Does the Future of CBD Supplements look like Red Yeast Rice?

The CBD & Hemp market continues to grow and capture the imagination of consumers and entrepreneurs. Applications are becoming more diverse, CBD marketing is more brazen and aggressive, and CBD doses are increasing (more is always better – right?).

The potential impact of dosing is concerning given the paucity of safety data. All of this leads to the burning question, “where will this all end up”? One could postulate that the FDA will eventually say enough is enough and ban it as it has done previously with ephedra. That action that was driven by adverse events. However, until comparable adverse events are identified and linked to CBD that may be an unlikely scenario. Nevertheless, few can imagine that the current wild west approach will be sustained.

Is it possible to look back into our past to predict the future? In this article I want to pose the concept that the way that Red Yeast Rice has been managed could predict how CBD will be regulated in the future. Let’s explore what that means.

Hemp vs Marijuana

Most consumers are aware that CBD comes from hemp. However, they may not know where in the plant it comes from. The source of CBD is not hemp seeds, these are basically cannabinoid-free but are used as a source of omega-3 fatty acids. This is why hemp seeds can be found in your breakfast cereal. However, some marketers are mixing hemp seed oil with cannabinoid-containing hemp extracts. That does not resolve the confusion. Further, CBD is just one out of 113 different chemicals called cannabinoids, that are found in the flowers/stems of Cannabis sativa. Additionally terpenes, aromatic chemicals, are also co-localized and thought to contribute to the biological actions of cannabinoids.

By contrast, in marijuana, delta 9-tetrahydrocannabidiol (THC), is the active of interest. The quantities of THC in hemp extracts are thought to be below the threshold for biological actions and the dominant cannabinoid in hemp is CBD. It is this difference in chemical profile in hemp extracts vs. marijuana that has opened up the market for CBD-based products, while the legal status of marijuana remains unresolved at the federal level.

The average consumer struggles mightily to differentiate the marketing of hemp products based on where in the plant it is generated, what is the difference between extracts of hemp seed vs CBD containing extracts, the difference between hemp and marijuana, the range of cannabinoids and terpenes in the product.

Where are the Guardrails?

Responsible marketers of CBD products seek a better definition of the boundaries within which they can operate. Clearly, excess levels of THC represents one boundary. Hemp products should have less than 0.3% and many use additional extraction procedures that to eliminate all THC to ease assist interstate commerce. Often this lowers terpene content and that may compromise efficacy, but that is another area for discussion.

The other boundary is less well recognized and that is the use of concentrated or pure CBD. The FDA has approved a cannabidiol (CBD) as a drug for childhood epilepsy (Epidiolex, Epidiolex Approval ). The FDA approval process is difficult, lengthy and burdensome, but it rewards companies that pass through that process. To have a myriad of companies sell the same chemical (cannabidiol or CBD) as a supplement is not something that the FDA approves. Supplement companies have not met the burden of proof of safety that the pharmaceutical company has delivered.

In the frenzy to use higher and higher doses of CBD in a product, companies may rely on added concentrated or pure forms of CBD to achieve the desired dose. The FDA could view this product as adulterated with an unapproved drug.

What can Red Yeast Rice Teach us?

Red Yeast Rice is a traditional Chinese medicine that also contains monacolin K, and that is chemical identical to the pharmaceutical Lovastatin, which is a statin that is widely used to lower cholesterol levels and prescribed for cardiovascular health. The benefits of monacolin K and lovastatin are identical, as are the side-effects, as they are chemically identical.

The critical difference is that Red Yeast Rice has only trace amounts of monacalin K (lovastatin) in it. The FDA has not prevented the sale of Red Yeast Rice as a supplement. However, if a product is found to have more than these natural trace levels of monacalin K, then the FDA views the product to be adulterated, and an unapproved drug that cannot be legally sold as a supplement (FDA & Red Yeast Rice).

The critical information here is that the FDA recognizes that the identical chemical form of the drug does exist in nature and as such it is legally sold as a supplement. However, if a Red Yeast Rice product is tested and found to have levels of monacalin K that exceed this natural level, then it has clearly been adulterated, with the pharmaceutical lovastatin. That renders the product an unapproved drug, and not a supplement.

It is easy to see a similar position being taken with hemp extracts and CBD. If a hemp product contains levels of CBD that exceed what is found in nature, then it has been topped off with additional CBD, and CBD (cannabidiol or epidiolex) is a drug. That would render the product an unapproved drug just as an adulterated Red Yeast Rice product that has levels of lovastin that exceed that found in nature.

At this stage it is important to state that I am not a lawyer (nor slept in a specific hotel chain or played one on TV). So this article is not a legal opinion, it is meant to simply pose the question “What if….”. My background is in drug discovery and academic medicine, with well over a decade of business development activity in the natural products sector.

One boundary for CBD remains clear and that is the THC (marijuana) boundary. Few are paying attention to the other boundary with epidiolex. In designing products within this arena it is possible to create products that meet consumer needs and avoid both of these boundaries. To do that one has to know where the guardrails are, and to not leave the playing field.