The Complexities of Regulating Cannabinoids: Navigating the FDA’s Role in the Hemp Industry

The NHA Chair and Executive Director recently had a conversation with a senior Food and Drug Administration (FDA) official covering a wide range of topics. The discussion aimed to express industry concerns, from hemp grain for animal feed to cannabinoid regulations. We also sought insight into the FDA’s thinking regarding all these issues.

With perhaps the exception of the Drug Enforcement Agency (DEA), the FDA is the government agency that the hemp industry most loves to hate. But is this assessment fair?

While, on the surface, it is a little hard to fathom why it has taken a staggering four-plus years to get to the point where the FDA publicly states that they can’t regulate CBD under the existing framework they have to work with, the reality is that NHA has been telling our members and anyone who cared to listen that this was the FDA’s position since our first comprehensive meeting with them prior to the passage of the 2018 Farm Bill. It was not the message most wanted to hear, it was largely ignored, and the CBD industry pressed on and expanded.

That said, of course, we recognize the vast importance of CBD and other cannabinoid products for the industry and the benefits they provide for consumers. We also recognize the extreme importance of reasonable regulation, which protects both the consumer and the industry.

So, what in the world is taking so long?

Well, to state the obvious…it’s complicated. And the rise of intoxicating cannabinoids did nothing to simplify the issue. In fact, Delta 8, in particular, has caused quite the uproar. While many states scramble to ban it outright or attempt to regulate it, others think that simply changing the federal definition of hemp to put these cannabinoids back on Schedule 1 of the Controlled Substances Act will fix the problem. It won’t.

The truth is the entire cannabis plant and industry are unique. Unique in their uses, unique in their benefits, unique in their legal status, unique in their perceived harms, and unique in their capacity to evolve and spin off new products. On the CBD side, sure, the FDA could probably come up with something, but would that same something also work for every new cannabinoid product that is on the market and will come to market? It’s important to remember that the FDA has an obligation to ensure the safety of everything we put in or on our bodies; it’s a role we often take for granted. And despite the valid claim that cannabis never killed anyone, we must also acknowledge that there have been adverse reactions and even some deaths. Not necessarily due to the molecules themselves, but in the way they were prepared and ingested. Incidences that could have been avoided with proper regulation.

At the end of the day, the hemp industry’s frustrations are valid. After all, what other industry is so eager to be regulated and validated? While decidedly difficult, we all have to take a deep breath. There is still a whole lot of education that needs to be done, especially when it comes to the bifurcation of industrial hemp from cannabinoid hemp. But together, we CAN do this. We need to work with both the FDA and our Congress to make sure we get this right. Get it right for the CBD industry, get it right for all the other minor cannabinoids, and get it right to prepare for a future where no parts of the cannabis plant are considered Schedule 1 drugs.

NHA will have a seat at the table with FDA as they move these matters forward. We look forward to participating in listening sessions in the coming months and we will be proposing to Congress legislation that creates the framework that will allow the FDA to expeditiously bring about the regulations that take all of these factors into account.

We’ve got your back.