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Carol King

 

During the Prohibition era, a harrowing story in the New York Times reported that 5 people had never made it through the 1922 Christmas Day celebrations as they died drinking “poisoned rum.”  This was not the only instance. In his book Prohibition, Edward Behr recorded 750 times that New Yorkers perished from alcohol poisoning, with hundreds of thousands more suffering blindness or paralysis as a result.  These alcohol-related poisonings occurred from drinking industrial methanol, also known as wood alcohol; a poisonous substance that was legally used in industrial and household products under strict government regulation but was fatal when otherwise consumed.  In Prohibition America, when legal alcohol was not available, people made their own “bathtub gin,” homemade rum and similar concoctions by mixing whatever methanol or solvents they could get their hands-on adding lots of spices and sugar to cover up the taste.

Fast forward almost 100 years to today, and we have what may also prove to be a case of poisoning in the epidemic of acute lung illness associated with vaping, and particularly vaping illicit THC cannabis oil throughout 38 states. Between August 23rd and September 21st, 7 deaths and 530 cases of lung illness have been linked to vaping.  Such a sudden outbreak in a particular geographical region, and in a short period of time, sheds doubt on the idea that the cause stems from well-established products like the e-cigarettes or vapes that have been available worldwide for over 12 years.  More likely, investigators suggest that a poison has affected a new product, ingredient or part of the production process; either in the huge underground illicit market, the legal market, or both.  So far it is still under investigation by health authorities at the state and federal levels, and they are focusing on whether toxic chemicals have indeed made their way into vaping products.

Primarily introduced for adult use as a tobacco replacement, vaping involves heating up (rather than burning) a liquid that consists of nicotine, flavoring agents (7-8000 of which are available), propylene glycol, or vegetable glycerine.  It is heated to a high temperature which then vaporizes that liquid into an aerosol. People then inhale the aerosol into their lungs.  The nicotine gives their brain the nicotine hit that its craving, while the flavors make it all more palatable.  The CDC and public health scientists investigating vaping and its link to the recent lung illness outbreak have indicated that scans show pneumonia like symptoms, but there is no infection present, so something the patients are inhaling may be causing their lungs’ immune system to react.  Many who have become ill were vaping cartridges containing THC (the chemical extracted from cannabis) so their lungs may have got inflamed by the vitamin E oil used to dilute THC on the illicit market, or by a dirty batch of THC itself.  The CDC has stated that 80% of the cases involving illness or death have been tied to vaping illicit marijuana/THC carts, not legal vapes or e-cigarettes.

Evidence of the availability of dirty THC had already emerged in Spring 2019 when a testing lab in northern California identified certain contaminants in illegal or homemade cannabis oil that are extremely dangerous when heated.  After a bust where $5 million worth of illegal cannabis vape cartridges were seized in Mendocino County California, the Sheriff had the oil tested and the lab report found it to be contaminated with a whole range of pesticides and one specific fungicide – myclobutanil. Myclobutanil releases a fatal cyanide when it is heated to 400 degrees.  In the tested batch, the concentration of myclobutanil was 7300 times the legal amount allowed by California’s pesticide regulations.  Another troubling fact emerged when David Kurzfeld, who owns Modular Processing Systems, a lab that cleans up contaminated oil for the licensed Cannabis industry, pointed out that not only is some of the oil they clean really badly contaminated with pesticides, fungicides and toxins, but that growers who process cannabis for the illicit market don’t have their oil tested or cleaned.  As he stated, “you can’t have your illegal marijuana tested in a state licensed lab if you don’t have a state license to grow it.”  He also noted that it is common practice even among legal cannabis producers to sell off any contaminated products that don’t meet state standards cheaply on the illicit market.

Another bust, this time in Wisconsin, illustrated another way bad THC gets into the illicit vaping oil or vape cartridge market.  In this case two Wisconsin brothers, Tyler and Jacob Huffhine, were running what is known as a “pen factory,” an important cog in the distribution of tainted cartridges. Pen factories buy empty vape cartridges and fake packaging from China, then fill them with U.S. bought THC liquid, which may or may not be contaminated itself.  Similar to methods used in other illegal drug operations, they then cut their product with other substances. This is not to say that they are intentionally including ingredients that can harm, it is an exercise in cost savings. They do this by diluting the more expensive THC ingredient, with oils that cost far less.  For example, THC can cost $4000 a kilo for medium grade or $8000 for high grade, but additives can be purchased for $100 a kilo. The result is a product that looks like the THC vaping products sold in states such as California and Colorado where cannabis is legal.  In the Wisconsin case, the vaping cartridges seized had logos resembling legal brands, (e.g. Dabwoods instead of the legal Blackwoods) and other fake versions of the legal Chronis Sour Patch and Dank King Louie.  Police investigating the case say the Huffhines brothers were producing about 3000 cartridges a day.

In the investigation being conducted by New York authorities, they are testing for THC, nicotine, cutting agents (diluents and thickeners), poisons, and toxins. They have confirmed that a synthetic vitamin E oil, formally called tocopheryl acetate is tainting most of the seized cartridges.  Makers say they are using it because it’s a cheaper cutting agent, however the effects can be linked to the recent deaths and illnesses because the mineral oil is inhaled.  One of the symptoms of Lipoid pneumonia is weakness, and this is caused by a lack of oxygen moving through the body due to the diseased lung. When a person inhales an oil, such as tocopheryl acetate (synthetic vitamin E oil), it interferes with the fluid lining the surface of your lungs which normally allows your lungs to transfer oxygen into your blood.  The oil coats the fluid and prevents it from doing its job. In return, the body produces an inflammatory immune reaction, and attempts to purge the oil. When this fails (which it always does), the cells die. This prompts the immune system reaction and starts doing more harm to the body than the oil did in the first place. If doctors are unable to diagnose and prescribe steroids quickly, the patient’s lungs may never recover.

The New York findings also correlate with reporting in California that found a new diluent known as Honeycut had entered the illicit vape cartridge market in late 2018.  When tested independently, Honeycut was found to contain tocopheryl acetate (synthetic Vitamin E oil), and two manufacturers confirmed to reporters that they do sell it to the vape cartridge market.  More problematic, is that in some states tocopheryl acetate is actually legal to use, despite very little research about its toxicity. This may explain the case of one victim from Oregon, who died even though he only reported using vape cartridges purchased legally. Oregon allows tocopheryl acetate use in vape cartridges if the ingredient is disclosed on the label.  In fact, Mr. Extractor of Oregon, a manufacturer who sold diluents into the vape cartridge market, provided evidence that while his product contained the vitamin E oil, he had obtained permission to use it from the Oregon Liquor Control Commission and thought it was safe.

The tragedies that occurred during the prohibition era, like alcohol poisoning and others, as well as the recent epidemic with vaping, pose an interesting dichotomy in America. The principle of individual freedom is vitally important, but there is also a role for government in terms of regulation, and also ensuring the safety and standards of products consumed by the people.  For the issue of vaping, and the safe use of certain chemicals like the synthetic vitamin E oil being added to consumables however, American authorities have yet to set down a streamlined standard and process for the market.  Standards are applied through bodies like the Food and Drug Administration (FDA) and the 2009 Tobacco Act, which granted the power to regulate any new tobacco and nicotine products that came on to the market. Yet, the recent epidemic and even earlier instances of synthetic substances in vapes, reinforce the fact that products have entered the market before the government was prepared for effective regulation. This also highlights the lack of sound enforcement of existing law, as well as sound enforcement of the ban on underage sales.  In some ways, on this issue, the FDA is not providing adequate support or confidence to producers or consumers.

For example, by May 2020 manufacturers will be required to submit pre-market tobacco applications (PMTA’s), which include separate applications for every component or part, as well as comprehensive studies and toxicological testing that might cost millions for each product.  Each separate combination of devices will have to be proven “appropriate for the protection of public health” but no standard technical guidelines were outlines, which made it difficult for business owners to know what the requirements would be to ensure market approval.  Current rules also mandate the minimum purchase age of 18, a ban on free samples, and left open the possibility of a flavor ban at a future date.

Opponents of vaping and e-cigarette products have long-campaigned against “kid-appealing flavors” in tobacco products, arguing that because the FDA had banned flavored cigarettes (except menthol), flavors should also be banned for other tobacco products- including bottles of e-liquids.  For vaping businesses however, a flavor restriction would be the worst outcome. Flavored e-liquid is one of the most profitable and attractive to consumers. Presently, vaping manufacturers do not need to list their ingredients and there are thousands of different flavors available, all with different formulations.

 

Noting a substantial increase in the number of high school students who vape, along with the 8 recent deaths and the outbreak of lung illnesses, the Trump administration proposed banning flavored cartridges (carts) for e-cigarettes and vapes in the coming months.  At the state level, Michigan went further and became the first state to enact a total ban on all flavors except tobacco flavor.  New York announced their intention to take harsh regulatory measures, and California, New Jersey and Massachusetts are looking at similar proposals. They may be correct to err on the side of caution, especially with a product that hasn’t been diligently explored. Researchers don’t have decades of epidemiological data to ascertain the risks. Recall that heroin was once marketed as a safe alternative to morphine before its harmful consequences were established.  Still, the epidemic has also reared its head in Europe and the UK, where vaping oil is more tightly regulated. In fact, one of the chemicals used to make synthetic vitamin E oil, trimethylhydroquinone, is actually banned in the EU due to its potential carcinogenic effects.

While we await the final conclusions from the ongoing investigations into the spate of deaths and illnesses, as well as details of the FDA’s proposals on flavors, it is worth reiterating an earlier point: that for Americans, individual freedom is of vital importance. There needs to be a balance between people’s freedom, ensuring high safety standards, and keeping minors safe too.  We should also make sure that the issue of adult vaping is considered in the context of reducing the tobacco related harm associated with traditional cigarettes, one of the reasons the vape industry was born in the first place. It is similarly important to note that voters can be motivated by single issues they care about. Vape use has the potential to be such an issue.  For example, in 2016 President Trump won Michigan by 11,000 votes and FDA funded survey data finds that 5.4% of adults in Michigan vape, which works out to represent 423,000 adult vapers in Michigan.  ATR polling shows that 4 out of 5 of these adults consider themselves single issue voters on the issue of vaping. This is a statistic that is mirrored in 12 key swing states.