Is CBD Legal?

The verdict is in: Cannabis regulation is a lot more complicated than marijuana.

On June 25, 2018, the U.S. Food and Drug Administration (FDA) announced its first-ever support of a marijuana-derived pharmaceutical drug. Epidiolex (cannabidiol or CBD) passed to treat two rare pediatric seizure ailments, Lennox-Gastaut syndrome and Dravet syndrome. On September 27, 2018, the Drug Enforcement Administration (DEA) announced its scheduling of Epidiolex – and future drug products containing CBD derived from marijuana with no more than 0.1 percent tetrahydrocannabinol – in Schedule V of the Controlled Substances Act (CSA). These results represent historical milestones in the journey of cannabis from the origin of textiles and medicines in the early nineteenth century to an illicit drug and now an FDA-approved drug.

Cannabidiol (CBD) is one of more than a hundred cannabinoids discovered in Cannabis sativa L. (Cannabis spp. or cannabis), a plant more recognized colloquially as “marijuana” or hemp. CBD was first isolated in 1940 and characterized structurally in 1963. Forecasted retail sales of CBD products -hemp, marijuana, and pharmaceutical – as high as $1.9 billion by 2020. CBD is poised to become the darling of the medical Cannabis campaign.

Convoluted Law

Despite its rapidly growing demand and practice, the regulatory status of CBD in the United States remains convoluted, even after the approval and scheduling of Epidiolex. The source of CBD is critically essential in determining its legal status. The most common source, botanically speaking, is the plant Cannabis sativa L. (Cannabis), which encompasses both marijuana and hemp. Various schema for differentiating marijuana from hemp (e.g., Genotype, phenotype, Drug-type Cannabis v. fiber-type cannabis, etc.).

Still, from a regulatory standpoint, the difference between marijuana and hemp is based on chemical composition. Specifically, to the concentration of delta-9 Tetrahydrocannabinol (THC). This is the primary intoxicating compound found in cannabis.

Hemp is a cultivar of Cannabis sativa with low concentrations of THC. Although restrictions on THC concentrations for hemp differ internationally, THC concentrations cannot exceed three-tenths of one percent (0.3%) in the United States. Hemp-derived and marijuana-derived CBD each have their novel regulatory status and consequent legal implications.

CBD From Marijuana is Still a Schedule 1 Substance

Despite the scheduling of Epidiolex, CBD from marijuana is still deemed a Schedule I controlled substance by the DEA under the 1970 Controlled Substances Act. As such, CBD from marijuana has no accepted medical use, a lack of accepted safety for use under medical supervision, and a high potential for abuse. While the scheduling of Epidiolex represents the first time that the DEA has acknowledged that marijuana has a “currently accepted medical use,” it did not change the regulatory status of CBD itself.

On May 22, 2018, the DEA issued an internal directive which stated, “Products and materials made from the Cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) do not fall under the CSA.” Although these statements clarified that CBD derived from a source other than marijuana was not a controlled substance, they did not expressly state that CBD from industrial hemp was lawful. Furthermore, these parts of the plant are not viable sources of CBD. As a result, confusion remains.

CBD also comes from some hemp cultivars. Historically, hemp was bred as an industrial crop to produce fabrics, rope, and other textiles from its long stalks. Despite not being explicitly defined or mentioned in the CSA, it is a controlled substance by the DEA since the CSA passage in 1970.

The Hemp Farming Act of 2018

On December 20, 2018, The Hemp Farming Act of 2018, S. 2667 (2018 Hemp Bill) became law and formally and definitively removed hemp from the list of controlled substances. The 2018 Hemp Bill redefines hemp as all parts of the Cannabis Sativa plant that do not exceed 0.3% delta-9 THC by dry weight, including “derivatives,” “extracts,” and “cannabinoids.” Notably, the 2018 Hemp Bill explicitly removes popular hemp products, including hemp-derived CBD, from the CSA purview.

Before the 2018 Hemp Bill passage, domestically cultivated hemp was only federally lawful when grown under a state-sanctioned pilot program. In 2017, a total of 23,343 acres of hemp grew across 19 states. As of this writing, 41 states have passed legislation to allow them to take advantage of hemp pilot programs under the 2014 Farm Bill. Today, only a minority of the hemp-derived CBD products available in the U.S. come from domestically cultivated hemp. As the 2018 Hemp Bill fosters more significant investment in this area, this will change.

Non-Psychoactive Hemp

In addition to industrial hemp, CBD may also be lawful if it comes from “non-psychoactive hemp” imported into the United States. The Ninth Circuit Court of Appeals uses Non-psychoactive hemp in a pair of companion cases filed against the DEA by a national trade organization, the Hemp Industries Association (HIA). This case is regarding a DEA rule, which would have made it illegal to import any hemp products that contained any THC, including trace amounts. In a February 6, 2004 ruling, the Court found that the DEA had exceeded its authority in enacting the rule and struck it down as void and unenforceable.

The Court used the term “non-psychoactive hemp” and stated, “The non-psychoactive hemp used in Appellants’ products come from industrial hemp plants grown in Canada and Europe.” The flowers contain only a trace amount of the THC contained in marijuana varieties grown for psychoactive use. Confusion remains as to whether the Court, in effect, legalized the whole hemp plant for importation, including the “flowering tops,” so long as it contains no more than trace amounts of THC, or whether it simply reiterated the mature stalks exception in a different context. The Court never addressed that distinction. Cases addressing hemp, which both preceded and succeeded in this ruling, do not resolve the issue.

Despite the FDA and DEA’s confusion and stance, hemp-derived CBD products can currently be purchased online and over-the-counter (OTC) throughout most countries as if they were dietary supplements. In contrast, Qualifying patients in states with medical marijuana laws can only purchase marijuana-derived CBD products by qualifying patients in states with medical marijuana laws (30 states and the District of Columbia as of this writing) or by consumers in states with adult-use/recreational laws (9 states and the District of Columbia as of this writing).

Before Epidiolex

Before the approval of Epidiolex, the FDA explicitly stated that “CBD products do not fall under the dietary supplement definition.” They excluded CBD because of its status as an Investigational New Drug (IND) under the Food, Drug, and Cosmetic Act (FD&C Act).20 CBD is no longer an Investigational New Drug (IND). It is an approved one. As a result, CBD cannot be part of a dietary supplement.

Epidiolex

This preclusion is not entirely novel. Biostratum, a pharmaceutical company, requested the FDA take action against manufacturers of pyridoxamine-containing dietary supplements in a somewhat similar case. The reason that Biostratum submitted an IND application for pyridoxamine dihydrochloride. It took the FDA three and a half years to formally conclude that these products violated its regulations. Products containing pyridoxamine and sold as dietary supplements are not currently permitted.

There is another precedent that informs how the FDA might alter its enforcement approach in the future. In April 1997, Pharmanex, a dietary supplement manufacturer, was advised by the FDA that its mevinolin-containing dietary supplement, named Cholestin, was a drug, not a dietary supplement. Mevinolin, also known as monacolin K, is a constituent of red yeast rice and has lower elevated cholesterol levels.22 Mevinolin is chemically identical to lovastatin (brand name Mevacor), an FDA-approved drug manufactured by Merck. The FDA concluded that Cholestin contains lovastatin concentrations that exceeded traditional red yeast rice products. The product was thus more similar to a drug than any red yeast rice product available. While Cholestin is no longer available, many red yeast rice products remain on the market with naturally occurring lovastatin concentrations.

In the Cholestin case, the FDA’s argument hinged on lovastatin concentration in red yeast rice products exceeding some traditional standards. The vast majority of hemp-derived CBD oil products available today contain concentrations by weight of CBD below 5% compared to Epidiolex, which is ≥ 99% CBD. Given this precedent, it is possible, and perhaps even likely, that the FDA will restrict products enriched with isolated CBD but not hemp extracts that contain naturally occurring concentrations of CBD.

The FDA may restrict products containing isolated CBD but not hemp extracts containing naturally occurring CBD concentrations.

With the FDA approval of Epidiolex and the FDA’s public proclamation that CBD products do not fall under the statutory definition of a dietary ingredient, the future of online and over-the-counter CBD products is uncertain. The FDA has the authority to enforce the Federal Food, Drug, and Cosmetic Act (FD&C Act) against products with CBD. It is worth noting that the FDA is a public health agency with a myriad of competing priorities and a limited enforcement budget. When considering enforcement action, the FDA weighs multiple factors, including benefits and harms. To date, injuries associated with hemp-derived CBD products have been largely undocumented.

In the absence of strict FDA enforcement and oversight, widespread mislabeling of CBD products exists. Independent research has confirmed that the CBD content in almost 70% of CBD products available online are incorrectly labeled. The FDA sent warning letters to 25 companies in 2015-16 for violations of the FDA rule. The FDA has also sent cease and desist letters to companies for making drug claims about CBD products, including claims that they treat or even cure cancer.