The Looming Regulatory Crisis for Cannabis Vapes—and How to Prevent It
Imagine federal cannabis vape regulations so stringent that only a handful of products are approved. Leaving the door wide open for a black market of unregulated, unsafe products. It’s a future possibility that will become an unfortunate reality if the FDA regulates cannabis vapes the same way they have regulated e-cigarettes.
The cannabis industry stands on the edge of a transformative moment: the potential rescheduling of cannabis by the federal government. While this may signal progress, it also brings urgency to the cannabis vape sector. It means it is more important than ever to proactively develop and promote scientific testing and research to set the foundation for industry standardization and future federal regulations.
The ACTIVE™ team believes the path forward is clear: the cannabis vape industry must prepare for the impending regulatory landscape. Without robust research and advocacy, the cannabis vape market risks being regulated under the same framework as nicotine vapes - which presents significant safety concerns and could hinder industry growth.
We saw what happened to e-cig, and we can’t let cannabis experience the same pitfalls.
Lessons from E-Cig: Avoiding Regulatory Pitfalls for Recreational Cannabis
Nicotine vapes, known as Electronic Nicotine Delivery Systems (ENDS), must submit to stringent FDA oversight through the Premarket Tobacco Application (PMTA) process. The application requires testing for a range of harmful compounds, including formaldehyde, arsenic, and benzene, creating a high standard for safety. While these standards have merit, they do not consider the unique challenges of cannabis oil vaporization.
Cannabis vapes currently fall under state regulations, with fewer requirements around aerosol chemistry, device materials, and extractable testing. As the complexity of cannabis formulations increases, we must advocate for testing protocols that reflect the unique nature of cannabis vaporization rather than lumping our products into the same category as ENDS.
To date, only 23 ENDS products have been approved by the FDA for sale. This limited number has stifled market growth and led to a surge in illicit products, putting consumers at risk. We cannot plague the cannabis vape industry with the same pitfalls.
This potential regulatory landscape is a wake-up call for the cannabis vape sector. As an industry, we must advocate for smart, sensible regulations that build on the progress states have already made. We see the opportunity to lead the charge in demonstrating the industry’s ability to self-regulate and prioritize consumer safety.
Prioritizing Safety in Cannabis Vapes
One of the most critical steps we can take is to differentiate between devices intended for cannabis oil and those designed for nicotine. It’s widely understood that nicotine vapes are not suited for cannabis oil use, and using improper hardware can lead to safety issues. ACTIVE™ is committed to pushing for regulations that address these differences through objective measures such as oil rheology, device thermography, puff topography, and emissions chemistry.
To ensure the well-being of consumers and the market, the cannabis industry must align on third-party hardware certifications that are fit for purpose. We also advocate for standardized ingredient and vapor safety testing, especially regarding additives. Illicit operations have been known to use unsafe diluents like vitamin E, which pose severe risks when inhaled. Standardizing safety protocols for inhalation should be a top priority for the industry.
Research and Development: Preparing for Federal Regulations
Establishing strong R&D and quality control programs is crucial. While future federal regulations may require aerosol emissions testing, starting with extractable and leachable testing provides a solid first step in assessing device safety. Additionally, developing machine-puffing topography standards that reflect cannabis vape users’ actual behavior, rather than relying on standards designed for nicotine vapes gives credence to cannabis science.
ACTIVE™ is leading the charge by conducting a groundbreaking peer field study to characterize puff topography specific to cannabis vape use. Get High for Science™ is a study that measures key factors like puff duration, flow rates, volume, and frequency and can even extrapolate milligrams of THC consumed using an industry-standard 510 cannabis vape device. This data demonstrates significant differences in puff behavior between cannabis and nicotine vapes, reinforcing the need for dedicated standards in cannabis vaporization research. The findings also highlight the inadequacy of current nicotine-based puff machine standards, such as Coresta 81 and ISO 20768, when applied to cannabis products.
This research lays the foundation for standardizing a cannabis-specific puff machine topography, and we hope it encourages further collaboration within the industry. Having accurate puff behavior data is crucial for building evidence-based regulations that ensure consumer safety and product efficacy
Alongside Get High for Science, ACTIVE™ has partnered with Abstrax and McKinney Regulatory Science Advisors to launch a state-of-the-art toxicology program aimed at closing data gaps and addressing potential regulatory concerns for inhalable cannabis products. The Risk Assessment and Toxicological Evaluation Program (RA-TEP) is a comprehensive initiative designed to evaluate the safety of ingredients—particularly terpene-based flavors—used in cannabis vapes. By prioritizing consumer safety, this program sets a new standard for risk assessment in the cannabis industry, one inspired by established practices in other sectors but tailored to the unique demands of cannabis vaporization.
A Unified Voice for Self-Regulation in the Future of Cannabis Vapes
The number of stakeholders involved in creating just one cannabis vape is remarkable. Every part of the supply chain—from the raw materials for the hardware to the extracts themselves—plays a role in determining the risks and safety of the final product. By joining forces and advocating through organizations like VapeSAFER, we can help shape regulations for cannabis vapes.
Science and safety must always lead the way. Industry standards set by respected groups like ASTM and ISO (International Organization for Standardization) are key to informing sensible regulations. These standards reinforce why testing is important, garner concern about what needs testing, and are the best ways to ensure product safety.
To avoid the regulatory hurdles plaguing the e-cigarette industry, we must stay one step ahead—by being prepared and proactive.
Visit the VapeSAFER website to find out more.
Meet the authors
Randy Reed is the Vice President of Scientific Solutions at ACTIVE®. As an award-winning scientist, Reed brings over twenty years of hands-on experience in botanical extraction, cannabinoid formulations, and cutting-edge delivery systems. With a career spent pushing the boundaries, Reed's mission is simple: to make every puff safer, smarter, and a whole lot smoother.
Katelyn Schneider brings the stories of ACTIVE® to life as Marketing Manager. Whether she’s catching the details that matter or capturing the big picture, Schneider shapes each blog into a piece that doesn’t just inform but inspires. Her passion for the plant fuels her work, driving her desire to educate and help break the stigma around cannabis.