CV Sciences Inc (CVSI)

[Benjamin Wulf]

The FDA holds an advisory non binding position that any CBD above the natural levels found in hemp before 1994 is a drug ingredient and not a food ingredient.

Because this is just an advisory non binding position the FDA cannot be sued regarding their incorrect position until they make a final rule.

FDA is holding a public meeting regarding this in 2019.

Being compliant with the FD&CA for a new dietary ingredient require either:

Filing a NDI with the FDA (these currently will be denied because of the non binding advisory position of the FDA)

FDA determines CBD to be a GRAS ingredient.

New dietary ingredient goes through the self-GRAS regulatory process. Although it is not necessary to have the FDA review it is generally a good idea to have the FDA issue a no questions letter in response to the self-GRAS determination. (CVSI did this but has not submitted to the FDA)

So is CVSI lawful? Technically yes but not permanently because the FDA could issue a final rule which then could be fought in federal court.

So CVSI shares the same fate as CWEB and others in that they need FDA to say any CBD above natural levels found in hemp before 1994 is a food ingredient and a drug ingredient which therefore allows self-GRAS and NDIs for hemp extract formulations with CBD above natural levels found in hemp before 1994.

Some key elements of why the FDA can be defeated in federal court if they make a final rule. There are 3 case histories on this particular issue; red yeast rice; a form of vitamin B6 and one other I don't recall. Here is what differs in this case that I think is interesting:

the most interesting thing about this case compared to the 3 prior is #1 the neuro-protectant and other protectant properties of healthy people of high CBD hemp extracts which could open up for constitutional violations and (top side bell curve 10-25% CBD as percent of hemp extract) #2 the fact that it was impossible to market before ind and substantial clinicals because of the regulations of another federal agency (dea) which could open up for antitrust violations. probably why fda came out saying we are reviewing allowing it. they know this might be a tougher case than the last 3.

The FDA position is this. Since the CBD IND and substantial clinical trials (Epidiolex) happened before the legal marketing of CBD as a food ingredient then the ingredient must be a drug ingredient. That is it that is the FDA position and nothing more. For more info on this case go here -> https://www.regulations.gov/document?D=FDA-2017-P-6692-0044&fbclid=IwAR0TYhnqA7UN1gsvC82MU36kzqHHl_ph-Li9T0JC_ZYzlERTU1OjtWMYZJY

I expect the FDA will allow hemp extracts to contain up to 25% CBD to be lawful food ingredients but that isolated cannabidiol will not be allowed to be a food ingredient.

Here is what the FDA said regarding reviewing this subject last week -> "Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients." and "Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products."

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm

The showdown with the FDA will happen most likely in 2019 and in the event they do issue a final rule banning CBD as a food ingredient it is expected to go to federal court for a 3-10 year court battle.

Because of this anyone like CVSI who has self-GRAS are generally insulated from enforcement from the FDA as long as they follow all other parts of the FD&CA and their self-GRAS is reputable and built on sound science.