The Food and Drug Administration (FDA) issued an update to Congress this week on the status of rulemaking for CBD.
While the process remains ongoing, the agency announced that it is actively exploring pathways to allow for the marketing of cannabidiol as a dietary supplement and is developing enforcement discretion guidance. It will also be reopening a public docket to solicit additional scientific information about the risk and benefits of the cannabis compound.
After hemp and its derivatives were federally legalized under the 2018 Farm Bill, FDA was mandated under separate appropriations legislation passed late last year to provide an update on its regulatory approach to CBD within 60 days. That deadline passed last month, but the report and a supplementary notice were made public on Thursday.
“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions,” the agency told lawmakers. “Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.”
FDA has previously issued warnings to CBD companies that make unsubstantiated claims about the therapeutic potential of the non-intoxicating compounds, and it said it remains concerned about such practices and will continue to take enforcement action against such businesses.
The agency reviewed what’s known about CBD—acknowledging that data was limited “because cannabis-derived CBD was a Schedule I controlled substance” prior to hemp legalization. The roadblocks to research caused by marijuana’s ongoing restrictive Schedule I status is something legalization advocates have long pointed out.
“Thus, limited systematic data exist to inform our approach,” FDA wrote. “As more data on CBD become available, we will be able to refine—and, perhaps in some cases, revise—our thinking and approaches.”
The report notes that there are means to develop FDA-approved drugs based on CBD, as has been done for one prescription medication to treat severe seizure disorders, but it stressed that “CBD is not a risk-free substance” and could impact liver health and have adverse interactions with other drugs. Further, the agency said it is concerned about mislabeling and the presence of adulterants in unregulated products.
That said, FDA said it is “actively evaluating what and how much data would be sufficient to support a conclusion that CBD can safely be allowed in dietary supplements under certain conditions.” To expedite the process, it is also “evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process of a rulemaking.”
“Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities based on the known risks to public health. As we move forward, FDA intends to continue taking action to address violations we identify that put the public at risk.”
There are a number of questions that FDA is considering as it continues to develop regulations for CBD products.
“1. What happens if you use CBD daily for sustained periods of time?
2. What level of intake triggers the known risks associated with CBD?
3. How do different methods of exposure affect intake (e.g., oral consumption, topical, smoking or vaping)?
4. What is the effect of CBD on the developing brain (such as children who take CBD)?
5. What are the effects of CBD on an unborn child or breastfed newborn?
6. How does CBD interact with herbs and botanicals?
7. Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?
8. Are there differing safety concerns for use in certain animal species, breeds, or classes?
9. Are any residues formed in edible tissues of food producing animals?”
While CBD is not currently allowed to be marketed as a dietary supplement, FDA wrote that it “has the authority to remove this exclusion through rulemaking.” Answering these questions—through the reopened public docket as well as discussions with government partners—will help facilitate that process. The docket will remain open “indefinitely” for stakeholders to submit relevant information to assist in the rulemaking process, it said.
“We recognize the high level of interest in dietary supplements as a potential pathway for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements,” FDA said.
“Given the significant public interest in the potential for CBD dietary supplements, as well as the extent to which many such products are available on the market, FDA has been taking a highly proactive approach to analyzing relevant safety questions. Rather than waiting for data to be submitted, we have been actively working to identify and review all available data to understand the risk profile of CBD and the potential for CBD to be safely included in dietary supplements, under certain conditions of use.”
But allowing CBD to be sold as a dietary supplement creates certain concerns, it said. For example, dietary supplement makers are not regulated in the same way as, say, pharmaceutical companies, and so that would “limit our ability to provide systematic and comprehensive oversight over all CBD products.”
To fill the gap in product-specific information about CBD, FDA said it will set up a system for proprietary data to be submitted to the agency in the hopes that the process “will enable responsible industry participants to share relevant information with FDA about specific products, which could help inform appropriate regulatory steps.”
Another notable component of the report concerns CBD vaping products. The agency said such products increase the risk of toxicity issues and could also appeal to youth. It emphasized that CBD vaping items cannot be marketed as a drug without FDA approval.
“We remain focused on educating the public about the number of questions that remain regarding CBD’s safety,” FDA said in a separate notice for the public on Thursday. “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.”
We’re seeing CBD being marketed in a number of different products & understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons. Aside from one prescription drug, no other CBD products have been evaluated/approved by FDA.
— Dr. Stephen M. Hahn (@SteveFDA) March 5, 2020
Though FDA has consulted with government partners at the federal, state, local and international levels, it has yet to do so for tribal entities. The agency stands “ready to do so,” the report states, adding that FDA plans to host a call with state public health officials on CBD safety issues.
FDA said it has received feedback inquiring about whether “full spectrum” or “broad spectrum” hemp products that contain CBD are allowed to be marketed. There’s a lack of clarity to that end because, as the agency noted, while such terms generally indicate that the products are not CBD isolates, some contain high levels of the compound.
“We are actively seeking information from individual manufacturers, trade groups, and others regarding the processes by which ‘full spectrum’ and ‘broad spectrum’ hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products,” it said. “Such information will be critical to informing our evaluation of the regulatory status of such products.”
These efforts are in line with our mission to protect the public, foster innovation & promote consumer confidence. We’re committed to working efficiently to further clarify our regulatory approach – using science as our guide & upholding our rigorous public health standards.
— Dr. Stephen M. Hahn (@SteveFDA) March 5, 2020
The agency also acknowledged a separate congressional mandate to conduct product sampling of CBD products on the market to determine the extent to which there is contamination or adulteration. It said it is actively developing a plan to accomplish that within the 180-deadline set in last year’s spending legislation.
“As this report outlines, we have made progress, but there are still areas where timely attention is needed,” FDA said. “Ultimately, we remain steadfast and committed to working with all stakeholders to ensure the protection and promotion of public health. This is especially so with respect to our government partners at the federal, state, local, territorial, tribal and international levels.”
While the report does not offer much in the way of policy updates and largely describes ongoing efforts to develop CBD rules, FDA does appear to be heeding the opinion of lawmakers and stakeholders who have repeatedly implored the agency to provide a pathway for marketing of the compound.
Relatedly, the newly installed commissioner of FDA said last week that given the widespread availability and interest in CBD, it would be a “fool’s game” to ban them.
Read the full FDA report on CBD below:
Photo by Kimzy Nanney.
New Congressional Resolution Condemns Police Brutality And War On Drugs
Twelve House members introduced a resolution on Friday condemning police brutality in light of the recent law enforcement killings of two black individuals that have galvanized mass protests. The measure specifically notes the racial injustices of the war on drugs.
The resolution is partly motivated by the killings of George Floyd in Minnesota, where a police officer suffocated him to death, and Breonna Taylor in Kentucky, where she was fatally shot by police during a botched drug raid.
Protests have erupted across the U.S. this week, with calls for justice and law enforcement accountability. The new House measure, if adopted, would formally align the body with that sentiment, condemning police brutality, racial profiling and excessive use of force.
The drug war has contributed to those problems, the lawmakers said, with people of color being more likely to be arrested for drug offenses than white people despite similar rates of consumption.
The “system of policing in America, and its systemic targeting of and use of deadly and brutal force against people of color, particularly Black people, stems from the long legacy of slavery, lynching, Jim Crow laws, and the War on Drugs in the United States and has been perpetuated by violent and harmful law enforcement practices,” a provision of the resolution states.
In addition to condemning “all acts of brutality, racial profiling, and the use of excessive force by law enforcement officers and calls for the end of militarized policing practices,” the resolution urges the Justice Department to investigate individual cases of police violence and racial profiling and establish all-civilian review boards to provide community oversight of policing.
The measure also “calls for the adoption of sound and unbiased law enforcement policies at all levels of government that reduce the disparate impact of police brutality and use of force on Black and Brown people and other historically marginalized communities.”
Reps. Ayanna Pressley (D-MA), Ilhan Omar (D-MN), Karen Bass (D-CA) and Barbara Lee (D-CA) led the resolution. Other cosponsors include Reps. Joaquin Castro (D-TX), Katherine Clark (D-MA), James McGovern (D-MA), Rashida Tlaib (D-MI), Alexandria Ocasio-Cortez (D-NY) and Joseph Kennedy III (D-MA).
The resolution @Ilhan & I are introducing today aims to ensure that those responsible are held accountable and calls for systemic reforms at all levels of government to end the scourge of police brutality in our society. #SaveLivesNow https://t.co/8vlMiY4j83
— Congresswoman Ayanna Pressley (@RepPressley) May 29, 2020
“From slavery to lynching to Jim Crow, Black people in this country have been brutalized and dehumanized for centuries,” Omar said in a press release. “The war on drugs, mass criminalization, and increasingly militarized police forces have led to the targeting, torture and murder of countless Americans, disproportionately black and brown.”
We can’t just continue to watch our communities be brutalized by the police.
I am proud of my sisters in Congress for joining me in condemning police brutality and look forward passing this resolution. https://t.co/qeSaRB5dMZ
— Ilhan Omar (@IlhanMN) May 29, 2020
“The murder of George Floyd in my district is not a one-off event. We cannot fully right these wrongs until we admit we have a problem,” she said. “As the People’s House, the House of Representatives must acknowledge these historical injustices and call for a comprehensive solution. There are many steps on the path to justice, but we must begin to take them.”
Advocacy groups including the Leadership Conference on Civil and Human Rights, Drug Policy Alliance, Color of Change, ACLU chapters and NAACP Legal Defense and Educational Fund have endorsed the resolution.
This measure is being introduced one week after 44 members of the House sent a letter to the Justice Department, calling for an independent investigation into a fatal police shooting of Taylor.
In that letter, the legislators cited prior excessive force incidents with two of the three officers involved in Taylor’s shooting—as well as prior alleged improper enforcement by the department’s SWAT team in a botched marijuana raid—as evidence of the need for an investigation.
“For too long, Black and brown bodies have been profiled, surveilled, policed, lynched, choked, brutalized and murdered at the hands of police officers,” Pressley said about the new resolution. “We cannot allow these fatal injustices to go unchecked any longer. There can be no justice for George Floyd, Breonna Taylor, or any of the human beings who have been killed by law enforcement, for in a just world, they would still be alive. There must, however, be accountability.”
Joe Biden’s New Disability Plan Includes Boosting Medical Marijuana Research
Presumptive Democratic presidential nominee Joe Biden’s new plan for people with disabilities involves promoting research into the therapeutic potential of marijuana.
The former vice president, who remains opposed to broader cannabis legalization, said he will “ensure people with disabilities have a voice in their government and are included in policy development and implementation.” That includes cannabis policy.
“A Biden Administration will prioritize the research needed to advance science-based federal policies related to the use of marijuana for medical conditions, chronic pain, and disabilities,” the plan, released on Thursday, states.
Thirty years ago, I proudly cosponsored the landmark Americans with Disabilities Act. It was an enormous step forward, but there's more work to do. So today, I’m releasing my plan to achieve full participation and equality for people with disabilities: https://t.co/psuNvKzYej
— Joe Biden (@JoeBiden) May 28, 2020
This is another example of Biden featuring marijuana issues in broader policy platforms. Earlier this month, he released a plan on racial justice that included his existing modest cannabis reform proposals for decriminalization and automatic expungements.
But while advocates agree with the need for those policy changes, they’ve remained disappointed about Biden’s ongoing opposition to adult-use legalization—something they argue should go hand-in-hand with the social justice principles he’s touted.
The presumptive nominee has argued that more research needs to be done on the potential risks and benefits of marijuana before he’s be open to legalization. In a recent interview, a host pushed back and said, anecdotally, there have been decades of research given that millions of people consume cannabis.
Biden agreed and said he knows “a lot of weed smokers” but, in agreeing to that premise, he seemed to signal the people he knows who consume marijuana have demonstrated the need to maintain prohibition.
While he’s given no indication that he’s willing to embrace legalization ahead of the November election, some are holding out hope that a criminal justice task force he formed with former rival Sen. Bernie Sanders (I-VT) will push him in that direction. Most of the members of that group support legalization.
The former vice president does support legalizing medical marijuana, rescheduling cannabis under federal law, decriminalizing the plant, providing for automatic expungements and allowing states to set their own laws.
Federal Judge Gives Arkansas Marijuana Legalization Activists A Boost With Signature Gathering Ruling
Activists behind a marijuana legalization initiative in Arkansas are seeing glimmers of hope that they will be able to qualify for the November ballot despite serious setbacks caused by the coronavirus pandemic.
A federal judge ruled on Monday that the secretary of state must accept signatures that were not collected in-person or notarized, as has been required by existing policy, because of excessive burdens that imposes on campaigns amid the health crisis. Legalization advocates say the temporary injunction, which comes before a final ruling, gives them confidence their measure can qualify ahead of a July 3 deadline to submit signatures.
Now people can download, print and mail in signed petitions—significantly bolstering the chances the legal cannabis campaign can make up for the petitioning deficit created by stay-at-home orders and social distancing requirements enacted due to the COVID-19 outbreak.
In the April lawsuit that brought about the federal injunction (which was not filed by legalization activists but by another initiative campaign), plaintiffs also made the case that full-scale electronic signature gathering should be permitted. U.S. District Judge P. K. Holmes empathized with that request in his order, noting that in many scenarios outside the ballot process, officials have recognized the validity of digitally signed documents—including in legal proceedings he oversees.
“It is not that electronic signatures cannot similarly be determined to be genuine. In fact, electronic signatures are commonplace and accepted for all manner of official business, and not only by the State, but by this Court,” he said. “Counsel for Plaintiffs and the Secretary of State electronically signed the briefing on this very motion, and the Court has electronically signed this opinion and the order.”
However, the judge said there must be a balance that takes into account the state’s interest in ensuring the validity of signatures and so he’s doubtful the final ruling will provide for digital signatures.
In any case, the court’s temporary injunction bodes well for the marijuana reform campaign, Arkansans for Cannabis Reform, which says it was on the path to qualifying before in-person signature gathering was suspended. Melissa Fults, executive director of the group, told Marijuana Moment in a phone interview on Wednesday that she’s confident the new policies will help the initiative get placed before voters.
“I am still confident. We’re going to give a hard push these next four-and-a-half weeks—hoping and praying that we get signatures and get them turned in and get on the ballot,” she said. “And I think it’ll pass once it gets on the ballot.”
Arkansas voters approved a medical cannabis ballot measure in 2016.
As the state begins the process of reopening, Fults said the campaign will also be engaging in limited in-person collection with enhanced safety mechanisms in place, as well as “drive by” gathering for people to sign the initiative from their vehicles.
In order to make the ballot, the group needs to submit about 90,000 valid signatures from registered voters by July 3. Fults said they’ve collected roughly 20,000 so far, and so these last five weeks will prove critical.
Under the proposal, adults 21 and older would be able to purchase and possess up to four ounces of cannabis flower and grow up to six plants and six seedings.
A minimum of one dispensary must be licensed per county, and there must be at least 30 shops per congressional district.
Tax revenue from marijuana sales would first go toward implementation. After that, 60 percent would be used to fund public pre-K and after school programs and 40 percent would fund the operations of the University of Arkansas for Medical Sciences.
Another campaign that was working to put cannabis legalization on the state’s ballot told the Arkansas Democrat Gazette on Tuesday that it is ending its effort for the year and will shift its focus to 2022. An Arkansas True Grass spokesperson said “we weren’t able to do any of our spring events” because of the virus, leaving them without an opportunity to qualify.
Here’s a status update on other drug policy reform efforts throughout the country:
Activists in Montana and Nebraska have resumed signature gathering with new safety measures in place for campaigns to legalize adult-use marijuana and medical cannabis, respectively.
In Arizona, the organizers of a legalization effort asked the state Supreme Court to instruct the secretary of state to allow people to sign cannabis petitions digitally using an existing electronic system that is currently reserved for individual candidates seeking public office. That request was denied but in March the campaign expressed optimism that they had amassed enough signatures to qualify anyway.
Separate Oregon campaigns to decriminalize drug possession while significantly expanding substance misuse treatment and to legalize psilocybin mushrooms for therapeutic purposes recently submitted more than enough raw signatures to qualify for ballot access, though they must still be verified.
Activists in Washington State are continuing to work on a drug decriminalization and treatment measure.
Washington, D.C. activists behind a psychedelics decriminalization campaign are more confident that they will be able to make the ballot after the District Council voted in favor of a series of changes to signature gathering protocol.
A federal judge recently ordered Ohio officials to accept electronic signature submissions to place local marijuana decriminalization measures on the ballot—a decision that could potentially have positive implications for a statewide legalization campaign in the works.
California activists had hoped to get a measure to legalize psilocybin on the state’s November ballot, but the campaign stalled out amid the coronavirus pandemic.
A California campaign seeking to amend the state’s cannabis law asked for a digital petitioning option, but state officials haven’t signed on.
A campaign to legalize cannabis in Missouri officially gave up its effort for 2020 due to signature collection being virtually impossible in the face of social distancing measures.
North Dakota activists said they plan to continue campaign activities for a marijuana legalization initiative, but it’s more likely that they will seek qualification for the 2022 ballot.
Idaho medical cannabis activists announced that they are suspending their ballot campaign, though they are still “focusing on distributing petitions through online download at IdahoCann.co and encouraging every volunteer who has downloaded a petition to get them turned in to their county clerk’s office by mail, regardless of how many signatures they have collected.”
Prior to the COVID-19 outbreak and stay-at-home mandates, measures to legalize marijuana for medical and recreational purposes qualified for South Dakota’s November ballot.
The New Jersey legislature approved putting a cannabis legalization referendum before voters as well.
And in Mississippi, activists gathered enough signatures to qualify a medical cannabis legalization initiative for the ballot—though lawmakers also approved a competing (and from advocates’ standpoint, less desirable) medical marijuana proposal that will appear alongside the campaign-backed initiative.
Read the federal judge’s order on Arkansas signature gathering below: