CBD is Everywhere- Is it Legal?

Ah, you are asking a very good question! And, of course, like many things surrounding cannabis, the answer isn’t a straightforward yes or no.

A bit of background: The cannabis plant has over 60 different chemical compounds known as cannabinoids. Until very recently the cannabinoid that drew the most interest was THC, (tetrahydrocannabinol) because this is the compound that induces an intoxicating effect, in other words, gets you high. But now, another cannabinoid is starting to steal the show from THC and that’s CBD (cannabindiol).

In the last few years commercial and healthcare interest in CBD, which is non-intoxicating, has grown tremendously in part because of the 2018 Farm Bill signed into law in December of 2018, which took effect on January 1, 2019. (https://www.congress.gov/bill/115th-congress/house-bill/2/text).

Since the 2018 Farm Bill, CBD is everywhere! You can find CBD products in a wide range of places including but not limited to, hair salons, cosmetic outlets, pharmacies, dentists and chiropractors offices, gift shops, gas stations, on-line sellers, bookstores, grocery stores, and pyramid marketing companies,

So if it's being sold everywhere, it must be legal right?!? Well, it depends.

The facts, nothing but the facts: The legal status of CBD is very confusing for everyone, including regulators and government departments. Let’s start with the Controlled Substances Act of 1971. This Federal law identifies cannabis, any aspect of cannabis, as a schedule 1 drug. According to the Federal Drug Administration (FDA), Schedule 1 drugs have no medical use, have a high potential for abuse and are otherwise dangerous and illegal. The 2018 Farm Bill did not remove cannabis from the schedule 1 drug list, but it did separate the legal designation of cannabis into hemp and marijuana.

Under the Farm Bill, hemp is described as a cannabis plant producing less than 0.3% THC, which can now be grown and cultivated with strict Federal and State oversight and licensing. It also allows for hemp derived products, including cannabinoids, to be transferred or sold across state lines for commercial and other purposes provided that the hemp plant was cultivated consistent with State and Federal regulations and by a licensed grower.

Note that although the Farm Bill removes schedule 1 designation for hemp plants, it does not include language specifically legalizing CBD (https://www.fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019). In fact, CBD derived from cannabis plants with greater than 0.3% THC remains illegal and cannot be sold on the open market. CBD from cannabis plants with greater than 0.3% THC can only be sold in a medical cannabis dispensary.

What About the FDA? The 2018 Farm Bill clearly indicates that the FDA retains jurisdiction over hemp products. This means that the FDA’s existing rules governing food, cosmetics, supplements, human and veterinary drugs also apply to any product containing CBD. Currently no health claims can be made about supplements unless they are researched and fully substantiated. The same standard is also applied to hemp. In addition, under FDA law, no food, supplement or product can be sold across state lines if it contains an active ingredient in an approved, existing medication. What this means is that a food product or supplement cannot contain an active ingredient that is also found in medications physicians would prescribe for medical conditions such as diabetes or high blood pressure. This law is meant to protect the public and when viewed from the perspective of diabetes or high blood pressure medication makes total sense.

But, this muddies the water for CBD because in the same year that the Farm Bill passed, the FDA approved the drug Epidiolex®, a plant-based CBD medication used to treat severe forms of childhood epilepsy. This means that CBD is an active ingredient in a prescribed medication. And although there’s been a flood of CBD products on the commercial market since January 2019, foods, cosmetics and supplements with CBD are actually in violation of the FDA statues.

What’s the Bottom Line? The FDA is very concerned about the health claims being made by commercial entities who have been adding CBD to a wide range of products. This is because the only rigorous research to date on CBD has been on Epidiolex® and Sativex®, a plant-based medication for spasticity that has a 1:1 ratio of CBD to THC. Sativex® is approved for medical use in Europe and is in phase III clinical trials in the US.

The FDA is trying to expedite the usual processes of investigating and approving CBD. As of January 26, 2023 the FDA has concluded that the existing regulatory frameworks for foods and supplements are not appropriate for CBD because it hasn't been fully studied in terms of dose, efficacy, risk, and drug interactions.

Although there is no real concern that an individual citizen is at risk for legal action by using a commercially available hemp derived CBD product, the FDA is issuing cease and desist letters to purveyors who make health claims about their CBD products.

This is all to say that CBD remains a gray and murky issue. Click here for a link to the FDA website dedicated to the regulation of cannabis and cannabis-derived products.

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