While cultivating hemp is now fully legal at the federal level, recent actions from the FDA may have the booming cannabidiol (CBD) product market pumping its brakes.
The U.S. Food and Drug Administration (FDA) recently published a revised Consumer Update, titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” where it clarifies the legality of marketing CBD products and airs its concerns about the hemp-derived compound’s prolonged health effects.
In the Consumer Update, the FDA emphasizes that of all the oils, lotions, food, beverages and numerous other CBD products on store shelves, only one has been approved by the FDA—Epidiolex, a prescribed oral solution used to treat two rare, severe forms of epilepsy.
The regulatory crackdown comes on the heels of the FDA issuing warning letters to 15 companies in late November for illegally selling CBD products in ways that violate the Federal Food, Drug, and Cosmetic (FD&C) Act. The companies are required to respond with plans to correct the violations within 15 working days.
In its consumer update, the FDA says it recognizes the “significant public interest” in CBD but warns of the numerous unknowns involved with using the compound in products. It adds that it is working to answer the unknowns through ongoing efforts, such as feedback from a recent FDA hearing and information through a public docket.
“As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended,” the FDA says in the Consumer Update.
With limited data available on CBD’s health effects so far, the FDA says its chief concerns include:
- CBD’s potential to harm users before they become aware of its effects.
- Noticeable side effects of CBD, which include “changes in alertness” (or drowsiness), gastrointestinal issues and changes in mood.
- The unknown aspects of CBD, which include:
- Its effect with prolonged use.
- Its effect on the developing brains of children.
- Its effects on developing fetuses or breastfed newborns.
- Its effect on others in special populations, such as the elderly, adolescents, pregnant women and pets.
- How it interacts with other herbs, botanicals and medications.
- Its effect on the male reproductive system.
Of notable concern is CBD’s potential for liver injury, which the FDA says it discovered during its review of the marketing application for Epidiolex. FDA says the risk can be managed under medical supervision, but its effects on general CBD users who aren’t monitored are unknown.
Brightfield Group, a CBD and cannabis research firm, estimates the CBD market, currently worth $5 billion, will reach $23.7 billion by 2023.
Published at Fri, 06 Dec 2019 18:05:00 +0000