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Hemp Extract v. CBD Isolate Under US law

The following summary of the major laws that the FDA polices, and how they relate to hemp specifically, is taken largely verbatim from an educational video on the topic by Klee Irwin [1]. The only changes to this text have been for the sake of clarity. 

There are two major groups of laws the FDA enforces:

  1. The (DSHE) "dish-AY" law - Dietary Supplement Health and Education Act of 1994
  1. Food, Drug and Cosmetics Act

If the FDA has approved for significant clinical trials, or given a new drug status to a substance, then that same substance, which is approved as a drug, cannot simultaneously be sold as a food additive, a food or a food supplement.

The question, then, is that since GW Pharma was given a new drug status for Epidiolex and another product made from CBD, can anybody now, take hemp, which is now legal,  and pluck out the CBD molecules and sell it as a food, a food supplement or a food additive.

The answer is no, they cannot, because that substance, CBD, was approved as the active ingredient in a pharmaceutical.

How about this question: can someone sell a full spectrum extract of the hemp plant -- which means you pull out the fibers, you pull out the waxes, and the lipids, ... -- can you then sell that substance as a food additive, a food supplement, or a food? The answer is, yes you can.

So, when one hears statements by the FDA, which are true, that you can't sell CBD, they must understand that legally, hemp extract is not CBD. 

For example, on Walmart.com you can find, on the “shelf”, dietary supplements containing White Willow bark extract. 

The bark of the White Willow tree contains a high percentage of a chemical called Salicin, which is the drug ingredient in Aspirin. 

Given that Aspirin is approved as an OTC drug, can you pluck Salicin out of White Willow bark extract and sell it as a supplement? No, you cannot. 

Can you do what Walmart does, legally, and sell White Willow bark extract that contains a meaningful quantity of the drug Salicin, naturally occurring? Yes, you can.

Can you highlight the fact that the supplement product has the drug Salicin in it?  Yes, you can. 

Just as Walmart can legally sell a White Willow bark extract that boldly brags of the milligram content of Salicin in the bottle, without violating FDA law, one can take full spectrum hemp extract, which contains a meaningful amount of CBD, and put CBD prominently on the label, and sell the product without any violation of this aspect of FDA law.  

Would the same be true for a product containing isolated CBD?  No, because the isolated chemical is not a full spectrum extract.

Let's talk about another FDA consideration: NDI, which stands for New Dietary Ingredient.  The FDA maintains a running list of approved dietary supplements. If you find a new herbal product in the forests of the Amazon, and you want to bring it to America and sell it as a dietary supplement, you cannot do so without its being on the NDI list. 

However, there is one exception, related to the letter N, in New. 

So, what defines New?  New dietary supplements are substances, as dietary supplements, that were not in the food supply prior to DSHE being signed by Clinton in 1994. 

What about hemp extract?  Was full-spectrum hemp extract in the food supply prior to 1994?  Indeed it was.  In fact, for over 120 years, hemp extract has been sold in America and advertised in places like the Sears and Roebuck catalog.   This extract was in some cases called by its popular name from the Arabic language, hashish.   Hashish is a full-spectrum extract of the cannabis plant.  So, well before 1994 hemp extract was readily available to American consumers in the food supply.

One would not even apply to have hemp extract added to the NDI list, because it has been in the food supply for many years prior to 1994.  We would be in the wrong line, so to speak.  It would be like checking into customs when you go back into your country through the "foreign visitors" line.   You shouldn't be in that line, or on that list, at all.

The last category of FDA consideration is GRAS, which stands for Generally Accepted as Safe.  Is hemp extract generally accepted as safe?  There are hundreds of clinical studies on the cannabis plant, some on full-spectrum extracts of the plant, others on isolated molecules from the plant.  There are studies on smokable ingestion, edible ingestion and so on.  Some are animal studies, some are human, some are in vitro. Each of these many hundreds of studies has a safety section.  Out of all the studies, and indeed in the history of the country, there has never been a known death due to an overdose of this plant or any of its sub-constituent molecules.

The purpose and intent of GRAS is for substances that have not been exposed at meaningful levels in the American diet.  When something has been readily available in the food supply for countless decades, there is a grandfathering-in effect with respect to GRAS. Indeed, hemp extract products have for years been sold in the market with full knowledge of the FDA, and no questions of safety, that is GRAS, have been raised by the agency.

 

Conclusion

Is CBD a legal ingredient? No.

Is hemp extract a legal ingredient? Yes

Therefore, since Mountjoy Sparkling CBD is made from full-spectrum hemp extract, it is a legal product.

Indeed, any CBD product made using Mountjoy's NanoTonic extraction is legal under US law, including those laws that the FDA enforces. 

 

 

[1] https://cannabusiness.law/cbd-hemp-and-the-fda-the-video-primer-you-need-by-klee-irwin/