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Tuesday, 10/13/2020 2:28:20 PM

Tuesday, October 13, 2020 2:28:20 PM

Post# of 30145
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 White House (OMB) and FDA met with a flurry of interested parties between 7/30 - 8/20

Nearly all of those parties submitted documents to the FDA, usually some sort of white paper supporting their respective arguments for taking the chains off the CBD industry

And then the meetings stopped

There have only been 3 additional meetings held since 8/20 and in none of those meetings were any documents submitted

I consider those meetings courtesy meetings

Global Widget (9/8) is part of the Validcare liver safety study, GW Pharma (Greenwich Biosciences 9/17) makes Epidiolex and Parry/Romani/Deconcini/Symms (9/22) are lobbyists for HR 5587

I’ve recently communicated with the parties who appear to hold the most clout — Canopy Growth, GW Pharma, FDA, White House (OMB) and a number of movers and shakers in the Hemp industry, and exactly when the FDA’s Enforcement Discretion Policy For CBD Products will be released is not something that is typically telegraphed

The most common refrains were “FDA doesn’t say anything beforehand,” “they are very tight-lipped,” “they don’t publicize timeframes,” and “it could happen tomorrow, next week or next month”

Canopy Growth was very optimistic about the CBD Isolate formulation, particularly for Beverages/Foods, GW Pharma seemed resigned to the fact that federally sanctioned OTC CBD products were inevitable and their biggest concern was around dosage (they want to keep the allowable dosages as low as possible), the FDA told me literally nothing, OMB was also like trying to squeeze water from a rock, and the Hemp industry has already done the best they can to advocate for the most optimal CBD Enforcement Policy and are now laser focused on passing legislation through Congress that will formally legalize CBD Products


Sleek

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