A couple of key points from the article by Danny Brody from Cannabis Investors Magazine
The GRAS Solution
The first of the FDA’s concerns is easily overcome – reputable companies are avoiding specific health claims that might trigger the FDA’s interest and letting the media educate consumers about CBD’s benefits. This method is fueling the massive growth of CBD in tinctures, lotions, and the like, and even CBD for pets.
But putting CBD into food products is a more difficult hurdle to jump.
While the FDA has said they will “advance new steps to better define public health obligations related to CBD,” it has not yet been clarified. Right now, you can legally buy a beverage containing THC in California, but not a beverage containing CBD.
However, there are certain pathways companies can go down and still receive FDA approval. Some foods derived from hemp that may not contain CBD or THC are a prime example. Some foods are classified as “Generally Recognized as Safe” (GRAS). Attaining GRAS status clears the substance to be used in foods and beverages without fear of regulation.
Self-affirmed GRAS is when a company, rather than the FDA, does research on a food product and shares their evidence with the FDA. If the FDA doesn’t question the self-affirmation, the company may assume that the food is GRAS until it is told otherwise.
Some companies have already achieved a self-affirmed GRAS determination regarding the non-CBD containing parts of hemp, like the seeds, oils, and proteins.
CV Sciences (OTC: CVSI) claims that it has achieved self-affirmed GRAS for a CBD product. It is the only CBD company to have done so, though I believe that Charlotte’s Web (CSE: CWEB, OTC: CWBHF) is close and other companies will follow.
Aside from GRAS certification, the FDA has scheduled a public hearing for May 31, 2019 to allow the public to comment, share their feedback, and discuss any foreseeable challenges with CBD-related products.
The main thing they’re after is information and data related to the safety of CBD products. My belief is that with no “intoxicating” effect, and only positive comments from the public about the effects of CBD-infused products, this should be fairly straight forward.
With the FDA’s commitment to protecting consumers, I believe companies will be required to go through the approximately 12-month and nearly $1 million process to achieve GRAS affirmation before they’ll be able to sell any food or beverage products, though the FDA or Congress could speed up matters if either chooses to do so.
With these products soon to be legally marketed in human foods without approval, it’s going to open up an entirely new wave of fully FDA-legal, fully FDA-compliant products in the CBD space, paving the way for significant new opportunities.
In the meantime, as we see with the big retailers getting into CBD, there are plenty of opportunities with the tinctures, creams, lotions, and other non-food CBD products to produce enormous growth for the industry.
You can be sure that Greg and the NICI team will be working tirelessly to deliver you the best opportunities to secure your retirement fortune.
Couple of thoughts about the Friday hearing. The hearing will be very helpful to those companies who do not make health claims about their CBD products, and who can categorically affirm to the safety and consistency of their product. (correct amount of CBD per label description )
So in essence the FDA is basically going to listen to information about the science as perceived by a number of companies (companies attending are getting allotted speaking time, CVSI getting 5 minutes by MacKay).
The FDA certainly knows what CBD is....in view of their ruling on Epiodiolex. So they are not strangers to the compound.
Contrary to a consistent opinion offered here by Mr. V, the Self Affirmed GRAS toxicology report is going to be very vital;. So it is more than a nothing burger.
FDA is all about safety period. You will also see in the article they are also about policing companies who are making false health benefits claims.
I see two very key catalysts on the horizon, one being California giving the okay for CBD edibles / consumables..and as for the hearing what the FDA message may be is "show us your proof of safety of your product". The proof will need to be third party such as with an AIBMR lab company.
AIBMR labs and CVSI did in fact share their toxicology findings with the FDA. They know the science behind our products. As the article says, if the FDA does not challenge it then it stands as self affirmed but not FDA endorsed. The FDA is not in the business of endorsing various products or companies.
In the end, we will see some sort of frame work for regulation and safety. This is where CVSI has the decided edge. Stuart Tomc has been wanting this for a while.
Finally, one other interesting note from the hearing. If you are in the business of retailing CBD and you do not show up at the hearing, you are going to draw negative attention to your company.
The one thing the FDA will definitely get from the hearing is a snap shot of the landscape of CBD companies currently in existence. They will see "who's who" for sure.
But if you're speaking at the FDA panel, you are going to need to know what you are talking about and be able to back it up with factual data.
Bottom line......the CBD retail field will begin to get thinned out post FDA hearing.
You can count on it
AI
