SOURCE: Pure Bioscience

PURE Bioscience

June 17, 2015 08:41 ET

PURE Resubmits Food Contact Notification to FDA for SDC Antimicrobial Use in Raw Poultry Processing

Reactivates Commercial Path Into New Market Segment; Addresses USDA Salmonella Action Plan

SAN DIEGO, CA--(Marketwired - Jun 17, 2015) - PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that it has resubmitted a Food Contact Notification (FCN) to the US Food and Drug Administration (FDA) for Silver Dihydrogen Citrate (SDC) as an online reprocessing (OLR) antimicrobial for raw poultry processing.

PURE believes its FCN resubmission has adequately addressed the FDA's prior issues regarding the FCN originally submitted in July 2014 and withdrawn without prejudice in November 2014. The Company's resubmission follows constructive discussions with the FDA regarding results of new SDC testing:

  • Demonstrating materially significant reduction in Salmonella contamination in poultry,
  • While achieving silver residue levels that are virtually non-detectable and,
  • Are well below existing FDA guidelines.

Salmonella: Most Frequently Reported Cause of US Foodborne Illnesses -- SDC provides the potential to dramatically reduce the amount of contaminated poultry parts sold to US 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 US. This 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.

  • Salmonella is responsible for an estimated 1.2 million food borne illnesses each year.
  • In testing, the USDA has found that at least 25% 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) has the potential to play an important role in the solution.

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.
  • Upon the FCN becoming effective, PURE will immediately submit the FCN to the Food Safety and Inspection Service (FSIS) of the USDA for a new technology review.
  • Subject to receipt of both FDA and USDA approval, PURE could begin commercialization of SDC as early as the end of the calendar year for use in poultry processing.

Food Safety Problems - The SDC Solution

US public health statistics track pathogens in the food supply chain - clearly demonstrating an ever increasing need for more effective, efficient and safer interventions. Processing aids or interventions commonly used in the US food industry today are highly toxic chemistries. In addition, pathogens can become increasingly resistant and render current interventions less efficacious.

PURE believes that SDC is a significant improvement over current processing chemicals and provides important advantages because SDC does not induce bacterial resistance and is:

  • More effective in reducing or eliminating pathogens
  • Easier to handle and dilute
  • Non-corrosive to processing equipment
  • Non-toxic - does not create noxious fumes

PURE estimates that the U.S. market opportunity for poultry processing aids is currently in excess of $300 Million. Given the immediate market need and the proven superior efficacy of SDC against Salmonella, PURE believes that it can achieve significant market penetration upon receipt of FDA and USDA approvals.

Hank R. Lambert, CEO of PURE, said, "We feel confident to make the resubmission at this time because we have good reason to believe that our new test results included in our FCN resubmission clearly and adequately address the FDA's earlier concerns. 

"Also, we are already working with a number of major brand poultry processors who are using our PURE® Hard Surface disinfectant. We believe our test results will be compelling to both the FDA and the USDA, and 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 an important and significant new market for SDC as a food safety solution," Lambert concluded.

About PURE Bioscience, Inc.

PURE Bioscience, Inc. is focused on developing and commercializing our proprietary antimicrobial products primarily in the food safety arena -- providing 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 http://www.purebio.com/ 

Forward-looking Statements

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, including acceptance of the Company's PURE Hard Surface disinfectant by SUBWAY® franchisees; and the ability to convert successful evaluations into customer orders; the ability of the Company to develop effective new products and receive required regulatory approvals for such products, including the required data and regulatory approvals required to use its SDC-based technology as a direct food contact processing aid in raw poultry processing; competitive factors; dependence upon third-party vendors, including to manufacture its products; and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission, including Forms 10-Q and 10-K. 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. 

Contact Information

  • Contacts:

    Peter C. Wulff
    CFO & COO
    PURE Bioscience, Inc.
    619-596-8600 ext.111
    Email Contact

    Terri MacInnis
    VP of IR
    Bibicoff + MacInnis, Inc.
    818-379-8500
    Email Contact

    Tom Hemingway
    Redwood Investment Group
    714-978-4425
    Email Contact