FDA Approval Boosts PURE Bioscience (OTCMKTS:PURE)

PURE Bioscience (OTCMKTS:PURE) is one of the most exciting names on the OTC markets after getting another FDA approval to start the New Year. PURE announced that the FDA has completed its review of the safety and efficacy of the proposed use of silver dihydrogen citrate (SDC) as a fresh produce processing aid and declared PURE Bioscience's food contact notification (FCN) to be effective as of January 7, 2016. SDC is the active ingredient in PURE Control. This is the second big FDA news from PURE after announcing last month that the FDA had 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.These two key FDA approvals are big events on the OTC markets. While other companies are hoping for FDA approvals, PURE is actually getting the nod from the all-powerful FDA. In looking at each approval, it's pretty exciting stuff for PURE and its shareholders. As CEO Hank Lambert said:

"Attaining FDA approval as a direct food contact processing aid for fresh produce is a second catalytic milestone for PURE. The Company recently (December 18, 2015) also received FDA approval or our powerful SDC antimicrobial technology for use as a raw poultry processing aid."

In regards to silver dihydrogen citrate (SDC) as a raw poultry processing aid, 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 USDA trials are expected to take 45-60 days. 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.Every year, one in six Americans become sickened by some sort of foodborne illness. In the US, poultry processing aids and interventions represents a $350+ million annual market. PURE Control will be marketed to replace the toxic chemicals presently used during online reprocessing as well as in other intervention steps. The EPA has already approved PURE Hard Surface disinfectant (applied on surfaces that come into contact with food but not directly on the food itself) and 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.Helping to drive this excitement for PURE is the recent news about the e coli breakout at Chipotle Mexican Grill locations. PURE Control can go a long way toward alleviating many of the foodborne illness outbreaks like those recently experienced by Chipotle that were linked to produce processors. Both human health and brand reputation are at risk. Retailers, restaurant chains and suppliers are seeking opportunities to be safety leaders -- and PURE Control offers a means to make food safer for consumers.The Centers for Disease Control and Prevention (CDC) has identified leafy greens as the primary source of foodborne illness. Recent, highly visible incidents of foodborne illness outbreaks reported in the media are linked to produce processors and underscore the pressing need for more effective pathogen reduction solutions. PURE Control will be applied as a spray or dip on produce intended for processing. PURE has been talking to a number of US produce processors, retailers, and distributors to prime demand for PURE Control. Among these are some of the largest vegetable and fruit processors, grocery and restaurant chains, according to PURE.

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PURE Bioscience is one of the most talked about names on the OTC markets. With a market cap of $77 million and a huge increase in volume, things are looking good for shareholders as we start 2016. Don't miss out on our latest updates on PURE and all of our other hot stock picks by signing up below!

Disclosure: We have no position in PURE either long or short. We have not been compensated for this article.