The short answer?
It’s a work in progress.
Here's the current status of CBD in the United States. Hemp prohibition is over. With the 2018 Farm Bill passing in December of last year, hemp-derived CBD was legalized, and dozens of CBD companies have opened their doors since.
However, CBD-based food and beverage companies have been slow to start business. The main reason? The FDA currently considers cannabidiol (CBD), including hemp-derived CBD, an “unlawful substance."
The good news? This may change sooner rather than later. The FDA has scheduled a hearing on May 31st, 2019 to consider the legality of CBD in food and beverage-based products. So, is CBD FDA-approved? What does this mean for CBD as an industry?
Let's consider these questions:
What is the FDA?
What is the FDA's stance on CBD?
What did the 2018 Farm Bill do for CBD and the FDA?
Are there any FDA-approved CBD products?
What is the future of CBD and the FDA?
What Is The FDA?
You’ve probably seen labels and symbols on prescriptions at your local pharmacy that read “FDA Approved.” Or perhaps you’ve bought a bottle of vitamins or supplements that lists the disclaimer These statements have not been evaluated by the FDA. This substance is not intended to treat or cure any disease.
What exactly do these labels mean?
The FDA, or The Food and Drug Administration, performs the role of protecting US citizens by regulating substances used for pharmaceutical, health, or wellness purposes. In order for a drug to reach the market, it must first be approved by the FDA. For a drug to receive FDA approval it must undergo animal testing followed by four phases of human clinical trials.
Once a drug has successfully passed all four phases, it is eligible for review and approval.
FDA & CBD
The FDA is also the governing and enforcing group for all pharmaceuticals, foods, beverages, and supplements in the US. The FDA ensures that no organization makes claims about the uses or benefits of a certain substance without any scientific backing or regulations in place.
The FDA has the authority to fine and potentially close businesses that make false claims about the healing powers of certain substances, and can also put limitations on the types of products sold at retail locations, restaurants, and marketplaces.
In regards to CBD, on March 28th the FDA sent warning letters to three different brands of CBD companies who listed medical claims on their websites and product labels. These companies were asked to revise their information, for the protection of their customers, or face a monetary fine, followed by a potential company shutdown.
The 2018 Farm Bill
In November of 2018, the Senate passed the Farm Bill, making all hemp and hemp-derived products federally legal as long as they contain .3% or less THC. The Farm Bill also
Currently, the FDA does not regulate CBD oil. The only organization that has established a regulations system of verification and approval of CBD products is the US Hemp Authority. Back in January of 2019, they announced their first class of 13 CBD companies who received the seal of approval for their practices and quality of product. You can read more about those 13 brands in our blog post about the US Hemp Authority.
FDA-Approved CBD Products
There is one CBD-based drug on the market called Epidiolex. It was developed and approved by a company called GW Pharmaceuticals based in the UK. This is the premier drug specifically for children suffering from epilepsy and seizure disorders. Because it is the only legal drug on the market that utilizes CBD, it is very expensive and may not be suitable for the average patient.
Families have started to venture out on their own in search of CBD products that can alleviate their needs. This has led to the FDA stepping in and pushing the conversation about regulations forward. While it may look like this is a step backwards in providing people with CBD, we believe FDA support is crucial to the success of the industry and the common person.
Looking to the Future
There is exciting hope for the future. With the FDA hosting its first hearing on CBD on May 31st, discussing the possibility of legalizing CBD in food and beverages, we could see immediate changes overnight. Their goal is to find a way to regulate recently legalized hemp products such as CBD.
With the FDA’s approval, we will begin to see places like restaurants, groceries, convenience stores, and even big retailers carry CBD products. This will be a win for everyone.
Is CBD FDA-approved?
In short, it's complicated. While the 2018 Farm Bill did make hemp federally legal throughout the United States, the FDA is still taking steps to ensure the overall regulation of CBD products, specifically in food or beverages.
Keep an eye on the calendar for May 31, 2019, as we will find out more when the FDA has its first hearing about CBD in the food industry.
Overall, the FDA is dedicated to protecting the common person by regulating and approving various substances. CBD is not included in that list of substances, however, this may change moving into the future.
We're Here To Help!
We hope that this article helped to clarify exactly what the FDA’s role in CBD regulation is, while educating you on what the future may hold.
If you’re interested in learning more or have any other questions feel free to call us at 502-209-8808 or contact us here. We’d love to hear from you!
At Anavii Market not only do we provide the right information to help you make confident decisions, but we also curate quality products that have been third-party tested and personally-tested by at least one member of our staff.
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