an average reduction in Salmonella of 2.75 log10 CFU/cm2 when applied as an OLR spray and 6.28 log10 CFU/cm2 when combined with an immersion chilling process simulating current U.S. industry practices.
- The importance of this data indicates that the use of SDC antimicrobial solution in poultry processing has the potential to enable plants to achieve non-detectable Salmonella levels post-chill process.
- Additionally, a sensory evaluation of SDC showed no difference in color, appearance or odor in treated poultry. The Company believes that these test results exceed current U.S. industry best practices. In addition, given the non-toxic properties of SDC, the Company believes there are safety benefits for users, production line personnel and the surrounding environment.
- SDC offers a highly effective alternative to hazardous and difficult to blend chemicals currently used as OLR treatments in raw poultry processing.
- SDC is a significant improvement over current processing practices. The product is:
- Easier to handle and dilute
- Non-corrosive to processing equipment
- Does not create noxious fumes
- PURE believes that poultry processors will also benefit from the highly stable solution, ease of use and improved worker safety.
Salmonella - Most Frequently Reported Cause of U.S. Foodborne Illnesses
Salmonella is responsible for an estimated 1.3 million food borne illnesses each year. In testing, the USDA has found that 24% of chicken parts in the food supply chain were contaminated with Salmonella. The demonstrated ability of SDC to reduce Salmonella to levels below the detection limit, when applied during the on-line reprocessing of raw poultry products, provides the potential to dramatically reduce the amount of contaminated poultry parts sold to U.S. consumers.
The USDA's Salmonella Action Plan, a top Department priority, aims to significantly reduce the number of Salmonella related food borne illnesses in the U.S.. The USDA initiative drives increased scrutiny to poultry inspection and processing practices. Poultry processors need new, highly effective antimicrobial interventions that can provide a heightened level of control over Salmonella that current interventions are not achieving.
Hank Lambert, CEO of PURE said, "We believe that the test results included in our FCN submission, generated by incorporating SDC as an intervention component of an integrated food safety system for poultry processing, will be compelling to both the FDA and the USDA. We are optimistic that both agencies will view these results as a potential breakthrough in the industry's ability to dramatically reduce the Salmonella that persists through poultry processing -- thus opening a significant and important new market for SDC as a food safety solution."
About PURE Bioscience, Inc.
PURE Bioscience, Inc. is focused on developing and commercializing our proprietary antimicrobial products that provide solutions to the health and environmental challenges of pathogen and hygienic control. Our technology platform is based on patented stabilized ionic silver, and our initial products contain silver dihydrogen citrate, or SDC. SDC is a broad-spectrum, non-toxic antimicrobial agent, which offers 24-hour residual protection and formulates well with other compounds. As a platform technology, SDC is distinguished from existing products in the marketplace because of its superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it. PURE is headquartered in El Cajon, California (San Diego metropolitan area). Additional information on PURE is available at www.purebio.com.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause our actual results to differ materially from the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the Company's cash position and liquidity requirements, the Company's failure to implement or otherwise achieve the benefits of its proposed business initiatives and plans, acceptance of the Company's current and future products and services in the marketplace, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission, including our annual report on Form 10-K filed October 24, 2013. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.