Professional Documents
Culture Documents
Issue n. 51
Maryland and
Missouri Vote The Evolution of
The Dark Side of
to Legalize the European
Psychedelic Trials
Recreational Cannabis Lab
Cannabis
Analytical Cannabis Digest
CONTENTS
04
What the Cannabis Industry Needs to
Know About Novel Synthetic
Cannabinoids
17
The Nose Knows Which Cannabis
Products Will Feel Good, Study
Finds
08
Oregon’s Cannabis Regulator Adds a
“Second Lab” Rule to Combat
Lab Shopping
20
Cannabis Smoke Impairs Endothelial
Function Regardless of Cannabinoid
Profile, Study Finds
09
Another California Lawsuit Alleges That
a Cannabis Company Exaggerated
THC Levels of Products
23 The Evolution of the European
Cannabis Lab
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02 | Analytical Cannabis Digest
December 2022
Two years ago, at the tail-end of 2020, US voters gave their single
greatest collective endorsement of legal cannabis. Alongside the 2020
presidential election, five states asked voters whether they wanted
legal access to cannabis. All five ballot measures passed. Jack Rudd
It was a feat that was always going to be hard to top. Perhaps it’s no
surprise, then, that this time around, alongside the 2022 mid-term
elections, cannabis was a little less successful at the ballot box.
Voters in two of the states, Maryland and Missouri, approved their
legalization measures. Voters in Arkansas, North Dakota, and South
Dakota, however, rejected their respective proposals. Leo McGuinness
Read the full details of the story in this, the 51st Analytical Cannabis
digest. And read on to learn the latest developments from the world
of cannabis testing and science.
Mariana Gil
In the world of research, we speak to the authors of a new study
that found that cannabis smoke impairs the body’s endothelial
functions, regardless of whether the cannabis was CBD- or
THC-rich.
analyticalcannabis.com | 03
Analytical Cannabis Digest
D
elta-8-THC does occur naturally in cannabis, This is exactly what Chris Hudalla, president and
but only in trace levels. To get substantial chief scientific officer at ProVerde Laborato-
quantities of the compound, it must be syn- ries, explored in his latest webinar for Analytical
thesized via a semi-synthetic isomerization process Cannabis, “Changing potency landscapes: Emer-
from cheap and readily available CBD. gence of synthetic cannabinoids”.
But such synthetic processes pose a number of im- Hudalla discussed the reaction pathways used
portant questions for the industry. Firstly, is this in these synthetic processes, highlighted the
process legal? And, if so, is the process safe? complexity of analyzing the resultant synthetic
product mixtures, and discussed how these syn- “In each of these regulatory statements, it’s clear
thetic cannabinoids are already impacting the that the delta-8 is not necessarily the culprit of con-
commercial landscape. cern,” Hudalla said. “It’s more the production in an
unregulated environment, and the fact that these
contaminants exist that very little information is
Semi-synthetic cannabinoids: a legal available for.”
gray area
The latest FDA release reminds consumers that
The Agricultural Improvement Act of 2018, also delta-8 THC products have not been approved
known as the Farm Bill, effectively legalized the or evaluated by the FDA for safe use. Addition-
production of industrial hemp as well as “any part ally, the FDA highlights that the making of these
of that plant, including the seeds thereof and all products can involve the use of harmful chem-
derivatives, extracts, cannabinoids, isomers, acids, icals, with the potential for other compounds
salts, and salts of isomers” so long as the total THC of unknown safety to be generated during the
content of the plant is less than 0.3% by dry weight. synthetic process.
Whether it was the intent of the lawmakers or “These products are produced without regulatory
not, the inclusion of the words “derivatives” and oversight. In the process, many identified contam-
“isomers” has so-far allowed some in the can- inants are observed in these products, and no effi-
nabis industry to increase their scope and begin cacy or toxicity information is available for most of
producing semi-synthetically derived products, these contaminants,” Hudalla said. “The CDC has
such as delta-8 THC. recorded over 600 adverse events associated with
these products.”
Delta-8 THC has become a popular trend recently
as the cannabinoid is moderately intoxicating but Delta-8 THC and other minor cannabinoids are
exists in this legal gray area. produced by the cannabis plant in a very selective
manner. However, in a synthetic process, it be-
“The industry thought process is that hemp is le- comes much harder to control the stereochemis-
gal under the Farm Bill, [so] CBD extracted from try of the compounds being produced. As a result,
hemp is natural and, therefore, legal; trace levels the synthetic/semi-synthetic production of delta-8
of delta-8 THC have been observed in [hemp] bio- THC and other minor cannabinoids opens the door
mass and, therefore, is a natural product. And since to lesser-known isomers also being made.
delta-8 is naturally occurring, a derivative pathway
from CBD [to delta-8 THC] for production should To understand the potential dangers of this un-
be illegal,” Hudalla said. controlled stereochemistry, Hudalla points to the
thalidomide disaster of the 1950s and 60s. Thalid-
“The problem with that thought process is that omide was a drug used widely for treating nausea
conversion of CBD into delta-8 THC is not a nat- during pregnancy. But the drug had an enantio-
ural process,” he continues. “Many isomers are mer that could cause birth defects. Thalidomide
formed that are not naturally occurring. And so was quickly taken off of the market once these
there are both legal and consumer safety issues health risks were realized. The thalidomide story
that arise from some of these unknown isomers has since become an important lesson in the im-
and contaminants.” portance of evaluating isomers and enantiomers in
drug development.
analyticalcannabis.com | 05
Analytical Cannabis Digest
compounds that vary in terms of their carbon “tail” depending on the speed, which is based on ion mo-
length, and these can each have distinct proper- bility, these ions can separate further almost into a
ties. For example, delta-9 tetrahydrocannabiphorol second dimension.”
(THCP), which features a heptyl chain in place of
delta-9 THC’s usual pentyl chain, is approximately Currently, most labs are not focused on such com-
30 times more active than delta-9 THC when com- plex synthetic mixtures, and so when delta-8 THC
paring binding activities. products or products with similar synthetic origins
arrive for testing, it is likely that they are simply not
As Hudalla highlights, it is important to con- being detected and reported. This is something that
sider all these possibilities for synthetic or more attention and increased regulatory oversight
semi-synthetic processes, such as converting CBD could address, so that certificates of analysis are
into delta-8 THC. not inadvertently inaccurate by omission.
kilos of hemp biomass to produce one kilo of natu- Transparency and accurate labeling is critically
ral delta-8 THC extract,” Hudalla explained. important in the cannabis industry; consumers de-
serve to know what they are putting in their bodies.
“If we do a little bit of math on that $400 per kilo But through deliberately misleading product mar-
for the biomass, the raw plant material alone would keting and/or unsatisfactory testing methods that
be about $22 million to produce that kilo of delta-8 are not designed to handle these complex synthetic
extract. So if somebody’s telling you that they’re products, this is currently not guaranteed.
selling you natural delta-8, I would be a little
bit skeptical.” “Currently these synthetic products are synthesized
in a completely unregulated environment, giving
It is also possible to find cannabis f lower being sold rise to multiple contaminants of concern. Many of
on the market that is marketed as belonging to some these contaminants have not been identified and
special high delta-8 THC strain. Such products are most laboratories ignore their presence, making
frequently just regular cannabis f lower that has most laboratory COAs unreliable when it comes to
been sprayed with a diluted delta-8 THC extract, these synthetics,” Hudalla said. “More research is
Hudalla said, and so it comes with the same ques- absolutely required to understand these products
tionable safety risks. and those potential contaminants.”
analyticalcannabis.com | 07
Analytical Cannabis Digest
C
annabis regulators in Oregon have added a new products around different labs until one returns re-
rule to combat the issue of lab shopping. sults with high enough THC levels.
Cannabis companies in Oregon now face the “There’s a lot of voices that don’t want THC to be
possibility that their product samples may be sent to the sole factor and the skewed THC is something the
a second lab of the regulator’s choosing, so the prod- consumer fixates on and it’s not fair,” OLCC Com-
uct’s contents can be verified. missioner Matt Maletis said in a statement.
The new rule was approved by the Oregon Liquor The OLCC’s new second-lab rule mirrors another
and Cannabis Commission (OLCC) on November 17 recent effort by Pennsylvania’s cannabis regulator.
and will come into effect on January 1, 2023. In that state’s medical cannabis system, cannabis
producers are now required to have their marijuana
Lab shopping is a growing issue within the legal can- material tested by two different labs. The first test
nabis industry. Products with higher THC levels are should be carried out around the time of harvest; the
often considered more desirable by consumers, so second, after the cannabis has been processed into a
some cannabis companies are known to “shop” their sellable product.
T
wo California-based cannabis companies have This investigation was carried out at the behest of
been accused of inflating the THC levels of Weed Week, which published an article on its find-
their products. ings on September 8.
In a class action lawsuit filed on October 28, seen by The test results found that the King Roll Master Kush
Analytical Cannabis, a plaintiff alleges that pre-rolls x Cannalope Kush Infused 4-Pack pre-roll had a THC
sold by the companies Greenfield Organix and LPF content between 33 and 36%. This range is substantially
JV Corporation contain less THC than advertised. lower than the product’s advertised THC content, 47%.
The lawsuit follows another, filed by the same law- The plaintiff in the suit is said to have purchased a
yers on October 20, that claimed another company, King Roll product in March at a “premium” price, one
DreamFields Brands, had exaggerated the levels of that was justified by the purported high THC levels.
THC on the packaging of its pre-rolls.
“Plaintiff and the class therefore sustained an eco-
Into the lawsuit nomic injury and paid a price premium as a result
of Defendants’ false and misleading labels,” the
According to the lawsuit, Greenfield’s King Roll lawsuit writes.
pre-roll products first came under suspicion in Sep-
tember following an independent lab test of several The plaintiff seeks damages, equitable relief, attor-
California pre-roll brands. ney’s fees, and an injunction.
analyticalcannabis.com | 09
Analytical Cannabis Digest
Analytical Cannabis has reached out to LPF JV Cor- The practice is called lab shopping, and it’s a blight
poration, also known as Loudpack, for comment. on the cannabis testing sector.
The suit was filed by Christin Cho and Simon “We still see this today with lab shopping – cus-
Franzini of Dovel & Luner, LLP, the same law tomers, in some cases, seeking results to be guar-
firm that filed the recent lawsuit against anteed,” Jeff Journey, CEO of SC Labs, told
DreamFields Brands. Analytical Cannabis in July.
C
alifornia’s cannabis regulator has tightened officials, and local cannabis regulators for pro-
some of its rules and loosened others. viding valuable feedback and input during this
important process.”
In an announcement on November 10, the
Department of Cannabis Control (DCC) said that its
update “consolidates, clarifies, and makes consistent Some of the updates include:
licensing and enforcement criteria for commercial
cannabis businesses”. A new clarification that cannabis products intended
for inhalation shall only contain “cannabis, cannabis
“The adoption of these regulations represents DCC’s concentrate, terpenes, rolling paper, leaf, pre-roll
commitment to advance rational regulatory im- filter tips,” or ingredients permitted by the United
provements that remove unnecessary and burden- States Food and Drug Administration as an inactive
some regulatory challenges for cannabis operators ingredient for inhalation.
and advance protections for consumers,” DCC Di-
rector Nicole Elliott said in a statement. Tighter cannabis-advertising rules to prevent prod-
ucts from appealing to children. The terms “candy”
“I want to applaud the contributions of our many or “candies”, for instance, are banned from appear-
partners, including our licensees, public health ing on cannabis packaging.
analyticalcannabis.com | 11
Analytical Cannabis Digest
More f lexible delivery options for consumers liv- The removal of a previous requirement for cultiva-
ing in California regions with limited access to le- tors to weigh individual plants after harvest.
gal cannabis. Businesses will also be more able to
expand their vehicle f leets in response to demand A new rule for consumption lounges; they will now
and curbside deliveries, which were prioritized be able to sell pre-packaged food and beverages.
during the beginning of the pandemic, will now
be permanent. Further information on the new rules can be
found here.
A new minimum age requirement for employees at
licensed cannabis businesses; they must now be at
least 21 years old.
T
wo US states have voted to legalize recreational, Once the Maryland and Missouri policies are imple-
adult-use cannabis. mented, which could take months or years, the US
will include 21 states (and the District of Columbia)
As part of the US midterm elections, Arkan- that permit the use of recreational cannabis.
sas, Maryland, Missouri, North Dakota, and South
Dakota all had recreational cannabis proposals on
their ballots. Two wins and three losses for cannabis
Voters in two of the states, Maryland and Missouri, In Arkansas, voters rejected the marijuana measure,
have approved their legalization measures. Voters in Issue 4, which would have allowed adults aged 21 or
Arkansas, North Dakota, and South Dakota, howev- older to possess up to an ounce (28 grams) of can-
er, have rejected their respective ballot proposals. nabis. A 10% cannabis sales tax would have helped
analyticalcannabis.com | 13
Analytical Cannabis Digest
fund state law enforcement and operations at the buy and possess up to an ounce (28 grams) of can-
University of Arkansas for Medical Sciences. nabis and 0.14 ounces (4 grams) of concentrates. If
the ballot had been approved, the state’s legal market
The Arkansas legalization proposal lost by 56% to was set to open on October 1, 2023. There were no
44%, according to the New York Times. provisions for criminal expungements.
In Maryland, voters approved Question 4, which will The North Dakota legalization proposal lost by 55%
now allow aged 21 or older to posses up to 1.5 ounces to 45%.
(43 grams) or two cannabis plants from July 1, 2023.
The measure also allows those with criminal re- In South Dakota, voters also rejected their ballot
cords of cannabis possession to seek expungements. measure that would have legalized adult-use canna-
A “business assistance fund” will be established, too, bis. The measure would have permitted adults aged
to help fund small cannabis businesses. 21 and older to buy and posses up to an ounce of can-
nabis (28 grams) and to grow up to three plants for
The Maryland legalization proposal won by 67% personal use. The proposal didn’t include any provi-
to 33%. sions on cannabis sales taxes or criminal expunge-
ment.
In Missouri, voters also passed Amendment 3, which While most of the ballot measures were rejected by
will now allow adults aged 21 and over in the state to state voters, many legalization advocates are still cel-
purchase and possess up to three ounces (85 grams) ebrating the two victories in Maryland and Missouri.
of cannabis and grow up to six plants at home. A 6%
cannabis sales tax will help fund veterans’ health “A growing number of voters recognize that can-
care and substance misuse treatment. Automat- nabis policy reform is in the best interest of public
ic expungements will also be processed for people health and safety, criminal justice reform, social eq-
with certain non-violent marijuana offenses on their uity, and personal freedom,” Toi Hutchinson, presi-
criminal records. dent and CEO of the Marijuana Policy Project, said
in a statement.
The Missouri legalization proposal won by 53%
to 47%. “State-level legalization victories are what’s neces-
sary to move the needle forward at the federal level.
“It just shows that this is not a partisan issue,” John That is how we build cannabis champions in Con-
Payne, who led the Missouri campaign to legal- gress who are committed to taking meaningful ac-
ize recreational cannabis, told the Associated Press. tion to put an end to prohibition once and for all.”
“This is something that transcends partisan divides.”
T
he US Senate has passed a bill that would permit The bill moves on
more medical cannabis research.
The bill directs the Drug Enforcement Administra-
The bill, the Medical Marijuana and Can- tion (DEA) to help register practitioners to conduct
nabidiol Research Expansion Act, was passed by cannabis research, and manufacturers to supply can-
the US House of Representatives in July. It then nabis for the research.
went to the Senate, which passed it on Wednesday,
November 16. The bill also:
The act will now head to the president’s desk for • Requires the DEA to assess whether there is an
his approval – a first for a cannabis-specific piece adequate and uninterrupted supply of cannabis
of legislation. for research purposes.
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Analytical Cannabis Digest
• Allows physicians to discuss the potential harms “Our bill will make it easier to study how these
and benefits of cannabis and its derivatives (in- medications can treat various conditions, result-
cluding CBD) with patients. ing in more patients being able to easily access
safe medications.”
• Mandates the Department of Health and Human
Services and the National Institutes of Health to A previous iteration of the bill passed through the
report on the therapeutic potential of cannabis House and Senate back in 2020, but progress stalled
for various health conditions as well as the im- over concerns about a clause that would have permit-
pact on adolescent brains and on the ability to ted researchers to study cannabis from dispensaries.
operate a motor vehicle. With that clause revoked, the current bill is expected
to be soon signed by President Biden.
“There is substantial evidence that marijuana-de-
rived medications can and are providing major
health benefits,” Dianne Feinstein, one of three sen-
ators who introduced the bill into the Senate, said in
a statement.
W
hat makes a “quality” cannabis strain? Is it This finding could have wide-reaching implications
a high THC content? A certain terpene pro- for public health, the researchers say, as the results
file? According to a new study published appear to support an intra-industry campaign to
in Psychoactives, the most significant predictor of a de-emphasize THC in the marketplace.
cannabis strain’s appeal is its smell.
Based on data generated by volunteer judges at a local Pleasant subjective aromas predict
craft cannabis competition, researchers determined a pleasant experience
that THC dose, THC potency, and total terpene con-
tent had no significant correlation with whether the This study looked at 278 cannabis samples that had
judges reported an enjoyable experience. However, been entered into the 2019 and 2020 editions of the
a pleasant aroma was positively correlated with re- Cultivation Classic cannabis competition, held an-
ports of pleasant subjective effects. nually in Portland, Oregon. As a part of the com-
analyticalcannabis.com | 17
Analytical Cannabis Digest
petition, all samples were sent for cannabinoid and isolated. However, despite the terpenes’ role in
terpene analysis at a third-party testing laboratory. cannabis aroma, this study found that total ter-
pene content was not associated with an increased
A total of 276 volunteer competition judges were subjective appeal.
each given a sample kit containing samples from
between 8 to 10 cannabis strains entered into the This lack of relationship between subjective appeal
competition. Over the course of approximately one and THC potency, THC dose, and total terpene con-
month, the judges were asked to use each sample tent may have important consequences for public
and then answer an online questionnaire about each health, the researchers say. Past research has linked
sample’s subjective effects and desirability. This the frequent consumption of high-potency products
included ranking the appeal of each strain’s smell to poor mental health, as well as substance use prob-
and overall effects, as well as noting any changes to lems and an increased risk of psychosis.
mood. Additionally, the judges were asked to record
what method of consumption was used. The study’s findings could also support existing
efforts to de-emphasize high-THC products in
The study authors used this information to compile the marketplace.
a “composite appeal score” for each sample, which
could then be compared against other factors such as “The market here is dominated by THC, when really
the cannabis strain’s potency. the sophistication of the chemistry within the plant
is such that you should be evaluating the quality of
They found that a pleasant aroma was the stron- your cannabis based on something much broader;
gest contributor to subjective appeal. The strains based on a broader set of data points that give you
that smelled the most appealing were the most like- a more specific indication of what the effects will
ly to result in desirable subjective effects and pos- be,” Jeff Gray, co-founder of SC Labs, told Analytical
itive mood. The researchers also found that there Cannabis earlier this year.
was a high degree of consensus about which strains
smelled pleasant. The researchers suggest that the strong emphasis
placed on aroma might mean that the cannabis in-
dustry could benefit from adopting a model where
Want a feel-good strain? Ignore the cannabis is sold in a way where consumers can smell
THC label the f lower before purchase.
industry-level issues such as terpene drift, as Dr. For example, it was only last year that scientists dis-
William Vizuete, chief scientific officer at the odor covered what is responsible for cannabis’ distinctive
mitigation company Byers Scientific, previously told skunk-like odor — not terpenes, but volatile sul-
Analytical Cannabis. fur compounds (VSCs). And according to Dr. Alex
Guenter, Byers’ senior scientist, studying these sul-
“What we’ve been looking at lately is terpene drift, fur-containing thiol compounds can be very tricky.
or the eucalyptol that’s being emitted by the can-
nabis,” Vizuete said. “We need to know what those “Odor perception is related to the mixture of com-
emissions of those molecules are by strain and plant’s pounds, the ratios of the terpenes. And the thiols are
life cycle. And there’s hundreds of different strains, really important for how we perceive odors. And so
which means there could be hundreds of different we need to know the starting point, which is how
kinds of profiles.” the ratios are coming off these different plants,”
Guenter explained.
Terpene drift has become a hot topic as cannabis
reform has allowed for large-scale, outdoor, legal “And it’s a real challenge because the thiols are
cannabis and hemp farms to set up shop. Given the present a thousandfold less than the terpenoid com-
high numbers of volatile organic compounds that are pounds. It’s like looking for a needle in a haystack.”
produced by the cannabis and hemp plant, there was
a fear that these could taint other nearby agricultur-
al crops. Though one recent study on a hemp farm
and nearby wine grape farm did not find this terpene
drift to be an issue, research into cannabis odor and
the various factors which may affect terpene drift is
still very much in its infancy.
analyticalcannabis.com | 19
Analytical Cannabis Digest
E
xposure to cannabis smoke or cannabis vapor bis material. They found that exposure to smoke and
can lead to problems with endothelial function, vapor from all materials led to significant impair-
regardless of the cannabis’ previous drying treat- ments in endothelial function.
ment or its cannabinoid profile, suggests new research
presented at the American Heart Association’s Scien- This may have important implications for the gen-
tific Sessions 2022. eralizability of previous research into cannabis
and endothelial function, the researchers say, as
In this new work, researchers from the Division of past studies primarily worked with material from
Cardiology at the University of California San Fran- the University of Mississippi, supplied through the
cisco studied rats exposed to cannabis smoke and National Institute on Drug Abuse (NIDA).
vape aerosol generated from different lots of canna-
Function impaired regardless of drying or The researchers assessed the rats’ endotheli-
cannabinoid content al function using f low-mediated dilation (FMD)
tests administered pre-exposure and 10 minutes
For this study, the UCSF researchers used an auto- following exposure.
mated smoking machine with a special nose cone to
expose groups of laboratory rats to cannabis smoke They found that the rats’ performance in the FMD
or vaporizer aerosol, as if they had been directly us- test was significantly impaired after exposure to
ing inhalable cannabis. cannabis smoke and vapor, regardless of the can-
nabis material being used. Additionally, no signifi-
Five different batches of cannabis material were cant recovery of FMD was seen in the rats exposed
used in this study. Three batches were sourced from to cannabis smoke 30 minutes post-exposure.
NIDA and included a cannabinoid-depleted “pla-
cebo” product, a medium-THC and medium-CBD Based on these results, the researchers say that acute
product that had been dried aggressively under hot exposure to cannabis smoke or aerosol will im-
air, and a batch of similar composition that had been pair endothelial function, regardless of the source
dried gently. The fourth batch was a high-THC low- of the cannabis material, its composition, or its
CBD product from Biopharmaceutical Research drying regimen.
Company (BRC), an alternative Drug Enforcement
Administration-approved supplier. Commercially
available hemp cigarettes were also included. Real-world material
analyticalcannabis.com | 21
Analytical Cannabis Digest
For many years, this single cultivation facility at “It is important to note that we have previously
UMiss was the sole approved source of cannabis shown that cannabis smoke and cannabis leaf vapor-
for scientific studies in the United States. As a re- izer aerosol leads to impaired endothelial function,
sult, some began to question the research done using NIDA research marijuana,” Springer said.
on this material, and whether the findings were “The goal of this study was to show whether this
generalizable to the products actively being used result held true even if the cannabis being used was
by consumers. more like real-world material, i.e., higher THC lev-
els and more gentle drying conditions that don’t risk
“The different cannabinoid profile and different dry- losing as many volatile terpenes.”
ing regimen have been viewed with suspicion as pos-
sible reasons that our [past] results may not be rele-
vant to real-world cannabis,” Springer said. “These
were reasonable concerns, but our results here show Not only is poor
that these concerns are unfounded.”
endothelial function
correlated with increased
The importance of endothelial function
risk of coronary heart
The endothelium is a thin membrane lining that disease, but directly the
covers the walls of blood vessels and the inside
of the heart. But the endothelium is more than a reduction of endothelial
simple barrier between tissues and the blood; it function is a first step
is also an endocrine organ capable of releasing
substances that control vascular relaxation and con- toward atherosclerosis
traction and enzymes that control blood clotting and
immune function.
Moving forward, Springer and his UCSF colleagues
“Endothelial function is viewed as a mark of a healthy will be examining serum samples taken from the rats
vessel, in that various intrinsic properties of the cells that were exposed to the different materials used in
that make up the blood vessel wall are all working this study, to evaluate whether there are any differ-
properly,” Springer explained. ences in cardiovascular risk between the groups. If
so, Springer says that the team will look to identify
“Not only is poor endothelial function correlated whether these changes are mediated by the CB1 or
with increased risk of coronary heart disease, but CB2 cannabinoid receptors. Another study looking
directly the reduction of endothelial function is a at the differences in endothelial function after sec-
first step toward atherosclerosis later, and resulting ondhand smoke exposure is also currently underway.
from that, increased future risks of heart attacks and
strokes, as well as more specialized problems such as
erectile dysfunction.”
T
he lethargic legacy model of the contract ana- companies throughout the entire drug lifecycle from
lytical laboratory is proving increasingly insuf- ideation and discovery to clinical trials and regula-
ficient for the needs of the rapid development tory compliance.
of modern pharmaceuticals. Nowhere is this more
evident than in promising nascent drug research This is important as changes in the regulatory land-
areas, such as cannabis-based drug applications, ex- scape and the growing role of compliant data de-
plains QNTM founders, Justin Ihnken and Connor mand a level of agility and evolution for drug devel-
Murphy, in collaboration with Anthony Macherone, opers that laboratories need to constantly keep up
strategic technical scientist at Agilent. with, explains Ihnken.
Denmark-based QNTM Labs, is a fully licensed “There’s an increased focus on quality data across
EU-good manufacturing practice (GMP) analytical the entire lifecycle of pharmaceuticals and medical
laboratory taking a fresh approach to the role con- products, which the traditional contract laboratory
tract partner labs and the degree of expertise they model is proving to increasingly fall short of. This
possess. In contrast to the traditional contract lab created an opportunity to reinvent the way that
model, QNTM Labs favours a value-added holistic pharmaceutical companies interact with the labora-
method, working in lockstep with pharmaceutical tory services part of the industry.”
analyticalcannabis.com | 23
Analytical Cannabis Digest
Macherone agrees and adds that “data integ- “Cannabis-based drug development is interesting
rity, management, and archival are critical because there are hundreds of potentially relevant
in the modern laboratory and customers are compounds unique to the cannabis plant,” says Mur-
required to comply with an increasingly complex phy. “At the moment, however, there are limited
regulatory environment.” clinical trial data to substantiate product use cases,
which means the laboratory needs to play an even
larger role in identifying and measuring critical in-
Out with the old, in with the new formation surrounding cannabis APIs [active phar-
maceutical ingredients]. That’s what’s going to drive
QNTM has chosen to have its strategic approach decision making.”
championed by Agilent, a company that also recog-
nises the limitations of the contract lab model when
it comes to increasingly complex nascent industries, Driving an emerging Europe-led market
such as cannabinoid-based pharmaceuticals. From
product development to data management, the his- QNTM Labs operates a state-of-the-art EU-GMP
torical precision of laboratories is becoming increas- pharmaceutical facility that offers end-to-end sup-
ingly muddled with risks that can seriously affect a port for developing cannabis-based pharma prod-
laboratory and its reputation. ucts. The lab leverages its expert team of specialists
in pharmaceutical compliance and natural product
chemistry, who understand the complexity of han-
dling a biological pharmaceutical product that may
Cannabis-based naturally lack stability and be subject to degradation.
QNTM Labs’ mission is to improve transparency and Nurturing the green shoots of growth
increase access to robust scientific analyses, work-
ing hand-in-hand with global drug manufacturers As Europe’s cannabinoid-based pharmaceuticals
and pharmaceutical industry stakeholders through businesses continue to grow and develop, so will
analytical testing, contract research, and clinical the need for collaboration with lab testing partners
trial support. and the need for strategic guidance. QNTM Labs has
placed itself at the forefront of analytical capabilities
“Our company was founded on the basis of help- by using cutting edge analysis and analytical meth-
ing fix the holes that currently exist in this indus- odologies, that drive innovation and deliver results.
try,” says Murphy. “Even as regulators working
to establish standards, there is still so much com- What is clear is that the market for cannabis-based
plexity and nuance to meeting requirements. We pharmaceuticals will continue to grow and QNTM
pride ourselves on sitting down with our custom- Labs will be helping its customers maximise their
ers and helping them understand the requirements opportunities, now and in the long term.
their products need to meet as a manufacturer of
cannabis-based pharmaceuticals.
“Our team has decades of experience on both the Disclaimer: Agilent products and solutions are in-
manufacturing and analytical side of the industry tended to be used for cannabis quality control and
and deeply understand the frustrations that exist in safety testing in laboratories where such use is permit-
bringing a drug to market – which is what our solu- ted under state/country law.
tion tackles head on.”
analyticalcannabis.com | 25
Psych Corner: The Science Behind Psychedelics December 2022
C
olorado voters have approved a ballot measure eligible for therapeutic use, at least until 2026; other
that will decriminalize the personal possession compounds could be approved from then onwards.
of psilocybin and several other psychedelics.
Proposition 122 also mandates the formation of a
Over 95% of votes have been counted, according to 15-member Natural Medicine Advisory board, which
the New York Times. From this proportion, it appears would oversee the therapeutic program.
voters approved Proposition 122 by a margin of 54%
to 46% during the US midterm election on Tuesday, Anyone with a criminal conviction for possession or
November 8. use of a relevant psychedelic compound will now be
able to petition a Colorado court for record sealing.
Once enacted, the proposal will give any adult in
the state, aged 21 and over, the legal right to pos- As the measure pertains to decriminalization, not
sess, use, cultivate and share psilocybin, ibogaine, legalization, the sale of psychedelics will still be pro-
mescaline (not derived from peyote), DMT, and hibited in Colorado.
psilocyn without fear of arrest.
The state now becomes the second in the US to ef-
The ballot measure also requires the state Depart- fectively permit the use of psychedelics; Oregon
ment of Regulatory Agencies to regulate a therapeu- became the first in 2020.
tic psychedelics program, which would license treat-
ment centers and therapists. Denver, the capital city of Colorado, also decrimi-
nalized “psilocybin mushrooms” in 2019.
analyticalcannabis.com | 27
Psych Corner: The Science Behind Psychedelics
I
nterest in psychedelic medicine has never been high- search”, Roggen warned that while the rapid prog-
er. Possession and use of psychedelic drugs have been ress in psychedelic science is encouraging in many
decriminalized in Oregon and Colorado, and the ways, there is a clear need to improve the ways in
latest research appears to support the effectiveness of which some of these trials are handled.
psychedelic-assisted psychotherapy in treating severe
depression. Most American psychiatrists view psilocy- Additionally, as some in the sector look to patent
bin and ketamine as safer than alcohol or Xanax, too, their inventions, Roggen offered a short introduc-
according to a recent study. tion to the psilocybin crystals and how these are
relevant to the intellectual property debates that are
But among the jubilation, some psychedelic experts sure to come as the sector expands.
are whispering a word of caution.
“We will soon be able to be all treated with psyche- Patient safety and flawed trials
delics, and we will all be healed and everyone is hap-
py, right? Not so fast,” says Dr. Markus Roggen, pres- “Everyone is looking at psychedelics. With that at-
ident and chief science officer of Vancouver-based tention comes scrutiny, and it’s not all rosy,” Roggen
Delic Labs. said. “There is some bad news.”
Speaking to audiences at the recent Analytical Earlier this year, Health Canada announced the
Cannabis webinar, “Advances in Psilocybin Re- suspension of a clinical trial for MDMA-assisted
psychotherapy following “concerns for participant in advance. This gives additional credibility to the
safety.” These concerns were raised after video study’s interpretation.
footage emerged showing two of the trials’ thera-
pists physically restraining a distressed PTSD pa- There are also some improvements that can be made
tient during the trial. that are more specific to the psychedelic science sec-
tor. For example, Alberta recently moved to impose
“This patient came to the MDMA trial because of stricter regulations on who can provide psychedel-
PTSD, as a result of sexual abuse in her youth. And ic-assisted therapy sessions.
during therapy, she was blindfolded, she was inap-
propriately touched, she was pinned down, and the Under the new rules, “only a psychiatrist or a physi-
therapist started a sexual relationship with her out- cian in consultation with a psychiatrist can prescribe
side of that trial,” Roggen summarized. a psychedelic drug for the purposes of treating a psy-
chiatric disorder, unless the drug is ketamine provid-
“There are so many no-nos in this aspect. And it was ed outside of psychedelic assisted psychotherapy.”
all filmed, and no actions were taken by the trial
organizers while this happened, and it was only re-
viewed years later.”
Everyone is looking at
After reviewing both of the trials for MDMA-assisted
psychotherapy, Health Canada suspended the afore- psychedelics. With that
mentioned study and asked the second trial, run by attention comes scrutiny,
the Multidisciplinary Association for Psychedelic
Studies (MAPS), to correct several issues related to and it’s not all rosy
record-keeping and staff training.
analyticalcannabis.com | 29
Analytical Cannabis Digest
morphs will have different absorption in the body, As research continues within the psychedelics sec-
and different medical effects.” tor, this issue of patenting crystalline structures is
certainly likely to raise its head again. Roggen’s own
If a psychedelic company has the correct polymorph lab, Delic Labs, has recently began working with a
for a certain application, with all of its favorable ab- crystallization expert to further explore cannabi-
sorption and therapeutic properties, then the com- noid and psilocybin crystallization, with a view to
pany can treat a patient with it. Importantly, the better understanding the chemistry which controls
company can also patent it. these processes.
This is already happening; Compass Pathways was “Crystals are not just the boring end product. It has
granted a US patent for a psilocybin structure named a lot of inf luence on biological uptake, patentabili-
Polymorph A in October 2021. This patent was sub- ty, medical effects, and the value foundation of this
sequently challenged by a group arguing that this industry,” Roggen said.
sort of discovery should not be patentable. However,
Patent Trial and Appeal Board (PTAB), a group of
administrative judges within the United States Pat-
ent and Trademark Office, recently decided that this
petition would not move forward to trial.
Iquistimis; hiconsultuid
arbis. Ex nonoven
erdiusque forunces iam
morsu ius.
Ra inatquid consimiu
videm actus, pos huidet
A
new study by researchers at the Univer- cently, ayahuasca retreats and research projects –
sity of Melbourne has analyzed adverse exploring the beverage’s potential effects on health,
effects reported by users of the hallucinogenic spirituality, and personal growth – have seen its
tea, ayahuasca. use expand globally.
The hallucinogenic beverage ayahuasca has been Ayahuasca is made by prolonged heating or boil-
used for religious and medicinal purposes by ing of the Banisteriopsis caapi stem with the leaves
Amazonian tribes for thousands of years. More re- of the Psychotria viridis plant. B. caapi provides a
analyticalcannabis.com | 31
Analytical Cannabis Digest
source of harmine, which inhibits the breakdown of were vomiting and nausea (68.2%), headache (17.8%),
dimethyltryptamine (DMT) supplied by P. virdis, in- and abdominal pain (12.8%). The researchers em-
creasing the bioavailability of DMT in the body and phasize that vomiting and nausea are considered a
resulting in hallucinogenic side effects. “normal” effect of ayahuasca for experienced users:
“In the case of traditional ayahuasca ceremonies and
At the University of Melbourne, Dr. Daniel Perkins even in non-traditional ceremonies, not only is vom-
is involved in a number of research projects sur- iting/nausea not considered an adverse effect, but it
rounding medicinal psychedelics and medicinal is even sought out for its purging and perceived spir-
cannabis. He is the director of the Global Ayahuasca itual cleansing benefits,” they wrote in the paper.
Project, which aims to increase the understanding of
ayahuasca drinking across the world, includ- Approximately 2.3% of the participants reported
ing why people drink it, the reported impacts of aya- that they required medical attention for any ad-
huasca on health and wellbeing, and the potential verse effects. “These results are consistent with
risks associated. His team’s latest research, published previous studies, with regular users reporting that
in PLOS Global Public Health, provides potentially most adverse physical effects seem to not be seri-
the largest source of information on ayahuasca’s ad- ous and do not compromise health,” Perkins and
verse side effects to date. colleagues explained.
pressed how they are considered a positive element Implications for global health
of their ayahuasca journey.
There are limitations to the study design that must
Ayahuasca is not just a pharmacological experience be acknowledged and could limit its validity, includ-
– it is considered a spiritual practice in its tradition. ing its reliance on self-reported data gathered in a
“In the context of such experiences, it is not sur- retrospective nature. However, the large sample size
prising that a process of psychological integration makes this work “the most important source of in-
and assimilation may be required,” Perkins and col- formation regarding ayahuasca’s adverse effects” to
leagues noted. date, in the research team’s opinion. But what does
this resource tell us? It appears that ayahuasca has
notable – though rarely severe – side effects on both
physical and mental health, which have implications
for public health.
I have had numerous “In that sense, ayahuasca practices can hardly be as-
experiences where sessed with the same parameters used for prescrip-
tion medicines,” the authors say, “since the myriad
ayahuasca has brought of its effects include challenging experiences that are
difficult patterns into intrinsic to the experience, some of which are con-
sidered as part of its healing process.”
my awareness in my
daily life, which is never “Many are turning to ayahuasca due to disenchant-
ment with conventional Western mental health
comfortable but always treatments, however the disruptive power of this
results in growth in the end, traditional medicine should not be underestimated,
commonly resulting in mental health or emotional
– an anonymized quote challenges during assimilation.”
from one of the survey
“While these are usually transitory and seen as part
participants of a beneficial growth process, risks are greater for
vulnerable individuals or when used in unsupportive
contexts,” the researchers concluded.
analyticalcannabis.com | 33
Analytical Cannabis Digest
Out of CANNtext
I “Just one-in-ten U.S. adults say
n an industry awash with milestone events and
expert-led commentary, we know it’s impossible to
keep up to speed with it all. To help you out we’ve marijuana should not be legal
pulled together a selection of our favorite quotes and at all.”
comments from key opinion leaders from across the
industry this month. The results come from a recent Pew Research
Center poll of 5,098 adults in the US.
Connect with like-minded Know you’re in the right Keep up to date on the
professionals from the place – all our group latest cannabis industry
cannabis industry members are screened to news and research
ensure suitability
Discuss and debate Our editors are on hand Receive exclusive group
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March 2022
SALES
Kelly Giles | Sales Director
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EDITORIAL
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jack@analyticalcannabis.com
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analyticalcannabis.com | 36