The Honorable Merrick B. Garland Attorney General
U.S. Department of Justice
The Honorable Anne Milgram, Administrator Drug Enforcement Administration
8701 Morrissette Drive
Springfield, Virginia 22152
Submitted via Electronic Docket
July 17 , 2024
Re: Part 2 of 2 of the Public Comments from
the National Drug & Alcohol Screening Association Docket No. DEA–1362
Dear Attorney General Garland, Administrator Milgram, and staff of the Drug Enforcement Administration’s Drug & Chemical Evaluation Section of the Diversion Control Division,
The undersigned, National Drug & Alcohol Screening Association (NDASA) hereby respectfully submits Part 2 of 2 of our comments in Docket No. DEA-1362; A.G. Order No.5931-2024, “Schedules of Controlled Substances: Rescheduling of Marijuana”. 99 FR 44597 (May 21, 2027). As we explained in Part 1 of our comments, DEA-2024-0059-20326 (https://www.regulations.gov/comment/DEA-2024-0059-20326), we are very concerned about the significant transportation safety repercussions of this rescheduling, which we believe are unintended consequences of this rulemaking action. In the interests of domestic transportation safety, we are submitting Part 2 of our comments today to explain the unintended safety impact and how catastrophic accidents can be avoided. In this second part of our comments, we are addressing the substantive subject matter of this Notice of Proposed Rulemaking (NPRM) and how the supporting evidence that must be considered should result in a different outcome regarding the rescheduling of marijuana under the Controlled Substances Act (CSA).
NDASA has also submitted a timely Request for Hearing in this matter to address factual inaccuracies submitted by the Department of Health and Human Services (HHS) and upon which the Drug Enforcement Administration (DEA) and the Attorney General are expected to rely for the decision about rescheduling marijuana from Schedule I to Schedule III under the CSA. It is essential that the final rule rest upon solid reasoning and reliable facts, which we will plan to address at hearing and will also provide in these public comments.
Our non-profit association, NDASA, represents a diverse coalition of employers and contractors, including medical professionals, substance abuse professionals, laboratory and toxicological experts, certified drug and alcohol collections professionals, designated employer representatives, major transportation industry employers and their professional associations, large and small business owners, who are on the front lines
of protecting the safety of commercial and public transportation in our nation. Our membership reaches tens of thousands of employers and millions of American workers nationally.
Unintended Transportation Safety Consequences If Marijuana Becomes Schedule III
As we explained in Part 1 of our comments, NDASA and its membership are extremely concerned about the unintended consequences of rescheduling marijuana from Schedule I to Schedule III of the CSA. Specifically, such rescheduling would end the United States Department of Transportation’s (DOT) ability to test safety-sensitive transportation employees for marijuana use. Marijuana drug testing has been an effective method of deterrence for commercial transportation safety-sensitive employees across the nation. Transportation safety sensitive employees include, but are not limited to: airline pilots, air traffic controllers, school bus drivers, subway and train operators, ferry operators, pipeline operators and truck drivers. These safety- sensitive employees have been subject to testing for marijuana and other drugs since shortly after catastrophic accidents caused by marijuana use occurred in the mid- and late- 1980s.
Rescheduling marijuana to Schedule III would abruptly end DOT-regulated testing for marijuana and would have a profoundly detrimental impact on transportation safety in the United States. As mentioned above, our members are on the front lines of protecting the safety of commercial and public transportation nationwide. We are deeply invested in maintaining effective measures to prevent needless accidents caused by those under the influence of marijuana and other impairing substances.
Analysis of the Eight Factors Set Forth in 21 U.S.C. 811(c) the Attorney General Must Consider for Rescheduling
With the above-mentioned safety goals in mind, we will address some of the factual errors, inconsistencies, and policy problems in this Notice of Proposed Rulemaking (NPRM). We are also asking some questions that need to be decided before any rescheduling of marijuana can be done. The purpose of our comments is to show that moving marijuana to Schedule III is premature and it fails to meet the criteria for the proposed rescheduling. We urge the Attorney General to consider the transportation safety and public concerns raised by NDASA’s comments.
1. Marijuana’sactualorrelativepotentialforabuse.
A. “Whether there is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community.” 99 FR 44601
In its analysis, HHS concluded “the vast majority of individuals who use marijuana are doing so in a manner that does not lead to dangerous outcomes to themselves or others.” 99 FR 44601. Their conclusions include the statement “the public-health risks posed by marijuana are lower compared to those posed by other drugs of abuse (e.g., heroin, oxycodone, cocaine), based on HHS’s evaluation of various epidemiological databases for emergency department (‘‘ED’’) visits, hospitalizations, unintentional exposures, and most importantly, overdose deaths.” 99 FR 44601.
When HHS and DEA addressed this issue in 2016, they noted the abuse potential is complex when the substance varies in potencies and other dimensions, and there is no single measure of abuse potential. As noted in the DEA’s 2016 Federal Register Notice that maintained marijuana as a Schedule I drug, DEA and HHS were in agreement when they said:
Scientifically, a comprehensive evaluation of the relative abuse potential of a substance can include consideration of the following elements: Receptor binding affinity, preclinical pharmacology, reinforcing effects, discriminative stimulus effects, dependence producing potential, pharmacokinetics, route of administration, toxicity, data on actual abuse, clinical abuse potential studies, and public health risks. Importantly, abuse can exist independently from tolerance or physical dependence because individuals may abuse drugs in doses or patterns that do not induce these phenomena.
81 FR 53769 (Aug.12, 2016)
The potencies of marijuana plants have been enhanced by cross-breeding and other botanical changes. The increase of potencies has come from the distilling of the cannabis oils for the purposes of vaping, edibles and concentrates. With marijuana potencies reaching more than 90% tetrahydrocannabinol (THC) for some of these products, more than ever we are finding a tremendous increase in substance dependency and toxicity. Consequently, none of these complicating factors cited by DEA in the citation above have decreased or improved since 2016, and the HHS conclusion above is not supportable.
B. “Whether there is significant diversion of the drug or drugs containing such a substance from legitimate drug channels.” 99 FR 44602
Marijuana has been considered to be a Schedule I drug since the inception of the Controlled Substances Act of 1970. Marijuana was placed in Schedule I by the United States’ Congress because it is a drug or substance with no currently accepted medical use and a high potential for abuse. Consequently, its use is prohibited. The Federal government has not yet changed its consideration of marijuana as a Schedule I substance. Therefore, there are no “legitimate drug channels” for this Schedule I controlled substance.
In the absence of any legitimate drug channels, HHS incorrectly reached its finding “that there is a lack of evidence of significant diversion of marijuana from legitimate drug channels.” 99 FR at 44602. NDASA is questioning whether it is possible to create a presumption that there are currently “legitimate drug channels” for this Schedule I drug.
The DEA, as the Federal government’s leader in intervening in illegal drug trade, is aware of and has provided valuable insight into problems with the supposedly “legal” marijuana markets for several years. In May, the DEA published its National Drug Threat Assessment 2024 (NDTA 2024). https://www.dea.gov/documents/2024/2024-05/2024-05-24/national-drug-threat-assessment-2024 Specifically, DEA noted that the legalization of marijuana has occurred in several States but:
the black market for marijuana continues, with substantial trafficking by Mexican cartels, and Chinese and other Asian organized crime groups profiting from illegal cultivation and sales, as well as exploitation of the ‘legal’ market. The price of marijuana in illegal U.S. markets has remained largely stable for years, even as the potency of marijuana has increased exponentially.
NDTA 2024, page 37.
NDASA and its membership are concerned about the significant activity by international players who exploit the State marijuana laws to flood the nation with illegal and dangerous marijuana products. As DEA said in May:
Black-market marijuana cultivation, processing, and trafficking is expanding, as criminal organizations exploit loopholes in the laws and regulations governing the marijuana “industry” to establish large cultivation sites and reap huge profits from the sale of marijuana and other THC products. In recent years, there has been a notable uptick in the number of illicit marijuana cultivation sites linked to Chinese and other Asian organized crime groups. Asian investors have emerged as a new source of funding for illegal marijuana production in the United States…
NDTA 2024, page 40.
It is naïve to think that there is not significant diversion under State legalization laws. DEA explained how the international players infiltrate the “home growing” provisions allowed in many States:
drug trafficking organizations have been involved in illegal marijuana cultivation for decades, operating industrial-scale indoor marijuana grows in residential homes, primarily in the western United States. Many of these home-grows pretend to operate under business registrations granted by state licensing authorities in jurisdictions where marijuana cultivation and sales are “legal” at the state level but, absent overt evidence such as the trafficking of marijuana across state lines or the commission of non-drug crimes such as money laundering and human trafficking, it can be difficult for law enforcement to immediately identify violations or discover an illegal grow. Across jurisdictions with a state-level “legal” framework for cultivation and sales, Asian drug trafficking organizations defy restrictions on plant quantities, production quotas, and non-licensed sales, and hide behind state-by-state variations in laws governing plant counts, registration requirements, and accountability practices. In January 2024, a federal jury in the Western District of Oklahoma convicted two Chinese nationals of drug trafficking conspiracy connected to trafficking nearly 28 tons of black-market marijuana shipped from an Oklahoma grow facility licensed by the Oklahoma Medical Marijuana Authority.
NDTA 2024, Page 40.
NDASA and its membership have seen some of this first-hand. We have also witnessed the connection between illicit drug use to drug-trafficking to human-trafficking. To think that moving marijuana to Schedule III will provide a better system for oversight of those who use sinister methods to sidestep oversight is worse than naïve, it is actually supportive of a destructive trend that causes deaths within our nation.
Finally, we acknowledge not only the deaths of Americans through the illegal drug trade, but we also recognize with gratitude the DEA agents who risk their lives to monitor, intercept and halt the illegal drug trade. With respect, we honor the memory of DEA Agent Enrique (“Kiki”) Camarena Salazar, who was murdered by Mexican drug traffickers in 1985. Every October, we stand with DEA on their “Red Ribbon Day”, in remembering Kiki Camarena and others who have fallen in the line of duty, trying to protect our nation from illegal drug trafficking. It is wrong to open this door to increased marijuana use and distribution in the United States.
C. “Whether individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of their professional practice.” 99 FR 44602.
HHS admits that “[o]utside of the Federal- and State-sanctioned medical use of marijuana, individuals are using marijuana on their own initiative for medical, as well as nonmedical, purposes.” 49 FR 44602. We would like to point out that there are no validly prescribed dosages of marijuana under Federal law at this time. Those who currently provide marijuana “medical recommendations” are in violation of Federal law and are more frequently than not financially tied to the dispensary-system profit base.
In addition, HHS cites 2022 data from the National Survey on Drug Use and Health (NSDUH) that found 61.9 million people used marijuana in the last year. The data HHS provided is actually contrary to determining that it is acceptable within the criteria for Schedule III of the CSA to move marijuana in light of this data.
D. “Whether the drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that it will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that they have a substantial capability of creating hazards to the health of the user or to the safety of the community.” 99 FR 44602.
Marijuana is not a new drug, and it has a potential for abuse proven by its current prevalent use and its supply chain through illegal sources, including drug cartels. The medical and recreational use of marijuana in the US is at levels of potency from 5% THC to more than 90% THC, as mentioned above.
HHS has understated its conclusion that marijuana “has the potential for creating hazards to the health of the user and to the safety of the community.” 99 FR at 44603. While we agree with this potential, it is important to note that the “potential” is being realized across the nation. In other words, the cannabis-related mental health disorders are causing undue burden to the nation’s addiction-treatment and mental health facilities to the point of near crisis. Even hospital emergency rooms are overwhelmed by the mental health crisis and injuries due to marijuana use and dependency. The data from emergency rooms across the nation contradict the HHS statement that “marijuana is not typically among the substances producing the most frequent incidence of adverse outcomes or severity of substance use disorder.” 99 FR 44603
In response to the 2016 petition for rescheduling marijuana to Schedule III (81 FR 53688, Aug. 12, 2016), DEA and HHS both found that marijuana had a high potential for abuse. As NDASA would address at a hearing on this rulemaking, that high potential for abuse has not changed. In fact, there is a much higher potential for abuse as products with 60% – +90% THC dominate the market. Vaping products alone have reached an epidemic, according to the FDA 2021. https://www.fda.gov/news- events/congressional-testimony/epidemic-continues-youth-vaping-america-06232021
2. Scientific Evidence of Marijuana’s Pharmacological Effects, If Known
In recognition of the extensive discussion on pages 99 FR 44603- 44606 about studies HHS conducted through SAMHSA and FDA, with the knowledge that high potency marijuana is addictive. Why would HHS want to unleash another addictive substance on the nation through the pharmacy system? Knowing how destructive the opioid epidemic has become, this seems completely illogical, to the point of being both arbitrary and capricious. Although oxycodone, oxymorphone, hydrocodone and hydromorphone can be legally prescribed, their use has caused the nation’s Opioid Crisis. How could HHS study the impact and not recognize they are on the cusp of making available, through prescriptions, another potential health crisis in the U.S.?
3. The State of Current Scientific Knowledge Regarding Marijuana
There is a broad range of products that fall within the CSA’s definition of marijuana, all with varying potencies. With this spectrum of THC-heavy products, NDASA maintains that there is not current scientific evidence to support rescheduling marijuana.
As the DEA noted in the NPRM, “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” 99 FR 44607.
Also, it is important to note that HHS made the following statement, with which we agree because it is actually contradictory to making a finding in support of rescheduling:
Products sourced from State-authorized adult-use and medical-use programs are subject to a patchwork of inconsistent product standards and safety requirements. Although some State programs have a set of standards (for example, on manufacturing, testing, labeling, and packaging), each program’s controls are different, leading to a wide variation of products across State- authorized programs. And the illicit marketplace is not subject to any standards or oversight. As a result, the range of products within the CSA’s definition of marijuana encompasses a large degree of variation in forms for consumption, composition of biologically relevant constituents, potency, and contaminants.”
49 FR 44606.
With this picture of “inconsistent product standards and safety requirements” and large “range of products”, how could marijuana be eligible for rescheduling at all?
How will physicians know how to prescribe and dose? Will the Federal government set a framework and guideline for prescribing and dosing? How can the Federal government reschedule marijuana to a Schedule III pharmaceutical without knowing what the different potencies can do? The variables in potencies make this impossible without extensive research, which has not been conducted.
What about the drug interactions and contraindications? For example, if one consumes acetaminophen and marijuana, there is a high probability of sever liver damage.
Will Schedule III marijuana be a pharmaceutical? Will it be dispensed by licensed pharmacists? Will it be encapsulated in a pill form, or will it be dispensed as a plant? How would a pharmacist dose and dispense a plant?
Will the Federal government now recommend patients consume a medication in a combustible form (smoking) with associated lung damage? Will the known long-term carcinogenic effects be listed on the marijuana packaging? Has the Surgeon General weighed in on this, since there is a Surgeon General’s warning for cigarettes? Is the Federal government prepared for the law suits that will ensue over long-term health problems and medical conditions resulting from premature rescheduling of marijuana?
Will edibles and vaping formulations be available at local pharmacies? Will the prescribers of marijuana have DEA licenses to prescribe? Will their prescriptions be tracked in a national database?
Has HHS considered that rescheduling marijuana will create a national medical marijuana system that will preempt any State’s adult-use (recreational) marijuana laws? If this preemption is not enforced by the Federal government after it reschedules marijuana, there would be a dual system whereby recreational use of a prescribed medication is allowable. This would create a dangerous precedent for legal recreational use of all other medications prescribed in accordance with the Controlled Substances Act.
If the Federal government were to impose rescheduling incorrectly and prematurely, it would cause great embarrassment to any Presidential Administration associated with such action. The unintended consequences to safety, as pointed out in Part 1 of NDASA’s comments, as well as the unintended consequences to public health discussed here cannot be ignored.
4. Marijuana’s History and Current Pattern of Abuse
NDASA is concerned that the wrong conclusions are being drawn to permit rescheduling of marijuana. Looking at the following, it is clear that the history and current pattern of abuse do not support moving marijuana to Schedule III.
For example, HHS admitted that there is extensive and significantly increasing “use of marijuana for medical and nonmedical purposes”. 99 FR 44610. NDASA and its membership agrees. The National Survey on Drug Use and Health (NSDUH) results from 2022, which were cited by HHS at 99 FR 44608 further demonstrates this.
In addition, the DEA’s information from the World Health Organization (WHO) supports this. WHO said “cannabis is globally the most commonly used psychoactive substance under international control …[with] the global annual prevalence of cannabis consumption is 2.5 percent or about 147 million people” 99 FR at 44610.
Furthermore, as noted by DEA, when they quoted the WHO for data from the year 2016, “an estimated 28.6 million individuals aged 12 or older were current (in the past month) illicit drug users. By 2020, approximately 59.3 million individuals aged 12 or older reported using an illicit drug within the past year; 83.6 percent (49.6 million) of those past-year illicit drug users reported using marijuana.” 99 FR 44610. With the Domestic Cannabis Eradication and Suppression Program eradicating 4,435,859
illegally cultivated outdoor cannabis plants and 1,245,980 illegally cultivated indoor plants, totaling 5,681,839 illegally cultivated marijuana plants (99 FR 44610), NDASA remains concerned that the depth and breadth of the growth of illicit marijuana growing and production will not be slowed, but will actually increase, if marijuana becomes a Schedule III drug.
As the DEA has requested, we would like to provide “additional data on marijuana’s pattern of abuse… appropriate for consideration in assessing this factor. “ 99 FR 44610. In 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) published the National Survey on Drug Use and Health which showed that 4.8 million people ages 12 and older in the U.S. have been diagnosed with Marijuana Use Disorder. This was double the rates reported in 2002. According to the DSM-IV Diagnostic and Statistical Manual of Mental Disorders, 25 – 50% of daily marijuana users develop a marijuana use disorder and 19% of lifetime users meet criteria considered “severe symptoms”. Also, 48% of those individuals are unable to work as a result of the severity of the disorder. NDASA will provide additional data if our request for hearing is granted, demonstrating the U.S. workforce and the health of eligible working adults are impacted detrimentally by current policies and unfettered potencies in contemporary commercialized cannabis products across the U.S.
5. TheScope,Duration,andSignificanceofAbuse
To address this, factor #5, “HHS analyzed the consequences over time of marijuana abuse compared to the abuse of other substances…“ 99 FR 44610. The HHS data actually indicates that the criteria for this factor was not met because the data provided in the NPRM shows marijuana is highly addictive, causes Substance Abuse Disorder (SUD), and that marijuana is the first or second most common drug for which people are admitted for in-patient treatment. The facts simply do not support the HHS conclusions on this factor.
Instead, in response to HHS’s conclusions that other drugs were greater in the “scope, duration, and significance of abuse”, DEA countered with their reasoning from their 2016 denial of a petition to reschedule marijuana to a Schedule III drug. “In 2016, DEA found that abuse of marijuana is widespread and significant. 81 FR 53739…. DEA notes that national data demonstrate that marijuana is one of the most widely used federally illicit substances in the United States…” 89 FR 44613.
As NDASA noted above, the vast spectrum of potencies for marijuana results in addiction, emergency room admissions, and a mental health crisis in this nation. This increasing pattern of abuse cannot be ignored. According to the National Institutes of Health there is an 11-fold increase of risk of psychoses with cannabis use in those ages 12 – 19. The Lancet reports that daily marijuana use increases odds of developing psychotic disorder by 5 times, especially with high potency products. A meta-analysis on the association between the level of cannabis use and the risk of psychosis concluded across 18 studies of over 66,000 individuals that higher levels of cannabis use increase the risk of psychotic outcomes. We need not exacerbate these critical issues without first finding appropriate drug policy responses and treatment solutions.
6. What, if Any, Risk There Is to the Public Health
HHS reached the following conclusion without reliable support: “that the risks to the public health posed by marijuana are low compared to other drugs of abuse (e.g., heroin (schedule I), cocaine (schedule II)), based on its evaluation of various epidemiological databases for ED visits, hospitalizations, unintentional exposures, and, most importantly, for overdose deaths.” 99 FR 44614. Importantly, HHS is using this conclusion to move a Schedule I drug to Schedule III, saying it is not as addictive as other drugs in Schedule I and II. That is not a logical conclusion.
If marijuana is the most widely used drug in the world and is the basis for SUD, as HHS cited elsewhere in their recommendations to the DEA and the Attorney General, how can it be characterized as not being a clear risk to the public health?
Noting this clear contradiction of HHS’s current conclusion on this factor, DEA cited the findings that both DEA and HHS reached in 2016, when they determined that:
[t]ogether with the health risks outlined in terms of pharmacological effects above, public health risks from acute use of marijuana include impaired psychomotor performance, impaired driving, and impaired performance on tests of learning and associative processes. Chronic use of marijuana poses a number of other risks to the public health including physical as well as psychological dependence.’’ 81 FR 53739–40, and cited at 99 FR 44614.In 2013, National Institutes of Health stated the risk of car collisions doubles after smoking cannabis due to substantial driving impairment particularly in occasional smokers. Meta-analysis of similar studies repeatedly determines that only 1 ng/mL of THC creates a 3 – 7 times risk of motor vehicle collision due to substantial driving impairment. Additionally, drivers report a false sense of driving safety post-cannabis use in spite of their increased risk. While we are summarizing hundreds of data points in brief paragraphs, NDASA strongly encourages a renewed effort to follow the proven science with an eye toward whether or not solutions exist to address the deficiencies caused by increased cannabis use amongst U.S. citizens before compounding these complicated issues.
7. Marijuana’s Psychicor Physiological Dependence Liability
Despite multiple sources of information showing psychic dependence and that marijuana was “the third most frequently reported primary substance of abuse, after alcohol (31.2 percent) and heroin (20.6 percent)”, 99 FR 44614, HHS made a finding that this was not a sufficient concern to maintain the substance in Schedule I of the CSA. 99 FR at 44614. Similarly, with respect to psychological dependence, “HHS reported that up to 40 to 50 percent of individuals who use marijuana on a regular basis may experience physical dependence.” 99 FR 44615. In fact, HHS concluded that it “found experimental and clinical evidence that chronic, but not acute, use of marijuana can produce both psychic and physical dependence in humans.” 99 FR 44615
DEA referred back to its 2016 findings regarding long-term heavy use of marijuana as being likely to lead to physical and psychological dependence and that this dependence is underdiagnosed and undertreated in the medical setting. 81 FR 53740 and 99 FR 44615. There was no evidence submitted to show the 2016 findings by DEA and HHS regarding the psychic and physical dependence on marijuana have disappeared or even diminished.
As referenced above, marijuana dependence disorder has doubled since 2002 in the U.S. and in 2016 the National Institutes of Health furthermore reported cannabis- specific barriers to treatment, which demonstrate challenges in successfully overcoming use disorders associated with marijuana. This review of therapeutic outlooks reiterated that heavy cannabis use is associated with cognitive impairment, increased risk for psychotic disorders and other mental health problems as well as lower education attainment and unemployment. Problems without an efficacious solution, to which the U.S. appears prepared to increase, compound and complicate.
With all of these conclusions in place, it appears that there is no support for rescheduling marijuana under this 7th required criteria. HHS may have concluded otherwise, but the information in the NPRM undercuts this conclusion.
8. Whether Marijuana Is an Immediate Precursor of a Substance Already Controlled Under the CSA
HHS concluded that marijuana is not a derivative of another drug since “HHS concluded that marijuana is not an immediate precursor of another controlled substance. HHS Basis for Rec. at 61. This finding is consistent with DEA’s finding in 2016. 81 FR 53740.” 99 FR 44615
While we agree that marijuana is not an immediate precursor of another substance already under the CSA, it is important to note that marijuana has many derivates. If marijuana is moved from Schedule I in the final rule, would the derivatives of marijuana, including concentrated THC products, elixirs, extracts, and other variations with inordinately high THC potencies be included in the any rescheduling of marijuana? Without detail of what is actually prescribable, we believe there would be extensive confusion.
VII. Determination of Appropriate Schedule for Marijuana
NDASA respectfully disagrees with the three findings HHS has made after conducting the eight-factor analysis above. Specifically, marijuana continues to maintain the high potential for abuse that HHS and DEA found in 2016. Also, the availability of marijuana and marijuana-derived products with extremely high levels of THC produces higher degrees of negative outcomes for the health of the individuals using marijuana and the safety of those around them.
It is an incorrect finding “that marijuana has a currently accepted medical use in the United States, specifically for the treatment of anorexia related to a medical condition, nausea and vomiting (e.g., chemotherapy induced), and pain.” 99 FR at 44616. It is not “marijuana” but a synthetic pharmaceutically produced product (i.e., Marinol, Dronabinol) currently in Schedule III of the CSA that provides the acceptable medical use HHS has described.
Unlike Marinol and Dronabinol, marijuana is not pharmaceutically produced in carefully measured dosages. NDASA remains concerned any final rule that would reschedule marijuana to permit its use does not provide for marijuana to be dosed and dispensed by licensed pharmacists in the United States. If it is not able to be dosed and dispensed by licensed pharmacists, then it does not meet the criteria for being a Schedule III drug.
Importantly, neither WHO nor the American Medical Association (AMA) has definitively said that marijuana has a legitimate medical purpose. Instead, WHO and AMA support research into determining whether marijuana has a legitimate medical purpose. For example, the AMA supports research in the area of using cannabis for medical purposes, but also has posted cautions for providers regarding encouraging the use of cannabis because of risks and the lack of research available.
Certainly, the logical conclusion must be that without scientific evidence that eliminates Schedule I qualifiers for cannabis, without further research conducted on how to address the deficiencies and negative outcomes presented by cannabis use and potency controls, without explicit evidence of empirical data that charts a path to successful treatment and recovery of cannabis use disorder and without a solid plan for the medical determination of benefits, warnings for contraindicators of other drugs and dosing structures that physicians can rely upon, it is premature to reschedule marijuana.
Respectfully submitted,
M. Jo McGuire, Executive Director
National Drug & Alcohol Screening Association 1629 K Street NW, Suite 300
Washington, DC 20006
- Read Part 1 of NDASA’s response to the proposed rescheduling of marijuana
- Read about some unintended consequences of marijuana legalization by Bill Current
- Find details about how to provide comment for the DEA’s proposed rulemaking