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.
Idaho Medical Marijuana Activists ‘Likely’ To Seek Signature Gathering Relief After Court Ruling
A campaign to legalize medical marijuana in Idaho is preparing to potentially collect signatures again, as they are likely to seek the same relief that a federal court recently granted a separate campaign that found its petitioning efforts crippled by the coronavirus pandemic.
The judge said activists behind Reclaim Idaho, which is pushing an initiative on school funding, can start collecting signatures in-person and electronically for 48 days starting July 9. While the Idaho Cannabis Coalition wasn’t involved in that case, they feel the ruling will apply to them and they’re actively monitoring the situation.
“We are in the process of working with the local medical marijuana campaign to assess whether Judge Winmill’s order provides a route for the medical marijuana initiative to still qualify for the November ballot,” Tamar Todd, legal director for the New Approach PAC, which is lending support to the state cannabis effort, told Marijuana Moment.
“The medical marijuana campaign is similarly situated to the Reclaim Idaho campaign and will likely ask for a similar extension of time and permission to collect signatures electronically from the Secretary of State, and if necessary, from the District Court,” she said. “I don’t know the exact timeline as there are a number of moving pieces but it will be quick.”
On June 23, U.S. District Judge B. Lynn Winmill gave the state two options: either allow electronic signature gathering for 48 days or simply place the Reclaim Idaho initiative on the ballot regardless of the signature requirement. The state chose neither and proceeded to request that the ruling be stayed.
The judge denied the state’s request to stay the order, so the signature gathering for the school funding campaign can proceed on July 9. The state has since filed an emergency motion with the U.S. Court of Appeals for the Ninth Circuit to challenge the lower court’s ruling.
“The district court order severely and unquestionably disrupts Idaho’s election,” the state deputy attorney general wrote in the motion.
The deadline to submit 55,057 signatures to qualify the cannabis initiative passed on May 1, shortly after the group announced it was suspending petitioning activities because of the health crisis and the stay-at-home social distancing measures the state enacted. The cannabis campaign said it has about 45,000 raw signatures on hand at this point, and they’re confident that can fill the gap if they get the deadline extension and electronic petitioning option.
Under the proposed measure, patients with qualifying conditions could receive medical cannabis recommendations from physicians and then possess up to four ounces of marijuana and grow up to six plants.
While advocates say passing medical marijuana in one of the remaining states without such policies on the books would be a victory for patients in its own right, it could also have outsized federal implications. A House-passed bill to protect banks that service state-legal cannabis businesses from being penalized by federal regulators is currently sitting in limbo in a Senate committee chaired by a senator who represents the state.
Creating a medical marijuana program in Idaho, which is one of small handful of states that don’t yet even have limited CBD laws, could put additional pressure on Senate Banking Committee Chairman Mike Crapo (R-ID) to move the financial services legislation in Congress.
Summer Dreams Of Marijuana-Infused Slushies Are Melted By Oklahoma Regulators
Bad news for Oklahoma medical marijuana patients trying to beat the summer heat with a marijuana-infused slushy: State regulators say the icy beverages “are unlikely to meet requirements set forth in Oklahoma statutes and rules” for cannabis products.
As the weather heats up, THC-infused slushy machines have been popping up at more and more Oklahoma dispensaries. Made by companies such as Glazees, which offers flavors such as watermelon and blue raspberry, the THC-infused drinks sell for about $12-$15.
But despite their popularity with some patients, regulators say the slushies fail to comply with a number of state rules, such as a requirement that products be packaged in child-resistant containers. Dispensaries themselves also “are not allowed to alter, package, or label products,” regulators said.
State rules further require that all medical marijuana products be tested in their final form. “In this instance, the finished product is the slushy mixture to be dispensed to patients/caregivers, not the syrup,” regulators said. “If water, ice, or any other substance is added to the product, additional testing is required to ensure the product is safe for consumption and final-product labeling is accurate.”
The OMMA has received multiple inquiries regarding the processing and dispensing of marijuana-infused slushies on-site at medical marijuana dispensaries. Learn more here: https://t.co/3b6XFzYe2f pic.twitter.com/MPq4Z3PWft
— Oklahoma Medical Marijuana Authority (@OMMAOK) July 2, 2020
Regulators didn’t specify how adding water or ice to cannabis products could affect consumer safety, however.
The Oklahoma Medical Marijuana Authority (OMMA) issued the update on Thursday in what it called a “slushy-machine guidance” memo. The office said it had received “multiple inquiries regarding the processing and dispensing of marijuana-infused slushies on-site at medical marijuana dispensaries.”
It’s not the first obstacle encountered by Oklahoma marijuana businesses, which began popping up across the state voters passed a medical marijuana law in 2018.
Earlier this year, lawmakers passed a wide-ranging medical cannabis expansion bill, which would have allowed out-of-state residents to obtain temporary licenses, permitted licensed businesses to deliver marijuana to customers and eliminated jail time for for first-time possession convictions. But Gov. Kevin Stitt (R) then vetoed the bill, and lawmakers didn’t hold a vote to override the action.
Oklahoma activists also filed a proposed marijuana legalization ballot measure in December, but it’s unlikely the campaign can gather enough signatures to put the measure before voters this November. Their signature-gathering was largely delayed due to the coronavirus pandemic, and only last week did the state Supreme Court rule that the campaign could initiate petitioning. Supporters now have about 90 days to gather nearly 178,000 signatures from registered voters.
Photo courtesy of Max Pixel
Virginia Lawmakers Announce Plans To Legalize Marijuana, One Day After Decriminalization Takes Effect
Only a day after a new marijuana decriminalization law took effect in Virginia, top state lawmakers are announcing that they’re already looking ahead to full legalization.
A group of Democratic legislators on Thursday announced plans to introduce a bill to legalize and regulate a commercial cannabis market in the state. While the measure isn’t set to be filed until next year, lawmakers framed legalization as necessary in the fight for social and racial justice.
“Decriminalizing marijuana is an important step in mitigating racial disparities in the criminal justice system, but there is still much work to do,” House Majority Leader Charniele Herring (D) said in a press release. “While marijuana arrests across the nation have decreased, arrests in Virginia have increased.”
Other lawmakers backing the broader legalization push include Sens. Adam Ebbin (D) and Jennifer McClellan (D), as well as Del. Steve Heretick (D).
On Wednesday, the state’s new marijuana decriminalization policy took effect. The law, approved by lawmakers earlier this year and signed by Gov. Ralph Northam (D), removes criminal penalties for low-level marijuana possession. Under the change, having up to an ounce of cannabis is now punishable by a $25 fine and no threat of jail time or a criminal record.
Prior Virginia law punished simple marijuana possession with up to 30 days in jail, a $500 fine and a long-term criminal record.
“This bill will prevent low-level offenders from receiving jail time for simple possession while we move toward legalization with a framework that addresses both public safety and racial equity in an emerging market,” Herring said of the new law, which she sponsored in the House of Delegates and Ebbin led in the Senate.
The decriminalization measure also contains a provision to study future legalization. It requires a bevy of executive agencies, including “the Secretaries of Agriculture and Forestry, Finance, Health and Human Resources, and Public Safety and Homeland Security,” to convene an expert working group to study the matter. That panel’s report is due in November.
A separate legislative agency, the Joint Legislative Audit and Review Committee (JLARC), is also studying the impacts of possible legalization as the result of yet another resolution approved by lawmakers this year.
Lawmakers said on Thursday that the JLARC report, which is due in December, would inform how they shape legalization legislation they expect to file in 2021.
“Elements of the JLARC study include review of best practices from states such as Illinois that have developed a legal framework, testing and labelling recommendations, and measures to reduce illicit sales,” according to a press release from Ebbin’s office. “The study will also examine how best to provide redress and economic opportunity for communities disproportionately impacted by marijuana prohibition, and recommend programs and policies to reinvest in affected communities.”
The Virginia Legislative Black Caucus doesn’t want to wait for the results of the two reviews, however, and is pushing fellow lawmakers to take up cannabis legalization during a special session in August. In addition, the caucus has said its members intend to file bills to implement automatic expungement, ban no-knock warrants, require courts to publish racial date on people charged with low-level offenses and enact other sweeping criminal justice reforms.
Jenn Michelle Pedini, development director for the legalization advocacy group NORML and executive director of the group’s Virginia chapter, said the organization, which has worked with lawmakers on past reforms, looks forward to continuing to bring evidence-based cannabis policy to Virginia.
“For far too long, young people, poor people, and people of color have been disproportionately impacted by cannabis criminalization, and Virginia must take immediate steps to right these past wrongs and undo the damage that prohibition has waged upon hundreds of thousands of Virginians,” Pedini said. “It is time to legalize and regulate the responsible use of cannabis by adults in the Commonwealth.”
Ebbin said that despite the meaningful step of decriminalization, the state still has a long way to go.
“Today Virginia is taking an important first step in reducing the harm caused by the criminalization of cannabis,” he said in a statement. “The prohibition of marijuana has failed and the consequence of this failure has been felt overwhelmingly by Virginians of color, but it has not ended. It will only end when it is replaced by a regulated adult-use market that emphasizes equity—making whole those who have been burdened most by making sure they have a seat at the table and access to the marketplace. We are looking forward to doing the hard work needed to get this right.”
In the meantime, the Senate Democratic Caucus has announced it will pursue a bill during the special session next month to end law enforcement searches of people or vehicles based solely on the smell of marijuana, which critics say is a recipe for discriminatory enforcement. The group also noted that the chamber approved legislation during the regular legislative session that would have expunged certain marijuana charges and convictions, but that those bills didn’t make it to the governor’s desk.