A Search for Legal Clarity: CBD and FDA Regulatory Issues Breed Confusion

As the co-founder of CBD Hemp Experts, the people who know me have caught wind that I’ve been on a mission to bring the benefits of CBD to the masses, and I don’t think that mission is going to see an end any time soon. Consumer interest is definitely out there—that’s without question. At least 72 percent of Americans have touted they’d be willing to give CBD a try for chronic pain, and the projected revenue numbers for the coming years proves just how much consumer interest there is. One study proposes that the CBD market could rake in a whopping $16-billion by 2025. With that, let’s clarify the regulatory issues surrounding CBD and the FDA.

The First Battle Won: The 2018 Farm Bill 

When the Farm Bill passed late last year in 2018, it was a huge milestone for the hemp industry as a whole. It is the passage of this bill that is partly responsible for those massive revenue predictions everyone and their brother is talking about where CBD is concerned. The well-received bill allowed for broad (yet highly regulated) hemp cultivation nationwide, made it possible for hemp-derived products to be legally transported across state lines, andoffered no restrictions on possession or sale of hemp-derived products like CBD. 

CBD As a Consumer Product: The Confusion

All of this has been great news for that spotlighted little cannabinoid CBD, obviously. However, there is a tremendous amount of confusion to consider. Many food and beverage manufacturers stepped up to the plate a long time ago with interest in infusing CBD into their edible products. There have been some pretty major players showing interest in CBD as a food or beverage ingredient, like Ben & Jerry’s and even Coca-Cola. But here’s the quandary: The FDA has not yet established a clear regulatory framework for CBD because they’re not sure whether it should be treated a medicine or a dietary supplement, both of which have very different rules for regulation as a product or ingredient. 

CBD is unique. It has already been approved for use in an actual drug, Epidiolex, which can effectively treat certain types of severe epilepsy. Currently, the United States federal law says: 

“…any substance being studied as a drug also can’t be regulated as a food or supplement.”

If CBD were to qualify as both a medicine and a supplement, it would be a completely new territory for the FDA to step into. Actually, this kind of unique situation could involve new and specific laws regarding only CBD. As exciting as this may be to consider, it only slows down the regulatory processes that so many are working hard to get established. 

People from all angles are joining forces to try to push the FDA into creating some clear guidelines and to do so fast. Consumer advocates, CBD manufacturers, and even lawmakers have come together. The lack of regulation hinders a lot of processes in the industry. For example, Coca-Cola can’t yet use CBD in products because the FDA can’t say that it’s legal to do so without designating CBD as a supplement. Even once they do, things like dosage guidelines would have to be established. The FDA is notorious for being slow about establishing guidelines for new things like CBD, but people are really pressing for faster action since so many could reap benefits. 

Yes, you can find CBD in everything from cat food to makeup and food—all it takes is a quick Google search. With anything else, the FDA may be swatting down these products as soon as they show up, but not with CBD. Instead, the Administration is only concerned with products that make absolute health claims, and pretty much everyone else is being left alone.  

The FDA’s First CBD Hearing 

The FDA set up a task force to work through all the CBD-regulation complications. They had a hearing on May 31st with the goal of determining if new regulation could be written for CBD outside of the existing laws. The hearing, which involved not just public officials but also the public, manufacturers, and more interested parties, was the first of its kind for the FDA. 

No real definitive information came out of the hearing. The executive director of the Hemp Industries Association stated that the 10-hours of testimony gave the panel both some good and bad points to consider about CBD. There are major concerns at this point from many because if the FDA does decide to restrict CBD on some level, it could put multiple companies out of business who have developed CBD products. 

My Final Notes and Thoughts 

I have only high hopes for the future of CBD. With so much scientific research surfacing about the therapeutic advantages of the cannabinoid and the seemingly safe profile, I just can’t see the FDA doing anything major to pull this stuff out of the public’s hands. Maybe I can’t help but to be a little optimistic because I believe in the power of CBD so much. With any luck, the FDA will go with their initial plan of making special arrangements for CBD as a highly diverse product that can qualify as both a supplement and medicine.