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FDA Chief Warns CBD Rulemaking Could Take Years Without Congressional Action

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The outgoing head of the Food and Drug Administration (FDA) suggested on Tuesday that it would take several years for the agency to come up with rules around allowing hemp-derived cannabidiol (CBD) in food products—unless Congress steps in.

At a Brookings Institution event, FDA Commissioner Scott Gottlieb recognized that there’s strong interest among the cannabis industry and lawmakers in developing a regulatory framework through which CBD from hemp could be extracted, sold and introduced into the food supply. The problem is that “CBD didn’t previously exist in the food supply, and it exists as a drug under the statute.”

“It can’t just be put into the food supply,” he said, arguing that current law only allows the FDA to “contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rulemaking process.”

That rulemaking process can take two to three years for conventional products, and so because CBD is “more complex”—due to its association with marijuana—and has already been approved by the FDA as a drug to treat epilepsy (in the form of Epidiolex), it could theoretically take much longer to develop those regulations.

“We’ve never done this before,” Gottlieb said. “It would be a highly novel rulemaking process.”

In the meantime, the FDA is putting together a “high-level work group” that will work to identify “some potential legislative pathways might be to create a framework for allowing CBD into the food supply.”

Gottlieb said he expects the group to release some recommendations by the summer, as Business Insider first reported.

The commissioner said the work group will be formally announced within the next week and would involve a public meeting to solicit comments from stakeholders.

While Congress might have intended to permit the marketing of hemp-derived CBD through the 2018 Farm Bill, the commissioner indicated that additional legislation that specifically addresses CBD regulations would be necessary to allow the ingredient in the food supply. He said there’s precedent for such actions, citing legislation around human growth hormone and fish oil.

“I think you need to come up with a framework that defines concentration levels, where you would create some kind of cut off, and that would be up to the agency to do,” he said. “Congress would obviously give directions to the agency to do that.”

“CBD in high concentrations isn’t risk-free, and in low concentration, it probably is safe—I don’t want to make a declaration here. It’s also a question of whether it’s providing any kind of therapeutic benefit in those concentrations, although people seem to believe that it has some value. But this is a process that the agency would have to work through. I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation that would specifically address CBD.”

Gottlieb made similar comments in response to questions from members of a House Appropriations subcommittee last month, where he announced that the agency would hold a public meeting in April to gather input from stakeholders on CBD regulation.

In the new comments, the commissioner also added that he felt the Drug Enforcement Administration (DEA) would have to “formally de-schedule” hemp-derived CBD before moving forward with regulatory changes, in spite of the fact that the agriculture legislation shifted regulatory responsibility for the crop and its derivatives from the Justice Department to the U.S. Department of Agriculture.

“I think the prevailing view is that the plain language of the statute [of the Farm Bill] intended for that, but I’m not sure that DEA has done that yet,” he said. “But that’s another step that would have to take place. DEA would have to formally de-schedule CBD derived from hemp.”

The desire for clarity around CBD’s legality post-Farm Bill passage has been widespread. For example, the U.S. Postal Service issued an advisory earlier this month spelling out rules for mailing hemp-derived CBD. Representatives from state agriculture departments also heard talk about “alternative approaches” to regulating the compound at a conference last month.

In his remarks at Brookings, Gottlieb announced that the CBD work group would be co-chaired by Amy Abernethy, FDA’s principal deputy commissioner, and Lowell Shiller, the agency’s acting associate commissioner for policy.

In the meantime, it is clear that lawmakers want FDA to move on the issue.

“Every meeting I go into on Capitol Hill, almost every meeting, I get asked about this,” Gottlieb said.

U.S. Postal Service Issues Advisory On Mailing Hemp-Derived CBD

Photo courtesy of YouTube/Brookings Institution.

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.

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Congressional Committee Asks JUUL For Documents On Marijuana Partnerships

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Is the e-cigarette company JUUL planning on expanding its stake in the marijuana industry?

That’s one question the chair of a congressional subcommittee asked the company in a letter concerning JUUL’s role in the “youth e-cigarette epidemic” earlier this month.

Lawmakers have frequently criticized JUUL for making products—specifically flavored e-cigarette cartridges—that allegedly appeal to young people at a time when rates of cigarette use are steadily declining. But while JUUL was developed by the cannabis vaporizer company PAX, it hasn’t announced plans to further partner with marijuana companies.

Rep. Raja Krishnamoorthi (D-IL), who chairs the House Subcommittee on Economic and Consumer Policy, apparently sees the possibility on the horizon, though.

In a letter sent to JUUL on June 7, the congressman said his panel was investigating youth e-cigarette usage and, specifically, how the company’s marketing tactics might be exacerbating the issue. He requested documents on everything from clinical trials on how JUUL devices divert people away from traditional cigarettes to communications on the company’s rationale for the nicotine concentration of JUUL pods.

Tucked within the extensive request is a question about potential marijuana partnerships. Krishnamoorthi asked for:

“All documents, including memoranda and communications, referring or relating to proposals, plans, and/or intended partnerships or collaborations between JUUL and any cannabis-related companies, including but not limited to Cronos Group.”

It’s not clear where the Cronos-specific mention comes from, but the company has perviously caught the interest of the tobacco industry. The maker of Marlboro cigarettes, Altria Group, invested almost $2 billion in the Canada-based cannabis company in December. Two weeks later, Altria invested $13 billion in JUUL.

Marijuana Moment reached out to JUUL, Cronos and Krishnamoorthi’s office for comment, but representatives did not respond by the time of publication.

If a partnership does emerge, it would likely be met with some controversy, as opponents and proponents of marijuana reform alike have long expressed concern that the tobacco industry would take over the cannabis market and commercialize it in a way that mirrors how it peddled cigarettes.

Of course, given that tobacco use is declining and tobacco companies generally have the infrastructure that would make a pivot to cannabis relatively simple, such a partnership would not be especially surprising.

Senate Majority Leader Mitch McConnell (R-KY) has made the case several times that tobacco farmers in his state could leverage the federal legalization of industrial hemp and its derivatives by growing the crop to offset profit losses from declining tobacco sales.

Read Rep. Krishnamoorthi’s full letter to JUUL below:

2019-06-07.Krishnamoorthi t… by on Scribd

Americans Want CBD Available Over-The-Counter, Poll Finds

Photo courtesy of Wikimedia.

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New York Lawmakers Might Actually Vote On Marijuana Legalization This Week

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With just days left before the end of the legislative session, efforts to legalize marijuana in New York have been revived, with a possible vote this coming week.

Though momentum to pass a legalization measure seemed to largely die off after lawmakers in neighboring New Jersey announced they wouldn’t move forward with plans to end cannabis prohibition through the legislature, advocates are increasingly optimistic that a deal in the Empire State is imminent.

Democratic members in both the Senate and Assembly held conferences last week to discuss details of the legislation. Spectrum News reported that the meetings went well, with members indicating that there’s support for the measure.

That’s just one of several positive signs that a proposal many observers thought was dead for the year has new life.

On Saturday and Sunday, staff for legislative leaders from both chambers and Gov. Andrew Cuomo (D) met to negotiate provisions of a revised legalization plan.

On Wednesday, an earlier Senate version of the bill was assigned “same as” status in the Assembly version. That means the current proposals in each chamber lined up with identical language and is considered to be an indicator that the legislation could pass.

Assembly Speaker Carl Heastie (D) said on Friday that his party has yet to determine whether they’ll bring the bill to the floor, but he added that “I think there is support in the conference.”

He also characterized the window of time until the end of the session on Wednesday as “an eternity.”

Cuomo, who said late last month that passing legalization remains a top 10 priority, has said that lawmakers who fail to approve items on his agenda, including ending cannabis prohibition, “should all be primaried, because that is a failure of a basic progressive agenda.”

On the flip side, the chairman of New York’s Democratic Party said earlier this month that if the Senate approves the legalization bill, they run to risk of alienating voters in certain areas such as Long Island and upstate New York. But that argument neglects to account for recent polling that shows voters in those regions strongly support legalization.

Notably, the measure’s most vocal opponents with the anti-legalization Smart Approaches to Marijuana have been sending email blasts in recent days urging their supports to call senators and voice opposition to the bill, giving the impression that the group is anticipating a vote.

Assembly Majority Leader Crystal Peoples-Stokes (D), sponsor of the legalization legislation, seemed to confirm that suspicion on Friday, stating that after “conversations with my co-sponsor and colleague in the Senate, I am even more confident of a path for victory.”

But despite that confidence, the fate of legalization in New York remains murky. An analysis earlier this month found that legalization was two votes short of a needed majority in the Senate.

Meanwhile, a number of key elected officials are calling on the governor and lawmakers to not only push legalization over the finish line but to include certain key provisions in the final legislation.

State Attorney General Letitia James (D) sent a letter urging that the bill expunge prior cannabis records.

“Before we create a booming business for legal marijuana, we must provide relief to those individuals that have paid much more to society than what was due,” she wrote.

New York City Mayor Bill de Blasio (D), a 2020 presidential candidate, also pushed for expungements and said in a Twitter thread that legalization should “empower local business and not big corporations.”

And the Manhattan and Albany County district attorneys co-authored an op-ed calling leaders to “correct staggering inequities and promote public safety by passing” legalization.

 

The Buffalo News reported on Sunday afternoon that there were still a number of outstanding issues left to be settled between lawmakers, including whether or not home cultivation of cannabis would be allowed, how tax revenue would be allocated and whether localities would have to proactively opt in to allowing marijuana businesses or if there would instead be an opt out provision for those wanting to ban cannabis commerce.

The session ends on Wednesday, and so far no vote has been scheduled in either chamber.

Meanwhile, lawmakers early on Monday morning filed what appears to be backup legislation to expand the decriminalization of marijuana and to provide a process to expunge or vacate prior cannabis convictions. And others support putting legalization on the ballot through a referendum that voters can decide on.

The situation is very fluid, and over the next few days advocates will be stepping up the push for action in Albany. On Sunday, they held a rally outside Cuomo’s Manhattan office.

Bill Allowing Interstate Marijuana Commerce Heads To Oregon Governor’s Desk

This post has been updated to include the latest developments as well as comment from a number of elected officials.

Photo courtesy of Philip Steffan.

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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Texas Governor Signs Bill To Expand State’s Medical Marijuana Program

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The governor of Texas signed a bill into law on Friday that significantly expands the state’s medical cannabis program.

The legislation, which was overwhelmingly approved by lawmakers last month, adds multiple medical conditions to the list of disorders that qualify patients of low-THC marijuana. Currently only patients with intractable epilepsy qualify under the CBD-focused program.

New qualifying conditions include epilepsy, multiple sclerosis, terminal cancer, autism, spasticity and amyotrophic lateral sclerosis.

Gov. Greg Abbott (R) signed the bill with little fanfare.

Reform advocates said the legislation is a big step in the right direction, even though it doesn’t go as far as they’d hoped. A 0.5 THC cap on marijuana products remained in the bill, for example, and a section that would have established a research program to study the therapeutic potential of cannabis was removed.

“Cannabis is effective medicine for many patients suffering from debilitating medical conditions,” Heather Fazio, director of Texans for Responsible Marijuana Policy, told Marijuana Moment. “HB 3703 represents a positive step toward a functional medical cannabis program, but sadly, it still leaves behind millions of Texas families that could benefit from legal access.”

Also this legislative session, the House of Representatives approved bills to more comprehensively expand the medical cannabis program and to decriminalize marijuana possession, but they died in the Senate.

Abbott signed a hemp legalization bill earlier this week.

Bill Allowing Interstate Marijuana Commerce Heads To Oregon Governor’s Desk

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.
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