Food and Drug Administration (FDA) Commissioner Scott Gottlieb revealed new details about plans to pursue alternative pathways for CBD regulation and also acknowledged that federal prohibition drives research into medical marijuana overseas on Wednesday.
Gottlieb’s latest comments were in response to questions from Reps. Barbara Lee (D-CA), Chellie Pingree (D-ME) and Mark Pocan (D-WI) during a hearing before a House Appropriations subcommittee.
Among the revelations that came out of the hearing was that Gottlieb will shortly announce that the FDA will hold a public meeting “sometime in April” to hear from stakeholders about how to best regulate CBD derived from hemp, which was legalized late last year as part of the 2018 Farm Bill. He also said he’d be forming a working group comprised of agency experts to inform him on regulatory options for CBD.
Pocan wanted to know “how actively” the FDA was considering different pathways to regulate food and dietary supplements that contain hemp-derived CBD, and he requested a timeline for when the agency expects to release guidance on the issue.
“I’ll say at the outset that we heard Congress loud and clear with respect to that legislation,” Gottlieb said, referring to the Farm Bill. “I understand Congress wants there to be a pathway for CBD to be available.”
But he added that this “is not a straightforward issue.” Not only has the already FDA approved a CBD medication for epilepsy, Epidiolex, which generally means the compound can’t be added to food, but it’s also the “subject of substantial clinical investigation”—another reason it wouldn’t be be allowed in the food supply.
That said, “the law does allow us to go through a regulatory process and go through a notice and comment rule-making to establish a framework to allow it to be put into the food supply,” Gottlieb said. Their first step to that end will be a public meeting “sometime in April” that the agency will soon formally announce.
The commissioner offered a theoretical regulatory model that the FDA could implement for CBD.
CBD could potentially exist “in a high concentration, pure formulation as a pharmaceutical product” and also exist “at a different concentration as a food product or dietary supplement.” The reason the agency would want that separation is “because we want to preserve the incentive to study CBD as a pharmaceutical product,” Gottlieb said.
“We believe it does have therapeutic value and has been demonstrated,” he said. “But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”
If the task of developing an alternative regulatory approach for CBD proves “sufficiently complicated,” Gottlieb said the FDA will “come back and have a discussion with Congress about how we might be able to work together on this,” suggesting that further legislative action beyond the Farm Bill may be necessary.
Rep. Andy Harris (R-MD) briefly followed up on Pocan’s questioning and said he goes into markets and see “displays of CBD-containing products, and it’s not at the pharmacy behind the counter obtained with a prescription.”
“I think this is something that crept up on us and I appreciate your answer to Mr. Pocan on that,” Harris said.
Pingree was the lead author of a bipartisan letter that was sent to the commissioner last week, inquiring about the timeline for the FDA’s guidance on how businesses can lawfully sell hemp-derived CBD products across state lines. At the hearing, the congresswoman said she wanted to “emphasize the need for some sense of urgency” around the issue.
“I will tell you that we’re deeply focused on this. We have taken on other hard challenges before,” Gottlieb said. “I think we have a good track record of trying to come to resolution on other challenges. You have my commitment that I’m focused on this one.”
Today I asked Commissioner Gottieb about FDA's timeline and resources to develop legal pathways for food products with #CBD. He said the agency is developing a working group focused on this issue, but if it takes too long Congress may need to act. #mepolitics pic.twitter.com/l8TX0DrrVD
— Chellie Pingree (@chelliepingree) February 27, 2019
The commissioner said he will soon announce “a high-level working group that’s going to report to me on this, with some senior officials in the agency who are going to be chairing that.”
“I will tell you that if we make a determination that the pathway here is going to be a multi-year regulatory process that could take two, three, four years, I will come back to Congress to have a discussion about whether or not there are other frameworks that could help address this,” he said.
Further, the FDA may “need statute that either addresses this as a whole framework or address CBD specifically.”
Lee, who became the first woman and first person of color to co-chair the Congressional Cannabis Caucus in January, said she was excited to have the opportunity to speak about two of her favorite subjects: “Cuba and cannabis.”
For the latter, she focused on the FDA approval of Epidiolex. Specifically, she wanted to point out that a UK-based pharmaceutical company was awarded the drug approval because the UK government licenses them “to privately grow strains of cannabis for the purpose of drug development.”
“Is it possible under our US federal system, Schedule I, can a U.S.-based company similarly bring a plant-derived cannabis-based drug to market via the traditional FDA review and approval process?” Lee asked. “Because so many states now have passed medical marijuana initiatives and it’s a shame that we haven’t been able to move forward with the research.”
“With respect to cannabis-derived compounds, it really depends on which active ingredient you’re talking about—whether you’re talking about THC or CBD and whether or not it’s being derived from marijuana or hemp,” Gottlieb said.
He added that it remains an “active question” as to whether hemp-derived CBD was legalized under the 2018 Farm Bill, which would mean the compound “can be studied in a more fluid fashion.” (Some experts don’t see this as an open question, however, as the agriculture legislation did remove hemp-derived products from the Controlled Substance Act.)
The commissioner said he has his “own personal opinion” about the issue but said his lawyers wouldn’t want him to give a “legal opinion.”
“I think we’re going to have a resolution on that very soon about whether or not the CBD derived from hemp doesn’t fall under the scheduling process,” he said.
Finally, Gottlieb conceded that existing federal marijuana laws mean that “the ability to conduct research on marijuana is more restricted, more heavily regulated.” While he said he didn’t know “all of the nuances” around it, one problem is that there’s only one federally authorized marijuana manufacturer in the United States, and that lack of supply has driven some researchers to conduct studies in other countries.
“Over the years, you have seen, in all candor, companies go overseas to conduct research with foreign-grown product that is more easily sourced for the purposes of clinical trials,” he said. “I think the issue you’re getting at is a valid one. The only thing I can say is that the environment here is changing quickly.”
“Very quickly,” Lee agreed.
“We would certainly support more research,” Gottlieb said.
Photo courtesy of YouTube/House Appropriations Committee.
Hemp Farmers Guaranteed Federal Crop Insurance Through Disaster Bill Amendment
The Senate approved a bill on Thursday that is mostly focused on providing relief aid to areas impacted by natural disasters—but it also includes a provision ensuring that hemp farmers qualify for federal crop insurance.
The hemp section was inserted into the legislation at the behest of Senate Majority Leader Mitch McConnell (R-KY). Though similar language already exists in the 2018 Farm Bill, which federally legalized hemp and its derivatives, the senator took an added measure to provide clarity to farmers who want access to the insurance option ahead of the 2020 planting season.
“Beginning not later than the 2020 reinsurance year, the Federal Crop Insurance Corporation shall offer coverage under the wholefarm revenue protection insurance policy (or a successor policy or plan of insurance) for hemp (as defined in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o)),” text of the provision states.
“Provided, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985,” it continues.
The Senate passed the bill by a vote of 85 to 8. The House is expected to approve the disaster legislation by unanimous consent by the end of the week, and President Donald Trump has offered assurances that he will sign it into law.
The legalization of hemp has sparked strong interest among farmers in states from Colorado to Kentucky, but it will still be some time until the U.S. Department of Agriculture (USDA) develops and implements its federal regulatory guidelines.
Agriculture Secretary Sonny Perdue said that while his department would not rush its rulemaking process, it still intends to implement the regulations before the 2020 planting season. After that point, USDA would be able to approve regulatory plans submitted by individual states.
McConnell, who championed the hemp legalization provision, has urged the quick and effective implementation of such regulations, and he’s suggested that he’d introduce standalone legislation to resolve any “glitches” in its rollout.
While not a standalone bill, the hemp-focused provision of the disaster legislation seems to indicate he plans to make good on that promise.
The senator has made much of his pro-hemp agenda, arguing last month that his role in reforming hemp laws is at “the top of the list” of reasons why voters should reelect him in 2020. He also cited hemp as an agricultural alternative to tobacco when he introduced a bill this week to raise the minimum age requirement to purchase tobacco products from 18 to 21.
Congressional Report Urges DEA Action On Marijuana Cultivation Applications
A congressional committee report attached a large-scale spending bill containing marijuana-related protections has been amended to include a call for the Drug Enforcement Administration (DEA) to finally act on long-pending applications for federal licenses to grow cannabis for research purposes.
The legislation itself, which was released by a House subcommittee last week, could still be further amended as it goes through the legislative process. But as approved by the full House Appropriations Committee on Wednesday, the bill stipulates that none of the Fiscal Year 2020 funds it allocates may be used by the Justice Department to interfere in state-legal medical marijuana programs.
The provision has been federal law since 2014, but its inclusion in the initial subcommittee proposal as introduced is the earliest it has ever surfaced in the legislative process for the annual spending bill. While advocates hoped broader protections for adult-use cannabis states would also be included in the base legislation, that rider isn’t in the bill—at least not yet.
There was also a technical problem with the legislation that wasn’t resolved by the committee manager’s amendment, the text of which has not been posted but was obtained by Marijuana Moment. The medical cannabis provision lists the states and territories its protections apply to—but it left out the U.S. Virgin Islands, which legalized medical marijuana in January.
Similar errors have occurred in past versions of the legislation, when legal medical cannabis states North Dakota and Indiana were not included in an earlier version of the rider, and advocates hope that the language will be amended on the House floor.
But while that fix didn’t make it into the bill at the committee level, the directive to the DEA about cannabis cultivation licenses was added to the committee report attached to the bill via the manager’s amendment.
“The Committee urges the Drug Enforcement Administration to expeditiously process any pending applications for authorization to produce marijuana exclusively for us in medical research,” the revised report states.
The DEA has faced significant pressure from lawmakers, advocates and scientists to approve applications for additional marijuana manufacturers to produce research-grade cannabis. Currently there is only one federally authorized facility, and the quality of its product has long been criticized.
DEA announced a process to license additional cultivators during the final months of the Obama administration in 2016, but the Justice Department under then-Attorney General Jeff Sessions refused to act on more than two dozen pending applications. Current Attorney General William Barr has pledged to look into the matter, and has said he agrees that approving additional manufacturers is necessary.
Advocates hope that the new committee report language could help to finally spur movement at the department.
“The DEA is a disaster on marijuana and they need to stop obstructing research ASAP,” Michael Collins, director of national affairs for the Drug Policy Alliance, told Marijuana Moment.
“It’s beyond ridiculous that they won’t act on these applications. Even prohibitionists like Project SAM agree,” he added, referring to the anti-legalization group Smart Approaches to Marijuana. “And when the guys who get their drug policy from the 1920s say you’re behind the times, that’s pretty embarrassing.”
Justin Strekal, political director for NORML, said that Sessions “was the only government official opposed to cannabis research, and he is no longer employed.”
“Now is the time for AG Barr to follow through on his commitment and allow researchers pathways to consumer-grade cannabis,” he said.
Another provision included in the appropriations bill would offer protections for states that have implemented industrial hemp pilot programs under the 2014 Farm Bill. The Justice Department wouldn’t be allowed to use its funds to interfere in such programs under the proposal.
Of course, the 2018 version of the agriculture legislation removed hemp and its derivatives from the Controlled Substances Act, shifting regulatory responsibility onto the U.S. Department of Agriculture instead of the Justice Department, so that provision may not be especially relevant going forward.
The bill will next head to the Rules Committee, which will decide the list of amendments—potentially including additional cannabis-related ones—that can be considered on the House floor.
Read the text of the manager’s amendment with the DEA marijuana language below:
Managers Amendment FINAL by on Scribd
Photo courtesy of Mike Latimer.
House Committee Approves Immigration Bill With Marijuana Protections
A congressional committee voted in favor of a wide-ranging immigration bill on Wednesday, and the legislation includes marijuana-related protections for people who were brought to the U.S. as children.
Under the DREAM Act as approved, having low-level cannabis convictions, or engaging in state-legal cannabis-related activities such as working in the regulated marijuana industry, would not be counted against applications for permanent resident status for so-called Dreamers.
The House Judiciary Committee advanced the bill in a 19-10 vote, without specific discussion about the cannabis provisions.
The section concerning eligibility for permanent status stipules that having three or more misdemeanor convictions could be grounds for ineligibility—but the bill creates an exemption for “simple possession of cannabis or cannabis-related paraphernalia” or “any offense involving cannabis or cannabis-related paraphernalia which is no longer prosecutable in the State in which the conviction was entered.”
The text seems to indicate that immigrants who engaged in cannabis-related activities prior to a state reforming its marijuana laws would still be protected even if that activity was not state-legal at the time.
Similar language appears under a separate section about grounds for a provisional denial of an application for adjustment of status. Applicants would be exempted from such a denial if their conviction was for “simple possession of cannabis or cannabis-related paraphernalia” or “any offense involving cannabis or cannabis-related paraphernalia which is no longer prosecutable in the State in which the conviction was entered.”
A previous version of the legislation, filed in March, didn’t include the specific eligibility requirements related to certain criminal activity, nor did it contain any explicit marijuana protections. It’s possible that House Democrats thought up the exemptions during a brainstorming session earlier this month about potential bill revisions aimed at building more support.
The next likely stop for the DREAM Act will be the House Rules Committee before heading to a full floor vote.
There’s been growing interest in reforming marijuana policies as they apply to immigrants and visitors to the U.S.
Earlier this month, four congressional Democrats sent a letter to the head of the Justice Department and Department of Homeland Security to end the practice of rejecting naturalization applications solely because the applicant worked in a state-legal marijuana market. That came after the U.S. Citizenship and Immigration Services (USCIS) released a memo specifying that such activity could render them morally unfit for citizenship.
And last week, Rep. Earl Blumenauer (D-OR) introduced legislation aimed at resolving marijuana-related border issues, whereby visitors who admit to using cannabis or working in their country’s legal industry can be denied entrance.
Photo courtesy of Philip Steffan.