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Increased Regulation Needed as CBD Marketplace Grows
A sign reading “CBD AVAILABLE,” often highly visible and prominently located, has become an all-too-familiar sight in a growing number of areas. If one investigates further, a broad range of products will be on display: pills, drinks, salves, lotions, and even gummies. And they will be advertised to soothe the skin, relieve pain, improve wellbeing, and even improve concentration focus. Sometimes, they will even claim to mitigate or cure mental illness or substance use. But is any of this true?
The honest answer is that we simply do not know. This dilemma has fostered the development and implementation of the Collaborative for Cannabinoid Science and Safety (CCSS) by representatives from the pharmacy and food supplement industries, consumer safety groups, and related health and behavioral health academic fields.
Marijuana from the hemp plant contains CBD (technically, cannabidiol). However, CBD does not contain THC (technically, tetrahydrocannabinol), a psychoactive agent found in marijuana that produces a high. CBD is usually sold as an oil or extract, a vaporized liquid, or an oil-based capsule. Available CBD-infused products include food, drinks, and beauty aids. For most of these products, purity and concentration are unknown, despite sometimes being listed on the label.
We do know that the Food and Drug Administration (FDA) has approved CBD oil as a medicine for treatment of severe epileptic seizures in young children. The drug, Epidiolex, is used to address seizures in Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. However, because the FDA has not defined a clear, efficient path for research on CBD, or the more than 120 other cannabinoids that come from the hemp plant, other potential medical applications remain to be identified and tested in research projects.
Similarly, neither has the FDA developed a clear path for determining that other non-medical CBD products are pure, safe to use, and able to produce the effects claimed. Just last week, the FDA announced that it currently does not have the appropriate regulatory framework to address this issue, and that it is prepared to work with Congress to develop such a pathway.
“The use of CBD raises various safety concerns, especially with long-term use,” the FDA wrote in a press release. “Studies have shown the potential for harm to the liver, interactions with certain medications, and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations, such as children and those who are pregnant.”
Granted these issues, what are some of the necessary actions to develop appropriate pathways for cannabinoids, including CBD, as medicines and as food supplements or beauty aids? These actions would include the following:
A product registry for food supplements and beauty aids containing CBD. This registry would document the name and contact information of the producer, as well as specifics on the product, such as product name, formulation, degree of purity based on credible laboratory analysis, and other related research on effects.
Clear determination of the difference between a food supplement or beauty aid and a medicine. Essentially, this would involve the specification of a cutting point, i.e., dosage, or a range of concentration that determined one category versus the other. Because the FDA has not done this for CBD, some states now are using a range of cutting points for this purpose.
An improved, more efficient pathway for approval of medicines derived from cannabinoids. Because more than 120 cannabinoids have been identified, this pathway should be defined specifically for use with these medical products. Further, research in this area should be encouraged.
A mechanism for reporting adverse reactions to food supplements and beauty aids containing CBD. Like the system already in place to report adverse reactions to medications, a parallel system is needed to report adverse reactions to food supplements or beauty aids containing cannabinoids.
In the absence of such national steps to protect purity, safety, and effectiveness, persons with behavioral health conditions are at continuing risk of using CBD-enhanced products that have made false or unsubstantiated claims about mitigating or curing mental health or substance use conditions. This is particularly problematical if such products are used in lieu of behavioral health treatments that actually are evidence-based. Hence, it is essential that the FDA work quickly with Congress to address these essential reforms.
Ron Manderscheid, PhD, is the former president and CEO of NACBHDD and NARMH, as well as an adjunct professor at the Johns Hopkins Bloomberg School of Public Health and the USC School of Social Work.
The views expressed in Perspectives are solely those of the author and do not necessarily reflect the views of Addiction Professional, the Psychiatry & Behavioral Health Learning Network, or other Network authors. Perspectives entries are not medical advice.
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