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| ==Sandbox begins below== | | ==''Introduction to Quality and Quality Management Systems''== |
| Before getting directly into testing and regulations surrounding cannabis testing in the U.S., it's useful to review the past and current state of the cannabis industry in general. This chapter talks about the U.S.'s past with cannabis; how it's used medically and recreationally; how it's cultivated, tested, and distributed; and other industry aspects affected by the political and social climate in the U.S.
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| ==1. Overview of the cannabis industry in the United States==
| | The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems. |
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| 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.
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| ===Brief history of cannabis in the U.S.===
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| [[File:Drug bottle containing cannabis.jpg|right|160px]]''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''.<ref name="GRINCannabis11">{{cite web |url=https://npgsweb.ars-grin.gov/gringlobal/taxonomygenus.aspx?id=2034 |title=Genus: Cannabis L. |work=U.S. National Plant Germplasm System |publisher=U.S. Department of Agriculture |date=01 January 2011 |accessdate=20 January 2017}}</ref> Broadly speaking, both "industrial hemp" and "recreational marijuana" are scientifically similar in that they both refer to the ''cannabis'' plant. The important difference between the two is how they've been bred by humans, particularly in regards to their biochemical composition. Hemp—which has historically been used to create clothing, food and feed, paper, textiles, and other industrial items—tends to be bred to have lower levels of the psychoactive component tetrahydrocannabinol (THC) and higher levels of the non-psychoactive component cannabidiol (CBD).<ref name="SwansonControlled15">{{cite journal |title=Controlled Substances Chaos: The Department of Justice's New Policy Position on Marijuana and What It Means for Industrial Hemp Farming in North Dakota |journal=North Dakota Law Review |author=Swanson, T.E. |volume=90 |issue=3 |pages=599–622 |year=2015 |url=https://law.und.edu/_files/docs/ndlr/pdf/issues/90/3/90ndlr599.pdf |format=PDF}}</ref><ref name="DeitchHemp03">{{cite book |title=Hemp – American History Revisited |author=Deitch, R. |publisher=Algora Publishing |location=New York City |year=2003 |pages=232 |isbn=9780875862262}}</ref> However, some cannabis strains have intentionally been bred to maximize the psychoactive component THC; this is often referred to as marijuana (or the older term "marihuana"), a change arguably driven by newspaper reporters post-1900.<ref name="BaccaWhat14">{{cite web |url=http://www.alternet.org/drugs/whats-difference-between-hemp-and-marijuana |title=What's the Difference Between Hemp and Marijuana? |author=Bacca, A. |work=Alternet |publisher=Independent Media Institute |date=05 June 2015 |accessdate=10 April 2017}}</ref><ref name="ThompsonTheMyst13">{{cite web |url=http://www.npr.org/sections/codeswitch/2013/07/14/201981025/the-mysterious-history-of-marijuana |title=The Mysterious History Of 'Marijuana' |author=Thompson, M. |work=NPR |publisher=National Public Radio |date=22 July 2013 |accessdate=10 April 2017}}</ref>
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| 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.<ref name="DeitchHemp03" /> 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.<ref name="DeitchHemp03" /> 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.<ref name="Senate1860">{{cite web |url=http://www.nytimes.com/1860/02/16/news/senate-88150825.html |title=Senate |author=U.S. Senate |work=The New York Times |date=15 February 1860 |accessdate=20 January 2017}}</ref> 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.<ref name="WaltonMari38">{{cite book |author=Walton, R.F. |title=Marijuana, America’s New Drug Problem |location=Philadelphia |publisher=B. Lippincott |year=1938 |page=37}}</ref><ref name="WoodwardTax37">{{cite web |url=http://www.druglibrary.org/schaffer/hemp/taxact/woodward.htm |title=Taxation of Marihuana |author=Woodward, W.C.; House of Representatives, Committee on Ways and Means |work=Schaffer Library of Drug Policy |date=04 May 1937 |accessdate=20 January 2017}}</ref><ref name="CaversTheFood39">{{cite journal |title=The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions |journal=Law and Contemporary Problems |author=Cavers, D.F. |volume=6 |pages=2–42 |year=1939 |url=http://scholarship.law.duke.edu/lcp/vol6/iss1/2/}}</ref>
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| 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.<ref name="MeierPolitics16">{{cite book |url=https://books.google.com/books?id=J4wYDQAAQBAJ&pg=PT58 |title=The Politics of Sin: Drugs, Alcohol and Public Policy: Drugs, Alcohol and Public Policy |author=Meier, K.J. |publisher=Taylor & Francis |year=2016 |page=58 |isbn=9781315287270}}</ref> Progress picked up steam again in the late 1990s into the 2000s, particularly in states such as California, Massachusetts, Connecticut, Washington, and Colorado.
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| As of December 2018, thirty-three U.S. states have approved some sort of broad decriminalization or legalization of medicinal and/or recreational marijuana.<ref name="BerkeMichigan18">{{cite web |url=https://www.businessinsider.com/legal-marijuana-states-2018-1 |title=Michigan is the 10th state to legalize recreational marijuana. This map shows every US state where pot is legal |author=Berke, J.; Gould, S. |work=Business Insider |publisher=Insider, Inc |date=07 November 2018 |accessdate=13 November 2018}}</ref> Additionally, neighboring Canada has legalized the purchase, growth, and consumption of marijuana in small amounts across the country<ref name="PorterCanada18">{{cite web |url=https://www.nytimes.com/2018/11/11/world/canada/marijuana-legalization-teenagers.html |title=Canada’s Message to Teenagers: Marijuana Is Legal Now. Please Don’t Smoke It |author=Porter, C. |work=The New York Times |publisher=The New York Times Company |date=11 November 2018 |accessdate=13 November 2018}}</ref>, while Mexico's Supreme Court has legalized "all forms of non-commercial adult use" of the plant.<ref name="TimmonsMexico18">{{cite web |url=https://www.upi.com/Mexicos-Supreme-Court-legalizes-cannabis-for-recreational-use/9621541024238/ |title=Mexico's Supreme Court legalizes cannabis for recreational use |author=Timmons, P. |work=UPI |publisher=United Press International, Inc |date=31 October 2018 |accessdate=13 November 2018}}</ref> Industrial hemp has also been addressed in a more serious fashion in the U.S., with 39 states having introduced some sort of hemp cultivation and production programs, 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).<ref name="NCSLState18">{{cite web |url=http://www.ncsl.org/research/agriculture-and-rural-development/state-industrial-hemp-statutes.aspx |title=State Industrial Hemp Statuses |publisher=National Conference of State Legislatures |date=08 August 2018 |accessdate=13 November 2018}}</ref><ref name="81FR53395">{{cite journal |url=https://www.federalregister.gov/documents/2016/08/12/2016-19146/statement-of-principles-on-industrial-hemp |journal=Federal Register |title=Statement of Principles on Industrial Hemp |volume=81 |issue=156 |date=12 August 2016 |pages=53395–6 |accessdate=14 February 2017}}</ref> However, cannabis, including industrial hemp, remains a Schedule I controlled substance, as determined by the U.S. Food and Drug Administration<ref name="LegerMari16">{{cite web |url=http://www.usatoday.com/story/news/2016/08/11/dea-marijuana-remains-illegal-under-federal-law/88550804/ |title=Marijuana to remain illegal under federal law, DEA says |author=Leger, D.L. |work=USA. Today |publisher=Gannett Company |date=11 August 2016 |accessdate=20 January 2017}}</ref>, including extracts and other derivatives such as cannabidiol (CBD).<ref name="WallaceLegal17">{{cite web |url=http://www.thecannabist.co/2017/01/13/hemp-dea-extracts-marijuana-cbd-judicial-review/71387/ |title=Legal challenge filed against DEA’s new marijuana extract rule |work=The Cannabist |author=Wallace, A. |publisher=The Denver Post |date=13 January 2017 |accessdate=14 February 2017}}</ref> (However, the DEA moved CBD-based prescription drugs with a THC content below 0.01 percent to Schedule 5 classification in September 2018.<ref name="Romza-KutzCBD18">{{cite web |url=https://www.thompsoncoburn.com/insights/blogs/tracking-cannabis/post/2018-10-01/cbd-drugs-moved-to-schedule-5-no-promises-for-cannabis |title=CBD drugs moved to Schedule 5; no promises for cannabis |author=Romza-Kutz, D. |publisher=Thompson Coburn LLP |date=01 October 2018 |accessdate=13 November 2018}}</ref>) 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.
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| ===Medical and recreational use===
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| In its 2018 World Drug Report, the United Nations Office on Drugs and Crime estimated that 3.9 percent of the global population—roughly 192.2 million people—used cannabis in 2016.<ref name="UNODCWorld16">{{cite web |url=https://www.unodc.org/wdr2018/prelaunch/WDR18_Booklet_2_GLOBAL.pdf |format=PDF |title=World Drug Report 2018: Global Overview of Drug Demand and Supply |author=United Nations Office on Drugs and Crime |publisher=United Nations |isbn=9789210450584 |date=June 2018 |accessdate=13 November 2018}}</ref> Focusing in on the United States, the Substance Abuse and Mental Health Services Administration (SAMHSA) estimated that in 2017 the country had 40.9 million past-year marijuana users.<ref name="SAMHSAResults16">{{cite web |url=https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf |format=PDF |title=Results from The 2017 National Survey on Drug Use And Health: Detailed Tables |author=Substance Abuse and Mental Health Services Administration |editor=RTI International |page=167 |date=07 September 2018 |accessdate=13 November 2018}}</ref> It's not clear if that total includes legal medical marijuana users, which numbered roughly 3.5 million in May 2018 according to non-profit ProCon.org.<ref name="ProConNumber18">{{cite web |url=https://medicalmarijuana.procon.org/view.resource.php?resourceID=005889 |title=Number of Legal Medical Marijuana Patients (as of May 17, 2018) |publisher=ProCon.org |date=17 May 2018 |accessdate=13 November 2018}}</ref> When compared to SAMHSA's estimate of 11.1 million users in 1997<ref name="RabkinDrug99">{{cite book |url=https://books.google.com/books?id=ZvzBdlolKrQC&pg=PA16 |title=Drug Control: DEA's Strategies and Operations in the 1990s |author=Rabkin, N.J. |publisher=U.S. General Accounting Office |year=July 1999 |pages=172 |isbn=9780788184833}}</ref>, 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.<ref name="HasinMedical15">{{cite journal |title=Medical marijuana laws and adolescent marijuana use in the USA from 1991 to 2014: Results from annual, repeated cross-sectional surveys |journal=The Lancet Psychiatry |author=Hasin, D.S.; Wall, M.; Keyes, K.M. et al. |volume=2 |issue=7 |pages=601–608 |year=2015 |doi=10.1016/S2215-0366(15)00217-5}}</ref><ref name="WallAdol11">{{cite journal |title=Adolescent Marijuana Use from 2002 to 2008: Higher in States with Medical Marijuana Laws, Cause Still Unclear |journal=Annals of Epidemiology |author=Wall, M.M.; Poh, E.; Cerdá, M. |volume=21 |issue=9 |pages=714–716 |year=2011 |doi=10.1016/j.annepidem.2011.06.001 |pmid=21820632 |pmc=PMC3358137}}</ref><ref name="HarperDoMed12">{{cite journal |title=Do Medical Marijuana Laws Increase Marijuana Use? Replication Study and Extension |journal=Annals of Epidemiology |author=Harper, S.; Strumpf, E.C.; Kaufman, J.S. |volume=22 |issue=3 |pages=207–212 |year=2012 |doi=10.1016/j.annepidem.2011.12.002 |pmid=22285867}}</ref> Regardless, with 33 U.S. states now having some type of legalization law on the books<ref name="BerkeMichigan18" />, the number of marijuana users isn't likely to decrease any time soon in the U.S.
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| ===Cultivation and distribution===
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| At the federal level, marijuana is considered a Schedule I drug and remains illegal.<ref name="GPO21USC812">{{cite web |url=https://www.gpo.gov/fdsys/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap13-subchapI-partB-sec812.htm |title=§812. Schedules of controlled substances |work=United States Code |publisher=U.S. Government Publishing Office |date=03 January 2012 |accessdate=27 January 2017}}</ref><ref name="LegerMari16" /> (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.<ref name="BajajHowThe14">{{cite web |url=https://takingnote.blogs.nytimes.com/2014/07/30/how-the-federal-government-slows-marijuana-research/ |title=How the Federal Government Slows Marijuana Research |author=Bajaj, V. |work=Taking Note: The New York Times |publisher=The New York Times Company |date=30 July 2014 |accessdate=25 January 2017}}</ref><ref name="CheslerGov15">{{cite web |url=http://weedrush.news21.com/government-restrictions-lack-of-funding-slow-progress-on-medical-marijuana-research/ |title=Government restrictions, lack of funding slow progress on medical marijuana research |author=Chesler, J.; Ard, A. |work=News21: America's Weed Rush |publisher=Carnegie Corporation of New York; John S. and James L. Knight Foundation |date=15 August 2015 |accessdate=25 January 2017}}</ref><ref name="WeissTestimony16" /><ref name="JosephDEA16">{{cite web |url=https://www.statnews.com/2016/08/10/marijuana-medical-research-dea/ |title=DEA decision keeps major restrictions in place on marijuana research |author=Joseph, A. |work=STAT |publisher=Boston Globe Media |date=10 August 2016 |accessdate=25 January 2017}}</ref><ref name="RudroffMari17">{{cite web |url=http://www.newsweek.com/marijuana-regulation-blocks-vital-ms-research-544886 |title=Marijuana Regulation Blocks Vital Multiple Sclerosis Research |author=Rudroff, T. |work=Newsweek |publisher=IBT Media, Inc |date=21 January 2017 |accessdate=25 January 2017}}</ref>, and promises to expand grow-ops for research have fallen flat.<ref name="GurmanMari18">{{cite web |url=https://www.wsj.com/articles/marijuana-research-applications-go-nowhere-at-justice-department-1536404401 |title=Marijuana-Research Applications Go Nowhere at Justice Department |author=Gurman, S. |work=The Wall Street Journal |publisher=Dow Jones & Company, Inc |date=08 September 2018 |accessdate=13 November 2018}}</ref><ref name="OrdoñezTrump18">{{cite web |url=https://www.miamiherald.com/news/nation-world/national/article221305965.html |title=Trump fired Sessions. Here are four takeaways from the attorney general’s tenure |author=Ordoñez, F.; Kumar, A. |work=Miami Herald |publisher=The McClatchy Company |date=07 November 2018 |accessdate=13 November 2018}}</ref>
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| 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:
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| * 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 precisely following state and local law.
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| * 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.<ref name="BelvilleCanI16">{{cite web |url=http://www.weednews.co/can-i-take-marijuana-from-one-legal-state-to-another/ |title=Can I Take Marijuana From One Legal State To Another? |work=Weed News |author=Belville, R. |publisher=WN Media, LLC |date=28 November 2016 |accessdate=31 January 2017}}</ref>
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| * 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.<ref name="FindLawMari">{{cite web |url=http://smallbusiness.findlaw.com/business-laws-and-regulations/marijuana-business-licenses-permits-and-planning.html |title=Marijuana Business: Licenses, Permits, and Planning |work=FindLaw |publisher=Thomson Reuters |accessdate=31 January 2017}}</ref><ref name="LeaflyHome">{{cite web |url=https://www.leafly.com/news/cannabis-101/home-cannabis-cultivation-laws-a-state-by-state-guide |title=Home Cannabis Cultivation Laws: A State-by-State Guide |work=Leafly - Cannabis 101 |publisher=Leafly Holdings, Inc |accessdate=31 January 2017}}</ref><ref name="ProCon28Legal16">{{cite web |url=http://medicalmarijuana.procon.org/view.resource.php?resourceID=000881 |title=28 Legal Medical Marijuana States and DC: Laws, Fees, and Possession Limits |work=ProCon.org |date=28 December 2016 |accessdate=31 January 2017}}</ref>
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| ===Testing and research===
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| [[File:Marihuana Test.jpg|left|180px]]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.<ref name="WeissTestimony16">{{cite web |url=https://www.hhs.gov/about/agencies/asl/testimony/2016-09/the-state-of-the-science-on-the-therapeutic-potential-of-marijuana-and-cannabinoids/index.html |title=Testimony from Susan R.B. Weiss, Ph.D. on The State of the Science on the Therapeutic Potential of Marijuana and Cannabinoids before Judiciary Committee |author=Weiss, S.R.B. |work=ASL Testimony |publisher=U.S. Department of Health & Human Services |date=13 July 2016 |accessdate=25 January 2017}}</ref>
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| While the research, analysis, and processing of cannabis has been ongoing for centuries<ref name="DeitchHemp03" />, 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 C<sub>21</sub>H<sub>26</sub>O<sub>2</sub>.<ref name="WoodCann1899">{{cite journal |title=III.—Cannabinol. Part I |journal=Journal of the Chemical Society, Transactions |author=Wood, T.B.; Newton Spivey, W.T.; Easterfield, T.H. |volume=75 |pages=30–36 |year=1899 |doi=10.1039/CT8997500020}}</ref> As of mid-2015, 104 of the more than 750 constituents of ''Cannabis sativa'' have been identified as cannabinoids<ref name="RadwanIso15">{{cite journal |title=Isolation and pharmacological evaluation of minor cannabinoids from high-potency ''Cannabis sativa'' |journal=Journal of Natural Products |author=Radwan, M.M.; ElSohly, M.A.; El-Alfy, A.T. et al. |volume=78 |issue=6 |pages=1271-6 |year=2015 |doi=10.1021/acs.jnatprod.5b00065 |pmid=26000707 |pmc=PMC4880513}}</ref>, "a class of diverse chemical compounds that act on cannabinoid receptors in cells that modulate neurotransmitter release in the brain."<ref name="WHOTheHealth16">{{cite book |url=http://www.who.int/substance_abuse/publications/cannabis/en/ |title=The health and social effects of nonmedical cannabis use |author=World Health Organization |editor=Hall, W.; Renström, M.; Poznyak, V |publisher=World Health Organization |pages=95 |year=2016 |isbn=978921510240}}</ref>
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| 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<ref name="HazekampCanna12">{{cite journal |title=Cannabis - from cultivar to chemovar |journal=Drug Testing and Analysis |author=Hazekamp, A.; Fischedick, J.T. |volume=4 |issue=7–8 |pages=660–7 |year=2012 |doi=10.1002/dta.407 |pmid=22362625}}</ref><ref name="BushWorlds15">{{cite web |url=http://www.seattletimes.com/seattle-news/worldrsquos-strongest-weed-potency-testing-challenged/ |title=World’s strongest weed? Potency testing challenged |author=Bush, E. |work=The Seattle Times |publisher=The Seattle Times Company |date=18 February 2015 |accessdate=25 January 2017}}</ref><ref name="RutschQuality15">{{cite web |url=http://www.npr.org/sections/health-shots/2015/03/24/395065699/quality-testing-legal-marijuana-strong-but-not-always-clean |title=Quality-Testing Legal Marijuana: Strong But Not Always Clean |author=Rutsch, P. |work=Shots |publisher=National Public Radio |date=24 March 2015 |accessdate=25 January 2017}}</ref><ref name="KuzdzalUnrav15">{{cite journal |title=Unraveling the Cannabinome |journal=The Analytical Scientist |author=Kuzdzal, S.; Lipps, W. |issue=0915 |year=2015 |url=https://theanalyticalscientist.com/issues/0915/unraveling-the-cannabinome/ |accessdate=19 January 2017}}</ref><ref name="CrombieMari16">{{cite web |url=http://www.oregonlive.com/marijuana/index.ssf/2016/07/marijuana_labs_prepping_for_st.html |title=Marijuana labs prepping for regulation and oversight; no lab licenses issued yet |author=Crombie, N. |work=The Oregonian |publisher=Oregon Live LLC |date=25 July 2016 |accessdate=25 January 2017}}</ref><ref name="KuzdzalACloser16">{{cite web |url=http://event.lvl3.on24.com/event/13/38/14/4/rt/1/documents/resourceList1484589923854/emerging_cannabis_industry_whitepaper.pdf |archiveurl=http://web.archive.org/web/20170210234439/http://event.lvl3.on24.com/event/13/38/14/4/rt/1/documents/resourceList1484589923854/emerging_cannabis_industry_whitepaper.pdf |format=PDF |title=A Closer Look at Cannabis Testing |author=Kuzdzal, S.; Clifford, R.; Winkler, P.; Bankert, W. |publisher=Shimadzu Corporation |date=December 2016 |archivedate=19 January 2017 |accessdate=19 January 2017}}</ref> and evidence-based research of marijuana continues to be slow and bogged down in regulation.<ref name="BajajHowThe14" /><ref name="CheslerGov15" /><ref name="WeissTestimony16" /><ref name="JosephDEA16" /><ref name="RudroffMari17" /> 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<ref name="HazekampCanna12" /><ref name="BushWorlds15" /><ref name="RutschQuality15" /><ref name="KuzdzalACloser16" /> will only serve to hinder the industry. To the second issue, in 2016 some within the federal government seemed to recognize the roadblocks to improved evidence-based research and began working to slowly improve how researchers can legally acquire and test marijuana in the U.S.<ref name="WeissTestimony16" /><ref name="JosephDEA16" /><ref name="Romza-KutzTheSilver16">{{cite web |url=http://www.thompsoncoburn.com/insights/blogs/tracking-cannabis/post/2016-08-15/the-silver-lining-in-the-dea-s-refusal-to-reclassify-cannabis |title=The silver lining in the DEA’s refusal to reclassify cannabis |work=Tracking Cannabis |author=Romza-Kutz, D.; Roth V., F. |publisher=Thompson Coburn LLP |date=15 August 2016 |accessdate=25 January 2017}}</ref>, though those attempts have since been rebuffed by the Justice Department.<ref name="GurmanMari18" /><ref name="OrdoñezTrump18" />
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| Regardless, an excerpt from the previously mentioned testimony of NIDA's Dr. Weiss illustrates the sentiment still felt by many researchers today:
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| <blockquote>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.<ref name="WeissTestimony16" /></blockquote>
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| 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.<ref name="NIHMari16">{{cite web |url=http://apps1.seiservices.com/nih/mj/2016/ |title=Marijuana and Cannabinoids: A Neuroscience Research Summit |publisher=National Institutes of Health |date=23 March 2016 |accessdate=25 January 2017}}</ref><ref name="jCannaCSC19">{{cite web |url=https://www.cannabisscienceconference.com/ |title=Cannabis Science Conference |publisher=jCanna, Inc |accessdate=13 November 2018}}</ref>
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| ===Other areas of concern===
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| 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.
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| ====Banking====
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| 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).<ref name="HillBanks15">{{cite journal |title=Banks, Marijuana, and Federalism |journal=Case Western Reserve Federal Law Review |author=Hill, J.A. |volume=65 |issue=3 |pages=597–647 |year=2015 |url=http://scholarlycommons.law.case.edu/caselrev/vol65/iss3/7}}</ref> In an attempt to ease the concerns of industry players as well as banks in states that had implemented 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."<ref name="KovaleskiUS14">{{cite web |url=https://www.nytimes.com/2014/02/15/us/us-issues-marijuana-guidelines-for-banks.html |title=U.S. Issues Marijuana Guidelines for Banks |author=Kovaleski, S.F. |work=The New York Times |publisher=The New York Times Corporation |date=14 February 2014 |accessdate=25 January 2017}}</ref><ref name="FinCEN_BSA14">{{cite web |url=https://www.fincen.gov/resources/statutes-regulations/guidance/bsa-expectations-regarding-marijuana-related-businesses |title=BSA Expectations Regarding Marijuana-Related Businesses |author=Financial Crimes Enforcement Network |publisher=U.S. Department of the Treasury |date=14 February 2014 |accessdate=25 January 2017}}</ref> 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<ref name="LegerMari16" /><ref name="JosephDEA16" />, keeping the FinCEN guidance in place as a recommendation for how federal authorities should enforce existing law.
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| 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<ref name="HansenBanking16">{{cite web |url=http://bigstory.ap.org/article/804ae396daab4ba98f814b186f872ef6/banking-woes-easing-some-legal-pot-businesses |title=Banking woes easing for some legal pot businesses |author=Hansen, K.; Johnson, G. |work=Associated Press: The Big Story |publisher=Associated Press |date=20 April 2016 |accessdate=25 January 2017}}</ref>, and up again to 411 in March 2018.<ref name="AngellMoreBanks18">{{cite web |url=https://www.forbes.com/sites/tomangell/2018/06/14/more-banks-working-with-marijuana-businesses-despite-federal-moves/#4d828ed21b1b |title=More Banks Working With Marijuana Businesses, Despite Federal Moves |author=Angell, T. |work=Forbes |publisher=Forbes Media, LLC |date=14 June 2018 |accessdate=13 November 2018}}</ref> 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 Trump administration's wavering stance. California, which in November 2016 legalized recreational use of marijuana beginning in 2018, petitioned the administration to clarify its 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."<ref name="BloodCali16">{{cite web |url=http://bigstory.ap.org/article/d54ea614db274238986a8e0d77dbb147/california-treasurer-asks-trump-guidance-pot-banking |title=California treasurer asks Trump for guidance on pot, banking |author=Blood, M.R. |work=Associated Press: The Big Story |publisher=Associated Press |date=02 December 2016 |accessdate=25 January 2017}}</ref> An attempt by the state in 2018 (Senate Bill 930) to "license privately financed banks that would issue checks to [cannabis-related] businesses to pay rent and state and local taxes and fees" was rejected, complicating the matter further.<ref name="MyersCalif18">{{cite web |url=http://www.latimes.com/politics/la-pol-ca-legislature-bills-roundup-20180816-story.html |title=California lawmakers reject marijuana banking plan and panic buttons for hotel workers in a frenzy of Sacramento action |author=Myers, J. |work=Los Angeles Times |publisher=Los Angeles Times Communications, LLC |date=16 August 2018 |accessdate=13 November 2018}}</ref>
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| 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.<ref name="LeBlancUSSen17">{{cite web |url=https://lasvegassun.com/news/2017/jan/02/us-sen-warren-seeks-to-pull-pot-shops-out-of-banki/ |title=US Sen. Warren seeks to pull pot shops out of banking limbo |author=LeBlanc, S. |work=Las Vegas Sun |publisher=Greenspun Media Group |date=02 January 2017 |accessdate=25 January 2017}}</ref> 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<ref name="LampachQA13">{{cite web |url=https://mjbizdaily.com/qa-with-steep-hill-lab-ceo-david-lampach-cannabis-testing-market-could-hit-40m-in-2-years/ |title=Q&A With CEO of Steep Hill Halent: US Cannabis Testing Market Could Hit $40M by 2016 |work=Marijuana Business Daily |author=Lampach, D. |publisher=Anne Holland Ventures, Inc |date=20 November 2013 |accessdate=25 January 2017}}</ref><ref name="MartinProfit16">{{cite web |url=http://www.cacannabislabs.com/ |title=Profitability in the Cannabis Laboratory Industry |work=Association of Commercial Cannabis Laboratories |author=Martin, R.W. |publisher=Association of Commercial Cannabis Laboratories |date=May 2016 |accessdate=25 January 2017}}</ref><ref name="TulsiABright16">{{cite web |url=http://www.labmanager.com/research-specific-labs/2016/10/today-s-cannabis-research-market |title=A Bright Future for Cannabis Testing Services |work=Lab Manager |author=Tulsi, B.B. |publisher=LabX Media Group |date=03 October 2016 |accessdate=25 January 2017}}</ref>, causing some to believe consolidation of such labs will occur before the industry can really even take off.<ref name="LampachQA13" /><ref name="DigiPathAUnique16">{{cite web |url=http://digipath.com/wp-content/uploads/2016/10/Digipath-Company-Report.pdf |format=PDF |title=A Unique Investment Vehicle in Laboratory Testing |publisher=DigiPath, Inc |date=October 2016 |pages=36 |accessdate=25 January 2017}}</ref> In early 2018, one of three testing laboratories in Alaska was forced to suspend its operations after Wells Fargo said it would foreclose on their space if they did not move out, demonstrating the continued difficulties and tensions laboratories are facing with banks.<ref name="APAlaska18">{{cite web |url=https://www.seattletimes.com/seattle-news/marijuana/alaska-marijuana-testing-lab-closes-leaving-only-2-in-state-2/ |title=Alaska marijuana-testing lab closes, leaving only 2 in state |author=The Associated Press |work=The Seattle Times |publisher=Seattle Times Company |date=01 April 2018 |accessdate=13 November 2018}}</ref>
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| ====Advertising====
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| 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."<ref name="WhiteIfCali16">{{cite web |url=http://www.sacbee.com/news/politics-government/capitol-alert/article96040082.html |title=If California legalizes pot, will TV ads be far behind? |author=White, J.B. |work=The Sacramento Bee |publisher=The McClatchy Company |date=17 August 2016 |accessdate=25 January 2017}}</ref> 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.<ref name="McGreevyQA16">{{cite web |url=http://www.latimes.com/politics/la-pol-sac-proposition-64-marijuana-legalization-qa-20161030-snap-20161029-story.html |title=Q&A: Proposition 64 would legalize recreational use of marijuana though it's illegal under federal law. How will that work? |author=McGreevy, P. |work=Los Angeles Times |publisher=tronc, Inc |date=30 October 2016 |accessdate=25 January 2017}}</ref> Additional changes occurred in California in the form of Assembly Bill 2899, updating how licensees can and can not advertise cannabis and cannabis products.<ref name="MalsburyCali18">{{cite web |url=https://www.cannalawblog.com/california-cannabis-advertising-changes-coming/ |title=California Cannabis Advertising: Changes Coming? |author=Malsbury, A. |work=Canna Law Blog |publisher=Harris Bricken |date=27 August 2018 |accessdate=13 November 2018}}</ref>
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| 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).<ref name="ReinThePot15">{{cite web |url=https://www.washingtonpost.com/news/federal-eye/wp/2015/12/21/the-pot-business-may-be-legal-but-newspapers-cant-run-ads-for-it-the-u-s-postal-service-says/ |title=The pot business may be legal, but newspapers can’t run ads for it, the U.S. Postal Service says |author=Rein, L. |work=The Washington Post |publisher=WP Company, LLC |date=21 December 2015 |accessdate=25 January 2017}}</ref> 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.<ref name="OxenfordAccepting16">{{cite web |url=http://www.broadcastlawblog.com/2016/12/articles/accepting-advertising-for-marijuana-or-marijuana-paraphernalia-the-trademark-office-rules-on-a-related-issue-that-provides-more-reason-for-caution/ |title=Accepting Advertising for Marijuana or Marijuana Paraphernalia: The Trademark Office Rules on a Related Issue that Provides More Reason For Caution |author=Oxenford, D. |work=Broadcast Law Blog |date=13 December 2016 |accessdate=25 January 2017}}</ref> (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."<ref name="AdliObtain16">{{cite web |url=http://adlilaw.blogspot.com/2016/12/obtaining-trademark-protection-for_9.html |title=Obtaining Trademark Protection for Cannabis Businesses |author=Adli, D. |publisher=ADLI Law Group |date=21 December 2016 |accessdate=25 January 2017}}</ref>) Even billboards are an issue, with California's state lawmakers proposing new regulations on billboard-based marijuana advertising weeks after the state passed its recreational legalization laws.<ref name="McGreevyPotAds16">{{cite web |url=http://www.latimes.com/politics/la-pol-ca-pot-ads-snap-20161221-story.html |title=Pot ads along highways? Lawmakers wrangle over legalization's consequences |author=McGreevy, P. |work=Los Angeles Times |publisher=tronc, Inc |date=21 December 2016 |accessdate=25 January 2017}}</ref> And state laws, such as those found in Alaska, can create their own set of challenges in staying legal with marijuana advertising.<ref name="AndrewsGaps16">{{cite web |url=https://www.adn.com/alaska-marijuana/2016/12/26/gaps-in-alaska-marijuana-advertising-rules-cause-worry/ |title=Gaps in Alaska marijuana ad rules cause worry |author=Andrews, L. |work=Alaska Dispatch News |publisher=Alaska Dispatch Publishing |date=27 December 2016 |accessdate=25 January 2017}}</ref> Even Canada, which legalized recreational use of marijuana in the fall of 2018, has strict advertising rules laid out by Health Canada, with harsh penalties for violators.<ref name="CeccoHowDo18">{{cite web |url=https://www.theguardian.com/world/2018/jun/06/canada-weed-legalisation-cannabis-marijuana-vendors-marketing-tactics |title=How do you market weed when you can't market weed? |author=Cecco, L. |work=The Guardian |publisher=Guardian News |date=06 June 2018 |accessdate=13 November 2018}}</ref>
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| 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.<ref name="StilsonWhyMari17">{{cite web |url=http://www.adweek.com/news/advertising-branding/why-marijuana-marketing-will-be-bigger-ever-year-175246 |title=Why Marijuana Marketing Will Be Bigger Than Ever This Year |author=Stilson, J. |work=Adweek |publisher=Adweek, LLC |date=03 January 2017 |accessdate=25 January 2017}}</ref>
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| ==References==
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| {{Reflist|colwidth=30em}}
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| ==Citation information for this chapter==
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| '''Chapter''': 1. Overview of the cannabis industry in the United States
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| '''Edition''': Second edition
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| '''Title''': ''Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States''
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| '''Author for citation''': Shawn E. Douglas
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
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| '''Publication date''': December 2018 | | ;1. What is quality? |
| | :''Key terms'' |
| | :[[Quality (business)|Quality]] |
| | :[[Quality assurance]] |
| | :[[Quality control]] |
| | :''The rest'' |
| | :[[Data quality]] |
| | :[[Information quality]] |
| | :[[Nonconformity (quality)|Nonconformity]] |
| | :[[Service quality]] |
| | ;2. Processes and improvement |
| | :[[Business process]] |
| | :[[Process capability]] |
| | :[[Risk management]] |
| | :[[Workflow]] |
| | ;3. Mechanisms for quality |
| | :[[Acceptance testing]] |
| | :[[Conformance testing]] |
| | :[[Clinical quality management system]] |
| | :[[Continual improvement process]] |
| | :[[Corrective and preventive action]] |
| | :[[Good manufacturing practice]] |
| | :[[Malcolm Baldrige National Quality Improvement Act of 1987]] |
| | :[[Quality management]] |
| | :[[Quality management system]] |
| | :[[Total quality management]] |
| | ;4. Quality standards |
| | :[[ISO 9000]] |
| | :[[ISO 13485]] |
| | :[[ISO 14000|ISO 14001]] |
| | :[[ISO 15189]] |
| | :[[ISO/IEC 17025]] |
| | :[[ISO/TS 16949]] |
| | ;5. Quality in software |
| | :[[Software quality]] |
| | :[[Software quality assurance]] |
| | :[[Software quality management]] |
|
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|
| <!--Place all category tags here--> | | <!--Place all category tags here--> |
