PURE Bioscience Receives Final FDA Acknowledgement Letter
Published: May 24, 2017
Begins USDA In-Plant Trial for PURE Control® Antimicrobial
SAN DIEGO--(BUSINESS WIRE)--PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented non-toxic silver dihydrogen citrate (SDC) antimicrobial, announced that the Company has received final acknowledgement from the US Food and Drug Administration (FDA) that its Food Contact Notification (FCN) for use of PURE Control® in raw poultry processing to reduce pathogens became effective last week. The FCN for PURE Control will be added to the list of effective notifications for FCNs, which is available on the FDA website: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/Notifications/default.htm.
As previously announced on April 27, 2017, the FDA had completed its review of the safety and efficacy of the proposed use of SDC in concentrations up to 160 PPM as a raw poultry processing aid, and set an effective date of May 18, 2017.
USDA In-Plant Poultry Processing Trial
On Monday PURE is initiating an in-plant raw poultry processing trial in which SDC-based PURE Control will be spray applied to whole chicken carcasses during Online Reprocessing (OLR). The USDA has already approved PURE Control for use in pre-OLR and post chill poultry processing.
- This trial is now expected to be completed by early calendar Q3. PURE has just received the necessary scheduling clearances from the plant and the local FSIS inspector.
- The trial will be conducted following the protocol proposed by PURE and approved by the USDA-FSIS, and will be monitored by FSIS inspection personnel in the plant.
- Assuming a successful plant trial, and that no additional trials are required by the USDA, PURE anticipates that the USDA-FSIS will issue a “Letter of No Objection” in approximately 4-6 weeks after completion of the trial, stating that PURE Control is approved for use in OLR applications and list SDC as an approved poultry processing aid in Attachment 1 of the FSIS Directive 7120.1 Table 3.
Upon receipt of the “Letter of No Objection,” PURE can immediately commercialize PURE Control for OLR applications and begin to market PURE Control as a superior raw poultry processing aid into the +$350m US market.
Superior Benefits of PURE Control
FDA approved PURE Control antimicrobial is applied directly onto raw poultry carcasses, parts and organs as a spray or dip during processing to eliminate pathogens causing foodborne illness, including Salmonella. PURE is not aware of any equally effective, lower toxicity solution to eliminate Salmonella in poultry processing – and believes PURE Control is the breakthrough solution the poultry industry has been seeking.
SDC is distinguished by the fact that it is both more effective and non-toxic. Currently used poultry processing intervention chemistries, most notably Peracetic acid (or PAA), are highly toxic, irritants to users, negatively impact the environment, are corrosive to equipment, and have a negative yield impact.
Hank R. Lambert, CEO of PURE, said, “We are enthusiastically taking the final steps toward commercializing PURE Control as a raw poultry processing aid - our second large and important US market for the product. Once we complete the in-plant poultry trial for OLR applications and obtain USDA approval, we look forward to achieving meaningful market penetration in the US processing aids markets for both poultry and produce, a combined +$650m US market opportunity.”
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 it mitigates bacterial resistance. 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 any forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s ability to receive required regulatory approvals for use of PURE Control in OLR poultry processing, including the required data from plant trials, on a timely basis, or at all; 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 the Company’s ability to convert successful evaluations and tests into customer orders, the timing of customer testing and orders, customers continuing to place product orders as expected and to expand their use of the Company’s products throughout their operations; the ability of the Company to develop effective new productsand to receive required regulatory approvals for such products, including the required data from plant trials; 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 (the SEC), including its Form 10-K for the fiscal year ended July 31, 2016, its Form 10-Q for the first quarter ended October 31, 2016 and its Form 10-Q for the second quarter ended January 31, 2017. 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.
PURE Bioscience, Inc.
Hank Lambert, 619-596-8600 ext.103
Bibicoff + MacInnis, Inc.
Terri MacInnis, 818-379-8500
VP of IR
Redwood Investment Group
Tom Hemingway, 714-978-4425