Expanding its science-backed program designed to prioritize consumer safety, preserve product quality and support consumer choice
IRVINE, Calif., Jan. 29, 2025 /PRNewswire-PRWeb/ -- Abstrax, a pioneer in cannabis research and terpene innovation, has expanded its Risk Assessment and Toxicological Evaluation Program (RA-TEP) to identify existing safety benchmarks for cannabis inhalation products. This enhanced program represents the deepest dive into the safety of cannabis vape formulations, building on years of research, collaboration, and proactive science to address consumer safety and regulatory challenges.
RA-TEP is designed to address critical gaps in the evaluation of terpene-based flavors and other ingredients used in cannabis vaporizers. By integrating rigorous lab testing with advanced methods tailored to the unique characteristics of cannabis formulations, the program goes beyond industry norms that often rely primarily on literature reviews. Modeled after FDA testing standards for comparable consumer products, RA-TEP accounts for real-world scenarios and usage patterns, emphasizing Abstrax's unwavering commitment to scientific rigor, consumer safety, and consistent, science-based regulatory practices.
"This isn't just about meeting regulatory requirements—it's about redefining what safety means for cannabis products," says Kevin Koby, Co-Founder and CEO of Abstrax. "With RA-TEP, we're setting a gold standard that prioritizes the consumer, builds trust, and ensures every product is backed by science."
A Comprehensive, Science-Based Approach
RA-TEP adapts reputable methods to thoroughly evaluate the unique qualities of cannabis vape products. This includes adapting methodologies used for nicotine e-vape liquids to account for oil-soluble cannabis formulations and unique puffing behaviors of cannabis consumers.
The key steps in RA-TEP include:
1) Literature Review: Identification of priority health effect endpoints (e.g., carcinogenicity, mutagenicity, reproductive or developmental toxicity).
2) Algorithm for Exposure Assessment: Leveraging sales and survey data to estimate daily consumption.
3)Ingredient Hazard Identification: Lipophilicity studies and acute inhalation evaluations to assess risks.
4) Aerosol Chemistry: Use ACTIVE's hardware to monitor 11 cannabinoids, 12 VOCs, 18 carbonyls, and 21 heavy metals over the typical shelf life of products to understand potential degradation and migration.
5) Toxicology and Biological Activity Studies: Genotoxicity, mutagenicity, and cytotoxicity evaluations.
RA-TEP's robust framework goes beyond common continuous materials review programs by providing a detailed investigation into inhalation risks and shelf-life stability.
Abstrax's team of scientists took an industry standard toxicology algorithm and adapted it to include data on cannabis and flavor formulation ratios, along with cannabis consumption habits. This improved algorithm, which is now considered in the ASTM standard that Abstrax helped draft, leverages consumer data to consider real-world exposure scenarios. The program evaluates products using ACTIVE's (formerly AVD) Alpha Pen w/ PowerWave paired with its C3 510 cartridge, selected for their proven reliability and widespread use, ensuring results reflect actual consumer experiences.
RA-TEP goes beyond conventional Continuous Materials Review (CMR) programs by addressing risks and hazards associated with inhalation that have been overlooked in the industry. For example, RA-TEP incorporates lipophilicity studies to mitigate risks linked to compounds like vitamin E acetate, the most likely cause of the 2019 EVALI crisis. RA-TEP also uses 3rd party labs to ensure accurate, unbiased results and tests genotoxicity, mutagenicity and cytotoxicity to establish an industry benchmark for understanding the toxicity of flavored cannabis vaping formulations.
"We're not just identifying risks—we're proactively solving them," said Jennifer Guild, VP of Regulatory and Quality at Abstrax. "RA-TEP equips the industry with a science-based framework that empowers manufacturers to deliver flavorful, economically viable products while safeguarding consumer health."
To bolster the program's effectiveness, Abstrax collaborated with McKinney Regulatory Science Advisors, experts in inhalation toxicology, and ACTIVE, a leader in cannabis vaporizer technology. These partnerships bring complementary expertise, integrating device performance, oil formulation knowledge, and regulatory science into the RA-TEP framework.
In addition to RA-TEP, Abstrax operates in full alignment with 21 CFR Part 110 and integrates HACCP, underscoring their unwavering commitment to quality and safety. The team is proud to have achieved full SQF certification for Food Safety in Food Manufacturing and Quality (previously known as Level 3), with a strong score of 95, surpassing cGMP standards. This certification is a hallmark of excellence within the Global Food Safety Initiative (GFSI) and reflects their dedication to exceeding quality expectations.
As the first terpene supplier to achieve full SQF certification, Abstrax significantly outperforms the more common ISO 9001:2015 and FSSC 22000 benchmarks. The SQF program, one of the most esteemed GFSI pathways, stands as a testament to their commitment to delivering products of unparalleled quality and safety. Abstrax's strong score of 95 further demonstrates their dedication to superior quality systems, far exceeding industry norms.
RA-TEP represents a transformative step for the cannabis market, providing regulators and manufacturers with a science-based framework for growth. As a founding member of VapeSAFER, Abstrax is uniting with industry leaders to advocate for sensible, data-backed legislation at both state and federal levels. By leveraging this health and safety data, Abstrax aims to empower lawmakers to create consistent regulations that prioritize consumer safety while supporting industry innovation. As cannabis adoption continues to expand across the United States, Abstrax's dedication to safety and active participation in multiple industry coalitions, including VapeSAFER, reinforces efforts to build consumer trust in the legal market.
For more information on RA-TEP and Abstrax's commitment to advancing cannabis safety, visit https://abstraxtech.com/pages/quality-and-compliance.
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 harnesses its divisions to craft transformative CPG applications via innovative technology and more sustainable, all natural, and cost effective ingredients. Abstrax Tech produces groundbreaking peer reviewed research publications, discovers new flavor compounds, and produces 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 Hops provides the most advanced 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. Abstrax offers the utmost in safety, quality and regulatory adherence, ensuring seamless integration into product lines. Delve deeper with Abstrax at AbstraxTech.com and AbstraxHops.com.
Media Contact
Abstrax PR, Abstrax, 1 2139258177, [email protected], www.abstraxtech.com
SOURCE Abstrax
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