PURE Bioscience Receives final FDA acknowledgement
By PURE Bioscience Inc.
By PURE Bioscience Inc.
May 26, 2017, San Diego, Cali. – PURE Bioscience, Inc., creator of the patented non-toxic silver dihydrogen citrate antimicrobial, announced that the company has received final acknowledgement from the U.S. 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.
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.
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.
PURE will be 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 U.S. market.