A Regulatory Crossroads for CBD
On November 25, 2019, the U.S. Food and Drug Administration (FDA) issued 15 warning letters to CBD manufacturers, signaling a shift in its regulatory posture. In the same communication, the agency revealed its intention to develop a formal “pathway” for the sale and marketing of CBD products—a move that could mirror the Premarket Tobacco Product Application (PMTA) process used for vape and tobacco products.
This announcement marks a pivotal moment for the CBD industry, which has operated in a regulatory gray area since the 2018 Farm Bill legalized hemp-derived CBD.
What Is the PMTA—and Why Does It Matter for CBD?
The PMTA process, introduced to regulate e-cigarettes and vape products, requires manufacturers to submit extensive scientific data proving that their products are appropriate for public health. The cost? An estimated $1 million per product.
This framework has already reshaped the vape industry, favoring large corporations with the resources to navigate the process. For example:
- Altria, a major tobacco company, successfully cleared its IQOS device through the PMTA in April 2019.
- The same year, Altria invested $13 billion in JUUL, acquiring a 35% stake in the company.
If the FDA applies a similar model to CBD, the implications could be just as dramatic.
The Challenge for Small CBD Businesses
In regulated industries, the FDA enforces Current Good Manufacturing Practices (cGMP) under specific codes:
| Industry | cGMP Code |
|---|---|
| Pharmaceuticals | 21 CFR 211 |
| Medical Devices | 21 CFR 820 |
| Dietary Supplements | 21 CFR 111 |
| Cosmetics | 21 CFR 700 |
| Food | 21 CFR 101 |
| Beverages | 21 CFR 165 |
These standards require routine inspections, documentation, and compliance, which can be costly and complex. If CBD is subjected to similar scrutiny, small and underfunded companies may struggle to survive.
Strategic Decisions Ahead
The looming regulatory shift forces CBD companies to make a critical choice:
- Stay in the unregulated market, risking future enforcement and limited scalability
- Invest in compliance and infrastructure, preparing for a regulated future dominated by well-funded players
Either path carries risk—but only those who adapt early will be positioned to compete, especially as pharmaceutical giants eye the CBD space.
Final Thoughts: A Market in Transition
The FDA’s intention to create a PMTA-style pathway for CBD products could reshape the competitive landscape. While it may raise the barrier to entry, it also offers a path toward legitimacy, safety, and consumer trust.
For CBD brands, the time to act is now. Whether that means scaling up, seeking partnerships, or exiting the market, the decisions made today will define who leads the CBD industry tomorrow.