Committee Blog: Manufactured Product Safety — Vaporizer Delivery Devices

by NCIA’s Cannabis Manufacturing Committee 

Product safety isn’t an endpoint, it’s a journey. That’s what we told you in the 2021 series premiere, and it continues to hold true. In the last post, we revisited the Vaporizer Liquid Formulations portion of the NCIA’s policy council white paper to provide guidance to the industry. This time, we’re republishing the Vaporizer Delivery Devices section below. We’ve learned more about EVALI since its original publication, and while some of the specifics may be a little dated, the principles remain relevant to helping you understand vapor product safety.

Over the course of the next several months, we’ll bring you new content with the following working titles.

The Importance of Testing Vapor Products as a System

Edibles Stability – Microbial Growth Due to Insufficient Packaging

Terpene Limits Across Multiple Product Formats 

So, while we wait with bated breath for this exciting new content, enjoy the excerpt below!

Excerpted from The Key To Consumer Safety: Displacing The Illicit Cannabis Market Recommendations For Safe Vaping. Access the full report and citations.

Background 

While the technology used to vaporize cannabis extracts have been around for many years, advancements in vaporization technology and supply chains over the past decade have led to widespread adoption and growth of vaporization as a preferred method of cannabis consumption. Vaporizer devices offer the benefits of being discreet, allowing for metered consumption, and eliminating carbon associated with combusting cannabis flower. However, not all vaporizer devices are created equal and manufacturers should develop an understanding of the nuances of different vaporizer devices to ensure the delivery of a safe and high-quality experience. Aside from considering experiential qualities such as taste and the amount of vapor produced, manufacturers should consider at least the following three categories of issues that can present safety risks.

Physical Design Considerations

Vaporizer devices should be mechanically and electrically safe. This starts with relatively basic considerations that include ensuring the device is mechanically sound, does not leak alkaline or heavy metals, and is not configured in a manner that presents a safety hazard. In the early 2010s, there were many reported instances of vaporizer devices exploding. This was primarily due to improper electrical design and battery cell protection. Battery cells that are not protected from drawing current beyond their rated capacity or are allowed to drain too deeply present a safety risk. In fact, this risk led to the development of the UL 8139 standard for e-cigarette battery safety and the FDA recently relaxed its prohibition on e-cigarette battery changes in order to allow manufacturers to comply with this standard. UL 8139 is applicable to vaporizer devices and anyone who sources or develops a vaporizer device for the cannabis market should voluntarily comply.

Contamination by Hardware

Vaporizer device hardware should be tested for the presence of heavy metals. Currently, some manufacturers use Restriction of Hazardous Substances (RoHS) testing or rely on vendor representations that the components and materials being used are certified as FDA food-grade. The California Bureau of Cannabis Control mandated heavy metals testing standards for the three categories of cannabis products, including inhalable cannabis products, starting on December 31, 2018. 

Vaporizer device hardware that comes into contact with cannabis formulation should also be free of other contaminants. It is important to consider both contaminants that could be immediately detectable in vaporizer devices as well as those that can be released or created over time. Vaporizer devices are designed using a variety of industrial manufacturing processes, some of which can leave residual oils, biological agents, or other substances in the device. It is important that device manufacturers clean incoming components, assemble them in a clean environment, then store and ship them in a manner that prevents re-contamination. Depending on the nature of the component, one or more of a cleaning bath or ozone treatment may be used for cleaning. After cleaning, assembly of vaporizer components should be performed in a cleanroom environment under appropriate current Good Manufacturing Practices (cGMP). Unfortunately, simply asking a device manufacturer whether it operates in such a manner is not sufficient to be certain that it does. There is no substitute for first-hand inspection of manufacturing processes. While it may not be practical for U.S.-based cannabis manufacturers to maintain a constant presence in the country of manufacture, it is possible to hire local agents who are skilled in audit practices and can perform unannounced inspections to verify that desired practices are implemented within the supply chain. 

As noted above, hardware may also introduce contamination into the formulation over time, either through the process of leaching heavy metals or through chemical reaction. Leaching is a process whereby soluble constituents that may be present in materials dissolve into a formulation. A well-known example was the discovery that plasticizers present in certain plastic food and beverage containers were leaching and then being consumed. As a result, new types of plastics were developed for improved food safety. Vaporizer components that contact cannabis formulations may present a similar issue and leaching may be tied to metals, ceramics, plastics, or other materials. In addition to leaching, certain materials may react with cannabis formulations, especially those with high terpene content which tends to be more volatile. Moreover, metal components in contact with formulations may be especially susceptible to leaching and lead to contaminants such as heavy metals in the formulation.

The good news is that it is possible to address this risk of leaching through the use of appropriate base materials and or plating. Base materials such as stainless steel are good candidates because of their low tendency to react with formulations. Plating other materials with corrosion-resistant metals is also possible; however, care must be taken to specify the right material and plating thickness while also ensuring the plating is not damaged during assembly.

With proper material selection and design, it is possible to reduce the risk of such contamination, including through conducting stability tests. In a stability test, a formulation is placed into the vaporizer device for a period of time, then removed and tested for contaminants. A good guide is to design the stability test to align with the desired shelf life of the product. That doesn’t necessarily mean the test needs to be as long as the rated shelf life. Typically, elevated temperature tests are used to determine stability and can cut the duration of the test to 50% or less of the desired shelf life. In addition, by taking measurements at intermediate intervals, stability can be better characterized and the point at which contaminants would exceed their respective limits can be projected.

Device Impact on Formulation: Control the Heat

The most fundamental, yet perhaps the most underappreciated aspect of vaporizer devices is how they vaporize cannabis formulations. Setting aside dry herb vaporizers, all liquid cannabis vaporizers basically work by bringing the formulation into contact with a hot surface in order to heat it and thus create vapor. While this may seem straightforward, there are a number of subtleties that affect the outcome. First, the temperature of the hot surface must be hot enough to heat the liquid, yet not so hot as to cause components of the formulation to degrade into byproducts that could be harmful. In fact, one study demonstrated how changing the voltage, and thus the temperature of an unregulated vaporizer device can affect the production of such degradants. While more advanced vaporizer devices attempt to control vaporization temperature by using heating elements made of specific materials that indirectly measure temperature and regulate the power delivered to the heating element, the majority do not.

Different formulations have different compositions and contain constituents that vaporize and degrade at various temperatures. This means that to fully control vaporization, the vaporizer device must be configured precisely to the requirements of the formulation in use. Second, many vaporizer devices do not heat uniformly. Rather, the heated surfaces heat unevenly, creating hot spots that can locally trigger thermal degradation. Temperature control circuits typically measure an average temperature and do not prevent such hot spots. Finally, the majority of vaporizer devices, whether they contain fiber wicks or ceramic, rely on capillary action to bring the formulation into contact with the heated area or surface. During a puff, capillary action is also what replenishes the formulation at the heated surface, and such capillary replenishment takes time. Depending on the viscosity of the formulation and the duration of the puff, a heated surface that was initially saturated with the formulation can become dry and hot during the course of a puff. Experienced users sometimes refer to this as a “dry hit,” which can be perceived when a cartridge runs dry or during a long puff. Dry hits can result in increased thermal degradation.

Armed with this understanding of the nuances of vaporizer devices, one can appreciate how the common business model of selling cartridges with a universal 510 threaded connection that can be used in conjunction with any number of batteries, any number of power settings, and filled with a variety of formulations makes it difficult to guarantee what is produced during vaporization. In order to understand and control the output of a vaporizer device, the system should be designed, configured, and tested as a whole; cartridge and battery, plus formulation. Closed systems with proprietary connectors and one-piece designs do not face the cartridge-battery mismatch challenge, but should still be tested in conjunction with the target formulation using a reasonable worst-case puff duration. And while new systems under development that employ non-contact heating methods may not present the same temperature control challenges, they too should be validated as a whole.


The Cannabis Manufacturing Committee (CMC) focuses on reviewing existing business practices and state regulations of concentrates, topicals, vaporizers, and edibles, ensuring the manufacturing sector is helping shape its destiny.

Member Blog: Growing Beyond THC – Terroirs and Terpenes Are The Future Of Premium Cannabis

By Eric Sklar, CEO and Co-founder of Napa Valley Fumé 

I’m a serial entrepreneur and my roots in Napa Valley run deep. I’ve been a cultivator in this beautiful terroir for over 40 years, initially as a wine guy from a family of growers and makers, and now as the Co-Founder and CEO of a premium seed-to-sale cannabis company. I see a lot of similarities between wine and cannabis, comparisons that paint a bright, accessible, and profitable future for our industry. 

Wine + Cannabis Offer Interesting Comparisons

Both are agricultural products that are highly regulated, though cannabis far more so given the industry is still in its infancy. 40 years ago, when my family started in the wine business they experienced similar business challenges, or as I like to call them – opportunities. 

Like wine, cannabis comes in a variety of strains and formats. Also, like wine, cannabis is extremely well suited to the growing conditions of California’s terroirs, especially those where I live in Northern California. If you think about the wide variety of wine varietals – Cabernet, Pinot, Sauvignon Blanc, Rieslings, and so on – there is an even greater variety of cannabis strains – Lemon Sour Diesel, Double Chem OG, Budzilla, Bogota Berry, etc. There is something for every palette, which pre-legalization, I am not sure many people really paid attention to. This is all to say, that just as there are many different ways to enjoy wine depending on your tastes, your budget, or your intentions and preferences, the same is true for cannabis. 

There’s so much more. If you’ve ever had a great wine or even a decent wine, you know that there are all these flavors and aromas that layer on each other and evolve over time, interacting in different ways to create this wonderful sensory experience that’s both about taste and smell. The same goes for cannabis. Premium cannabis is as complex as the most complex wine. Both wine and cannabis contain terpenes and it’s the variety of different terpenes in each of them that determines the flavors, aromas, and overall experience. Coming from wine, this is something I understand and I think as people explore cannabis without the stigma of prohibition, they will begin to seek out terpene-rich strains, just as they now seek out complex wine profiles – perhaps unknowingly given how wine is such a normalized product in today’s society.

Of course, there are obvious differences between cannabis and wine. The plants themselves are very different. One’s an annual plant and one’s a perennial vine. But, they both produce very similar compounds that make the sensory experience of their flower and fruit so much richer. 

Let’s Talk Terpenes

You’ve probably been hearing a lot more about terpenes lately. They’re kinda the new ‘it’ thing in our industry. Terpenes are organic compounds in plants responsible for the unique smells and tastes of your favorite plants, flowers, and fruits. Most people don’t know this but with both wine and cannabis, most of what you think you’re tasting is actually what you’re smelling. It’s these terpenes that give your favorite wines and cannabis strains their signature scents.

Some of them overlap — there are some of the same terpenes in both cannabis and wine grapes like limonene and myrcene. And then there are some terpenes that are more unique to one plant or the other. But it’s the same compounds and so coming out of wine, it was such a natural thing for me to say, I’m not in this to build the strongest, highest-THC-get-you-wasted product. I wanted to develop something that honored the terroirs I’ve come to know and love. A premium product offering, with the same wonderful components of the wines I’ve been creating and the same rich variety of flavor profiles as the grapes I’ve been growing for all these years.

As chemicals go, terpenes offer delicate but very distinctive aromas but they are volatile and, if you’re not careful, will disappear quite quickly. You have to work to maintain them to keep them from evaporating from your flower as from your wine. Taking the time and care to capture and preserve these aromas and flavors that are truly unique to each strain and varietal makes for a much richer experience than the extreme high that some people chase, the cannabis equivalent of Night Train. With cannabis, quickly harvesting the flower and getting it into a temperature and humidity-controlled drying room helps maintain these volatile compounds as does the way you cure and store the flower after the initial drying. In wine, we preserve the terpenes with careful barreling and bottling.

The best way to enjoy terpenes is to use a flower vaporizer. Just heating it up enough to release everything without burning it and without burning rolling paper that covers up the subtle aromas of the terpenes.

Outdoor Growing Enriches the Final Product

The cannabis plant has been growing outside for millennia and our hypothesis at Napa Valley Fumé is that growing outdoors creates a wider range of terpenes and a richer, more nuanced consumption experience. A plant, like a human being, is a holistic entity, it’s a being of a sort. If you took a person — like in The Truman Show — and never let them outside, what would that do to that being?

In truth, we don’t really know what indoor growing does to the plant. But what I think is that these plants are meant to be grown outside. That’s where they do their best. They have to contend with elements that make them stronger, and other factors like pests, which over time create resistance, again making them stronger. They are also receiving full-spectrum sunlight that changes each day of the year. As the year goes on, the color spectrum starts to vary. It is bluer in the spring and redder in the fall. So while I get the efficiency of indoor growing, I believe that all of these environmental elements together with the heating during the day and cooling at night and the fact that different growing regions have different climates and terroirs, you get the best, most interesting plants when you grow outdoors.

Terroir: As Important to Cannabis as They are to Wine Grapes

Terroir is a great word because it’s not just about one element, it’s about everything in a given place. The altitude, the soil, the mineral content of the water, the directional exposure to the sun. In Napa where we’re based, the terroir is affected by the fog that comes up from the Bay. We measure the temperature days over the course of the whole growing season, assessing the total heat that the plant received. All of these things contribute to the terroir and the terroir informs and enriches the sensory experience of the resulting fruit and flower.

Plants, whether you’re talking about grapes or cannabis, will perform differently in different terroirs and will express themselves in different, nuanced ways. For me, this suggests a bright future for sun-grown cannabis with a wide variety of strains each displaying the unique signature of their terroir. The same seed grown across different terroirs expresses really differently, resulting in a distinct profile in the flower and an enhanced consumption experience. 

Bottom Line: Terpenes, Terroirs, and Outdoor Growing Paint a Bright Future

This plant has so much to offer and is so expressive. While there’s a place for both indoor and outdoor, it seems to me that the most expressive form of this plant, with the most interesting aromas and flavors, comes when you grow in the full spectrum of sunlight outdoors. To attain the same rich variety in your cannabis experience as you do with wine, you want to do it outdoors, you want to tend them for the greatest terpene expression, you want to pick your strains at the beginning for that. Optimizing for terpenes doesn’t just have a flavor effect, it also shapes the psychoactive effect of the flower. The right terpenes and compounds can make the resulting high sleepier or more energetic, as well as providing other health benefits that are currently supported by anecdotal evidence and will likely be born out in the research that is currently underway.

As with the trajectory of the wine industry, we believe that educating consumers about terpenes and terroirs and offering them a wider variety of products and consumption experiences, will expand the category, creating a bright future for all of us. I’m excited and encouraged by articles like this one from Wine Magazine that suggest that we’re on to something. 


Eric Sklar is an entrepreneur, Napa Valley vineyard owner and public official. He and his family have been growing grapes in Napa Valley for 40 years and he planted his first licensed cannabis garden in 2018. Eric is the CEO and co-founder of Napa Valley Fumé, LLC, a cannabis management and branding company that has launched brands such as LAKE GRADE with a few others in the works. He is also the co-founder of the Napa Valley Cannabis Association and the President of California Fish and Game Commission, a position he has held since 2016.

In 2005, Eric founded Alpha Omega Winery in Rutherford, CA and was managing partner until 2013. He’s held positions on the Board of the Napa Valley Vintners, as well as Napa Valley Vintners’ Community and Industry Issues Committee. In 1989, he founded Burrito Brothers’ Inc., a restaurant chain based in Washington, DC, which he sold in 1999. Eric was also an adjunct professor at Georgetown University’s School of Business where he taught courses in entrepreneurship, business strategy and marketing. He has held several other political positions including Assistant Press Secretary to Vice Presidential candidate Geraldine Ferraro in 1984.

Eric received a Bachelor of Arts degree in Political Science at the University of California at Berkeley in 1984, a Diploma in Business Studies at the London School of Economics in 1986, and a Master of Business Administration at Georgetown University in Washington, D.C. in 1997.

Sponsored Blog: A Different Way To Consume Cannabis

Sponsored blog post by Dynavap

There’s more than one way to consume cannabis — through the more traditional method of smoking with a pipe or joint, or through newer methods of vaping. Both will get the job done, but with vaping, there are certain benefits that allow better taste and a cleaner experience, while using less cannabis in the process, and saving money.

People who vape can save money in how much cannabis they purchase by using less with vaping, while still retaining the same high, and having the ability to reuse leftover remnants to make edibles. When you smoke traditionally, the result is combustion of the plant; however, vaping extracts the components from the plant, leaving material called ABV intact. ABV can be used for making edibles, effectively doubling the usage of any dry herb product you put into your vaporizer. With Dynavap vaporizing products, Dynavap team members and customers have found vaporizing cannabis makes your supply last longer because of efficiency in the consumption process.

Vaping cannabis is better from a health standpoint, in comparison to smoking. One Dynavap employee has personally attested that he felt less winded while doing physical activities after switching over to vaping. Vaping also allows for cleaner consumption of cannabis — allowing for a less harsh experience instead of combusting the material and putting chemicals created by that action into your lungs. Vaping also provides a better experience and allows people to taste the nuances of the material they’re consuming in comparison to traditional smoking methods. With vaping, those nuances become more pronounced and noticeable. Plus, with vaping, the smell dissipates faster and doesn’t hang on clothing, which allows people to enjoy cannabis in a more stealth fashion and be able to go about their daily lives afterward.

By dialing in the temperature, you can alter the effects by controlling which compounds are vaporized allowing you to customize your experience regardless of strain. Low temperatures will vaporize more of the compounds that give you the feeling of euphoria, creativity, and being energized. Overindulgence will have the opposite of the desired effect so consume responsibly. Higher temperatures will vaporize the more sedative compounds giving you that body relaxation you may be looking for.

Give vaporization a try and let us know what your favorite difference is in the comments. If you want to purchase a DynaVap vaporizer visit: https://www.dynavap.com/ or email jeff@dynavap.com with any questions.

 

Video Spotlight: W Vapes

Learn more about NCIA member W Vapes in this month’s video spotlight. The California-based, award-winning vaporizer company focuses on pure, pesticide-free, CO2 extracted, lab-tested oil. Their products are now also available in Nevada.

Member Spotlight: W Vapes

This month, we checked in with Dr. Juli Crockett of W Vapes, a vaporizer and extraction brand that originally launched in California, and is a Sustaining level member of NCIA. W Vapes was named one of the “Best Vape Cartridges” of 2016 at the California Chalice Cup. Juli also sits as a Co-Chair on NCIA’s recently launched Policy Council.

WVapes_Copy of w_logo_nobkgCannabis Industry Sector:
Extraction/Manufacturing

NCIA Member Member Since:
December 2015

Tell me a bit about your background and why you launched W Vapes?

The first W Vapes products were officially launched in California in August of 2015. A short two years later, and we are about to transition to being a national brand with locations in Oregon, Nevada, and beyond. W Vapes is becoming W The Brand.

Dr. Juli Crockett with Edibles Magazine Editor-in-chief Patrick Moore
Dr. Juli Crockett with Edibles Magazine Editor-in-chief Patrick Moore

How it all began? A family history of multiple types of cancer, as well as other ailments, led our co-founders to the research and development of our extracts. A defining moment that confirmed their faith in this amazing medicine was after providing cannabis oil to a family member with Tourette’s syndrome who experienced more than 100 ticks per day. After a single dose of cannabis oil his ticks subsided completely. They then knew their mission was to bring high quality cannabis to the people. After working for years in every aspect of the cannabis industry, from growing to dispensaries to manufacturing, their small, home-grown pen company (RELM) was sought out by visionary investors that recognized the massive potential of their high quality oil. From that union, W Vapes was born. I suppose you could call me the midwife? I was recruited in early 2015 to help with the launching of the W brand in California. While my official title is Chief Compliance Officer, we all have worn a whole mess of hats in the past two years, which goes along well with my diverse background in the arts (playwright, theater director, singer, bandleader), PhD in Philosophy, experience as a Marketing Director in the adult toy industry, and undefeated professional boxer. It sounds like a unique resume, however, the cannabis industry has no shortage of dreamers, daredevils, and polymaths. I’m in excellent company.

What unique value does W Vapes offer to the cannabis industry?

WVapes_pen_IMG_2609W Vapes is a unique hybrid that combines incredible quality standards and a deep commitment to patient safety with sophisticated, sleek branding and marketing savvy. A big differentiator is that our extractions are single-origin, strain-specific, and always pesticide-free. The oil in our cartridges and dabs comes from a single strain of a single batch of cannabis flower. There are no additives, flavorings, store bought terpenes, mixing of strains, synthetics, or cutting agents. One source, one strain, nothing else. We work with farmers that employee pesticide-free practices to produce high quality cannabis flowers, which we transform via small batch CO2 supercritical extractions into the liquid soul of the plant.

We are purists, plain and simple. We believe that the mission of the extraction process is to preserve and amplify the authentic soul of each cannabis strain. The vaping experience should be the inhalation of the concentrated soul of a plant, with no additives, synthetics, flavorings, or adulterants in the mix. That is why we do small-batch, single-origin, strain-specific extractions of certified and lab-tested, pesticide-free, potency-proven cannabis flowers. Our motto is “Gold In/Gold Out.”

Cannabis companies have a unique responsibility to shape this growing industry to be responsible and treated equally as any other industry. How does W Vapes help work toward that goal for the greater good of the cannabis industry?

WVapes_butterfly_File_006Our goal and mission is to make the highest quality extracts accessible to all. Everyone deserves excellent, pure medicine. We have already distinguished ourselves by bringing more healthy delivery systems (such as glass and stainless steel cartridges, rather than plastic) to the masses, which is quickly becoming the industry standard. We hope to continue to innovate and influence the cannabis space in positive ways by always demanding the best for ourselves, patients and all people.

Our mission is to bring pure, pesticide-free, clean medicine of the highest quality to patients that may not even know or care about quality, pesticides, and clean medicine. We are a high-end product that is still affordable, as we believe that good, clean medicine should be the rule and not the exception.  

What kind of challenges do you face in the industry and what solutions would you like to see?

W Vapes Co-Founder, Amber Abbott
W Vapes Co-Founder, Amber Abbott

Staying on top of the ever-changing and ever-developing regulatory landscape is a big challenge. It can be difficult for a company to make future plans when the future is still somewhat unknown. As an industry we face the paradoxical challenges of lack of regulation in some areas and over regulation in others on the horizon. Overall, the solutions we seek are being treated like any other industry, held to those standards, and given the same incentives and opportunities. Access to banking, sensible taxation, functional regulations, all with a focus on patient safety and the healthy growth of the cannabis industry — allowing for maximum participation by the people who created the cannabis industry over the past decades.

Why did you join NCIA? What’s the best part about being a member?

Being engaged in the political process, locally and at the state level, is of the utmost importance during this time of transition, when so many laws and regulations are being created and implemented. This is why it was important for us to not only join NCIA, and our local state affiliate CCIA (California Cannabis Industry Association), but to become deeply involved with both organizations. I currently sit on the Board of Directors for CCIA, several of its committees, and serve as a Co-Chair on NCIA’s newly formed Policy Council. This is an unprecedented moment in which the pioneers of the cannabis industry have the opportunity to come together and speak with a collective and powerful voice. The future of the industry is being defined and decided every day, in every moment. We do not have time to waste. This is our moment.

Contact:
W Vapes Website
W Vapes Facebook


Note: NCIA member profiles highlight members and stories within our cannabis industry community. They do not constitute an endorsement or recommendation of specific products or services by NCIA.

 

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