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Friday, 08/16/2019 4:31:26 AM

Friday, August 16, 2019 4:31:26 AM

Post# of 30145
FULL SPECTRUM CBD OIL AND CBD ISOLATE ARE 2 COMPLETELY DIFFERENT THINGS

First of all, I have family in town so I haven’t been able to post all day

But I did wake up early this morning (Thursday) and did my usual daily reading extra early

And I came across this story and immediately became suspicious of the headline:

FDA exec: Don’t expect an exception for CBD
https://hempindustrydaily.com/fda-unlikely-to-grant-cbd-exception/

The reason why the headline struck me as being very odd is because I followed the National Hemp Business Summit very closely and read the entire keynote speech from the FDA’s Lowell Schiller and I found it to be generally very positive for the FDA’s likelihood of nationally legalizing CBD isolate in the food supply and in dietary supplements

On the other hand, I found Schiller’s remarks to be generally very negative for the future of nationally legal Full Spectrum CBD Oil in the food supply and in dietary supplements

So there are 2 angles here that most strongly attract my interest

1) Why did hempindustrydaily publish this “story”?

2) When is the Full Spectrum CBD Oil industry going to admit that their products are not going to attain FDA approval for national distribution anytime soon because the FDA will not permit THC in the food supply or in dietary supplements?

Before we get into the analysis, you need to understand something about hempindustrydaily.com and hempsupporter.com

First of all, I absolutely love both websites

They are extremely informative most of the time and usually pretty accurate as well

But it’s important to know that both of these websites are run by the Hemp lobby, which is why they are so informative in the first place

Now here is a very key fact — the vast majority of the CBD industry makes and sells Full Spectrum CBD Oil, which contains up to .3% THC — the 2 biggest brands in America, Charlotte’s Web and PlusCBD (CV Sciences) sell Full Spectrum CBD products, as do 9 out of the top 10 brands — Medterra is the one exception in the top 10, with all of their products being THC-Free Pure CBD Isolate, and I wish they were a public company because I would love to invest in them — in fact, there is only 1 publicly traded company in America today whose entire lineup is THC-Free Pure CBD Isolate and we all know who that is

So the companies backing hempsupporter.com and hempindustrydaily.com are largely selling CBD with up to .3% THC

When Dr. Gottlieb’s Washington Post piece stating how the FDA could immediately permit THC-Free Pure CBD Isolate into the food supply was published on July 30th, I was dying to see what hempsupporter.com and hempindustrydaily.com would say about it, because as I’ve just pointed out, both of them strongly back the legalization of CBD with up to .3% THC in it — and at the same time, they largely ignore the completely different category of CBD Isolate products

And both of those websites, hempindustrydaily in particular, cover every major story in the CBD industry, so certainly they would be providing a take on Gottlieb’s perspective

When neither website commented on Gottlieb’s Washington Post piece, that told me everything I needed to know — they were speechless because the story was a very bad one for the Full Spectrum CBD community — so they decided to completely ignore it — why would they want to draw attention to a story that is devastating for them?
In fact, hempsupporter.com has been completely silent since July 31st — no news stories in August at all

But I thought maybe it was just a fluke, maybe the guys who normally would write about Gottlieb’s piece were just away on summer vacation... I always try not to rule anything completely in or out based on only 1 or 2 data points... but when Gottlieb appeared on C-SPAN and CNBC in 2 separate video interviews on August 7th and August 9th, and both hempindustrydaily and hempsupporter remained completely silent once again and didn’t report on either interview, it became obvious that Gottlieb’s words told the same devastating story that the FDA will not approve THC in the food supply

The utter lack of acknowledgement of the FDA’s message, delivered by Gottlieb himself via multiple channels of communication, by the hemp industry insiders only served to reinforce the confidence I possess in my take on the FDA framework and my “interpretation” of Gottlieb’s media barrage

I placed “interpretation” in quotes because though I provided my interpretation of Gottlieb’s Washington Post piece, he also says “No THC” and “purified CBD” (which means “NO THC”) very clearly multiple times, so my argument is fact based and not simply reliant on interpretation

Now let’s get straight to the evidence — that’s what real DD is all about

Dr. Scott Gottlieb, the former FDA commissioner who appointed Lowell Schiller and Dr. Amy Abernethy to the FDA’s working group on CBD charged with creating a regulatory framework, has written an Op-Ed in The Washington Post, appeared on CNBC, and also appeared in a 30 minute segment on C-SPAN, all within the last 2 weeks

Nobody has given us a glimpse inside the mind of the FDA like Dr. Gottlieb has — in his written editorial and in both of the videos he appeared in, he discussed the mechanisms whereby CBD could be added to the food supply/dietary supplements in great detail

Here are the 3 links to each of these sources

Dr. Gottlieb’s Washington Post July 30th piece on CBD:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150296023

Dr. Gottlieb’s August 9th CNBC interview where he clearly states “No THC”:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150438670

C-SPAN 30 minute interview with Dr. Gottlieb on August 7th where he outlines in the most specific detail yet how the FDA can allow “purified CBD” (No THC) into the food supply “immediately”

I will highlight the most relevant part, but I urge you to watch the entire interview as it is the most enlightening take out there on the FDA’s position on CBD:

12:50-14:50 is where Dr. Gottlieb explains how FDA can allow “purified CBD” into the food supply immediately:

https://www.c-span.org/video/?463295-3/washington-journal-dr-scott-gottlieb-discusses-regulation-cbd

Now let’s move onto the poorly written article that hempindustrydaily published yesterday

My commentary will be in bold

FDA exec: Don’t expect an exception for CBD
https://hempindustrydaily.com/fda-unlikely-to-grant-cbd-exception/

CBD treatments are promising, but far more research needs to be done before federal authorities can allow them in foods and dietary supplements, according to a leader of the U.S. Food and Drug Administration’s new cannabinoid work group.

No supporting evidence is given for making such a direct proclamation that Lowell Schiller communicated “CBD treatments are promising, but far more research needs to be done before federal authorities can allow them in foods and dietary supplements”

There is no citation of Mr. Schiller’s words because he never said this — instead they just provide a link to his entire keynote speech — that’s terrible reporting with no supporting evidence given



Talking to the National Industrial Hemp Council, Lowell Schiller warned CBD producers in attendance that the FDA plans to treat hemp extracts like any other new ingredient going into foods or drugs – meaning that without research on dosing and drug interactions, the agency is unlikely to approve over-the-counter use.

There are so many things wrong with this paragraph that I don’t even know where to start, so I’ll just address the most important points

First of all, Lowell Schiller never used the term “hemp extracts” in his speech

Hemp extract is the code word for Full Spectrum CBD Oil, which is probably why the author threw that term in there — it’s a demonstration that they think the whole CBD industry revolves around Full Spectrum CBD Oil

But CBD Isolate exists and is an important component of the CBD market, even if it only makes up a minority of the market — and that’s what Lowell is talking about here

Here is what Lowell Schiller actually said:
“That brings me back to something I said a moment ago, and if you take one thing away from these remarks, it should be this: We treat cannabis and cannabis derivatives, including cannabinoids like CBD, the same as we do any other substance.”

So when Lowell Schiller said that the FDA would “treat CBD like any other new ingredient going into foods or drugs”, that was actually a huge win for CBD isolate — prior to Lowell’s keynote speech, the Hemp industry had been begging for the FDA to allow all of the different forms of CBD to utilize the regulatory frameworks already in existence that allow a new ingredient into the food supply and dietary supplements, but the FDA had refused to do so, arguing that CBD was a special case due to the fact that it was also the active ingredient in Epidiolex (FDA-approved CBD Drug) — before Lowell’s speech, the FDA had opined that CBD would need to meet a different standard than is typical, that a new pathway would have to be conceived — so Lowell’s admission that the FDA would treat CBD isolate like any other novel ingredient seeking to enter the food supply was a huge victory for CBD — a huge victory for the CBD industry should never be classified as “a warning” — that simply makes zero sense — instead, it should have been celebrated, so why wasn’t it?

The answer is because these hemp insiders don’t really care very much about CBD isolate because almost all of their focus has been on Full Spectrum CBD Oil (CBD + THC + CBG/CBN/CBC, etc.)

At the same time, they realize that Schiller and Gottlieb have been talking pretty glowingly about CBD Isolate (THC-Free) while at the same time slamming the idea of THC being present in CBD products like is seen in Full Spectrum CBD Oil (up to .3% THC)

This puts hempsupporter and hempindustrydaily in a strange position — they backed the wrong horse (Full Spectrum) and haven’t been able to bring themselves to publicly admit it yet, so instead of celebrating CBD Isolate’s increasing momentum with the FDA, they simply just pretend that CBD Isolate doesn’t exist


“meaning that without research on dosing and drug interactions, the agency is unlikely to approve over-the-counter use.”

Yes, this is plainly obvious
And guess what?
CBD Isolate has a pretty healthy amount of that sort of data and Full Spectrum CBD Oil does not, so the FDA is likely to approve CBD isolate for over-the-counter use

Ignoring the existence of CBD Isolate is a terrible thing to do, and ignoring the real story of THC being completely blocked by the FDA from having any chance to enter the food supply alongside CBD is embarrassing for websites that cover the Hemp-CBD story as closely as these 2 websites do

So if the author wrote “Don’t expect an exception for Full Spectrum CBD Oil (.3% THC)” then the article would have been reporting real news

If the author wrote “FDA unlikely to grant Full Spectrum CBD Oil exception”, then the article would have been reporting real news

But remember, they couldn’t even bring themselves to write that article after Gottlieb came out on 3 separate occasions and spelled it out for them in plain English “NO THC IN THE FOOD SUPPLY, ONLY HIGHLY PURIFIED CBD ISOLATE WILL BE PERMITTED”

“CBD Isolate” is a very valid form of CBD, so why not just come out and admit what’s really going on, instead of ignoring the facts?


“We don’t hold a grudge against (cannabinoids), but we also don’t hold them to a lower standard of safety or absolve them of other requirements,” he told the gathering in Portland, Oregon.
“Consumers have a right to expect the same level of FDA protection with respect to hemp and derivatives like CBD as they would expect with respect to any other substance.”


Again, this is a huge victory for CBD — that’s what CBD Isolate actually is — CBD and nothing else

Notice that Lowell references “hemp derivatives like CBD” and not “hemp derivatives like CBD and THC” even though both CBD and THC are derivatives of hemp

Full Spectrum CBD oil is not CBD — it’s CBD with THC in it, along with hundreds of other cannabinoids such as CBN, CBG and CBC

Lowell never talks about THC as a potential derivative of hemp, because the very word derivative connotes the possibility of federal legalization, so the FDA talks about CBD as a derivative and THC as an impurity and contaminant in CBD products



Schiller repeated FDA concerns about:
• Potential adverse effects from CBD use, including liver damage.
• The lack of data on long-term use of CBD.
• Unproved claims of therapeutic benefits from CBD.
“If we don’t think we’ll have the data to say that some level of CBD can be safely added to a food or dietary supplement, then we wouldn’t want to create an exception for CBD,” he said.

This is very true, so the most important question is: “Does the FDA have the data?”

And this is why real DD wins every single time and fake news/terrible analysis is a loser’s game

I listened to a podcast last week — the 4th time I’ve heard Gottlieb speak about the FDA framework for CBD in the past 2 weeks — and I’m paraphrasing here but this is what he said...

“We know with very good certainty what dose of CBD is too high to allow in foods and dietary supplements in terms of public safety, and we also know with pretty good certainty what dose would be most likely to be safe in the long run... where we really need more data is to help us figure out where the real cutoff should be, which is somewhere in between these two extremes... but for now, we could go ahead and allow very low doses of CBD in the food supply without too much concern about putting public safety at risk



Schiller told the industry group the FDA is excited about cannabinoids’ potential for therapeutic use, but more research is needed. He said the agency would report progress on its cannabinoid review in “early fall.”

Gottlieb has all but admitted he is ready to issue a framework, so there is only one credible question left...

Is Gottlieb working in cahoots with the FDA as the bad cop in order to get the message out about THC being a no-go in the FDA’s framework?

Or is Gottlieb just out there on his own, with no connection to the FDA’s current thinking on the CBD framework?

I’ve made it clear that I believe the former option is the correct one

We are all going to find out in October, when the FDA only allows CBD isolate in the food supply and dietary supplements and kicks Full Spectrum CBD Oil to the curb

I think at that point Mitch swoops in to save the day for Full Spectrum CBD Oil by announcing his plans to pass legislation “protecting the entourage effect that THC under .3% provides in Hemp extracts”



Sleek

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