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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 Marijuana Moment's Sacramento-based senior editor. His work has also appeared in High Times, VICE and attn.

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Virginia Has Sealed 64,000 Marijuana Distribution Charges Since Legalization Took Effect This Summer

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“These aren’t just numbers and there are families attached.”

By Ned Oliver, Virginia Mercury

Virginia has sealed records documenting more than 64,000 misdemeanor marijuana distribution charges since the state legalized the drug in July.

The figure came out Thursday during a meeting of the legislature’s Cannabis Oversight Commission.

Officials said the records were scrubbed from the state’s criminal record database, which is used by employers like school boards, state agencies and local governments to screen employees.

The state had already sealed 333,000 records detailing charges of simple possession last year after the state reduced the offense to a civil infraction on par with a traffic offense, said Shawn G. Talmadge, the Deputy Secretary of Public Safety and Homeland Security.

Lawmakers directed the state to expand that effort when they voted to broadly legalize recreational use of marijuana earlier this year.

The legislature also agreed to a broader expungement reform that will automatically seal other misdemeanor charges, including underage possession of alcohol, use of a fake ID, petit larceny, trespassing and disorderly conduct. Talmadge said those charges will remain in the system until the state finishes updating the software it uses to track criminal records.

“As of right now, the process is proceeding,” he said.

Members of the oversight commission also heard from two advocates who urged them to move fast to address people currently imprisoned for marijuana offenses—a category of people the legalization legislation passed this year did not address.

Chelsea Higgs Wise, the leader of the advocacy group Marijuana Justice, and Gracie Burger, with the Last Prisoner Project, said Department of Corrections data suggests there are currently 10 people being held solely on serious marijuana charges.

They said it remains unknown how many more are being held because of marijuana related probation violations.

“These aren’t just numbers and there are families attached,” Burger said.

This story was first published by Virginia Mercury,

Nevada Sold More Than $1 Billion In Marijuana In One Year, Officials Report

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DEA Proposes Dramatic Increase In Marijuana And Psychedelic Production In 2022, Calling For 6,300 Percent More MDMA Alone

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The Drug Enforcement Administration (DEA) is proposing a dramatic increase in the legal production of marijuana and psychedelics like psilocybin, LSD, MDMA and DMT to be used in research next year.

In a notice scheduled to be published in the Federal Register on Monday, the agency said there’s been a “significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes,” and it wants authorized manufacturers to meet that growing demand.

DEA had already massively upped its proposed 2021 quota for cannabis and psilocybin last month, but now it’s calling for significantly larger quantities of research-grade marijuana and a broader array of psychedelics to be manufactured in 2022.

It wants to double the amount of marijuana extracts, psilocybin and psilocyn, quadruple mescaline and quintuple DMT. What especially stands out in the notice is MDMA. The agency is proposing an enormous 6,300 percent boost in the production of that drug—from just 50 grams in 2021 to 3,200 grams in the coming year—as research into its therapeutic potential continues to expand.

LSD would see a 1,150 percent increase, up to 500 grams of the potent psychedelic.

Marijuana itself would get a 60 percent boost under DEA’s proposal, up to 3.2 million grams in 2022 from the 2 million grams last year.

Here’s a visualization of the proposed quota increase from 2021 to 2022 for marijuana and cannabis extracts:

For all other THC, psilocybin, psilocyn and MDMA:

And for other psychedelic substances like LSD, mescaline and DMT:

DEA said in the Federal Register notice that it has been receiving and approving additional applications to “grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes” to achieve these ambitious quotas.

“DEA supports regulated research with schedule I controlled substances, as evidenced by increases proposed for 2022 as compared with aggregate production quotas for these substances in 2021,” the agency said, adding that it working “diligently” to process and approve marijuana manufacturers applications in particular, as there’s currently only one farm at the University of Mississippi that’s permitted to cultivate the plant for research.

“Based on the increase in research and clinical trial applications, DEA has proposed increases in 3,4- Methylenedioxyamphetamine (MDA), 3,4-Methylenedioxymethamphetamine (MDMA), 5-Methoxy-N,N-dimethyltryptamine, Dimethyltryptamine, Lysergic acid diethylamide (LSD), Marihuana, Marihuana Extract, Mescaline, Psilocybin, Psilocyn, and All Other Tetrahydrocannabinols to support manufacturing activities related to the increased level of research and clinical trials with these schedule I controlled substances.”

Here are the exact numbers for the proposed 2021 and 2022 quotas:

Substance 2021
2022 proposed
Marijuana 2,000,000 3,200,000
Marijuana extract 500,000 1,000,000
All other tetrahydrocannabinol 1,000 2,000
Psilocybin 1,500 3,000
Psilocyn 1,000 2,000
MDMA 50 3,200
LSD 40 500
Mescaline 25 100
DMT 50 250
5-MeO-DMT 35 550
MDA 55 200

A 30-day public comment period will be open after the notice is formally published on Monday.

It’s difficult to overstate just how significant the proposed 2022 increases are, but it’s certainly true that scientific and public interest in marijuana and psychedelics has rapidly increased, with early clinical trials signaling that such substances show significant therapeutic potential.

National Institute on Drug Abuse (NIDA) Director Nora Volkow told Marijuana Moment in a recent interview that she was encouraged by DEA’s previous proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.

Advocates and experts remain frustrated that these plants and fungi remain in the strictest federal drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.

A federal appeals court in August dismissed a petition to require the DEA to reevaluate cannabis’s scheduling under the Controlled Substances Act. However, one judge did say in a concurring opinion that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the therapeutic value of marijuana.

Separately, the Washington State attorney general’s office and lawyers representing cancer patients recently urged a federal appeals panel to push for a DEA policy change to allow people in end-of-life care to access psilocybin under state and federal right-to-try laws.

Singer Melissa Etheridge And Activist Van Jones Promote Psychedelics Reform As Movement Grows

Image element courtesy of Kristie Gianopulos.

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Supreme Court Won’t Hear Case On Legalizing Safe Drug Consumption Sites, But Activists Are Undeterred

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The U.S. Supreme Court (SCOTUS) has rejected a request to hear a case on the legality of establishing safe injection sites where people can use illicit drugs in a medically supervised environment.

The justices announced on Tuesday that they decided against taking up the case raised by the nonprofit Safehouse, despite the pleas of attorneys general from 10 states and D.C. who recently filed amici briefs urging the court’s involvement.

Representatives from 14 cities and counties, as well as the mayor of Philadelphia, which is at the center of the current case, also filed briefs in support of the case in recent days.

Safehouse was set to launch a safe consumption site in Philadelphia before being blocked by a legal challenge from the Trump administration. It filed a petition with the nation’s highest court in August to hear the case.

But while the Supreme Court declined to take action—and the Biden administration passed up its voluntary opportunity to weigh in at this stage, which may well have influenced the justices’ decision—activists say the battle will continue at a lower federal court level, where the administration will have to file briefs revealing its position on the issue.

“We were disappointed that the government chose not to respond to our petition,” Safehouse Vice President Ronda Goldfein told Filter. “They said, ‘We’re going to waive our right to respond,’ [and] the Supreme Court declined to review our case. Ordinarily that sounds like the end of the road—but in our case we are still pursuing our claims in a different venue.”

That venue will be the the federal district court in Philadelphia, where activists plan to submit multiple arguments related to religious freedom and interstate commerce protections. The Biden administration will be compelled to file a response in that court by November 5.

“If they don’t respond, they lose,” Goldfein said.

A coalition of 80 current and former prosecutors and law enforcement officials—including one who is President Joe Biden’s pick for U.S. attorney of Massachusetts—previously filed a brief urging the Supreme Court to take up Safehouse’s safe injection case.

Fair and Justice Prosecution, the group that coordinated the amicus brief, also organized a tour of Portugal for 20 top prosecutors in 2019 so they could learn about the successful implementation of the country’s drug decriminalization law.

If the Supreme Court were to have taken the case and rule in favor of Safehouse, it could have emboldened advocates and lawmakers across the country to pursue the harm reduction policy.

The governor of Rhode Island signed a bill in July to establish a safe consumption site pilot program where people could test and use currently illicit drugs in a medically supervised environment. It became the first state in the country to legalize the harm reduction centers. It’s not clear whether the Department of Justice will seek to intervene to prevent the opening of such facilities in that state.

Massachusetts lawmakers advanced similar legislation last year, but it was not ultimately enacted.

A similar harm reduction bill in California, sponsored by Sen. Scott Wiener (D), was approved in the state Senate in April, but further action has been delayed until 2022.

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