Skip to main content

This cannabis-derived drug just got approved, but that won’t make it easier to get edibles

This cannabis-derived drug just got approved, but that won’t make it easier to get edibles

/

Once again, the government says it’s okay to get cannabis from your doctor, but not over the counter

Share this story

cannabis (flickr cc)

Last week, the Drug Enforcement Agency gave the all-clear for Epidiolex, an epilepsy drug derived from cannabis, to be sold on the market. Though cannabis is still illegal at the national level, Epidiolex is now in the least restrictive category of drug regulation, Schedule V. The move is a good news for pharmaceutical companies that want to develop their own cannabis-based drugs, but it won’t mean much for other cannabis “wellness” products.

Epidiolex, made by GW Pharmaceuticals, treats severe forms of childhood epilepsy and is the first drug derived from natural cannabis that is approved by the US Food and Drug Administration. Epidiolex includes cannabidiol (CBD), a chemical that comes from the cannabis plant that is not psychoactive. (In terms of legality, no one really knows how to classify it yet.)

CBD wellness products should still be regulated

Though the FDA approved the drug back in April, GW couldn’t sell it because the DEA has deemed cannabis a Schedule I drug along with heroin, LSD, and cocaine, meaning it is considered to have “no currently accepted medical use and a high potential for abuse.” Now, Epidiolex specifically — but not CBD or cannabis in general — is Schedule V. “The DEA is saying, ‘if you’ve satisfied FDA, you’ve satisfied us,’” says Andrew Ittleman, a partner of the law firm Fuerst Ittleman David & Joseph. It’s showing a “fair amount of deference” to the FDA.

In other words: CBD in an FDA-approved product is okay and has a low potential for abuse, and CBD in a product not approved by the FDA is as dangerous as heroin. (Sorry about your CBD lattes.)

Schedule V includes the other anti-seizure drugs, so it makes sense that the DEA made this choice, says Stephanie Yip, an analyst with Informa Pharma Intelligence. For context, other cannabis-based drugs on the market (these are synthetic, whereas Epidiolex is natural) are in Schedules II and III because they contain the psychoactive component THC. Yip adds that, in the past four years, the number of companies doing cannabis research has grown from 16 to 40; these are mostly smaller companies, not including partnerships. The main research interest is pain and then chemotherapy-induced nausea and vomiting.

it’s not enough to reschedule a single drug and expect that to dramatically change the landscape

So expect pharmaceutical companies to take note. But this won’t have much of an effect on the CBD wellness products — including mascara, bath bombs, and weed lube — that are popping up everywhere. “I don’t believe there is a practical application for a cannabis manufacturer,” says Serge Chistov, an investor in Honest Marijuana Company. The government might be softening its grip, but the decision is so limited that “it really doesn’t help us unless we want to go the FDA route.”

And the FDA route is bureaucratic and expensive. Because cannabis remains Schedule I, it’s difficult for scientists, both in academia or industry, to do research on the drug. Daniel Friedman, an NYU neurologist who co-authored a study investigating the effectiveness of Epidiolex, told The Verge that the team had to go through a complicated bureaucratic process. This involved obtaining a special license from the DEA, special equipment, and “all that infrastructure makes it prohibitive to do studies in other conditions by people who may want to do so, but don’t have the resources.” These same restrictions mean that as of 2013, fewer than 20 randomized controlled trials (the gold standard for scientific research) have tested the benefits of marijuana, according to the American Medical Association.

That leaves many manufacturers bypassing the FDA entirely. Most CBD products are not exactly legal, and there are plenty of gray areas as individual states decide what to do. In fact, the FDA has sent “warning letters” to CBD manufacturers before, though with giant corporations like Coca-Cola considering CBD drinks, there’s unlikely to be a real crackdown.

We have ended up in a labyrinth of contradictory rules: it is extremely difficult to obtain the license to study cannabis, a dangerous drug. But if you do study it and it gets approved, the cannabis is not dangerous anymore. It’s good that Epidiolex has been moved to Schedule V, but this narrow move won’t solve these two larger and interconnected problems. It’s too hard to study cannabis, full stop. And precisely because it’s so difficult to study, there’s a lot of hype and misinformation, which makes it easy for people to shill CBD and cannabis products that might not live up to their promises. This quasi-legal industry remains unregulated and potentially full of snake oil salesmen. Last year, the FDA tested CBD wellness products, and many didn’t contain the amount they had claimed.

Ittleman doesn’t believe that the DEA will reschedule cannabis anytime soon because the administration is strongly against legalization. (Don’t forget: Attorney General Jeff Sessions has publicly stated that “good people don’t smoke marijuana.”) Ittleman is probably right, but the DEA’s decision regarding Epidiolex is still a move forward. However, it’s not enough to reschedule a single drug and expect that to dramatically change the landscape. Our other issues remain, and they will until we accept once and for all that cannabis is hardly the same as heroin.

Today’s Storystream

Feed refreshed Two hours ago Dimorphos didn’t even see it coming

T
Thomas RickerTwo hours ago
Check out this delightful DART Easter egg.

Just Google for “NASA DART.” You’re welcome.


R
Twitter
Richard Lawler12:00 AM UTC
A direct strike at 14,000 mph.

The Double Asteroid Redirection Test (DART) scored a hit on the asteroid Dimorphos, but as Mary Beth Griggs explains, the real science work is just beginning.

Now planetary scientists will wait to see how the impact changed the asteroid’s orbit, and to download pictures from DART’s LICIACube satellite which had a front-row seat to the crash.


M
The Verge
We’re about an hour away from a space crash.

At 7:14PM ET, a NASA spacecraft is going to smash into an asteroid! Coverage of the collision — called the Double Asteroid Redirection Test — is now live.


Asian America learns how to hit back

The desperate, confused, righteous campaign to stop Asian hate

Esther WangSep 26
E
Twitter
Emma RothSep 26
There’s a surprise in the sky tonight.

Jupiter will be about 367 million miles away from Earth this evening. While that may seem like a long way, it’s the closest it’s been to our home planet since 1963.

During this time, Jupiter will be visible to the naked eye (but binoculars can help). You can check where and when you can get a glimpse of the gas giant from this website.


E
Twitter
Emma RothSep 26
Missing classic Mario?

One fan, who goes by the name Metroid Mike 64 on Twitter, just built a full-on 2D Mario game inside Super Mario Maker 2 complete with 40 levels and eight worlds.

Looking at the gameplay shared on Twitter is enough to make me want to break out my SNES, or at least buy Super Mario Maker 2 so I can play this epic retro revamp.


R
External Link
Russell BrandomSep 26
The US might still force TikTok into a data security deal with Oracle.

The New York Times says the White House is still working on TikTok’s Trump-era data security deal, which has been in a weird limbo for nearly two years now. The terms are basically the same: Oracle plays babysitter but the app doesn’t get banned. Maybe it will happen now, though?


R
Youtube
Richard LawlerSep 26
Don’t miss this dive into Guillermo del Toro’s stop-motion Pinocchio flick.

Andrew Webster and Charles Pulliam-Moore covered Netflix’s Tudum reveals (yes, it’s going to keep using that brand name) over the weekend as the streamer showed off things that haven’t been canceled yet.

Beyond The Way of the Househusband season two news and timing information about two The Witcher projects, you should make time for this incredible behind-the-scenes video showing the process of making Pinocchio.


R
External Link
Russell BrandomSep 26
Edward Snowden has been granted Russian citizenship.

The NSA whistleblower has been living in Russia for the 9 years — first as a refugee, then on a series of temporary residency permits. He applied for Russian citizenship in November 2020, but has said he won’t renounce his status as a U.S. citizen.


E
External Link
Emma RothSep 26
Netflix’s gaming bet gets even bigger.

Even though fewer than one percent of Netflix subscribers have tried its mobile games, Netflix just opened up another studio in Finland after acquiring the Helsinki-based Next Games earlier this year.

The former vice president of Zynga Games, Marko Lastikka, will serve as the studio director. His track record includes working on SimCity BuildIt for EA and FarmVille 3.


A
External Link
Vietnam’s EV aspirant is giving big Potemkin village vibes

Idle equipment, absent workers, deserted villages, an empty swimming pool. VinFast is Vietnam’s answer to Tesla, with the goal of making 1 million EVs in the next 5-6 years to sell to customers US, Canada and Europe. With these lofty goals, the company invited a bunch of social media influencers, as well as some auto journalists, on a “a four-day, multicity extravaganza” that seemed more weird than convincing, according to Bloomberg.


J
James VincentSep 26
Today, 39 years ago, the world didn’t end.

And it’s thanks to one man: Stanislav Petrov, a USSR military officer who, on September 26th, 1983, took the decision not to launch a retaliatory nuclear attack against the US. Petrov correctly guessed that satellite readings showing inbound nukes were faulty, and so likely saved the world from nuclear war. As journalist Tom Chivers put it on Twitter, “Happy Stanislav Petrov Day to those who celebrate!” Read more about Petrov’s life here.


Soviet Colonel who prevented 1983 nuclear response
Photo by Scott Peterson/Getty Images
J
The Verge
James VincentSep 26
Deepfakes were made for Disney.

You might have seen the news this weekend that the voice of James Earl Jones is being cloned using AI so his performance as Darth Vader in Star Wars can live on forever.

Reading the story, it struck me how perfect deepfakes are for Disney — a company that profits from original characters, fans' nostalgia, and an uncanny ability to twist copyright law to its liking. And now, with deepfakes, Disney’s most iconic performances will live on forever, ensuring the magic never dies.


E
External Link
Hurricane Fiona ratcheted up tensions about crypto bros in Puerto Rico.

“An official emergency has been declared, which means in the tax program, your physical presence time is suspended,” a crypto investor posted on TikTok. “So I am headed out of the island.” Perhaps predictably, locals are furious.


R
The Verge
Richard LawlerSep 26
Teen hacking suspect linked to GTA 6 leak and Uber security breach charged in London.

City of London police tweeted Saturday that the teenager arrested on suspicion of hacking has been charged with “two counts of breach of bail conditions and two counts of computer misuse.”

They haven’t confirmed any connection with the GTA 6 leak or Uber hack, but the details line up with those incidents, as well as a suspect arrested this spring for the Lapsus$ breaches.