With an ethanol shortage in COVID times, responsible companies are turning to Santé Laboratories to ensure their sanitizers are safe, FDA compliant and really contain what’s printed on their labels.
The Food and Drug Administration (FDA) now maintains a lengthy and growing list of hand sanitizer brands that consumers should avoid, having confirmed they contain as much as 81% methanol and other impurities including potentially deadly 1-propanol. “While hand sanitizers and associated claims are regulated by the FDA, the agency now has a waiver program due to the unprecedented time of COVID-19 which doesn’t require manufacturers to substantiate label claims. This was in an effort to allow hand sanitizers to get on shelves quickly, under the assumption manufacturers would continue good manufacturing practices,” explains Mike Sandoval, President of Santé Laboratories, a bio-hemp pharmaceutical contract research organization (CRO). “However, the lack of FDA regulatory oversight has opened the market to anyone wanting to get into this lucrative space, even the unscrupulous.”
Sandoval, whose company has fully grasped the importance of its role with hand sanitizer testing, explains that when the pandemic hit, traditional hand sanitizer manufacturers with unparalleled track records could not keep up with the skyrocketing demand. Meanwhile, cannabis and hemp manufacturers that were casualties of extraordinary revenue losses and employee turnover identified a new opportunity to survive. “They had to pivot to and focus on creating and enhancing products such as hand sanitizers and disinfectants, especially those who were making high volumes of CBD oils as they have amenity-rich infrastructure to make mass quantities.”
But this demand also created an ethanol shortage. “After pure ethanol began running out, what remained were the non-pure forms and nontraditional sources of ethanol. Issues arose as manufacturers began procuring large volumes of non-tested raw materials and compounding hand sanitizers from non-qualified sources.”
Sandoval says this is why Santé Laboratories, a leading CDMO in nutraceuticals and bio-hemp, jumped at the opportunity to help protect consumers. Equipped with advanced analytical instrumentation and subject matter capacity, they’ve been flooded with testing these products. “Central to our mission, we’re committed to providing continuity and transparency in the contract lab service industry. We’ve observed enormous market entry of nontraditional companies offering hand sanitizers for mass consumer and B2B use. Businesses, their employees and customers should be able to trust what they purchase or provide to create ‘work-safe’ environments. But this trust has been destroyed by vendors sourcing unsafe hand sanitizers. In response, the FDA recently released guidelines for hand sanitizers that provide final product limits for impurities. Before those guidelines were released and till today, Santé Laboratories not only complies, but exceeds expectations for the FDA’s criteria.”
Elevating the hand sanitizer market
An ISO/IEC 17025:2017 accredited facility, Santé Laboratories is not just a CBD testing lab. “We’re an end-to-end contract research organization with vast capabilities to accommodate bio-hemp testing research, testing and product development. Recreational CBD labs simply do not have our level of expertise and capacity,” Sandoval comments. “We are inspired and energized to address this market. We have what it takes to gather the data, and the capacity to test a large number of products.”
Working with complex samples requires subject matter expertise to leverage existing methods to meet USP and ICH method validation requirements to produce scientifically valid test reports. Recreational labs commonly use GC-FID to screen common classes of solvents used in the extraction industry, which are not commonly identified as hand sanitizer impurities. “At Sante, we follow USP and ICH validation requirements, and leverage Thermo Fisher’s most advanced gas chromatography and mass spectrometer instruments to provide our customers trusted data,” explains Sandoval.
Why Elite Health Partners chose Santé Laboratories
Not long ago, Colorado-based Elite Health Partners entered into a testing exclusivity and global collaboration with Santé Laboratories. This partnership was established to codevelop shelf-stable commercial products for the dietary supplement and cannabinoid marketplaces, with an initial emphasis on private label skin care products.
After it was revealed that hand sanitizers with unsafe ingredients had made it into the U.S. marketplace, Elite Health Partners immediately began working with Santé Laboratories to produce hand sanitizers with verified safe ingredients for its customers. “This pivot demonstrates the flexibility and expertise that come with both companies being at the top echelon of their respective industries,” says Sandoval.
“We are very satisfied to have reached this agreement with Santé Laboratories, our partner of choice for third-party testing, research and development, and incorporation of their shelf-stable and highly absorbable formulation technology,” said Elite Health Partners Chief Operations and Financial Officer Jeff Jordan.
“Given their distinctive and reliable testing capabilities and manufacturing capacity, and as well as global market presence and leadership in banking, drug development, analytical chemistry, hemp research and related sciences, we look forward to working closely with the remarkable team at Santé to further accelerate and expand our product pipeline to introduce more effective and shelf-stable product offerings to our existing and new customer base.”
Applying this same fortitude to elevate the bio-hemp industry
Sandoval says Santé Laboratories will bring the same level of expertise and transparency to the rapidly emerging cannabinoid industry. “Scientific excellence in testing and product innovation is the heart of our business, and what has been missing in the CBD industry,” he concludes. “I believe that no other lab catering to the bio-hemp industry has our level of expertise, capability, fortitude and passion to elevate the hemp industry.”
For additional information about Santé Laboratories’ capabilities, visit www.Santélabs.com.