FDA Hearing on CBD Raises More Questions than Answers

By Ben Droz

Last Friday, May 31, the FDA held its first ever, full day public meeting on Cannabis.  7am-6pm, the meeting is part of a Public Comment Period  for “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds”

(Docket ID FDA-2019-N-1482)  https://www.regulations.gov/docket?D=FDA-2019-N-1482&fbclid=IwAR05aRmzKEcjdjqrDU80qZDgtNWe6ew9-QmFeOCkv-7oBg5p2skbESnrX6Y  This docket is accepting comments until July 2^nd, and is a very important part of the FDA regulation process.

A panel of 13 Senior FDA officials heard from some 140 people, live from the FDA building in Silver Spring.  The day kicked off with great testimony from hemp lobbyists Jason Amatucci and the Hemp Roundtable’s Jonathan Miller, articulating the position of the hemp industry, that CBD should be viewed as a food ingredient or dietary supplement.  This is already how CBD is being being used.

The conflict comes from the fact that the Pharma drug Epidiolex seems to the FDA to be to similar to plant derived hemp extract, and therefore, does not qualify as a dietary supplement.  While hemp has been a food ingredient since before the enactment of DSHEA in 1994, the FDA seems to think that modern hemp extracts are somehow different because of their processing.  But in fact, it is not different, it is simply a plant derived extract, like any other legal plant derived dietary supplement that you can get at any health food store.  Hemp attorney Rob Kight articulated this point.

But there was also testimony against our causes.  There was testimony that confused and conflated hemp and marijuana.  There was testimony that looked at the complexities of the issue rather than seeing it as simply, let people have CBD.

I personally like to just ignore the haters, and have valid reasons to do so.  Firstly, all of the confusion stems from the mis-interpretation from the FDA of the language in the Farm Bill that specifically protects hemp extracts and cannabinoids.  The FDA is in charge of keeping the public safe, not to restrict natural plant extracts.  All CBD products should meet a baseline of requirements to be in the market, such as C-GMP manufacturing standards, and trackability of supply chain.  Anything more than that should only apply to pharmaceutical grade dosage, which could be in the hundreds and hundreds of milligrams per day.

Importantly, and possibly to reflect the idea that the FDA knows that hemp derived CBD is in fact legal, the FDA is not actually holding the meetings and comment period on hemp CBD.  Instead, it is “products containing cannabis or cannabis derived compounds”.  By using the word “cannabis” rather than  the 2019 definition of “hemp”, the FDA is taking comment on all cannabis products.  This would show that any testimony or criticism against CBD, would be relating to any “cannabis derived CBD”, not necessarily including legal, hemp derived CBD.

There is certainly lots of other insights to gain from comments and the meeting.  Because of hemp’s popularity, there is a lot more commentary coming out about this, and FDA is open to comments for another three weeks.  Former FDA Commissioner Scott Gottlieb previously said it could take 3-5 years, so stay tuned for more!!

Ben Droz is contributing editor of Hemp Magazine,  (hemp.co) available at newsstands and Whole Foods nationwide.  You can also see updates from @TheHempGuy (instagram.com/thehempguy) or read his blog at www.theHempGuy.com . @theHempGuy (Instagram)