Are Legal PA Vapes Safe?

Top Researchers and PA Grower/Processors reassure patients 

As most have heard, there is a whirlwind of stories and conflicting information regarding the recent outbreak of lung illnesses and deaths related to vaping, which is causing confusion nationwide and within the PA Medical Cannabis Program. In an effort to alleviate stress and fear, we tried to get to the bottom of exactly what is safe and not safe, by going directly to a very credible source. 

Dispense Publisher Sven Hosford and Editor Kristal Oknefski spoke with Jahan Marcu, Phd., a renowned cannabis researcher and author, and Founder and Chief Scientific Officer for The International Research Center on Cannabis and Mental Health (IRCCMH).

Marcu spent a number of years researching CBD and was featured in Dispense Magazine back in January, regarding the findings. The study was to evaluate the safety of CBD products as they had been seeing an increase in illness or injury related to vaping “garage style” or “street style” CBD cartridges.

“It was sort of a culmination of a number of years of begging people who had instrumentation and access and licenses to test these products which are being manufactured and distributed euphemistically, outside of any state regulatory program, or outside of a licensed operator, he said. “So, you know, fairly illicit products. If you were to compare it to the alcohol industry, this would be like buying moonshine off the side of the road.” 

The interview began with a discussion explaining the different types of vaping, to clear up the apparent confusion between nicotine, CBD and THC that is found on the street, in dispensaries recreationally and medically. Jahan first spoke about the possible dangers of e-cigarettes and the “fillers” or “thinners” that are used in their production, namely Vitamin E Acetate, which is the key focus in the investigation into these illnesses.

“They’re much like inhaling anything that isn’t clean air,” he said. “It can lead to respiratory issues, as we know from inhaling various plant materials like tobacco or cannabis, it can lead to issues such as coughing and lung infections. Our lung tissue is very sensitive – it’s very thin – and anything that interferes with the diffusion of oxygen can be an issue. So, if you have something like a grease, like Vitamin E Acetate, if there is enough there it can coat the lungs and make it hard to breathe.”

Vitamin E is safe in many ways that it is utilized, however, it has not been studied much when it comes to its use in e-cigarettes or other vaping equipment.

“While things like Vitamin E are perfectly safe in a lotion, it really has not been studied for when you heat it at different temperatures for different amounts of time and inhale it,” he said.

“But why this issue is so confusing is that there are nebulized products that have Vitamin E in them that are safely delivered, so there are a lot of factors here,” he continued. “As we’ve seen in the past with vape pens, and the Propylene Glycol issue, with formaldehyde-releasing agents, when it’s overheated, or not stored properly and degrades over time. Many other variables can really make this a little difficult to suss out what exactly is the culprit here.”

Jahan then touched on vaping plant material and how it differs from regular vaping methods.

“The data shows that when you use, say, Storz & Bickel Volcano, one of the vaporizers that have been studied clinically for what it produces and there is much less, but still some hydrocarbons that you see in smoke, so the risks are much less reduced,” he continued. “Now, however, if you have contaminates in there, it could be delivered in the vapor as well.”

The wide range of potentially harmful products offered on the market, from your local convenience store, or your favorite headshop, and the products which are used in their development seem to be the lead focus in the investigation and make things a whole lot stickier. 

“It seems the media has really latched on to Vitamin E Acetate,” he said. “We see this a lot when it comes to these public health issues. Whatever is associated with it, people start dropping the ‘C-Word’ all over the place. The ‘C-Word’ is Causality or Cause – just because something is associated with it does not mean it’s a cause.

“Some of the things we have to keep in mind is that sometimes our most important compounds that can cause negative effects, you only need very, very little of them. So, theoretically, no one really knows what’s going on right now, but I feel that it is unlikely that the most common ingredient would be the most dangerous thing in these products. It might be something we’re not even aware that is in the products yet.”

“Part of getting down to the bottom of this issue is freeing up labs that do more of this kind of product testing to do more of some R&D type of research,” Jahan said. “Like, hey, maybe we should test for these various Schedule 1 Substances in these products – maybe we should test for things that aren’t dictated by politicians. We should test for things that we’re seeing out in the real world that might affect it. I’ve heard of everything under the sun appearing in vape pens and people getting accidentally exposed to things from synthetic cannabinoids to DMT unwillingly, from getting what they thought was a THC or CBD vape pen. There’s no shortage of these anecdotes out there.”

Jahan then spoke of the information he’s come across that, out of all, brought the most fear.

“I don’t know – all of it,” he said. “When I think about the industry I like to compare it and keep it in context with things, you know? So far more astronauts have died on missions than people from vaping – but we are already seeing calls to ban these products outright. That, to me, is scary. Just because some people got sick on moonshine doesn’t mean we have to ban the whole industry and alcohol everywhere. That didn’t work very well at all and even, in the early stages of prohibition, had led to a ton of counterfeit products – formaldehyde, and acetone containing liquors that were really nasty.” 

Jahan said there is a lack of data, but as of now, it is accurate to assume that the issues are arising from the “street bought” unregulated regulated products.

“So, I’ve been talking with a lot of colleagues in the field, companies, researchers, patients, consumers, clinicians, just trying to get a real sense,” he said. “Everyone has theories, but we have a lack of data right now, but with talking to some of the clinicians, there was this kind of theme coming up – especially among the clinicians. They said it’s really tricky because if people are using an illicit vape pen – a vape pen they got from a gas station – that’s not the product they are bringing into the clinics. They’re bringing in the legal products.

“There’s this old saying that I’ve been saying for a decade – when it comes to drug use, it’s never one drug,” he said. “There’s no such thing as these mouse models where they’re gonna get one drug for the rest of their life – that is never going to happen with humans. People are taking caffeine, medications, using illicit and licit substances, sometimes simultaneously. People call it polypharmacy these days. So, it’s really hard to know what’s happening when the average person is probably afraid to go to a health professional or someone and say they were using or were given a product that was purchased outside of the legal program. There are a couple of different products – there are counterfeit products, the FDA bought a bunch of products online that did not have CBD in them, as an example.

“There are issues with diversion, which is also kind of a dirty word to say, but NIDA researchers put out a very interesting paper last year called ‘Six policy lessons relevant to cannabis legalization,’” he said. “The thing that really struck me about it is that the National Institute of Drug Abuse researcher said bans on THC extracts and THC caps do not work and have the opposite of their intended impact. So in states like New Jersey and other places that have banned these products, they see a huge illicit market that is completely unregulated and a source of ‘that’s where the diverted products go’ because there is huge demand for them there because people simply cannot buy products of a significant potency in their state. Other regulatory issues, like not being able to reprocess materials – say a company has to make a product from A to B to C to D, all these steps, and it fails the QC test whether it’s contaminated or not, or if it’s a lab error or a number of other instances that can happen, that product cannot be sold. It goes in the dumpster. So there are products that have been reported ending up on the east coast that were from other adult-use states that no longer sell those items anymore. You also don’t know if it’s the real product or if someone is copying the packaging. Some of this stuff is very sophisticated. I think that companies can do things such as putting batch numbers or tracking numbers on their product can really help to protect them, so that if someone does do a knock-off of their product, they can actually track it. Things like that can potentially protect these companies. People can go to jail for not doing their due diligence.”

“I’d like to contextualize things and be like ‘this issue, while it seems like it’s really unique and scary’  – these types of things are actually really common when it comes to making things for humans to consume,” Marcu said.

Jahan’s words are not only true but if we look at the facts in comparison, it seems as if the media may be making too much hype and there are other things that could be focused on that are affecting lives daily – such as tobacco taking over 400,000 lives a year. 

“When you don’t have a lot of information, you can sensationalize stuff,” he said. “When there aren’t a lot of facts and hard data to turn to, in the absence of information, you see theories run amuck. We see this a lot. I think what we have to keep in mind is a lot of this stuff is observational, and it gives us a lead into what is a factor and whether or not it was a good factor or a bad factor in these situations. So I think there may be some secondary causes in some of these vape issues. Some of it could be related to using a combination of different products, it could be related to the products themselves in certain individuals that are susceptible, but we really have to get down to the point where we can predict, with reliability or a degree of probability, like THIS will happen if you use this product. We’re really not there yet and there isn’t enough data to say THIS caused THIS, but we do have some leads. There’s just a lack of data as to which of these compounds are safe for inhalation.”

Jahan, as well as the staff here at Dispense Magazine, assure anyone purchasing products from the PA Medical Marijuana program, that it is indeed safe to continue to buy medicine from your local dispensaries. At the very least, it is far less risky than purchasing something illicit.

“There is less of a risk in terms of buying a regulated product vs. an unregulated product,” Marcu said. “There’s also the issue that if there is a problem, they can track it and figure out what it is and take appropriate steps to either remediate it, address the health concerns, or prevent it from happening in the future. These places have inspections, there are standards for these products and the businesses want to stay open. Their business functions on repeat customers and transparency. If you want to get a product, you need to make sure it’s tested and trackable. End of story.”

Pennsylvania growers, processors, and dispensaries are professional operations offering some of the best medicine on the market and operate with great transparency. In fact, Pennsylvania Grower/Processors have been quick to respond and are making a concerted effort to assure their clients that their products are safe.

Most offered statements informing patients that they “do not use vitamin E acetate as an additive in any vape products, or cutting agents such as polyethylene glycol (PEG), propylene glycol (PG), vegetable glycerin (VG) or medium-chain triglycerides (MCT), which are used by many manufacturers.”

Some also reassured everyone that their “vaping hardware is produced by vendors that maintain the highest quality standards… and all products are third-party tested for any outside contaminants to ensure compliance with all applicable state laws.”

Find all available statements here.

Currently, the number of illnesses stands at 380 and a sixth death was reported Friday. The Centers for Disease Control and Prevention has updated and revised the national total of illnesses linked to the use of e-cigarettes, aka vaping, dropping the count from 450 possible cases to 380 confirmed and probable cases, the agency announced late Thursday.

The new figure follows a clearer clinical definition for the illness as well as further investigation into individual cases. The 380 confirmed and probable cases now span 36 states. The CDC added that the current number of cases “is expected to increase as additional cases are classified.”

Outbreaks such as this are generally a product of unlicensed markets where consumers have no legal alternative. It’s no different than recent Spice/K2 poisonings, as well as unregulated CBD market poisonings. The first reports came out of the prohibition state of Wisconsin, which has 35 cases, and Kings County, CA, which has banned legal access to tested cannabis, alongside 60% of local cities and counties; California has 67 potential cases and one death (all illicit market-related); Illinois has 52; New York reports 64 cases; Texas has 25 confirmed cases; On Monday, Kansas reported one suspected death; Minnesota has 28 cases. In contrast, Oregon has one suspected death and one suspected illness. Colorado has four suspected cases. On Wednesday, the state of Washington announced its first suspected illness.

Wisconsin police announced one related arrest Tuesday. California officials raided two unlicensed cannabis stores selling THC carts on Friday.

Most media reports indicate that illegal/street cartridges are to blame for these illnesses and deaths. The CDC is advising anyone who owns illicit vape cartridges to throw them away immediately. The CDC, FDA, and HHS advised consumers Thursday to avoid buying cannabis vapes or using products off the street. They are unregulated, untested, and are often contaminated. If you purchase an illicit market disposable vaporizer cartridge – either THC or nicotine – and it’s filled with the wrong additive at the wrong amount, using it carries the risk of immediate injury to your lungs.

As of now, the suspected diagnosis is a form of pneumonia. In many cases, symptoms and treatment mirror a condition called lipoid pneumonia, previously found in patients who inhaled mineral oil.

So far, scientists aren’t certain what is causing it, but New York health officials have confirmed that synthetic vitamin E oil (tocopheryl-acetate) is tainting most seized vape carts in that state. Pen makers report using it because it’s a cheap thickener. The FDA is now specifically looking at forms of vitamin E oil. New York has subpoenaed three thickener-makers – Floraplex, Honey Cut, and Mass Terpenes – after tests showed all three products were tocopheryl-acetate. On Friday, SC Labs of California found Floraplex’s Uber Thick to be almost completely composed of tocopheryl-acetate. As of today, a Google search for Honey Cut revealed they have recently closed, and a search for Mass Terpenes shows the site is offline.

The FDA has received about 120 samples for testing. So far, they’ve found vitamin E acetate in 10 of the 18 THC samples. The FDA is testing seized carts for THC, nicotine, cutting agents called diluents, additives, pesticides, opioids, poisons, and toxins. One New York patient who tested his cart found it contained formaldehyde, pesticide, vitamin E oil, and “a little dab of THC.”

Health officials have confirmed that among the tainted carts are ones with the brand names Chronic Carts, Dank Vapes, and West Coast Carts, but the condition is linked to multiple illicit market brands across multiple states.

In a post shared on LinkedIn and Twitter, Constance Therapeutics of California confirmed earlier this week that the company holds a patent on the use of alpha-tocopherol in a vape pen for medical cannabis patients and insists the product is safe for inhalation.

Founder Constance Finley said she developed it in consultation with an oncologist and has witnessed it used by more than 5,500 sick cancer patients.

“We do not have a single reported case of lung distress that has come to our attention,” said Finley.

Finley pointed out the distinction between the alpha-tocopherol her company uses and the tocopheryl-acetate found in some illicit vape cartridges, citing a 2013 New York Times article and a research paper showing differences in lung reaction to different tocopherols. Finley said she considers tocopheryl-acetate unsafe to use in any vape cartridges.

On September 9, the American Medical Association urged the public to stop vaping any e-cigarette. The next day, President Trump mulled banning flavorings in legal e-cigarettes.

Officials urge anyone who has used a black market cartridge in recent days or weeks and subsequently developed shortness of breath, dizziness, nausea, weakness, and tiredness to see a physician and bring the cartridge with you. We at Dispense encourage you to bring the actual cartridge, not a legal one instead. Honesty with your health care provider is essential to a proper diagnosis. 

Stay tuned to DispenseMagazine.com for the latest on this, as well as related features.