Oct 25, 2022,12:00pm EDT
Confusion clouds Utah’s medical cannabis industry as products loaded with synthetic cannabinoids appear on shelves, indistinguishable from typical products made from the real thing: cannabinoids found in abundant amounts naturally.
Hot hemp grown in Utah is making its way into Utah dispensaries as CBD is synthesized into delta-8 THC, and a variety of other cannabinoids, which the FDA says poses “serious health risks.” Sometimes delta-8 THC is further processed into THC-O. Many other cannabinoids, reagents, and byproducts with unknown risks are being detected.
They’re aggressively marketed, made from hemp using solvents in a chemical process, but often promoted as psychoactive. Going a bit beyond simple extraction, the CBD molecule is modified to make hemp derivatives psychotropic, which requires a solvent plus an acid to serve as a catalyst.
Per the 2018 Farm Bill, any hemp plant, or derivative thereof, that contains more than 0.3 percent delta-9 THC on a dry-weight basis is hot and noncompliant.
But the state cleverly provided a pathway for federally regulated hemp derivatives to enter into the autonomous state program for the manufacturing and sale of medical cannabis, without an autonomous program for industrial hemp. This includes the manufacturing of an agricultural commodity—CBD biomass and other hemp derivatives—for the sole purpose of developing a psychotropic synthetic derivative sold in Utah’s medical cannabis program.
Industrial Hemp (Cannabis sativa) growing commercially. (Photo by: Edwin
Remsberg/VWPics/Universal Images Group via Getty Images)
VWPics/Universal Images Group via Getty ImagesThat could be a violation of federal law, according to groups including Utah-based patient advocacy group TRUCE (Together for Responsible Use and Cannabis Education) and the Arizona-based FOCUS (Foundation of Unified Cannabis Standards).
On October 21, the Utah Department of Health and Human Services (DHHS) released a bulletin to Utah medical cannabis patients regarding the detection of synthetic cannabinoids in state sponsored medical cannabis sales. The DHHS now requires that if a medical cannabis product contains a synthetic or derivative ingredient, the label will include the following statement: “This product contains a derivative and/or synthetic cannabinoid.” But some advocates say it isn’t enough.
Defining Synthetic Cannabinoids
“Our biggest concern is Title 26 Utah Health Code Chapter 61a Utah Medical Cannabis Act doesn’t define synthetic cannabinoids,” says TRUCE Founder Christine Stenquist, who helped shape Utah’s medical cannabis effort. “We see the introduction of synthetic cannabinoids in Title 4 Utah Agricultural Code Chapter 41, Hemp and Cannabinoid Act.”
Stenquist led the charge to push both local and federal regulators to address the issue of syntheticcannabinoids and unwanted byproducts. TRUCE adopts a patient-first philosophy, which means the cleanest flower and no delta-8 THC.
Makers of delta-8 THC and other cannabinoids thrive in the grey area, due in part to the way it’s defined. “The grey areas surrounding the use of multiple nomenclatures, which carry the same meaning by definition, in numerous, yet separate sections of State Code, have caused extreme confusion and should be a concern to regulators, industry participants, and patients alike,” says FOCUS President and Founder Lezli Engelking.
Many medical cannabis processors in Utah are producing refined distillate and oil showing large amounts of unknown compounds, previously not seen before. In a recent test sample obtained through a Utah processor, strong indications that cannabinoids such as delta-6a10a THC are being detected, and spikes in the samples indicated unknown byproducts. In some cases, these unknown signals compose over 20% of the sample by weight.
“In our state, by law, Utah considers D6a-10a a naturally occurring cannabinoid, not a derivative or a synthetic,” Stenquist says. “Our inquiries through calls and email exchanges over the past month with subject matter experts Dr. Ethan Russo, Dr. Muhammad Elsohly, and Dr. Chris Hudalla indicated that this is, in fact, a synthetic byproduct of a poorly processed flower.”
In Stenquist’s email exchange with the Utah Department of Agriculture and Food (UDAF), it was suggested these were “naturally occurring cannabinoids, but they aren’t produced in abundance by the flower.”
The Department continues, “They occur in greater abundance in cannabinoid concentrates extracted with ethanol. They have been present in such concentrates since the beginning of the program, and they are present in these concentrates in other states as well. The reason we started investigating them was that they started showing up in larger amounts in some concentrates and we were concerned about producers not controlling their extraction and distillation processes
sufficiently. We have seen no evidence that these cannabinoids are harmful to human health, but we are monitoring their presence and literature on them out of an abundance of caution.”
If a patient wants to avoid delta-8 THC and similar compounds, good luck telling those products apart from typical delta-9 THC products, given the fine print on COAs.
“My concern was that this has been occurring since the beginning of the program. Patients have complained about the quality since the market opened,” Stenquist says. “By law, the Department must keep a list of registered cannabinoid products that the Department has determined, under Section 4-41-403, safe for human consumption.”
State regulators in Utah and beyond aren’t necessarily concerned about delta-8 THC and similar cannabinoids. UDAF responded in an email, “… we have seen no evidence to suggest that they are any more harmful than any of the other cannabinoids listed on the COA.”
The Industrial Hemp Production Plan submitted by UDAF to the US Domestic Hemp Production Program states they recognize that hemp may not be introduced into commerce and must be destroyed if it exceeds the allowable concentration of THC: “All industrial hemp plant parts resulting from a lot or harvested plant material represented by a sample with a THC concentration greater than the acceptable industrial hemp THC level shall be prohibited from being further handled, processed, or entered into the stream of commerce.”
Yet in multiple instances, the Department has made rules defining “industrial hemp waste” as both “(a) a cannabinoid extract above 0.3% total THC derived from verified industrial hemp biomass; or (b) verified industrial hemp biomass with a total THC concentration of less than 0.3% by dry weight.”
This rule paved the way for the allowance of cannabis cultivation facilities to purchase and enter into the inventory control system, Stenquist says. Under their rule-making, “Industrial hemp waste” described in this Subsection (5)(a) is considered to be cannabis for all testing and regulatory purposes of the Department.
“Like the rest of the country,” Stenquist says, “our state had a massive over-production of CBD industrial hemp. Processing ‘cannabinoid products’ from Industrial hemp into various cannabinoid analog profiles is less costly to the producer than cultivating cannabis from seed. In June 2019, the Ag department began the rule-making process for the cannabis program claiming authority from Title 4 Utah Agricultural Code Chapter 41, the Hemp and Cannabinoid Act, which does not provide authority for the medical cannabis program. In this rule-making process, utilizing the Hemp and Cannabinoid Act, we begin to see the marrying of industrial hemp into the medical cannabis program.
They did this by defining cannabis processing facilities as ‘a person that: a) acquires or intends to acquire cannabis from a cannabis production establishment or a holder of an industrial hemp processor license under title 4, chapter 41, Hemp and Cannabidiol.’ However, in the Medical Cannabis Act definitions: (4) ‘Cannabis cultivation facility’ means the same as that term defined in Section 4-41a-102. (5) “Cannabis processing facility” means the same as that term defined in Section 4-41a-102. And yet, Section 4-41a-102, Part 1, Industrial Hemp Section 102 Definitions. (Effective 5/4/2022)
“There are no definitions for either a cannabis cultivation facility or a cannabis processing facility,” Stenquist says.
Per Utah Administrative Code, the State allows for a whopping 10% difference between the indicated amount and the actual amount of a given cannabinoid in a product, and requires that any concentrates containing derivative or synthetic cannabinoids need to be isolated to greater than 95% known cannabinoids. A 5% margin of error is allowed for variation in testing for the derivative and synthetic cannabinoids. There are currently no limits placed on the amount of a cannabinoid that a product can contain, but producers are required to indicate the amounts of each cannabinoid that a product contains and indicate if a cannabinoid is synthetically derived.
As cannabis produces THC in response to UV light, in high elevations like Utah there is more UV light. That said, almost all hemp crops grown outdoors Utah are likely to test over the legal THC limit, regardless of genetics.
Despite the herculean efforts to keep hemp from going hot, processors turn around and reactivate delta-8 THC and other cannabinoids in many states, and it’s tolerated in many jurisdictions.
Extraction technician Jacob Ostler filtering out hemp plant material from 99% isopropyl alcohol for extraction at CW Hemp. March 10, 2017. (Photo by Joe Amon/The Denver Post via Getty Images)
ProVerde Laboratories was established in 2013—one of the first ISO 17025-accredited analytical laboratories specific to cannabis, focusing on the required regulatory testing of marijuana products. In the last few years, ProVerde has seen synthetic cannabinoids starting to dominate much of the hemp industry, and now even the marijuana industry.
“We have tested thousands of delta-8 THC based consumer products, and in all those thousands of samples, have not yet seen one that is not contaminated,” says ProVerde President and Chief Scientific Officer Christopher J. Hudalla, Ph.D. “Typical levels of contamination from synthetic byproducts, most of which are not found in nature, can range from 3% to more than 30% of the
total product. As compounds never observed before in nature, they have not been studied for efficacy or toxicity. We put a note on each certificate of analysis that says: In addition to compounds reported here, multiple cannabinoid isomers or byproducts, which do not occur naturally, were observed in this sample and cannot be identified. No toxicity data is available for these unknown compounds, and as such would not be recommended for human consumption.”
Stenquist and others are concerned about the way these products are sourced. “One of the early vendors here didn’t have enough product on the shelves and so they brought hot hemp from the hemp side of it over to the THC side of the medical program. [Another said] how CBD biomass showed up in his lab and he was instructed to make something out of it. Just CBD biomass—like just sludge.”
“That’s really concerning to me as a patient, a brain tumor patient,” Stenquist says. “The whole point in having patients in a program like this is to have safe, clean products, and to get patients off the black market. This is driving patients back to the black market. But now they feel emboldened, they’ve got their medical card. But why should I use the state’s dirty product? You know, it sends some really weird messaging right now to our patients.”
Are Delta-6a10a, Delta-8, and Delta-10 THC Safe?
The short answer is we don’t know conclusively if cannabinoids like delta-8, delta-6a10a-THC and delta-10-THC are safe.
As a board-certified neurologist, psychopharmacology researcher, and author, Dr. Ethan Russo, also serves as the founder and CEO of CReDO Science an intellectual property holding company devoted to research and development in the cannabis and endocannabinoid system.
“Although I do not recommend banning such substances, as prohibition of these and other compounds has proven ineffective and often counter-productive, I do feel that synthetic cannabinoids should be excluded from state-sponsored sales,” Dr. Russo said in response to concerns raised in Utah.
“Very simply, while delta-8, [delta-6a10a], and delta-10 tetrahydrocannabinol (THC) isomers can be found in herbal cannabis, it is usually in trace amounts,” Russo continued. “Their occurrence in that context is probably safe for human use at low doses. In contrast, many products available in commerce contemporaneously are synthetically manufactured, usually from cannabidiol, and often appear in doses that would never be found in natural products. It is possible to make a blanket assertion that all products with delta-8 THC content of significant concentrations are contaminated with [delta-6a10a] , delta-10 THC, possibly other isomers, and residual solvents, making them public health risks. To date, no formal studies of [delta-6a10a] THC or delta-10 THC have been done with respect to their toxicology (poison potential), pharmacokinetics (appearance and breakdown in the body), let alone their pharmacodynamic effects in humans.”
“As such, it is my formal professional opinion that all cannabis-based products sold in Utah and elsewhere should be accompanied by a certificate-of-analysis (CoA) on each batch of material, and that no synthetic cannabinoids should be endorsed for commerce by any state agency,” Russo said.
Hudalla acknowledged the size and scope of the delta-8 THC industry, but it’s a compound that isn’t necessarily proven safe.
“I have significant concerns about the synthetic cannabinoids which are being widely distributed throughout the U.S.,” Hudalla said. “In my opinion, the distribution of synthetic cannabinoids is one of the largest consumer fraud cases in history. This year, the market for delta-8 products has been estimated at almost $10B. That is a large market for a mixture of products that “might not harm you.”
Hudalla added that most laboratories and regulators are treating these novel synthetic compounds as agricultural products—but these products are not agricultural in nature. They most likely won’t have traditional agricultural contaminants, but instead synthetic contaminants—almost all of which are not part of a typical cannabis safety screen.
“We have zero data that shows these are not toxic, that they do not cause birth defects, cancer, or other long-term health implications,” Hudalla said, however adding that they ‘probably’ are not toxic. “But who knows?” he said. “Most of these have not even been studied yet in animal models, much less on human subjects…..except through the widespread distribution of these products with no safety profiles. Essentially, we are using, in real-time, unsuspecting consumers as guinea pigs to see if there are any long-term negative health impacts from consumption of these synthetic products. Imagine if the pharmaceutical industry tried this approach to drug development.
Delta-8 THC products are tolerated in several states to some degree.
“Much of the industry has obscured the truth about these synthetic concoctions, by framing the debate around whether delta-8 THC is legal under the US Farm Bill,” Hudalla said. “And with that diversion are obscuring the fact that delta-8 THC does not exist in the consumer market, at least in any consumer safe form. What is in the consumer market does contain delta-8, but in a mixture of synthetic reagents and byproducts with unknown toxicity. That fact seems to be omitted from all of the public and regulatory discussions on the topic. I have heard multiple times from regulators and public health professionals, that they do not want to limit or ban these products because we do not know for sure if they are dangerous. Contrary to that, my belief is that it is the regulators and public health professionals have the responsibility to limit or regulate these products until we know they are safe.
“To say I have significant concerns about the widespread distribution and consumption of these products would be an understatement.”
Joe Dougherty, communications director for the Utah Department of Health and Human Services provided the following statement: “The safety of patients participating in the state medical cannabis program is always our highest priority. We want to provide individuals and their families with all available information so they can make informed decisions about their health, and the health of their loved ones.”
Current Utah law includes the following requirements:
∙ That all cannabis products are independently tested in a laboratory (4-41a-701) in order to identify and quantify any cannabinoids.
∙ That products follow best practices regarding human safety standards (4-41a-603(4)).
∙ That ingredients are clearly displayed on a labeled container (4-41a-701(4)).
“The Utah Department of Agriculture and Food (UDAF) and independent Utah laboratories, only test products to determine what cannabinoids they contain. UDAF relies on experts at the FDA, USDA, DHHS, and other similar bodies who have relevant expertise to make determinations on the safety of all ingredients.
“At this time, we have found no evidence showing harm or benefit from any of the synthetic or derivative cannabinoids that have been identified as present in medical cannabis products in Utah. We recommend that patients work with their healthcare provider or pharmacist to weigh the risks and benefits of using any product that contains an unfamiliar ingredient.
“There are several processes and entities, which help inform recommendations and guidelines for using medical cannabis products. Among them is the Cannabis Research Review Board, whose purpose is to review available research related to the human use of cannabinoid products and recommend guidelines that may be used by qualified medical providers and pharmacists who recommend cannabinoid products to their patients. The Utah Department of Health and Human Services works closely with the Cannabis Research Review Board, industry leaders, patient advocacy groups, medical providers, and the Utah Department of Agriculture and Food to provide transparency to patients on known risks and benefits of medical cannabis products so they can make informed decisions about their health.”
The Cannabis Research Review Board meetings are public and any recommendations based on the currently known evidence of these products can be found here.
Make your voice heard today. The DHHS Center for Medical Cannabis is holding a Medical Cannabis Market Analysis Public Input Meeting today on October 25, 2022.
Updated with clarity from the Utah Department of Health and Human Services at 6:22 pm.
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