By now we should all be used to the fact that no matter what, some part of the federal government will stand in the way of legal sales one way or another. More recently we’ve seen issues crop up with the United States Postal Service – thankfully it seems like this problem will be resolved rather simply with the passage of a proposed bill.
We’ve also seen all the times legal businesses have been denied banking services or even having their social media pages removed (which isn’t a federal invasion itself, but those terms and conditions would be different if they did not comply with federal laws). This time the focus is all going to legally sold CBD products, which the FDA is reminding us doesn’t quite fit their regulations.
This past week, 8 different marketers of CBD products received letters from the Food and Drug Administration letting them know that they were not in compliance with FDA regulations. The main issue being addressed was the fact that many of these companies are referring to CBD as a health supplement (which, technically, it is).
The big problem? According to the FDA, CBD cannot be considered a supplement because it is actually considered a “new drug” ever since companies like GW Pharmaceuticals’ got permission from the government to do clinical trials on CBD based medications Epidiolex and Sativex.
“You should be aware that, based on available evidence, FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.”
Other problems established in the letter include the lack of clear directions for the intended use of the products and the fact that they claim that the products are beneficial to treat certain diseases (which they are – but the federal government hasn’t caught up with the rest of us…).
The companies were given 15 days to respond to the letters, in writing, with a detailed plan on the actionable steps they are taking to ensure that their products are in-line with the requirements of the FDA. If it will take longer than 15 days to make the necessary changes they are required to have an idea of how long it will take to fix. The letter also does not necessarily outline every violation, rather the majority and most common violations.
Considering CBD products are the cannabis products with no psychoactive ingredient (THC), you wouldn’t think the government, let alone the FDA, would waste their time. Apparently however, they want to prove that they still have control – even if the products are being sold legally to a community who knows what the benefits are.
While this isn’t the first time the FDA has sent out letters like this, let’s hope it’s the last.