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Tuesday, 04/20/2021 10:45:57 PM

Tuesday, April 20, 2021 10:45:57 PM

Post# of 30141
CBD Legalization


In late March 2021, ValidCare issued a press release stating that their CBD Liver Safety Study demonstrated no liver safety issues with CBD taken at typical daily doses — according to many experts in the CBD industry, this appears to be the final step required in order for the FDA to issue their Enforcement Discretion Policy For CBD Products

VALIDCARE’S CLINICAL STUDY REPORTS PRELIMINARY RESULTS OF CBD LIVER SAFETY

Investigators report to FDA no evidence of liver toxicity in the 839 adults consuming oral CBD


https://validcare.com/press/validcares-clinical-study-reports-preliminary-results-of-cbd-liver-safety/


“Hopeful to pass CBD Legalization in early 2021”


HR 8179 is 2020’s version of The CBD Dietary Supplement Legalization Bill

The 2021 version, HR 841, was filed on 2/4/21 and is virtually the same bill as HR 8179, so when Miller is saying that he is “hopeful to pass HR 8179 sometime in early 2021,” this means that he is hopeful to pass the Legalization of CBD Dietary Supplements (HR 841) sometime in “early 2021”

Miller also says he expects legislation to “Legalize CBD as a Food and Beverage Additive” in 2021

Watch him go on record here about CBD Legalization in Supplements, Food and Beverages — timestamped so just hit play:





According to all of the research I’ve done, when the CBD Food and Beverage Legalization Bill is filed, it will only be for CBD Isolate due to the lack of safety data on the other CBD formulations and other cannabinoids:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161576602


— — —


HR 841 starting out with 18 Cosponsors on Day 1


Check out the newly released CBD Legalization Bill here:

https://www.congress.gov/bill/117th-congress/house-bill/841/cosponsors?searchResultViewType=expanded


Compare that to HR 8179, the CBD Legalization Bill from the last Congress, which only had 1 cosponsor on Day 1:

https://www.congress.gov/bill/116th-congress/house-bill/8179/cosponsors?q={%22search%22:[%22Hr+8179%22]}&r=1&s=1&searchResultViewType=expanded


So HR 841 is off to an excellent start thus far


— — —


My Take On 2021 CBD Legalization in Dietary Supplements Bill


The significance of this recently announced legislation is that only CBD Isolate and Broad Spectrum CBD now have a chance to be legalized by Congress in 2021:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161538535


The Problem with Full Spectrum CBD is the THC


I have been warning about Full Spectrum CBD since mid-2019, when virtually all observers wrongly predicted that CBD Isolate would be disallowed due to the drug exclusion rule in the FDCA because it is too similar to Epidiolex, while I maintained the exact opposite — that CBD Isolate would be the 1st formulation permitted by the FDA due to its superior safety data, with the drug exclusion rule being a subject for legislation in Congress

I also contended that THC and Full Spectrum CBD had too many safety risks for it be legally permitted to be sold in retail stores all over America anytime soon — and now the exact opposite of what the legal experts had been saying has happened, and it’s THC that is being forbidden, so Full Spectrum CBD will remain illegal even after this CBD Legalization bill passes

I laid out my thoughts on why CBD Isolate was the best bet to become the first formulation permitted for national sales in July 2019 here:

AN FDA-CENTRIC CANNABINOID-BASED PARADIGM FOR CBD PRODUCT REGULATION


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150123700


Even though nobody has seen the contents of the FDA’s CBD Enforcement Discretion Policy...

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157109217


FDA Enforcement Policy for CBD Products only includes CBD Isolate right now


Based on everything I have read and everybody with whom I have spoken, it’s very likely that only regulations for CBD Isolate products are currently included in the FDA’s CBD Enforcement Discretion Policy — whether that will be changed under a Biden administration remains to be seen, but Jonathan Havens thinks that the FDA’s CBD Enforcement Policy is coming out in Q2 of 2021:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161040221


In late March 2021, ValidCare issued a press release stating that their CBD Liver Safety Study demonstrated no liver safety issues with CBD taken at typical daily doses — according to many experts in the CBD industry, this appears to be the final step required in order for the FDA to issue their Enforcement Discretion Policy For CBD Products

VALIDCARE’S CLINICAL STUDY REPORTS PRELIMINARY RESULTS OF CBD LIVER SAFETY

Investigators report to FDA no evidence of liver toxicity in the 839 adults consuming oral CBD


https://validcare.com/press/validcares-clinical-study-reports-preliminary-results-of-cbd-liver-safety/


Now the battle will be between FDA and Congress — CBD Isolate is a lock, whereas Broad Spectrum CBD may or may not make the final version of the CBD Legalization Bill


FDA only wants CBD Isolate to be legalized, as they believe there isn’t enough safety data on the other cannabinoids like CBG, CBN, CBC, etc

In addition, they want to save the other cannabinoids for the pharmaceutical industry

For those reasons, FDA is not in favor of allowing Broad Spectrum CBD in 2021

So as things stand right now, CBD Isolate in Dietary Supplements is an absolute lock to wind up in the finalized version of The 2021 CBD Legalization Bill, and that’s where I’m placing my bets

Last week’s CBD Legalization in Dietary Supplements Bill could remain as is and move through Congress without any changes to it

But if any specific changes are made to HR 841, I think there are essentially 3 possibilities:

1) The non-CBD cannabinoids (Broad Spectrum cannabinoids CBG/CBN/CBC, etc) are deleted, as the FDA wins in the FDA vs Congress battle, and the bill winds up being purely a CBD Isolate Dietary Supplements Legalization Bill

2)Broad Spectrum CBD is permitted to sell as a Dietary Supplement as long as the concentrations of all the cannabinoids are not altered, i.e. it would be illegal to add more CBG into Broad Spectrum Oil — and only CBD can be sold in isolate form — it would be illegal to sell CBG or CBN Isolate, for example

3) CBD Isolate in Foods and Beverages is added to this bill

In terms of food and beverages, only CBD Isolate has a chance to be legalized as an additive right now, because as I’ve always stated, CBD Isolate has the most safety data and when you look at the research on CBG, CBN, CBC, etc, it’s not even close in terms of quantity and quality of data

If CBD Isolate in foods and beverages is not added to this bill, I fully expect to see a separate bill in 2021 for CBD Isolate Legalization in Foods and Beverages

Jonathan Miller has already gone on record right here that we will see legislation for CBD Isolate in foods and beverages in 2021:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161039812

So whether Congress can win the battle with FDA and include Broad Spectrum CBD and the individual non-CBD and non-THC cannabinoids themselves remains to be seen

I think one reasonable compromise between both sides is to allow CBD Isolate only in both Dietary Supplements and Foods/Beverages, just like we saw in Peterson’s 2020 CBD Legalization Bill, HR 5587:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155119606


The really big money seems to be in Full Spectrum CBD Oil and CBD Beverages/Foods, but Congress and FDA seem to both agree that it’s still too early to legalize the sale of CBD products with THC (Full Spectrum CBD) in retail stores, so that leaves CBD Isolate in Foods and Beverages as the more feasible big money option


Molson Coors was the first traditional company to make a CBD Beverage, which they announced in January 2021:


https://www.bloomberg.com/news/articles/2021-01-13/molson-aims-to-create-mass-cbd-drink-brand-with-veryvell


In March 2021, Canopy Growth launches CBD-infused sparkling water line in the U.S.


https://www.cnbc.com/2021/03/02/canopy-launches-cbd-infused-sparkling-water-line-in-the-us-.html


Canopy Growth Launches ‘Quatreau’ CBD Drinks In U.S.


“We think there’s a fairly clear regulatory path and way to enter the market, and we’re really comfortable with the future opportunity,” Kovacevic said.

https://www.forbes.com/sites/chrisfurnari/2021/03/02/canopy-growt


When rumors that Coca Cola was interested in CBD Beverages in Oct 2018 started swirling, the market went absolutely bonkers for CBD Beverages:


http://schrts.co/MCRGTvhg


Here’s a very well written recent article that covers a lot of ground:

Could 2021 be the breakout year for cannabis-infused food and beverages

https://www.fooddive.com/news/could-2021-be-the-breakout-year-for-cannabis-infused-food-and-beverages/593403/


The bottom line for me is that as things stand right now, only CBD Isolate is a lock to be included in any finalized legislation involving CBD Legalization that passes Congress in 2021

That’s the case for both Dietary Supplements and Beverages

And that’s where I’ll continue to be positioned for 2021


Sleek

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