Did FDA Legalize CBD/THC While We Weren’t Looking?

U.S. Food and Drug Administration (FDA)

This is my take on FDA and CBD:

1) FDA accepted Hempseed Oil as Generally Recognized As Safe (GRAS) per DSHEA (GRN 778 on December 20, 2018). 

2) FDA has long known of the presence of cannabinoids in hempseed oil, studies show as much as 225 ppm THC, and since Hemp is usually at least 20:1 CBD:THC, that means at least 4,500 ppm CBD, or 0.45%. (The resin adhering to the outside of the seed shell contains cannabinoids. That resin is so difficult to remove that HIA sued DEA over it and won in 2004.)

3) Congress was aware of the presence of cannabinoids in hempseed oil when it approved 3,000 ppm max THC in the 2018 Farm Bill, meaning at least 60,000 ppm CBD, or 6.0%, is possible. Many studies going back decades show the presence of THC in many hempseed oils, and FDA knew this when it approved GRN 778.

4) In 2004 the Ninth Circuit Court of Appeals ruled that since THC is a natural constituent of hempseed oil and cannot be easily removed, it was legal for hempseed oil and foods to contain undisclosed THC, and also permanently enjoined DEA from enforcing the CSA on hemp products. That ruling could rationally be considered to apply to CBD from hemp. It also ruled Congress never Scheduled any natural cannabinoid. The ruling, binding nationally, pierced the government’s “zero tolerance” THC stance. Undisclosed THC was then “legal” in hempseed oil and hemp foods, and today are found in almost every grocery store in the country. If a crackdown on CBD in foods is anticipated, start with hempseed oil. At least CBD products have pro-consumer disclosure like FDA prefers.

5) By approving hempseed oil as GRAS knowing it contained cannabinoids including THC and CBD, FDA therefore also approved as GRAS all of the constituents of hempseed oil, including cannabinoids. The parts making up the whole are inseparable from the whole; if the whole is GRAS then so are the parts, including cannabinoids. 

6) Both Congress and the Courts decided cannabinoids are not worthy of disclosure on labels of hempseed oil, and FDA knew it but never demanded disclosure. It can’t now claim the thing never needing disclosure before is suddenly separate from the whole and in need of new regulation, after millennia of use. For decades FDA had one opportunity after another to regulate undisclosed THC or CBD if it was a cause of legitimate concern for drug test interference or legality, yet time and again it refused. Not even when issuing GRN 778 did it make restrictions or exclude cannabinoids from it. FDA knew full well it was giving GRAS status to cannabinoids when it approved GRN 778.

7) Therefore, cannabinoids including but not limited to CBD and THC are GRAS under GRN 778.

What does FDA say? This:

In “FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)“:

Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

My response is 1) these cannabinoids have been in our foods for thousands of years around the world, including commercial foods sold legally in the US (as the table above reveals); and 2) no one (except perhaps God/Nature) is “adding” CBD or THC to anything. It’s already in there, unavoidably and incidentally. The Ninth Circuit Court of Appeals ruled it is legal, and FDA never objected in the decades it has known.

CBD (and THC) have been sold for years before GW’s 2015 IND application in various legal products including dietary supplements, foods, hempseed oil, and patent medicines (popular and efficacious OTC cannabinoid products sold by pharmacists and made by drug companies still in existence today, long before FDA existed). Among others, Jason Cranford marketed a legal CBD product in 2010.

FDA has a pending list of pre-DSHEA ingredients to announce, and a case for 12,000 years of safe and continuous human and animal consumption of cannabinoids was made in one submission. There are many precedents of a substance being a food, a dietary supplement, and a drug, much like hemp flower products which contain CBD.

In its last sentence, FDA asks for “interested parties” to present the agency with evidence. Is that you, are you an interested party? Then feel free to tell them.

CBD companies kicked the door open the dietary supplement industry created with DSHEA, and used HIA v DEA 2004 for legal cover. There’s ~20,000 unregistered New Dietary Ingredients, what’s one more? With 12,000 years of safe use around the world, hemp flower products deserve to be considered foods existing before DSHEA. With ~150 Cannabinoids we still have many more to address. But it remains to be seen, FDA might take the elegant route and agree.

Free Downloads

Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients, 18 pages, by Richard Rose. Hemp flower products have been consumed by humans and animals for thousands of years, and should be grandfathered under DSHEA. Here’s why.

It’s Nigh Time To Grandfather Hemp in the US, 16 pages, by Richard Rose. Made the case for doing what FDA finally did December 2018: grant GRAS status to hempseed products. I included CBD, FDA didn’t.

CBD is Not a Novel Food in EU, 7 pages, by Richard Rose. The same argument I made about CBD and hemp flower products to FDA, I make to the EU regarding Novel Foods and CBD extracts. They have been used for thousands of years across Europe, and are not new ingredients requiring expensive registration for every single new product.

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