Currently, marijuana (cannabis) is prohibited under federal law.  Cannabis was arbitrarily placed in Schedule I of the regulatory system that was created under the Controlled Substances Act (CSA) of 1970 and has remained there for more than 4 decades despite the science that proves it never belonged there in the first place.  There are 5 levels of control under the CSA, ranging from Schedule V, the lowest level of control to Schedule I, the forbidden drugs.  As of September 2017, there are 29 states and Washington, DC that recognize cannabis as medicine, 8 states that have “legalized” adult use of cannabis, and a dozen additional states that allow restricted use of cannabis high in cannabidiol (CBD), a non-intoxicating cannabinoid.  The U.S. is left with a patchwork of varying state laws conflicting with federal law and activists pushing for some sort of reform including measures such as re-scheduling, de-scheduling and legalizing.  What do these terms mean and what would the cannabis laws and regulations look like under the various scenarios?

Pre-prohibition Cannabis:

Cannabis sativa or Cannabis indica has been growing wild for millennia and used by humans as a source of food, medicine and fiber. In early American history, some states such as Kentucky and Virginia, required farmers to grow hemp (the cannabis plant low in THC) because of its valuable fiber in making ropes or fabrics, among other uses.  The cannabis plant was also a source of medicine, and as it became more established in the U.S., several pharmaceutical companies sourced their medicine as Cannabis Americana (picture of Ely Lilly bottle label).  Up through the 1930s one could find cannabis medicines in the form of tinctures, tablets, salves and even cigarettes.

However, with the end of the alcohol prohibition, the Bureau of Narcotics and Dangerous Drugs, headed by Harry Anslinger, had lost its purpose.  Anslinger needed another target for his department and found it among the Mexicans who were smoking marijuana and the “negroes” smoking reefer.  This was cannabis by other names.  Anslinger created a “reefer madness” hysteria about a new drug menace called marijuana, despite the fact that that same plant was known as a valuable medicine.  The misinformation campaign ultimately led to the passage of the Marihuana Tax Act of 1937, which marked the beginning of the cannabis prohibition (Bonnie & Whitebread, 1974).  The subsequent tax on cannabis along with other factors led to the removal of cannabis from the U.S. Pharmacopoeia by 1942.

By the 1960s marijuana use was associated with the anti-Vietnam war protesters and via the passage of the Controlled Substances Act in 1970, President Nixon used this as a means to control African Americans and hippies.  Marijuana was initially placed in the forbidden category, with the plan to create a national commission to study the issue and make a final recommendation (National Commission on Marihuana and Drug Abuse,1972).  When the commission found that cannabis did not fit the criteria, Nixon simply ignored their findings and left it in Schedule I (Downs, 2016).

The Comprehensive Drug Abuse Prevention and Control Act (CSA) of 1970:

The impetus for the CSA was for the U.S. to create legislation in response to the global Single Convention on Narcotic Drugs, signed in New York in 1961.  The purpose of the federal CSA was to regulate the manufacture, importation, use and distribution of potential drugs of abuse according to their “abuse potential” in alliance with the international treaty entitled the Convention on Psychotropic Substances, signed in Vienna in 1971.  See the side bar for the placement of various drugs in the 5 levels.  Interestingly, alcohol and tobacco were not included in the list of controlled substances.  While the Department of Health and Human Services helps determine the abuse potential of drugs, the Drug Enforcement Administration (DEA) has the authority to add to, remove from or change the level of control of a drug within the CSA listing.  Congress, through legislation, has the authority to remove cannabis from the CSA completely.

To be placed in Schedule I, a drug must meet 3 criteria: 1) has a high potential for abuse, 2) is not safe for medical use, and 3) has no currently accepted medical use in treatment in the U.S.  Schedule II drugs are highly addictive, but have accepted medical use and are considered safe under medical guidance.  Schedule III drugs are less addictive than Schedule II, and Schedule IV drugs are less addictive than Schedule III drugs, and Schedule V drugs are less addictive than those in Schedule IV. 

The regulations for these drugs are restricted according to the placement, with the most restricted in Schedule I to the least restricted in Schedule V.  Schedule I drugs cannot be prescribed to patients.  Schedule I drugs may be studied, but that requires a special license from the DEA to do so and the supply of cannabis must come from the only federal government approved source that is grown at the University of Mississippi under the control of the National Institute of Drug Abuse (NIDA).  Schedule II drugs include the strong opioids that are locked in the “narcotics cabinet” on the hospital units or in clinics.  Prescriptions for Schedule II drugs are limited to 30 days and cannot be called in to a pharmacy – that means that a patient needs to see their practitioner at least monthly in order to continue taking a Schedule II medication.  However in 2007, the regulations were amended to allow a care provider to write three 30-day dated prescriptions, providing a 90-day supply of their medication.  Prescriptions for Schedule III and IV drugs require prescriptions that can be oral, written, or faxed and may not be filled or refilled more than 6 months after the initial date or refilled more than 5 times after the date of the prescription unless renewed by the practitioner.  Schedule V drugs can only be distributed or dispensed for medical purposes.

Is Cannabis in the Wrong Schedule?

Cannabis is an herbal plant not a drug. The cannabis plant does not meet any of the 3 criteria for placement in Schedule I and there is clear evidence that it does not belong in the controlled substances listing.  Cannabis is no more addictive than caffeine.  The cannabis plant is “one of the safest therapeutically active substances known to man,” as determined in 1988 by the DEA’s own Administrative Law Judge, in his findings in the petition to the DEA by the National Organization for the Reform of Marijuana Laws (NORML) that was initially submitted in 1972 (Young, 1988).  And finally, per the passage of multiple states passing laws that allow for the medical use of cannabis, there is “currently accepted medical use of marijuana in treatment in the U.S.”

So, should cannabis be re-scheduled to a less restrictive, legal level of control?  If not in Schedule I, which schedule would be appropriate?  When dronabinol (Marinol®) was first approved by the FDA in 1985, it was placed in Schedule II.  Dronabinol is synthetic THC in sesame oil – it is the specific constituent in the cannabis plant that causes the intoxication or high.  After years of minimal to no diversion, the DEA down-regulated dronabinol to Schedule III – the only drug in the Scheduling system that has ever been down-regulated.  One would have to question why the whole plant is in a more restrictive schedule than the pure intoxicating constituent.

A more accurate way to look at this is to acknowledge the difference between the whole plant and medicinal products made from the plant.   When products are made from the cannabis plant to be sold to patients (whole plant formulations or isolated cannabinoids), there must be regulations in place to ensure safety and quality control related to the processing, packaging, and labeling of the product.  Within the realm of medical cannabis is a wide range of products, from flowers, to tinctures and oil concentrates, to transdermal patches, to topicals, etc. and a wide range in dosage of these products.  The question here is: Do any medical cannabis products even belong in the CSA listing?

Legalize or De-Schedule?

The terms legalize and de-schedule are terms used in the discussion of cannabis law, but they are not synonymous terms.  Placing the plant cannabis in Schedule I ultimately means that our federal government has prohibited the planting of cannabis seeds, cultivating the plant, and using the plant. 

To “legalize” cannabis actually accepts the notion that our government does indeed have the right to prohibit this plant and that the government can then ultimately “allow” the legal use of it.  If one accepts the idea that the government can outlaw a plant, then it follows that the government may choose to legalize the sale and use of cannabis, but not allow anyone to grow their own.  Or the government may choose to restrict the legal use of cannabis to adults as with tobacco cigarettes and restrict the development of medicinal products to pharmaceutical companies.  The argument against “legalization” of cannabis is similar to the argument for the initial placement of cannabis in Schedule I – how does one justify the power of government to “allow” or “not allow” a person to grow a natural plant?  How can the government put our military at risk to defend our country and its freedoms and then threaten the wounded warriors if they choose to use this plant to ease their suffering?

De-scheduling would end the federal prohibition.  De-scheduling cannabis would mean that it does not belong in the CSA regulations and hopefully sends a message that our government should not have the power to prohibit a highly valuable natural plant.  Cannabis should be recognized as a healing herb, a green leafy vegetable, and/or a beautiful plant.  This live plant is non-toxic and poses no public health risk and to the contrary, it actually helps clean the air and the environment from toxins.  If de-scheduled, anyone could grow their own cannabis plants and do with them as they choose, or purchase the plant at a farmer’s market and make their own food or medicinal products.  Compare this to growing your own grapes or purchasing them and being able to make your own wine if you choose.  Fresh grapes are a food source, but they can be fermented to create an intoxicant.

Most folks are not interested in growing their own food or making their own medicine, but if cannabis were de-scheduled farmers could grow the herb under the guidelines established by the American Herbal Pharmacopoeia and a person could buy various nutraceuticals or herbal remedies from an herbalist, or in a dispensary or health food store.  Just recently Whole Foods has begun to offer packaged “Baby Hemp Leaves and Kale” in their produce department.  At the same time, pharmaceutical companies could isolate various cannabinoids and/or develop synthetic cannabinoids to create cannabinoid medicines and go through the FDA approval process to get them to market. 

Regulations for Public Safety:

The authors of this article are nurses and as such we are patient advocates and hold great concern for the health and safety of our patients and the public in general.  It is crystal clear that the current federal prohibition of cannabis causes great harm to individuals, families and communities.  Despite the fact that many states have laws that allow patients access to medical cannabis, as long as the federal prohibition continues, numerous problems remain: non-violent people will get arrested and incarcerated for growing or possessing this plant, persons may be forced to relocate simply to access this medicine, patients cannot travel out of state or country with their medicine, loss of employment due to a urine test positive for cannabis metabolites, health care providers are not educated about the medical use of cannabis, health care providers cannot write prescriptions and are hesitant to write cannabis recommendations, hospitals won’t allow patients to use it in their facilities, patients won’t openly discuss their use of it with their health care provider, and subsequently patients don’t get medical guidance with their use of cannabis by a health care provider.

While rescheduling cannabis to a less restrictive schedule would open the door to pharmaceutical research and the creation of pharmaceutical grade medicines, greed would be the driving force.  Patents will become prevalent as they insure exclusivity to the developer/investor in an effort to aid in recouping the multi millions of dollars required to receive FDA approval.  Money, lots of money, will be the driving force in these arenas.  Cost and accessibility will become a major obstacle for those most in need.  Even if states continue to allow cannabis dispensaries to provide the medicine during the interim, most states don’t allow patients to grow their own medical cannabis, so the patient would be stuck with the local dispensary and the local state “patient registration” rules that generally don’t provide confidentiality.  The problem with simply rescheduling cannabis is that the government would continue to consider the plant a drug that must be controlled. 

De-scheduling cannabis could end the prohibition of this plant and that would allow anyone to grow it.  De-scheduling will allow for a more open marketplace including big pharma, smaller pharmaceutical companies striving towards whole plant medicine in a modern medicinal form, herbalists creating medicine from long standing traditions, and backyard growers making their own concoctions.  De-scheduling will not exclude pharmaceutical companies from producing products that they believe will be superior, but putting the cannabis plant in ANY schedule will concede it to pharmaceutical control and eliminate all the other possibilities.

De-scheduling allows all uses of the plant.  As a food source one can grow it as a green leafy vegetable (baby leaves or juiced leaves and flowers) or purchase it in the produce department of a grocery store or at a farmer’s market.  As a whole plant, herbal medicine, it can be purchased over the counter with assurance that it met quality control standards.  Herbal medicines don’t need FDA approval.  Herbal medicines found on the shelves of health food stores and small herb shops must follow strict manufacturing standards for product safety as nutraceuticals.  (See side bar).  Most have the stamp of approval from independent labs that test their product for purity and potency.  Reputable nutraceutical companies seek out third party testing to assure their customers of the quality of their products.

Where Do You Stand?

Cannabis is not a new drug, it is an ancient plant that has been valued and used by humans throughout the centuries.  The “drug” marijuana has been demonized for the last eight decades in the U.S. despite the fact that its prohibition has been based on lies and exaggerations.  There is a growing acceptance by the public for access to medical cannabis and as a result, more states will be allowing patient access to cannabis either by a citizen-driven initiative or state legislation.  Federal legislators are presenting bills to effect changes in the Schedule I placement of cannabis. 

Today we have an opioid overdose epidemic resulting in 92 deaths/day and Veterans are committing suicide at the low estimate of at least 22/day.  Science and countless anecdotal reports indicate that cannabis can be an effective tool to help reduce these tragic deaths, let alone ease chronic pain for so many others.  This is not the time for nurses and other health care professionals to stay mute on the issue.  It is our ethical responsibility to advocate for our patients best interests. Rescheduling will increase cost, decrease access, and waste a lot of precious time in more rule-making.  Rescheduling will benefit a few, not the majority.  De-scheduling will open the door for all to enjoy this highly beneficial and versatile plant.  Which do you choose? 

References:

Bonnie, RJ & Whitebread, II, CH (1974). The Marihuana Conviction:  A History of the Marihuana Prohibition in the United States.  Charlottesville: University Press of Virginia.

Downs, D (April 19, 2016). The science behind the DEA’s long war on marijuana. Scientific American.  https://www.scientificamerican.com/article/the-science-behind-the-dea-s-long-war-on-marijuana/

National Commission on Marihuana and Drug Abuse; (1972). Marihuana: A Signal of Misunderstanding. Washington, DC: Government Printing Office.

Young, F. (Sept. 6, 1988). In the Matter of Marijuana Rescheduling Petition, Docket #86-22, Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge. Washington DC:U.S. Dept. of Justice, Drug Enforcement Administration.

Controlled Substances Scheduling Sample Listing

Schedule I:  Heroin, LSD, mescaline, Ecstasy, marijuana, psilocybin, methaqualone

Schedule II:  Cocaine, amphetamine, morpine, fentanyl, hydrocodone, methadone, oxycodone, phencyclidine, pentobarbital, opium

Schedule III:  Anabolic steroids, buprenorphine (Suboxone), dronabinol (Marinol), dihydrocodeine, ketamine

Schedule IV:  Benzodiazepines, chloral hydrate, phenobarbital, tramadol

Schedule V:  cough suppressants with small amounts of codeine, anti-diarrheals with small amounts of opium, some anticonvulsants, lomotil (mixed with atropine to make it unpleasant to grind up, cook and inject).

More About Nutraceuticals, Dietary Supplements, or Herbal Medicines

“FDA regulates the dietary supplements under the Dietary Supplement Health and Education Act of 1994. These do not require premarket approval and it’s the responsibility of the marketer to ensure the safety and labeling compliance of their products with the regulations. The claims need to comply with the regulatory guidelines issued by the FDA. The manufacturing of dietary supplements should be done as per the current GMP for dietary supplements.”  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678984/

Good Manufacturing Practice (GMP) specifies many requirements for quality control of starting materials, including correct identification of species of medicinal plants, special storage and special sanitation and cleaning methods for various materials. In the quality control of finished herbal medicinal products, particularly mixed herbal products, it is more difficult to determine whether all the plants or starting materials have been included.  http://apps.who.int/medicinedocs/en/d/Js7916e/2.html

The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.

Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements.

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids.

Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).  https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/default.htm

What is a nutraceutical? “It is a dietary supplement that, in a credible clinical study, is shown to have a beneficial effect.”  http://thedecrapitationsociety.com/2015/12/02/whats-the-difference-between-a-nutraceutical-and-a-dietary-supplement/

Authors: Mary Lynn Mathre, RN,  Nancy Quigley, RN, Elizabeth Dost, RN, Dawn-Marie Merrill LPN,SDC,QA,CCC

Reprinted with permission from Cannabis Nurses Magazine