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Overview of the cannabis industry in the United States

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.

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 grow 100 hemp plants for export to England.[3] Colonial American continued its growth, use, and exportation of hemp, even beyond the foundation 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 of 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 January 2017, twenty-eight U.S. states have approved some sort of 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 help production, with federal removal of hemp containing no more than 0.3 percent THC from the controlled substances list.[10] However, cannabis containing more than 0.3 percent THC remains remains a Schedule I controlled substance, as determined by the U.S. Food and Drug Administration.[11] 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.[12] Focusing in on the United States, the Substance Abuse and Mental Health Services Administration estimated that in 2014 the country had 35.1 million past-year marijuana users.[13]

Cultivation and distribution

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 totally more than $111 million in 2015.[14]

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.[15] As of mid-2015, 104 of the more than 750 constituents of Cannabis sativa have been identified as cannabinoids[16], "a class of diverse chemical compounds that act on cannabinoid receptors in cells that modulate neurotransmitter release in the brain."[17]

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[18][19][20][21][22][23] and evidence-based research of marijuana continues to be slow and bogged down in regulation.[24][25][14][26][27] 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[18][19][20][23] 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.[14][26][28]

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.[14]

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.[29][30]

Other areas of concern

When examining the current 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 (grow operations), 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 that Federal Deposit Insurance Corporation (FDIC).[31] In an attempt to ease concerns of industry and 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."[32][33] 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[11][26], 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.[34] 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."[35]

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.[36] 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[37][38][39], causing some to believe consolidation of such labs will occur before the industry can really even take off.[37][40]

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."[41] 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.[42]

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, citing 21 U.S. Code § 843(c).[43] 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.[44] (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."[45]) Even billboards are an issue, with state lawmakers proposing new regulations on marijuana advertising on them weeks after the state passed its recreational legalization laws.[46] And state laws, such as those found in Alaska, can create their own set of challenges in staying legal with marijuana advertising.[47]

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.[48]

Regulatory scheme

Federal

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.[49] Marijuana was initially placed under Schedule I[49] and remains there today.[11][26][50] As a Schedule I drug, the federal government is indicating marijuana has[49]:

  • "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".

The Reorganization Plan No. 2 of 1973 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).[51][52] Then President Richard Nixon said of the transition[51]:

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.[51] Since then the DEA has taken various steps — with guidance from the Food and Drug Administration (FDA)[53] — 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 in maintaining marijuana as a Schedule I drug.[28][54]

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).[55] 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.[56] 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.[57] 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.[58]

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.[59] The language of the memo essentially said "get off your butts and nail those suckers."[60] Cambron et al.[57] and Fairman[61] 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 in unnecessarily on states that have passed legalization laws and 2. Washington and Colorado legalizing recreational use of cannabis.[57] 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."[62] 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.[63][57] 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.[60]

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 consistent with state laws.[64] Before being passed in December 2014, the amendment had actually been introduced and defeated six times in the previous 10 years.[65] 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.[66][67]

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 January 2017, it was last renewed through April 2017; however, with the new Trump administration coalescing — including Trump's demonstrably anti-drug U.S. Attorney General nominee 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][68][69][70]

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.[11][26][50] Reasons included known health issues such as prenatal exposure and negative impacts on several biological systems as well as limited research and new drug applications.[28] 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."[71]

State medical and recreational

Laboratory testing of cannabis

Tests and standards

Reports

Lab equipment used

Software

Testing labs and pricing info

Future of cannabis testing and market trends

Resources

Trade shows

Producers and vendors

Software vendors

LIMS

Seed-to-sale

LIMSpec

References

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