Inherent Dangers in Designer CannabinoidsWhy lawmakers and regulators need to move faster to regulate lab-produced cannabinoids.
Advocates for cannabis and hemp legalization started their mission decades ago. Since then, hundreds have led the charge to change the stigmas and stereotypes associated with cannabis consumption and open the necessary pathways for the legal cultivation and production of these highly functional plants.
However, like most consumable products, without regulation and control, the temptation of profits can lead to unethical activities. Dan Brackett from ArgosRM Food Safety once said, "Compliance is not synonymous with due diligence; in fact, it's only a component of due diligence."
Imagine learning that your favorite bottle of whiskey contained methyl alcohol or your favorite sandwich from the corner deli was made with expired meats or salmonella-infested spinach. Similarly, the tobacco industry has frightfully displayed what happens when consumers use contaminated products. Corn, wheat, and soybean production, along with the pesticide use therein, is creating cancer hotspots and health crises all across the country.
The cannabis and hemp industries are not, and should not be, exempt from observing safety regulations in the cultivation, extraction, and production of any consumable product.
Designer Cannabinoids and the Inherent Dangers in Playing with Chemistry
Sadly, the rise of designer cannabinoids combined with a lack of oversight has produced a pathway to profit without requiring due diligence or acquiring any discipline. Without compliance, rules, and regulations, there can be no due diligence, and a recent report filed by the US Cannabis Coalition (USCC) regarding Delta-8 products illustrates what can happen when consumable products are produced in an industry with no regulation or oversight.
USCC Reported Findings in Delta-8 THC Products
In April of 2021, the USCC, in partnership with ProVerde Labs, tested 16 samples of Delta-8 THC products obtained from non-regulated retail operations located in California, Florida, Nevada, Texas, Michigan, Massachusetts, North Carolina, and Indiana. Here are a few statistics from their results:
- Only one of the 16 samples had compliant amounts of Delta-9 THC. All others ranged from 1.3% to 5.3% Delta-9 THC. The mean Delta-9 concentration was 10 times more than the legal limit of .3% of hemp-derived THC.
Heavy Metals and Contaminants
- Lead was found in 4 out of the 16 samples.
- 7 samples failed USP limits for copper, chromium, and/or nickel.
- Every sample contained 7-10 unknown compounds with unknown toxicological significance.
- Dichloromethane and methanol were found in one sample.
- Hexane was found in three samples.
- Acetone was found in every sample.
- Ethanol was detected in 13 samples.
- Heptane was found once.
- Isopropanol was in 9 of the 16 samples tested.
The study did mention that "all detected levels of residual solvents were below the US limits for inhalation." However, as a habit-forming substance and a medical or recreational product, producers cannot determine or limit how much of a particular product consumers use. Many consumers use these products every day, several times a day.
According to chemical safety data sheets, this may be cause for serious concern. Here are a few excerpts about these chemicals:
- Methylene-chloride, or dichloromethane, is listed as a "probable human carcinogen," and the major effects from chronic inhalation exposure to methylene chloride in humans include effects on the central nervous system such as headaches, dizziness, nausea, and memory loss.
- Chronic inhalation exposure to hexane is associated with sensorimotor polyneuropathy in humans, with numbness in the extremities, muscular weakness, blurred vision, headache, and fatigue observed.
- According to the CDC, long-term exposure to inhaled Acetone may cause kidney, liver, and nerve damage, as wells, increased congenital disabilities and lowered ability to reproduce in animal studies.
- Repeated inhalation of n-heptane can be irritating to the respiratory tract. Inhalation of fumes and vapors may cause headaches, dizziness, drowsiness, unconsciousness, and other central nervous system effects, including coma and death. While ingestion can cause nausea, vomiting, diarrhea, stomach pain, headache, intoxication, and heart failure.
- While the body knows how to break down alcohol, inhaling alcohol through vaping can cause alcohol poisoning much faster than ingestion. In fact, inhaling isopropyl alcohol can cause nausea, vomiting, irritation of the nose and mucous membranes, throat irritations, and even difficulty breathing.
Delta-8 is Only the Beginning
Kim Stuck, CEO and Founder, of Allay Consulting and former investigator for the Denver Department of Public Health and Environment, stated during an interview with Cannabis Tech:
"We didn't just legalize THC and CBD, there are all these other cannabinoids that exist naturally in the plant, and when you add chemists to the equation, now we are starting to see all of these other synthetic cannabinoids."
While Delta-8 THC is being produced and touted as "marijuana light" with less potent effects than the traditional Delta-9 cannabis products, another synthetic cannabinoid, THC-O Acetate, is emerging on the market on the opposite end of the spectrum. Suggested to be stronger than Delta-9, THC-O products may cause much more potent intoxicating effects and can be produced in much the same way as Delta-8 is being produced today.
Stuck explained, "they can take CBD, turn it into Delta-8, and then use acetic anhydride to make it into THC-O. So that's just adding another chemical step there, and few producers are testing for residual solvents or by-products."
"The problem is that these products are being sold outside of the context of regulation, without warnings on the labels or safety precautions," she continued. "And, all it's going to take is one person to be hospitalized because they had a nasty reaction to it, and it could affect the entire industry very negatively."
Stuck also emphasized that it's not all about consumption either. The process of making THC-O is extraordinarily flammable and extremely dangerous. "I have a feeling that people who are making this in their basement and unregulated labs are going to start seeing fires, and people are going to get hurt," she warned.
Ethical Producers Encourage Regulation
Although some producers believe the bans are monetarily charged, especially in states with legal cannabis, the truth is, chemical intoxicants must be regulated. Regulations level the playing field for all producers and ensure that consumers are getting safe, consistent products.
Vince Sanders, CEO of CBD American Shaman, stated during an interview, "You have a lot of people out there that couldn't care less about their fellow man. They're just interested in making a buck, and when you're in an unregulated wide-open industry like this, it's going to happen."
Sanders explained that American Shaman goes through in-house testing, as well as full-panel third-party testing. "Anything we do is tested batch by batch, piece by piece," Sanders stated.
Additionally, as a vertically integrated producer, they have a chemist and chemical engineer on staff. But maybe most impressively, Sanders said they even spot-check products from retail shelves and retain all of that data for three to five years, dated and barcoded.
"Safety is our highest concern. Our intention is to do good things for good people and be fortunate enough to make a living doing it. We're not going to jeopardize that by taking shortcuts," Sanders exclaimed.
Unfortunately for CBD American Shaman and other companies with good intentions, without regulation, less scrupulous producers have the advantage, and they are only being hurt by the companies who aren't playing by the rules. Elaborating on this concept, Sanders stated, "I have no problem with competition - as long as everybody's doing it correctly, right? Good players don't stand a chance in a market where bad players are allowed to keep doing what they're doing because they're going to take the cheapest route possible and use the shadiest processes."
"If you're not doing things in an appropriate manner, you may be doing more harm than good," Sanders concluded.
Stuck agreed with this sentiment in a separate interview. Speaking about the producers who are cutting corners, she said, "Those are the ones who really don't care, and they aren't concerned about their consumers – they're just in it to make a buck."
"Unfortunately," she continued, "for them, the industry doesn't matter that much."
Banning Cannabinoids is NOT the Answer, Regulation Is
As with most intoxicating substances, the knee-jerk reaction to controlling them is to make them illegal. However, like most professionals in the industry, Stuck believes that outright banning the production of these cannabinoids probably isn't the best approach and warns that banning the production of Delta-8 THC and other designer cannabinoids, such as Delta-10, THC-O, and newcomer, HHC, may backfire in the long run.
"If they're going to ban it, they're going to have to ban something new every single week," Stuck said. "They just need to be regulated in a way that makes sense so that people can take advantage of them. Who knows, maybe THC-O will be helpful with cancer patients someday."
But, as illustrated earlier, without formal regulations to dictate how the products are produced and mandating testing standards, consumers simply don't know what they might be consuming when purchasing a lab-produced product. Combine the lack of consumer knowledge with deceptive marketing practices, and you have a recipe for disaster.
"All it takes is one headline," Stuck warned, "just one negative headline has the potential to set back an entire industry and make us all look bad."