Book:Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States/Regulation, standardization, and quality/Federal regulation of cannabis

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Now that we have a bit of background on the cannabis industry, the next logical step is to look more closely at the regulations and standards that shape it. This chapter looks at the federal, state, and local regulations and the slowly evolving standardization process for laboratory testing of cannabis in the U.S. We also take a look at quality and what that means in the cannabis testing lab today.

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2. Regulation, standardization, and quality

2.1 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.[1] Marijuana was initially placed under Schedule I[1] and remains there today.[2][3][4] As a Schedule I drug, the federal government is indicating marijuana has[1]:

  • "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).[5][6] Then President Richard Nixon said of the transition[5]:

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.[5] Since then, the DEA has taken various steps—with guidance from the Food and Drug Administration (FDA)[7]—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.[8][9]

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).[10] However, the following talking points represent the most recent important federal-level changes and rulings that have impacted federal regulation 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.[11] 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.[12] 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.[13]

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.[14] The language of the memo essentially said "get off your butts and nail those suckers."[15] Cambron et al.[12] and Fairman[16] 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

Two years later, Deputy Attorney General James M. Cole issued a follow-up memo to his original, 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.[12] The second memorandum sought to reduce the emphasis on the size of the grow-op and increase emphasis on—using a case-by-case basis—"whether the operation is demonstrably in compliance with a strong and effective state regulatory system."[17] 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.[18][12] 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.[15]

December 16, 2014 to current: Lee-Joyce Amendment

A tenuous truce of sorts arrived with the passage of the Rohrabacher-Farr (later Rohrabacher-Blumenauer, Joyce, and today Lee-Joyce) 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.[19] Before being passed in December 2014, the amendment had actually been introduced and defeated six times in the previous 10 years.[20] 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 all these instances, the courts ruled against the DoJ, setting precedent against further department action.[21][22]

One of the downsides of Rohrabacher-Farr is that it essentially acted as a short-term rider attached to several spending bills since December 2014. Due again for renewal in April 2017, and with the new Trump administration coalescing—including Trump's demonstrably anti-drug U.S. Attorney General Jeff Sessions—some in the industry were concerned the amendment would not be renewed, opening the door again for the DoJ to implement stronger enforcement.[23][24][25][26][27] However, the Amendment continued to live on as the Rohrabacher-Blumenauer Amendment, with Rep. Earl Blumenauer taking over as co-lead with the retirement of Rep. Farr. Alternative bills had continued to be proposed in the meantime, including a more permanent version of Rohrabacher-Blumenauer introduced by Representative Dana Rohrabacher of California; however, Speaker Paul Ryan implemented rules prohibiting amendments to budgetary legislation, and the fact remained that Congress was still reluctant in hearing bills that would change the country's marijuana laws.[28][29]

The Rohrabacher-Blumenauer amendment was renewed through December 8, 2018[30] However, earlier in the year, Rep. David Joyce submitted an amendment to protect against federal intrusions on medical marijuana patients abiding by state cannabis laws. Passing in May 2018 and acting the same as Rohrabacher-Blumenauer, the new Joyce Amendment was good through the 2019 fiscal year.[31] However, vows by President Trump in late 2018 to shut down the government "for border security"[32] left some to wonder if a shutdown would affect the continuity of the Joyce Amendment.[33] In June 2019, a modified version of Rohrabacher-Blumenauer by Blumenauer-McClintock-Norton was approved by the U.S. House, which added on protections for adult-use cannabis users as well as medical cannabis users.[34] It was attached to a large-scale appropriations bill[35][36], but the broader version was removed last-minute, leaving only the original protections for medical cannabis.[37]

In June 2022, another take on Rohrabacher-Blumenauer, the Lee-Joyce Amendment, passed through the House Appropriations Committee as part of a budget rider for 2023 Commerce, Justice, Science and Related Agencies. Like prior iterations, it would prohibit the DoJ from using federal funds to interfere with state authority and act against adults using cannabis in compliance with state, tribal, or territorial law, though this version covers both medical and recreational cannabis.[38] Of course, Lee-Joyce still ultimately needs to make it through Senate scrutiny in 2022/2023.

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.[2][3][4] 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.[8] 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."[39]

December 2018: Congress votes to reconcile and approve the 2018 Farm Bill

In April 2018, Majority Leader Mitch McConnell introduced the Hemp Farming Act of 2018, which later found its way into the 2018 Farm Bill. On November 29, lawmakers "struck a deal in principle" to finalize the 2018 Farm Bill, which, if passed, would remove industrial hemp from the Controlled Substance Act's definition of "marijuana" as well as strike it from Schedule I.[40][41][42] On December 20, 2018, President Trump signed the Farm Bill into law, legalizing the cultivation and sale of hemp at the federal level.[43] With this, expectations were that this would represent a logical next step that will eventually see the U.S. government take further action to legalize derivative products and even cannabis.[41] However, despite hemp legalization, legal experts such as those at The National Law Review noted the potential for additional problems to arise, particularly in the realm of cannabidiol (CBD) derived from industrial hemp. Citing a "schizophrenic" state of law across federal and state governments and agencies regarding the status of CBD, expectations were such that the FDA may step up enforcement of CBD infractions, and civil suits against manufacturers who make unjust medical claims about CBD-infused products may rise in number.[42] In fact, some of the first significant warnings were made by the FDA in November 2019, sending warning letters to 15 companies for violating terms of the Federal Food, Drug, and Cosmetic Act, as well as violating marketing and formulation regulations.[44]

January 15, 2020: House Committee on Energy and Commerce, Health Subcommittee holds first ever cannabis-related hearing

The House Health Subcommittee of the House Committee on Energy and Commerce has held its first ever cannabis hearing, titled "Cannabis Policies for the New Decade." Though no votes or updates to legislation came out of the hearing, much debate over existing and future legislation took place. The primary focus of the hearing was the discussion surrounding cannabis research and cannabis' current scheduling, as well as the problems that come from it. While the committee members agreed that more government-authorized cannabis farms for research materials, as well as more researchers, were needed, there was much disagreement about how to go about with either rescheduling or descheduling cannabis. Bills in various stages of process were discussed, including H.R. 171 on rescheduling THC-containing cannabis to Schedule II, H.R. 601 on producing more research-grade cannabis, and H.R. 2843 on removing cannabis from scheduling, though with numerous stipulations. While nothing specific was resolved, Subcommittee Chairwoman Anna Eshoo reportedly indicated that future hearings would be held, which may include non-agency stakeholders.[45]

December 4, 2020 to current: MORE Act

In 2020, Representatives Nydia M. Velázquez and Jared Golden introduced the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, which would decriminalize "marijuana at the federal level while enabling states to set their regulatory policies without the threat of federal intervention."[46] (It also contained provisions to "make it easier for cannabis businesses legal under state laws to get help from" the Small Business Administration (SBA).[47][48][49]) The House voted to pass the legislation in early December 2020, but it was expected to go nowhere in the Senate later that month.[50] Expections were, however, that With changes in the makeup of the Senate in January 2021, a reasonable chance would exist that the MORE Act, or a modified version of it, could work its way through the Congress.[51] It again received support from the House Judiciary Committee in September 2021[52] and in April 2022.[53] As of July 2022, MORE is still in the hands of the Senate Committee on Finance, and it's not clear what happens next.[54]

An alternative to the MORE Act—H.R.3105 - Common Sense Cannabis Reform for Veterans, Small Businesses, and Medical Professionals Act—was introduced in 2021, but it remains in the House Subcommittee on Crime, Terrorism, and Homeland Security as of July 2022.[55][56]

2021 to current: CAOA Act

At the beginning of 2021, Democratic senators Schumer, Wyden, and Booker made an informal proposal concerning cannabis reform, culminating in a July 2021 discussion draft of what was called the Cannabis Administration and Opportunity Act (CAOA). As described, CAOA would remove cannabis from the Controlled Substance Act, embrace state cannabis laws, make the FDA the lead regulator, expunge/resentence unjust convictions, guarantee Federal benefits for cannabis users, and more.[57][58] CAOA is expected to be formally introduced at some point in the summer of 2022.[59]

References

  1. ↑ 1.0 1.1 1.2 "§812. Schedules of controlled substances". United States Code. U.S. Government Publishing Office. 3 January 2012. https://www.govinfo.gov/content/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap13-subchapI-partB-sec812.htm. Retrieved 08 July 2022. 
  2. ↑ 2.0 2.1 Leger, D.L. (11 August 2016). "Marijuana to remain illegal under federal law, DEA says". USA. Today. Gannett Company. https://www.usatoday.com/story/news/2016/08/11/dea-marijuana-remains-illegal-under-federal-law/88550804/. Retrieved 08 July 2022. 
  3. ↑ 3.0 3.1 Joseph, A. (10 August 2016). "DEA decision keeps major restrictions in place on marijuana research". STAT. Boston Globe Media. https://www.statnews.com/2016/08/10/marijuana-medical-research-dea/. Retrieved 08 July 2022. 
  4. ↑ 4.0 4.1 Grubbs, A. (13 August 2016). "DEA Declines Request to Reclassify Marijuana, Citiing Its 'High Potential for Abuse'". CNSNews. Media Research Center. http://www.cnsnews.com/news/article/alex-grubbs/dea-declines-request-reclassify-marijuana-citiing-its-high-potential-abuse. Retrieved 08 July 2022. 
  5. ↑ 5.0 5.1 5.2 "Reorganization Plan No. 2 of 1973". United States Code. U.S. Government Publishing Office. 3 January 2012. https://www.govinfo.gov/content/pkg/USCODE-2011-title5/html/USCODE-2011-title5-app-reorganiz-other-dup96.htm. Retrieved 08 July 2022. 
  6. ↑ "Drug Enforcement Administration: 1970–1975" (PDF). DEA History In Depth. U.S. Drug Enforcement Administration. Archived from the original on 19 January 2017. https://web.archive.org/web/20170119115022/https://www.dea.gov/about/history/1970-1975.pdf. Retrieved 08 July 2022. 
  7. ↑ Hamilton, K. (27 June 2016). "The FDA told the DEA whether pot is medicine — but it won't tell the public". Vice News. Vice Media, LLC. https://www.vice.com/en/article/pa443y/dea-fda-marijuana-schedule-1-status-decision. Retrieved 08 July 2022. 
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  11. ↑ Ogden, D.W. (19 October 2009). "Memorandum for Selected United State Attorneys on Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana". Justice Blogs. Department of Justice. https://www.justice.gov/archives/opa/blog/memorandum-selected-united-state-attorneys-investigations-and-prosecutions-states. Retrieved 08 July 2022. 
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  20. ↑ Brekke, D. (30 May 2014). "House Votes to End Medical Marijuana Prosecutions". KQED News. KQED, Inc. https://www.kqed.org/news/137576/house-votes-to-block-medical-pot-prosecutions. Retrieved 08 July 2022. 
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  30. ↑ Sherman, E. (18 October 2018). "Despite Canada's legalization of pot, cannabis stocks need more than a puff of smoke to stay lit". NBC News. https://www.nbcnews.com/business/business-news/despite-canada-s-legalization-pot-cannabis-stocks-need-more-puff-n921721. Retrieved 08 July 2022. 
  31. ↑ Misulonas, J. (18 May 2018). "Congressional Committee Passes Amendment Protecting Medical Marijuana Laws from Jeff Sessions". Civilized. Archived from the original on 23 September 2020. https://web.archive.org/web/20200923023929/https://www.civilized.life/articles/congressional-commitee-passes-medical-marijuana-amendment/. Retrieved 08 July 2022. 
  32. ↑ Bolton, A. (11 December 2018). "Senators dumbfounded by Trump vow to shut down government". The Hill. https://thehill.com/homenews/senate/420809-senators-dumbfounded-by-trump-vow-to-shut-down-government/. Retrieved 08 July 2022. 
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  34. ↑ Fernandez, J.G. (2 July 2019). "House of Representatives Approves Amendment to Protect Legal Cannabis". Shepherd Express. https://shepherdexpress.com/cannabis/cannabis/house-of-representatives-approves-amendment-to-protect-legal/. Retrieved 08 July 2022. 
  35. ↑ Kopp, E. (4 March 2020). "States turn to unenforced federal law to slow medical marijuana legalization". Roll Call. https://rollcall.com/2020/03/04/states-turn-to-unenforced-federal-law-to-slow-medical-marijuana-legalization/. Retrieved 08 July 2022. 
  36. ↑ Tax Attorney (28 February 2020). "President Trump Seeking To Prosecute Legalized Adult-use Marijuana Businesses". Blog - Jeffrey B. Khan. https://www.kahntaxlaw.com/president-trump-seeking-to-prosecute-legalized-adult-use-marijuana-businesses/. Retrieved 08 July 2022. 
  37. ↑ Angell, T. (21 December 2019). "Trump Says He Can Ignore Medical Marijuana Protections Passed By Congress". Forbes. https://www.forbes.com/sites/tomangell/2019/12/21/trump-says-he-can-ignore-medical-marijuana-protections-passed-by-congress/#154d87594256. Retrieved 08 July 2022. 
  38. ↑ Herrington, A.J. (30 June 2022). "House Panel Approves Amendment to Protect State Legal Cannabis Programs". High Times. https://hightimes.com/news/house-panel-approves-amendment-to-protect-state-legal-cannabis-programs/. Retrieved 08 July 2022. 
  39. ↑ "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. https://www.federalregister.gov/documents/2016/08/12/2016-17955/applications-to-become-registered-under-the-controlled-substances-act-to-manufacture-marijuana-to. Retrieved 08 July 2022. 
  40. ↑ Pamuk, H. (29 November 2018). "U.S. lawmakers seal Farm Bill agreement in principle". Reuters. https://www.reuters.com/article/us-usa-farmbill/u-s-lawmakers-seal-farm-bill-agreement-in-principle-idUSKCN1NY21M. Retrieved 08 July 2022. 
  41. ↑ 41.0 41.1 Milligan, S. (4 December 2018). "Legalization of Hemp Could Be First Step for Federal Marijuana Protections". U.S. News and World Report. https://www.usnews.com/news/national-news/articles/2018-12-04/legalization-of-hemp-could-be-first-step-for-federal-marijuana-protections. Retrieved 08 July 2022. 
  42. ↑ 42.0 42.1 Stewart, I.A.; Kloss, J.M.; Willner, N.M. (4 December 2018). "Will Hemp-Derived CBD Be Fully Legal with Passage of the 2018 Farm Bill? Not Quite…". The National Law Review. https://www.natlawreview.com/article/will-hemp-derived-cbd-be-fully-legal-passage-2018-farm-bill-not-quite. Retrieved 08 July 2022. 
  43. ↑ Cohen, B.; Bleicher, M.C.; Fortier, D.L. et al. (31 December 2018). "What Does the 2018 Farm Bill Mean for the Hemp and CBD Businesses?". Perkins Coie LLP. https://www.perkinscoie.com/en/news-insights/what-does-the-2018-farm-bill-mean-for-the-hemp-and-cbd-businesses.html. Retrieved 08 July 2022. 
  44. ↑ U.S. Food & Drug Administration (25 November 2019). "FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns". Press Announcements. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details. Retrieved 08 July 2022. 
  45. ↑ Norwinski, E.J.; Landgraf, L.C.; Blackwood, K. et al. (10 February 2020). "United States: Recent Congressional Efforts To Address The Cannabis Policy Gap". Mondaq. https://www.mondaq.com/unitedstates/Cannabis-Hemp/891270/Recent-Congressional-Efforts-To-Address-The-Cannabis-Policy-Gap. Retrieved 08 July 2022. 
  46. ↑ "House Passes Legislation to Make Small Businesses in Cannabis Industry Eligible for SBA Lending Programs". Committee News. Small Business Administration. 4 December 2020. https://smallbusiness.house.gov/news/documentsingle.aspx?DocumentID=3480. Retrieved 08 July 2022. 
  47. ↑ "Statement of the Hon. Nydia M. Velázquez on Unlocking Potential? Small Businesses in the Cannabis Industry". Press Releases. Small Business Administration. 19 June 2019. https://smallbusiness.house.gov/news/documentsingle.aspx?DocumentID=2689. Retrieved 08 July 2022. 
  48. ↑ Scott, V. (19 June 2019). "Lawmakers explore easing rules on small cannabis businesses". The Hill. https://thehill.com/policy/finance/449419-lawmakers-explore-easing-rules-on-small-cannabis-businesses/. Retrieved 08 July 2022. 
  49. ↑ "Golden, Velázquez Press SBA to Revise Financial Assistance Policy for Marijuana-Related Businesses". Press Releases. Small Business Administration. 12 June 2019. https://smallbusiness.house.gov/news/documentsingle.aspx?DocumentID=2673. Retrieved 08 July 2022. 
  50. ↑ Welsh, D. (4 December 2020). "House Approves Decriminalizing Marijuana; Bill To Stall In Senate". NPR. https://www.npr.org/2020/12/04/942949288/house-approves-decriminalizing-marijuana-bill-to-stall-in-senate. Retrieved 08 July 2022. 
  51. ↑ Krane, K. (6 January 2021). "Democrats Win The Senate: The Impact On Marijuana Policy". Forbes. https://www.forbes.com/sites/kriskrane/2021/01/06/democrats-win-the-senate-the-impact-on-marijuana-policy/. Retrieved 08 July 2022. 
  52. ↑ "Federal: Support The Historic MORE Act". NORML. 30 September 2021. https://norml.org/act/federal-support-the-historic-more-act/. Retrieved 08 July 2022. 
  53. ↑ Le, J.N. (4 April 2022). "The House Does It Again: MORE Act Ready for Senate Action". The National Law Review. https://www.natlawreview.com/article/house-does-it-again-more-act-ready-senate-action. Retrieved 08 July 2022. 
  54. ↑ "H.R.3617 - Marijuana Opportunity Reinvestment and Expungement Act". Congress.gov. Library of Congress. 4 April 2022. https://www.congress.gov/bill/117th-congress/house-bill/3617. Retrieved 08 July 2022. 
  55. ↑ "H.R.3105 - Common Sense Cannabis Reform for Veterans, Small Businesses, and Medical Professionals Act". Congress.gov. Library of Congress. 9 November 2021. https://www.congress.gov/bill/117th-congress/house-bill/3105. Retrieved 08 July 2022. 
  56. ↑ Lange, T. (13 May 2021). "Congressional Cannabis Caucus Co-Chairs Introduce Federal Reform Legislation". Cannabis Business Times. https://www.cannabisbusinesstimes.com/article/republican-cannabis-caucus-co-chairs-introduce-federal-reform-legislation/. Retrieved 08 July 2022. 
  57. ↑ Fayne, A.; Havens, J. (19 July 2021). "Senators Schumer, Booker and Wyden Introduce Comprehensive Legislation to End Federal Cannabis Prohibition". JDSupra. https://www.jdsupra.com/legalnews/senators-schumer-booker-and-wyden-1167488/. Retrieved 08 July 2022. 
  58. ↑ Booker, C.; Wyden, R.; Schumer, C. (July 2021). "Cannabis Administration & Opportunity Act" (PDF). https://norml.org/wp-content/uploads/2021/07/CAOA-Detailed-Summary-Web-Cover-1.pdf. Retrieved 08 July 2022. 
  59. ↑ Schiller, M. (24 June 2022). "‘The Clash Between State and Federal Law in the Cannabis Industry’: 4 Key Takeaways on Federal Policy Reform Efforts". Cannabis Business Times. https://www.cannabisbusinesstimes.com/article/4-key-takeaways-federal-cannabis-policy-reform-efforts/. Retrieved 08 July 2022. 
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