AUSTIN, Texas, March 31, 2021 /PRNewswire/ -- U.S.-based Santé Laboratories is confident it independently met requirements requested by the Food Standards Agency (FSA) in the United Kingdom (UK) for its water-based cannabidiol (CBD) formulation in time to the eagerly awaited March 31, 2021 deadline. Santé Laboratories is a contract research organization (CRO) that specializes in manufacturing their proprietary drug delivery technology to develop and commercialize shelf-stable, water-dispersible, and bioavailable bioactive ingredients for finished consumer and drug products. It's been reported that the UK's fast-approaching deadline has a number of important CBD brands scrambling to fulfill the exhaustive list of safety and characterization studies to satisfy the application process. Only approved CBD ingredients and products will be allowed to remain on the UK market as they await formal authorization by the FSA.
"Novel Food Applications for CBD ingredients and finished products must be confirmed and validated by March 31, 2021; however, the initial expectation was for companies to submit their application(s) at least 5 weeks prior to the deadline to accommodate the agency review process," explains Santé Laboratories President, Mike Sandoval.
"Santé Laboratories has allocated more than $600,000 in capital to satisfy the requirements of the Novel Foods process. We look forward to announcing the FSA's assessment of the sufficiency of safety, toxicology, and shelf-life data sets necessary to support our wellness brand RESET Bioscience Balance CBD SKU in the UK," confirms Sandoval. Introduced in 2017, RESET Bioscience is the world's first uniquely water-based, THC-free* CBD ingestible drops.
Safety and dosing will be pivotal measures
Due to documented toxicity of CBD in high doses, the UK is responsibly regulating CBD dosing at 70 mg/day. "The low-dose market is here and now, and we admire that the UK established this standard," says Sandoval. "We are committed to breaking down the barriers of traditional oil-based CBD formulations for RESET and private label brands that desire to market a low-dose solution to their consumers."
RESET CBD delivers several other unique competitive advantages
There are a number of reasons for enthusiasm expressed by Sandoval especially for RESET Bioscience market potential in the UK. "From my understanding, once our CBD ingredient and formulation is FSA approved, we will be able to distribute our product under our RESET Bioscience label and private label. Our private label capacity enables us to meaningfully advance companies that were unable to meet the FSA deadline as well as offer a better way to supplement CBD to their consumers."
CBD in RESET Bioscience is manufactured using Santé Laboratories' proprietary lipid-based delivery system for highly efficacious bioavailability. Other key advantages include:
RESET Balance CBD is proven to be room temperature stable for 14 months or longer. "This is very uncommon in the CBD industry, if not, absent," Sandoval observes.
RESET Balance CBD is manufactured under cGMP using pharmaceutical equipment.
To further support the brand's purity standards, RESET products are uniquely formulated with FDA GRAS excipients and without the use of surfactants.
With a less crowded market, retailers are motivated to assign shelf space to superior CBD products. "Today's market is saturated with oil formulations that have been white-labeled from redundant manufacturers. Brands now have the opportunity to differentiate their product portfolio with our technology that will exceed consumer experience," says Sandoval.
RESET Bioscience is fast-emerging as a category leader in open markets around the world including USA, the United Kingdom, and Hong Kong. The company's influencer program is also taking off quickly, with consumer testimonials pouring in praising the brand.
For additional information about Santé Laboratories' capabilities, and for information on offering RESET or private labeling in the UK, visitwww.Santélabs.com.
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Biography: Mike Sandoval
As Co-Inventor of Santé Lab's drug delivery technology, Mike serves as the President and Chief Operating Officer at Santé Laboratories and responsible to support commercialization and business development strategy and execution, laboratory and business tech ops, regulatory affairs, and day-2-day performance.
Prior, Mike served as President and CEO of XEO Pharmaceuticals, the world's first startup friendly Contract Research Organization (CRO) helping drug startups and 503A pharmacies support early stage R&D and IND-enabling analytical programs. He oversaw business development and strategic collaborations with universities, incubators, and companies. At Xeris Pharmaceuticals, Mike led Research & Development (R&D) Operations, R&D, and early-stage procurement and outsourcing activities, developed and curated Xeris' external R&D pipeline opportunities through strategic collaborations with large pharmaceutical companies. Notably, he is named inventor on several drug delivery patents that allowed the company to overcome FDA hurdles during CMC scale-up as well as raised $2.1mm in non-dilutive grant funding to commercialize drug delivery technology for epilepsy.
At Austin Texas Incubator (ATI), he gained experience managing biopharmaceutical portfolio companies and helped companies develop commoditization strategies and non-dilutive funding applications by leveraging early-stage research.
Mike holds a double BS from Oregon State University in Biology and Toxicology and an MS from The University of Texas at Austin School of Pharmacy for Pharmaceutical Sciences. During graduate school, Mike was President of the School of Pharmacy Graduate Student Association (PGSA) and awarded Teaching Assistant of the Year from the School of Pharmacy for unwavering commitment to teaching Clinical Pharmacokinetics and Physical Chemistry. He published more than 10 peer-reviewed scientific papers, book chapters, and patents, and presented at select drug delivery conferences. Now, he is President and COO of Santé Laboratories in Austin, Texas, overseeing all operations in the lab and business.