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In this episode, moderator Bethany Moore and David Vaillencourt, CEO of The GMP Collective, were joined by expert panelists Darwin Millard, Technical Director at Cannabis Safety & Quality (CSQ), Shawna Vreeke, Head of Research and Toxicology at True Terpenes, and Audra Horridge, Vice President of Technical Solutions at ACTIVE.
In this episode, we discussed the current state of the U.S. cannabinoid vape product space, common issues impacting cannabinoid vape products, potential health and safety concerns from using cannabinoid vape products, as well as the regulatory challenges facing the growth of the cannabinoid vape product market.
You can watch the full webinar recording here on our YouTube channel.
We received a large number of excellent questions both prior to and throughout the webinar and have compiled answers to as many of them as possible. Some of the questions may have been lightly edited for clarity.
Q: How can cannabinoid liquid vaporizers (carts and disposables) and dry herb vapes better distinguish the differences between themselves and their risk profiles to the general public?
A: Industry, consumers, and regulators can collaborate to publish guidance documents highlighting the differences in risks between herbal product vaporizers and cannabinoid-containing substance vaporizers. The ASTM D37 committee has developed useful classification systems and guides, such as:
Q: Are there cannabinoid vape product regulations that require testing for the different contaminant classes such as pesticides, metals, solvents, microbials, and mycotoxins? If so, what contaminants have been detected?
A: Yes, cannabinoid vape products are regulated similarly to other cannabinoid products and must be tested for contaminants including pesticides, metals, solvents, microorganisms, and biotoxins. Similar to all other cannabinoid products, these requirements often differ from jurisdictions. All these contaminants have been detected in cannabinoid vapes. The focus should be on identifying the source of these contaminants, whether from the device or the product inside, or as a product of the reactivity between the device, the product inside, and the application of heat. In 2022, a paper was published by Pruyn et al. titled “Quality Standards in State Programs Permitting Cannabis for Medical Uses” that looked at the variability in testing requirements across state medical programs and is available here: https://www.liebertpub.com/doi/10.1089/can.2021.0164
Q: What are problem additives for vaporizers? I am seeing MCT oil in products to be vaporized.
A: The lack of research around what happens when additives are heated up and inhaled makes answering this a challenge. Problem additives include but are not limited to:
Q: There have been instances where companies have standardized THC content by using additives such as PEG 400, based on the claim that PEG 400 is GRAS. Would you say a company claiming something is GRAS when it isn’t is a red flag?
A: GRAS (Generally Recognized As Safe) is a food safety standard and does not apply to inhalation. Food safe does not mean vape safe. Companies should use GRAS status as a starting point in a toxicological risk-based assessment for determining daily inhalation exposure limits, which are different from ingestion exposure limits. This is another example of why it is critical that companies making and selling these products have qualified scientists and/or toxicologists on staff.
Q: Have you seen any synthetics being used in vape products? If so, what kind?
A: Yes, synthetic ingredients are used in vape products, including cannabinoids like THCP, HHC, d8-THC, CBG, and CBN. Some cannabinoids, such as CBG and CBN, may be products of precision fermentation, while others, like THCP and HHC, are manufactured or converted from other substances. Some of these compounds may be found naturally but are in such small quantities (trace level) that they must be made synthetically to meet consumer demand.
Q: What are the panel’s concerns with vaping highly purified cannabinoids that happen to be synthesized, such as d9 THCV?
A: Regardless of whether the cannabinoid is manufactured or not, humans have never consumed minor cannabinoids like THCV in the concentrations we see today. It would be false to claim that THCV at high concentrations has the same level of safety as d9-THC. We have extensive consumer safety data for d9-THC but not for other cannabinoids including d8-THC, THCV, CBD.
Q: Can finer temperature control for inhalation of cannabis oils act as a preventative measure to minimize damage to consumer health?
A: Yes, temperature control is crucial in preventing overheating and thermal degradation. The ASTM D37 Vape Device Safety & Testing Initiative is developing standards for power limiting and over-ramp protection to promote consumer safety and device longevity.
Q: How do the safety concerns of liquid vapes compare to dry herb vaporizers?
A: Generally, dry herb vaporizers may be considered safer than cannabinoid-containing substance vaporizers due to different risk profiles. However, dry herb vaporizers are also subject to material breakdown over time, while liquid vapes might have concerns about metal leaching and component reactions. Long-term studies are needed to evaluate the risks of both types of devices.
Q: What changes are made to devices intended for distillate versus rosin?
A: Typically, manufacturers adjust the aperture diameter and atomizer resistance. Larger apertures allow more material to hit the atomizer, while lower resistances heat up faster. These adjustments ensure the device functions properly with the specific material.
Q: If rosin extracts are naturally ~70% cannabinoids, what is being vaporized from the remaining 30%?
A: The remaining 30% likely consists of aromatic compounds, fats, waxes, and other lipids.
Q: Is it typical for vape manufacturers to consider human factors when designing vapes to avoid consumer misuse?
A: No, it is not typical. However, manufacturers who see the value in collecting consumer usage data are more likely to design safer and more effective products.
Q: What are the best practice tips for all-in-one vapes and 510 thread cartridges?
A: Best practices include avoiding leaving devices in hot places, maintaining clean connections, and following manufacturer instructions for use and storage.
Q: How can issues with clogging be solved?
A: Clogging can be mitigated by controlling the ceramic core formation process, investing in filtration to remove particulate matter, and ensuring consistent viscosity of vape formulations. Manufacturers should work together to design devices fit for purpose.
Q: If using whole flower from a dispensary in a vaporizer, do you have concerns about harmful substances?
A: Vaporizing anything carries inherent risks. If the flower is contaminated, the risk from inhaling aerosolized vapors increases. However, purchasing from a tested and trusted source reduces the likelihood of harmful substances being present.
Q: What reporting requirements are implemented to identify and track adverse events from using vapes, and what changes have occurred since the EVALI episode?
A: The FDA and Health Canada track adverse events, and anyone can voluntarily fill out a form through the following links:
Additionally, anyone that may experience an adverse event should always reach out to their healthcare provider, as well as alerting the appropriate state regulatory body (if in the US), and contacting the company directly. Links to all state regulatory agencies can be found on CANNRA’s website here
Q: When it comes to vaporizer safety issues, there is perhaps nothing more fraught than the disposal of these devices. What are your thoughts on improving vape disposal? Is recycling viable?
A: The ASTM D37 Vape Device Safety and Testing Initiative has identified the need for a Guide to Vape Device and Battery Disposal as one of its top 5 priority standards to develop. Proper disposal and recycling are essential topics that need to be addressed through standards development.
Q: Are there any standards in progress for batteries?
A: Yes, the ASTM D37 Vape Device Safety and Testing Initiative has prioritized developing a Guide to Vape Device and Battery Disposal over the next 18 months.
Q: Is vape lithium battery disposal a real issue that states should be looking into?
A: Yes, lithium-ion batteries are classified as unique recyclables and require separate disposal from municipal and other forms of waste. The issue is significant with All-In-One devices where the battery and cartridge are combined. These devices pose a challenge for disposal as they contain both recyclable batteries and cannabinoid-containing waste, which must be rendered irretrievable before disposal. Proper disposal of the lithium-ion batteries is regulated by the EPA in addition to state and local laws to prevent lithium battery fires and ensure safety. Meeting both the requirements of rendering the cannabinoids irretrievable and EPA laws to address environmental risks is very complicated as doing so poses a significant safety risks for a technician from lithium battery fires.
Q: Could ornate glass design and/or water act as a form of inline filtration to help with cannabis oil vaporization?
A: Yes, some designs incorporate in-line media filtration to remove harmful constituents from the smoke/vapor. However, there is some evidence from toxicology studies suggesting that the vapor produced from cannabis oil does not contain concerning levels of thermal degradants. A wider study should be conducted to see if pushing the hardware increases risk.
Q: What are your thoughts on Color Remediation Column technologies that often use silica, charcoal, bentonite clay, and other media to filter out unwanted colors from extracts and concentrates?
A: Silica inhalation is not unique to the cannabis industry. It is a known issue in many other industries. Ceramic products used in vapes could pose a risk if not high quality – which includes being brittle and improperly assembled. ACTIVE has done preliminary testing on their products and did not find silica nanoparticulates of concern. In extraction, the risk of inhalation is mainly when the column contents are dry. More research is needed to determine if silica particulates transfer and if they are at levels high enough to cause harm. Conducting a study to determine if silica particulates come from the ceramic atomizer or the media column could provide valuable insight for risk assessments.
Q: What is the best method for filling cartridges on a small level operation? Does filling units by hand affect the end product, or is automation a better option?
A: The best method depends on the number of units to be made per day. For a few cartridges, hand-filling with a dosing syringe is suitable. For a few hundred or thousand cartridges, automation might be necessary.
Q: Why should consumers trust any hardware originating in China?
A: All hardware currently comes from China. One needs to look at the merits of the company supplying these products and how the company operates and their quality level, including certifications (GMP, ISO, etc.) and operational practices. Companies that own their factories and have defined internal specifications, vendor qualifications, and third-party audits are more trustworthy.
Q: Can you share the ASTM recommendation for 10% terpene content verbiage?
A: According to ASTM D8449 “Standard Specification for Label Content and Style, Format, Location, and Prominence of Elements for Consumer Products Containing Cannabinoids”, products containing more than 10% by weight or volume total terpene content shall be labeled with the following warning statement: “This product contains concentrated terpenes. Consume at your own risk.”
Q: Are there any additional health concerns or improvements in all-in-ones? Does a cartridge attached to hardware it was designed for lead to a better and healthier smoking experience?
A: All-in-ones can match battery power output with coil resistance, potentially reducing overheating and degradation. High-performing products result from thorough research and development. 510 batteries can offer adjustable voltage output to help reduce these issues.
Q: Where can we read the 30 proposed standards that Darwin mentioned?
A: The proposed standards are categorized into Topography and Performance, Aerosolized Vapors and Emissions, Device/Hardware Design, Components and Interactions Therewith, and Consumer Usage Characteristics. Becoming a member of ASTM International Committee D37 on Cannabis is the best way to learn more about and to get involved in the development of the proposed standards.
Q: How is the industry protecting against underage use of flavored vape products?
A: Recreational and medical markets are age-restricted to 21+, and budtenders are trained to check IDs diligently. States have enacted packaging regulations to prevent products from mimicking children’s products or using popular cartoon characters.
Thanks again to everyone who tuned in. Catch up on all of our past webinar episodes on our YouTube channel, and be sure to register for our next webinar in August.
