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Overview of the cannabis industry in the United States

Author, for citation: Shawn E. Douglas

The following is a brief overview of the cannabis industry in the United States. It's meant to give a quick and concise review of where cannabis use, regulation, testing, and research have been and where they are now. Many of the topics touched upon here will be expanded upon later in this guide.

Brief history of cannabis in the U.S.

Drug bottle containing cannabis.jpg

Cannabis is a rapid-growing, flowering plant that has been used for centuries for industrial, medicinal, and recreational purposes. The plant includes three species or subspecies: indica, ruderalis, and sativa.[1] Both industrial hemp and recreational marijuana are derived from cannabis plants, but with important differences in biochemical composition. Hemp — which has historically been used to create clothing, food and feed, paper, textiles, and other industrial items — tends to have lower levels of the psychoactive component tetrahydrocannabinol (THC) and higher levels of the non-psychoactive component cannabidiol (CBD).[2][3] Some cannabis strains have intentionally been bred to produce low levels of THC, while others have been bred with the intent to maximize the psychoactive component.

Cannabis cultivation began in England's Jamestown colony of America in earnest around 1611, via formal orders. Several years later those orders turned into a royal decree, enacted by the Virginia Company, asking colonists to each grow 100 hemp plants for export to England.[3] Colonial America continued its growth, use, and exportation of hemp, even beyond the formal founding of the United States. During that time, growers undoubtedly were using the female plant (which flowers and has higher levels of THC) to treat aches and pains as well as enjoy it recreationally. By the time the U.S. Civil War arrived in the 1860s, however, the growth and use of industrial hemp declined as increased cotton and wood use took away much of the profitability of hemp.[3] Around the same time, local governments began recognizing tonics, tinctures, and extracts from cannabis plants as potentially dangerous substances, labeling them as hypnotics, narcotics, or even poisons.[4] In the early twentieth century, U.S. labeling and prescription laws — such as the the Pure Food and Drug Act of 1906 at the federal level as well as various state laws — saw further restrictions put on cannabis, effectively culminating in the Marihuana Tax Act of 1937 and the Federal Food, Drug, and Cosmetic Act of 1938. With the passage of those acts, hemp and marijuana essentially became illegal, controlled substances.[5][6][7]

State efforts to decriminalize marijuana were somewhat successful in the early 1970s, though progress towards that goal slowed again with the Reagan Administration's war on drugs.[8] Progress picked up steam again in the late 1990s into the 2000s, particularly in states such as California, Massachusetts, Connecticut, Washington, and Colorado.

As of March 2017, twenty-eight U.S. states have approved some sort of broad decriminalization or legalization of medicinal and/or recreational marijuana.[9] Industrial hemp has also been addressed in some regard, with 16 states having legalized commercialized industrial hemp production and the federal government making certain concessions on it (Cannabis sativa containing no more than 0.3 percent THC, grown under a state-sanctioned agricultural pilot program).[10][11] However, cannabis, including industrial hemp, remains a Schedule I controlled substance, as determined by the U.S. Food and Drug Administration[12], including extracts and other derivatives such as cannabidiol (CBD).[13] This federal classification continues to clash with changing state laws and regulations at an increasing pace, creating both opportunities and difficulties for involved citizens at all points along the industrial, economic, and social chain.

Medical and recreational use

In its 2016 World Drug Report, the United Nations Office on Drugs and Crime estimated that 3.8 percent of the global population — roughly 183 million people — used cannabis in 2014.[14] Focusing in on the United States, the Substance Abuse and Mental Health Services Administration (SAMHSA) estimated that in 2014 the country had 35.1 million past-year marijuana users.[15] It's not clear if that total includes legal medical marijuana users, which numbered roughly 2.4 million that year according to non-profit ProCon.org.[16] When compared to SAMHSA's estimate of 11.1 million users in 1997[17], it becomes clear that reported marijuana use has increased in the United States over the past few decades, whether it's through legalization efforts or otherwise. Some have pointed to the expansion of medical marijuana laws acting as gateways for increased adolescent use; however, multiple studies have tried but failed to find such a cause and effect relationship.[18][19][20] Regardless, with 28 U.S. states now having some type of legalization law on the books[9], the number of marijuana users isn't likely to decrease any time soon in the U.S.

Cultivation and distribution

At the federal level, marijuana is considered a Schedule I drug and remains illegal.[21][12] (Federal regulation of cannabis is discussed in detail later under "Regulation and standardization.") This doesn't leave a lot of options for researchers and the like. In fact, the only federally-granted grow operation (grow-op) as of this writing is the University of Mississippi, contracted by the National Institute on Drug Abuse (NIDA) to grow marijuana for approved research studies.[22][23][24][25][26] (That may change for the better in 2017; see the next section on testing and research for more.)

On the state level, the growth, testing, and distribution of cannabis depends on state law, which can vary from state to state. This topic is discussed further in the "Regulation and standardization" section, but here are the key points:

  • Federal law makes it illegal to cultivate and distribute marijuana, even in a state that has legalized such activity. However, while there's no legally binding guarantee cultivators and distributors won't be pursued by federal law enforcement, they can limit their chances of such federal enforcement by following to the letter state and local law.
  • Despite some of the variances among state laws, one aspect largely remains consistent: it's illegal to distribute marijuana over state lines, even when distributing between two states with similar laws.[27]
  • Regulations on the personal and commercial cultivation and distribution of marijuana vary significantly from state to state. Some states make a limited pool of available licenses available; others don't offer them or instead have specific alternative treatment or non-profit centers that handle growth and distribution.[28][29][30]

Testing and research

One area that continues to expand — while taking advantage of new scientific research and techniques — is the laboratory sphere, particularly in research, regulation, and standardization activities. According to July 2016 testimony from Susan R.B. Weiss, Division Director at the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) alone supported 281 cannabinoid research projects totaling more than $111 million in 2015.[24]

While the research, analysis, and processing of cannabis has been ongoing for centuries[3], it wasn't until 1896 that Wood et al. conducted one of the first documented chemical experiments to determine the constituents of cannabis. Several years later, the researchers were able to correctly identify the extracted and isolated cannabinol from the exuded resin of Indian hemp as C21H26O2.[31] As of mid-2015, 104 of the more than 750 constituents of Cannabis sativa have been identified as cannabinoids[32], "a class of diverse chemical compounds that act on cannabinoid receptors in cells that modulate neurotransmitter release in the brain."[33]

Yet in the United States, when it comes to 1. enacting the broad level of testing required to ensure public safety — whether it be medical, recreational, or industrial use of cannabis — and 2. researching and better understanding the pharmacokinetics and pharmacodynamics (medical use and benefit) of cannabinoids in the human population, many have argued that laboratory testing of cannabis is still in its infancy[34][35][36][37][38][39] and evidence-based research of marijuana continues to be slow and bogged down in regulation.[22][23][24][25][26] In regards to the first issue, as some form of legalization continues to sweep across states, regulators, users, and industry are recognizing the need for improved standardization of the production and testing of medical and recreational marijuana; the current state of improper labeling and potentially harmful contaminants[34][35][36][39] will only serve to hinder the industry. To the second issue, some within the federal government seem to recognize the roadblocks to improved evidence-based research and are working to slowly improve how researchers can legally acquire and test marijuana in the U.S.[24][25][40]

An excerpt from the previously mentioned testimony of NIDA's Dr. Weiss summates this well:

The current state of the research on marijuana and its constituent cannabinoids suggests the potential for therapeutic value for a number of conditions; however, more evidence is needed before marijuana or cannabinoid products (beyond those already approved through the Food and Drug Administration [FDA]) are ready for medical use. Promising preclinical findings do not always prove to be clinically relevant, and even fewer lead to new treatments. Moreover, clinical studies of sufficient quality to meet FDA standards for drug approval are currently lacking for most conditions. Among the factors that impact this research are the specific statutory requirements and treaty obligations that govern research on marijuana. NIH is working closely with the Office of National Drug Control Policy (ONDCP), the Drug Enforcement Administration (DEA), and FDA to explore ways to streamline these processes to facilitate research.[24]

In the meantime, government entities such as the National Institutes of Health and non-profits such as jCanna push forward with scientific conferences, summits, and roundtables that bring scientists and interested parties together to share existing knowledge and testing techniques.[41][42]

Other areas of concern

When examining the current state of the U.S. cannabis industry, it's important to note a few additional areas of concern that impact it, again tightly linked to federal regulations (which are discussed extensively in the next section): banking and advertising. Issues related to both of these topics continue to limit how state-based grow-ops, dispensaries, and testing laboratories are funded and operated.

Banking

Since the U.S. federal government still considers marijuana to be illegal, by extension banks and credit unions — which are regulated by a patchwork collection of federal (and state) laws — put themselves into potentially dangerous territory by accepting money from depositors engaging in federally illegal activities; the bank can be punished by federal institutions such as the Federal Deposit Insurance Corporation (FDIC).[43] In an attempt to ease the concerns of industry players as well as banks in states that had implements legalization efforts, the Treasury Department's Financial Crimes Enforcement Network (FinCEN) released a guidance document in February 2014 that "does not grant immunity from prosecution or civil penalties to banks that serve legal marijuana businesses" but rather "directs prosecutors and regulators to give priority to cases only where financial institutions have failed to adhere to the guidance."[44][45] However, the guidance has remained just that: guidance; it doesn't prevent federal law enforcement or regulating agencies from taking action. An August 2016 attempt to reclassify marijuana into a lower classification than Schedule I failed[12][25], keeping the FinCEN guidance in place as a recommendation for how federal authorities should enforce existing law.

According to an Associated Press report in April 2016, the guidance has had some sort of impact, with banks and credit unions willing to handle any money associated with marijuana increasing from 51 in March 2014 to 301 in March 2016.[46] However, this hasn't prevented those in states with newly minted medical and recreational marijuana legalization laws from being worried about how cannabis money will be handled, particularly with the new Trump administration taking the reigns of government. California, which in November 2016 legalized recreational use of marijuana beginning in 2018, has already petitioned that administration to clarify it's policy early on. "We have a year to develop a system that works in California and which addresses the many issues that exist as a result of the federal-state legal conflict," wrote California Treasurer John Chiang to Trump. "Uncertainty about the position of your administration creates even more of a challenge."[47]

Similar legalization changes in Massachusetts prompted its senator, Elizabeth Warren, along with nine other senators, to write to FinCEN in early 2017 requesting even clearer, more friendly guidance for marijuana vendors.[48] Yet it remains to be seen if entities outside of grow-ops and dispensaries will see banking relief. In particular, testing laboratories continue to struggle with managing cash flow and acquiring bank lending for their operations[49][50][51], causing some to believe consolidation of such labs will occur before the industry can really even take off.[49][52]

Advertising

Advertising of marijuana products is another area of concern, though the regulations and laws regarding it are less clear. When it comes to television and radio broadcasting and its associated advertising, a federally granted broadcasting license stands to be lost, care of the Federal Communications Commission (FCC). The trouble is, it's not clear if the FCC would act against broadcasters; the FCC hasn't issued guidance in the same way FinCEN has. "I don’t think anybody knows, and that’s the problem," said California Broadcasters Association President Joe Berry in an August 2016 report published by the The Sacramento Bee. "Without a clear indication [from the FCC on marijuana advertising], the vast majority of broadcasters are going to stay away from this issue."[53] California, of course, made recreational marijuana legal, and its proposed law sought to address the issue of advertising, including "a provision restricting TV and radio ads so they are not targeted to minors," while also addressing the authority of the FCC to enforce regardless.[54]

Other forms of advertising also remain problematic. In late November 2015, the United States Postal Service (USPS) out of Portland, Oregon published its interpretation of federal law regarding "mailpieces containing advertisements about marijuana," regarding it illegal to distribute certain forms of marijuana advertisement while citing 21 U.S. Code § 843(c).[55] The U.S. Patent and Trademark Office (PTO) has, controversially, also gotten involved, stating that trademarking of a "brand controlled substances or related paraphernalia that are illegal to possess or sell" legally doesn't fit within a trademark's commercial viability because at the federal level marijuana is not legal for commerce.[56] (Legal experts such as Dariush Adli suggest "creative ways" of getting around this, from registering trademarks in multiple states to registering "non-cannabis merchandise in order to generate some federal protection for their mark."[57]) Even billboards are an issue, with state lawmakers proposing new regulations on billboard-based marijuana advertising weeks after the state passed its recreational legalization laws.[58] And state laws, such as those found in Alaska, can create their own set of challenges in staying legal with marijuana advertising.[59]

Despite all this, at least one financial consultant believes marijuana marketing will become more prevalent: GreenWave Advisors' Matthew Karnes estimates spending will jump to $75 million by 2021.[60]

Regulation and standardization

Federal regulation of cannabis

Dea color logo.svg

On October 27, 1970, the Controlled Substances Act put into place five schedules or classifications of drugs that would be regulated in some fashion, and drugs were initially classified into those schedules, followed by annual reviews and updates.[21] Marijuana was initially placed under Schedule I[21] and remains there today.[12][25][61] As a Schedule I drug, the federal government is indicating marijuana has[21]:

  • "a high potential for abuse";
  • "no currently accepted medical use in treatment in the United States"; and
  • "a lack of accepted safety for use of the drug or other substance under medical supervision".

Then came the Reorganization Plan No. 2 of 1973, which took existing enforcement entities such as the Bureau of Narcotics and Dangerous Drugs and placed them into a new, unified entity called the Drug Enforcement Administration (DEA).[62][63] Then President Richard Nixon said of the transition[62]:

The enforcement work could benefit significantly, however, from consolidation of our anti-drug forces under a single unified command. Right now the Federal Government is fighting the war on drug abuse under a distinct handicap, for its efforts are those of a loosely confederated alliance facing a resourceful, elusive, worldwide enemy.

The DEA was given numerous responsibilities, including but not limited to the development of enforcement strategy; investigation and prosecution preparation of suspects violating federal law; regulation of drugs and other controlled substances; and coordination and cooperation with state and local government drug enforcement efforts.[62] Since then the DEA has taken various steps — with guidance from the Food and Drug Administration (FDA)[64] — to regulate and enforce the availability and use of controlled substances such as marijuana. As the decriminalization and legalization efforts of states have increased in past decades, this has brought federal regulation and enforcement conflicts to those states that have decriminalized and legalized, largely due to the federal government's insistence on maintaining marijuana as a Schedule I drug.[40][65]

Numerous changes in policy and controversies have occurred since the Controlled Substance Act and DEA were implemented, including a 22-year-long effort by the National Organization for the Reform of Marijuana Laws (NORML) to have marijuana rescheduled (1972–1994).[66] However, the following talking points represent the most recent important federal-level changes and rulings that impact federal regulation of and enforcement of laws relating to cannabis.

October 19, 2009: The Ogden Memorandum

Deputy Attorney General David W. Ogden issued a memorandum "intended solely as a guide to the exercise of investigative and prosecutorial discretion" in regards to state-based laws allowing medical cannabis.[67] The guidance essentially told U.S. attorneys to not prosecute those entities complying fully with state cannabis laws. Researchers generally agree that this memo acted "as a catalyst for expansion of [state-sanctioned and gray market] cannabis supply in states with poorly defined regulations," though the degree to which it influenced such growth remains poorly documented and requires further investigation.[68] To be sure, it likely had some effect, as the number of licensed patients using medical marijuana in the state of Colorado increased from 4,800 in 2008 to 41,000 in 2009, and operating dispensaries jumped to more than 900 by mid-2010.[69]

June 29, 2011: The Cole Memorandum 1

Deputy Attorney General James M. Cole issued a memo as a follow-up to the Ogden Memo, muddying the waters in the process. While stating that the stance of efficiently using department resources as outlined in the Ogden Memo still stood, Cole also made it clear that large grow-ops that didn't qualify as "caregivers" had sprung up since.[70] The language of the memo essentially said "get off your butts and nail those suckers."[71] Cambron et al.[68] and Fairman[72] suggest this memo had some impact as evidenced by declines in cannabis patient registration from 2011–2013 in Colorado, Michigan, and Montana.

August 29, 2013: The Cole Memorandum 2

Deputy Attorney General James M. Cole issued a follow-up memo to his original two years later, following 1. on the heels of then President Obama reiterating publicly that the Department of Justice (DoJ) was to not focus unnecessarily on states that had passed legalization laws and 2. Washington and Colorado legalizing recreational use of cannabis.[68] The second memorandum sought to reduce the emphasis on the size of the grow-op and increase emphasis on — by a case-by-case basis — "whether the operation is demonstrably in compliance with a strong and effective state regulatory system."[73] The memo also clarified specific cases where federal enforcement would be warranted, including distribution to minors, interstate transport, and preventing drugged driving (though it didn't state how). Generally speaking, states saw little federal intervention except in the case of state law being broken or requiring dispensaries to move further away from schools.[74][68] Despite the memo, some attorneys continued to see Cole Memorandum 2 as nothing more than unclear language that had no legal weight for anxious growers and distributors in states where cannabis was legalized.[71]

December 16, 2014 to current: Rohrabacher-Farr Amendment

A tenuous truce of sorts arrived with the passage of the Rohrabacher-Farr Amendment in December 2014. The amendment prohibited the DoJ from spending funds to prevent or enforce against state laws that allow for medical marijuana cultivation, distribution, and use, particularly when those actions are performed consistently with those state laws.[75] Before being passed in December 2014, the amendment had actually been introduced and defeated six times in the previous 10 years.[76] The DoJ later went on to challenge the amendment on several occasions, from U.S. v. Marin Alliance for Medical Marijuana in 2015 to a collection of 10 different cases from California and Washington in 2016. In both cases, the courts ruled against the DoJ, setting precedent against further department action.[77][78]

One of the downsides of Rohrabacher-Farr is that it has essentially acted as a short-term rider attached to several spending bills since December 2014. As of March 2017, it was last renewed through April 28, 2017; however, with the new Trump administration coalescing — including Trump's demonstrably anti-drug U.S. Attorney General Jeff Sessions — some in the industry are concerned the amendment may not be renewed, opening the door again for the DoJ to implement stronger enforcement.[9][79][80][81][82] Alternative bills are continuing to be proposed, including a more permanent version of Rohrabacher-Farr introduced by Representative Dana Rohrabacher of California; however, Speaker Paul Ryan has implemented rules prohibiting amendments to budgetary legislation, and the fact remains that Congress remains reluctant of hearing bills that would change the country's marijuana laws.[83][84]

August 11, 2016: DEA denies petition to reschedule marijuana out of Schedule I

A request made by two governors and a psychiatric nurse practitioner to the DEA asking it to reschedule marijuana into any other schedule other than Schedule I was denied, as had been done with previous attempts in 2009 and 2011.[12][25][61] Reasons included known health issues such as prenatal exposure and negative impacts on several biological systems, as well as limited research data and new drug applications.[40] At the same time, however, the DEA also recognized the need for further research and the lack of legal marijuana sources for researchers, publishing a policy statement stating intent "to increase the lawful supply of marijuana available to researchers."[85]

State and local regulation

As of January 2017, 28 states have some sort of broad decriminalization or legalization laws for cannabis on the books.[9] In October 1973, Oregon became the first state to enact decriminalization laws for marijuana, imposing a $100 fine for possession of less than an ounce. Eleven other states followed a similar path within five years.[86] The next wave of changes began with the passage of medical marijuana legislation in California — the Compassionate Use Act — in November 1996, followed by similar legislation in Oregon and Alaska in 1998, Maine in 1999, and Colorado, Hawaii, and Nevada in 2000.[68][87] Other states continued to add decriminalization and medical marijuana laws in the 2000s. But it wasn't until 2012 that Colorado and Washington became the first states to make recreational marijuana legal, followed by Alaska, Oregon, and the District of Columbia in 2014.[68] Colorado, Maine, Massachusetts, and Nevada followed suit in 2016.[88]

As shown by Cambron et al. in 2016 (before the November election results)[68], dispensaries, possession limits, and interstate ID card acceptance can vary significantly among affected states. California, Colorado, Michigan, Oregon, and Washington lead in number of dispensaries; Massachusetts, Oregon, and Washington in maximum possession limits; and Arizona plus five others allowed ID cards from other states. Yet allowed dispensaries can number in the single digits, possession limits can be as low as one ounce, and numerous states still don't honor ID cards from other states.[68]

Then there's the matter of state differences in testing, enforcement, advertising allowances, etc. It helps to turn to professional associations and organizations — who often lead the charge for improved, more relevant standards — to sort through the variances. The Association of Public Health Laboratories (APHL), for example, has published its Guidance for State Medical Cannabis Testing Programs to help sort through the confusing tangle of existing testing laws, where they exist. They exemplify this variation of law in their document[89]:

As with most programs in the United States, every state takes a different approach. For example as of January 2016, New Jersey’s Public Health & Environmental Laboratories only test cannabis plant material. Just across the Hudson, however, New York’s Public Health Laboratory will not be testing any plant material, only cannabis extracts. In addition, the New York Department of Health will provide an oversight role for commercial cannabis laboratories that are licensed by the federal Drug Enforcement Administration (DEA) and approved for testing cannabis products. On the other hand, New Jersey state government does all testing in-house for the medical cannabis program.

As such, unlike their federal counterpart, it's difficult to make broad generalizations about cannabis regulations and their enforcement in the states. It becomes even more difficult when examining states that don't have clear, well-considered regulations or strong enforcement powers. Cambron et al. emphasized this issue in regards to the supply side, saying: "States without clearly defined regulations for medical cannabis supply have fostered gray markets for cannabis whereby individuals without documented medical conditions are able to easily obtain medical cannabis authorizations. This scenario has created substantial challenges for law enforcement in multiple states."[68]

Cole et al. argue that in the end, it will take pressure on the federal government "to set up policy guardrails to steer state regulatory systems" in a more unified and safe direction. Drugged driving, use by minors, interstate distribution, relation to crime and firearms, consumer safety, and advertising are all issues the government should be tackling towards that goal, they say. Not that states aren't addressing these regulatory concerns; they are, but not in consistent ways.[90]

Standardization

While federal, state, and local governments wrestle with the regulatory frameworks surrounding cannabis, scientists and government officials are carrying on, doing what they can to harmonize those regulations with emerging industry standards and guidelines. For example, state officials from Colorado, New Mexico, Oregon, and Washington teamed up to give a presentation called "State Regulatory Approaches to Cannabis Testing, Operations and Product Logistics" at the July 2016 Cannabis Quality, Strategies and Solutions Summit. That presentation focused on the harmonization of regulatory standards and frameworks across states, as well as discussions of what scientific efforts are required to support those standards and frameworks.[91] Additionally, organizations such as Americans for Safe Access Foundation (ASAF), American Herbal Pharmacopoeia (AHP), American Herbal Products Association (AHPA), and the American Oil Chemists' Society (AOCS) have been developing standards, methods, and certifications for analysis, extraction, labeling, and laboratory operations surrounding medical (and recreational) marijuana.[92][93][94][95][96]

Notable among those organizations is the Foundation of Cannabis Unified Standards (FOCUS), which has been working to produce internationally applicable voluntary consensus standards for various parts of the cannabis business chain, including cultivation, extraction, laboratory testing, and packaging. FOCUS completed its public review process and finalized its standards in July 2016, though at that time it wasn't clear how to gain access to them.[97] New information came to light in March 2017, when FOCUS and ASTM International announced a collaboration between the two entities, which will, pending April 2017 ASTM board approval, see the formation of volunteer committee D37 at ASTM and the further adaptation of FOCUS' standards for a future ASTM release.[98][99]

Laboratory testing of cannabis

The overview mentioned how regulators, users, and industry are calling for improved standardization of the production and testing of medical and recreational marijuana. Without proper testing, several issues are bound to arise[34][35][36][39][96][100]:

  • label claims may not match actual contents;
  • contaminants may linger, causing illness or even death;
  • chemical properties and medicinal benefits of specific strains and their unique cannabinoid-turpene profiles can't be isolated; and
  • research on potential therapeutic qualities can't be replicated, hindering scientific progress.

In 2011 — a year before any U.S. state had enacted broad legalization of recreational marijuana — California NORML reported that its assessment of analytical cannabis testing laboratories' accuracy found that while California labs broadly reached +/- 20 percent consistency from a replicate sample, three out of 10 provided unfavorable results on at least half of their tests. Similar wide-ranging discrepancies were also found among edibles, extracts, and tinctures, and NORML found that none of the labs could reach two decimal points precision of cannabinoid results despite laboratory claims stating otherwise.[100] Another report out of Washington State in January 2015, not long after recreational marijuana sales to the public (requiring accredited lab testing prior) began[101], found blind tests of recreational marijuana at dispensaries could range as much as 7.5 percent in accuracy from its corresponding label.[35] Further issues in 2016 with alleged partiality by some Washington testing laboratories prompted emergency proficiency testing rules to be enacted.[102][103] (Proficiency testing essentially requires a laboratory in question to test a sample with known properties, and then those results are compared to those of a neutral third-party lab testing the same sample.)

These discrepancies and deficiencies highlight the growing need for homogenization of testing methods and procedures, if not nationally at least across an entire state. Such homogenization would, in theory, not only positively affect the quality of product but also provide greater consumer confidence that label and product match. As Marketing Director Scott Kuzdzal of Shimadzu pointed out during a January 2017 webinar on analytic testing of cannabis, poor sample preparation, lack of thorough testing, and the manual process itself — which can introduce user error, particularly when good laboratory practices aren’t used — all can contribute to discrepancies between label and product.[104] When dispensaries, edible manufacturers, and supplement companies perform insufficient lab testing or overstate claims on labels, it reduces consumer confidence, and both state and federal authorities — including the FDA — have to interject.[102][103][105]

As was mentioned at the end of the previous section on state regulation, efforts to improve testing methods and procedures, with the goal of seeing the best of them become standards, are ongoing. Where are those efforts now, and where are they going? Before we can examine that, we first need to briefly look at what aspects of cannabis are actually being analyzed.

Analytical aspects of cannabis

Cannabinoids

As of mid-2015, researchers have identified 104 of the more than 750 constituents of Cannabis sativa as cannabinoids[32], active chemical compounds that act in a similar way to compounds our body naturally produces. Many of our body's cells have cannabinoid receptors capable of modulating neurotransmitter release in the brain and other areas.[33] The plant's cannabinoids vary, with each bonding to specific receptors in our body, providing differing effects. From a theoretical and medical standpoint, crafting a strain of cannabis that has specific cannabinoids that can aid with a particular malady, while also carefully reproducing the grow conditions to consistently make that strain in the future, is a desirable but difficult goal to achieve.[106]

Lab testing of cannabinoids is done primarily as a measure of psychoactive "potency," though cannabinoids have many other potential therapeutic uses. Current laboratory testing looks at only a handful of cannabinoids; more research and development of analytical techniques that can quickly and accurately detect and separate the the rest is required.[37] Some of the major cannabinoids tested for include[37][89][107]:

  • THC (∆9-Tetrahydrocannabinol): This is the most commonly known cannabinoid found in cannabis, notable for its strong psychoactive effects and ability to aid with pain, sleep, and appetite issues. Included is its analogue ∆8-Tetrahydrocannabinol (which shows notably less strong psychoactive effects than ∆9[108]) and its homologue THCV (Tetrahydrocannabivarin), which tends to appear in trace amounts and has a more pronounced psychoactive effect, but for a shorter duration. THCV shows promise in fighting anxiety, tremors from neurological disorders, appetite issues, and special cases of bone loss. Also notable is Δ9-THCA (Δ9-Tethrahydrocannibinolic acid), a non-psychoactive biosynthetic precursor to THC.
  • CBC (Cannabichromene): This non-psychoactive cannabinoid is found in trace amounts; however, it tends to be markedly more effective at treating anxiety and stress than CBD (see next). It's also notable for its anti-inflamatory properties and potential use for bone deficiencies.
  • CBD (Cannabidiol): CBD is a non-psychoactive component of cannabis, typically accounting for up to 35 to 40 percent of cannabis extracts. It acts as a counter-balance to THC, regulating its psychoactivity. It's been researched as a treatment for anxiety, sleep loss, inflammation, stress, pain, and epilepsy, among other afflictions. Included is its homologue CBDV (Cannabidivarin), which is also non-psychoactive and demonstrates promise as a treatment for epileptic seizures. Also notable is CBDA (Cannabidiolic acid), a non-psychoactive biosynthetic precursor to CBD.
  • CBG (Cannabigerol): This cannabinoid is also non-psychoactive but only appears in trace amounts of cannabis. If has potential as a sleep aid, anti-bacterial, and cell growth stimulant. Also notable is CBGA (Cannabigerolic acid ), a non-psychoactive biosynthetic precursor to CBG.
  • CBN (Cannabinol): CBN is mildly psychoactive at best and appears only in trace amounts in Cannabis sativa and Cannabis indica. It occurs largely as a metabolite of THC and tends to have one of the strongest sedative effects among cannabinoids. It shows promise as a treatment for insomnia, glaucoma, and certain types of pain.

Terpenes

Mandated lab testing of terpenes — volatile organic compounds that distinctly affect cannabis aroma and taste — is done primarily as a way to ensure proper labeling of cannabis and related products, including extracts and concentrates, so buyers have confidence in what they are purchasing.[109][110][111] However, additional lab research goes into terpenes as they also show potentially useful pharmacological properties[109][111][112], and they demonstrate synergies (referred to at times as the "entourage effect") with cannabinoids that largely still require further exploration.[96][112][111][113] Testing for specific terpenes (discussed later) is less of a standardized practice, though it's rapidly improving.[109] Commonly tested terpenes by third-party testing labs include[111][110][112][96][107][114]:

  • Bisabolol
  • Caryophyllene
  • Cymene
  • Humulene
  • Limonene
  • Linalool
  • Myrcene
  • Phytol
  • Pinene
  • Terpinolene

Contaminates

Generally speaking, a contaminate is an unwanted substance that may show up in the final product, be it recreational marijuana or a pharmaceutical company's therapeutic tincture. The following are examples of contaminates that laboratories may test for in cannabis products.

Pesticides: Pesticides represent the Wild West of not only growing cannabis but also performing analytical testing on it. One of the core issues, again, is the fact that on the federal level marijuana is illegal. Because it's illegal, government agencies such as the Environmental Protection Agency (EPA) don't test and create standards or guidelines for what's safe when it comes to residual pesticides, let alone how to best test for them.[115][116] Additionally, researchers face their fair share of difficulties obtaining product to test. The end result is we don't know much about how inhalation of pesticide-coated marijuana smoke affects long-term health[115][116], and we don't have standards for pesticide application and testing.[96] With numerous pesticide products and little oversight on what growers apply to their plants, combined with the technical difficulty of testing for pesticides in the lab, pesticides remain one of the most difficult contaminates to test for.[96] That said, several classes of of pesticides are commonly applied during cannabis cultivation and can be tested for by labs[89][39][117]:

  • avermectins: functions as an insecticide that is useful against mites, which are a common problem for cultivators
  • carbamates: functions as an insecticide, similar to organophosphates, but with decreased dermal toxicity and higher degradation
  • organophosphates: functions as the base of many insecticides and herbicides, valued for its easy organic bonding
  • pyrethroids: functions as the base of most household insecticides and exhibits insect repellent properties


Solvents: In 2003, Canadian Rick Simpson published a recipe of sorts for preparing cannabis extract via the use of solvents such as naphtha or petroleum ether. Claiming the resulting oil helped cure his skin cancer, others hoping for a cure tried it, and the solvent method of preparation grew in popularity. Dubious healing claims aside, the solvent extraction method remains viable, though it has evolved over the years to include less harmful solvents such as supercritical carbon dioxide, which has low toxicity, low environmental impact, and beneficial extraction properties.[96][118][119] However, chemical solvents are still used, and if not evaporated out properly, the remaining solvents can be particularly harmful to sick patients using the extract. As for what solvents should be tested for, it gets a bit trickier, though Chapter 467 of United States Pharmacopeia and The National Formulary, the Oregon Health Authority's December 2015 technical report on contaminant testing of cannabis, and the Massachusetts Department of Public Health's response to public comments on cannabis testing provide helpful guidance. Listed solvents include benzene, butane, cumene, dimethoxyethane, hexane, and pentane, among others.[39][89][96][117][120][121]


Heavy metals: 2013 research on contaminant testing on the behalf of Washington State provides insights into heavy metals and why they're looked for in cannabis testing. That research, as well as other sources, tell us[39][89][96][122]:

  • Heavy metals contribute to several health problems, including those of a neurological nature.
  • Cannabis can "hyperaccumulate metals from contaminated soils."
  • Research parallels can be found in tobacco research and how the FDA regulates heavy metal content in foods.
  • The most prominently tested heavy metals include arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), mercury (Hg), and nickel (Ni).


Mycotoxins and microorganisms: "The ideal conditions for cannabis growth are also ideal for the growth of potentially harmful bacteria and fungi, including yeast and molds," say Shimadzu's Scott Kuzdzal and William Lipps, "therefore microbial contamination poses health risks to consumers and immunocompromised individuals."[37] In truth, these concerns have already borne out; most recently the University of California, Davis reported in February 2017 one of its patients had contracted an incurable fungal infection from inhaling aerosolized marijuana. They later tested 20 marijuana samples from Northern California dispensaries — using specialized techniques — and found a wide variety of potentially hazardous microorganisms.[123]

The degree to which such contaminates commonly appear in grown and stored cannabis material and to which microbiological contaminates should be tested is not clear, however. As mentioned previously, neither the U.S. EPA or neighboring Health Canada provide any significant guidance on cannabis testing, including microbiological contaminates.[124] Like heavy metal testing, parallels are drawn from microbial testing guidelines and standards relating to tobacco and food, where they exist.[124] As warm, moist environments are conducive to microorganism growth, maintaining stable moisture levels during cultivation and storage is essential. Regularly measuring water activity — how moist something is — is particularly useful as a front-line preventative tool to better ensure microbial growth is limited.[117] Regardless, testing of some kind is still required by many U.S. states, including for organisms such as[37][89][96][117][123][124][125][126]:

  • Aflatoxin
  • Alternaria
  • Aspergillus
  • Cryptococcus
  • E. coli
  • Mucor
  • Penicillium
  • Salmonella

Methods and guidelines

Now that we've addressed what's being tested for, we can move on to how they're being tested and what's being done to improve testing methods and procedures, including associated guidelines and recommendations. It would be beyond the scope of this guide to include every state's laws and guidelines on cannabis testing; entities such as Leafly Holdings[127] and CannaGuard Security[128] provide such online resources. Instead, this section will focus on current and promising techniques using generalizations based on information from multiple sources. If any guidelines and recommendations are known, they'll be included.

Sampling

Random, representative sampling is encouraged. When dealing with solid cannabis, BOTEC Analysis recommends a "quartering" method that divides the sample into four equal parts and takes portions from opposite sections of a square-shaped arrangement of the sample. For liquid cannabis products, remembering to stir before sample collection is advised.[89] When deriving a sample from a cannabis-laden edible, the QuEChERS approach used by food safety labs for pesticide testing has practical use.[129] In fact, a variety of parallels have been drawn from the food and herbal medicine industries' sampling guidelines, including from the Codex Alimentarius Commission's CAC/GL 50-2004 General Guidelines on Sampling as well as various chapters of the United States Pharmacopeia and The National Formulary.[89][130] As the APHL points out, "[g]ood sampling is key to improving analytical data equivalency among organizations," and it provides a solid base for any future testing and standardization efforts.[89]

Additional sampling insight can be found by examining other states' guidelines, e.g., Massachusetts' Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana-Infused Products for Massachusetts Registered Medical Marijuana Dispensaries.[131]

Cannabinoid testing

Quantifying cannabinoids for label accuracy is a major goal of testing, though calculation and testing processes may vary slightly from state to state. Despite any differences, laboratorians generally agree that when testing for cannabinoids such as THC and CBD, as well as their respective biosynthetic precursors THCA and CBDA, the methodology used must be scrutinized. The naturally occurring THCA of cannabis isn't psychoactive; it requires decarboxylation (a chemical reaction induced by drying/heating that releases carbon dioxide) to convert itself into the psychoactive cannabinoid THC. Chemical calculations show that the process of decarboxylation results in approximately 87.7 percent of the THCA's mass converting to THC, with the other 12.3 percent bubbling off as CO2 gas.[132] The problem with this in the testing domain is gas chromatography (GC) involves heating the sample solution. If you, the lab technician, require precise numbers of both THCA and THC, then GC analysis poses the risk of under-reporting THC total values.[89] As such, liquid chromatography-diode array detection (LC-DAD) may be required if a concise profile of all cannabinoids must be made, primarily because it provides environmental stability for them all during analysis. If GC is used, the analysis requires extra considerations such as sample derivatization.[89][96][133][134]

The APHL briefly describes analysis methods of cannabinoids using both LC and GC on pages 31–32 of their May 2016 Guidance for State Medical Cannabis Testing Programs. They also point to New York Department of Health - Wadsworth Center's various guidance documents (MML-300, -301, and -303) for methodologies when testing sample types other than solids, particularly using high-performance liquid chromatography photodiode array detection (HPLC-PDA).[89][135] Overall, methods used in cannabinoid testing include[89][96][135][136][137]:

  • Fourier transform infrared spectroscopy (FTIR; has limitations, such as requiring standard samples tested w/ other methods)
  • Gas chromatography flame ionization detection (GC-FID; requires sample derivatization for both acid and neutral compounds; good with standards like 5α-cholestane, docosane, and tetracosane)
  • Gas chromatography mass spectrometry (GC-MS; requires sample derivatization for both acid and neutral compounds; good with standards like deuterated cannabinoids)
  • High-performance liquid chromatography photodiode array detection (HPLC-PDA; stable for all forms of cannabinoids)
  • High-performance liquid chromatography UV detection (HPLC-UV)
  • Supercritical fluid chromatography (SFC; newer technology w/ added benefits)
  • Thin-layer chromatography (TLC; older, less common technology)
  • Ultra-performance chromatography (UPC; newer technology w/ added benefits)

Terpene testing

Identifying and quantifying terpenes is one of the more difficult tasks facing laboratorians[96]:

Terpenes present an analytical challenge because they are nonpolar and structurally similar, and many structural isomers exist. Mass spectrometry (MS) cannot distinguish terpenes that co-elute from a GC column because many have the same molecular weight and share fragment ions.

Of course, types of gas chromatography work; but like cannabinoids, terpenes can degrade with the high heat of gas chromatography.[137] Combined with the problems mentioned above, highly specialized gas chromatography processes that include additional steps — such as full evaporation technique headspace gas chromatography flame ionization detection (FET-HS-GC-FID) — can be used to produce cleaner results, particularly for volatile components.[96] It's less clear if high-performance liquid chromatography (HPLC) is used frequently; some entities such as Eurofins Experchem Laboratories claim HPLC works best for them[137], while others such as Restek Corporation claim the method is problematic at best.[138]

Overall, methods for terpene identification and analysis include[96][114][136][137][139]:

  • Full evaporation technique headspace gas chromatography flame ionization detection (FET-HS-GC-FID; tends to be semi-quantitative)
  • Gas chromatography flame ionization detection (GC-FID)
  • Gas chromatography mass spectrometry (GC-MS)
  • Headspace gas chromatography mass spectrometry (HS-GC-MS)
  • High-performance liquid chromatography (HPLC; may have limitations due to coelution of terpenes and cannabinoids at certain ranges[138])

Contaminate testing

LC MS pic.jpg

Pesticides: Gas and liquid chromatography methods are by and large the staple of testing methods for pesticides, which remain "the hardest analyses that are going to be done in the cannabis industry."[96] Notably, high-performance liquid chromatography tandem-mass spectrometry (HPLC-MS/MS) tends to be one of the most thorough methods says Emerald Scientific's CTO Amanda Rigdon. "Ninety-five percent of the pesticides out there can be analyzed by HPLC-MS/MS, although there are some that you would need a GC-MS/MS for," she says.[96] Testing methods that have been used include[89][139]:

  • Gas chromatography electron capture detection (GC-ECD)
  • Gas chromatography mass spectrometry (GC-MS)
  • Gas chromatography tandem-mass spectrometry (GC-MS/MS)
  • Liquid chromatography mass spectrometry (LC-MS; also high-performance or HPLC-MS)
  • Liquid chromatography tandem-mass spectrometry (LC-MS/MS; also high-performance or HPLC-MS/MS)

For quantification of pesticides in cannabis, the EPA's Residue Analytical Methods (RAM) or FDA's Pesticide Analytical Manual (PAM) provide guidance to labs.[89][140][141]


Solvents: Testing for solvents is largely standardized into a couple of options, which have parallels to existing pharmaceutical testing standards outlined in Chapter 467 of United States Pharmacopeia and The National Formulary (USP <467>)[120][89][96][139]:

  • Headspace gas chromatography/mass spectrometry (HS-GC/MS)
  • Full evaporation technique headspace gas chromatography flame ionization detection (FET-HS-GC-FID)

Massachusetts and Oregon — and likely other states — have used a variety of guidance documents such as USP <467>, reports from the Commission of the European Communities' Scientific Committee on Food (now the European Food Safety Authority), and the International Conference on Harmonization's (ICH) Q3C(R5)[89][121][117] to set their action level testing values for particular solvents.


Heavy metals: The methods used for quantifying levels of highly toxic metals in plants depend on ease-of-use, level of accuracy, and overall cost. The following methods are most common for testing cannabis and other plants[39][89][96][142][139]:

  • Inductively coupled plasma atomic emission spectroscopy (ICP-AES), sometimes called inductively coupled plasma optical emission spectrometry (ICP-OES) (at times coupled with an ultrasonic nebulizer)
  • Inductively coupled plasma mass spectroscopy (ICP-MS)
  • Inductively coupled plasma tandem-mass spectroscopy (ICP-MS/MS)

For quantification of metals in cannabis, the U.S. FDA's ICP-MS methodology document is often used.[89][140]


Mycotoxins and microorganisms: A standard method of testing for the existence of microorganisms is through the process of culturing a sample in a Petri dish, a common diagnostic method in microbiology. Enzyme-linked immunosorbent assay (ELISA) is also used, particularly to identify mycotoxins. However, Petri culture analysis isn't rigorous, and ELISA can be time consuming, as it's limited to one mycotoxin per test.[39][96][124] The following are other, more precise techniques that are improving laboratorians' analyses, particularly using DNA snippets of microbiological contaminates[39][96][124][143]:

  • Quantitative polymerase chain reaction (qPCR)
  • Whole metagenome shotgun (WMGS) sequencing
  • Matrix-assisted laser desorption/ionization (MALDI)
  • High-performance liquid chromatography (HPLC)
  • Liquid chromatography tandem-mass spectrometry (LC-MS/MS)

The extent of mycotoxin testing required remains in question by several entities. The Association of Public Health Laboratories (APHL) claims "[t]here is no readily available evidence to support the contention that cannabis harbors significant levels of mycotoxins."[89] The Oregon Health Authority takes a more middle-ground approach, noting that testing for E. coli and Salmonella will "protect public health," though Aspergillus only deserves a warning for people with suppressed immune systems due to its prevalence in the environment.[117] USP <561> recommendations largely limit mycotoxin testing of botanical products to those borne from root or rhizome material[144], "which THC-containing cannabis products presumably do not possess," emphasizes the APHL.[89] Regardless, U.S. Pharmacopeia's Chapter 561 remains a useful document for testing guidelines and limits regarding microbials.[144][89] In the less common case of dealing with powdered cannabis — a relatively new THC extract form — Chapter 2023 provides at least some testing parallels, though Dr. Tony Cundell, a microbiologist consulting for the pharmaceutical industry, suggests USP <2023> doesn't go far enough for immunocompromised patients.[145]

Somewhat related and worth mentioning is moisture content testing. As previously mentioned, warm, moist environments are conducive to microorganism growth, and regularly measuring water activity is useful for the prevention of microbial growth.[117] The APHL references specifications from the Dutch Office of Medical Cannabis that recommend water content be between five to ten percent in cannabis.[89]

Reports

There's little in the way of standardization for lab reporting of cannabis test results, though some U.S. states have outlined requirements for what must be included in such reports. The Oregon Health Authority's Oregon Administrative Rules, Chapter 333, Division 64, Section 0100: Marijuana Item Sampling Procedures and Testing stipulates that any report must include total THC and total CBD (by dry weight) and, if discovered, "up to five tentatively identified compounds (TICS) that have the greatest apparent concentration." It also lays out requirements for pesticides, failed tests, limits of quantification, and specimen identifiers such as test batch number.[146]

In late January 2017, Pennsylvania released its temporary regulations in support of its new medical marijuana program (28 Pa. Code Chapter 1171), which includes a section on test results and reporting (1171.31). The regulations stipulate reporting by electronic tracking system, with stipulations on using certificates of analysis which include lot/batch number and the specific compounds and contaminates tested.[147] Regulations aside, it's largely up to the laboratory — and often by extension, the software they're using — to decide how a report is formatted. Some labs like Seattle-based Analytical 360 offer clean, color-based certificates of analysis, with high-magnification photographs, the chromatogram, potency, cannabinoid content, contaminate content, and explanation of limits, with the name of the approving analyst.[148][149] Others may simply generate a computer printout with the basic data and a legend.[150] Reports may originate from the measuring device itself (e.g., an integrator in a chromatography device), a middleware or data station attached to the instrument, or a laboratory information management system that accepted data from the instrument.[151]

Though not directly related to laboratory testing, it's worth noting states also have their own reporting requirements for growers, processors, and dispensaries. Both Oregon and Washington, for example, require monthly reports related to medical marijuana transfers.[152][153]

Lab equipment

As indicated in previous sections, spectrometry and chromatography have played and will continue to play an important role in cannabis laboratory testing. This should not be surprising: "mass spectrometry is superior to other spectral techniques in such features as sensitivity, selectivity, generation possibility of molecular mass/formula, and combinability with chromatography."[154] Analyzing complex chemical compounds that have many features and which are at times difficult to differentiate from each other proves challenging, but these technologies excel in meeting that task.[154] Refer to the previous "Methods and guidelines" section to note the specific technology associated with each molecule and contaminate. Aside from spectrometry and chomatography equipment, the analysis of microorganisms in cannabis may turn to DNA analysis methods that require additional equipment such as a thermal cycler (qPCR) or sequencer (WMGS), or ELISA, which utilizes a photometer or spectrophotometer. Of course, preparing and storing samples requires equipment as well, such as microplates, centrifuges, comparison standards, capillaries, chemicals, columns, Petri dishes, scales, and disposable gloves. Software-based data management systems may also constitute as equipment and are discussed in the next section.

When it comes to purchasing lab equipment specifically for cannabis testing, a 2015 interview with Emerald Scientific's CTO Amanda Rigdon (then with Restek Corporation) provides good advice[155]:

  • Industry-specific instrumentation isn't needed in most cases as most of the techniques and equipment used in food and herbal medicine testing have strong parallels to cannabis testing.
  • That said, some sample preparation tools, standards, and consumables specifically marketed to the industry may very well make the job quicker and more reliable.
  • Appropriate sample preparation techniques are just as vital as the equipment you use.
  • Do your research; many instrument companies are examining methodologies usable on conventional equipment, lessening the need for more expensive devices.
  • If buying used equipment, make sure the original manufacturer is still in-business and producing consumables and replacement parts. Make sure your planned methods match the equipment, and make sure it's not so old that it can't be serviced by a qualified technician.

Software

Laboratories increasingly depend on software to analyze, store, and share critical data from instruments and experiments.[156] This has led to the development of laboratory-specific software like the laboratory information management system (LIMS), electronic laboratory notebook (ELN), and chromatography data management system (CDMS; sometimes simply CDS). These and other software systems such as "seed-to-sale" programs can also play an important role in the cannabis testing laboratory.

LIMS

Laboratories of all types use LIMS software to manage the wide variety of data, testing and analysis workflows, and other enterprise activities typical of them. This generally includes — but is not limited to — sample reception, workflow management, sample tracking and analysis, quality control, instrument data management, data storage, reporting, and document management.[157] The cannabis testing laboratory is no exception, though its activities differ slightly from, for example, a clinical pathology laboratory. As such, a few additional features outside of what's typically found in a generic LIMS are required.

Features that may be incorporated into a cannabis testing LIMS that you might not necessarily find in an all-purpose LIMS include[158][159][160][161]:

  • sample loading screens optimized for the industry, including differentiation between medical and recreational marijuana
  • pre-loaded compliant test protocols, labels, and reports optimized and readily adjustable for a rapidly changing industry
  • tools for creating new, compliant test protocols, labels, and reports
  • a web API to integrate with state-required compliance reporting systems
  • chain-of-custody (CoC) tracking, when necessary
  • support for inventory reconciliation

As previously discussed, industry-specific test protocols largely focus on cannabinoids, terpenes, and a wide variety of contaminates, including excess water. However, as regulations continue to be in a state of flux and not particularly standardized, most LIMS developers are including the ability for users to adjust their protocols and even add new ones. And while CoC functionality is not entirely foreign to generic LIMS, it's particularly important in an industry where currently transporting even a cannabis test sample across state lines can create huge problems.

In cases where daily sample processing is infrequent and only a couple of chromatography machines are used, laboratories may weigh a decision between a LIMS and a chromatography-specific CDMS.

CDMS

Scientists on the research side of cannabis are certainly using CDMSs from Agilent, Thermo Scientific, Waters, and other to manage the data coming out of their chromatography equipment[162][163][164], and slowly but surely some of those CDMSs are beginning to also support spectrometer data management in a similar way.[165] Additionally, some chromatography system developers will collaborate with CDMS vendors to develop software drivers — code that essentially acts as a translator between a device and a program — so chromatography devices can interact fully with the CDMS.[166]

The CDMS likely has a place in the cannabis testing lab as well, though it may depend on the lab's data management needs and goals. In more complex labs with multiple instruments and significant daily processing workflows, a LIMS may make more practical sense.

Seed-to-sale

The use of seed-to-sale software is an emerging trend that is only tangentially related to laboratory testing of cannabis. Rather than at testing laboratories, seed-to-sale software is found at cultivation sites, production facilities, and dispensaries, and that software is typically designed to be able to integrate with testing laboratory or other software. The goal: create a complete record of transaction, from the grown plant to the lab, producer, and seller. This sort of tracking is mandated in various ways by many U.S. states with legalization laws. "It’s there to prevent the diversion of marijuana, which the federal government still lists as a Schedule I substance, the most dangerous class of drugs," wrote Daniel Rothberg of the Las Vegas Sun in December 2015. "Tracking also ensures product safety, assists with audits and helps facilitate recalls."[167] This type of software is able to track plant yields, attempted theft or diversion, patient preferences, extraction methods, batch weights, and various financial statistics for analysis.[168][167]

Future of cannabis regulation, testing, and market trends

Regulation and market

Medical cannabis demo 2.JPG

On February 23, White House Press Secretary Sean Spicer indicated for the first time that the Trump administration would indeed be ramping up enforcement in states that have legalized recreational marijuana use, stating "I do believe that you’ll see greater enforcement," adding that "there’s a big difference between the medical use ... that’s very different than the recreational use, which is something the Department of Justice will be further looking into."[169] Five days later, U.S. Attorney General Jeff Sessions continued to send pessimistic signals, stating he was "dubious about marijuana," and that "[w]e have a responsibility to use our best judgment ... and my view is we don’t need to be legalizing marijuana."[170] Several days later, seemingly in response to both Spicer's and Sessions' comments, 11 U.S. senators sent a letter to Sessions asking him to keep in mind Trump's campaign promises of letting states decide their own fate on legalization efforts.[171]

Until demonstrably intrusive federal enforcement actions take place in states with legalized recreational marijuana, it won't be clear if the administration is simply making an implied, noisy threat in order to bring more in the industry to heel. More certain is mounting evidence that a growing majority of U.S. voters believe the federal government should not be enforcing its laws in such states: 64 percent agreed on this in 2012[172], rising to 71 percent in 2017.[173] Despite such support, it may largely be up to the states in the future to twist the arm of the federal government. Legal representatives at Thompson Coburn expressed this idea well in a blog post in November 2016[40]:

The cannabis industry may have to consider forcing the federal hand by providing credible data on the safety of cannabis as it was invited to do in the DEA decision, in addition to the continuing to support the groundswell of approval at the state level. At some point, in the near future, the state regulatory position and the federal position will have to be reconciled. The industry can and should prompt that reconciliation by a clear united message to federal lawmakers. Without that, it remains unlikely that agencies, such as the FDA, will change its position on cannabis. A lack of change will inhibit market growth and prevent the cannabis industry from reaching its potential.

The obvious issue with expanding research and testing on cannabis and of its safety is acquiring the product within a legal framework and a reasonable time frame. As mentioned previously, the DEA has recognized the need for more federally approved growers than the NIDA center at the University of Mississippi (which came under fire in March 2017 for not testing its provided samples for mold and other contaminants in any standardized fashion[174]), and they've begun accepting applications for additional entities looking to grow marijuana for researchers.[85] Assuming the Trump administration doesn't force the DEA to change course — and signs point to the administration at least being on spoken record of supporting medical marijuana and associated research[175] — researchers will optimistically have more options for acquiring research-quality cannabis in the future. This should in turn allow researchers a shot at more focused studies that provide efficacy and safety data related to the medical use of cannabis.[40] In fact, this has been a goal of Dr. Susan Weiss, Division Director of Extramural Research at the National Institute on Drug Abuse (NIDA) for some time. In July 2016 testimony to the U.S. Judiciary Committee[24] and in a February 2017 research paper set to be published in The International Journal of Drug Policy[176], Weiss cautiously recognizes and promotes the need for further evidence-based cannabis research, emphasizing both the healthy and detrimental effects evident so far in the plant and its constituents. She said of recent federal actions towards this goal[24]:

Multiple agencies (NIH, ONDCP, DEA, and FDA) are working together to find ways to streamline the process to facilitate research while meeting international and legislative obligations under the Single Convention on Narcotic Drugs and the Controlled Substances Act. In addition to actions taken by the Department of Health and Humans Services to eliminate the Public Health Services (PHS) committee review for non-federally funded marijuana research, the DEA recently streamlined the administrative process for CBD research to allow researchers to obtain a waiver of the requirement for review of changes to an approved protocol in their DEA research registrations, and is attempting to address the marijuana diversity and product development concern by licensing additional manufacturers.

Another recent and significant body of research that may have future influence on cannabis research itself is a massive January 2017 cannabis literature review published by the National Academies of Sciences, Engineering, and Medicine. This 440-page report detailed the National Academies' findings after reviewing more than 10,700 abstracts related to cannabis. Among its final recommendations, the authors called for[177]:

  • public and private entities to fund and support a national cannabis research initiative that looks to fill key knowledge gaps;
  • government agencies to develop research methods and standards that may act as a guide towards higher-quality cannabis research;
  • government agencies, non-profit associations, and state and local health departments to fund and support efforts to improve federal, state, and local public health surveillance systems and efforts; and
  • government, non-government, and industry entities to work together towards developing a report on existing regulatory barriers to research and how to overcome them.

However, some researchers such as Mayo Clinic psychiatrist and researcher Michael Bostwick are less convinced that the barriers will fall — claiming federal entities shift too much focus on the detrimental effects and not enough on the potential benefits — and aren't optimistic about the direction the Trump administration will take.[178] Despite this pessimism, predictions of substantial revenues in states where recreational marijuana is legalized or could be legalized persist.[179][180][181] The latest national estimates by market research and analytics company New Frontier Data put the U.S. marijuana industry at $24 billion by 2025, with 255,000 total jobs by 2019.[182] Yet entities such as the Denver-based Marijuana Policy Group and cannabis law firm Vicente Sederberg LLC preach caution when dealing with tax revenue estimates and economic projections in the U.S. cannabis market[182], pointing to CIBC World Markets' grossly inflated tax revenue estimate of $142 CAD ($106 USD) per resident in January 2016, an overshot of about 300 percent.[183] "This is a fast-paced, changing market with varying different dynamics that have more to do based on governmental and regulatory dynamics than they do on consumer dynamics," said Vicente Sederberg's director of economics and research Andrew Livingston.[182]

Indeed, current and future regulatory dynamics seem to be the biggest wildcards in making market-based predictions, with predicted tax and associated revenue estimates capable of both being significantly too high (by inadequately taking into account local and regional cultural and economic statuses) or too low (by not anticipating new states legalization efforts, research breakthroughs, or ties to other mainstream but related industries).[182][183] Additionally, too much regulation can put a stranglehold on a state's cannabis program development — as it has done in Minnesota[184] — causing related grow-ops and laboratories to take significant losses or even go out of business.

Lab testing

Future-looking estimates on cannabis lab testing are more difficult to find. The primary numbers being floated around originate from a June 2015 market report published by GreenWave Advisors titled Marijuana lab testing: An in depth analysis of investing in one of the industry’s most attractive plays. GreenWave suggested that if the U.S. were to quickly legalize cannabis at the federal level, lab testing revenues alone would be $553 million by 2020, $866 million including related activities such as data analysis and consulting.[185][186][187]

As for advances in cannabis lab testing, Kuzdzal et al. of Shimadzu envision a future where improvements in standardization, quality control, and research will shift what is tested and how its tested[39]:

The cannabis industry and cannabis testing are in their infancies. As the need for better quality control continues and standardization is introduced, it is likely that lower limits for the various cannabis contaminants will be established and regulations will be introduced. Mass spectrometry will likely play a greater role in quantitation as detection levels are lowered and confirmatory tests are required. The health benefits of terpenes present in cannabis will also provide a fertile area of scientific research. CBD, CBG and other compounds appear to have a synergistic relationship with each other as well as with various THC forms and terpenes. This field needs much more investigation to determine mechanisms of action, bioavailability and health benefits.

Lab testing of cannabis should continue to provide more exact and useful results as methods and standards continue to evolve. Disparity of results between two labs for the same sample are continuing to narrow as states increasingly add testing requirements to their cannabis legislature.[188] Those testing requirements are increasingly based off a growing body of recommendations, guidance, and standards developed by the likes of the Americans for Safe Access Foundation (ASAF), American Herbal Pharmacopoeia (AHP), American Herbal Products Association (AHPA), American Oil Chemists' Society (AOCS), and the Association of Public Health Laboratories.[92][93][94][95][96][89] Proficiency tests such as the Emerald Test[189], which allows multiple labs to test an anonymous sample and compare results, should also continue to drive improved performance from cannabis testing labs.[188]

Another potential trend to keep an eye on with these testing laboratories: consolidation. Currently there's not a lot of data on the extent consolidation has affected the number of cannabis testing labs or how they operate; the industry is arguably still in its infancy. Regardless, mentions in press and practical examples demonstrate that consolidation is a real concern for the industry, if not now in the future. Suggestion of such came from Steep Hill Halent's CEO David Lampach in late 2013, anticipating "huge consolidation in general and fewer companies as a result."[49] The previously mentioned GreenWave Advisors as well as CannaSafe Analytics have also lent their voices to this idea in recent years.[190][191]

Production

Outside the lab, on the production side, resides a glimpse of technology that ties several of the previously mentioned ideas together: growing cannabis as an environmentally modified organism (EMO). A June 2016 article published in Motherboard references the Controlled Environment Systems Research Facility (CESRF) in Canada and its effort to apply innovations in growing plants in closed environments (such as on spaceships) to cannabis production.[192] Specifically, the researchers see promise in being able to precisely control grow conditions to produce a plant with a particular ratio of active chemicals. As such, the previously mentioned synergistic relationship of cannabis' chemicals can be more carefully studied, and the end product, once studied and methodically tested, could potentially "achieve the status of a conventional pharmaceutical commodity that a doctor can rely on and prescribe."[192] CESRF isn't alone in developing grow technology that can tailor the necessary conditions for a particular strain. Several Israeli-linked start-ups (see the last section "Non-U.S. policy" for more) like Corsica Innovations (LEAF) and Flux (Eddy) have been developing similar grow technology that may transform future research.[193][194][195]

With better research, more definitive fact-based decisions can be made in the regulatory sphere, better guiding medical and recreational marijuana policy. That said, keep an eye on developments in controllable production methods; advances in this area stand to improve many of the other facets of research and testing discussed.

Big Marijuana

Both U.S. states and the federal government have a long, sometimes torturous history with regulating and controlling the production and sale of drug-containing products such as pharmaceuticals, tobacco, beer, wine, and spirits. As such, it seems intuitive to examine the successes and failures of those past efforts when considering what to do with cannabis. One aspect of that examination that raises concern among some is the likelihood of a narrow group of commercial interests taking over all aspects of cannabis production, testing, distribution, and sales. Taking from "Big Pharma," "Big Tobacco," and "Big Alcohol," some fear a similar "Big Marijuana" industry will develop.[196] These fears can be found among small private growers at the hyper-local level[197], all the way up to the state government level.[198]

In fact, in a 2015 Pathways Report, the state of California — including its Lt. Governor Gavin Newsom — expressed this very concern in regards to how best to regulate marijuana in the state. When considering the marijuana industry structure, they found that controls should be put in place to better incentivize smaller industry players, stating "[t]he goal should be to prevent the growth of a large, corporate marijuana industry dominated by a small number of players, as we see with Big Tobacco or the alcohol industry."[198] Despite that advice, major California-based industry players such as Steve DeAngelo — who owns one of the largest medical marijuana dispensaries in the world and co-founded Steep Hill Labs — remain concerned that mandates for distribution, which mirror alcohol regulations, will only undermine small cannabis businesses in the state.[197]

Anti-marijuana alliances such as Smart Approaches to Marijuana (SAM) and corporation-friendly pro-cannabis Marijuana Policy Project (MPP) act as opposing special interest groups, one fighting against Big Marijuana, the other borrowing from a libertarian approach proposing regulation of marijuana in a way similar to alcohol.[197][199][200] These and other special interest groups inevitably bring about the perception that, as the Brookings Institution puts it, "the marijuana industry is as self-serving as any other commercial lobby," further propelling worries of Big Marijuana.[199]

If worries of large corporations taking over significant portions of cannabis production, testing, distribution, and sales markets actually come to fruition, how will they potentially manifest? The previously mentioned concern of increased consolidation of testing labs is arguably one sign, as is DeAngelo's concern of forced distribution contracts taking away from smaller businesses. Brookings also points out concerns of large firms gaining hold over the evolving regulatory status as well as upward trends in antisocial marketing, though they also argue against undue alarmism of commercialization at the same time.[196]

Another manifestation of how Big Marijuana may be taking hold is through the patenting of cannabis strains and methods. PBS' Nova reported in October 2016 that a group of California growers were granted a patent for "compositions and methods for the breeding, production, processing and use of specialty cannabis,"[201] raising concerns about how Big Pharma could capitalize. Mowgli Holmes — founder of Phylos Biosciences, a genetics testing laboratory for cannabis — says as much: "Everyone is terrified of some big corporation with deep pockets coming in and taking over ... and they should be." To fight against the misappropriation of patents for "public domain" cannabis strains, he and others have developed Phylos Galaxy to better track relations between existing cannabis strains and the creation of new strains. From a lab testing perspective, a small but increasing number of qualified labs could test not only for potency, terpenes, and pesticides but also genetically verify in a standardized format that a unique strain is actually what it is claimed to be, providing slight competitive advantage.[201] As the patenting trend continues (most recently a patent was issued to a Florida company for an "apparatus and methods for biosynthetic production of cannabinoids"[202]) the intellectual property war over strains and methods is bound to get more heated; as such, the development of accurate and open genetic and other laboratory testing methods may become increasing vital.

Non-U.S. policy

Treaty decades.png

Aside from a few mentions of Canada and European regulation, this guide has focused solely on the state of cannabis and related lab testing in the United States. However, it would be remiss to not look at how policy elsewhere may potentially impact the U.S. cannabis market, if nothing else at least indirectly. Broadly speaking, other countries like the Netherlands and Portugal have put more emphasis on decriminalization and recreational legalization of marijuana than on researching and providing marijuana for medical purposes.[203] Israel has been one of the major exceptions to this generalization, arguably "up to 10 years ahead of other countries in innovation in the cannabis industry."[195] The country has been involved with cannabis research since the 1960s, and today it has its hands in many medical research-based initiatives (though recreational marijuana is still illegal), including[195][204]:

  • The Green Book, a set of written protocols and policy detailing how doctors should work with medical marijuana (still in draft phase as of March 2017) as well as how it would be commercialized across the country; includes training and certification of 100 doctors for prescribing it[205][206]
  • the creation of the Medical Cannabis Unit, a government agency that regulates medical cannabis research and use
  • the development of significant investment and infrastructure for clinical trials involving medical cannabis
  • the development of a national institute for medical marijuana research
  • the discussion of potentially exporting cannabis and/or cannabis-related extracts and derivatives
  • several higher education facilities offering courses and research opportunities on cannabis
  • several start-ups developing improved cultivation, pharmaceutical, and medical device technology

Another major country challenging traditional cannabis regulation is Uruguay, which in December 2013 adopted the first stages of regulatory legislation that will ultimately make the cultivation, sale, and use (recreational and medical) of cannabis in the country legal and government-controlled. In part due to concerns regarding gang-related violence and a tentative but not proven connection to black-market cannabis, the country has since carefully and methodically implemented the laws and regulations with the goal of keeping in mind evidence-based research and the potential social impact.[207] In fact, a late February 2017 press release from Canadian company Emblem Corp. stated it and Uruguayan ICC International Cannabis Corporation would, pending finalization of regulatory processes between the two countries, begin a partnership that would have Emblem import CBD (cannabidiol) from ICC "to help fulfill the demand in the Canadian market."[208]

The reality of all this — combined with the legalization momentum in the U.S. and other countries — means that new pressures are being applied to organizers of international treaties and policy, and any future changes to those treaties and policy may inversely apply pressure back on the U.S. government to update its stance on cannabis. An October 2014 Brookings Institution interview revealed some of the issues "straining the limits of an international drug control regime that most participants, including the United States, have long understood to be quite strict."[209] Drug treaties such as the Single Convention on Narcotic Drugs (1961), Convention on Psychotropic Substances (1971), and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) represent hard policy that the U.S. government (as well as other federal governments) has followed steadfastly for years. However, a dichotomy begins to form when federal governments bend those treaties either through outright legalization or, as is the case in the U.S., by allowing the states power to determine their own laws.[209]

As a result of these stresses, policy experts around the world are shining light on the need for not only federal governments but also international agencies such as the United Nations' World Health Organisation (WHO) to move forward with critical reviews of existing cannabis research in the social and medical domains and determine if revising cannabis' scheduling is appropriate. Additionally, policy experts urge United Nations members to discuss and amend existing treaties, even if such amendments only provide greater flexibility in regards to marijuana.[209][210]

Whether or not the decriminalization and legalization efforts of Israel, the Netherlands, Uruguay, and other foreign governments has a noticeable impact on international and U.S. federal law remains to be seen. However, it would be foolish to entirely ignore foreign policy when considering the future of cannabis — and by extension its laboratory testing — in the United States.

Final thoughts

This guide has attempted to provide insight into various aspects of the current status of laboratory testing of cannabis in the U.S. By extension, it has required a closer look at many non-testing or tangentially related aspects of cannabis, including history, regulations, standards, methods, equipment, and software. The guide has also attempted to look at the potential future of testing, a more difficult feat that has required inspection of — and speculation on — a mix of statistics and politics, as well as government and social policy and how they may all affect the future of cannabis testing. We learned that many point fingers at the U.S. federal government for being responsible for several cannabis-related issues, including lack of clear government support for cannabis research, lack of standardization of testing and analysis methods for said research, and wavering policy that remains inconsistent at best. At root is the fact that the federal government maintains cannabis (and its constituents) as a Schedule I drug, by extension declaring that it has no respectable medical use. This and related decisions have slowed down the academic study of cannabis, including its analysis, quality testing, and research and use as a medical treatment. The development, implementation, and reassessment of cultivation and testing standards and methods have largely been piecemeal; additionally, those efforts have been enacted in an environment where, despite the legal status in a state, fear that the federal government will inevitably intervene slows progress even further.

Despite these barriers, the speed at which U.S. states have adopted some form of legalization of cannabis has pushed scientists and researchers to collaborate and improve standards and methods. Necessity continues to be the mother of invention, driving those in the industry to adapt or perish in a difficult, inconsistent market. State officials are teaming up at industry conferences and sharing ideas. Non-profit organizations are joining forces with major standards agencies to expand and improve good laboratory practices. Researchers — whether on their own or with the help of others internationally — are learning more about the cannabinoid and its interaction with terpenes, driving new insight into potential therapeutic remedies. Overall public perception about marijuana consumption and use is gradually shifting towards a positive light, even when so little is still understood about the long-term ramifications of its use. Commercial interests are taking notice, and so are international treaty makers. All of this adds up to forward momentum in the cannabis industry, with warts and all.

Many factors will affect the future of cannabis regulation, testing, and research in the future; in the process, we're certain to see both ups and downs as political and social climates continue to change. However, as marijuana consumption and hemp-based manufacturing methods continue to see expanded support, consumers and manufacturers, as well as all those involved in between, will always clamor for a safer product that is "as advertised." Laboratory analysis will play an important role in that effort, whether it's in the medical research lab, the quality control lab, or the manufacturer's lab. It will be imperative for all interested parties to further work together to ensure methods are sound and standardized in a realistic and beneficial way to ensure that in the end consumers will get the best possible product available.

Resources

Key reading






Reference material




Law and regulation






Publications and blogs


Standards and guidance








Accreditation and certification






Testing




(Note year; still provides historical perspective)


New York State Department of Health:





Scientific conferences and trade shows











Associations, organizations, and interest groups


Testing labs and pricing info

The prevalence of testing laboratories in any given state depends on a few factors: legalization status, state laws regarding testing, and strictness of regulations. Labs typically appear as stand-alone, third-party entities. Though not common, some testing laboratories are located within dispensaries (e.g., Champlain Valley Dispensary in Vermont[211]) and treatment centers (e.g., Sanctuary ATC in New Hampshire.[212]).

The following are known active cannabis testing labs (those currently in the licensing process are not included):

Alaska


Arizona:


Arkansas:

  • Laboratory testing requirements being drafted


California:


Colorado:


Connecticut:


Delaware:


District of Columbia:

  • Steep Hill plans on expanding to here.


Florida:


Hawaii:


Illinois:


Maine:


Maryland:


Massachusetts:


Michigan:


Minnesota:

  • Not clear; independent labs must be approved by Commissioner of Health.[215] Two labs — Aspen Research and Legend Technical Services — were approved to do testing in 2015, but neither lists those services on their website.[216]


Montana:


Nevada:


New Hampshire:

  • The state mandates testing, but it's not clear which independent laboratories are approved to do so.


New Jersey:

  • Cannabis testing is performed by the Department of Health and Senior Services.[217]


New Mexico:


New York:

  • "The Department's Wadsworth Center Laboratory will perform initial testing and analysis of final medical marijuana products until independent laboratories receive certification from the New York State Environmental Laboratory Approval Program (ELAP)."[218]


North Dakota:

  • The state mandates that its compassion centers must test cannabis in-house or have it done by a contracted facility, though it's not clear what labs are performing such testing.[219]


Ohio:

  • Licensing requirements for testing labs will become clearer in September 2017.[220]


Oregon


Pennsylvania:

  • Steep Hill plans on expanding to here. Laboratory testing rules will become clearer later in 2017.[222]


Rhode Island:


Vermont:

  • The Department of Public Safety "may require laboratory testing of cannabis produced by a registered dispensary. The Department may specify the testing methodology. The registered dispensary shall bear the costs of any testing required by the Department."[223]


Washington:

Support services

The following entities are known to provide consulting and support services of various types to cannabis testing labs (as well as cultivators, dispensaries, etc.):

Testing hardware and supplies vendors


Software vendors

Cannabis-oriented LIMS

CDMS

See the CDMS vendor page.

Seed-to-sale

This is a representative sample of solutions and not a directory of all available solutions:

LIMSpec

References

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