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The DEA Just Placed a Marijuana-Derived Drug In Schedule V

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The Drug Enforcement Administration (DEA) placed a marijuana-derived drug in Schedule V of the Controlled Substances Act on Thursday.

The medication, Epidiolex, contains purified cannabidiol (CBD), a non-psychoactive ingredient in cannabis. It was approved as a treatment option for severe forms of epilepsy by the Food and Drug Administration (FDA) in June.

Following that approval, the DEA was given 90 days to make a scheduling decision for the product.

“Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States for purposes of the [Controlled Substances Act],” DEA Acting Administrator Uttam Dhillon wrote. “Accordingly, Epidiolex no longer meets the criteria for placement in Schedule I of the CSA.”

“DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” Dhillon later said in a press release. “DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.”

Epidiolex is the first purely cannabis-derived medication to gain FDA approval. However, the FDA has previously approved drugs that contain synthetic THC, or dronabinol, including Marinol and Syndros. The DEA classified those prescription medications as Schedule III and Schedule II, respectively.

But Epidiolex is unique because its primary ingredient is a natural component of cannabis: CBD. Because of that, there’s been speculation that the DEA’s decision to schedule the drug would have wide-ranging implications for CBD products overall.

But the DEA’s Federal Register filing says the action does not apply to CBD products other than Epidiolex and any generic versions FDA may approve in the future.

“As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana… including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.”

FDA Commissioner Scott Gottlieb said in a press release that the agency will “continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products.”

Placing a drug lower on the schedules of the Controlled Substances Act doesn’t mean it becomes fully legal. It will be a regulated product and exclusively available via prescription. Marijuana remains strictly prohibited—a Schedule I drug—under federal law.

GW Pharmaceuticals, which developed Epidiolex, released a statement Thursday applauding the DEA’s scheduling decision.

“We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” Justin Gover, GW’s CEO, said.

“With this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA.”

Kate Bell, general counsel at the Marijuana Policy Project, told Marijuana Moment that it was encouraging that the DEA placed Epidiolex in Schedule V—but that given the safety profile of CBD, it doesn’t deserve to be scheduled at all.

“We are excited to have Epidiolex available to the patients who can benefit from it, particularly since it can be prescribed and therefore covered by health insurance,” Bell said. “At the same time, we need to keep fighting to de-schedule the cannabis plant itself in order to end the tension between state and federal laws and make the whole range of medical marijuana products accessible to, and affordable for, more patients.”

DEA Wants More Marijuana Grown And Fewer Opioids Produced In 2019. Really.

Photo courtesy of Brian Shamblen.

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Kyle Jaeger is an LA-based contributor to Marijuana Moment. His work has also appeared in High Times, VICE, and attn.

Politics

People With Marijuana Convictions Should Know About National Expungement Week

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Marijuana legalization is a solid first step, but there’s still a lot of work to be done to resolve  socioeconomic and racial inequities brought about by the war on drugs.

Hence, we now have National Expungement Week. The first-of-its-kind campaign, supported by a coalition of cannabis and social justice organizations called the Equity First Alliance, is taking place from October 20-27.

The organizations will offer “expungement and other forms of legal relief to some of the 77 million Americans with convictions on their records,” according to the campaign website. “These convictions can restrict access to housing, employment, education, public assistance, and voting rights long after sentences have been served.”

In an open letter, the alliance also said it was “largely unsupported by the cannabis industry and by the traditional funders of equity work.” While a main argument in support of legalization is that it would help to repair drug war damages, which have disproportionately affected communities of color, the laws and markets created by the successful movement haven’t necessarily lived up to its name, the alliance wrote.

To that end, the campaign has organized events across the country—from Los Angeles to Boston—to provide legal services to those whose criminal records are able to be reduced or expunged. You can check out the full list of events here.

The alliance’s agenda touches on numerous reform policies, including using marijuana tax revenue to fund communities that have been impacted by prohibition, implementing social equity programs, ensuring corporate responsibility for businesses that profit off cannabis and providing affordable medical cannabis for low-income patients, among other policies.

“We believe that we have a short but vital window of opportunity to change the course of the cannabis industry—and by doing so, we can prevent further harms to the most impacted communities and create a model of reparative economic and criminal justice.”

Adam Vine, co-founder of Cafe-Free Cannabis and an organizer with the campaign, told Marijuana Moment that the campaign is necessary “because millions of Americans have been harmed by the war on drugs and continue to face collateral consequences for convictions that may have happened years ago.”

“These consequences restrict people’s access to employment, housing, education, and social services, so our coalition decided to do something about it,” he said. “We are coordinating these events to provide free legal relief and to say that as states move towards cannabis legalization, expungement needs to be the first priority.”

Marijuana Use Will No Longer Be Prosecuted In Manhattan

Photo courtesy of Brian Shamblen.

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Politics

Chris Christie Finally Recognizes Marijuana Legalization As States’ Rights Issue

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Famously anti-marijuana former New Jersey Gov. Chris Christie (R) isn’t jumping on the pro-legalization train any time soon—but new comments suggest he might be softening his opposition a smidge, recognizing marijuana reform as a states’ rights issue.

Speaking at Politicon on Saturday, Christie took a question about his cannabis stance from YouTuber Kyle Kulinski, who asked him to weigh in on studies showing that states with legal marijuana programs experience lower rates of opioid addiction and overdoses compared to non-legal states. He was quick to dismiss the research, contending that other studies show the “exact opposite.”

“I just don’t believe when we’re in the midst of a drug addiction crisis that we need to legalize another drug,” Christie said, echoing comments he’s made as chair of President Donald Trump’s opioids committee.

Then he pivoted, acknowledging that some will push back on his anti-legalization position by pointing out that alcohol is legal. “I get that,” he said, “but I wasn’t here when we legalized alcohol.”

Kulinski seized on that point and asked the former governor if he’d vote to ban alcohol.

“No, I wouldn’t ban it. You can’t put the toothpaste back in the tube, and that’s a big, important argument about marijuana because once you legalize this, that toothpaste never goes back in the tube.”

Christie stood out among other Republican and Democratic contenders during his 2016 presidential run by maintaining that in addition to personally opposing legalization, he’d crack down on legal cannabis states and enforce federal laws nationwide if elected.

“If you’re getting high in Colorado today, enjoy it,” Christie said in 2015. “As of January 2017, I will enforce the federal laws.

So it came as something of a surprise when the former governor went on to say in the Politicon appearance that “states have the right to do what they want to do on this,” signaling a modest shift in his anti-marijuana rhetoric. States should have that right even though, as Christie put it, “broad legalization of marijuana won’t, in my view, alleviate or even minimize the opioid crisis.”

It’s unclear what’s behind the apparent shift from hardline prohibitionist to wary federalist, but who knows… maybe Christie experienced an epiphany at a Melissa Etheridge concert he attended earlier this month.

Etheridge, who recently spoke with Marijuana Moment about her cannabis advocacy and use of the drug for medicinal purposes, reacted to a tweet showing Christie at one of her recent performances, where he reportedly knew every word of her songs and sang along.

Christie, for his part, replied that he “enjoyed every minute of a great performance and a truly wonderful group of fans.”

Hm…

GIF by #ActionAliens

Melissa Etheridge Talks Art, Culture and Marijuana Advocacy In The Legalization Era

Photo courtesy of Gage Skidmore.

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Politics

Marijuana Support Grows: Two Out Of Three Americans Back Legalization, Gallup Says

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Two-thirds of Americans now support legalizing marijuana, the highest percentage ever in Gallup’s ongoing decades-long series of national polls on the topic.

The new survey released on Monday shows that U.S. adults back ending cannabis prohibition by a supermajority margin of 66 percent to 32 percent. That’s more than a two-to-one ratio.

Please visit Forbes to read the rest of this piece.

(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)

Photo courtesy of Jurassic Blueberries.

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