Now That Hemp Is Legal, Is Cannabidiol (CBD) Legal Too?

Green Wheat Field, Vincent van Gogh (1889) Source: Public Domain “Good people don’t smoke marijuana.” — Jeff Sessions, US Attorney General (2017-2018) With President Trump signing off on the Agricultural Improvement Act of 2018 (aka the 2018 Farm Bill) last month, the federal government now fully recognizes hemp as a legal agricultural product. But while…

Now That Hemp Is Legal, Is Cannabidiol (CBD) Legal Too?


Public Domain

Green Wheat Field, Vincent van Gogh (1889)

Source: Public Domain

“Good people don’t smoke marijuana.”

— Jeff Sessions, US Attorney General (2017-2018)

With PresidentTrumpsigning off on the Agricultural Improvement Act of 2018 (aka the 2018 Farm Bill) last month, the federalgovernmentnow fully recognizes hemp as a legal agricultural product. But while many reports are claiming that this means that cannabidiol (CBD) is also legal, that’s not quite correct. With a lot of misinformation flying around, and contradictions between state and federal laws, things are admittedly somewhat confusing. Let’s try to sort things out by answering some questions about hemp, CBD, and what has recently changed in federal law.

What is hemp?

Hemp is a variety of theCannabis sativaplant that is grown specifically for industrial purposes. For millennia, people have used hemp fibers from the stalks and stems of the plant to make rope, textiles, paper, and many other products and have also used its seeds (and the oil from the seeds) as a food source. In the US however, heavy regulation and taxation of hempdatingback to the Marihuana Tax Act of 1937 and subsequently through the Controlled Substances Act of 1970 all but rendered hemp farming in the US a legal impossibility for most of the past century.

In recent years however, with increasing state legalization of cannabis and a burgeoning multibillion-dollar cannabis industry, US farmers have increasingly lobbied to remove federal restrictions against growing hemp. The Agricultural Act of 2014 (aka the 2014 Farm Bill) signed by President Obama set the stage for this to happen by loosened restrictions on hemp, allowing universities and state agriculture departments to grow it for research purposes. Now the 2018 Farm Bill opens those gates more broadly, allowing licensed farmers to grow hemp and transport it across state lines based on agreements and regulations to be established between states and the federal government.

Note that the federal definition of hemp requires that it contain less than 0.3% delta-9-tetrahydrocannabinol (THC), the euphorigenic component of cannabis. And while the terms “cannabis” and “marijuana” are often used interchangeably, the Controlled Substances Act of 1970 specificallyexcluded the mature stalks of the cannabis plant used in industrial applications — essentially hemp — from its definition of marijuana.

What is cannabidiol?

Along with THC, cannabidiol (CBD) is one of more than a hundred “phytocannabinoids” contained in theCannabisplant. Relative to the amount of THC in marijuana grown for recreational use, the amount of CBD is trivial, with the proportion of THC to CBD increasingly widening over the past several decades.1The breeding of cannabis strains with more THC and less CBD has occurred in response to recreational consumer demand. More THC means more of a “high,” whereas CBD — which can oppose some of the effects of THC — doesn’t have any euphoric effects and may interfere with the high produced by THC. So, for the most part, CBD-laden marijuana has not been what recreational users are looking for.

In the past several years however, public interest in CBD has skyrocketed based on claims — largely unsubstantiated through good clinical research thus far — that it may be a kind of cure-all miracle drug, with therapeutic effects ranging from pain relief to eradicating cancer. In fact, while CBD research has been limited due to federal restrictions, preliminary evidence does suggest that it might help withpsychiatricconditions likeanxietydisorders (note that while many people claim that CBD is not “psychoactive,” it’s potential as an anxiolyticmedicationsuggests otherwise) and  recent randomized, controlled clinical trials suggest a possible role in the treatment of psychotic disorders.2,3In 2018, the Food and Drug Administration (FDA) approved Epidiolex, a form of CBD manufactured by GW Pharmaceuticals, for the treatment of rare forms of pediatric epilepsy (see my blogpost “Cannabis for Kids: Can Marijuana Treat Childhood Seizures?“).

Within the cannabis industry, CBD products have become a hot commodity, with some companies using hemp-derived sources to extract CBD in order to stay on the right side of federal law. Just how much CBD is contained in hemp isn’t clear however. There isn’t much in the stalks and seeds of the cannabis plant, but breeders have been developing hemp and marijuana strains with “high CBD” content and extracting CBD from plants in the form of concentrated oils. In states where they’re legal, CBD products are increasingly popular and are often included as an additive to beverages and other food products.

With the increasing hype surrounding CBD, some — including this author — have speculated that it will become the nexthealthfad, like takingfish oilor opting for a gluten-freediet, whether or not the research to support far-reaching health benefit claims pans out (see thisrecentNew York Timesop-ed by Cornell Medical College psychiatrist Richard Friedman urging caution). “Big Beverage” companies like Coca-Cola have even been exploring whether they should jump in the ring lest they miss out, bringing CBD infused drinks to the mass market sometime in the not-too-distant future (see my blogpost “Coca, Cola, and Cannabis: Psychoactive Drugs as Beverages“).

What’s legal and what’s not?

Here’s where things can get confusing. With increasing legalization of cannabis and cannabinoids, more and more states have legalized cannabis and its constituents including THC and CBD for either medical or recreational use (several states have specifically legalized CBD products, but not THC or cannabis in general). But the federal government has held firm, keeping marijuana illegal as a Schedule I drug (defined as having no accepted medical use in the US, a lack of accepted safety for use under medical supervision, and a high potential for abuse) per theDrug Enforcement Agency’s classification of controlled substances.

Since marijuana is illegal on a federal level, but legal on a state-by-state basis, growers and cannabis businesses cannot legally transport cannabis products across state lines. Some companies that make CBD products — usually supplied in the form of lotion, oils, and pills — have done so anyway, based on the claim that CBD derived from hemp can be classified as botanical extract and a dietary supplement. But over the past few years, the FDA has issued numerous “cease and desist” letters to companies produce cannabis products warning them not to make health-related CBD claims andmaking clear that it does not consider CBD a dietary supplement.

The FDA’s refusal to allow companies to market CBD as a dietary supplement is based on the fact that federal classification as a dietary supplement requires that a substance has not been authorized for investigation as a new drug or medicine. Since Epidiolex has been studied in clinical trials by GW Pharmaceuticals going back several years now and was granted orphan drug status by the FDA in 2013, CBD cannot therefore be classified as a dietary supplement. Or so the FDA says. But cannabis companies are arguing that they startedmarketingCBD as a dietary supplement before there were any drug trials involving CBD, such that they should still be allowed to claim dietary supplement status for their products. Thus far however, the FDA isn’t budging on this issue.  

In 2016, the Drug Enforcement Agency (DEA) created anew coding category to classify “marihuana extracts”like CBD, but in doing so made clear that CBD was still classified as a Schedule I drug and therefore still illegal. Although the 2018 FDA approval of Epidiolex meant that the DEA removed this specific CBD drug from Schedule I classification,all other non-FDA approved forms for CBD remained classified as Schedule I drugs.

Now, with the passing of the new 2018 Farm Bill,hemp and hemp-derived products have been officially removed from the purview of the Controlled Substances Act, such that they are no longer subject to Schedule I status. Meaning that so long as CBD is extracted from hemp and completely pure (withoutany THCsomething the DEA doubts is possible) and grown by licensed farmers in accordance with state and federal regulations, it is legal as a hemp product.

But in response to the 2018 Farm Bill, the FDA issued a statement noting that the new legislation preserves the FDA’s authority to regulate cannabis and cannabis-derived compounds like CBD, regardless of its source. It also voiced specific concerns about unsubstantiated health-related CBD claims and iterated the unlawfulness of marketing CBD as a dietary supplement or adding it into food products (read thefull FDA statement here). So while hemp cultivation and the extraction of CBD from it may now be legal, what the federal government will allow to be done with CBD products from that point on remains to be seen.

Note that the original federal distinction between hemp and marijuana in the Controlled Substances Act of 1970 was intended to separate useful industrial applications of hemp from the potentially hazardoussmokingor other consumption of marijuana and its constituents for recreational purposes. In thefine print of the Controlled Substances Acthowever, exemption of hemp from the definition of marijuana didnotinclude the resin extracted from the mature stalks of plants which might be expected to contain concentrated cannabinoids. While the 2018 Farm Bill passed by a Republican majority US Senate and House of Representatives in order to provide relief to farmers so that they can now grow hemp for industrial applications and apply for grants and insurance to do so, it may not have been intended to provide a new pathway to extract and purify CBD from hemp plants with the intent of large-scale human consumption as a food additive, dietary supplement, or medication. But make no mistake — cannabis companies are excited about and are intending to negotiate just this possibility. We’ll have to see how the FDA and DEA, and in turn federal judges and legislators, respond.

 

To learn about more about marijuana and cannabinoids from a medical perspective, see my three-part series “AParent‘s Guide to Modern Marijuana”:
► Part 1: “Skunk, Wax, and Edibles: What Marijuana Is Your Child Using?

► Part 2: “Zombie Outbreak!? “Spice” and the Synthetic Cannabinoids

► Part 3: “Cannabis for Kids: Can Marijuana Treat Childhood Seizures?

And alsoCoca, Cola, and Cannabis: Psychoactive Drugs as Beverages

References

1. ElSohly MA, Mehmedic Z, Foster S, et al. Changes in cannabis potency over the last 2 decades (1995-2014): Analysis of current data in the United States.Biological Psychiatry2016; 79:613-619.

2. Crippa JA, Guimares FS, Campos AC, Zuardi AW. Translational investigation of the therapeutic potential of cannabidiol (CBD): Toward a new age.Frontiers in Immunology2018; 9:2009.

3. Pierre JM. Cannabidiol for schizophrenia: Promise or pipe-dream?Current Psychiatry2019 (in press).

I hereby give credit where credit is due to the author

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