The White House is currently reviewing a federal plan for marijuana and CBD research.
The Food and Drug Administration (FDA) submitted draft guidance on the issue last week to the White House Office of Management and Budget (OMB).
Details about the document—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—are sparse. But an FDA spokesperson indicated to Marijuana Moment that it’s related to the agency’s ongoing work to develop broader CBD regulations that could eventually allow for the marketing of cannabis products as dietary supplements or food items.
“We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products. We are working toward a goal of providing additional guidance, and have made substantial progress,” FDA said in a statement. “There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence.”
“As part of our work, the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed,” the statement continues. “An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform our consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards.”
What remains to be seen is whether FDA plans to wait for this specific guidance to be finalized and for the resulting research to be completed before it gets around to issuing final rules for CBD products in general. Stakeholders have been eagerly awaiting those regulations so they can fully take advantage of the legalization of hemp and its derivatives.
“We will continue to update the public about our path forward as our work progresses, and provide information that is based on sound science and data,” FDA said.
While sending the guidance to OMB could be interpreted as a positive development signaling that FDA is making progress on the development of regulations, former FDA Commissioner Scott Gottlieb said on Saturday that White House policies requiring OMB to review scientific documents in the first place represent an onerous step that’s delayed the issuance of guidance.
It’s also worth noting FDA’s effort to modernize definition of “healthy” on food labels to help consumers make more informed choices about diets has been under OMB review since August 2019. Will technical and scientific guidance critical to advancing patient care move faster? 2/2
— Scott Gottlieb, MD (@ScottGottliebMD) May 30, 2020
The FDA spokesperson declined to comment on the former commissioner’s statement.
The agency first announced in January that it planned to publish guidance on cannabis research this year. It’s not clear how long the OMB review will take or when the document will be finalized for public release.
In addition to sending the guidance to the White House for review, FDA is also soliciting public input about the safety and efficacy of CBD in comment period it has decided to keep open indefinitely. The agency said in an update to Congress in March that it has several specific questions it wants answered before deciding whether the cannabidiol can be lawfully marketed. That includes questions about the impact of different methods of consumption and drug interactions.
In the meantime, FDA is maintaining enforcement discretion when it comes to action against companies that sell CBD products regardless of the lack of regulations and has said it is currently targeting sellers that make especially outlandish or unsanctioned claims about the therapeutic value of their products.
It sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection, for example.
FDA sent a letter warning to a company about its marketing of injectable CBD products that led to a voluntary recall last month.
The agency also publicized a voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.
FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.
Photo by Kimzy Nanney.
USDA Approves Hemp Plans For Six Additional States And Three Indian Tribes
The U.S. Department of Agriculture (USDA) has signed off on hemp plans for six additional states and three Indian tribes this month, with a new batch of approvals coming on Friday.
Illinois, Indiana, Michigan, New Mexico, Oklahoma and South Dakota each had their regulatory proposals accepted within the past two weeks, as did the Comanche Nation, the San Carlos Apache Tribe of Arizona and the Seminole Nation of Oklahoma.
That raises the total number of approved plans to 69.
USDA has been signing off on hemp proposals on a rolling basis over the past year. Last month, it accepted plans from Utah and the Torres Martinez Desert Cahuilla Indians.
The South Dakota Department of Agriculture (SDDA) has received final approval by the United States Department of Agriculture (USDA) for the South Dakota Industrial Hemp Plan.
— SD Dept of Ag (@SDAgriculture) October 16, 2020
Illinois and Oklahoma were among a group of states that USDA had asked to revise and resubmit their initial proposals in August.
While the agency released an interim final rule for a domestic hemp production program last year, industry stakeholders and lawmakers have expressed concerns about certain policies it views as excessively restrictive.
USDA closed an extended public comment period on its proposed hemp regulations earlier this month. Its initial round saw more than 4,600 submissions, but it said last month that it was reopening the feedback period in response to intense pushback from stakeholders on its original proposal.
The federal Small Business Administration (SBA) said last month that the new 30-day comment window is too short and asked USDA to push it back, and it also issued a series of recommended changes to the interim final rule on hemp, which it says threaten to “stifle” the industry and benefit big firms over smaller companies.
All told, it appears that USDA is taking seriously the feedback it’s received and may be willing to make certain accommodations on these particular policies. The department’s rule for hemp is set to take effect on October 31, 2021.
In July, two senators representing Oregon sent a letter to Perdue, expressing concern that hemp testing requirements that were temporarily lifted will be reinstated in the agency’s final rule. They made a series of requests for policy changes.
Senate Minority Leader Chuck Schumer (D-NY) wrote to Perdue in August, asking that USDA delay issuing final regulations for the crop until 2022 and allow states to continue operating under the 2014 Farm Bill hemp pilot program in the meantime.
Sen. Cory Gardner (R-CO) also called on USDA to delay the implementation of proposed hemp rules, citing concerns about certain restrictive policies the federal agency has put forward in the interim proposal.
The earlier pilot program was initially set to expire on October 31, but it was extended to September 2021 through a congressional continuing resolution that the president signed late last month.
The senators weren’t alone in requesting an extension, as state agriculture departments and a major hemp industry group made a similar request to both Congress and USDA in August.
Perdue has said on several occasions that DEA influenced certain rules, adding that the narcotics agency wasn’t pleased with the overall legalization of hemp.
Amid the coronavirus pandemic, hemp industry associations pushed for farmers to be able to access to certain COVID-19 relief loans—a request that Congress granted in the most recent round of coronavirus legislation.
While USDA previously said that hemp farmers are specifically ineligible for its Coronavirus Food Assistance Program, that decision was reversed last month. While the department initially said it would not even reevaluate the crop’s eligibility based on new evidence, it removed that language shortly after Marijuana Moment reported on the exclusion.
Two members of Congress representing New York also wrote a letter to Perdue in June, asking that the agency extend access to that program to hemp farmers.
Hemp farmers approved to produce the crop do stand to benefit from other federal loan programs, however. The department released guidelines for processing loans for the industry in May.
Meanwhile, USDA announced last week that it is planning to distribute a national survey to gain insights from thousands of hemp businesses that could inform its approach to regulating the industry.
AOC Wants To Work With Republicans To Legalize Marijuana And End War On Drugs
Democrats and Republicans might be divided on a number of major policy issues, but Rep. Alexandria Ocasio-Cortez (D-NY) said on Thursday that ending the drug war and legalizing marijuana are increasingly standing out as exceptions to hyper-partisanship in Congress.
The congresswoman made the point during a virtual town hall alongside cannabis reform ally Rep. Earl Blumenauer (D-OR), stating that since she took office, it’s been encouraging to see members on both sides of the aisle come together on issues concerning “civil rights policy and civil liberties,” including ending “drug prohibition laws.”
“We’ve been able to propose solutions on a wide spectrum towards decriminalization, towards legalization, and that is increasingly becoming a position that more Republicans are amenable to,” she said.
For example, her spending bill amendment to divert $5 million in funding from the Drug Enforcement Administration to an opioid treatment program was approved without opposition in the House last year, Ocasio-Cortez said.
“That’s defund before defund became a widespread demand that we heard this year—and Republicans supported it,” she said, referencing progressive calls to defund law enforcement amid protests over police killings of black Americans. “So there are some areas where you can find common ground.”
Blumenauer also said at the event that “part of why we are fighting so hard to eliminate the failed prohibition on cannabis is because that’s been a tool that’s been used against people of color in particular that has horrific consequences and helps fuel that prison pipeline that has wreaked such havoc on our communities.”
To that end, Ocasio-Cortez said that, beyond federally legalizing cannabis, it’s important for lawmakers to ensure that any regulated markets that emerge are structured in a way that encourages participation by communities most hurt under prohibition.
“There are different ways that we can go about legalizing cannabis in the United States, and you can go about it in a way that concentrates power in a [Big Agriculture] way that concentrates power in big banks and that cuts out small mom and pops,” she said. “And then there’s another path towards legalization where everyday people and especially the black and brown communities that have been disproportionately impacted by the war on drugs can be at the front of the line of enjoying the economic benefits of legalization.”
“I think we’re just so past due to make sure that we’re legalizing cannabis in the United States and that we’re expunging people’s records from the absolutely unjust war on drugs,” the congresswoman said. “It is an incredible priority.”
New York Will Legalize Marijuana By April And Regulate CBD-Infused Drinks, Governor’s Advisor Says
The top marijuana advisor to New York Gov. Andrew Cuomo (D) says cannabis legalization legislation will again be introduced through the state budget in January, with the goal being to enact the reform by April. He also previewed state regulations for hemp-derived CBD products, including allowing infused drinks and food items.
During an interview with Canopy Growth Corp.’s David Culver on the company’s recently launched video series, “Under The Canopy,” Assistant Counsel Axel Bernabe talked about how efforts to legalize marijuana in surrounding states underscore the need for reform in New York. And he said the legislation the governor will be introducing will serve as a “model” for other states, prioritizing social equity and economic development.
In this episode of #UnderTheCanopy we speak to Axel Bernabe of @NYGovCuomo's office who answered our questions on New York’s upcoming #hemp regulations, #cannabis #legalization, and the Gov.’s pandemic response. Watch here: https://t.co/5SzWFMnFSU
— Canopy Growth (@CanopyGrowth) October 14, 2020
But he also recognized that neighboring New Jersey may beat the Empire State to the punch, as voters are positioned to approve a legalization referendum next month.
“We’re watching New Jersey closely. We’ve always been confident that we get to this before New Jersey, so if they pass the referendum they still have to have agreement between the governor the Senate over there,” he said, referring to necessary implementing legislation that will need to be approved if voters pass the ballot question. “We’re working on this. We’re going to reintroduce this in our budget in January. We think we can get it done by April 1.”
That said, a top New Jersey senator recently indicated that lawmakers in the Garden State could pass the enacting bill as soon as the first week of November.
Over in New York, Cuomo has included legalization in his budget proposal for the last two years, but negotiations have consistently stalled out in the legislature, with sticking points such as how cannabis tax revenue will be allocated preventing a deal from being reached.
“If Jersey can beat us to it, then they’ll get the gold star—but I still think we’re going to set the model here.”
Bernabe said he’s especially excited about the public safety and economic development components of the administration’s forthcoming legalization proposal. And he spoke about the need to ensure social equity for communities historically targeted by the war on drugs, adding that there will be some changes from this year’s version in light of other states’ experiences.
“I would say equity pervades the entirety of the bill. It pervades it on the licensing front, it’s on the revenue side and the use of funds and providing capital and loans,” he said.
Also in the interview, Bernabe talked about pending regulations for hemp-derived cannabinoids. While those who grow the crop for fiber, seeds and other agricultural purposes are covered under existing rules, he said the administration is “literally putting the final tweaks” on policies for consumer CBD products that will take effect at the beginning of 2021.
“We’re excited because we’ve taken the bull by the horns so to speak. I think people recognize that there are a lot of sectors or product lines that haven’t really had some thorough regulation attached to them,” he said. “You can pick a number of them but probably the most high-profile or obvious ones are something like vapes—so CBD or other cannabinoid extract vapes. Flower, even some tinctures, and foods and beverages.”
“How do you regulate that? What are the parameters around it? What’s permissible? What’s not?” he said. “We dug deep. I don’t know that we’ll get everything right. We had to make some calls.”
NY is on the cusp of opening their hemp market – but what went into the regulatory process to make this a reality? Axel Bernabe from @NYGovCuomo's office discusses this & all things cannabis-related in this episode of #UnderTheCanopy Click here to watch: https://t.co/5SzWFMnFSU pic.twitter.com/HEK351bG5o
— Canopy Growth (@CanopyGrowth) October 18, 2020
The administration official offered an example of a regulation they’re likely to pursue that other states have avoided: creating rules for cannabinoid-infused drinks and food items.
“We think of this in terms of consumer protection. Those products are already out there. There’s no sense in trying to pretend they’re not,” he said, adding that one way they’re planning to ensure those protections is to set a maximum 25 milligram CBD dose per serving.
“We’re really doing it across the board on this,” Bernabe said. “We’re really looking at every product class and trying to strike a balance between consumer protection and letting people have what they’re obviously using extensively for health and wellness.”
As the administration finalizes those rules, the state’s hemp industry also recently got some news about broader regulations. Since a congressional continuing rider signed by the president last month extends the 2014 Farm Bill pilot program for the crop until next September, the New York Agriculture Department said it will similarly allow hemp businesses to continue to operate under the existing program until September 30, 2021.
“With so much uncertainty right now, we applaud [the department’s] move to extend these rules,” Allan Gandelman, president of the New York Cannabis Growers and Processors Association, said in a press release on Wednesday.
Photo courtesy of Mike Latimer.