The push to pull FDA kicking and screaming into Cannabis regulation is misguided. Look at CBD, it couldn’t even get off its hands despite demands from all Stakeholders. With no budget, it was destined to fail.
FDA has been anti-science and lying about the plant for 88 years, from Day One. First the Pure Food and Drug Act to attack Cannabis patent medicines, then “no medical use” and Schedule 1 since 1972. In fact, FDA was founded in part to rid society of popular and efficacious Cannabinoid “patent medicines” made by some of today’s drug companies and dispensed by pharmacists.
Everything about FDA history and culture is 180° opposite Cannabis history and culture. The agency has had a long standing single-active-molecule policy for the medicines it approves, while Cannabinoid producers want as many of the plant’s 500+ active chemicals present (the “Entourage Effect”).
FDA already regulates (badly) a cousin to Cannabis, namely botanicals sold as foods and dietary supplements. Its Office of Dietary Supplements is the agency’s redhaired stepchild, shoved down its throat by Sen. Hatch and his DSHEA law in 1994.
Despite being one of the world’s great social movements ten years ago and ordered by Congress to do so, FDA couldn’t be bothered to regulate CBD, which resulted in the industry’s crash; domestic hemp acres plummeted 95% from 2019 levels in just five years.
And with FDA’s drug preclusion policy, the first product in each treatment space gets to own it, like Epidiolex does with CBD. One-by-one each Cannabinoid that we rely on will be given a monopoly, with a matching price. Delta-9 is next, if/when Sativex is approved.
And with a history as one of mankind’s first medicines, proprietary ownership (which drives patents and thus innovation) of her many aspects will be difficult, unlike novel synthetics.
FDA is not the agency to regulate plants, that’s a guarantee of failure short of an Office of Cannabis Medicines staffed by true believers and run by Dr Ethan Russo.
But the last thing FDA will do is inspect a state-legal dispensary or grow, that would be completely foreign to them. The same Tenth Amendment that protects them now will do so even after rescheduling.
Even then it won’t regulate plants, just post-harvest materials like extracts, concentrates, or isolates. However, USDA is all about plants, they have the ag scientists and agronomists and extension offices. If you want a federal regulatory body for plants, let it be USDA.
They won’t like it any more than FDA but at least it’s in their wheelhouse. And no matter which agency it lands with, give it a budget if you want them to even lift a finger. Take some from DEA now that what was its main focus for decades is legal.
Expecting a sudden and complete reversal of almost a century of deeply bureaucratic institution’s culture is naïve, and we’ve suffered long enough at the hands of FDA’s lies.
Just give us federal and state descheduling allowing the states to regulate, give Big Pharma their Schedule 3, 4 or 5 for approved meds for insurance reimbursement, ask USDA to help farmers, give them all the budget to do it, and be done with it.
Rescheduling is a long political process. Descheduling already passed the House twice, and all House seats and 35 Senate seats are up in 2026. Once handed over to Big Pharma, FDA will wash their hands of it and descheduling will never get done. “We approved a pot pill, just take that.”
You can beg for rice and you can beg for beans, or you can demand the whole enchilada. That time is now.
Not a Pharmacist, rather I see the issue as a patient and consumer who has been under FDA’s thumb professionally since 1980 so I know how they be.
Invite FDA at grave peril. Even this pic from them is bizarre in its imagery, a cauldron and fire. If that public picture was okay to put out, can you imagine how they talk about it when we’re not around?
And from that image, it appears Delta-8 killed CBD at FDA.