When patients in the District
of Columbia and 16 states that have approved medical marijuana access cannabis (Cannabis spp.) to treat their health conditions, most do not
know the quality or potency of what they are receiving. Due to the absence of
generally accepted quality control and assurance in the industry, including a
lack of obtainable reference standards for phytochemical analysis, laboratories
often present inaccurate and inconsistent results to the public. Amounts of the
herb’s primary active ingredients like THC (tetrahydrocannabinol) and CBD (cannabidiol) — as well as levels of potential contaminants,
such as pesticides and mycotoxins — are often unknown or imprecise. An
increasing number of patients want consistency in their herbal medicinal
products, however, and valid testing could bring the medicinal cannabis industry
greater legitimacy.
“The ability to ascertain
potency and content of cannabis products sold in the dispensaries is critical
if we are going to be able to allow patients to know what they are getting and
for them to be able to re-access strains that are effective for them,” said
Donald Abrams, MD, an integrative oncologist who studies clinical cannabis at
the University of California San Francisco, where he is chief of
hematology/oncology at San Francisco General Hospital (e-mail, February 15,
2012).
Despite many rogue operations
offering no or low-quality testing, the published literature documents numerous
scientifically valid analytical methods for quantifying cannabis compounds,
including DeBacker et al. 2009 and Ross et al. 2000.1,2 That the state-based
medicinal cannabis industry is surviving without broadly implemented quality
control standards speaks to both its infancy and lack of regulation at the
state and federal levels as a result of its Schedule I controlled substance
status.
Since cannabis was removed
from the United States Pharmacopoiea in 1942,
quality control and assurance that came to be imposed on other food products
and botanical medicines has been eluded. This is in the process of changing,
however, as several non-profit organizations have initiatives focused on the
medicinal cannabis industry. The trade group American Herbal Products
Association (AHPA), for example, formed a Cannabis Committee in 2010 with the
goal of promoting and
protecting “responsible commerce in hemp
products, and to address legal issues related to hemp agriculture and the
emergence of medical cannabis as a legal product in numerous states.”3 Additionally, the American Herbal Pharmacopoeia
(AHP) is currently developing a cannabis monograph under the direction of
Executive Director Roy Upton. As is typical of all AHP work, the cannabis monograph will provide industry with
a variety of scientifically valid analytical methods used in the
identification, purity, and quality assessment of cannabis and its crude
products.
“There is a critical need for quality controls to be put in place in the cannabis
industry,” said Upton. “Those with commercial interests, including analytical
labs, are jumping on the cannabis money bandwagon using unvalidated and/or
inappropriate testing methodologies designed to give customers the answers they
want to hear and promote a false sense of security. We see the same practices
occurring in other sectors of the analytical labs industry and we hope the AHP
monograph will help to correct some of this through greater transparency and
methods validation” (e-mail, April 4, 2012).
In February of 2012, 3 California labs — Steep Hill, Pure Analytics, and CW
Analytical — founded the non-profit Association of California Cannabis
Laboratories (ACCL)4 to establish best practices for the industry.5
“[The cannabis testing
industry] is still in early stages of development, but making rapid progress,”
said Dale Gieringer, PhD, executive director of California NORML, a non-profit
that seeks to reform the state’s marijuana laws, (e-mail, March 20, 2012). In
early 2011, Dr. Gieringer in collaboration with Project CBD, analyzed the
testing practices of 10 anonymous cannabis labs.6,7 They found that
“the precision and proficiency of a majority of cannabis testing labs compared
favorably to other analytical testing industries,” but noted that some labs
“reported results that deviated substantially from the average, with
unacceptable deviations of more than 25% from the mean. Three of the 10 labs
performed unacceptably on half of the tests.”
“Seven out of the 10 labs we
looked at came up with reasonably consistent potency results,” said Dr.
Gieringer. “The ones that didn't had quality control problems; they either
weren't professionally run, or were using poor methodology.”6,7
According to Michelle Sexton,
ND, a clinical cannabis researcher at Bastyr University in Redmond, Washington, who owns her own
cannabis testing business, many labs have no experience with, or even a concept of what good laboratory practice entails.
“Marketing and profiteering is often at the heart of any industry,” she said, “and
when quality control is lacking, there is chaos” (e-mail, April 3, 2012).
Dr. Sexton suggested that concerned consumers ask about validation of
methodology — such as, “Who did it and how was it done?” — as well as if the
lab adheres to Good Laboratory Practices, has demonstrated complete separation
of cannabinoids, which internal controls are in place to assure accuracy of
results, and whether a “standard curve” is run with every sample set. If the
owner or operator cannot provide the answers to these questions — or does not
understand these questions — its analytical results may be questionable, she
said. (AHPA also provides a guidance document to help consumers in choosing an
analytical lab.8)
Impact of Quality Cannabis Analysis
Why is it important that growers
or dispensers invest in accurate analysis of their products? According to Dr. Sexton, it is a matter of
public safety. “When much of the flowering top being sold is grown indoors, it
is a target for fungal infection and pest infestation,” she said. “The
potential profit and cost of growing indoors then necessitates using chemical
warfare to bring a crop to market. If you consider that there are legitimately
ill patients accessing this medicine — such as patients with cancer, HIV,
neurodegeneration, liver disorders, kidney dysfunction, and more — it is an
imperative to hold those who grow and dispense cannabis as medicine to a high
standard of quality control.”
In addition, she continued, patients who have little tolerance or risk factors
for some side-effects of THC may have distressing experiences from high-potency
plant material, which a recent study reports is the trend rather than the
exception.9
After obtaining an accurate
analysis, a dispensary can label its products with potency content information,
which Steve DeAngelo — executive director of Oakland’s Harborside Health Clinic
dispensary — said enables patients to “more effectively self-titrate their
cannabis intake,” and “identify a particular cannabinoid profile that works
best for them, such as CBD-rich cannabis.” “Without cannabinoid potency
testing,” he noted, “these patients would be unable to identify the CBD-rich
medicine.”
When conducting clinical
research on any substance, including cannabis, it is essential to know and
document the potency of the study material. The only legal source of cannabis
for research in the United States, the National Institutes of Drug Abuse (NIDA)—which
contracts the University of Mississippi to grow its cannabis— labels the
container that holds the cannabis cigarettes.10
“I have generally trusted the
government and not had product re-tested,” said oncologist Dr. Abrams. “In
fact, since you have to document the use of each cigarette in the research,
sending one off to be confirmed might raise an eyebrow. NIDA cannabis is
generally less than 7% THC with little or no CBD. For most of the studies I have done, we
used their 3.5-3.9% THC cannabis.”
Some labs offer bacteria,
mold, and contaminants testing, which Dr. Abrams said is helpful. “I always recommend that my cancer patients shop
for organic produce to avoid herbicides, pesticides, and fertilizers — chemicals
that we don’t really need to have in our bodies. I would assume the same should
hold true for medicinal cannabis.” (AHPA
published a guideline on microbiology and mycotoxins in botanical products in 2003.11)
Possibly raising into question the validity of all cannabis testing, a peer
reviewer of this article noted that if the test is done on a cannabis bud
different from the one the patient actually receives, the testing is
“meaningless” because phytochemical content can range from plant-to-plant even
if it is the same strain. Also, storage time can affect a cannabis sample’s
potency. “This is why it is important to insure that adequate sampling of an
entire harvest is performed,” said Dr. Sexton.
If state-based medicinal
cannabis organizations were able to successfully implement high-quality testing
standards and operations, might the US government have more respect for the
industry and decrease raids and shutdowns?
“Not at all!” responded Dr.
Abrams, a sentiment voiced by the majority of this story’s sources, including
DeAngelo and Dr. Gieringer, who said, “It will take a top-down political
decision by Congress and/or the President to change policy. This will happen
only when there is enough public pressure for legalization.”
Editor’s Note: For an updated
look at the US state-based cannabis analysis industry, please see the upcoming
issue of ABC’s printed journal, HerbalGram
#94, due out this May.
—Lindsay Stafford
References
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content of both drug- and fiber-type cannabis seeds. Oxford
Journals. 2000; 24(8):715-717.
2. De Backer B, Debrus B, Lebrun P, et al. Innovative development and
validation of an HPLC/DAD method for the qualitative and quantitative
determination of major cannabinoids in cannabis plant material. J Chromatogr B Analyt Technol Biomed Life Sci. 2009;877(32):4115-24.
Epub 2009 Nov 6.
3. Cosgrove J. The cannabis conundrum: AHPA tests the controversial waters with
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Available at: www.nutraceuticalsworld.com/contents/view_online-exclusives/2010-05-20/the-cannabis-conundrum/.
Accessed April 4, 2012.
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Test” to assess the accuracy of analytical laboratories [press release].
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http://canorml.org/news/ringtest.html. Accessed March 26, 2012.
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Industry Insider. September 15, 2003. Developed
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Accessed April 4, 2012.
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cannabinoids in confiscated cannabis preparations from 1993 to 2008. Journal of Forensic Sciences. 2010;55:1209–1217.
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http://cms.herbalgram.org/herbalgram/issue85/article3485.html.
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Accessed April 4, 2012.
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