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FDA Says Marijuana Ingredient CBD Doesn’t Meet Criteria For Federal Control

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Last week’s decision by the U.S. Drug Enforcement Administration (DEA) to place a marijuana-derived drug in the least restrictive category under federal law was largely based on a recommendation from the Food and Drug Administration (FDA). But according to a recently released internal government letter, the FDA actually concluded that cannabidiol, or CBD, doesn’t meet the criteria for federal control at all.

CBD is a non-psychoactive ingredient in cannabis that serves as the basis of a new FDA-approved epilepsy drug, Epidiolex. In order to bring the drug to market, the FDA had to first evaluate its medical utility and potential for abuse and then submit its findings to the DEA.

Although the federal health regulatory agency’s review concluded that CBD shouldn’t be scheduled in any manner, the drug enforcement agency—citing international treaty obligations—opted to put Epidiolex in Schedule V and otherwise continue to classify CBD itself under the most restrictive category of Schedule I.

What the FDA determined about CBD:

Studies demonstrated that “CBD and its salts… do not have a significant potential for abuse and could be removed from the [Controlled Substances Act],” the FDA wrote to the DEA in May.

But the letter also mentioned that the FDA had been advised by then-DEA Acting Administrator Robert Patterson that federally de-scheduling CBD altogether would represent a violation of international drug treaties to which the U.S. is a party.

In April, the DEA “asserted that the United States would not be able to keep obligations under the 1961 Single Convention on Narcotic Drugs if CBD were decontrolled under the CSA,” the FDA letter reveals.

Therefore, the FDA amended its recommendation, advising the DEA to place CBD in Schedule V, the least restrictive category under federal law, instead.

“If treaty obligations do not require control of CBD, or if the international controls on CBD change in the future, this recommendation will need to be promptly revisited.”

There were three main takeaways from the FDA’s review of CBD: The substance has “negligible potential for abuse,” has a “currently accepted medical use in treatment” and abusing it “may lead to limited physical dependence” similar to other Schedule V drugs.

Altogether, there were eight factors that the FDA considered when making its scheduling recommendation. “Upon consideration” of those eight factors, the agency said CBD alone “could be removed from control” under the CSA.

“We reach this conclusion because we find that CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA.”

In its conclusion, the FDA also reiterated that the scheduling placement of CBD should be “revisited promptly” if international treaty obligations change.

The FDA and the DEA don’t always see eye-to-eye when it comes to marijuana.

While the DEA has consistently upheld the Schedule I status of cannabis in line with FDA recommendations, the health agency previously recommended altering the scheduling system, arguing that the current approach should be re-evaluated in order to “identify ways to encourage appropriate scientific research into the potential therapeutic benefits of marijuana and its constituents,” for example.

This year, the FDA rejected a petition from an anti-legalization group that called for further restrictions on cannabis. And FDA Commissioner Scott Gottlieb signaled tentative support for decriminalizing marijuana during an interview earlier this month. (Though also argued that youth marijuana consumption was more concerning than the use of e-cigarettes).

The DEA ultimately accepted the FDA’s scheduling recommendation and placed Epidiolex in Schedule V on Friday. But in its final notice, the DEA repeatedly emphasized that the rescheduling decision did not affect the legal status of marijuana or any CBD products except for Epidiolex and future generic, FDA-approved versions of the drug.

“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,” DEA Acting Administrator Uttam Dhillon 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.”

Marijuana Moment Patreon supporters can read the FDA’s full 27-page letter on CBD below:

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

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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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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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