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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 Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

Senate Votes To Send Hemp Legalization To President Trump’s Desk

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The Senate approved a far-reaching agriculture bill that includes a provision to legalize industrial hemp on Tuesday.

The vote gets the U.S. one step closer to ending its decades-long prohibition of a non-psychoactive plant in the cannabis family, empowering farmers to cultivate and sell a lucrative crop that can be used to create an exceptional range of products—from cosmetics to concrete.

The Senate and House Agriculture Committees had reconciled their respective versions of the 2018 Farm Bill last month, and lawmakers said they hoped to get it passed before the year’s end.

It seems Congress is positioned to meet that projection. The bill passed 87-13 in the Senate, and the House is expected to take it up soon. If the House approves the bill, it will be sent to President Donald Trump’s desk to be signed into law.

While debate on the legislation extended over several months, it quickly became apparent that the hemp legalization provision had bipartisan support. Separately, a compromise was reached over a provision that would ban people with felony convictions from participating in the hemp industry. The ban would be lifted after 10 years under the current legislation.

Hemp would no longer be controlled by the Justice Department if it’s ultimately approved. Instead, the U.S. Department of Agriculture would lightly regulate the crop.

Senate Majority Leader Mitch McConnell (R-KY), Sen. Ron Wyden (D-OR) and others cheered the inclusion of legal hemp in the Farm Bill.

You can read the full text of the hemp legalization provisions in the Farm Bill here.

Next House Agriculture Committee Chair Might Grow Hemp On His Farm

Photo courtesy of Brendan Cleak.

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Trump Threatens Government Shutdown, Raising Concern For Legal Marijuana Industry

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President Donald Trump is threatening to shut down the government if Democrats refuse billions of dollars in funding for a border wall—but the consequences of that action would extend far beyond border security.

If the president makes good on his promise to withhold his signature from essential appropriations bills this time, that could inadvertently leave the legal marijuana industry vulnerable to federal drug enforcement actions. A spending bill rider that has protected state medical cannabis programs from federal intervention since 2014 would expire, while the Justice Department and prosecutors would generally remain operational.

That’s because the Department of Justice has a contingency plan in place in the event of a government shutdown, and it exempts many employees, including U.S. attorneys and those who work for the Drug Enforcement Administration (DEA), from furlough.

“Criminal litigation will continue without interruption as an activity essential to the safety of human life and the protection of property,” the Justice Department explains in its contingency plan. U.S. attorneys are protected because they’re presidentially appointed and “are needed to address ongoing criminal matters and civil matters of urgency throughout the nation.”

“All agents in DEA field organizations are excepted from furlough because they support active counternarcotics investigations,” the document says.

The so-called Rohrabacher-Farr amendment would not be exempted, though. The legislation—which bars the Justice Department from using federal funds to interfere with state medical cannabis laws—is part of the the Commerce, Justice, Science, and Related Agencies (CJS) appropriations bill. While five out of the 12 annual appropriation bills for Fiscal Year 2019 have already been signed into law by the president, the CJS bill is yet to receive House of Senate floor votes.

Typically, the deadline to get appropriations passed is the end of the preceding fiscal year, September 30. But rather than hold a vote or allow federal departments to lose funding, lawmakers have passed a series of continuing resolutions this year, providing temporary funding and pushing back the deadline. The most recent two-week continuing resolution passed on December 7, so the new deadline is December 21.

It lawmakers don’t pass, or President Trump doesn’t sign, either a full-year or temporary extension of funding by then, the medical cannabis rider will expire, but federal drug enforcement capabilities will not. And that would leave medical marijuana patients and the businesses that serve them in a dicey position.

Similar concerns about the prospect of federal marijuana enforcement have been repeatedly raised under the Trump administration. In January, things seemed especially precarious, as the president’s threat of a government shutdown came weeks after then-Attorney General Jeff Sessions rescinded an Obama-era memo that provided guidance on federal cannabis enforcement practices.

That decision stoked fears that a shutdown would empower the Justice Department to act on the attorney general’s vehement opposition to marijuana reform. But after fewer than three days, a continuing resolution passed and state-legal marijuana activities continued unimpeded.

This time around, as the deadline approaches, the Justice Department head is Acting Attorney General Matthew Whitaker, who had served as Sessions’s chief of staff. Whitaker has said he sympathizes with medical cannabis patients, but he’s also criticized the Obama administration for its marijuana enforcement policies.

There’s no telling at this point whether Whitaker, the DEA or federal prosecutors would take advantage of broad exemptions from furlough and crack down on legal medical marijuana states in the event of a shutdown. But as always, the possibility puts the cannabis industry is an uncomfortable position.

Bipartisan Lawmakers Push For Marijuana Protections In Funding Bill

Photo courtesy of Gage Skidmore.

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Lawmakers From Both Parties Celebrate Hemp Legalization In The Farm Bill

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Members of Congress on both sides of the aisle are celebrating a hemp legalization provision that made it into the final version of the 2018 Farm Bill.

Perhaps no one is more pleased than Senate Majority Mitch McConnell (R-KY), who fought for the provision over months of debate on the wide-ranging agriculture legislation. He even signed the conference report finalizing the bill language with a hemp pen on Monday.

In opening remarks from the Senate floor on Tuesday, McConnell said the inclusion of hemp legalization is “a victory for farmers and consumers throughout our country.” It builds on the progress of the hemp pilot program he helped put in the 2014 Farm Bill, the results of which he said “have been nothing short of extraordinary.”

“Now American-grown hemp can be found in your food, in your clothes and even in your car dashboard,” he said. “The results mean jobs, economic growth and new opportunity.”

“At a time when farm income is down and growers are struggling, industrial hemp is a bright spot of agriculture’s future.”

Sen. Ron Wyden (D-OR) helped McConnell secure hemp legalization in the agriculture legislation and said “the outrageous and outdated ban on growing hemp has hamstrung farmers in Oregon and across the country” in a press release Tuesday.

“Hemp products are made in America, sold in America, and consumed in America,” Wyden said. “Now, hemp will be able to be legally grown in America, to the economic benefit of consumers and farmers in Oregon and nationwide.”

Fellow Oregon lawmaker Rep. Suzanne Bonamici (D-OR) also cheered the “good news” that the provision made the cut.

Sen. Michael Bennet (D-CO) touted hemp legalization in a tweet Tuesday.

“The finish line is in sight,” Bennet wrote. “Now Congress needs to do what’s right for Colorado & send this bill to [President Trump’s] desk by the end of the year.”

Sen. Mark Warner (D-VA) celebrated the hemp provisions as well.

As did Sen. Cory Gardner (R-CO).

Lawmakers are hoping to put the Farm Bill to a full House and Senate vote and deliver the legislation to the president this week. McConnell said on Tuesday that members of Congress should be prepared to work through the holiday break to make sure this and other bills, including criminal justice reform and legislation to fund parts of the federal government for Fiscal Year 2019, are seen all the way through.

Next House Agriculture Committee Chair Might Grow Hemp On His Farm

Via YouTube/Senate Majority Leader Mitch McConnell.

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