Has the FDA Approved CBD Oil?

While cannabidiol (CBD) is ever-presently pushed in the modern marketplace, the U.S. Food and Drug Administration (FDA) has not approved CBD oil use except for in the treatment of two relatively rare and debilitating seizure disorders.

According to a consumer update on the drug oversight agency’s website, there is simply very little information available currently about cannabis-derived substances. Its long-term effect on the body is of concern to the FDA as well as unsubstantiated claims connected to its advertising in various forms.

What Effect Has The Passage Of The 2018 Farm Bill Had On The FDA’s Approval Process?

In 2018, the Farm Bill passed which removed hemp from the category of marijuana according to very specific criteria. Those criteria noted that hemp was cannabis and derivatives with low concentrations of tetrahydrocannabinol (THC)—up to a cap of 0.3 percent as measured in dry weight.

While local laws are changing regarding the medical and recreational use of marijuana, the passage of the Farm Bill removed hemp from the realm of federal contraband in terms of a controlled substance and made it easier to conceive of FDA-approved CBD oil in the future.

Nevertheless, like every substance that is a part of medication, there are laws and regulations that must be adhered to in order to get to that point. This includes an extensive review of data as it relates to CBD’s effect on a particular population—such as infants and children—and whether the benefits of treatment for an ailment outweigh concerns in a risk-benefit analysis.

What Are The Conditions For Which The FDA Has Approved CBD Oil?

In a separate article posted by the FDA on June 25, 2018, it was noted that the agency had just approved Epidiolex—an oral suspension of CBD oil for use with two epileptic conditions. The conditions named were Lennox-Gastaut syndrome and Dravet syndrome, the latter of which was being medically treated for the first time with the introduction of this product.

Dravet Syndrome has an early onset in the first year of life, while Lennox-Gastaut syndrome starts roughly around 5-6 years of age. Both seizure disorders have very serious consequences in terms of children reaching physical and learning developmental milestones.

It was noted in the article that the CBD oil in the suspension doesn’t contain THC—the known psychoactive ingredient typically associated with marijuana use.

Former FDA commissioner Scott Gottlieb was quoted as saying that the agency was committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.

Gottlieb also remarked to the effect that in addition to introducing marijuana-derived treatments in an appropriate fashion to the American people, the FDA is also committed to rooting out illegal marketing efforts and false claims about CBD oil. He notes that this illegal marketing prevents patients from seeking care with known beneficial and measurable results.

How Have State Governments Approached Hemp and CBD Legalization?

Since the Farm Bill, also known by its official name, the Agriculture Improvement Act, legalized the production of industrialized hemp, the CBD industry has boomed. Now, the industry around approved CBD oil products is worth more than a billion dollars.

However, despite the legalization of hemp sale, CBD is largely unregulated. For example, the FDA has not explicitly explained if CBD can be legally used in food or not. This ambiguity, among other points that may lack regulation, can put consumers at risk. A lack of regulation may mean that products containing CBD may contain varying levels of CBD, regardless of what their labels say. This also may mean that CBD products could contain unadvertised and possibly dangerous additives.

Some states are attempting to combat the lack of regulations bypassing state laws to better control the growing, manufacturing, and licensing process for the hemp and CBD industry. One such law in New York attempts to control the flow of unregulated CBD products from other states to New York, as well as the products from within the state. In New York, some cannabis industry members did note that the law still did not offer answers for all areas of CBD’s legality, but approved of the law change nonetheless.

Though some of these state laws in New York and elsewhere may still leave some ambiguities, these steps to further outline the specifics of hemp and CBD legality are steps on a path towards making CBD products safe and reliable for consumers.

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This article is not legal advice. It is presented
for informational purposes only.