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.
Bernie Sanders Talks Marijuana With Killer Mike, Danny Glover And Ben & Jerry’s Founder
Sen. Bernie Sanders (I-VT) led a panel during a presidential campaign stop in North Carolina on Friday where he and surrogates—rapper Killer Mike, actor Danny Glover and Ben & Jerry’s founder Ben Cohen—discussed marijuana reform.
At one point, Cohen said that he was arrested after being caught smoking cannabis while he was in school but the police only charged him for littering—a discretionary decision that he said he likely wouldn’t have been afforded if he was black. He speculated that without that privilege, the incident could have cost him loans that allowed him to build his ice cream empire.
Sanders, a 2020 Democratic presidential candidate, opened the conversation by asking Killer Mike to weigh in on the impact of the drug war, particularly on communities of color.
The artist said the “war on drugs, we now know from history, has been a tremendous failure” and that it “was never a war on drugs, it was a war on progressive white kids and black people.”
He discussed the racist origins of prohibition, the role cannabis criminalization has played in mass incarceration and emphasized the need to include restorative justice in a legal marijuana system.
“But we have a greater opportunity, and the greater opportunity is this: marijuana is going to be legal in our lifetime,” he said. “Beyond getting a little stoned in the morning, which I didn’t do this morning because I knew I had to come see you guys, marijuana provides through hemp paper, alternative to plastics, it provides jobs, resources, dispensaries.”
Watch the conversation about cannabis, starting at about 11:20 into the video below:
“We have an opportunity this time to take the people that are exiting jail, have expunged records and creating a pathway as wide as this aisle directly to legal marijuana and creating economic sustainability in the same communities that were robbed of that opportunity,” he said.
“As for me and my stoner friends, we’ll be buying Ben & Jerry’s and voting for Bernard Sanders.”
Glover joked that Mike’s plan is the “real green new deal that we need right here,” riffing off the name of climate change agenda backed by Rep. Alexandria Ocasio-Cortez (D-NY).
“What we’re talking about now is repairing the wrongs that were done on our communities, and we have a senator who’s going to be the president, who’s saying that we’re not only going to repair the wrongs of the war on drugs but we are going to bring back an era that we are organizing in our communities,” the actor said.
Cohen highlighted racial inequities in marijuana enforcement and broader societal structures, starting by noting that his parents were only able to enter the middle class with the help of a government program providing low-interest mortgages that black people were not entitled to. That program allowed him to go to a good school, he said, where he got busted for cannabis at one point.
“In the midst of getting my higher education, one summer I was smoking some pot with some friends on a beach and the cops caught us,” he said. “We were handcuffed and they took us to the station and they ended up giving us a ticket for littering a lighted cigarette butt on the ground.”
“But I am well aware that if I was black, I would’ve ended up with a criminal record that would have prevented me from getting the loans that we needed to start Ben & Jerry’s,” he said. “It’s really clear to me that if I was black, there wouldn’t have been a Ben & Jerry’s. I’m conscious of that, I think about that, and that’s one of the big reasons I’m supporting Bernie because he’s going to put an end to that system.”
The criminalization of marijuana has been a disaster for communities of color.
We will legalize marijuana, expunge past convictions and invest revenue from legal marijuana back into those communities. pic.twitter.com/x7xrzw1Eu4
— Bernie Sanders (@BernieSanders) September 21, 2019
Sanders closed the panel discussion by asking audience members to raise their hands if they knew someone arrested for marijuana, or were themselves arrested. He did a similar exercise at a campaign rally in South Carolina earlier this week.
After hands shot up, the senator said “this is what the war on drugs has done in this country.”
“It has criminalized so many people in this room. This is amazing,” he said. “The war on drugs has been incredibly destructive for millions and millions of people in this country and we’re going to end that war on drugs and we’re going to make marijuana legal.”
Photo courtesy of Facebook/Bernie Sanders.
Former Federal Prosecutor’s Marijuana Legalization Measure Advances In South Dakota
A measure to legalize marijuana in South Dakota—introduced by a former federal prosecutor and backed by a leading national cannabis advocacy group—was recently cleared for signature gathering.
Brendan Johnson, who served as the U.S. Attorney for the District of South Dakota and whose father represented the state in the U.S. Senate until 2015, filed the initiative in June. It received an official explanatory statement from the attorney general last month and its backers were given the green light to start collecting signatures last week.
“We are excited to move forward with these ballot initiative campaigns,” Johnson told Marijuana Moment. “South Dakota voters are ready to approve both medical marijuana and legalization at the ballot box next year.”
The Marijuana Policy Project (MPP) is supporting the proposed constitutional amendment, as well as a separate statutory initiative to legalize medical cannabis in the state that was approved for signature collection last month.
The former federal prosecutor’s measure, which is being steered by the committee South Dakotans for Better Marijuana Laws, would allow adults 21 and older to possess and distribute up to one ounce of marijuana. Individuals would also be allowed to cultivate up to three cannabis plants. The South Dakota Department of Revenue would be tasked with issuing licenses for manufacturers, testing facilities and retailers.
Sales would be taxed at 15 percent under the initiative, and revenue would be used to fund the program’s implementation, with additional monies going toward public education and the state general fund.
Beside legalizing marijuana, the amendment would also instruct the legislature to enact legislation to legalize hemp and medical cannabis. If the separate statutory medical marijuana legalization initiative, being coordinated by the group New Approach South Dakota, qualifies and passes as well, that latter requirement wouldn’t be necessary.
“The Marijuana Policy Project strongly supports the South Dakota campaign,” MPP Deputy Director Matthew Schweich, who led the organization’s efforts in support of previous legalization campaigns in Maine, Massachusetts and Michigan, told Marijuana Moment. “Across the country, and even in conservative states, voters are demanding marijuana policy reform. Our goal is simple: to effectuate the will of the people when elected officials choose to ignore it.”
Petitioners for the proposed constitutional amendment must collect 33,921 valid signatures from voters to qualify for the 2020 ballot. For statutory initiatives, 16,961 signatures are required. MPP’s involvement will likely bolster the campaign’s prospects of meeting that goal.
It’s already clear that marijuana reform measures are going to face resistance from certain quarters, with Gov. Kristi Noem (R) vetoing a hemp legalization bill in March and the state’s Republican party urging residents not to sign ballot petitions.
“Our campaign, South Dakotans for Better Marijuana Laws, will be working from now until Election Day 2020 to earn the support of South Dakotans from every corner of the state,” Johnson said.
Photo courtesy of WeedPornDaily.
Cory Booker Pledges To Back Only Marijuana Bills With Justice Focus As Banking Vote Approaches
With a vote on marijuana banking issues imminent in the House, Sen. Cory Booker (D-NJ) emphasized on Friday that he will not support cannabis legislation that doesn’t include restorative justice components.
In a tweet that linked to an earlier Marijuana Moment article on his cannabis stance, the 2020 Democratic presidential candidate wrote that “any marijuana legislation moving through Congress must include restorative justice for those most harmed by the War on Drugs in order to get my vote.”
As I said earlier this year, any marijuana legislation moving through Congress must include restorative justice for those most harmed by the War on Drugs in order to get my vote.https://t.co/Y1dOwgHbm2
— Sen. Cory Booker (@SenBooker) September 20, 2019
The statement comes at a critical moment in the marijuana reform movement. House leadership announced on Friday that the first full floor vote on a standalone piece of cannabis reform legislation—a bill to protect banks that service cannabis businesses from being penalized by federal regulators—will be held next week. But that development has also created controversy, with several advocacy groups arguing that a vote should be postponed until more wide-ranging reform legislation is passed.
Although Booker didn’t directly reference the banking bill his his tweet, its timing seemed to suggest that he sides with those groups—which include the ACLU, Human Rights Watch and Drug Policy Alliance—and that he wouldn’t support the Secure and Fair Enforcement (SAFE) Banking Act as written.
Booker’s Senate press secretary confirmed to Marijuana Moment in an email that his boss’s Twitter post was sent directly in reaction to the House banking news.
While some have made the case that the bill would help promote social equity by improving access to banking services for minority business owners, for example, others view the legislation as primarily benefiting large cannabis firms.
Throughout his campaign, the senator has emphasized the need for inclusive and comprehensive marijuana reform. He determined that a bill to protect state cannabis programs from federal intervention that he formerly cosponsored didn’t meet that standard and did not attach his name to the latest version.
“At this point it’s too obvious and urgent and unfair that we’re moving something on marijuana on the federal level and it doesn’t do something on restorative justice,” he told VICE in April. “I want that bill to have some acknowledgement of the savage injustices that the marijuana prohibition has done to communities.”
“I get very angry when people talk about legalizing marijuana and then give no light to how marijuana law enforcement was done in ways that fed upon poor communities—black and brown communities. This is a war on drugs that has not been a war on drugs—it’s been a war on people, and disproportionately poor people and disproportionately black and brown people.”
Booker also said that he wants to couple conversations about legalization with talk of expunging prior cannabis convictions “in the same breath.”
The senator’s potential future opposition to a House-passed cannabis banking bill could prove problematic as its supporters work to shepherd the legislation through a chamber where it already faces an uphill path under anti-marijuana Majority Leader Mitch McConnell (R-KY) and skepticism from other GOP lawmakers.
Photo courtesy of Senate Democrats.