Outgoing FDA Commissioner Scott Gottlieb sat down with C-SPAN recently and spoke to Bloomberg News Health Policy Reporter, Anna Edney.
Below is a summary.
So, what gives?
Seeing as hemp has been criminalized for almost a century, the world of US legislature hasn’t seen anything on the level of CBD before.
While hemp might be legal with the passing of the 2018 Farm Bill, there’s still quite a bit that needs to be done by Congress before things on the legal CBD front can move confidently forward.
What exactly did Gottlieb have to say?
For one, he said that the issue for the FDA is that the Farm Bill has passed and farmers who grow hemp want to be able to make CBD hemp extract and sell it.
Gottlieb also mentioned that food companies, like legitimate food companies, also want to put CBD into the food supply.
Here’s where things get tricky.
Gottlieb says that because CBD didn’t previously exist in the food supply and it exists as a drug under the statute, it can’t just be “put into the food supply.”
The only way it could be is if it previously existed in the food supply.
The law only allows the FDA to contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rule making process.
And since the FDA hasn’t ever done this before, Gottlieb is saying it will be a highly novel rule making process.
Normal rule can take two or three years…and that’s where “common rules” are concerned.
There are literally no “common rules” that exist when it comes to CBD.
Gottlieb says that when you think of a more complex rule like this where the FDA hasn’t done it before, it is likely to take much longer.
Gottlieb says that the FDA is putting together a working group and a public meeting will soon be issued to the government agency can solicit public comment.
He mentions that it will be a “high-level working group”, one that’s put together by the FDA Principle Deputy Commissioner and FDA Associate Commissioner of Policy.
This working group will look towards “potential legislative pathways that might create a framework for allowing CBD into the food system.”
Gottlieb believes this is what some in Congress intended with the 2018 Farm Bill.
He mentions there’s a precedent for Congress legislating on a one-off basis around specific substances, as well as a precedent for pharmaceuticals also existing as products that are put into food and dietary supplements, such as fish oil.
“I think you’d need to come up with a framework that defines concentration levels where you would create some kind of cutoff…and that would be up to the agency,” said Gottlieb.
He mentioned that Congress would give direction to the FDA.
He also mentioned that CBD in high concentrations isn’t risk free and that CBD in low concentrations is “probably safe” but that he didn’t want to make that declaration.
Gottlieb said there’s the question if CBD is providing any real therapeutic benefit at all in these concentrations, although “people seem to believe it has some value.”
This is a process the FDA will have to work through.
“The most efficient way to get to a pathway would be to move through legislation,” said Gottlieb.
He then said that this would be a legislation that would just specifically address CBD.
When asked when the working group would want to get that proposal to Congress, Gottlieb had the following to say:
“I don’t want to prejudge the outcome of that but we’re getting started right now. We’ve been briefing staff on the Hill around this. Almost every meeting I go into on Capitol Hill I get asked about this, so I think we would work through an efficient process with this and probably have some recommendations certainly this summer.”
He also brought up the fact that the DEA hasn’t “formally” descheduled CBD derived from hemp.
He also said there’s the question of how you differentiate between CBD derived from hemp and CBD derived from marijuana.
We’re certainly getting closer to the day when CBD can be sold freely in the US, but there’s still A LOT of work to be done.
Will we see a day where CBD is allowed in the food supply?
We sure hope so.
For now, we sit and wait for Congress to get together and outline exactly what we should expect.
We’ll be sure to keep you posted on any updates.