The Food and Drug Administration (FDA) announced earlier this month that it was accepting public comments on CBD regulations, and more than 400 people have already made their voices heard.
Comments published on Regulations.gov range widely in subject matter, but the main theme running through them is that regulations should be light and companies should be able to lawfully market products containing cannabidiol. Many added that marijuana in general should be legalized, even though the agency did not request that people weigh in on that broader issue.
The comment period was designed to help inform an upcoming public hearing on CBD regulations that the FDA is holding on May 31. Amy Abernethy, principal deputy commission of the FDA, tweeted a link for stakeholders to register for the hearing on Wednesday.
Are there particular safety concerns re: products with cannabis/cannabis-derived compounds? How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety & exposure? Comments/data on important issues like these can help inform FDA reg. oversight.
— Dr. Amy Abernethy (@DrAbernethyFDA) April 17, 2019
We’re seeking input re: FDA’s reg. strategy for existing products, lawful pathways by which appropriate products containing cannabis/cannabis-derived compounds can be marketed & how to make them more predictable/efficient. Register or submit to the docket: https://t.co/xISRzDgN1S pic.twitter.com/maBllYjr3O
— Dr. Amy Abernethy (@DrAbernethyFDA) April 17, 2019
The FDA listed out several questions mostly concerning the safety of cannabis-derived products, how to enact quality control measures and what “validated analytical testing is needed” to ensure that CBD is manufactured in a consistent manner.
David Mangone, director of government affairs at Americans for Safe Access, offered some tips on how to submit effective comments in an earlier interview with Marijuana Moment, and one of the takeaways was that the FDA is primarily interested in receiving scientific evidence that addresses the agency’s specific questions—as opposed to personal anecdotes about CBD use.
Some, like Matthew Lubeck, followed that advice. He commented that CBD should be allowed into the food supply because “the bioavailability and reactiveness within the human body and the cannabinoid system” isn’t ideal when the compound is isolated.
Brent King offered an assessment examining the potential use of CBD as an exit drug from addictive substances such as opioids. He cited a study that showed reduced opioid overdoses in states that have loosened marijuana laws as an example.
“The gateway theory falls victim to the mistaken assumption that correlation alone implies causation,” King said. “Using the same logic, one could argue that drinking milk is a gateway to illicit drug use since most people who use illicit drugs also drank milk as young people.”
Others raised questions about the CBD market as it exists today—unregulated by the FDA as the agency continues to weigh possible options to allow hemp-derived CBD into the food supply or as dietary supplements. An anonymous comment expressed concerns about product consistency across companies that are already selling CBD, arguing that “variance from product to product is confusing” and makes it difficult to “make an informed decisions” about what products to use.
“The public needs protection from unscrupulous companies goals to get rich,” the person wrote.
All that said, most comments did not adhere to Mangone’s or the FDA’s guidelines. The vast majority of comments were anecdotal and individualized. People suffering from conditions such as anxiety, pain, post-traumatic stress disorder and insomnia urged the FDA to loosen restrictions on CBD, describing their own life-changing experience with the product. Several others talked about the health benefits of CBD that they observed in pets.
While that might not be what the agency asked for, that doesn’t change the fact that there is a broad consensus among those who took the time to comment: CBD is safe and has proven medical value, and people should be allowed to freely access it.
It’s not that simple from the FDA’s perspective, however. Former Commissioner Scott Gottlieb has repeatedly stressed that because CBD exists as an FDA-approved drug (Epidiolex) and hasn’t previously been introduced to the food supply, there’s no clear regulatory framework to put it through, even if that was the intention of the 2018 Farm Bill that legalized hemp and its derivatives.
Gottlieb has told members of Congress that additional legislation may be required to provide for the marketing of CBD, or else it may take years before the FDA can identify an alternative regulatory pathway. In the meantime, the FDA is taking a “risk-based” approach to enforcing laws governing CBD marketing that involves cracking down on companies making unsanctioned claims about the health benefits of their CBD products.
Federal requests for public input on cannabis-related policies are nothing new. Thousands offered their perspective on marijuana scheduling under international treaties when the FDA requested feedback on that issue last year. More recently, another federal agency solicited studies from the public on how cannabis can treat symptoms of Alzheimer’s disease.
Photo courtesy of Rick Proctor.
Santa Cruz City Council Approves Psychedelics Decriminalization Measure
The Santa Cruz, California City Council unanimously voted in favor of a resolution on Tuesday that would effectively decriminalize a wide range of psychedelics by making them among the city’s lowest law enforcement priorities.
The measure—which was originally sponsored by then-Vice Mayor Justin Cummings (D), who’s since become mayor—says the city shouldn’t expend “resources in the investigation and arrest of persons twenty-one (21) years of age and older solely for the personal use and personal possession of Entheogenic Plants and Fungi” such as psilocybin, ayahuasca and ibogaine.
It further stipulates that possession and use of psychedelics by adults “should be considered among the lowest law enforcement priorities for the City of Santa Cruz.”
This is the latest in a series of local policy victories for the psychedelics reform movement, which kicked off with a successful ballot measure vote in Denver to decriminalize psilocybin mushrooms last May. Oakland’s City Council then unanimously approved a measure to make a broad range of plant- and fungi-derived psychedelics among the city’s lowest law enforcement priorities.
Now activists across the country are hoping to replicate that resolution, with organizers in roughly 100 cities aiming to decriminalize certain psychedelic substances through ballot initiatives and legislative action at the local level.
In November, Santa Cruz’s City Council heard testimony from the group behind the resolution, Decriminalize Santa Cruz. It was then referred to the Public Safety Committee and was amended prior to returning to the full body for a final vote.
Councilmembers revised the original measure in order to “to recognize the need for harm reduction and education for youth and families about drug prevention.” A provision was also inserted to clarify that “the sale, use and cultivation of Entheogenic Plants and Fungi to and by minors should be considered an exception that should require appropriate investigation by the Santa Cruz City Police Department.”
The word “cultivation” was also removed from provisions specifying the measure’s scope. But before the full Council vote on Tuesday, several advocates used the public comment portion of the meeting to urge that it be added back in, and members adopted that request before approving the final resolution.
“With possession and use being inserted without cultivation, that actually encourages the black market because there’s nowhere else to go,” Cummings, the mayor, said. “If people are are cultivating at themselves they know exactly what they’re producing.”
Activists celebrated their city becoming the third in the U.S. in less than a year to decriminalize certain psychedelic substances.
“These eight months we’ve been working on the resolution, I’ve met so many people whose lives were saved by entheogenic plants and fungi,” Julian Hodge, a founder of Decriminalize Santa Cruz and a member of Students for Sensible Drug Policy, told Marijuana Moment. “The Santa Cruz City Council took a great step to help those people today. I am incredibly proud to be part of this movement, and can’t wait to see the change we continue to make in the future.”
Another provision of the measure instructs the city’s state and federal lobbyists to “work in support of decriminalizing all entheogenic psychoactive plants, and plant and fungi-based compounds listed in the Federal Controlled Substances Act.”
Beyond Decriminalize Santa Cruz, a newly formed group called Project New Day also advocated for the reform move. The organization, which is focused on promoting research into psychedelics for the treatment of addiction and other mental health conditions, sent a press release on Tuesday highlighting comments from a military veteran who overcame addiction with the help of medically supervised psychedelics treatment.
“Psychedelic-assisted therapy saved my life,” Dylan Jouras said. “It’s important that people know there is an effective way to get better from addiction and deep mental health issues.”
While the local Santa Cruz resolution wouldn’t allow legal sales of psychedelics, another group of advocates is currently collecting signatures toward placing a broad statewide psilocybin legalization initiative before California voters on the November ballot.
In Oregon, organizers are hoping to put a proposal before voters that would legalize psilocybin for therapeutic use. Separately, a campaign in that state is pushing a measure to decriminalize possession of all drugs with a focus on funding substance misuse treatment.
Democratic presidential candidate Andrew Yang said at an Iowa campaign stop last week that he wants to legalize psilocybin for military veterans.
New Mexico Lawmakers Approve Marijuana Legalization Bill
A New Mexico Senate committee approved a bill on Tuesday that would legalize marijuana for adult use.
With a little more than three weeks left in the state’s short 2020 legislative session, lawmakers are making clear their intent to advance the legalization proposal in a timely fashion.
The bill, which is supported by Gov. Michelle Lujan Grisham (D), cleared the Senate Public Affairs Committee in a 4-3 vote.
Sen. Jacob Candelaria (D) led the introduction of the bill before the committee, testifying that he believes “2020 is the year New Mexico becomes the third state to enact legalization of cannabis through legislative action,” following Vermont and Illinois.
“We know that New Mexicans across the state, from rural to urban centers, are with us on this issue.”
“Bringing an underground market aboveground takes a lot of deliberation, statewide input from community members and stakeholders, ingenuity and learning from other states’ experiences,” the senator, who is himself a medical cannabis patient, said. “The criminalization of cannabis disproportionately harms and criminalizes young people and people of color, sponsors violence and corruption by those who currently exclusively trade in cannabis in the black market. The current situation, our status quo that relies on a black market outside of the medical program, does nothing to curb youth access to cannabis.”
The governor included legalization in her formal 2020 legislative agenda and discussed the importance of establishing a well-regulated and equitable cannabis market in her State of the State address this month.
✅ SB 115, legalizing recreational adult-use cannabis, successfully passes out of its first committee! Recreational cannabis will be the next frontier of our economic expansion, creating 11,000 jobs across New Mexico & true economic potential for every part of the state. #SB115 pic.twitter.com/jgLnRX8UDY
— Michelle Lujan Grisham (@GovMLG) January 29, 2020
The day after Lujan Grisham’s agenda was released, lawmakers filed the legalization bill, which would allow adults 21 and older to possess and purchase marijuana from licensed retailers. The legislation also contains social justice provisions such as automatic expungements for prior cannabis possession convictions.
The proposal would not allow home cultivation; however, it does decriminalize the cultivation of up to three plants and six seedlings, making the offense punishable by a $50 fine without the treat of jail time.
Additionally, the bill would eliminate the gross receipts tax for medical cannabis sales, mandate that recreational dispensaries service registered patients and create a subsidy program for low-income patients to access marijuana.
Recreational cannabis sales would be taxed at nine percent, with revenue going toward that subsidy program in addition to a “cannabis industry equitable opportunity investment fund” to support entrepreneurs from communities most impacted by the drug war, a “community grants reinvestment fund” and a workplace training program, among other programs.
— NM Senate Democrats (@NMSenateDems) January 29, 2020
According to a fiscal analysis, the state stands to bring in nearly $6.2 million in recreational cannabis revenue in Fiscal Year 2021. By FY20204, that amounts would rise to nearly $34 million. Municipalities and counties would rake in additional revenues.
“Legalizing and regulating will bring one of the nation’s largest cash crops under the rule of law, generating an estimated between 11,000 and 13,000 jobs for New Mexicans in every corner of the state,” Candelaria said.
The legislation must still pass in two other panels—Judiciary and Finance—before it gets a full vote on the Senate floor.
This latest development at the committee-level is the product of months of work from legislators and the governor’s administration. Last summer, Lujan Grisham formed a working group tasked with reaching out to community members and stakeholders, studying various components of cannabis regulation and submitting recommendations ahead of the current session.
The final report, which was released in October, laid out a number of proposed rules and restrictions for a legal marijuana market.
Earlier last year, the New Mexico House of Representatives approved a bill to legalize marijuana but it later died in the Senate. Lawmakers did send Lujan Grisham a more limited bill to simply decriminalize cannabis possession, which she signed.
While it’s possible that the current committee-passed legislation will be amended as it makes its way to a full Senate vote, or that companion legislation could be changed in the House, recent polling shows that New Mexico residents are widely in favor of the general policy change. Three-out-of-four residents who participated in a state-funded survey that was released last month said they back legalization.
If all goes according to the governor’s plan, a final legalization bill will be delivered to her desk by the end of the session—and upon her signature, New Mexico would likely become the 12th state to legalize recreational marijuana.
That said, lawmakers in states across the U.S. are eyeing cannabis reform this year, and a marijuana legalization bill advanced in a New Hampshire House committee earlier on Tuesday.
Photo courtesy of Philip Steffan.
New Hampshire Lawmakers Approve Marijuana Legalization Bill
A New Hampshire House committee approved a bill on Tuesday that would legalize marijuana for adult use in the state.
While the legislation doesn’t provide for retail sales, it would allow individuals 21 and older to possess and gift up to three-fourths an ounce of cannabis and grow up to six plants. The model would be similar to neighboring Vermont’s non-commercial cannabis system.
The Criminal Justice and Public Safety Committee advanced the bill in a 13-7 vote.
“I think that the legalization of cannabis is more popular than the legislature itself or the governor or any other political entity in the state of New Hampshire,” Chairman Renny Cushing (D) said prior to the vote. “This is something that the people of the state of New Hampshire want. They don’t want to be treated like they’re criminals if they have a plant.”
Watch New Hampshire lawmakers discuss the marijuana legalization bill below:
This vote comes a week after the panel held a hearing on the proposal, with advocates and stakeholders testifying in favor of the reform move.
“Like most Granite Staters, this committee understands that it’s time for New Hampshire to stop prohibiting cannabis,” Matt Simon, New England political director for the Marijuana Policy Project, said in a press release. “Adults in the ‘Live Free or Die’ state should not be punished for their choice to use a substance that is objectively less harmful than alcohol.”
“Now that New Hampshire is literally surrounded by jurisdictions where cannabis is legal for adults, our current policies can no longer be justified in any way,” he said. “It’s time for the House, Senate and Gov. Chris Sununu to work together and move cannabis policies into the 21st century.”
A floor vote by the full House of Representatives is expected on February 6.
Tax-and-regulate marijuana legislation has advanced in the legislature in prior sessions, but it never arrived on the governor’s desk.
Even if it did make it that far, however, it’s unclear if Sununu, a Republican, would sign it. He’s voiced opposition to commercial legalization, and he vetoed a bill last year that would’ve allowed medical cannabis patients to cultivate their own marijuana, raising questions about whether he’d be willing to support this latest measure extending that right to all adults over 21.
In any case, the New Hampshire development comes amid a flurry of legislative activity around cannabis in the Northeast.
New York Gov. Andrew Cuomo (D) included legalization in his budget last week, as did Rhode Island’s governor, who pitched a state-run cannabis model in her plan. In New Jersey, the legislature approved a referendum to put the question of recreational legalization before voters during the November election. Top lawmakers in Connecticut are also confident that marijuana reform will advance this year. In Vermont, advocates are hopeful that lawmakers will add a legal sales component to the state’s current noncommercial cannabis law.
Photo courtesy of Philip Steffan.