WARNING: Why retail CBD may become illegal due to Red Yeast Rice.
December 1, 2019
In light of the recent FDA warnings, I have a warning that I want to share with everybody.
You may have to stop distilling and marketing CBD.
Why?
Definitions:
Let me make it clear that distilled CBD isolate is different from hemp seeds, hemp seed protein, and hemp seed oil, which are Generally Recognized as Safe (GRAS). These products are legally marketed in food and food additives. However, cannabidiol, Epidiolex® or a CBD isolate of hemp is a drug.
Everyone in the industry knows that GW Pharmaceuticals submitted a new drug application for Epidiolex® for the treatment of seizures. Once it was approved, under the FDCA, CBD became excluded from the dietary supplement definition, because CBD was NOT marked as a dietary supplement or conventional food before the FDA approved Epidiolex®.
Red Yeast Rice: Pharmanex v. Shalala
Pharmanex produced a dietary supplement called Cholestin to help promote healthy cholesterol levels, which was derived from red yeast rice. Cholestin contained lovastatin, also known as Mevacor, an FDA approved medication that lowers cholesterol. Donna Shalala, representing the FDA sued Pharmanex stating that Cholestin was considered a drug and that it could not be marketed without FDA approval. Pharmanex defense was that Cholestin comes from red yeast rice, which is a food ingredient.
Does this argument sound familiar? Yes, this is similar to the argument used by CBD companies stating that the Farm Bill legalized Hemp, and that CBD comes from Hemp, which is a dietary supplement and food ingredient. Therefore, since hemp is a dietary supplement, so is CBD.
In Pharmanex v. Shalala, the court concluded the following:
Cholestin also did NOT meet “Prior Marketing Clause,” because lovastatin was not sold as a dietary supplement before Mevacor® was approved as a prescription drug.
Cholestin did NOT meet the “dietary supplement” definition, because the lovastatin had already been approved as a drug before it was marketed as a supplement.
Pharmanex also had manipulated red yeast rice to concentrate the amount of lovastatin above the level found naturally, and therefore the “Drug Exclusion Rule” applied.
Epidiolex® is an example of a CBD isolate, meaning that it was repeatedly extracted and refined (Epidiolex® is NOT synthetic, but “extracted directly from cannabis plants that produce a large amount of CBD”). Hemp extract, that is within the legal definition of the FDA, is a full spectrum extract that contains numerous cannabinoids and terpenes. Full-spectrum hemp extract that contains CBD in its naturally occurring amount is likely outside of the FDA’s “Drug Exclusion Rule.” However, CBD isolate that exceeds the naturally occurring levels found within the hemp plant is under FDA’s regulation and likely, only legally sold as Epidiolex®.
Summary:
Without new regulations, if the FDA decided to sue one of the CBD labs right now, then the courts are likely to have the same conclusion as Pharmanex v. Shalala. To the FDA, cannabidiol is a generic name for a trade name drug called Epidiolex®. If you are selling a CBD isolate, then you are selling a drug. It is as if you were distilling and selling your own Tylenol® or Advil®. Someone is going to have a problem with that.
Update: January 16, 2020
H.R.5587 — To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of hemp-derived cannabidiol and hemp-derived cannabidiol containing substances.
Yesterday, January 15th, in the House of Representatives a bipartisan group introduced a bill that would amend the Food, Drug, and Cosmetic Act to include CBD as a dietary supplement. So hopefully everything that I have written may become useless soon.
DISCLAIMER:
Dr. Jay Park is currently involved in a full spectrum hemp extract startup.
