There are only four FDA-approved cannabis-based medicines that meet the U.S. Food & Drug Administration’s (FDA) standards for efficacy, safety, and quality. In 2018, FDA approved Epidiolex, a botanically derived cannabidiol (CBD) human drug product. Marinol (1985), Cesamet (1985), and Syndros (2016) are FDA-approved human drug products that are synthetic forms of delta-9 tetrahydrocannabinol (delta-9 THC).All other cannabis products, including those sold in state medical and recreational programs, are not reviewed or approved by the FDA. Inconsistent quality control standards in state programs as well as a paucity of robust clinical evidence on the safety and efficacy on non-FDA-approved cannabis products present challenges for physicians and their management of patients’ interest in using cannabis.

Below is a detailed explanation of the current regulatory environment with respect to cannabis in the United States that can serve as a valuable resource for physicians.

Joseph A. Schwartz, III
President, PRI

We need to talk…about cannabis.

With conflicting regulations, widespread misinformation, and a lack of high-quality clinical evidence, it is difficult for health care providers to access the tools needed to accurately inform and manage patients about cannabis.The information provided below can help you understand the science of cannabinoids, its relation to medicine, and how these current landscapes impact the medical community.

• The terms around cannabis and cannabis products are varied and confusing and depend on whether references to the terminology is colloquial, legal, commercial, or scientific.
• Cannabis is a complex plant that contains over 500 compounds – it is more than cannabidiol (CBD) or tetrahydrocannabinol (THC).
• The 2018 Farm Bill removed hemp (derivatives of cannabis with ≤ 0.3% delta-9 THC by dry weight) from the federal Controlled Substances Act (CSA) definition of marijuana (thereby descheduling those formulations and removing them from U.S. Drug Enforcement Administration jurisdiction), resulting in an explosion of hemp consumer products. However, the US Food and Drug Administration (FDA) maintains its authority over products containing cannabis and its components and cannabis formulations with > 0.3% delta-9 THC by dry weight remain schedule I controlled substances under the CSA.
• There are only 4 FDA-approved cannabis-derived or synthetic cannabinoid products that meet FDA standards for safety, efficacy, and quality. Non‒FDA-approved cannabis and cannabis-derived products are regulated under a patchwork of state regulation, evidentiary, and quality standards.
• The absence of rigorous safety and efficacy evidence supporting the therapeutic use of non-FDA-approved cannabinoid products and unreliable quality in non-FDA approved cannabis products present challenges for physicians and risks for patients.
• This ever-changing landscape has created uncertainty within the medical community regarding best practices for patients using non-FDA-approved cannabis and cannabis-derived products.
• Several medical societies released statements regarding their concerns about the lack of research supporting the use of cannabis and cannabis-derived products.

• Cannabis and cannabis-derived products are defined differently depending on speaker and content. Cannabis is the common name for the plant Cannabis sativa L.1 Under the CSA, cannabis is treated as either hemp (contains ≤ 0.3% delta-9 THC by dry weight) or marijuana (contains > 0.3% delta-9 THC by dry weight.)² Cannabis products may use marketing terms that do not have accepted scientific, legal, or regulatory definitions such as broad spectrum, hemp/hempseed oil, isolate, and medical or recreational cannabis/marijuana.^{1, 3, 4} It should be noted that medical and recreational cannabis only differ in intent of use.⁴ Recreational cannabis is sometimes called adult-use cannabis. Medical cannabis is sold to a consumer after they receive a recommendation by a health care provider who certifies that the patient suffers from a condition deemed qualifying by the laws of their state.⁵

Defining cannabis in scientific terms has also led to points of disagreement. It was once thought that cannabis had subspecies, such as “sativa” or “indica,” which indicate its potency and expected outcome (for example, uplifting or sedating).^{1, 6} Botanical science indicates that cannabis is a single species genus, Cannabis sativa L.1 It can be bred to create varying cannabinoid concentrations, but you cannot look at a plant and determine its cannabinoid content.^{1, 6} Appropriate assays are required.⁷

If you do an internet search you may find questions asking whether CBD, THC, and cannabis are the same thing. One consumer report found that nearly 4 in 10 consumers thought that CBD was another name for marijuana.⁸ In fact, CBD and THC are examples of one type of molecule found in the cannabis plant called phytocannabinoids.⁹ However, like many plants, cannabis is very complex and contains much more than just CBD and THC.¹⁰

Cannabis sativa L is a complex botanical mixture. Over 500 compounds are found in cannabis, including numerous phytocannabinoids, terpenes, and other biologically active compounds.^10-12

While phytocannabinoids are defined as being produced by cannabis, some of their active forms are not directly synthesized by the cannabis plant.⁹ For example, while CBD and THC are naturally produced in very low levels, usable quantities are formed by decarboxylation, a process where heat helps remove a carboxylic acid group from their precursor molecules cannabidiolic acid (CBDA) and tetrahydrocannabinolic acid (THCA). Over time or with additional heat, even more active and inactive metabolites may be created. Due to this instability and the number of phytocannabinoids in the cannabis plant, it can be difficult to fully distinguish an individual molecule’s role in therapeutic effects.¹¹

Phytocannabinoid instability is important because their levels and ratios can determine the physiologic effects of cannabis.^{7, 13} In one study, the amount of THC ranged from 0.3% to 20.8% due to genetic variation.¹⁴ Changes in humidity, temperature, radiation, soil nutrients, and parasites can also strongly influence cannabinoid content.¹⁵ A 2009 study showed that cannabis grown in cooler months generated a crop-yield and cannabinoid potency that were a quarter of plants grown in warmer months.¹⁶ Additional environmental impact results from soil contents as cannabis is an efficient bioaccumulator.^17-19 The cannabis plant can accumulate pesticides, heavy metals, radioactive compounds, hydrocarbons, and other chemical solvents.²⁰ Cannabis is so effective at removing contaminants that in 1986 it was used to decrease radiation levels in the soil after the Chernobyl disaster. As a result of these internal and external factors, cannabinoid content in botanical material is unpredictable. This unpredictability is compounded by the varying extraction and manufacturing methods used, which also impact the finished product cannabinoid content.⁷ These factors highlight why the lack of consistent regulation, quality control oversight, and standardized laboratory testing can impact patient safety.

• The regulation of cannabis has changed rapidly within the last 30 years.^21-26 The biggest change in federal cannabis regulation occurred when the 2018 Agricultural Improvement Act (also known as the Farm Bill) removed cannabis and its derivatives with ≤ 0.3% delta-9 THC by dry weight from the definition of marijuana and from schedule I in the Controlled Substance Ac (cannabis preparations containing > 0.3% delta-9 THC by dry weight remain schedule I controlled substances)t.^{26, 27} However, while hemp was no longer considered a controlled substance, the FDA retains authority over products containing hemp and its components under the federal Food, Drug, and Cosmetic Act (FD&C Act).^{24, 26}

It is at the state level where most of the change has taken place as individual states have enacted various laws to allow legal access to cannabis for medical use and/or recreational marijuana. In 1996, Californian voters approved Proposition 215, making it the first state to pass a medical marijuana initiative.²¹ By 2012, Colorado and Washington had legalized recreational marijuana. Utah became the first state to pass a CBD access law in 2014. By the 2020s, all but 2 states have allowed some access to cannabis or cannabis-derived products.^{21, 28}

Regardless of these state laws, it is still federally illegal to manufacture, dispense, prescribe, or possess marijuana (cannabis preparations containing > 0.3 % delta-9 THC by dry weight), which remains a schedule I substance under the federal CSA.²⁴ It is also illegal under the federal FD&C Act to sell food or supplements containing CBD or THC as both CBD and THC were studied as drugs before they were marketed as foods or supplements. As former FDA Commissioner Scott Gottlieb stated, “[FDA will] take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities.” Between 2015 – 2022, the FDA issued over 110 warning letters to producers of unregulated cannabis-derived products for unsubstantiated medical claims.²⁹ The United States Drug Enforcement Administration (DEA) also retain legal authority over marijuana under the Controlled Substances Act since it is still a Schedule I controlled substance.^{27, 30}

On January 26, 2023, the FDA announced that it believes a new regulatory pathway is needed for CBD products to be lawfully marketed in the United States, one which balances the public’s desire for access to CBD and the regulatory oversight required to manage risks.²⁵ In the statement, the FDA noted that they do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods and that they will continue to take action against cannabis-derived products in their role as protectors of public health and safety.^{31, 32}

The FDA has stated that products containing cannabis or cannabis-derived compounds will be treated the same as any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.³³ FDA has also said the agency’s drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. FDA stands ready to work with companies interested in bringing safe, effective, and quality products to market through the drug approval process.

The FDA-approval pathway ensures purity, consistency, and stability of cannabis based drugs and holds companies accountable to provide unbiased, substantial evidence of their drug’s efficacy and safety profiles. In a drug development program, multiple clinical trials provide detailed prescribing information, including dosing and safety data.^{34, 35} This process is critical as there will always be benefits and risks from a drug.³⁶ With this information, a health care provider can manage dosing and mitigate any potential risks for their patients when prescribing the drug.

Development of a medicine from the cannabis plant is complex. The same active pharmaceutical ingredient but in a different formulation or delivery method can impact the final safety and efficacy of the drug. As with any drug substance, the route of administration will affect the active ingredient pharmacokinetics.^37-39 Cannabinoids have poor solubility in water, thus various solutes are used and will change the bioavailability of the active pharmaceutical ingredient.⁴⁰ Even in the processing and packaging of a drug, issues with stability and degradation of cannabis compounds must be considered.^{40, 41}

As of July 2023, there are 4 cannabis or cannabinoid-based drugs that have been successfully approved by the FDA:

• 1 CBD product for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients 1 year and older.⁴²
• 2 synthetic delta-9-THC products for treating nausea with chemotherapy and anorexia associated with weight loss in AIDS patients.^{43, 44}
• 1 synthetic product with a similar structure to THC for treating patients with nausea associated with chemotherapy.⁴⁵

Based on the 4 FDA-approved CBD or THC drugs, CBD and THC may have the following side effects and drug-drug interactions in the conditions studied:^{46, 47}

This is a general list of possible interactions with these types of medication; it is not a complete list of all potential side effects or drug interactions.

When it comes to the FDA-approved formulations of THC, the FDA recommends a starting dose of 2.5 mg.⁴⁴ It was noted within those clinical trials that some patients experienced euphoria at this starting dose. Because these doses are regulated, health care providers will know the exact amounts of THC given to their patients. Unfortunately, this may not be applicable to non–FDA-approved cannabis and cannabis-derived products.^48-50

Non‒FDA-approved cannabis and cannabis-derived products exist under a patchwork of regulation, dependent on individual state policy to establish and enforce quality standards.²¹ All but 2 states allow access to cannabis and cannabis-derived products, yet, despite this robust access, there is a lack of consistent testing requirements.^{7, 21}

Remember that cannabis is a highly efficient bioaccumulator.^17-19 So, testing needs to be performed on cannabis-derived products to ensure they are free from things like fungal contamination, heavy metals, microbes, pesticides, and impurities.⁷ However, the lack of consistent manufacturing standards and testing can and has resulted in inconsistent and contaminated products on the market.^{29, 51-59}

Potency tests should also be performed to ensure the identity and quantity of cannabinoids match what is stated on the label.⁷ Several studies have found inaccuracies in commercial products, including hemp-derived and those for medical marijuana use, such as THC content much higher than what was on the product label.^60-62

*Cannabinoid products from 31 companies were purchased and analyzed for CBD content by high-performance liquid chromatography.

This ever-changing landscape has created uncertainty within the medical community regarding best practices for patients using cannabis and cannabis-derived products.^{8, 63, 64} There have been several studies that found that both the public and health care providers have misconceptions over how cannabis and cannabis-derived products are regulated and accessed.

Several medical societies have released statements regarding their concerns about the lack of research supporting the use of cannabis and cannabis-derived products in treating various disease states.

A statement released by the American Academy of Family Physicians, while recognizing the public support for medical marijuana and cannabinoids advocated that usage be based on high-quality, evidence-based public health, policy, and patient-centered research, including the impact on vulnerable populations.⁶⁵ The group concluded, “Utilizing an interdisciplinary, evidence-based approach to addressing both medical and recreational marijuana and cannabis use is essential to promote public health, inform policy, and provide patient-centered care.” The group also mentioned that approximately 9% of people develop a marijuana addiction, which may vary by age of first use and frequency of use. They also stated that marijuana has been linked to accelerating the trajectory of schizophrenia and psychoses, particularly in people that have pre-existing genetic indicators.

“Existing limited medical research does not support the present and proposed legislative policies across the country that promote cannabis-based products as treatment options for the majority of neurologic disorders,” said the American Academy of Neurology.⁶⁶

“Studies… show an association between cannabis use and increased rates of non-medical opioid use…,” said the American Society of Addiction Medicine.⁶⁷ The policy statement included reports of significant increases in cannabis vaping in US middle and high school students. The group also stated that cannabis use was associated with psychosis, psychiatric comorbidity, and cannabis use disorder (CUD) was associated with disability. “Evidence-informed substance use prevention and treatment interventions can avert or delay the initiation of cannabis use, stop the progression from use to harmful use or addiction, and reduce cannabis use-related negative health, social, and economic impacts…. An evidence-based approach to treatment can mitigate CUD-related harm.”

The American Academy of Pediatrics published a statement saying that the AAP “opposes “medical marijuana” outside the regulatory process of the US Food and Drug Administration.⁶⁸ . The AAP strongly supports research and development of pharmaceutical cannabinoids and supports a review of policies promoting research on the medical use of these compounds.

The American Psychiatric Association released a statement saying that they could not endorse the use of medical cannabis due to “…the lack of any credible studies demonstrating clinical effectiveness….⁶⁹There is great variability in the form, dose and potency of cannabis. Furthermore, there are numerous other compounds in products marketed as cannabidiol or cannabis with unknown health effects.”

“Although cannabis and cannabis derived products are becoming increasingly available in the United States, there is very little scientific evidence regarding their safety and effectiveness,” according to the Alzheimer’s Association.⁷⁰

In summation, while there is a clear interest in using cannabis-derived products, the evidence is not currently to the rigorous standards that we would expect from any other drug, and the agencies and associations who support the public and health care providers are concerned. While we all want to find therapies for patients with unmet needs, cannabis should not get a pass on the system of regulation that has served public health and safety for decades.

Understanding cannabis using evidence-based information will help the medical community develop solutions to mitigate harmful effects of cumulative exposure to unregulated cannabis-derived products. As more cannabis research is performed and new products develop, we must clearly differentiate between FDA-approved drugs and cannabinoid-based consumer goods Therefore, we need to encourage the development of more FDA-approved cannabinoid-based medications. Hopefully, through rigorous research, consistent testing, and FDA oversight a system could be established to ensure that cannabis and cannabis-derived products can be used safely and effectively, under medical professional oversight that will ensure appropriate dosing and mitigate any risks.

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