Book:Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States/Future of cannabis regulation, testing, and market trends/Regulation, market, and research

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What good would be a guide to the rapidly changing cannabis testing and regulation climate without some analysis of what the future may hold? This fourth chapter looks at the future of cannabis regulation and the associated market, as well as the future of lab testing and production. It also touches on fears of "Big Marijuana" and examines non-U.S. policy and how it may affect U.S. regulation in the future.

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5. Future of cannabis regulation, testing, and market trends

5.1 Regulation, market, and research

Medical cannabis demo 2.JPG

Until effective and demonstrable policy change takes place in the U.S. federal government concerning marijuana, the country's researchers, doctors, patients, laboratory personnel, and entrepreneurs will have to keep fighting uncertainty and a convoluted patchwork of state and federal regulations. More certain is mounting evidence that a growing majority of U.S. voters believe the federal government should not be enforcing its laws in states where cannabis is legal: 64 percent agreed on this in 2012[1], rising to 71 percent in 2017.[2] As for legal marijuana in general, a record high 68 percent of Americans believed it should be legal at the national level in November 2021.[3] Despite such support, it remains up to interest groups and the states to twist the arm of the federal government. Legal representatives at Thompson Coburn expressed this idea well in a blog post in November 2016[4]:

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 of expanding research and testing on cannabis and addressing 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[5]), and in 2016 they began accepting applications for additional entities looking to grow marijuana for researchers.[6]

In January 2020, the topic of needing more legitimate cannabis sources for cannabis research was brought up yet again, this time in the context of an official hearing exclusively on cannabis by the House Health Subcommittee of the House Committee on Energy and Commerce, titled "Cannabis Policies for the New Decade." The hearing provided an opportunity for legislators to discuss the "catch-22" of regulation and medical research: "Research is restricted because cannabis is currently considered a Schedule 1 drug under the Controlled Substance Act, yet more research would better determine if marijuana should be rescheduled or descheduled."[7] Lawmakers and witnesses both agreed that another limiter was having the University of Mississippi as the sole DEA-approved supplier of research-quality cannabis.

Ever slow to act, the U.S. government's Drug Enforcement Agency (DEA) finally, on December 18, 2020, finalized its amended "21 Code of Federal Regulations 1318 to facilitate the cultivation of marihuana for research purpose and other licit purposes to ensure compliance with the Controlled Substances Act (CSA) and treaty obligations."[8] This added an additional five grow-ops to support researchers.[8][9]

Optimistically, this will mean researchers will 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.[4] 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[10] and in an April 2017 research paper published in The International Journal of Drug Policy[11], Weiss cautiously recognized and promoted the need for further evidence-based cannabis research, emphasizing both the healthy and detrimental effects evident so far in the plant and its constituents[10]:

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.

Other entities have put subtle pressure on the federal government to better recognize and accommodate the need for further research. In January 2017, the National Academies of Sciences, Engineering, and Medicine published a massive cannabis literature review. 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[12]:

  • 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.

As of August 2022, it's unclear what effects this report has had. Regarding the first recommendation of a national cannabis research initiative, no such entity has fully taken up the charge. The National Institute of Drug Abuse (NIDA) has arguably filled these shoes the most, having since produced numerous reports[13][14] and re-emphasized its role as both an intermediary supplier of cannabis for researchers and a major funder of research on the misuse and negative effects of cannabis.[15][16] However, as Daniel Mallinson, a cannabis policy researcher at Pennsylvania State University, notes in August 2020, the funding and reporting of NIDA, as a government entity, is a reflection of the government's budget, and thus "is a political statement about what we value as a society," adding that "the fact that most of the cannabis money is going to drug abuse and probably to cannabis use disorder versus medical purposes ... says something."[16] A national cannabis research initiative that focuses more on therapeutic qualities than strictly the detrimental would be more welcome.

Regarding the rest of the recommendations, some progress has been made. As discussed in the second chapter, progress continues to be made on formal testing and accreditation standards for cannabis testing labs. However, this progress has been made almost exclusively by those outside the federal government. If government agencies were to rubber-stamp such standard methods and accreditation processes, it would arguably lend more weight to those methods and processes. Some states like Colorado continue to fund public health research and surveillance data collection[16][17], and in October 2020, the American Public Health Association (APHA) published a policy statement calling for "an evidence-based public health approach to regulating and controlling the legal commerce of cannabis products."[18] However, a more concerted effort by other states' health departments would potentially have a greater impact. Finally, the call for a multi-pronged "report on existing regulatory barriers to research" and how to overcome those barriers has yet to be heeded. Numerous articles have been published in journals in recent years[19][20][21][22], but it will likely take a larger think-tank of groups to make a more impactful proposal to legalization holdouts.

While the growing discussion on enabling research is encouraging, some researchers such as Mayo Clinic psychiatrist and researcher Michael Bostwick have historically been 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 government will take.[23] Despite this pessimism, predictions—and reports—of substantial revenues in states where recreational marijuana is legalized or could be legalized persist.[24][25][26] A 2017 estimate by market research and analytics company New Frontier Data put the U.S. marijuana industry at $24 billion by 2025[27], and a 2022 study by Grand View Research put it at $40 billion by 2030.[28] Yet entities such as the Denver-based Marijuana Policy Group and cannabis law firm Vicente Sederberg LLC have in the past preached caution when dealing with tax revenue estimates and economic projections in the U.S. cannabis market[27], 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.[29] "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.[27]

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).[27][29] Additionally, too much regulation can put a stranglehold on a state's cannabis program development—as it has done in Minnesota[30]—causing related grow-ops and laboratories to take significant losses or even go out of business.

Finally, on a social level, the push by many to legalize marijuana and, by extension, push for beneficial changes in federal marijuana policy, has been driven even further by dramatic increase in use of and health consequences surrounding opioids in the United States.[31] [32][33][34][35] What's not clear is how effective a replacement cannabis would be. Dr. Weiss again provides context, this time in the February 2018 workshop Cannabis and the opioid crisis: A multidisciplinary review[31]:

I think we need to be very circumspect in what we are expecting from cannabis with respect to the opioid epidemic. There is no doubt that there are many patients suffering from pain, and we do not have a lot of options to treat it, especially chronic pain. Moreover, the cannabinoid system has a lot of promise regarding analgesic potential and alternative medication approaches. Whether it is the plant, components of the plant, or other strategies to modify endocannabinoid function—these are all possibilities that we need to explore to both help abate the opioid crisis and treat patients with pain who continue to suffer.

From that same workshop, several additional insights were revealed[31]:

  • The National Academies' 2017 research recognizes "the classification of cannabis as a Schedule I substance [as something] that impedes the advancement of cannabis and cannabinoid research." Getting past that will require the federal government living up to its 2016 promise to expand approved grow-ops.
  • Getting marijuana rescheduled is further challenged by the fact that an entire plant and its constituents are scheduled. Difficulties arise because when we talk about rescheduling marijuana, the question has to be asked: "Are you talking about a plant that is mostly THC, that is mostly CBD (cannabidiol), that has unspecified different components in it?"
  • A major question remains concerning "whether cannabinoids and opioids interact at a pharmacological level." To further study this, not only do well organized studies need to be designed, but also, as previously mentioned, access to quality samples and a willingness to see the benefit in such research is still required.

As of August 2022, the Marijuana Data Collection Act is still making its way through the legal quagmire, stuck in the Senate's Committee on Health, Education, Labor, and Pensions.[36] Citing many of the previously mentioned issues and more, the proposed bill asks for the National Academy of Sciences "to conduct and update biennially a study on the effects of State legalized marijuana programs," among other tasks. Specifically the research would look at revenue impacts, medicinal use and safety, correlation with opioid abuse, criminal justice impacts, and employment impacts.>[36][37] Whether or not this bill passes, one may argue that its intent is inline with the sentiment of representatives at Thompson Coburn: "forcing the federal hand by providing credible data on the safety of cannabis."[4]


  1. Newport, F. (10 December 2012). "Americans Want Federal Gov't Out of State Marijuana Laws". Gallup, Inc. Retrieved 05 August 2022. 
  2. "Republicans Out Of Step With U.S. Voters On Key Issues, Quinnipiac University National Poll Finds; Most Voters Support Legalized Marijuana". Quinnipiac University. 23 February 2017. Archived from the original on 28 July 2020. Retrieved 05 August 2022. 
  3. "Support for Legal Marijuana Holds at Record High of 68%". Gallup. 4 November 2021. Retrieved 05 August 2022. 
  4. 4.0 4.1 4.2 Romza-Kutz, D.; Roth V., F. (15 August 2016). "The silver lining in the DEA’s refusal to reclassify cannabis". Tracking Cannabis. Thompson Coburn LLP. Retrieved 05 August 2022. 
  5. Hellerman, C. (8 March 2017). "Scientists say the government’s only pot farm has moldy samples — and no federal testing standards". PBS NewsHour. NewsHour Productions, LLC. Retrieved 05 August 2022. 
  6. "Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States". Federal Register 81 (156): 53846–8. 12 August 2016. Retrieved 05 August 2022. 
  7. Smith, J. (15 January 2020). "US House panel calls for stepped-up marijuana research, which could prove critical to federal reform". Marijuana Business Daily. Retrieved 05 August 2022. 
  8. 8.0 8.1 Diversion Control Division (18 December 2020). "Marihuana Growers Information". U.S. Drug Enforcement Administration. Retrieved 05 August 2022. 
  9. 13 April 2022. "Can DEA-backed cannabis growers strike gold via drug development?". Retrieved 05 August 2022. 
  10. 10.0 10.1 Weiss, S.R.B. (13 July 2016). "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". ASL Testimony. U.S. Department of Health & Human Services. Archived from the original on 04 May 2017. Retrieved 05 August 2022. 
  11. Weiss, S.R.B.; Howlett, K.D.; Baler, R.D. (2017). "Building smart cannabis policy from the science up". International Journal of Drug Policy 42: 39–49. doi:10.1016/j.drugpo.2017.01.007. PMC PMC5404989. PMID 28189459. 
  12. National Academies of Sciences, Engineering, and Medicine (12 January 2017). "The health effects of cannabis and cannabinoids: The current state of evidence and recommendations for research". The National Academies Press. pp. 440. doi:10.17226/24625. Retrieved 03 March 2017. 
  13. National Institute on Drug Abuse (6 February 2018). "Recommendations for NIDA's Cannabis Policy Research Agenda" (PDF). National Institutes of Health. Retrieved 05 August 2022. 
  14. National Institute on Drug Abuse (July 2020). "Cannabis (Marijuana) Research Report". National Institutes of Health. Retrieved 05 August 2022. 
  15. National Institute on Drug Abuse (27 March 2020). "NIDA's Role in Providing Cannabis for Research". National Institutes of Health. Retrieved 05 August 2022. 
  16. 16.0 16.1 16.2 O’Grady, Cathleen (27 August 2020). "Cannabis research database shows how U.S. funding focuses on harms of the drug". Science. doi:10.1126/science.abe5328. ISSN 0036-8075. 
  17. "Marijuana research". Colorado Department of Public Health & Environment. Retrieved 05 August 2022. 
  18. American Public Health Association (24 October 2020). "A Public Health Approach to Regulating Commercially Legalized Cannabis". Retrieved 05 August 2020. 
  19. Stith, Sarah See; Vigil, Jacob Miguel (3 June 2016). "Federal barriers to Cannabis research" (in en). Science 352 (6290): 1182–1182. doi:10.1126/science.aaf7450. ISSN 0036-8075. 
  20. Haney, Margaret (1 October 2020). "Perspectives on Cannabis Research—Barriers and Recommendations" (in en). JAMA Psychiatry 77 (10): 994. doi:10.1001/jamapsychiatry.2020.1032. ISSN 2168-622X. 
  21. Cooper, Ziva D; Abrams, Donald I; Gust, Steven; Salicrup, Alejandro; Throckmorton, Douglas C (28 November 2021). "Challenges for Clinical Cannabis and Cannabinoid Research in the United States" (in en). JNCI Monographs 2021 (58): 114–122. doi:10.1093/jncimonographs/lgab009. ISSN 1052-6773. PMC PMC8783595. PMID 34850896. 
  22. Ruheel, Mohammad Ali; Gomes, Zoya; Usman, Sana; Homayouni, Pargol; Ng, Jeremy Y. (1 December 2021). "Facilitators and barriers to the regulation of medical cannabis: a scoping review of the peer-reviewed literature" (in en). Harm Reduction Journal 18 (1): 106. doi:10.1186/s12954-021-00547-8. ISSN 1477-7517. PMC PMC8515704. PMID 34649577. 
  23. Grant, B. (23 January 2017). "Marijuana Research Still Stymied by Federal Laws". The Scientist. LabX Media Group. Retrieved 08 August 2022. 
  24. Morris, C. (21 October 2016). "The next big billion-dollar cannabis markets investors are rushing to". CNBC. Retrieved 08 August 2022. 
  25. Thomas, J.R. (7 February 2017). "Big pot of money waiting if CT legalizes marijuana, analysts say". The CT Mirror. The Connecticut News Project. Retrieved 08 August 2022. 
  26. Houghton, S. (14 February 2017). "Town Manager: Marijuana Shops Could Boost Tax Revenue". The Mashpee Enterprise. Enterprise Newspapers. Retrieved 08 August 2022. 
  27. 27.0 27.1 27.2 27.3 Wallace, A. (22 February 2017). "Report: America’s marijuana industry headed for $24 billion by 2025". The Cannabist. The Denver Post. Retrieved 08 August 2022. 
  28. Grand View Research, Inc (15 June 2022). "U.S. Cannabis Market to be Worth $40.0 Billion by 2030: Grand View Research, Inc.". PR Newswire. Retrieved 08 August 2022. 
  29. 29.0 29.1 Wallace, A. (22 December 2016). "What legal states need to know about sketchy pot tax predictions". The Cannabist. The Denver Post. Retrieved 08 August 2022. 
  30. Potter, K. (12 August 2016). "Big losses for Minn. medical marijuana providers". MPR News. Minnesota Public Radio. Retrieved 08 August 2022. 
  31. 31.0 31.1 31.2 Piomelli, D.; Weiss, S.; Boyd, G. et al. (2018). "Cannabis and the Opioid Crisis". Cannabis and Cannabinoid Research 3 (1): 108-16. doi:10.1089/can.2018.29011.rtl. PMC PMC5931647. PMID 29789812. 
  32. Bradford, A.S.; Abraham, A.; Adams, G.B. (2018). "Opioid Death Rate Acceleration in Jurisdictions Legalizing Marijuana Use—Reply". JAMA Internal Medicine 178 (9): 1281–2. doi:10.1001/jamainternmed.2018.3891. 
  33. Goldman, H. (13 July 2018). "New York Health Officials See Marijuana as an Alternative to Opioids". Bloomberg. Retrieved 08 August 2022. 
  34. Sukel, K. (1 May 2018). "Could Cannabis Legalization Help Ease the Opioid Crisis?". Pain Research Forum. International Association for the Study of Pain. Retrieved 08 August 2022. 
  35. "Unproven, Unsafe". Spotlight PA. 21 February 2022. Retrieved 08 August 2022. 
  36. 36.0 36.1 "S.1456 - Marijuana Data Collection Act". U.S. Government. 29 April 2021. Retrieved 08 August 2022. 
  37. Angell, T. (24 July 2018). "Federal Report On Marijuana Legalization Required Under New Bill". Forbes. Retrieved 08 August 2022.