Tag Archives: inhale

By Milan Patel

As the demand for legal cannabis continues to rise and more states come online, it is imperative to enact more rigorous and comprehensive testing solutions to protect the health of consumers. People use cannabis products for wellness and to find relief; they should not be susceptible to consuming pathogens and falling ill. Especially for immunocompromised consumers, the consequences of consuming contaminated cannabis or hemp are dire. Of course, there should be federal standards for pathogen testing requirements like we have for the food industry. But right now, as cannabis is not yet federally legal, testing regulations vary between states and in many states, testing requirements are too loose and enforcement is minimal. It is up to state legislators, regulators and cannabis operators to protect the health of consumers through implementing more stringent testing.

From the outset, the environmental elements needed to grow cannabis – heat, light, humidity, soil – make cannabis ripe for pathogens to proliferate. Even when growers follow strict sanitation procedures through the supply chain from seed to sale, contaminations can still occur. Cannabis companies need to be hypervigilant and proactive about testing, not just reactive. The lack of regulations in some states is alarming, and as the cannabis industry is highly competitive and so many companies have emerged in a short time, there are unfortunately unscrupulous actors that have skated by in a loose regulatory landscape, just in the game to make a quick buck, even at the expense of consumer health. And there are notable instances where states do not have enforcement in place to deter harmful manufacturing practices. For instance, there are some states that don’t mandate moisture control and there have been incidents of companies watering down flower so it has more weight and thus can be sold at a higher cost – all the while that added moisture leads to mold, harming the consumer. This vicious circle driven by selfish human behavior needs to be broken by stricter regulations and enforcement.

While in the short term, looser testing regulations may save companies some money, in the long run these regulatory environments carry significant economic repercussions and damage the industry at large, most importantly injury or death to customers and patients. Recalls can tarnish a company’s brand and reputation and cause sales and stock prices to tank, and since cannabis legalization is such a hotly contested issue, the media gloms onto these recalls, which opponents to legalization then leverage to justify their stance. In order to win the hearts and minds of opponents and bring about federal legalization sooner, we need safer products so cannabis won’t be cast in such a dangerous, risky light.

Certainly, there’s a bit of irony at play here – the lack of federal regulations heightens the risk of contaminated cannabis reaching consumers, and on the flip side recalls are used by opponents to justify stigmatizing the plant and keeping it illegal. Nevertheless, someday in the not-too-distant future, cannabis will be legalized at the federal level. And when that day happens, federal agents will aggressively test and regulate cannabis; they’ll swab every area in facilities and demand thorough records of testing up and down the supply chain; current good manufacturing practices (cGMP) will be mandated. No longer will violations result just in a slap on the wrist – businesses will be shut down. To avoid a massive shock to the system, it makes sense for cannabis companies to pivot and adopt rigorous and wide-sweeping testing procedures today. Wait for federal legalization, and you’ll sink.

Frankly, the current landscape of cannabis regulation is scary and the consequences are largely yet to be seen. Just a few months ago, a Michigan state judge reversed part of a recall issued by the state’s Marijuana Regulatory Agency (MRA) on cannabis that exceeded legal limits of yeast, mold and aspergillus, bringing contaminated cannabis back to shelves without even slapping a warning label on the packaging to inform consumers of the potential contamination. This is a classic case of the power of the dollar prevailing over consumer safety and health. Even in well-established markets, the lack of regulations is jarring. For example, before this year in Colorado, testing for aspergillus wasn’t even required. (Aspergillus inhalation, which can cause Aspergillosis, can be deadly, especially for people who are immunocompromised). Many states still allow trace amounts of aspergillus and other pathogens to be present in cannabis samples. While traces may seem inconsequential in the short term, what will happen to frequent consumers who have been pinging their lungs with traces of pathogens for 30 years? Consistently inhaling trace amounts of pathogens can lead to lung issues and pulmonary disease down the road. Look what happened to people with breathing and lung issues during the last two years with COVID. What’s going to happen to these people when the next pandemic hits?

We need state regulators and MSOs to step up and implement more aggressive testing procedures. These regulators and companies can create a sea of change in the industry to better protect the health and well-being of consumers. Just complying with loose regulations isn’t good enough. We need to bring shortcomings around testing into the limelight and demand better and more efficient regulatory frameworks. And we should adopt the same standards for medical and adult use markets. Right now, several states follow cGMP for medical but not adult use – that’s ridiculous. Potentially harming consumers goes against what activists seeking legalization have been fighting for. Cannabis, untainted, provides therapeutic and clinical value not just to medical patients but to all consumers; cannabis companies should promote consumer health through their products, not jeopardize it.

For best practices, companies should conduct tests at every step in the supply chain, not just test end products. And testing solutions should be comprehensive. Most of the common tests used today are based on petri dishes, an archaic and inefficient technology dating back over a century, which require a separate dish to test for each pathogen of interest. If you’re waiting three to five days to see testing results against fifteen pathogens and a pathogen happens to be present, by the time you see results, the pathogen could have spread and destroyed half of your crops. So, not only do petri dishes overburden state-run labs, but due to their inherent inefficiencies, relying on these tests can significantly eat into cannabis companies’ revenues. At PathogenDx, we’ve created multiplexing solutions that can identify and detect up to 50 pathogens in a single test and yield accurate results in six hours. To save cannabis companies money in the long run and to make sure pathogens don’t slip through the cracks, more multiplexing tests like the ones we’ve created should be implemented in state labs.

Right now, while the regulatory landscape is falling short in terms of protecting consumer health, better solutions already exist. I urge state regulators and cannabis companies to take testing very seriously, be proactive and invest in creating better testing infrastructure today. Together, we can protect the health of consumers and create a stronger, more trustworthy and prosperous cannabis industry.

February 16, 2022

Innovations in Dosing Technologies: Getting an Accurate Hit, Every Time

By Michael Sassano

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Cannabis products and medicines are progressing rapidly, eating away at the market share of smokable flower. Currently, the general adult use cannabis market is split in three, in order of popularity: cannabis flower, vaporizers and ingestible products like edibles or capsules. In the medical market, flower is increasingly being replaced by alternative methods of delivery – and the same trend is now starting to be seen in the adult use market.

This is to be expected to some extent. Initially, only flower was available to medical cannabis users. On top of not everyone feeling comfortable with smoking, inhaling a combustible substance into the lungs is not the healthiest consumption method for those already suffering from a serious illness.

In the present day, there are new alternatives to smoking that come without the risk and actually have additional benefits. For example, there are now much more precise ways to measure your cannabinoid intake than weighing out the flower you’re about to burn. As technology develops, there is an expectation that – despite flower sales being fairly stable last year – we will see continued incremental growth in the non-flower category, especially on the medical side.

Oral Cannabinoid Delivery

Thankfully for those who want to use non-smokable products, there are a growing number of alternative oral products that are currently available in the market or are under development.

Cannabis edibles might be the first products to come to mind when you think about non-smokable products – but for many medicinal users, these are actually a fairly unpopular option. While having a cannabis-infused brownie or gummy might be quite discreet compared to smoking a joint, the need for patients to take in extra sugar or extra calories every time they need to take their medicine can be off-putting. Additionally, tradionally infused edibles can take between one to three hours to feel as the body needs time to digest.

Cannabinoid capsules or pills have recently emerged as an equally discreet alternative to edibles. These pills come in many forms, including hard capsules containing ground cannabis flower, softgel capsules containing measured doses of cannabis extract, and gelatin-free alternatives. Though these pills, like edibles themselves, do come with a relatively long onset time.

Pills and edibles are also both affected by first-pass metabolism. This means that the active cannabinoids will be processed through the digestive system and the liver before passing onto the brain or the other organs. During this process, some amount of CBD or THC will likely be broken down by the body before it can make its effect felt, leading to inaccuracies between the labelled dose of a product and the active dose that reaches the brain or target area in the body.

To avoid these problems with first-pass metabolism, some have turned to use sublingual cannabis oils and tinctures. By placing a measured dose of oil under the tongue using a dropper, this theoretically allows for the fast absorption of THC or CBD into the bloodstream without the product being processed by the digestive system. However, in practice, these sublingual tinctures need to be held under the tongue for around ten minutes before they are fully absorbed. This is fairly difficult to do without accidentally swallowing some amount of the tincture, and so this still introduces some amount of uncertainty with dosing.

Fast-Acting Absorption

Fast-acting absorption techniques and nano emulsions are also gaining in popularity. Nanotechnologies and techniques have been developed by many firms, and boast claims of increasing absorption through the digestive system in order to effectively double the volume of cannabinoids absorbed into the body. Nano emulsions are also promising, which come with claims of up to four to five times more improved absorption. Such technologies rely on cannabis oils being immiscible with water-based substances, and process these cannabis oils in such a way that they become nanoscale droplets suspended in a larger mixture. Because of their size, these small pockets of cannabis oil are able to be absorbed rapidly through the gastrointestinal tract and into the bloodstream.

A drink additive, made by Splash Nano, that uses nano emulsion technology

Older liposomal and newer nano-liposomal combinations have also boasted similar claims. Liposomes are commonly used as a novel drug delivery system for pharmaceutical products to facilitate the absorption of drugs into the body, and the adaption of such techniques for the cannabis sector is also intended to dramatically improve the absorption of cannabinoids into the bloodstream. Given the marketing of these products, it can become confusing to know which is the best. The only way to know for sure is to have either a breath or blood analysis to see which style works and is best for the individual consumer.

As manufacturers progress from flower and basic products, the largest brands and more advanced medical companies are all producing ingestible products with fast absorption methods and additives. The difference is pronounced and significant enough that consumers and patients are starting to demand fast absorption products. As the market becomes more educated, you can expect that the market for fast absorption ingestible products will greatly outpace the older, more basic formulations. Of course, some emulsion additives will increase the operating costs for businesses, but over time, this difference will likely be fairly minimal.

Microencapsulation to boost cannabinoid absorption

Microencapsulation is another new method for producing drugs with high bioavailabilities, and the technique has recently made headlines in the cannabis industry.

Using a technique known as ionic gelation, or ionotropic gelation, scientists are able to trap drugs inside nano- or microscale capsules. These tiny capsules are robust enough to be able to protect the active drug ingredient–which in this case would be CBD or another cannabinoid–against the harsh environment of the gastrointestinal tract without necessarily limiting bioavailability.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Unlike the other oral dosing methods, cannabinoid microcapsules are not yet a commercially available product. However, there is early research indicating that this drug delivery technology could be a significant step forward in terms of improving cannabinoid bioavailability and absorption.

Published in the journal PLOS One, a new study from a team of Australian scientists reports that CBD microcapsules used in combination with a permeation-modifying bile acid can boost the peak concentration of CBD reaching the brain by 300 percent. These peak concentrations of CBD in the body also happened much earlier with the CBD microcapsules than with regular CBD oil, reflecting a faster absorption by the body.

This improved absorption and bioavailability addresses many of the limitations seen with traditional oral cannabinoid delivery. However, there is still potentially a very long road before these microcapsules are approved for general use in humans, making them an unrealistic option at present.

Metered Dose Inhalers

So far as innovative cannabis dosing technology that is currently available on the market goes, metered dose inhalers lead the way. Making up one-third of the market share, these devices are easy to use, discreet and are far less invasive than burning cannabis flower.

Heating and vaporizing a purified cannabinoid also exposes the user to fewer potentially harmful combustion products than smoking flower. Using vapes, manufacturers are also able to adjust the formulation of vape oils in order to deliver a truly consistent product. This can help the consumer to truly measure their intake of beneficial cannabinoids.

Vaporizers for general adult use are very common now and come in many forms and flavors. Until recently though, there were very few vaporizers that met the specific needs of the medical market, like being able to deliver very controlled doses of cannabinoids. Now, innovation in the sector has led to a number of companies developing special metered dose inhalers for this purpose. These devices use smart technology to only heat and vaporize a pre-set controlled dose of cannabis oil from their compatible cartridges, allowing for intake to be tracked more precisely. This is different from regular vapes, where the amount inhaled can vary depending on how deeply a person inhales, or other environmental factors.

Recently, Syqe Medical received approval from Health Canada for their metered dose cannabis vaporizer. There is already a similar registration for approval in the US and Europe that looks promising for similar devices.

Recreational acceptance of products, like these high-tech vaporizers, drives up spending on innovations that would otherwise just be novel ideas. The cannabis industry has a wealth of creative talent, and with the market beginning to tear away from flower and towards novel and innovative products, like vaporizers and fast acting ingestible products, now is the time for the medical market to invest in this talent and follow the demand and the money.

July 3, 2020

The Future of Vape Litigation: Temperature Control

By Michael Preciado

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The e-cigarette or vaping use-associated lung injury (EVALI) outbreak of 2019 caught the attention of many, and has brought with it the scrutiny of both regulators and plaintiffs’ attorneys eager to act as “civil prosecutors.” As Tolkien would say, the Eye of Sauron has now turned its gaze towards the cannabis vapor industry.

With the misinformation and negative publicity that the EVALI outbreak brought to the industry, vaporizer device manufacturers should expect more lawsuits to be filed against them through 2020 and beyond. The cannabis vapor industry should also expect the theories of defect alleged against their products to become more sophisticated as more plaintiffs’ attorneys enter the arena.

One theory of defect you should expect plaintiff’s attorneys to pursue in 2020 is what I generally refer to as “temperature control litigation.”

Here is the problem:

Typical additives in cannabis oil, while once thought to be safe, can degrade at higher temperatures into toxic chemicals. For example, the Vape Crisis of 2019 was largely attributed to a cannabis oil additive known as vitamin E acetate. While typically regarded as safe for use in nutritional supplements or hand creams, when used in cannabis oil, investigators believe vitamin E acetate can degrade into a toxic chemical when vaped—and is responsible for causing mass pulmonary illness for thousands of consumers.

Researchers do not fully understand how this process occurs, but chemists from the Royal College of Surgeons in Ireland found in a recent study that the key is understanding how temperatures affect chemicals when vaping. Through a process known as pyrolysis, the study found that vitamin E acetate can possibly degrade into ketene when vaped at higher temperatures—depending on the type of coil resistance, voltage and temperature configuration used in a vaporizer device. (Ketene has a high pulmonary toxicity, and can be lethal at high concentrations, while low concentrations can cause central nervous system impairment.) Similar studies have also shown that additives like Propylene Glycol (PG), Vegetable Glycerin (VG), and Polyethylene Glycol (PEG) can degrade into toxic chemicals at high temperatures—which has led Colorado to ban the use of PEG for inhalable cannabis products altogether.

More shocking, is that such temperature control issues are not limited to additives. It is very common for experienced users to experiment with low to high temperatures when vaping cannabis; it is believed that vaping cannabis at low temperatures (325-350°F) results in a mild high, while vaping cannabis at higher temperatures (400-430°F) results in a more euphoric feeling and intense high. But when cannabis is vaped at even higher temperatures (450°F +), industry experts do not really know if or how cannabinoids and terpenes degrade, which combinations of cannabinoids and terpenes affect degradation and what the health risks could be. It’s anyone’s guess.

Cheap batteries with the universal 5/10 thread can heat the product at inconsistent temperatures, raising safety and quality concerns

These temperature control issues are further complicated due to the universal 5/10 thread. Most consumers purchase cannabis oil through pre-filled “carts” (cartridges)—that are compatible with 90% of vaporizer batteries on the market because of universal 5/10 thread connectors. But vaporizer batteries can operate anywhere from sub-300 degrees to 800 degrees and above. Coupled with varying battery voltages, ceramic coil quality and oil quality, vaporizer batteries can produce a wide range of operating temperatures. Consequently, it is possible users could connect a cart to a vaporizer battery (set at too high a temperature configuration) and risk pyrolysis, change the chemicals inside their cannabis cart, and cause unknown harm to themselves.

Unquestionably, all of the above will result in lawsuits. Companies that manufacture cannabis oil will be sued for failing to conduct emissions testing to properly evaluate safe temperature settings for use of their carts. Vaporizer device manufacturers will be sued for failing to publish warnings, instructions and adequate owner’s manuals regarding the same. And the rallying cry against the cannabis vapor industry will be damaging. Plaintiff’s attorneys will accuse the industry of choosing profits over safety: “The cannabis vapor industry knew cannabis oils could turn into toxic chemicals when heated at high temperatures, but instead of conducting long-term emissions testing to evaluate those concerns, the industry chose profits over safety. As long as the industry made money, no one cared what dangers arose from elevated temperatures—and consumers paid the price.”

With the above as background, it is critical for the cannabis vapor industry to get serious about product testing. The industry needs to know if and why certain cannabinoids, terpenes and additives can turn into toxic chemicals when they are vaporized at high temperatures—and how the industry can guard against such dangers. And to cover their bases, the industry needs to publish proper warnings and owner’s manuals for all products. The time to act is now.