Joel Stanley understands the effect hemp-based wellness has had on people’s lives and how a federal ban could undo it.
The CEO of Ajna BioSciences co-founded and later served as CEO and chairman for Charlotte’s Web, one of the pioneers of using hemp-based products to relieve pain, promote sleep and more. The company is named after Charlotte Figi, a young girl who saw her quality of life improve after using one of the first Charlotte’s Web extracts to relieve her epileptic seizures.
But people who are managing serious medical conditions with hemp-derived products are now facing an uncertain future as Congress is expected to enact a ban later this year. The bill "prevents the unregulated sale of intoxicating hemp-based or hemp-derived products, including Delta-8, from being sold online, in gas stations, and corner stores, while preserving non-intoxicating CBD and industrial hemp products."
The stricter state and federal regulations could reduce retail revenues by $28.3 billion, displace 225,000 jobs and reduce state sales tax potential by $2.1 billion, effectively eliminating the majority of the nation’s 50,000 hemp operators, according to Whitney Economics, a cannabis and hemp consulting firm.
That’s part of why Stanley left Charlotte’s Web and is now looking to circumvent Congress and go straight through the FDA to advance Ajna's botanical medicines designed to treat PTSD and autism spectrum disorder.
How does your work with Ajna expand on what you started with Charlotte's Web?
Stanley: Charlotte's Web proved that full-spectrum hemp extract could make a real difference in people's lives, at a scale most people didn't think was possible for a consumer product.
With Ajna, we're taking what we learned from that experience into a different regulatory setting through the FDA botanical drug development pathway. This pathway allows us to rigorously study and standardize these medicines in controlled trials, and to eventually make them available through physicians and traditional pharmacy channels, with the potential for insurance coverage. Ajna is a different way of pursuing the same mission, which is access. It isn't a replacement for what Charlotte's Web does. It's a second door for patients who need a physician-prescribed, pharmaceutical-grade option.
What's at stake for patients if the federal hemp ban goes into effect?
Stanley: The real cost falls on the people who've built a treatment plan around a product that works for them and now have to wonder whether it will still be legally available. That's not hypothetical. We hear directly from families and consumers who have relied on hemp-derived options and are concerned about what changes in federal policy could mean for their access.
What it does, in a pretty unfortunate way, is make our work at Ajna even more important. Physician advocacy, pharmaceutical-grade standardization, insurance coverage, nationwide distribution through pharmacies—that was already the point. Now it carries an added layer of urgency because it reinforces the need for multiple reliable access pathways. Patients shouldn't have to depend on a single access pathway that can be taken away by one vote in Congress. For a lot of people, the stakes are whether a legal, reliable option they depend on will continue to exist.
Why does the FDA provide a clearer path for regulation than Congress? And what would FDA approval look like?
Stanley: FDA approval provides a clearer path because it has an established, science-based regulatory process for drug development, while policy set by Congress can change from one bill to the next. For Ajna, that means we know what evidence we need to generate, what standards we need to meet, and what the endpoint looks like.
FDA approval would mean completing the drug development process and reaching the point where our botanical medicine can be prescribed by physicians, dispensed through traditional pharmacy channels, and potentially covered by insurance. It’s a slower and more expensive path, realistically a few hundred million dollars and six or seven years, but it’s a defined one.
That’s separate from what’s happening with consumer hemp products. Those products also need a responsible regulatory framework, and Congress still has an important role in setting sensible statutory guardrails, things like per-serving THC limits, age restrictions, and testing and labeling standards, rather than definitions so restrictive that they sweep in non-intoxicating products. FDA can regulate within that framework, but some of those fundamental policy decisions need to come from Congress.
For Ajna, the distinction is that our pharmaceutical pathway doesn’t depend on the next Farm Bill cycle or congressional vote. We’re working through an established FDA process with a clear regulatory standard and a known endpoint. It may be the longer path, but we know where it leads and what we have to do to get there.
