CBD: The Legality & Regulation of the “Other” Cannabis Ingredient

By Abby Dockum.

Over the past several years, products containing cannabidiol—better known as CBD—have spread across the shelves of grocery stores and pharmacies. Sales of CBD products are expected to surpass $5 billion dollars in 2019, up 700% from 2018. This may be attributed in part to increased research on the health benefits of CBD, but it is more likely due to changes in CBD’s legal status.

What is CBD?

CBD, like tetrahydrocannabinol (THC), is an active ingredient of cannabis. Unlike THC, however, CBD has no psychoactive effect, meaning it does not cause a “high.” CBD is not addictive, and the World Health Organization reported that there is no evidence that CBD poses any public health risk.

While scientists are still working to determine the health benefits of CBD, there is strong evidence that it is effective in managing certain types of epilepsy, particularly among children. In addition, some studies suggest CBD may be useful in treating conditions including anxiety, insomnia, chronic pain, inflammation, and nausea.

CBD is available in many forms. It can be consumed orally in oils, capsules, drinks, and foods including chocolate or hard candies. It may be infused in cosmetic products like lotions, balms, and soaps. CBD can also be inhaled by vaping.

What is the legal status of CBD?

To understand the legality of CBD, one must first understand the law surrounding cannabis, from which CBD is derived. For legal purposes, cannabis can be divided into two types: hemp and marijuana. Under both federal and Arizona law, hemp is defined as a cannabis plant with a THC concentration of less than 0.3%, while marijuana contains at least 0.3% THC.

Before 2018, cannabis of both types was a prohibited Schedule I drug under the federal Controlled Substances Act. It was also illegal under state law with the exception of medical cannabis.

In 2018, Arizona legalized the possession, use, sale, and manufacture of hemp. Shortly thereafter, the federal government passed the 2018 Farm Bill, amending the Controlled Substances Act to exempt hemp from its list of prohibited drugs. By decriminalizing hemp, the state and federal governments also decriminalized the CBD derived from it, but CBD derived from marijuana plants remains illegal.

Even though CBD is now legal under statutory law, it is still subject to regulation by the Food and Drug Administration (FDA). In general, the FDA classifies CBD as a drug, meaning products containing CBD must be approved by the agency in order to be legally sold. Thus far, the FDA has approved only one CBD drug, an oral solution used to treat seizures. In addition, the FDA has left open the possibility that cosmetic products containing CBD may be free from regulation depending on their marketing. Otherwise, the sale of products containing CBD is generally prohibited by FDA regulations.

However, the FDA’s only enforcement mechanism has been sending warning letters to a handful of companies selling unapproved CBD products. Moreover, the FDA’s regulations apply only to those who sell CBD products, not to those who possess, buy, or use them.

What is the future of CBD policy?

The FDA is working with researchers who are conducting clinical studies on CBD products and could approve more products to be sold legally. However, that process could take years. Instead, in July, the FDA announced a public hearing and requested comments on CBD products, suggesting the initiation of a rulemaking process to create a more permissive and comprehensive CBD regulatory scheme.

Lawmakers have expressed support for this approach. In September, a group of senators wrote to the Acting Commissioner of the FDA urging the agency to act quickly in creating a regulatory framework for CBD. Senate Minority Leader Chuck Schumer issued a press release in October doing the same.

As it stands, CBD manufacturers have minimal concern about legal repercussions for selling unapproved products, but a comprehensive regulatory scheme is necessary is to protect consumers. Since the FDA currently treats almost all CBD product sales as prohibited but with minimal enforcement, there is no oversight of a $5 billion industry, leaving consumers vulnerable to mislabeling, false advertising, and other harmful practices. CBD is not going anywhere, so the FDA should take a more active role in its regulation.