Cannabidiol, commonly referred to as CBD, is one of over 100 distinct cannabinoids found in the cannabis plant. Like other cannabinoids, CBD is most prominently found in the resinous portions of the cannabis flower rather than in other parts of the plant, such as the stalk, seeds, or leaves.
First isolated in 1940, CBD is among the most studied cannabinoids – second only to THC. Preclinical studies and human trials have identified a host of therapeutic properties associated with CBD, including anti-convulsant, anti-psychotic, analgesic, and anti-diabetic effects. In safety studies involving human volunteers, short-term dosing with CBD has been shown to be safe and well-tolerated. Unlike THC, the administration of CBD is generally not considered to be mood-altering, although the cannabinoid may be anxiolytic in higher doses.
Is CBD available by prescription?
No. Because CBD is typically sources from traditional cannabis plants, federal agencies like the DEA and the FDA opine that it meets the criteria of a schedule I controlled substance and that therefore, it is illegal under federal law. By contrast, in 2018 the US Food and Drug Administration approved the prescription medication Epidiolex, which consists primarily of a standardized formulation of plant-derived CBD extracts. The schedule V medicine is explicitly approved for the treatment of two rare forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome, although a doctor may elect to prescribe it ‘off label’ for other conditions.
State laws authorizing the use of medical cannabis do permit patients with a physician’s recommendation to possess products containing plant-derived CBD, and numerous other states have enacted legislation explicitly exempting qualified patients from criminal prosecution for the possession of specific products or extracts containing CBD.
Are commercially available CBD products safe and effective?
In recent years, marketers have advertised a variety of CBD-related products online and in other venues. However, third-party analytical testing of some of these products has consistently found them to be of varying quality and safety. In some instances, products have been found to contain far lower percentages of CBD than advertised. In other instances, products alleging to be THC-free have been found to possess THC as well as other psychotropic adulterants. Further, in almost all instances, commercially available CBD products contain far lower quantities of CBD than are necessary to yield therapeutic effects in clinical trials.
Did the 2018 Farm Bill change the legal status of CBD under federal law?
Provisions of the 2018 Farm Bill amended the federal Controlled Substances Act of 1970 so that hemp plants containing no more than 0.3 percent THC are no longer classified as a schedule I controlled substance under federal law. The Act also broadens the definition of ‘hemp’ (Section 297A) to include “any part of the plant, including …. extracts [or] cannabinoids that do not possess greater than 0.3 percent THC on a dry weight basis.” This language allows for the legalization (under federal law) of some CBD-specific products, presuming they are derived from dually state/federally licensed hemp producers who are in compliance with both state and federal regulations, and are marketed in such a way that does not violate the Food, Drug and Cosmetics Act. (By contrast, there exists less legal clarity regarding the legality of novel cannabinoid products chemically synthesized from hemp-derived CBD. The DEA currently claims that such products are beyond the scope of the Farm Bill because they “do not occur naturally in the cannabis plant and can only be obtained synthetically. However, a 2022 Ninth Circuit Court of Appeals ruling (AK Futures LLC v. Boyd Street Distro, LLC) opined that the process used to manufacture the end product was irrelevant as long as it was initially sourced from either hemp or hemp-derived CBD.)
Shortly after passage of the Farm Bill, the FDA stated: “It’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. … We’ll 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.” In a 2020 report to Congress, the agency further cautioned that CBD-infused vape products “cannot be marketed for FDA-approved drug applications.” It issued similar guidance for CBD-branded cosmetic and topical products if they are “intended to affect the structure or function of the body, or is intended for therapeutic use.” The agency also opined that regulating over-the-counter hemp-derived CBD products in a manner similar to dietary supplements could potentially disincentivize further clinical research into the compound’s development as a prescription drug.
In January 2023, after failing to take any action to regulate either hemp-derived cannabinoid products or other novel synthetic cannabinoid products, the agency announcedthat Congress, not the FDA, would ultimately need to create a new regulatory framework overseeing the commercial production and sale of hemp-derived CBD products. The FDA’s announcement is online. The agency also posted a Frequently Asked Questions page, entitled, ‘FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers.’
Is traditional hemp a viable source for CBD?
Industrial hemp is traditionally grown for its fiber content. By contrast, cannabinoids are most prominently expressed in flowers, and to a lesser extent, in leaves. While the presence of CBD has been documented in some specific hemp strains, analytical data assessing cannabinoid content in hemp plants remains limited. This absence of data has lead some experts to question the viability of traditional hemp plants as efficient sources of CBD extraction as compared to traditional cannabis plants. Most recently, an analysis by researchers at the University of Minnesota concluded that high-CBD, low-THC crops are genetically related to traditional cannabis, not traditional hemp.
Will taking CBD cause one to fail a drug test?
In clinical trials, the oral administration of CBD does not result in detectable THC blood concentrations, and most experts in the field do not believe that it shares any similarities to THC or the THC metabolite following absorption. Specifically, a 2021 clinical trial concluded that subjects consuming oral doses of 300mg of CBD showed evidence of THC bioconversion and tested negative for the presence of THC in plasma. Therefore, the administration of CBD alone should not trigger a positive drug test for the carboxy-THC metabolite.
In instances where the administration of CBD products has resulted in a positive drug test result for carboxy-THC, this result is likely because the product itself possessed trace quantities of THC. In some other cases, it is possible that this may be a result of an error in the drug test itself, though more sophisticated technology should not yield false positive results. To date, is little if any evidence to support the theory that CBD is chemically transformed by the body to carboxy-THC following metabolization.
Is CBD clinically beneficial as an antiviral agent?
Despite numerous websites and online marketers opining that CBD possesses antiviral activity in the prevention and treatment of certain illnesses, such as influenza and/or COVID-19, there exists an absence of clinical; data substantiating these claims. According to a recently published literature review on the subject, only “circumstantial evidence” exists at this time to suggest that CBD may possess antiviral activity in a limited number of conditions, specifically in the treatment of hepatitis C and Karposi sarcoma. However, this data is based solely on preclinical findings. By contrast, there exists “no evidence from properly designed clinical trials to support the use of CBD for the treatment” of these or other conditions, such as the flu, West Nile virus, Ebola, or common cold viruses. The authors of the scientific review concluded, “Claims about the benefits of using CBD on viral infections were largely supported by CBD online retailers and most often appear to be a biased interpretation of the scientific literature or a dishonest manipulation of the information for commercial purposes.”
