At the end of November the FDA released two separate statements... One of which was 15 different warning letters to CBD companies, the other one was a consumer update. If you’ve seen these articles or headlines in the news, you might be pretty concerned. There are many articles out there saying that the FDA has cracked down on CBD, but that is not the reality of the situation. Truthfully, not much has changed at all!
So what has the FDA been saying?
Before the statement came out at the end of November, the FDA already had a very negative stance against the CBD industry. After the 2018 Farm Bill passed and the policy for hemp and CBD products was handed over from the DEA to the FDA, we knew that it was going to take some time for them to update their position on this substance.
People have been waiting all year for them to come out with new regulations, and in the meantime, the industry has not been waiting -- it is continuing to grow! Although, if you went on the FDA website, you would find that CBD is technically not allowed in food, drinks, or supplements. Which makes you think -- all of the products out there are food, drinks, or supplements. But the precedent was set early on, that if companies are doing the right thing and operating with integrity, then nothing illegal was being done. Instead, the only companies getting in trouble were the ones making health claims, which is the big thing NOT to do -- not only in CBD, but in the whole supplement industry in general!
What are these warning letters?
At the end of November there was a round of warning letters that went out to 15 different companies who were making a variety of health claims. Some of these companies were going as far as listing tabs on their website about cancer and opioid addiction -- very, very specific things that anybody could have told you are total red flags for the FDA! In addition to the warning letters, they issued a consumer update as well, which had some less than ideal comments about CBD. For example, that the compound “has the potential to harm you” and may have some toxic effects, impact your liver, memory production, the list goes on. What they failed to mention though, is that a lot of these studies were not reflective of the products currently out in the market.
Many studies that have been done by the pharmaceutical industry on CBD have been for very very high doses of isolate, which is very different than the full or broad spectrum, whole plant extracts that are in the products out there. In some of these studies they were doing, if you took the same equivalent of milligrams of CBD per kilogram of body weight, it would literally be thousands of milligrams of CBD. In reality, most people out there are taking 10 mg - 100 mg and is a more holistic extract than the isolate. As much as we would love for the FDA to come out with a full set of policies so the whole industry can move forward, it's a little more complicated than that.
Why is the FDA so complicated?
A lot of this complication comes from the pharmaceutical drug called Epadialex, which you can get prescribed by a doctor if you have a debilitating epilepsy condition. You can’t go to the doctor and get prescribed a drug, and then also go to the natural foods store or cafe and get that same compound added into your product. That’s just not how it works, and makes this a very unique situation for the FDA. We definitely don’t envy their position where they have to find out when to draw the line between pharmaceutical or supplement.
So that being said, really nothing has changed! More so, the FDA really dug their heels into the ground reiterating their original position, and in the same week that the FDA came out with these regulations, Canopy Growth, one of the largest cannabis holding companies, launched a line containing nearly 15 different seltzers and chocolates, all infused with CBD. So it’s very clear that, although the FDA has not said which CBD products are really legal to use, this multi-billion dollar industry is continuing to move forward.
To keep it simple, if you’re a CBD company… DON’T make health claims! Companies shouldn’t be making claims that promise the healing of any kind of chronic illness or disease. Over time, the FDA will come out with the right regulations...but don’t hold your breath, because it may not happen any time soon. What do you think about the FDA’s stance on CBD? Tell us your opinion on any of our social channels and tag @uncannywellness.