By Dr. Trish Hurford MD, MS | Co-Chair MoCann Health Education & Training Committee
The FDA has announced that federal regulators are exploring new regulatory pathways for CBD, which could influence future healthcare coverage. This represents a significant shift from the previously cautious approach to cannabis derivatives.
Millions of Americans purchase CBD at gas stations and wellness shops, often paying $50 to $100 per bottle out of pocket. However, doctors cannot prescribe it, insurance does not cover it, and the FDA has approved only one CBD drug, Epidiolex, for rare seizure disorders. As a result, a $5 billion market has developed largely outside the medical system, with inconsistent products and limited medical oversight.
The FDA recently announced it will not regulate CBD products under current drug and supplement frameworks, as existing rules do not ensure safety. Manufacturers would need to meet FDA purity and dosing standards. Medical training would include cannabinoids, rather than relying solely on patient reports from online purchases.
This is an announcement to explore options, not a policy change. However, the message is significant. In the coming decade, successful cannabis companies will be those that can manage FDA submissions, produce reliable clinical-grade products, and collaborate with hospitals. The FDA has indicated that the current unregulated approach to CBD is shifting as the agency seeks a new regulatory framework for appropriate oversight. The opportunities for companies positioned to operate within medical, compliance-driven frameworks — rather than purely retail markets — will be best aligned with the next phase of cannabinoid innovation.
Dr. Trish Hurford | Hurford Interventional Pain & Orthopedic Rehab Clinic.