FDA Drafts New Guidance Surrounding CBD Medications
Updated: Jul 1
For years, the FDA has been at odds with cannabis activists over its lack of progress with CBD medications. Currently, the FDA has only approved one prescription drug containing CBD for medical use, but, since then, the organization has been seemingly silent. Until now, that is.
In 2020, the Food and Drug Administration finally drafted some new guidance regarding medications using CBD. This kind of guidance is imperative for both the medical marijuana and medical scene, so Luna Cultivation exploring the impact today.
The History Between the FDA and CBD
Before we dive into these new ideas, it’s important to establish the history between the FDA and CBD as a substance.
Less than ten years ago, CBD was actively considered a Schedule I Controlled Substance despite containing absolutely no psychological or intoxicating properties whatsoever. The positive values were hardly discussed, and using it as health and wellness support in any aspect was practically unheard of. However, the opinion of the world--and the FDA--finally started to switch after meeting Charlotte Figi.
At the time, Charlotte Figi was a mere toddler when she was diagnosed with one of the rarest epilepsy disorders in the world. The disorder, Dravet’s Syndrome, was considered incurable and it appeared as though Charlotte was doomed to a life of hundreds of seizures a week. That was until her parents decided to turn a medical dispensary in Colorado. From there, Charlotte and her family found miraculous solace through a CBD extract.
The little girl went from having 300 grand-mal seizures a week to just two or three a month. With CBD, Charlotte was able to start progressing and growing like a normal little girl, living a happy, everyday life. The Figi’s story went viral, impacting both the public and the FDA directly. After this, and extensive research, the administration came out with the first FDA-approved drug containing CBD: Epidiolex. Approved for those with Dravet’s Syndrome and other severe epileptic disorders, this was one of the biggest steps the FDA took towards CBD medications.
After that, however, they seemed to fall back into the shadows. As CBD popularity exploded across the country, the FDA continued to stay in gray areas. Finally, this changed in mid-2020.
FDA Drafts New Guidance
The new guidance that the FDA has proposed this year is made to help speed up the approval process of CBD-based medications. Currently, the process to approve drugs such as these--medications like Epidiolex--is incredibly complicated, one of the biggest reasons why more of these medications have not been approved. That being said, these new guidelines allow for more opportunities for these CBD medications as long as the companies follow their strict regulations.
Primarily, the FDA states that these types of drugs must be derived from Cannabis sativa L and cannot contain any more than 0.1% THC. Currently, federal law states that hemp containing less than 0.3% THC is legal, so these drugs have to have even less. Along with this, these medications cannot contain any ingredients that affect or alter the state of CBD in any drastic way. What type of additive they are referring to isn’t entirely clear, but it’s obvious that they are concerned about the abuse of CBD’s non-psychoactive properties.
Other guidelines in the draft make references to proper testing, agricultural practices, and consistency. Of course, the process of approving these medications is still quite complicated, but the FDA is making it a lot more streamlined than it was in the past. As long as companies work diligently to follow these regulations, there is a very good chance that 2021 and the upcoming years may bring more medications as effective as Epidiolex.
The Impact on The Medical World
The broader acceptance of this kind of medication would mark a huge turning point within the medical community. For years, cannabis and medicine--though seemingly related--had such an adversarial relationship. Now, the more CBD-related medicine the community accepts, the more that this kind of relationship will be accepted. For so many people, CBD has been a source of relief and relaxation, but it’s one that many people simply cannot afford. With insurance not covering a substance like this, many are left unable to buy the few products that help. This new guidance, however, could change that.
Because these medications will be FDA-approved, that will make them much, much more likely to be covered by insurance. This kind of opportunity could be life-changing for so many Americans. Not only would they have access to medications that their body might accept more, but they will be able to actually afford the medication that makes them feel like themselves again.
Though we lost Charlotte Figi at the beginning of this year, medications like Epidiolex and future CBD medications are crafted specifically for people like her. People like Charlotte who have found relief nowhere else, and who just want to live a somewhat normal life. As an all-natural plant derivative, it only makes sense that this substance is finally being more widely accepted by administrations like the FDA.
What’s Left to Come
Whether or not we are going to see an influx of CBD medications in the upcoming years is still up in the air. Thankfully, things are looking promising. The FDA openly saying that they’re streamlining CBD medications shows that they’re finally understanding what kind of an impact these medications can have on families across the country. Whether it be young children like Charlotte or great-grandpas struggling with chronic pain, this new guidance brings hope to so many.
While it will likely be some time before we see any major change (or acceptance) within the FDA, the future is bright. Soon, we can only hope that cannabis and medicine can openly and warmly be discussed hand-in-hand. Until then, we’ll just have to wait and see what the FDA has to say.