FDA Hearings May Signal End of the CBD Movement
The FDA/CBD Dog and Pony Show
The FDA hosted a highly rare public hearing about CBD on Friday May 31.
How’s this for setting the tone?
In his opening remarks, acting FDA Commissioner Ned Sharpless expressed doubts about the compound’s safety: “There are real risks associated with [THC and CBD] and critical questions remain about the safety of their widespread use in foods and dietary supplements,” Sharpless said.
Original source : www.upi.com
Wow. What a party pooper.
Not sure what the “real risks” are, but Sharpless made sure he floated that dark cloud over the proceedings from the start.
And with that one remark, the FDA has perhaps tipped its hand. They might be about to serve CBD to Big Pharma on a silver platter. And these hearings are just for show.
It is easy for them. It’s the safest route. And really that’s how they are structured.
They work with billion-dollar companies who run multi-billion-dollar clinical trials. The FDA’s sustenance is research and data given to them by big companies. That’s what they live on.
They have no interest in Kentucky hemp farmers, nor are they interested in hearing from people who have been relieved of suffering by CBD. That stuff has no meaning to the FDA. If it isn’t clinical results, it’s like you’re speaking to them in a language they don’t understand.
FDA is Selectively Concerned
But on the other hand, it would be nice if the agency would tell us what these “real risks” are. Where is the scientific research indicating that? Apparently proof only works in one direction.
They have serious concerns about CBD (and vaping), but how many thousands of people died from opioids before they were concerned. Because if they grant approval of a substance, it’s safe forever. Give me a break.
GW Pharmaceutical Have a Point
The FDA are not going to change their whole setup because CBD is in demand. GW Pharmaceutical jumped through all their hoops and got approval for Epidiolex (cannabidiol). Are the FDA just going to let regular folks churn out CBD tinctures?
Not likely. There’s too much at stake.
First, the FDA’s authority and control are at risk. They will not let popularity supplant the processes they have in place. The CBD movement is a threat to their power.
Secondly, there is just too much money at stake. Big Pharma are going to get a major piece of the pie. It’s not exactly corruption or conspiracy. It’s just the way the whole thing is structured. The pharmaceuticals have money, they speak the FDA’s language. They give the FDA what they want.
It’s the FDA’s deal that’s been in place for 80 years. You give us trials, we give you approval and we maintain our power. It’s pure bureaucracy.
A Way Out?
All that being said, the CBD movement has put the FDA in a pickle. They’d love nothing more than to stuff the genie back in the bottle and hand the bottle over to Big Pharma.
But that is going to look really bad. They are going to have to play the “real risks” card a lot. And nobody’s buying that.
On the other hand, they can’t let popularity dictate their policy.
If only there was another way…
Well, there are some very powerful congress members who would love to save CBD for the people – one of which is Mitch McConnell, the author of the 2018 Farm Bill. They know the social and economic impact CBD will create if it becomes a dietary supplement.
Further, the former FDA chief, Scott Gottlieb, was practically begging congress to step in. It would be a nice, easy solution.
Only, the dance just has to be done correctly. Congress doesn’t want to diminish the FDA’s authority. The agency is technically an extension of congress.
So, if there’s any hope of saving the CBD movement, there are going to be concessions and all parties have to feel like they’ve won. But making deals is what congress does.
However, unless or until then, that happens, the FDA are running these hearings as a smoke screen to cover their collective butt if congress refuses to step in.