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Will The FDA Ever Approve CBD Oil?

Will The FDA Ever Approve CBD Oil?

Recently the FDA approved a new CBD-based prescription drug called Epidiolex for the treatment of two rare forms of intractable childhood epilepsy. Although these conditions represent only a minuscule portion of the conditions for which the cannabinoid compound known as cannabidiol shows promise as medicine, many hail the move as the opening of a floodgate for the prescribing of CBD for other conditions. And they are probably right.

The move will also result in the down-scheduling of hemp by the DEA, forever divorcing hemp from marijuana in the eyes of the law.

Since the FDA approved a CBD drug, does that mean it might approve CBD oil?

Will The FDA Ever Approve CBD Oil?

The Definition of CBD Oil

While some CBD oil on the market today is of extremely high quality, unfortunately for consumers, the CBD oil market is still in its Wild West phase. There are too few regulations for its production and marketing, and too few regulators to enforce them.

Just about anything can be called “CBD oil.” A manufacturer can add a drop of CBD isolate to a gallon of corn oil and call it “CBD oil” with exactly zero consequences, aside from bad reviews online. However, what most people refer to as “CBD oil” falls into one of two categories — refined hemp extracts, or CBD-infused oils.

[Also read: FDA Calls CBD “Beneficial," wants your opinion]

CBD oil products — all types — start their life out as an extract of hemp. This raw essential oil contains a variety of cannabinoids and terpenes and is commonly referred to as “raw hemp extract.”

Raw hemp extract can be further refined and filtered to produce a cleaner and more potent product which is commonly referred to as “full-spectrum CBD oil” and is known to provide an entourage effect — the combined effect of the particular ratios of cannabinoids and terpenes.

Full-spectrum oil can be further refined to isolate individual cannabinoids. The purified form of CBD is known as “CBD isolate.” CBD isolate can then be added to oils, tinctures, edibles, beverages and so on. However, none of these CBD-infused products contain the original spectrum of medicinally beneficial cannabinoids and terpenes — and therefore do not produce an entourage effect.

Will The FDA Ever Approve CBD Oil?

Will CBD Oil Ever Be Approved By the FDA?

So, if Epidiolex can be approved as a prescription drug, why can’t CBD oil be approved as a prescription drug? The answer lies in the consistency of the product.

The production and purity of CBD can be tightly controlled to produce a consistent product every time. Isolated CBD is just that — pure CBD. Consistent production means consistent dosing, which in turn results in relatively predictable physiological effects on the human body. When a person takes a dose of Epidiolex, or pure CBD isolate they are getting nothing else.

Full-spectrum CBD oil, on the other hand, depending on the crop from which it was extracted and the extraction method used, can vary greatly from batch to batch. Each batch of full-spectrum CBD oil will be higher or lower, in particular, cannabinoid or terpene compounds than every other batch. It would be near impossible to produce a consistent unrefined product.

And, in the case of CBD-infused products, although the production of the CBD itself can be tightly controlled, the control over the manufacturing of the final product, as well as the ingredients used, becomes very difficult. It requires GMP-certified pharmaceutical-grade facilities and FDA approved ingredients. So, it is possible to produce another drug which contains both CBD and other active compounds. However, the resulting drug will just not be considered “CBD oil.”

Will The FDA Ever Approve CBD Oil?

The Future of Cannabinoid-Based Medicine

As mentioned, the approval of Epidiolex has likely opened a floodgate of opportunity for the development of cannabinoid-based medications which contain individual purified cannabinoids including CBD, and delta-9 tetrahydrocannabinol (THC), and other less abundant cannabinoids such as cannabigerol (CBG), and cannabinol, (CBN).

If through rigorous clinical trials, any of these medicinal preparations are deemed to be markedly effective with little or no side-effects, cannabinoids could also be approved for use in an over-the-counter product such as cosmetics, pain relievers, dietary supplements, and so on.

But let’s not get ahead of ourselves. Far more laboratory research will be needed to warrant the undertaking of actual human clinical trials needed to determine CBD’s effects and unwanted side effects in the treatment of non-critical conditions — such as dry skin, zits, or occasional headaches — to receive FDA approval.