Abstrax partners with AVD and McKinney Regulatory Science Advisors to launch a state-of-the-art toxicology program that addresses data gaps and potential regulatory concerns for ingredients in cannabis products intended for inhalation.
TUSTIN, Calif., Nov. 28, 2023 /PRNewswire-PRWeb/ — Abstrax, the leader in botanical flavor technology, is thrilled to announce its partnership with Advanced Vapor Devices LLC (AVD), a leader in cannabis vaporizer technology, and McKinney Regulatory Science Advisors LLC to create and execute the cannabis industry’s most comprehensive inhalation risk evaluation program.
After several years of collaboration and research, the team is unveiling a Risk Assessment and Toxicological Evaluation Program (RA-TEP) for ingredients used in cannabis vaporizers. This program aims to establish guidance use levels for terpene-based flavors used in cannabis inhalation products. This approach prioritizes consumer safety over all else. Although this program is inspired by reputable risk assessment programs in other industries, this has never been done before in the cannabis industry.
In a recent presentation at a Cannabis Science Conference, Dr. McKinney cautioned the audience, “Beware of bad actors saying a lot but only doing a little…it’s time for the cannabis industry to have product regulations and guidance grounded in science and evidence.” He then explained that a cannabis product evaluation program should be based on established best practices currently used to evaluate other consumer products intended for inhalation. “We believe that the framework we are developing could become the cannabis industry standard.”
Abstrax’s comprehensive Risk Assessment and Toxicological Evaluation Program (RA-TEP) is being developed with guidance from McKinney Regulatory Science Advisors, LLC, and is modeled after FDA testing guidelines for similarly used consumer products. This program will be used to evaluate all of Abstrax’s botanically-derived and cannabis-inspired terpene formulations. RA-TEP may include, but is not limited to, the following list of steps:
- Focused Literature Review
- Ingredient Hazard Characterization
- Consumer Exposure Assessment
- Lipophilicity studies
- Genotoxicity, Mutagenicity, and Cytotoxicity studies
- Cannabinoid Testing
- Aerosol Inhalation studies
- Aerosol Degradation assessments
- Biological Activity assessments
- Shelf Life Stability testing
An important component of a Risk Assessment is determining a consumer’s exposure to aerosols from product use. To accomplish this, the Abstrax team designed a special algorithm, based on robust consumer use data from multiple manufacturers of inhalable cannabis products. AVD’s 510 thread EZ Click™ cartridges were selected for the study given AVD’s sizable market share and proven track record for reliability and safety. The AVD collaboration has helped bolster RA-TEP’s algorithm to offer a more realistic view of consumers’ use and exposure.
“By elevating the standards of inhalation safety and compliance, we’re not just safeguarding the consumer, but also pioneering a path of scientific rigor and integrity for the cannabis industry. Our commitment through the RA-TEP goes beyond merely meeting regulatory requirements,” said Abstrax Co-Founder and President Max Koby. “It’s about setting a new gold standard for how products are evaluated, ensuring they’re grounded in science, and fostering a culture of continuous improvement, safety and transparency.”
“We recognize the cannabis industry is facing a pivotal moment where the convergence of innovation and safety will mold and shape its future,” said Casey Creaney, VP of Product Integration at AVD. “AVDs cannabis-centric knowledge of device thermography, oil rheology, and puff topography in combination with McKinney RSAs expertise in inhalation toxicology and regulatory science complements Abstrax’s deep knowledge of flavorings, formulation, oil manufacturing, and innovation. This world class team enables the RA-TEP to bridge a current knowledge gap and provides the program with an evidence-based view of what cannabis vape consumers realistically experience.”
The RA-TEP addresses a more comprehensive range of risks and hazards than the Continuous Materials Review (CMR) approach used by other vape hardware and terpene suppliers because of a known cannabis industry knowledge gap. CMR only applies to consumer exposure via a single cartridge and fails to account for more comprehensive industry-standard inhalation toxicological methodologies. Furthermore, RA-TEP currently includes the dangers associated with vapes and e-cigarette-associated lung injuries, which was found to be linked to the lipophilicity of Vitamin E Acetate.
“It is imperative to take lipophilicity into consideration to prevent another crisis similar to EVALI (e-cig/vape-associated lung injury). RA-TEP is an important element of a comprehensive safety evaluation process,” says Jennifer Guild, VP of Regulatory and Quality at Abstrax. “We are currently the only terpene supplier testing for the factors that caused the 2019 vaping crisis. Unlike other industry CMR programs, the RA-TEP is examining Genotoxicity, Mutagenicity, and Cytotoxicity.”
To further assure customers of the highest quality products, Abstrax has achieved an SQF Level 2 Certification. SQF is the high-water benchmark within the Global Food Safety Initiative (GFSI) and drastically outpaces the expectations set by ISO 9001:2015 or other GFSI audits like FSSC22C that are ungraded and common amongst terpene suppliers.
For more information on the RA-TEP, visit https://abstraxtech.com/pages/terpene-research.
About Abstrax: Where Innovation and Science Meets Flavor Mastery
As the pioneering leader in the world of botanical flavor technology, Abstrax excels in crafting innovative terpene-driven, functional flavor solutions. Serving the cannabis, hops, flavor and fragrance industries, Abstrax is the trusted product development partner that forward-thinking CPG brands turn to when looking for a competitive edge. Founded in California by a team of award-winning PhD scientists, flavor chemists, and visionary product developers, Abstrax empowers brands to create next level products that transform the consumer experience through mood-enhancing flavors, cutting-edge aroma extractions, true-to-type all natural flavor solutions, and education. It harnesses the power of botanical terpenes and aromatics to craft transformative CPG applications via innovative technology and more sustainable, all natural, and cost effective ingredients. Through its three divisions – Tech, Labs and Hops – Abstrax is more than a key ingredient supplier; it’s an innovation partner. Abstrax Tech produces groundbreaking peer reviewed research publications, discovers new flavor compounds, and produces unparalleled terpene blends and flavors for tobacco, cannabis, and food applications – including botanically derived cannabis flavor experiences, live all-natural hemp derived terpenes, and mood-enhancing terpene-flavor systems. Abstrax Labs offers cutting-edge R&D, extraction and analytical technologies through its proprietary Terplytics™ system, a sensory quantification software application, which yielded the world’s most comprehensive cannabis cultivar phytochemical database. Its technology delivers the most advanced botanical testing for exploratory research, sensory quantification, strain validation, product development, and consumer insights. Abstrax Hops provides cutting-edge research, products, and services that push the limits of brewing innovation. Its wide range of solutions encapsulates the authentic varietal specific Hop Flavors, Dank Flavors, and next generation of advanced hop products including natural hop aroma extracts. Beyond its products and services, Abstrax guarantees the utmost in safety, quality and regulatory adherence, ensuring seamless integration into product lines. Delve deeper with Abstrax at AbstraxTech.com, AbstraxHops.com and AbstraxLabs.com.
About AVD
AVD is a leading vertically integrated manufacturer and distributor of cannabis vaporizer technology, recognized for best-in-class hardware designed exclusively for the cannabis extract industry. Decades of experience working with the cannabis plant inform AVDs personalized solutions for their Client Partners based on a deep understanding of the nuanced interplay between extraction methods, formulation, absorption, heating and vaporization delivery. Oil-touching parts are non-toxic, and AVD cartridges are constructed with the highest quality and safest materials available to comply with stringent heavy-metal regulations. AVD controls their entire supply chain, and is the partner of choice for leading oil brands, known for producing products that do not easily leak or break. Advanced design—including a proprietary ceramic core and No-Burn Technology™—gives consumers a premium flavor experience. AVD complies with HACCP, CGMP 820 and 110 standards, and is ISO 9001, 14001, 13485 and 45001 certified. Learn more at www.avd710.com.
About McKinney RSA
At McKinney Regulatory Science Advisors, LLC, we are more than just a consultancy; our dynamic team of adept scientific experts is devoted to guiding manufacturers in the cannabis and nicotine industries. Our primary objective is to assist clients in responsibly navigating the complexities of the regulatory landscape. We do this partly through our toxicological program, bringing together a team of experts with cumulative experience of over 200 years. Collaboratively, they design and implement product assessment and testing programs to provide comprehensive insight into the toxicological implications and potential risks associated with product use. Our firm was established by Dr. Willie McKinney and is based in Richmond, VA. We are committed to scientific integrity, public health, and high-quality service. Our core values — Persistent Excellence, Collaborative Trust, Advocate for Empowerment, Foster Transparency, Inspire Confidence, and Empower with Knowledge — serve as the pillars of our approach and operations. As specialists in regulatory science for cannabis and nicotine products, we strive to assist our clients in offering potentially less harmful and sustainable alternatives in these sectors. We collaborate closely with our clients, aligning our strategic guidance with their business goals to deliver timely, scientific, and regulatory-compliant solutions. Whether it’s raising awareness of potential risks through toxicological assessments and product science, engaging stakeholders, or facilitating interactions with regulatory bodies, our focus is to empower our clients’ product journey from conception to market. Trust McKinney Regulatory Science Advisors, LLC, to be your reliable partner in the rigorous and ever-evolving world of regulatory science. Our unwavering commitment to excellence, integrity, and providing accurate insights sets us apart within the industry. Learn more at www.mckinneyrsa.com.
