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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.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

Hemp Legalization Is Officially Headed to President Trump’s Desk For Signature

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The 2018 Farm Bill, which would legalize industrial hemp, is officially headed to President Donald Trump’s desk. The House passed the legislation on Wednesday, one day after the Senate approved it.

It’s been decades since the ban on hemp was imposed—a byproduct of the federal government’s war on marijuana and other drugs. The ban, it seems, will be lifted in a matter of days.

The House passed the bill, 369-47.

The votes come after months of debate over other aspects of the wide-ranging agriculture bill. But the hemp legalization provision, shepherded by Senate Majority Leader Mitch McConnell (R-KY), has received bipartisan support at every step of the legislative process.

Hemp legalization made it through a conference committee where the Senate and House Agriculture Committees reconciled their respective versions of the bill. McConnell marked the occasion this week by signing the conference report with a hemp pen, which he said on Wednesday that the president was free to use to sign the bill into law.

The hemp provision would allow U.S. farmers to grow, process and sell the crop. The Justice Department would no longer have jurisdiction over hemp under the legislation; rather, the U.S. Department of Agriculture would lightly regulate it.

One element of the hemp language created tension between lawmakers and advocates. The original Senate-passed bill prohibited people with felony drug convictions from participating in the hemp industry, but a compromise was reached last week that limited that ban in the final version to 10 years after the last offense.

House Democrats in the Agriculture Committee listed hemp legalization as one of several reasons they were calling for a “yes” vote on the legislation.

According to VoteHemp, if the president signs the bill before the year’s end, it will take effect on January 1, 2019.

Mitch McConnell Says Trump Can Borrow His Hemp Pen To Sign Farm Bill Into Law

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Marijuana Industry Border Issues Would Be Solved Under New Congressional Bill

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Marijuana can really mess up border and immigration issues for people who partake in consumption or participate in the industry, but that would change if a new bill being introduced in Congress this week is enacted.

Under current U.S. laws, people who admit to past cannabis use or who work for or invest in marijuana businesses can be barred from visiting the country under certain circumstances. And marijuana consumption, even if it is legal under state law, can lead to an immigrant being deported.

The new legislation, the Maintaining Appropriate Protections For Legal Entry Act, would provide exceptions for conduct that “was lawful in the State, Indian Tribe, or foreign country in which the conduct occurred” or that was “subsequently made lawful under the law or regulation of such jurisdiction,” according to a draft obtained by Marijuana Moment.

The bill, known as the MAPLE Act for short—surely a nod to the leaf on Canada’s flag—is being filed on Wednesday by Rep. Earl Blumenauer (D-OR).

U.S. border policies on entry by marijuana industry participants were slightly loosened just ahead of the launch of Canada’s legal marijuana market in October to clarify that people working for cannabis businesses are generally admissible to the U.S., with the caveat that “if a traveler is found to be coming to the U.S. for reason related to the marijuana industry, they may be deemed inadmissible.”

And that’s a key exception. Several Canadians traveling to a cannabis industry conference in Las Vegas last month were detained for hours, with one investor being given a lifetime ban from visiting the U.S.

While there is almost certainly not enough time for Blumenauer’s proposal to be considered and voted on by the end of the year, its language could easily be adopted into new legislation after the 116th Congress is seated in January.

In October, the congressman laid out a plan for a step-by-step approach to federally legalizing marijuana in 2019 in a memo to fellow House Democrats.

Marijuana Moment supporters on Patreon can read the full text of the new MAPLE Act below:

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Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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Politics

Chicago Mayor Wants Legal Marijuana Revenue To Fund Pensions

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Tax revenue from legal marijuana sales should be earmarked to fund pension programs, the mayor of Chicago said on Wednesday.

“Illinois legislators will be taking a serious look next year at legalizing recreational marijuana,” Mayor Rahm Emanuel (D) said in a speech to the City Council. “Should they follow that course, a portion of that revenue could go toward strengthening our pension funds and securing the retirement of the workers who depend on them.”

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 Daniel X. O’Neil.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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