Is CBD Oil Legal Now? With Epidiolex Approved, It’s Still Not Clear

The FDA approved Epidiolex, a CBD-based drug made from cannabis grown in the UK. It's not clear what the approval means for CBD products outside the FDA's purview. (AP Photo/David Goldman)

The legal landscape around CBD (cannabidiol) is unsettled and unclear, and it became even more confusing with today’s FDA approval of the CBD-based drug Epidiolex.

Epidiolex, a “pure plant-derived CBD” extract developed by the UK-based GW Pharmaceuticals, has been shown to drastically reduce seizures in large populations of children with epileptic syndromes. (For a clear explanation of what CBD is and how it affects the brain, see Leafly’s guide to cannabidiol by Dr. Dustin Sulak.)

'Anybody out there that says the law on CBD is definite one way or another is lying.'
Jonathan Miller, Attorney, US Hemp Roundtable

The FDA’s approval of Epidiolex could mean very big changes for CBD nationwide. Just ask the DEA.

“The FDA is the entity in America that approves medicines. Not DEA, we’re cops. We depend on them to tell us if something’s a medicine,” Barbara Carreno, the DEA press officer, told me earlier this month during an interview about the legal status of CBD. “If they on June 27 announce that they’re approving Epidiolex, absolutely we’ll go into a different schedule. There’s no ifs, ands, or buts about it.”

As it turns out, the FDA announced it was approving Epidiolex on June 25, two days earlier than Carreno predicted.

The FDA’s decision on Epidiolex could mean the FDA would largely take over regulation of the cannabidiol molecule. That could mean things like prescription CBD available at pharmacies or even over-the-counter CBD medications. But in the near term, it also means even more confusion around the legality of CBD.

Raw CBD Still Federally Illegal, Says DEA

As of right now, though, today, nothing has technically changed in the legal status of CBD outside of Epidiolex. And that legal status is anything but clear.

With demand for CBD booming, many companies are moving ahead and delivering products into an uncertain legal landscape.

I know this because I stumbled into the briar patch last month, when I wrote a story under the headline, “Court Rejects Challenge to DEA Rule, Leaving CBD Federally Illegal.”

The 9th US Circuit Court of Appeals had just upheld a DEA rule defining any extract of the Cannabis sativa plant as a Schedule I controlled substance if it contains one or more cannabinoids. That definition that seemed to include CBD extract, and my story reported it that way.

The backlash began almost immediately. America’s hemp industry, which has been fighting for more than a decade to expand the legality of industrial hemp and hemp-derived products, balked at our headline. “This ruling does NOT leave CBD federally illegal,” one PR person wrote in an emailed request for an “urgent correction.”

Meanwhile, the US Hemp Roundtable, an industry group comprising some of the bigger names in industrial hemp, issued a statement saying the decision “should not be read as a substantive setback” for the industry.

“Contrary to some early reports, this ruling does NOT classify hemp-derived cannabidiol (CBD) as a controlled substance, nor does it signify that the popular hemp product is federally illegal,” wrote Jonathan Miller, the group’s general counsel. “In short, the DEA’s ‘marijuana extract rule’ does not apply to hemp or derivative products such as hemp-derived CBD. Period.”

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Two Clashing Views

I was puzzled. On one hand, the 9th Circuit ruling seemed to say that any extract containing a cannabinoid qualifies as a controlled substance. On the other hand, here was the hemp industry, including the very people who challenged the DEA extract rule in the first place, claiming it wasn’t affected.

Wisely, my editor suggested I revisit the issue. CBD has become wildly popular, but consumers and manufacturers are still hearing mixed messages—not to mention sporadically having their CBD products seized by law enforcement. So I did. I’ve spent the past few weeks trying to find clarity on cannabidiol.

I’m afraid there’s not much of it.

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A Quiet Turf War

As America reconsiders its relationship with the cannabis plant, a war has been raging over industrial hemp. With each new battle, boundaries are erased and drawn again—and not always clearly. The result is a complicated legal landscape that provides plenty of room for opportunistic interpretation, and has left many scratching their heads.

'It’s not legal just because you want it to be and because you say it is.'
John Hudak, Brookings Institute

One of the first people I spoke to was Jonathan Miller, the hemp industry attorney who’d written that the DEA’s extract rule “does not apply to hemp or derivative products such as hemp-derived CBD. Period.”

Things seemed a lot less clear-cut once we were on the phone. When I asked him about the legality of hemp-derived CBD extract, he explained that there are various circumstances under which hemp could be produced and distributed, each of which might yield a different legal result.

“Anybody out there that says the law is definite one way or another is lying,” he told me.

I pointed out that the statement he wrote for the US Hemp Roundtable sounded awfully definite. How, I asked, could he be so certain hemp-derived CBD is legal?

“Read it again,” Miller insisted. “We don’t say that this decision declares CBD legal. What we’re saying is this decision does not declare CBD illegal.”

He’s correct; there is a difference. But if that was the legal truth behind the hemp industry’s sweeping statement, how much else out there was built on equivocation?

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Threading the Needle

It’s not difficult to find claims from CBD manufacturers—or even from reputable publications—that CBD extract is “legal in all 50 states.” That’s not true, as even the hemp-industry lawyers I spoke with acknowledged. But where did those claims come from? And under what circumstances, if any, is CBD truly legal?

John Hudak is a senior fellow at the Brookings Institute and has written extensively on cannabis law and policy. He chalked up the “legal in all 50 states” claims to simple misinformation. “People don’t understand public policy and they don’t take the time to understand public policy. Someone tells them that this is legal,” he said, “and it becomes a telephone game of it being legal.”

“The hemp industry is convinced of their own righteousness, but they’re unconvinced of their own ignorance. So they’re saying things that are false and wrong,” he added. “This idea that it’s legal in all 50 states, that it’s legal to ship across state lines… It’s not legal just because you want it to be and because you say it is.”

In a February 2017 blog post—which he said still ranks among the institute’s most popular—Hudak wrote that CBD “is illegal and always has been.”

I asked him whether anything happened during the past year to changed that.

“The latest guidance from the DEA does change this a little bit,” he replied, referring to a rule clarification issued by the agency. “It’s not changing it as much as the industry is suggesting, it’s not changing as much as advocates say it is, but what it’s saying is that there is a very specific subset of products from which CBD can be extracted.”

Is Cannabis Two Plants in One?

At this point, things get even more confusing. In the eyes of a botanist, Cannabis sativa is just one plant. In the eyes of federal officials, however, it’s at least two. Legally speaking, industrial hemp is defined as a Cannabis sativa plant that contains less than 0.3% THC. Any more THC and it’s classified as marijuana.

Marijuana, famously, is a Schedule I controlled substance, more tightly regulated than opium or cocaine. But under a congressional farm bill passed in 2014, individual states can establish hemp pilot programs, through which Cannabis sativa plants containing only trace amounts of THC—in other words, industrial hemp—can be grown and processed.

In Hudak’s view, CBD extract made from hemp that complies with a state’s hemp pilot program as authorized under the 2014 farm bill would indeed be federally legal. “If all of those details, all of those provisions are met, then yes, the CBD is legal,” he said.

Is Your CBD Federally Legal? Follow Leafly’s Flow Chart

Click on image to enlarge. Note: “R-B” refers to the Rohrabacher-Blumenauer budget amendment, which prevents the Justice Department from using any of its budget to interfere with state-legal medical cannabis use. (Illustration by Elysse Feigenblatt/Leafly)

Find the Source

Some in the hemp industry call this the “source theory.” Its logic is appealingly simple: CBD extract is legal under federal law if the Cannabis sativa plant it’s derived from is legal. “It’s lawful if the source is lawful,” explained Rob Kight, a hemp industry attorney based in North Carolina.

The logic of 'source theory' is simple: CBD extract is legal under federal law if the plant it’s derived from is legal.

Hudak at Brookings agrees with the so-called source theory—with a caveat. Pointing to provisions in the farm bill that seem to limit hemp cultivation to “institutions of higher education and State departments of agriculture,” he said the law appears to put restrictions on how hemp can be used commercially.

Kight, however, took issue with that interpretation. The farm bill defines a pilot program as one “to study the growth, cultivation, or marketing of industrial hemp,” and while Kight acknowledged the law “doesn’t give a lot of indication” as to precisely what that means, he argued that it provides more leeway than one might think. Commercial sales, for example, could actually be seen as a form of research into hemp’s economic viability.

As for the provision about limiting cultivation to institutions of higher learning or state departments of agriculture, he added, “There’s nothing unusual about a state licensing private actors.”

Enter the DEA

If some in the hemp industry are guilty of exploiting a murky legal situation to their favor, the same can be said of the DEA. As the war over CBD extract has unfolded, the law enforcement agency has engaged in its own equivocation, further complicating the conversation about what’s legal and what’s not.

“The DEA does not like CBD and cannabis extracts,” Kight, the North Carolina hemp lawyer said, “and it doesn’t want to admit circumstances under which it is lawful.”

When the DEA adopted its marijuana extract rule in 2016, many saw the move as a sign of the agency’s antipathy toward the plant and its pharmacological uses. The DEA itself, however, downplayed the rule as merely an administrative change, meant to bring US drug classifications more closely in line with international treaties.

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DEA’s Clarification Memo

In response to confusion over the new rule, the DEA issued a clarification memo. But, similar to how the hemp industry has sometimes exaggerated the legal protections for hemp-derived CBD, the DEA’s clarification struck some more as an effort to gain ground.

In theory, said Hudak at Brookings, “the DEA clarified this. But in reality, it set up what are some of the most restrictive rules about when CBD can be legal.”

That has frustrated attorneys who represent the hemp industry. The DEA has a responsibility to clearly state how it sees these issues, Kight said, but instead the agency sometimes seems to resort to obfuscation.

“What [the DEA] should be doing is acknowledging what the law is and saying, ‘This is how we’re going to enforce it,’” Kight said. “Instead, it’s begrudgingly moving as it has to and it’s continuing to muddy the waters.”

“The main difficulty is this confusion, lack of education, and complex system of rules and regulations that overlap,” he added. “When you add all the other layers and the marijuana extract rule … it just becomes a morass. No non-expert in the field could be expected to understand it.”

So I called the DEA.

Getting the DEA on the Record

When I spoke to Barbara Carreno, a DEA press officer, she acknowledged that the legality of CBD was a difficult subject. “There’s tremendous confusion out there, and it’s not surprising,” she told me.

The DEA says products like rope and fiber from Farm Bill-related hemp are legal. But CBD is not.

I asked whether there were any circumstances under which the DEA would agree that hemp-derived CBD would be legal. If hemp were grown legally under a state pilot program, for example, and if that hemp were then processed into CBD extract—the source theory in action—would the DEA consider that extract to be legal?

No, Carreno told me.

“CBD is separate from hemp,” she said. “The farm bill is about industrial hemp products. It’s a pilot program for growing marijuana with which to make industrial hemp products—the ropes, shampoos, things like that.”

Hemp fiber, for example, is used to make things like paper and textiles. Sterilized hemp seed can be eaten or turned into hemp milk, which makes for a tasty latte. “The definition of marijuana exempts those hemp products,” Correno said, “whereas the definition of marijuana within the CSA would include CBD as Schedule I because it’s made from viable seeds.”

But…That’s Not So

It’s worth pointing out that the last part of that statement—that CBD comes from “viable seeds” of the Cannabis sativa plant—simply isn’t true. CBD extract is typically made from all parts of the hemp plant—primarily its leaves, buds, and stalks—and doesn’t require the use of viable plant seeds at all.

I started to push back, but Carreno doubled down. “You have the CSA saying that; it’s by definition in the CSA,” she said. “CBD is made from viable seeds, which is not hemp.”

Carreno was the only DEA representative I spoke to for this story, so I don’t know if her statements reflect the agency’s views. The DEA’s clarifier actually says something different. But Carreno’s response underscores the ongoing confusion around hemp-derived CBD, even among people who are supposed to be setting the record straight—to me, a person who is supposed to be setting the record straight. See why people are so confused?

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Enforcement and Enforceability

As I was reporting this story, a package arrived at my desk. Inside were two 100-milligram bottles of hemp-derived CBD extract, sent as an unsolicited sample from a California manufacturer.

The juxtaposition was striking—and emblematic of the current market for CBD. Even as lawyers and federal agencies face off over whether or not this stuff is legal, enterprising businesses are already selling it online and at stores throughout the country.

Amid a confounding legal landscape and a booming market for CBD, many companies have decided to forge ahead and push the limit of what’s legal, whether out of ignorance, principle, or calculated risk.

Unfortunately, law enforcement is often just as confused about the law as anyone. Especially at the local level, lawyers for the hemp industry said, legal obstacles often stem from misinformation or misunderstanding. “What you see, across the country, are local or county-level arrests or seizures, and that has to do primarily with a lack of education,” said Kight. “It gets confusing, because in my experience probably 70% to 80% of the time, the local law enforcement are just uneducated.”

Shipments Flagged, Beer Rejected

What he means by this, he explained, is that sometimes CBD extract presumed legal under the source theory is flagged as illegal by authorities and seized. In other instances, regional postmasters have returned shipments as undeliverable.

The DEA’s extract rule has also reared its head in the alcohol industry, where a San Francisco brewery was recently told to cease production of a CBD-infused beer after federal alcohol regulators deferred to the DEA on whether the CBD oil being used was legal. Unsurprisingly, the DEA said it was not.

“To get into this business, you need to understand it’s a risk,” Miller, the Hemp Roundtable attorney told me. “There’s a risk of law enforcement. That’s just the nature of the beast.”

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Fight Not Worth It

Is it possible to challenge these decisions? Possibly, said Kight, but it’s an expensive legal fight that might not be worth the effort.

“What is someone to do?” he said. “There are ways and mechanism to challenge this, but it’s pretty convoluted. You’re not just challenging one agency.” Because a given arm of the federal government often internally defers to other agencies’ expertise on questions of health or drugs, legal challenges can become a complicated knot of arguing against self-reinforcing rules.

Kight said he advises clients to “walk that narrow path so it is legal,” such as by processing only hemp grown in accordance with state hemp pilot projects. He also encourages clients to keep records on their products so they have an easier time arguing legality if ever called into question.

Be Ready to Show It’s Legal

At Brookings, Hudak thinks that’s a good idea. Though there are certain provisions in congressional spending bills that restrict prosecution against state-legal hemp business, law enforcement’s decision to seize products or bring criminal charges is a matter of discretion, a human decision. Given the state of the market, Hudak said, you need to be ready to demonstrate why you think your product is legal.

If a producer finds itself in court defending its product, “the burden is going to be on the producer to show that the CBD was produced legally,” he said. “The benefit of the doubt is most likely going to be given to law enforcement by the courts.”

In other words, don’t assume that just because you’ve read somewhere that CBD is “legal in all 50 states” that the argument will carry much water in court.

Enforcement Is Uncommon

Consumers across the country, meanwhile, are left in the lurch. Sure, CBD extract—or products described as such—are available online, but the fact that some products may be legal certainly doesn’t mean all of them are. When I asked Miller how much of the hemp-derived CBD extract on the US market he thought might be legal, he replied, “I don’t know the percentages.”

Nor does it mean buyers are necessarily safe from enforcement. True, enforcement might be uncommon, but penalties—not to mention going through the legal process itself—can be daunting.

“It’s very hard to navigate because there’s so much misinformation out there,” said Hudak at Brookings. “When you get into stuff that’s purchased online, that’s shipped across state lines, you’re talking about potentially pretty serious crimes. It’s all pretty much a gray area.”

Where to Buy CBD Extract

The safest way to buy CBD extract for a growing number of Americans might be to not worry about whether or not it’s federally legal. In states with robust medical cannabis programs, CBD extracts are available for patients with a wide variety of medical conditions. Likewise, in adult-use states like California, CBD products are available to adults over 21 alongside products with THC.

“In a dispensary in Seattle, no one is lying to their customers and saying, ‘This joint I just sold you is legal in all 50 states,’” Hudak said. The fact the transaction is illegal under federal law is understood. But it exists at least in a place of some certainty, with federal prosecutors in most legal states acknowledging that going after law-abiding cannabis consumers isn’t a top priority.

In the context of a state medical marijuana program, legal protections are even stronger. The Rohrabacher-Blumenauer amendment, recently renewed by Congress, bars the Justice Department from using any federal funds to interfere with state-legal medical cannabis. These days, that’s about as clear-cut legal as you’re going to find.

Meanwhile, on Store Shelves…

Despite the legal morass, plenty of other hemp-derived extracts that have been carefully manufactured are available online and on store shelves. Here in Washington, CBD products are sold at beauty salons and vitamin stores. My morning coffee shop offers CBD-infused tea. In Los Angeles, trendy juice shops will toss in a shot of CBD oil for a slightly unreasonable fee.

Based on both personal and anecdotal experience, some of these products are wonderful. But they’re also inconsistent. That’s largely a reflection of the legal and regulatory confusion in today’s market.

Change could also come from hemp legislation introduced by US Sen. Mitch McConnell of Kentucky, who recently became a champion of his state’s industry, which dates back to 1775. Hemp industry attorneys say the bill would widen the scope of the source theory considerably. While a majority of hemp-derived CBD on the market might not yet be legal, “it will be soon, particularly if the McConnell bill passes,” Miller told me.

You might’ve missed it among the headlines, but the war over cannabidiol has been steadily simmering in the background. Tell your friends. You’re about to hear a lot more about CBD. And if we’re lucky, maybe someday the laws will catch up.

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Correction: An earlier version of this story misidentified where attorney Rod Kight is based. He’s located in North Carolina, not Kentucky.