Op-Ed: The Roots of CBD’s Weird FDA Status

CBD oil is a hot commodity for Colorado hemp extractors despite the lack of federal approval.
CBD oil is a hot commodity for Colorado hemp extractors despite the lack of federal approval. Scott Lentz
Just a couple of years ago, few people had ever heard of cannabidiol, or CBD. But now it's everywhere — on shelves at grocery stores and other shops, offered with smoothies and coffee, and widely available online.

By 2024, the domestic market for CBD is forecast to reach $20 billion, according to Colorado cannabis data analytics firm BDS Analytics. With sales of approximately $1.9 billion in 2018, that represents astounding growth in just a few years.

That said, CBD faces a wide range of hurdles on the regulatory and legal fronts. And it flirts with turning into a short-lived bubble. A general lack of research and science into CBD's benefits has created a Wild West of claims. People (illegally) champion CBD for everything from sleep to energy. They suggest it fights cancer, suppresses pain, alleviates anxiety and much more.

Unfortunately, few of these claims are backed up by rigorous scientific studies. At some point, consumers could grow weary of the wilderness of unfounded benefits and cures. After all, CBD can't be effective for everything.

It shouldn't be this way. The little science on CBD that does exist portends fantastic promise for human health, but thanks to the DEA failing to distinguish between psychotropic cannabinoids like THC and non-psychotropic cannabinoids like CBD and classifying all non-synthetic cannabinoids (as well as the plant Cannabis sativa L. itself) as Schedule I drugs for decades, researchers are just now beginning important research and clinical trials that should have been conducted years ago. The state cannabis legalization initiatives reignited research interest into these compounds, but thanks to the removal of hemp from Schedule I last year (THC, and the cannabis plant, remain on the list), more research finally can begin.

As a brief refresher: Congress passed the Controlled Substances Act (CSA) in 1971 at the urging of the Nixon administration. Soon thereafter, the Drug Enforcement Administration was founded and tasked with determining substances worthy of inclusion or removal from the CSA-established Schedules, along with the U.S. Food and Drug Administration. According to the DEA, the Schedules are organized by “the drug’s acceptable medical use and the drug’s abuse or dependency potential,” with perceived abuse rate as the determining factor.

As such, compounds with “no currently accepted medical use and a high potential for abuse” are classified as Schedule I substances.

But cannabis sits in Schedule I. The entire cannabis legalization movement in the United States rests on the foundation of the medical benefits of cannabis. This designation alone highlights the absurdity of Schedule I.

At the same time, states have passed laws legalizing marijuana, and the federal government has largely refrained from interfering, despite cannabis’s Schedule I designation. Unfortunately, state laws have little effect on the scant volume of scientific research into cannabis. With cannabis and THC classified as Schedule I drugs, federal money for research into them is largely unavailable. Additionally, Schedule I disincentivizes large corporations that typically invest in and conduct pharmaceutical trials from studying cannabis.

It's the very essence of catch-22: If research shows that cannabis offers medical benefits, then it could be removed from Schedule I, or even possibly completely de-scheduled. But since it is a Schedule I drug, serious scientific research into the plant is exceedingly difficult to conduct.

It is its Schedule I status that has facilitated the rise of the balkanized and inconsistent cannabinoid marketplaces.

Cannabis plants with a THC level greater than .3 percent dry weight by volume (for the purposes of this discussion, “marijuana”), natural THC and all compounds extracted from marijuana remain illegal, according to the federal government. This means that CBD and similar cannabinoids, which contain no THC, remain illegal if they were extracted from marijuana plants.
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Attorney Dave Rodman
Courtesy of Rodman Law Group
To make matters even more confusing, last year the FDA approved Epidiolex, a drug made from natural CBD extracted from the cannabis plant. The drug is used to treat seizures associated with two rare and severe forms of epilepsy: Lennox-Gastaut Syndrome and Dravet Syndrome.

Does the approval of a CBD drug suggest smooth sailing for CBD in coming months and years? What about the Hemp Farming Act of 2018, which legalized much hemp agriculture and manufacturing in the United States?

Hardly. Most hemp-derived CBD oversight now is in the hands of the FDA. The agency in May declared that cannabidiol products "are excluded from the dietary supplement definition," meaning that the FDA would not treat CBD like it does other plants, such as ginger, milk thistle and maca root, that are found in dietary supplements.

Why? Because GW Pharmaceuticals has an approved drug, Epidiolex, on the market, and CBD is the active pharmaceutical ingredient in the drug. According to statute, compounds in drugs cannot be used in dietary supplements.

So how does the FDA square this prohibition with the fact that countless CBD products are available all over the country in a great variety of establishments?

Well, it starts by holding hearings.

The agency held its first CBD hearing in May, during which I was invited to speak. The hearing was disconcerting. One powerful takeaway: We need much more education about CBD. People in the audience, presenters and even members of the panel continually said things that simply were not true. The volume of misinformation that was showcased at the hearing was worrisome, to say the least, but there was certainly some accurate information that was troubling in its own right

For example, one CBD product-testing company presented evidence demonstrating that out of 25 CBD products from the Midwest and Southeast tested, only one contained exactly what it advertised. Several contained dangerous synthetic cannabinoids, including DXM, an active ingredient in many cough medications and a powerful hallucinogen at higher dosages.

The FDA is feeling the pressure. Betsy Booren, an executive at the Grocery Manufacturers Association, said during that hearing: "As consumer interest for food, beverage, personal care and household products containing cannabis and cannabis derivatives continues to grow, the necessity for national uniform regulatory frameworks that protect public health is of critical importance." The association represents large consumer products goods companies like Coca-Cola, General Mills, the Kellogg Company and Procter & Gamble.

The hearing concluded with no clear path forward, but given the statements that have been coming out of FDA recently, it would appear that some kind of resolution is being planned. There isn’t much actionable information yet, but there are some general ideas on how FDA could proceed.

The administration could decide to treat CBD the same way it treats things like ibuprofen (over-the-counter designation), meaning that, among other things, the form of the drug will be fairly uniform, testing and standards will be rigorous and rigid, and gaining approval will be expensive. Infusing products like gummies and smoothies with CBD will probably be forbidden. Instead, CBD will come in a uniform pill.

The FDA also could draft a CBD equivalent of the Cole Memorandum, which essentially stated that the Department of Justice would not interfere with state cannabis business provided certain criteria were met, even though marijuana was illegal under federal law. In this case, the administration could let it be known that it will not interfere with hemp-derived CBD sales.

Lastly, it could opt to treat CBD like a dietary supplement, something the industry dearly wants, but this option seems unlikely.

It’s too early to tell exactly what is going to happen with CBD. It appears, however, that we are on the right side of history, and CBD and eventually cannabis soon will be treated reasonably.

Perhaps more importantly, cannabis and CBD have scrambled the government’s carefully crafted narrative regarding cannabis, which is hopefully just the opening salvo in a much broader war. The battles will inevitably move beyond cannabis and cannabinoids, and if there is to be any hope of victory, this war must address the fundamental regulatory structure of substance classification.

Schedule I is the most anti-science legislation ever drafted. Whether you advocate for sensible drug policy or are more of a Reagan-era “Just Say No” abstainer, it’s hard to argue that a substance is so dangerous that it can’t be studied at all.

A bottle of aspirin can kill an adult easily, but anyone can purchase it over the counter. Yet doctors and scientists are forbidden from even studying LSD, despite the fact that LSD has proven to be so safe that medical science has been unable to determine what’s called its “LD50,” a term the government uses to calculate the dosage that would cause 50 percent of humans taking the drug to die from an overdose. In other words, research has yet to show that a certain quantity of LSD can kill a human.

In comparison, the LD50 for aspirin is approximately 20 grams, and the LD50 for Tylenol is approximately 8 grams. The LD50 for Fentanyl is approximately 2 milligrams.

What about the Schedule I requirement that the drugs have no known medical benefit? We already reviewed the ridiculousness of Schedule I for cannabis, but what about other Schedule I drugs?

Among other things, LSD shows potential for treating alcoholism. This is not a recent discovery. Bill Wilson, the co-founder of Alcoholics Anonymous, participated in medically supervised experiments in the 1950s, and believed that “regular usage of LSD in a carefully controlled, structured setting would be beneficial for many recovering alcoholics.” The drug MDMA shows great promise as a treatment for post-traumatic stress disorder, among other things. Ibogaine appears to cure opioid dependence and eliminate withdrawal symptoms. Psilocybin has been shown to be effective for helping with trauma and easing the anxiety of patients with terminal illnesses come to terms with their fate. 2,5-Dimethoxy-4-iodoamphetamine (DOI), a psychedelic compound, is potentially the single-most-powerful anti-inflammatory yet discovered, and appears to block pulmonary inflammation, mucus hyper-production, airway hyper-responsiveness and turns off key genes in in-lung immune response. These effects block the development of allergic asthma in a mouse model.

The Schedule I classification, the arbitrary and capricious nature of what gets placed in that category, the prohibition of research into the compounds on it, the general Scheduling system as a whole — all of it amounts to historical and ongoing crimes against humanity.

There are numerous examples of substances that are classified as Schedule I drugs that have already been proven to have lifesaving or life improving effects. We believe that if Schedule I classification did not prohibit research, many more of the entries on that list could prove to be extremely valuable medicines. But as long as they remain confined on Schedule I, these medical benefits will remain either unknown or unusable.

To be clear, there are some compounds that shouldn’t be available to the public. Heroin and meth come to mind. Instead of rejecting the very idea of the government banning select drugs from public consumption, we advocate for sensible revisions to the law. Ethical studies of all scheduled substances are desperately needed.

I will say it again: The concept of Schedule I and all of its ramifications are monumentally, tragically and criminally flawed. The application of Schedule I and the CSA should be considered a crime against humanity. It is time for lawmakers to “Just say NO!” to fear and misinformation, and to embrace the betterment of their fellow man by removing substances like cannabis, LSD and MDMA from Schedule I, and to end the prohibition against regulated research and clinical trials for compounds that remain in the Schedule I category.

Dave Rodman is the founder and managing partner of The Rodman Law Group, a law firm based in Denver, that focuses on the cannabis, hemp, cannabinoid, and blockchain sectors.

Westword occasionally publishes essays and op-eds on matters of interest to metro Denver readers; find out more at [email protected]
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