Federal FDA regulators held hearings over the future status of CBD products in the United States on Friday. There was no decision to be made, it was just an opportunity for the industry to speak with the bureaucrats about the regulation of CBD that is sure to come. Unsurprisingly, no consensus was made on the FDA’s next steps toward regulation. They will be accepting public comments through July 2.
The most obvious finding, and one everyone should have expected, was that the FDA wants to see the kind of research they are used to seeing about the effectiveness and safety of CBD. We all know there are no studies done which are consistent with FDA standards as cannabis derived CBD is illegal under federal law so none could be performed. They are not impressed with the quality of the current data which could be a major stumbling block for CBD in the future.
Several people presenting at the meeting discussed the biggest problem in the unregulated CBD industry: really poor product with wildly incorrect levels of CBD compared to those labeled, outright "bunk" without CBD at all and most worrisome, some samples were adulterated with drugs such as melatonin and dextromethorophan. This is the one area the FDA is most likely to act on and certainly the most vital for patient safety and quality of response to CBD.
FDA officials asked the industry for information on adverse effects in the use of CBD, interaction of CBD with other drugs and side effects of CBD. Again, the type of data they are asking for is just not available.
Acting FDA Commissioner Ned Sharpless said it that regulators don't know much about CBD. Former FDA Commissioner Scott Gottlieb, on the cable shows said "Don't think [CBD] can't make you high." Perhaps those statements sum things up at the FDA with respect to CBD: We don’t know much about it and we have an animosity towards most things cannabis related.
Like the Wizard of Oz sending Dorothy out for the unobtainable Witch's Broom as payment for her request, the FDA wants the CBD industry to produce the kind of data it knows they can't.
Brian Nichol MD