I’m with family all week long
This week has been in my schedule as a vacation week since last Thanksgiving
I’ve been looking forward to this holiday/vacation week for a long time, and more recently I’ve viewed it as an opportunity for me to rest and recharge for December 2019 and the 12/20/19 potential dated catalyst of Mitch legalizing CBD in Foods and Dietary Supplements via making CBD exempt from the drug exclusion clause in the FDCA
So I refuse to allow the FDA’s announcement yesterday, and the media’s dramatization of it, to interfere with my vacation
GRAS was NEVER an expected outcome of the FDA’s report on CBD
So that is irrelevant
A complete red herring
Which means saying CBD may not be safe, or that CBD’s safety profile is up in the air, or that CBD may cause harm, is nothing new to those who’ve looked at the data on Epidiolex
Epidiolex is CBD with an average dose of 1,000 mg daily
And the Epidiolex data is the basis for the FDA’s remarks — that’s where the concerns for potential liver damage were laid out, that’s where the side effects of somnolence and diarrhea were quantified, etc
Epidiolex is a huge daily dose of CBD
The comparison between Epidiolex and what Food and Supplement makers are putting in OTC products is literally night and day — 1000 mg CBD daily vs 10-50 mg CBD daily
To repeat myself for the sake of emphasis...
Which means saying CBD may not be safe, or that CBD’s safety profile is up in the air, or that CBD may cause harm, is nothing new to those who’ve looked at the data on Epidiolex
FDA should have said “Epidiolex may cause harm” or “500-1500 mg of Pure CBD taken daily may cause harm”
Because there is no reliable research on taking 10-50 mg CBD every day (very low dose CBD) for 1-2 years
Literally nobody has done the research, because that is a much lower dose than has been utilized in clinical research on CBD
And that’s why FDA won’t be able to say anything really definitive about the safety of very low dose CBD for at least 1-2 years
Mitch’s legislation to legalize CBD in Foods and Dietary Supplements, most likely through making it exempt from the drug exclusion clause in the FDCA, remains on track
Unless I hear otherwise, the FDA’s remarks yesterday won’t impact Mitch’s legislation
Mitch’s legislation will allow the FDA to accept NDI notifications and long term safety data on very low dose CBD
Currently, FDA won’t even accept NDI notifications (with included safety data) for CBD-infused food or dietary supplements because they say that their illegality prevents them from doing so
FDA saying CBD is not GRAS is another way of saying that NDI notifications and food additive petitions with long term safety data on very low dose CBD will be required to prove safety
So Mitch’s legislation actually dovetails rather well with the FDA’s latest remarks
The FDA is not saying CBD in very low doses is not safe — they are saying that they don’t have the data to talk about long term safety of very low dose CBD
The only way for the FDA to get that data is for Mitch to legalize CBD in Foods and Dietary Supplements, so the FDA can finally accept NDI notifications and food additive petitions with long term safety data attached
So I continue to be laser focused on Mitch’s 12/20/19 legislation legalizing CBD in Foods and Dietary Supplements — that’s the real sector gamechanger
Sleek
AI
