Twenty-First Century Illicit Drugs and Their Discontents: Why the FDA Could Not Approve Raw Cannabis as a “Safe,” “Effective,” and “Uniform” Drug

Report Public Health

Twenty-First Century Illicit Drugs and Their Discontents: Why the FDA Could Not Approve Raw Cannabis as a “Safe,” “Effective,” and “Uniform” Drug

August 30, 2023 Over an hour read Download Report
Paul Larkin
Rumpel Senior Legal Research Fellow
Paul is a Senior Legal Research Fellow in the Meese Center for Legal and Judicial Studies at The Heritage Foundation.


The raw, agricultural form of cannabis is not capable of being approved for use by the Food and Drug Administration (FDA)—regardless of whether Congress or the U.S. Attorney General reschedules it downward from Schedule I. Rescheduling cannabis would not allow the drug to be distributed under federal law unless the FDA finds that it is a safe, effective, and uniform drug. The FDA could not do so under existing law, and the Attorney General cannot waive the Food, Drug, and Cosmetic Act’s requirements. Congress could do so by statute—but any such law would put at risk the health of users and nonusers in order to satisfy the desires of a minority for a transient high.

Key Takeaways

There is no proof that raw cannabis is safe, effective, and uniform as required by federal law for a new drug to be distributed in interstate commerce.

States that have approved the use of raw cannabis have not made the findings that the Food, Drug, and Cosmetic Act demands.

The possibility that cannabinoids might serve as a legitimate therapeutic treatment justifies research into their potentially therapeutic value.

In a May 2023 article published online in the Journal of the American Medical Association Network Open, the authors conducted a survey among medical cannabis users in Australia between December 2018 and May 2022 to determine if they reported improvements over time in their quality of life from their cannabis use.REF The authors concluded that “[p]atients using medical cannabis reported improvements in health-related quality of life, which were mostly sustained over time,” but they cautioned that “[a]dverse events were rarely serious but common, highlighting the need for caution with prescribing medical cannabis.”REF

The study illustrates some of the problems with contemporary debates over the legalization of cannabis. Replete with tables, charts, graphs, and statistical analyses, and published in the distinguished Journal of the American Medical Association, the Australian study appears to offer support for the proposition that cannabis is a legitimate medical treatment. The study certainly will be used for that purpose in public policy debates over the proper legal treatment of that drug, both in Australia and the United States. The problem is that, when critically analyzed, the study does not come close to proof that raw cannabis is a safe, effective, and uniformly made drug—the proof required by federal law for a new drug to be distributed in interstate commerce.

A central weakness in the study’s value is its reliance on the subjective evaluation of cannabis’ effects on individuals as proof of cannabis’ value on their quality of life.REF Drugs used for the treatment of diseases or injuries are not ordinary consumer goods like cell phones, motor vehicles, or stereo systems. That is, drugs are not widgets that we entrust to the judgment of the market, goods that may be sold without prior government approval and that succeed or fail based on consumer decisions about their value. Nor do we decide whether a drug should be legalized by polling users to learn whether they believe that it is “Awesome!” or “Gnarly!” This nation has taken a different course. Ever since 1938, when the federal Food, Drug, and Cosmetic Act (FDCA) became law,REF it has been a federal crime to distribute a drugREF in interstate commerce unless and until the Commissioner of Food and DrugsREF finds that the drug is safe, effective, and uniformly made.REF Prior authorization under a rigorous medical and legal standard is the rule of the road.REF

Reports like the one noted above—studies that uncomfortably resemble the analyses that modern corporations likely prepare for new varieties of candiesREF (substitute “chocolate” for “cannabis” in the above study, and see if it makes a difference in the outcome)—do not prove that a drug is safe and effective at treating a disease, its cause, or its sequalae; at best, they tell whether users “like” the drug. That finding might be interesting, but it is not tantamount to legal proof that the drug should be approved for medical use.

That is only one shortcoming of the Australian study. There are more:

  • The authors admitted the limitations of their study. There was no control group, so the authors could not determine whether adverse reactions were due to the subjects’ underlying medical conditions, the cannabis they used, or both.REF
  • Responses were voluntary, which poses the risk that only favorable reactions would be reported (perhaps to enable subjects to continue to receive cannabis).REF
  • “[N]o official prescribing guidelines exist in Australia” for cannabis as a treatment.REF Instead, “the target dose is determined on a case-by-case basis.”REF
  • Cannabis “[p]roduct types and cannabinoid content varied over time in accordance with the treating physician’s clinical judgement.”REF
  • With respect to (the admittedly small number of) parties smoking raw cannabis, there was no stated uniformity in the number, depth, and rate of inhalations.REF
  • Nearly half (48 percent) of the subjects were also taking opioid analgesics.REF

Even disregarding all those qualifications, the poll still does not help decide whether smoking raw cannabis is a legitimate therapeutic modality. Why? More than 70 percent of the subjects were being treated with cannabis for “non-cancer pain” or “anxiety,”REF subjective symptoms reported by a patient, rather than objective facts such as having recently undergone surgery or having been diagnosed with cancer. As Dr. Peter Bach, a physician and Director of the Center for Health Policy and Outcomes at the Memorial Sloan Kettering Cancer Center, explained, “[E]very intoxicant would pass that sort of test because you don’t experience pain as acutely when you are high. If weed is a pain reliever, so is Budweiser.”REF Plus the benefits were found to be relatively minor,REF and there were also adverse events.REF Even giving the study the benefit of every doubt, it does not prove that cannabis is a legitimate medical palliative.

My point is not that the study is worthless or that the authors acted in bad faith. It is not, and they did not. The study has limited usefulness when it comes to deciding whether raw cannabis is safe, effective, and uniformly made, which are the requirements that the FDCA imposes before that drug can be distributed across state lines. Just as further research is necessary to determine whether there are medically valuable cannabinoids that can and should be approved for use in treating disease—which the Food and Drug Administration has found in several cases—so, too, there is a need for additional research into whether cannabis products legitimately and properly produced by pharmaceutical companies can provide relief for the ailments noted by the subjects without producing adverse effects.

The gravamen of this Special Report is that, under long-standing federal law, the FDA Commissioner could not find that the raw (or agricultural or botanical) form of cannabis is a safe, effective, and uniformly made drug (requirements before anyone may ship that drug in interstate commerce) or that smoking raw cannabis is a legitimate therapeutic modality. The states that have approved smoking raw cannabis as a treatment for either a few specified ailments—or whatever ones a licensed physician is willing to risk his reputation by endorsingREF—did not make the findings that the FDCA demands. Without even genuflecting toward the findings that federal law requires before a drug can be approved, those states have washed their hands of the responsibility to protect the public health, whether by shifting the responsibility to (what are certain to be) underfunded state agencies or just passing the buck to physicians willing to recommend cannabis use for anyone who has a double sawbuck and 10 minutes to spare.REF Those states have simply succumbed to the demands or entreaties made by parties ostensibly seeking to alleviate the suffering of the afflicted or, in reality, simply seeking to get rich off of a beguiling, but habit-forming, drug. The dishonesty of those states’ decisions, the fetid justifications that they found acceptable for legalizing cannabis, is a testament to the proposition that hypocrisy is the tribute that vice pays to virtue. The parts below explain why.

The Complementary Roles of Federal and State Drug Regulation

Federal and state law serve complementary roles in the use of drugs to treat disease. State law governs the hands-on treatment of individual patients by state-licensed physicians, while federal law regulates what drugs may be distributed in interstate commerce.REF Under the FDCA, the responsibility to approve the distribution of a “drug” in interstate commerce rests with the Commissioner of Food and Drugs. Along with his or her principal lieutenants and staff, the commissioner must review all “new drugs”REF to determine whether they are “safe,” “effective,” and uniformly made for their intended treatment purposes.REF The nation has accepted that assignment of responsibilities for more than 80 years. Whether the drug is an antibiotic, antiviral, antifungal, antineoplastic, or antiwhatever, no state has refused to respect the FDA’s judgment that a drug is not safe, effective, and uniformly made by legalizing the sale under state law of any such drug.

With the exception of cannabis.

The Current—and Chaotic—State of American Law and Policy Governing Cannabis

The utility of cannabis as a medical treatment has been the subject of considerable debate within the medical profession. Some physicians believe that cannabis or its cannabinoids (biologically active constituents) have legitimate therapeutic uses in treating (for example) long-term pain, nausea, appetite suppression, the spasticity caused by multiple sclerosis, and other ailments.REF By contrast, other physicians (and nonphysician experts) strongly disagree. They see medical cannabis not as a legitimate pharmaceutical but as a mistaken belief in the therapeutic value of caring or as a fraudulent attempt to justify its distribution.REF They also believe that one cannot yet know the likely long-term harms from cannabis use (particularly today’s high-potency cannabis), because the states did not independently investigate cannabis’ potential long-term harms before legalizing it, and that they—and we—might regret those decisions.REF

Federal law, however, is clear. It prohibits the distribution of cannabis for any medical or recreational useREF but allows it to be cultivated for research purposes.REF Two acts of Congress are particularly relevant here: the Food, Drug, and Cosmetic Act of 1938 and the Controlled Substances Act of 1970.

The Food, Drug, and Cosmetic Act. The Food, Drug, and Cosmetic ActREF prohibits the interstate distributionREF of any “adulterated or misbranded” drug into interstate commerce,REF as well as the distribution of any “new drug”REF unless the Commissioner of Food and DrugsREF has found it to be “safe” and “effective” for its intended use.REF To enforce those requirements, the FDCA authorizes the government to pursue criminal prosecution and civil remedies, including the seizure of any adulterated drugs.REF

To obtain the FDA Commissioner’s approval, a drug sponsor must submit to the FDA sufficient information to enable the agency to answer those questions in the sponsor’s favor, as well as to prove that the drugREF is appropriately labeled. The sponsor must also establish that its manufacturing process will “preserve the drug’s identity, strength, quality, and purity.”REF To do so, a manufacturer must submit what is known in the trade as a New Drug Application, or NDA.REF

An NDA is a massive and complex document, containing extensive scientific and clinical data such as “full reports” of all years-long clinical trials, relevant nonclinical studies, and all other information that the FDA deems relevant to its evaluation of the drug’s safety and effectiveness, as well as a detailed description of the company’s manufacturing processes.REF The NDA must also include the labeling proposed for the drugREF and “an explanation of why its benefits exceed its risks under the labeling’s conditions for use.REF The FDA may approve an NDA only if it finds that the drug is “safe for use” under “the conditions of use prescribed, recommended, or suggested” in the proposed label.REF To make that finding, the drug’s probable therapeutic benefits must outweigh any risk of harm.REF

Safety and effectiveness testing generally proceeds in three phases.REF

  • Phase I encompasses initial clinical testing on a small number of people to assess safety;REF tolerability; pharmacodynamics (viz., the effect of a drug on the body); pharmacokinetics (viz., the movement of a drug through a body); and (only preliminarily) potential therapeutic benefits of the proposed new drug.REF
  • Phase II testing is critical because it is designed to determine and measure a safety and efficacy profile for humans far better than the results of Phase I does.REF Accordingly, medical and scientific experts play a critical role at this stage.REF
  • Phase III testing—which is more expensive and time consuming than prior stages and ordinarily takes 1.5 years to complete and analyze the data—seeks to confirm or refute the therapeutic effects of a drug on a particular disease shown in Phase II.REF

An NDA must also include “an explanation of why the drug’s benefits exceed the risks under the labeling’s conditions.REF To make that finding, the drug’s probable therapeutic benefits must outweigh any risk of harm.REF Finally, after approval, a drug sponsor must report to the FDA any newly identified adverse events or treatment risks.REF

Atop all that, a drug sponsor must also prove in its NDA that it follows good manufacturing practices, guaranteeing that the drug production manufacturing process will turn out approved, safe products.REF The sponsor also must establish that its drug will remain stable in whatever containers it proposes to use.REF In addition, the FDA may approve a new drug only if the agency finds that the drug is “safe for use” under “the conditions of use prescribed, recommended, or suggested” in the proposed labelREF and that the labeling is satisfactory to ensure safe dispensing, application, and use of a drug.REF

The FDA has never approved the raw cannabis plant as a treatment for any ailment,REF but it has approved the use of certain biologically active cannabis compounds, known as cannabinoids (or phytocannabinoids).REF The FDA has approved the synthetic delta-9-THC analogues dronabinol (Marinol) and nabilone (Cesamet) for treatment of chemotherapy-induced nausea and emesis, as well as appetite stimulation in cachexic patients suffering from cancer or HIV/AIDS wasting syndrome.REF The FDA has also approved Epidiolex, a purified form of cannabidiol (CBD), for use in treating Dravet’s Syndrome and Lennox–Gastaut Syndrome, severely debilitating forms of childhood-onset epilepsy.REF

The Controlled Substances Act of 1970. The other relevant law is the Controlled Substances Act of 1970 (CSA).REF The CSA directly incorporates the definition of the term “drug” found in the Food, Drug, and Cosmetic Act,REF and it defines the term “controlled substance” (with certain exceptions) as “a drug or other substance, or immediate precursor, included in Schedule I, II, III, IV, or V of part B of this title.”REF

A licensed physician may prescribe, and pharmaceutical companies and retail stores may distribute, any drug listed in Schedules II through V, which are subject to (decreasingly) strict regulations for public safety purposes. By contrast, drugs listed in Schedule I, such as cannabis, are illegal to manufacture, distribute, or possess because they have no accepted medical use and are dangerous.REF Schedule I drugs can be distributed for research purposes, but only under rules promulgated by the U.S. Department of Justice limiting distribution to legitimate investigators.REF

By contrast, the CSA places Schedule I drugs outside the boundaries of legitimate medical practice, classifying them as contraband even if a state-licensed physician would prescribe them for a specific patient.REF Any physician prescribing cannabis can be prosecuted for prescribing a controlled substance outside of legitimate medical practice, and the same potentially severe penalties apply alike to physicians and ordinary street dealers.REF When it passed the CSA in 1970, Congress placed cannabis into Schedule I.

There has been no material change in cannabis status under federal law since then. Congress empowered the U.S. Attorney General, in consultation with the Secretary of Health and Human Services, to reclassify cannabis,REF but no attorney general has yet done so.REF Since 1970, Congress has revised the FDCA and CSA on numerous occasions,REF and it has nibbled around the edges of the reclassification and legalization issues.REF Nonetheless, despite numerous entreaties to modify the CSA’s classification of cannabis,REF Congress has not fundamentally reconsidered whether the nation should legalize its use. The CSA’s scheduling system, and cannabis designation as a Schedule I controlled substance, remains in place.REF In addition, because the CSA must be read consistently with the FDCA,REF even if Congress completely removed cannabis from the CSA, the drug could not be distributed in interstate commerce without the FDA Commissioner’s approval.REF Together, those laws forbid the interstate and intrastate distribution of cannabis for any nonscientific investigatory purpose.

State Cannabis Regulation. Nonetheless, since 1996, numerous states have decided to liberalize their own state laws governing cannabis. At present, 42 separate jurisdictions—37 states, four territories, and the District of Columbia—have revised their laws to allow cannabis or its productsREF to be used for medical purposes, while 18 states, two territories, and the District of Columbia permit cannabis to be used recreationally.REF To be sure, some states have rejected bills that would have legalized cannabis for medical or recreational use, but a majority of states now allow it to be used under state law for one purpose or another. The oddity is that, because states cannot exempt their residents from the reach of federal law, the states that have legalized cannabis use are effectively—and openly—encouraging them to commit federal crimes, which leaves residents in the lurch if they follow through.REF

Why have the states decided to legalize cannabis under state law? Is it because the FDA deems cannabis a “safe” and “effective” drug under the FDCA, but the Justice Department has refused to give effect to that finding because the distribution of cannabis is a felony under a different federal law, the CSA? No. The federal government’s health care agencies, including the FDA, have consistently found that cannabis is not a safe and effective drug: On the contrary, it carries substantial risks, and smoking it is not a legitimate medical treatment modality. Although there has been a decades-long and still-ongoing debate over the medical effectiveness of cannabis and its compounds to treat disease or alleviate its symptoms, there is considerable scientific support for the agencies’ conclusion that agricultural cannabis is not a safe, effective, and uniform drug.

The FDCA and the FDA’s Rules Require that a New Drug Be Proven “Safe,” “Effective,” and “Uniform” to Be Distributed In Interstate Commerce

Raw cannabis cannot satisfy the FDCA’s safety, effectiveness, and uniformity requirements. That is true for a host of reasons, as the next subparts will explain.

At the outset, it is important to note that the age of the cannabis plant does not prove that it is “safe.” One argument advanced in favor of cannabis’ safety is that cannabis was used for medical purposes for centuries without scientific proof of its safety and efficacy.REF That is true but irrelevant. “Prior to the twentieth century, drug manufacturers could hawk any potion, claim treatment of any ailment, and hail efficacy or potency on a bottle’s label, all in the name of increasing sales.”REF Only in that century did American society reject a laissez faire approach to drug regulation. The Pure Food and Drug Act of 1906 required the contents of drugs to be disclosed,REF and the FDCA prohibited the commercialization of drugs until the FDA had found them to be safe, effective, and uniform.REF Accordingly, the historical treatment of cannabis in the 17th, 18th, or 19th centuries, whether in America or the rest of the world, is of no importance. What truly matters is how this nation treats cannabis today.

Another argument commonly advanced to prove cannabis’ safety is that, unlike opioids or alcohol, cannabis cannot depress the respiratory system, so overuse cannot prove fatal. That argument is true but only insofar as it goes. The number of cannabinoid receptors in the base of the brain, which controls automatic breathing (such as when we are asleep) is too few in number to shut down the brainstem’s regulation of nonconscious respiration.REF But cannabis use and driving can prove fatal to the driver as well as others, as discussed below.REF In fact, the available evidence shows an increase in cannabis-related crashes and fatalities in states that have legalized cannabis. Plus, there are other potential harms from smoking cannabis as a treatment or palliative. They are discussed below.

The Potential Harms to Cannabis Users

The Risk of Adulteration. As Dr. Nora Volkow, the Director of the National Institute on Drug Abuse, told Congress in 2020, “in general, adequate and well-controlled studies are lacking” to test the cannabis sold in states with legalized medical-use or recreational-use régimes.REF A result is that “individuals across the country are using cannabis strains and extracts that have not undergone the rigorous clinical trials required to show that they are safe and effective for medical use, and are not regulated for consistency or quality.”REF Commercially sold cannabis can be adulterated, and consumption of such cannabis poses several risks, risks that become particularly hazardous when that use is heavy, long-term, or begins in adolescence.

Much of the cannabis sold in states with medical or recreational cannabis programs has not undergone rigorous testing to ensure that is does not contain dangerous toxins. In fact, commercial cannabis can contain a “hodgepodge” of dangerous contaminants.REF Among them are microbials (e.g., E. coli, fungi, mold), toxins (e.g., aflatoxins), hazardous chemical solvents remaining from the extraction process (e.g., butane, hexane, propane), pesticides (e.g., organophosphates), heavy metals (e.g., arsenic, cadmium, lead, mercury), and other harmful (e.g., formaldehyde) or distasteful (e.g., insects) substances.REF

To be sure, randomized testing is now required by some jurisdictions, and where that is done regularly, consistently, and honestly, that practice should reduce the risk of adulteration to some extent.REF But that risk will not vanish. Why? Despite legalization, there still is a thriving illicit cannabis market.REF The universally acknowledged widespread existence of that industry;REF the preference that many users have for buying lower-cost cannabis (because illicit sellers do not pay taxes or comply with health and safety regulations); and the desire many users have to make their purchases in private (because buying from public, state-licensed cannabis dispensaries could “out” them as users) means that the cannabis used by the public will continue to possess a range of adulterants ranging from the unsavory to the toxic.REF California is a good example, because its illicit market is larger than its legitimate one and shows no signs of disappearing.

The Risk of Addiction and Dependence.REF Cannabis is not an ordinary consumer good because it can lead to dependence and addiction by users (as well as injury (or worse) to third parties). Like any other substance that produces an intoxicating effect (even if only during its initial use)—like alcohol, tobacco, or heroin—cannabis generates a pleasurable “high” that people enjoy. “Unfortunately, for some people the ‘rush’ that marijuana produces is more a curse than a blessing.”REF The reason is that heavy or long-term use can lead a person to develop a tolerance to THC, requiring ever greater quantities of the chemical to experience the same euphoria.REF That increasing-quantity user carries potential downsides. Among them are damage to a user’s mental or physical functioning;REF physical dependence on THC, which leads to the unpleasant experience of suffering withdrawal symptoms when use is discontinued; or to addiction, in which using cannabis becomes the fulcrum of one’s life.REF

Here, as often occurs elsewhere in science, including with respect to cannabis, there is no certainty that any one individual will or will not suffer mental deterioration, physical dependence, or addiction from heavy, long-term cannabis use. Nor is there any test that can alert someone to the certainty that cannabis use will shorten or degrade his life. It is a matter of probabilities. There are, however, some useful “rules of thumb,” according to two drug policy experts, Wayne Hall and Rosalie Pacula, that are helpful in this regard.REF There is a 10 percent risk for people who have ever used cannabis. That risk increases to between 20 percent and 33 percent for people who use the drug more often. The risk jumps to 50 percent—which is tantamount to a coin flip—for people who use cannabis daily. Given the labile nature of the adolescent brain, the risk is greater still for people who begin heavy or long-term use during their minority.REF As NIDA Director Volkow put it, “as compared with persons who begin to use marijuana in adulthood, those who begin to use in adolescence are approximately 2 to 4 times as likely to have symptoms of cannabis dependence within 2 years after first use.”REF Physical dependence is therefore a serious problem.

The Risk of Mental Illness. It has been known for centuries that cannabis use can cause acute, short-term hallucinations.REF A different question is whether overuse can cause long-term psychosis. For example, a well-known 1987 study of the relationship between cannabis use and more than 45,000 Swedish military conscripts found an association between long-term use and schizophrenia—namely, frequent cannabis smokers were six times more likely to have schizophrenia than non-smokers—but did not find a causal relationship.REF A 2012 report by the United Kingdom Schizophrenia Commission came to the same conclusion,REF as did a 2020 report by NIDA,REF which is reflected in congressional testimony given by Dr. Volkow that year.REF

Other researchers disagree. Some of them have concluded that factors, such as alcohol, cigarette, or non-cannabis drug use, confound the association between cannabis and psychosis, which prevents a causal relationship from being shown.REF Nonetheless, numerous reports, based on clinical studies or meta-analyses of the literature, have found a serious risk between long-term use or heavy use of high-potency cannabis and Cannabis Use Disorder (CUD)—namely, the inability to cease using cannabis despite its adverse psychosocial effects on a user’s lifeREF—and schizophrenia.REF Many of those studies have come not only in this century, but also in the past decade, particularly in the past three to four years.REF

This is not to say that any and all cannabis use triggers schizophrenia. That is not true. There is a consensus that experimental or small-scale cannabis use will not inevitably cause someone to suffer from schizophrenia. Nevertheless, a causal relationship between cannabis use and psychosis is “biologically plausible,” and there also is a material risk that use can speed along individuals toward that outcome if they are genetically predisposed to that illness.REF Factors such as the amount, potency, age of first use, and genetic disposition are critical. As one researcher concluded, “[w]hile only a minority of cannabis users develop a psychotic disorder, users who consume daily types of cannabis” with a 10 percent or greater THC content “are over 5 times more likely to suffer from a psychotic disorder than never users.”REF That is a particular risk for people who begin heavy, long-term use during adolescence.REF Dr. Volkow’s point is that we should be concerned about the risk that cannabis will accelerate the development of mental illness in people who, unfortunately, are already on that sad trajectory or use high-potency THC products for an extended period.

That is a serious public policy problem. If any other consumer good posed the same risk, members of the public and elected officials would daily express their outrage that the nation allows such a product to be sold, and congressional chairs would haul the FDA Commissioner to Capitol Hill for hearings and demand that he or she outlaw that good, immediately and forever.REF Indeed, if umbrage could be harnessed as energy, we would need no fossil or green fuels for a week or more after that hearing (at least until some other “crisis” captivated the public).

An important reason for reconsidering the relationship between heavy or long-term cannabis use and schizophrenia is the 15-fold increase in the THC content of cannabis products today over the weed smoked in the 1960s.REF The past 60 years have witnessed “ganjapreneurs” develop sophisticated indoor and hydroponic cultivation techniques, as well as the cross-breeding of cannabis strains, which have increased cannabis’ potency tremendously. Cannabis had a THC content of approximately 1 percent to 3 or 4 percent during the Summer of Love (1967), but the THC content in commercial cannabis products today approaches 100 percent pure THC. The increase is like switching from near beer to grain alcohol. No one could responsibly believe that the potency increase is immaterial. Distributers certainly do not; for them, it is an attractive selling point.

That increase has enormous clinical significance. As a general matter, “[s]mall changes in a drug product or substance can result in large changes of performance.”REF The same likely is true when the potency of a drug, like THC in cannabis, is increased, as several researchers have concluded.REF Today’s hyperpotent cannabis might exacerbate the effect that THC might have on people genetically predisposed to schizophrenia, as some observers have noted.REF That risk requires us to re-evaluate earlier studies on this aspect of cannabis legalization.

Variances in Labeling and Packaging. The FDCA prohibits mislabeling a drug.REF Commercially sold cannabis is subject to inaccuracies and inconsistencies in how dispensaries label their wares.REF More troubling still is the manufacture of edibles to resemble candies that children commonly consume.REF (That problem is discussed further below.REF) Even if that form is not, technically speaking, a “mislabeling” of the product, its design is to attract, induce, or fool children into believing that cannabis “Gummy Bears” are ordinary candy, despite overwhelming evidence that cannabis use can seriously harm them.

Potential Harms to Particular User Populations

The Potential Harms to Adolescents.REF Law can deem someone to be an adult at age 18,REF but law cannot govern biology. Starting before birth, the brain matures into a person’s mid-20s as it prunes existing neural pathways and creates new ones.REF In fact, the prefrontal lobe region, the area responsible for reasoning, judgment, decision-making, and other higher mental functions, is the last region to undergo neuromaturational development.REF Use of disabling substances like cannabis can have an adverse long-term impact on the labile brain.REF We have been aware of that risk for some time, as well as the adverse psychosocial outcomes that can follow impaired neural development.REF

Recently, however, a host of researchers has concluded that early onset and long-term regular cannabis use, or heavy use of high-potency cannabis, enhances the risk of resulting schizophrenia more than we once thought. According to those reports, either practice could damage the juvenile brain in ways that would not happen to adults and lead either to long-term psychosocial problems or render those users more susceptible than never- or experimental-users to the potential that cannabis has to accelerate the onset of schizophrenia.REF For all those reasons, it is no surprise that government agencies like the FDA and NIDA, and numerous respected private organizations, including the American Academy of Pediatrics, agree that juveniles should not use cannabis.REF

Not only cannabis’ ingredients but also its delivery system can prove troublesome for minors where it might not for adults. Consider edibles—cannabis-infused food products or drinks often packaged to resemble ordinary items, such as brownies, chocolates, cookies, candies, lozenges, and sodas.REF Some edibles have been labeled as “Pot Tarts,” “Buddahfinger,” “Munchy Way,” or Keef Kat,” while others resemble “Gummy Bears.”REF The labeling can confuse children. Plus, two features of edibles make them particularly attractive: They can be infused with sugar, which makes them desirable for juveniles with a sweet tooth, and their consumption does not generate the tell-tale aroma of burnt cannabis, thereby enabling users to lower their risk of detection and arrest.REF Finally, the risk of cannabis abuse by minors is also troublesome with respect to “vaping”—i.e., use of an Electronic Nicotine Delivery System devices (ENDS, also known as e-cigarettes or “vapes”). The devices aerosolize a solution held in a cartridge to enable users to limit damage from smoking by inhaling addictive nicotine without the carcinogenic tars. ENDSs can aerosolize a high-potency liquid THC- and nicotine-filled cartridge, thereby giving juveniles a two-fer: receipt of both drugs without the characteristic odor of burnt carbon. Not surprisingly, cannabis vaping is becoming common among minors.REF

The Potential Harms to Unborn or Nursing Children.REF Children and adolescents are not the only youngsters that might be adversely affected by cannabis use. Use of cannabis by pregnant women is on the rise. THC crosses the placenta,REF so children in utero and nursing unwillingly consume it.REF There is no conclusive proof that maternal cannabis use during pregnancy or nursing will or will not harm a child within or outside the womb.REF Some studies found a serious risk that THC might damage its involuntary recipient, for example, by impairing a child’s “higher-order executive functioning” during the “school-age years.”REF Other studies have found no material association between in utero cannabis use and a host of maladies, such as fetal mortality and malformation.REF The evidence therefore points both ways.REF

That uncertainty, however, does not end the inquiry; it raises the question of how we should proceed in the face of uncertainty. As noted by the U.S. Substance Abuse and Mental Health Services Agency, “[n]o amount of marijuana has been proven safe to use during pregnancy or while breastfeeding,”REF let alone the hyper-potent cannabis now available.REF The question is how we should proceed in the face of uncertain risks. At a minimum, the FDA should require warning labels specifically focused on the risks to pregnant and nursing women.REF Other options are available, too, such as making it a crime to distribute cannabis to a woman in either category.REF

The Potential Harms to Non-User Third Parties

Cannabis-Impaired Driving.REF Any discussion of the potential harms of cannabis to third parties should begin with the risk that cannabis users will drive under its influence, crash their vehicles, and maim or kill innocent passengers, pedestrians, or other drivers. Drug-impaired driving has not yet received the attention it deserves, let alone what we devote to alcohol-impaired driving.REF But all that it might take is the fatality of a well-known party (e.g., a professional athlete) or highly positioned victim (e.g., family member of a Senator) to generate intense scrutiny of this issue.REF Were that (unfortunately) to occur, a powerful case can be made that drug-impaired driving is as serious a public policy problem as alcohol-impaired driving. Indeed, in the Obama Administration, Office of National Drug Control Policy Director Gil Kerlikowski made that finding in 2010.REF

THC clearly impedes safe driving,REF even though some users mistakenly believe that it does not erode (or even enhances) their skills.REF That risk is not a trivial one.REF There is an increasing number of people who drive after cannabis use;REF the effect of cannabis on one’s driving skills does not necessarily dissipate quickly;REF and the danger is greatly increased if someone consumes a cannabis-alcohol cocktail (a not-infrequent occurrence),REF because each drug augments the impairing effect of the other one.REF

To be sure, the FDA would not deny approval to a drug simply because someone might illegally drive under its influence; opioids and benzodiazepines also have a disabling effect, but they can be lawfully prescribed. But the agency might demand that any business that packages or sells cannabis must note in the label and directions for use that no one should drive within a few hours of consuming cannabis, and that cannabis-impaired driving is illegal in every state.REF The FDA also could recommend that no one drive after consuming cannabis for at least a certain number of hours.REF Finally, the FDA could recommend that Congress invoke its Article I Spending Clause or Commerce Clause authority to adopt one or more measures to address it.REF

Cannabis-Induced Violence. We have known for some time that alcohol is perhaps the drug most commonly used by people who commit crimes.REF There is a considerable body of expert authority for the alcohol–crime nexus. Indeed, it would be reasonable to treat alcohol as a “criminogenic” drug—namely, a drug that leads to lawbreaking and violence by drowning judgment while someone is inebriated. At a minimum, alcohol can catalyze a person’s inherent violent tendencies.REF One psychiatrist colorfully described that phenomenon by saying that “[t]he conscience” is “that part of the mind which is soluble in alcohol.”REF

Does cannabis have the same criminogenic effect? Or do its users instead become passive and laid back, people who laugh, eat, and say “dude” a lot? The now-campy 1936 film Reefer Madness depicted cannabis use as being even more violence-inducing than alcohol. It portrayed cannabis-using adults as uncontrollably sex-crazed, homicidal maniacs. That over-the-top depiction of cannabis use allowed the drug’s advocates to lampoon their critics as being silly, out-of-touch, uncool ninnies. That has been an effective strategy for decades.

Here’s an example of that strategy in practice. In 2019, Alex Berenson, a former New York Times journalist, published a book entitled Tell Your Children (the original title of the film Reefer Madness) and subtitled The Truth About Marijuana, Mental Illness, and Violence, that addressed the troubling relationship between those three subjects. Along with a host of other information, Berenson reviewed five published studies between 2010 and 2018 on the issue. As he explained, skeptics were wrong to believe that cannabis use and psychosis were both attributable to an underlying genetic disorder.REF The “genes linked to schizophrenia” might “generally contribute to risky behaviors such as drug use,” but those genes “did not cause marijuana smoking.”REF At the same time, “[t]he reverse was also true.” That is, “[c]annabis raised the risk of schizophrenia both in people who already had higher than usual genetic odds of developing the disease”—the siblings of schizophrenics are the classic example—“and those at normal risk.”REF

The response to his book, by and large, was scathing, if not condemnatory.REF Critics said that Berenson posited that anyone who experiments with cannabis will immediately and permanently become a Mr. Hyde– or Hannibal Lecter–like homicidal maniac (which Berenson disavowed saying). Reviewers largely derided his cautionary description of a serious drug policy-criminal justice problem as if he had done precisely what he eschewed doing.

That approach does not represent the views of scientific professionals today. Recent studies have concluded that there is a need to reconsider the relationship between cannabis use or abuse and violence, whether toward third-party strangers or intimate partners. The relationship between the two is uncertain. Several studies, many published only in the past decade, have disagreed over the issue whether there is even an association (not a cause-effect relationship) between cannabis use and violence. There also appears to be a widespread agreement, however, that the subject needs further investigation.REF When that is done, Berenson’s critics ultimately might be able to say “I told you so”—or they might owe him an apology. Only time will tell.

Cannabis Has Not Been Proven to Be “Effective”

Is cannabis an effective treatment for some diseases or injuries? An argument in favor of legalizing medical-use cannabis is that it, or certain cannabinoids, treat the sequalae of various diseases, particularly non-cancer or neuropathic pain. There is a considerable body of literature making that claim.REF A goodly number of physicians have published books or articles endorsing that position.REF And a considerable number of individuals attest to its beneficial effects.REF

Even when considered as an analgesic, however, let alone as a treatment for disease, cannabis is not an “effective” drug simply because a large number of people would describe its euphoric feeling as “Awesome!” Rigorous scientific proof is essential. To establish a drug’s effectiveness, a drug’s sponsor must offer “substantial evidence” of the drug’s efficacy at treating the cause or sequalae of a certain disease or injury, which must be in the form of “adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved.”REF Neighborhood “budtenders” do not qualify.

The people who do—the experts at the federal agencies devoted to public health—have consistently found that raw cannabis is not an effective medical treatment. The FDA,REF the Office of the U.S. Surgeon General,REF the National Institute on Drug Abuse,REF the Substance Abuse and Mental Health Services Administration,REF and the Department of Health and Human Services (HHS)REF—those agencies have consistently found that botanical cannabis has not been proven to be a safe and effective drug. Even the Biden Administration reiterated that conclusion in a letter it sent to Congress in April 2022.REF

In a 2017 report entitled The Health Effects of Cannabis and Cannabinoids, the National Academy found that, among other things, there is substantial evidence that cannabis can alleviate chronic pain (pain lasting beyond three months) of moderate severity.REF (Aside from the general limitations of smokable cannabis as a medicine and studies about its potential analgesic effect,REF cannabis is insufficiently potent to substitute for opioids as the analgesic of choice for acute or severe pain stemming from motor vehicle crashes, surgery, gunshot wounds, terminal cancer, or other causes.REF) There are, however, multiple problems with treating raw cannabis as an analgesic for chronic moderate pain.REF Plus, several post-2017 studies and reports challenge the National Academy’s belief that raw cannabis is an effective treatment for people who suffer from chronic pain.REF Finally, the National Academy did not distinguish the analgesic effect of cannabis from that of alcohol, and the latter, as noted above, is not a legitimate therapeutic drug.REF

Cannabis Is Not a Uniformly Made Product

Proof that a drug is safe for use and effective at treating a disease or its symptoms or sequalae is not all that a pharmaceutical company must establish. A sponsor must also establish that the drug is pure to enable physicians to prescribe medications with confidence that their patients will receive the same therapeutical benefits from every pill or injectable solution in every batch. To prove that its drug is pure and uniform, a sponsor must establish that it follows good manufacturing practices.REF Here, again, raw cannabis falls short.REF

The Varying Features of Raw Cannabis. Commercially manufactured prescription and over-the-counter medicines contain “pure and stable” chemicals, which enables the FDA and physicians to know “precisely what their patients are taking.”REF Batch testing ensures that the amoxicillin, amantadine, amphotericin, and azacytidine manufactured today are the same as the ones produced yesterday and will be synthesized tomorrow. “The quality, safety, and efficacy of starting materials are basic prerequisites in the pharmaceutical industry,”REF and “[t]he pharmaceutical industry requires consistency in the active ingredients of source material.”REF Consistency is not just a virtue; it is a legal requirement.

One that cannabis cannot meet. As two experts have noted:

Though some herbal remedies do appear to be safe and effective, the opposite is closer to the truth. Cannabis is a good example. The number of parameters on which cannabis can vary is enormous from strain, growing conditions, harvesting methods and handling to storage and processing of the raw material to combining them with a wide variety of foods and other excipients in manufacturing to methods of administration (eating, smoking, “vaping,” applying to mucous membranes). At every step, from planting through consumption, myriad influences can alter dose, absorption rate, interactions among constituents, exposure to toxins, and a host of other factors that can result in underdosing, overdosing and various types and levels of acute and chronic poisoning, not excepting an increase in the probability of lung cancer.REF

Variance in Content. To start with, unlike the series of drugs noted above, which are produced by reputable pharmaceutical companies, cannabis, like other botanicals, is not a “standardized good.” That is, cannabis is not a single chemical compound or a product with precise and uniform ingredients, formulations, and potency in every batch.REF In fact, “[t]he number of species in the Cannabis genus has long been controversial.”REF Some believe that there is but one, highly polymorphic species (called Cannabis sativa L.); some believe that there are three species (Cannabis sativa L., Cannabis indicia, and Cannabis ruderalis), with the first two of primary interest; while others see cannabis as polytypic (having many species and subspecies).REF Moreover, due to selective breeding—initially done to increase fiber content for use as hemp, but now done to increase THC content for a bigger “kick”—cannabis comes in “hundreds of strains” with different chemical compositions.REF

Even within each species, seeds differ between and among wild and cultivated versions of the plant.REF Because of factors like “genetics, environment, growth conditions, and harvesting stage,”REF the cannabis plant itself is “a chemically complex and highly variable” productREF—said more colorfully, “a complex chemical slush”REF—containing hundreds of different chemicals.REF The variety is “enormous.”REF Because of selective breeding and cross-breeding, there are hundreds of strains of cannabis, with different chemical compositions. The chemical composition of a cannabis plant can vary along a host of parameters: strain, growing conditions, harvesting methods, handling, storage, and processing of the raw material; its use in a wide variety of foods or liquids; the addition of different excipients via nonpsychoactive components of, for example, a brownie; manufacturing process; and method of administration (ingestion, inhalation, application to mucous membranes, or “vaping”).REF The amount of different macronutrients (carbohydrates, fats, and proteins) matters.REF The stress on a plant also can affect its content. “[A]ny kind of stress tends to increase product potency somewhat, though usually at the cost of decreasing the total yield.”REF

Moreover, a cannabis plant from a particular strain still is not a single chemical compound or a product with precise and uniform ingredients, formulations, and potency. The chemical composition of a cannabis product sold at a dispensary can vary along a host of parameters, such as breeding, region, cultivation conditions, harvesting stage, storage time, and the like.REF That difference can matter to patients. As two pro-cannabis physicians have noted, “the cannabinoid production varies from plant to plant, and ten drops of one batch might be therapeutic, but ten drops of the next batch might have a much higher content of THC and sicken the patient.”REF The lack of certainty and uniformity in the chemical make-up of different varieties of cannabis is a critical shortcoming under the standards demanded by contemporary medicine and law because neither the FDA nor a treating physician could know precisely what substances a patient would use.REF

The ways in which individuals use cannabis also vary. Cannabis and its products are sold as the botanical flower (and its components), hash, hash oil, ointments, and edibles, whether solid (e.g., brownies or “Gummy Bear” look-alikes) or liquid (e.g., soft drinks or sauces). Those forms vary in their composition and potency.REF THC exists in assorted formulations for different methods of use: inhalation, ingestion, sublingual, intranasal, transdermal, and sublingual or rectal transference.REF Those differences matter.REF For example, THC reaches the brain far more quickly (and in a greater quantity) when a user inhales it rather than ingests or absorbs it, which explains why many users prefer to smoke a doobie rather than consume THC as a pill, in food, or in another manner.REF “Dabbing”—heating a cannabis extract and inhaling the fumes—also generates effects perceived as stronger and longer lasting than smoking.REF Moreover, many users titrate the amount inhaled to achieve their desired state of euphoria.REF

Accordingly, there is no standard number of occasions when someone will smoke marijuana, no standard number of total inhalations, and no standard depth or length of any one inhalation. The foregoing likely explains why major medical entities—such as the American Medical Association, the U.S. National Institutes of Health, and the Royal College of Physicians—recommend research into non-smoking cannabis delivery systems and why the FDA has never approved any drug in a smokable form.REF

Variance in THC Potency. There is considerable variation in the psychoactive component of cannabis—delta9-tetrahydrocannabinol, or THC.REF A variety of factors affects the THC content of a particular batch of cannabis, such as interplant differences, the part of a particular plant used (flowers contain more THC than stems), the environment in which cannabis is grown, the plant’s age, the season of the year, and so forth.REF Potency has increased markedly over the past decades due to considerations such as the strain, region, cultivation processes, processing stage, storage time, and other considerations.REF The THC component of cannabis has increased remarkably over time as growers have sought to enhance their profits by creating a better, more attractive, psychotropic product. Cannabis had a THC content of no more than 3 percent to 4 percent from the 1960s through the 1980s. Today, the THC content can be 12 percent to 20 percent in the plant form or in hashish (dried cannabis resin and crushed plants). As one report concluded, “Due to the wide range of approaches to cannabis resin production (including the cannabis plant material used and the method of extraction), THC concentrations can vary widely, from <1% to 30%.”REF Hash oil, an oil-based extract of hashish, has a greater THC content, in the range of 15 percent to 65 percent, while other extracts can have a 90-plus percent THC content.REF The range of THC in cannabis products makes it difficult for a physician to know exactly how much of that compound will reach a patient.REF

Those differences are important. As Dr. Volkow has noted, “increase in THC content raises concerns that the consequences of marijuana use may be worse now than in the past.”REF If “[t]he average person will get quite stoned on marijuana containing 1.1% THC,”REF use of 90-plus percent THC might have a logarithmically greater effect on a user, particularly one who is inexperienced or does not limit his or her intake.REF That is why Dr. Volkow has questioned “the current relevance” of findings in now-dated studies on cannabis’ effects, especially ones that assessed long-term outcomes.REF

In addition, higher-content THC cannabis might adversely affect some people, but not others. As this author has written before:

The potential toxicity of a drug is an essential feature of the early stages of a drug trial because no drug can be deemed safe if the minimum lethal dose and the potential adverse long-term effects are unknown. Concern with toxicity remains a critical issue throughout the remaining phases of a pharmaceutical trial. A drug that materially reduces the size of tumors is not safe if it is toxic to the liver and kidneys. A drug that provides short-term relief from respiratory distress is not safe if it causes long-term heart failure in everyone who uses it. Yes, there are tradeoffs involved in treatment. Some patients suffering from a fatal, incurable disease might be willing to sacrifice the quality of their remaining days for a larger number of them (or vice versa). But a physician cannot responsibly offer a patient a legitimate choice if there are no known data indicating what the short-term and long-term effects of a potent drug might be. As for cannabis sold for recreational use, where no physician is involved and the only advice comes from a financially self-interested “ganjapreneur” or “budtender,” the consumer cannot expect to receive a neutral, disinterested product analysis or recommendation for use.REF

Moreover, the psychoactive effect of THC varies according to an individual’s “set” (user expectation) and the “setting” (environment) in which the use occurs.REF Given their variance from person to person and occasion to occasion, a physician could not be confident when predicting the effect of THC use on an individual patient. The result is that neither the FDA nor a recommending physician would know the potency of the cannabis that a patient would use or the setting in which use would take place, leaving the agency and treating physician in the dark about its use.

Variance in CBD Potency. Another common cannabinoid besides THC is cannabidiol, or CBD. We are still learning about the potential psychodynamic properties of CBD, but what we know is encouraging. CBD has no known toxicities, and it does not appear to produce an effect that is euphoric, intoxicating, cognition-impairing, addictive, or psychosis precipitating. In fact, because CBD and THC might have possibly antagonistic pharmacological effects, CBD might serve to offset or moderate potential adverse results from using THC, such as anxiety, cognitive impairment, amotivational syndrome, dependence or addiction, and psychosis.REF Unfortunately, growers, seeking to create a product offering the ultimate “rush,” have increased the level of THC in their products and have reduced the CBD level over the past two decades, from a THC:CBD ratio of 2:1 to a ratio of 80:1 or higher.REF The result is that different stores, or even the same one, might sell cannabis with different potencies even if the THC content of all its products were the same.REF

Variances in Cultivation, Collection, and Manufacturing Practices. Good manufacturing practices are critical to ensure uniformity in any drug or drug product.REF The cannabis industry is no exception.

As Brian Thomas and Mahmoud ElSohly explained in their book The Analytical Chemistry of Cannabis, the need for good practices begins at the start of the cannabis plant life cycle. Growers should specify and rigorously control the seeds or clones used, and they should scrupulously record the conditions of their planting, growth, and harvesting in “a detailed protocol or batch production record.”REF Important for growers of cannabis for medical use is “the use of hygienic procedures to minimize microbial load,” such as bacteria or fungi.REF “Good manufacturing practices” are also “a critical activity” because “quality control” is “required to ensure the suitability of medicinal products.”REF The FDA and World Health Organization both have guidelines for good growing or manufacturing practices to be followed in the creation of herbal medicines.REF

Good laboratory testing practices are equally important because laboratories are where a traditional drug is manufactured and where a cannabis plant is turned into a product.REF The FDA also has several guidelines for what is known as “release testing,”REF the validation of pre- and post-formulation analytical testing methods to measure factors such as drug purityREF and stability;REF degradation; clarity; pH; variance in content, weight, and volume; and container-seal efficacy.REF Good cultivation and manufacturing practices, along with recommended pre- and post-formulation testing, helps to ensure that tomorrow’s product will be just as useful as yesterday’s and today’s. Every business should use them to ensure that the public receives a pure, uniform, and stable drug.REF Unfortunately, not all do.REF

* * * * *

For all the foregoing reasons, neither the FDA nor a physician can know precisely what substances will be found in a particular grower’s batch or a dispensary’s stock of cannabis; how much THC and CBD someone would receive by smoking raw cannabis; or, given the different circumstances under which it might be used, how it will affect a specific patient. The FDA therefore could not approve the plant form of cannabis as a therapeutically useful drug. In fact, the presence of toxic substances would render a drug adulterated and subject to administrative seizure by the FDA, as well as civil action or criminal prosecution by the U.S. Department of Justice for interstate distribution. And a physician could not know precisely how smoking cannabis would affect his or her patient.

Yes, the FDA has approved certain drugs produced by legitimate pharmaceutical companies from raw cannabis, and “[t]here are clearly several possible therapeutic indications for cannabis-based medicines.”REF Nonetheless, “for many of them the evidence for clinical effectiveness of the drug is still inadequate by modern standards.”REF As University of Pennsylvania Medical School Professor David Casarett succinctly put it, “A joint is hardly a medicine.”REF It has been said that ignorance is bliss, but it sure ain’t where medicine is concerned.

Going Forward

What lessons can be learned from our experience with medical-use and recreational-use cannabis? There are several.

Proposition 1. The present state of American law and policy governing the importation, cultivation, distribution, and possession of cannabis, whether for medical or recreational use, is utterly incoherent. As Dr. Peter Grinspoon accurately and colorfully put it in his 2023 book Seeing Through the Smoke, “You don’t have to be stoned to be dazed and confused by the current discord in our society around cannabis.”REF On that point, there is a consensus.

Proposition 2. Only Congress can remedy this problem. The states can revise their own drug laws to exempt whatever drugs they wish to legalize, because the Constitution does not require states to have a criminal code.REF But states cannot nullify federal law, whether it be the CSA or the FDCA, and Congress cannot order state and local law police officers to enforce federal law.REF The Supremacy Clause of Article VI makes federal law supreme as long as Congress has acted within its delegated authority,REF with the consequence that state-law defenses to the prosecution of an alleged CSA or FDCA violation have no force and effect.REF Here, too, there is no serious disagreement.

Proposition 3. Congress has not yet taken up the cross of resolving how federal law should treat cannabis. Knowing that they will make enemies however they vote, Members of Congress have pursued two paths. One is to pray (to keep my metaphors straight) that “this cup [will] pass from me,”REF perhaps by hoping one or more federal agencies will resolve the issue. Last year, President Joe Biden, a fervent believer in the Progressive theory of the superiority of expert administrative agency governance rather than congressional lawmaking, nudged two agencies down that path. In October 2022, he directed HHS Secretary Xavier Becerra and U.S. Attorney General Merrick Garland to reconsider the scheduling of cannabis.REF The Attorney General possesses that authority under the CSA,REF in consultation with the HHS Secretary, but none of Garland’s predecessors has invoked it to reschedule cannabis. What he and Becerra will decide to do remains to be seen.

Proposition 4. The states’ legalization of medical-use and recreational-use cannabis without examining or reexamining the potential harms from high-potency forms of that drug should be seen as the scandal that it is. In the rush to obtain a new source of revenue and to satisfy a vocal constituency clamoring for a substance that has (at best) only the same painkilling properties as bourbon, the states have chosen to disregard the 80-plus-year judgment that American society has made to forbid large-scale commercialization of a potentially dangerous drug until after it has been proved safe and effective by its sponsors. Maybe a few of those legislators thought that they were offering a respite from pain or other consequences of the maladies that the aged and ill can suffer. Nevertheless, even if “[c]aring without science is well intentioned kindness,” it is “not medicine.”REF This author has previously written that the claim, made both by cannabis’ sellers and physicians, that smoking a joint can cure what ails you “falls along the spectrum somewhere between risible and fraudulent.”REF

Medical marijuana is a sham that we have been selling to minors over the last twenty-five years. It is bad enough for adults to lie to serve their own venal purposes. It is worse for adults to teach their children by example that lying is an appropriate way to get what one wants. It is worst of all to incorporate those lies into our law. Yet, that is what we have done throughout the period of state medical marijuana schemes. (Yes, I used the word “scheme” intentionally, with all of the nefarious connotations that it implies). Minors have grown up believing that smoking marijuana is not harmful for two reasons. One explanation is simple: they have parents, relatives, siblings, or friends who smoked marijuana and did not die. Even presidential candidates have used marijuana and not only lived to tell the tale but also won election (and re-election). The other reason is more complicated, but unfortunately, more pernicious. Minors know that the states allow it to be sold, that the federal government has two agencies—the FDA and the DEA—whose mission is to protect the public against the use of dangerous drugs, and that the federal government has not shut down state medical marijuana dispensaries on the ground that they are run by unscrupulous charlatans threatening the public health with their product. State legalization efforts have been free riding on the public’s belief that, notwithstanding the oft-repeated statements by numerous federal agencies that the federal government has not approved marijuana for any legitimate therapeutic use, the federal government would not stand idly by while millions of people use a drug that could damage their health or well-being. So, minors use marijuana, and some will wind up doing so for a lengthy period, resulting for some in serious damage to their bodies, minds, careers, and lives. Dishonesty by adults leads to poor choices by some minors, which leads to poor lives for some soon-to-be adults. That is a serious adverse consequence of empowering the states, under the flag of federalism, to make nationwide scientific decisions about the safety of particular drugs.REF

Proposition 5. If Congress decides to legalize cannabis, reliance on the expertise, judgment, and good faith of the FDA is critical. Unfortunately, much of the debate over the efficacy of medical cannabis, as well as its recreational sibling, has been biased for one side or the other. As Carnegie-Mellon University Professor Jonathan Caulkins, an expert on cannabis, wrote in 2016, “Unfortunately, there is very little in the way of intellectually honest marijuana policy analysis.”REF Congressional debates over cannabis are likely to break down into partisan yelling matches. Even the “Tastes Great! Less Filling!” squabbles during commercial breaks for professional football games would be more enlightening than what we can expect from Congress. What we need is the judgment of an impartial, unbiased, scientifically educated group devoted to protection of the public health.

That is why we need to turn to the FDA for its honest scientific judgment. For more than eight decades, this nation has trusted that agency to decide whether a particular substance is a drug and, if it is, whether, in whatever form that is offered to the public, with or without a physician’s prescription, it is safe, effective, and uniform. The states that have legalized cannabis for medical use have simply thumbed their nose at the FDCA and taken the law into their own hands without even nodding towards the principle that only drugs with those characteristics should be sold to the public. Were Congress or Attorney General Garland to reclassify cannabis out of Schedule I so that a physician can legally prescribe it, the CSA would no longer forbid its distribution under all circumstances. The FDCA would remain in play, however, because Congress entrusted the FDA Commissioner, not the attorney general, with the responsibility to review new drugs for their safety, efficacy, and uniformity.REF

Proposition 6. Ultimately, the issue should not be seen as whether there is scientific proof that cannabis use causes the harms discussed above, such as physical dependance or addiction, adverse psychosocial effects in minors, an increase in maimings and deaths caused by drug-impaired driving, and so forth. Instead, the issue should be whether the risk of adverse effects of legalizing cannabis use justifies approving its use as a safe, effective, and uniform medication.

For 80-plus years, the burden of proof on those issues has rested with a drug sponsor; it must satisfy the FDA that its drug can be approved. At present, the potential harms that smoking raw cannabis poses for various populations have not been shown to be insufficient to permit its approval. Nor has it been shown to potentially save lives despite its adverse effects, as would be the question in the case of drugs used for cancer chemotherapy. The question is how much risk American society is willing to accept in this regard, not whether there is some potential benefit and no downside. As several scholars have explained:

The shift and change in the legal and illegal cannabis market, particularly in relation to high potency cannabis and its potential risks, have not been reflected in the public discourse around the harms of cannabis. From a research perspective, the epidemiological, experimental, and genetic evidence has resulted in a clear shift in the argument from ‘whether there is a causal relationship between cannabis and psychosis’ to the magnitude of the relationship. The potential harms of high potency cannabis use, especially during development and particularly in those with a family history of psychosis, need to be clearly explained to the public to address the imbalance in the narrative that cannabis is a harmless drug. The decisions about what to do with that information is then for both the public and policymakers to consider.”REF

Proposition 7. On a subject where we most need the dispassionate, science-based judgment of FDA officials, there is a serious question whether the FDA would be allowed to offer a purely medical and scientific judgment on the safety, efficacy, and uniformity of cannabis, rather than be told what to find by senior political appointees or even the President. A drug’s proponents bear the burden of proving safety, effectiveness, and uniformity, and in many instances much of the relevant science is unknown or what is known is inconclusive.REF To date, what we know demonstrates that the FDA could not approve smoking cannabis as a treatment for any medical condition.

Ordinarily, that would end the discussion. At one time, Presidents did not distort or coopt science for their own partisan political purposes, and scientists did not play partisan politics for their own personal advancement. Sadly, that day is now in the rearview mirror. Politics has infected medicine, science, and law. A recent series of Supreme Court decisionsREF makes it clear that the Biden Administration has no respect for rules of law that it does not like, particularly when those rules keep the President from satisfying his base or establishing his legacy. To achieve those ends, the Administration is not reluctant to claim that science supports its actions, regardless of what the science might actually be.REF Fiat politica, ruat caelum.REF

We can hope that career FDA officials would not give in to politics, but there is no certainty of that. Even if they do, however, theirs is not the last word on this subject, and recent evidence strongly suggests that theirs will not be the last word unless it is what the Biden Administration wants to hear.REF Xavier Becerra, Secretary of Health and Human Services, has authority over the FDA Commissioner, and he, a lawyer and former Member of Congress, is neither a physician nor a scientist. Plus, President Joe Biden has the final say, and he, too, has no scientific education, training, or experience. Leaving science-based judgments in the hands of politicians trolling for votes is not a promising way to proceed.


The possibility that cannabinoids might serve as a legitimate therapeutic treatment for the ill or injured justifies research into their potentially therapeutic value. But the raw, agricultural form of cannabis is not capable of being approved for use by the FDA, regardless of whether Congress or the U.S. Attorney General reschedules it downward from Schedule I. Rescheduling cannabis out of Schedule I would not allow the drug to be distributed under federal law unless the FDA finds that it is a safe, effective, and uniform drug.

As explained above, the FDA could not do so under existing law, for a host of reasons that make eminent public health sense, and the Attorney General cannot waive the FDCA’s requirements. Congress could do so by statute, but any such law would put at risk the health of users and nonusers. Whether society embraces or rejects the Millsian dislike of state-made paternalistic judgments ostensibly done for the betterment of individuals, there is no good reason to abandon the approach that the nation adopted 80-plus years ago when the FDCA became law or to force on unwilling third parties the risk of injury or death to satisfy the desires of a minority for a transient high.

Paul J. Larkin is the John, Barbara, and Victoria Rumpel Senior Legal Research Fellow in the Edwin J. Meese III Center for Legal and Judicial Studies at The Heritage Foundation. The author would like to thank Abby Carr, John J. Coleman, Robert L. DuPont, John G. Malcolm, Luke Niforatos, Charles D. Stimson, and Deborah Williams for valuable comments on an earlier draft of this Special Report. Abby Carr also provided invaluable research assistance. Marla Hess and Jessica Lowther provided invaluable editing assistance.


Paul Larkin
Paul Larkin

Rumpel Senior Legal Research Fellow