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Re: None

Wednesday, 09/02/2020 12:28:50 PM

Wednesday, September 02, 2020 12:28:50 PM

Post# of 30141
Status of FDA’s CBD Enforcement Policy

The best data we have to go on is right here:

https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=&rin=0910-ZA76&viewRule=true

You can see that the FDA met with a flurry of parties between 7/30 - 8/20

And then the meetings stopped

Since 8/20, only 1 scheduled meeting has popped up — Global Widget on 9/8

So what should we make of that sole appointment?

I looked up Global Widget and found that they are 1 of the 13 companies involved in the ongoing liver function safety data trial that the FDA is coordinating with ValidCare — in fact, they have already enrolled over 300 patients in this study, so the data is flowing in at a very rapid pace:

https://www.prweb.com/releases/irb_approved_observational_cbd_safety_study_is_now_underway/prweb17366921.htm

My best guess is that the FDA has finished scheduling meetings for feedback on their CBD Enforcement Discretion Policy, but because of Global Widget’s involvement in the liver safety trial, the meeting on 9/8 was scheduled as a courtesy to them

Otherwise, I would have expected to see more than 1 additional appointment after 8/20

Putting the Global Widget meeting aside, I wanted to see whether there was some kind of explanation for why the meetings stopped after 8/20, in order to figure out whether they might resume once again moving forward

I searched the calendar of all the FDA meetings to see whether the meetings stopped because the FDA wasn’t holding these types of meetings with anybody for awhile, i.e. a vacation period

And what I found was that they continued to hold meetings after 8/20 (check out August’s calendar by clicking on left arrow at the top left of calendar):

https://www.reginfo.gov/public/do/eom12866Search

So the most logical conclusion is that the FDA has finished holding meetings on their CBD Enforcement Discretion Policy

Which would mean that they are now at the final step of this process — they have gathered all the feedback and will now use that feedback to finalize their guidance before publishing it

How long will this final step take?

Under the election hypothesis, the answer is several weeks

It wouldn’t make sense for the FDA to publish their guidelines on November 1st — that’s too late to impact the election, as most farmers will be harvesting their hemp from late Sept - late Oct, in addition to the fact that most people will have already voted by then

The window that makes the most sense is sometime between mid-Sept - early October


Sleek

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