What is the Risk Assessment and Toxicological Evaluation Program?

The Risk Assessment and Toxicological Evaluation Program (RA-TEP) sets a new gold standard for cannabis product evaluation.

No one wants to see another event like the vape crisis of 2019. Reports of lung-related injuries and even consumer deaths were shocking, to say the least. The EVALI (e-cig/vape-associated lung injury) crisis did, however, serve as an important wake-up call.

Simply put, the approach used by many vape hardware and terpene suppliers wasn’t comprehensive enough to ensure product quality and consumer safety. 

In response to such an obvious health crisis, evaluation methods should have been strengthened in order to reduce, if not eliminate, consumer safety risks. At the very least, testing should have begun in order to determine the precise cause… but that didn’t happen.

Shockingly, evaluations haven’t changed much since then, and no supplier (other than Abstrax) is testing for what caused the vape crisis. 

At Abstrax, we believe the cannabis industry and its consumers, deserve so much better. That’s why we’ve been working over the past five years to create the new gold standard for cannabis product evaluation.

Through the development of the Risk Assessment and Toxicological Evaluation Program (RA-TEP), we’re seeking to finally establish acceptable ingredient use levels for terpene-based flavors used in cannabis products. And that’s just the beginning.

ADVANCING INHALATION SAFETY IN THE CANNABIS INDUSTRY

Are Current Toxicological Evaluations Inadequate for the Growing Cannabis Market?

The Continuous Materials Review (CMR), the current evaluation method used by many, only applies to consumer exposure via a single cartridge. Additionally, it also fails to account for more comprehensive industry-standard inhalation toxicological methodologies. 

The in-house “smoking machine” used by CMR to produce data often produces incomplete data and contaminated results 

Lipophilicity is completely overlooked in CMR studies. The lipophilicity of Vitamin E Acetate is believed to be the cause of the 2019 vape crisis that led to severe lung injury and even the death of some consumers. 

CMR studies don’t measure the genotoxicity, mutagenicity, and cytotoxicity of cannabis and vape ingredients applied directly to cells similar to human lung tissue.

Introducing the Risk Assessment and Toxicological Evaluation Program (RA-TEP)

Clearly, the lack of established guidance levels for terpene-based flavors in cannabis inhalation products is a serious issue. That’s why we decided to do something about it. 

In partnership with Advanced Vapor Devices (AVD), a leader in cannabis vaporizer technology, and McKinney Regulatory Science Advisors LLC, we’ve created the cannabis industry's most comprehensive inhalation risk evaluation program.

Our comprehensive Risk Assessment and Toxicological Evaluation Program (RA-TEP) is modeled after FDA testing guidelines for similarly used consumer products. The ten-step RA-TEP study may include, but is not limited to, the following:

• Focused literature review
• Advanced algorithm for exposure assessment
• Unbiased, third-party lab testing
• Industry-standard hardware
• Ingredient characterization
• Aerosol assessment
• Real-world cannabinoid testing
• Biological activity assessment
• Aerosol degradation assessments
• Shelf-life stability assessment

The cannabis industry is at a pivotal juncture where innovation and safety will mold and shape its future. As such, the development of RA-TEP is an important step toward an industry that promotes excellence and consumer safety.

AVD's 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.

Casey Creaney

VP of Product Integration at AVD

What Are The Differences Between RA-TEP and CMR?

In order to develop a more accurate and complete understanding of the safety of terpene ingredients used in cannabis products, RA-TEP uses more advanced methodologies, additional assessments, and third-party testing. 

The RA-TEP direct inhalation studies are completed by external, third-party labs to ensure reliable, independent, and trustworthy results free from bias. While it seems like this would be common practice, it represents a stark departure from the in-house labs used by CMR. Not only do regulatory authorities usually prefer data from independent labs, but in-house labs often lack the certifications and rigorous standards used by independent laboratories.

It was also important that RA-TEP take real-world inhalation scenarios into account. To accomplish this, the Abstrax team designed a special algorithm, based on robust consumer use data from multiple manufacturers of inhalable cannabis products. This algorithm enables us to establish guidance for ingredient use in terpene-based flavors intended for inhalable cannabis products.

This data, in combination with biological activity assessments that measure potential genotoxicity, mutagenicity, and cytotoxicity of ingredients, helps us understand the impact of cannabis ingredients on human health at various usage levels. 

Abstrax Tech: Setting the Gold Standard for Cannabis Product Evaluation

This isn’t just about meeting regulatory requirements. Abstrax Co-Founder and President Max Koby put it best when he said, "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."

From our full alignment with 21 CFR Part 110, HACCP integration, and our SQF Level 2 Certification, we are committed to moving the industry forward with innovation and integrity. Today, that means developing the world’s most extensive, and comprehensive, cannabis ingredient toxicology study. Tomorrow, we’ll continue to raise the bar for quality cannabis products customers can trust.

Contact us today to ensure your cannabis ingredients are of the highest quality and safe for consumers.