On May 31, 2019, the U.S. Food and Drug Administration (FDA) had the first-of-its-kind public hearing designed to solicit input and data concerning cannabis-derived compounds, with particular focus between pharmaceutical and nutraceutical products containing cannabinoids.
A panel of 13 senior FDA officials listened to nearly 150 stakeholders who were there to present to the FDA's hearing panel. The presenters were comprised of business owners, doctors, scientists, attorneys, patient advocates, and individuals from non-profits and state departments. We got on a call with Jonathan Miller, General Counsel for The US Hemp Roundtable, who was one of the first to speak at this hearing, to find out how it went and what’s next.
What were some of the key points that you wanted to get across at the hearing?
We were really excited that the FDA has now started this formal path to full recognition of CBD as a dietary supplement and food additive. Our main message is that CBD is very popular, it’s very safe, it’s being sold all across the country and we are asking the FDA to urgently move towards full regulation and to accomplish it in a way that protects consumers but that also recognizes the growing popularity and growing interest among hemp farmers.
What do you feel are some of the biggest problems facing FDA regulation?
The biggest problem is that we’ve got this cloud over the industry and that is due to statements made by the FDA, that in their opinion right now, CBD is not legal to be added to foods and not legal to be sold as a dietary supplement. They haven’t enforced that opinion. They haven’t gone after companies just for selling CBD. But that opinion being out there, it’s cast a cloud on the industry. There are state governments that are moving towards saying it’s illegal in their states and there are local law enforcement officials that have been ceasing products and in some rare cases arresting people and we want that to be stopped and the way that we can move forward is through strong regulation that is implemented expeditiously.
What are next steps after this hearing?
July 2nd is when formal comments are going to be submitted. We had 2 or 5 minutes to make our presentations at the hearing, over 100 people did. I imagine several hundred more will submit formal comments and that will be many many pages long, so this will get to the heart of the data that will demonstrate the safety of CBD, how and where it can be used, and with what population. And that will be a critical moment. Prior to that the US Hemp Roundtable has a meeting the CBD working group headed by the Deputy Administrator. We are going to hopefully make a more in-depth case, stronger case, and more granular case about why there’s this need to get this done urgently and why the FDA should feel comfortable the products are safe.
When do you think we will see some sort of actual FDA regulation of CBD actually happen? Since there is a sense of urgency with so many products flooding the market unregulated.
The typical process has taken 2-3 years. We are very hopeful that CBD has been out there, that we aren’t starting new, we aren’t having to start studies. The studies, we’ve been engaged on CBD for many years. That it will take a 12-month period, so we are hopeful that this will all be resolved in 12 months. And I know that Congress feels that way too. Congress, when they passed the Farm Bill, expected the hemp and hemp products like CBD to be available for the public and so there is a sense of urgency that the FDA act on this as soon and expeditiously as possible.
Everyone is talking about CBD right now, but there are so many other cannabinoids. When regulations are enacted, is the FDA (or you for that matter) including verbiage for the other cannabinoids so we don’t have to go through this process again, or will we be seeing specific regulations for specific cannabinoids as we are right now with THC and CBD?
We are hopeful that this will apply to all hemp extracts and that the regulation will bring other cannabinoids, as you know there are so many others and we are just beginning to understand the value of them. CBD is hot right now but who knows what’s going to be popular or prove to be effective down the road. So, we are hopeful that the FDA uses a broad brush. But it is very clear that at least the urgent need right now is CBD because it is so much flooding the market.
When the FDA finally does set forth their regulations for CBD, will the states still have the authority to make their own rules, for example even stricter regulations than whatever the FDA sets forth?
States have that right and we are hopeful they don’t exercise it. We are hopeful that will rely on what the FDA does, which many states do with so many food and supplement products. But some states may choose to ban CBD and that’s within their rights. We are hopeful they don’t. But that’s another reason we want the FDA to act quickly. Because if they don’t act, states might fill this vacuum with their own regulations and what will result will be a patchwork of regulations and it might not be “bad” or “good” but they will be different and we don’t want to see different regulations in different states because most companies want to sell in all 50 states and don’t want to do something on a label for one state that they don’t have to do for another.
The goal is to have hemp-derived CBD be recognized as a food additive and dietary supplement. Do you feel that the FDA is leaning more this way or towards CBD being classified as a drug which would come with much stricter regulation?
We think there is going to be two paths. There is going to be the drug-like. And there is other research being done for other drugs. And those products probably have higher concentrations of CBD. Those will be prescribed by doctors with medical claims and you can get it from a prescription using your insurance. But then there will be another path where it will be a dietary supplement and it will be sold over the counter in Whole Foods stores and grocery stores and drug stores. There will be no medical claims on those. You can’t use insurance, but people will have access to it. The example we like to demonstrate here, analogize to is fish oil. Fish oil in high concentrations is prescribed by doctors as a drug and there are medical benefits for its use. However, there is also fish oil that my wife makes me buy in the grocery store every couple weeks that she insists is good for my health and wellness. I’ve been married for 30 years so I listen to my wife. We think the same sort of thing is going to happen with CBD. In lower concentrations it will be a nutritional supplement and in real high concentrations it will be an effective drug.