William Sumner
Last week, the U.S. Food and Drug Administration (FDA) held its first public hearing on regulating cannabidiol (CBD). Over the last several years, CBD has been growing in popularity as a health and wellness product. That popularity has only been amplified by the passage of the 2018 Farm Bill, which removed hemp and hemp-derived products (CBD included) from the federal government’s list of controlled substances.
At stake in these hearings is a potentially billion-dollar market. According to Brightfield Group, the CBD market could grow to as high as $22 billion by 2022. How the FDA decides to regulate the substance will play a significant role in how high that figure grows. Currently, there are several competing ideas about how CBD should be regulated.
Some individuals want CBD to be treated as a pharmaceutical ingredient, which means that any product containing CBD would have to go through the lengthy and arduous FDA approval process. Others would rather see CBD classified as a nutritional supplement, which carries fewer regulatory requirements before hitting the market.
Many operators in both the hemp and cannabis industry would rather see the FDA create separate categories for CBD products, depending on their intended use. Products meant to treat, diagnose or cure an illness, like GW Pharmaceuticals’ epilepsy drug Epidiolex, would be treated as a pharmaceutical while food products or extracts containing CBD would be classified as a nutritional supplement.
During the hearing, FDA officials were looking for answers to three primary issue: how safe is CBD; what kind of rules should be in place to ensure product safety, quality, and consistency; and what sort of labeling requirements should govern CBD products? Listening to testimony from over 120 industry stakeholders, advocates, and medical professionals; officials heard varying responses.
While cannabis and hemp industry advocates argued for different classifications for different types of CBD products, individuals representing large biopharmaceutical companies argued tighter controls. One woman representing GW Pharmaceuticals argued that the FDA approval process was the only way to know for sure what the health effects of CBD are, arguing that her company did not know that CBD may negatively affect the liver until they conducted clinical trials.
It is also important to note that GW Pharmaceuticals is the only company with an FDA-approved CBD-based drug on the market at the moment.
While it appears that the FDA is committed to hashing out the details of how to regulate CBD, it is unlikely that the issue will be resolved soon. In a message on social media, acting FDA CIO and Principal Deputy, Dr. Amy Abernathy, emphasized that critical issues needed to be addressed before regulatory action is taken.
“Given the rapid expansion of the market, timely clarification of the path forward is critical,” Abernathy wrote, “but it’s our responsibility to ensure that the regulatory path is scientifically sound and in the interest of public health.”
An FDA appointed working group, chaired by Abernathy, is currently exploring potential regulatory pathways for CBD. Interested parties and industry stakeholders are also encouraged to provide written commentary, which can be submitted online. The deadline for written comments is July 2, 2019.
