The head of the Food and Drug Administration (FDA) said on Wednesday that the agency is taking a “risk-based approach” to enforcing current CBD regulations while it continues to pursue alternative pathways that would allow for its lawful marketing.
During one of his last days as FDA commissioner, Scott Gottlieb appeared before a House appropriations subcommittee and was asked by two members—Reps. Barbara Lee (D-CA) and Andy Harris (R-MD)—about the agency’s plans for regulating CBD derived from hemp, which was federally legalized under the 2018 Farm Bill.
Gottlieb repeated to Lee what he’s said at multiple hearings this year: while he recognized that Congress intended to allow the marketing of CBD products, FDA is still responsible for regulating it, and because it exists as an approved drug and hasn’t been previously introduced to the food supply, the agency has to develop a unique regulatory model that may take years to complete.
“That’s the conundrum here,” he said. “We don’t have a really modern proxy for where this has happened. That doesn’t mean we can’t create such a framework.”
Part of the solution to that “conundrum” will be gathering input from stakeholders at a public meeting scheduled for May 31.
Harris focused less on FDA’s regulatory plans and more on enforcement actions against companies that are already selling CBD products. He voiced concerns about the proliferation of CBD marketing online and in grocery stores, where he said there are no age restrictions to purchase the products.
The commissioner pushed back against the congressman’s suggestion that FDA wasn’t taking action against these companies and said that the agency has “taken enforcement action,” noting that it recently sent warning letters to three CBD companies who made unsanctioned claims about the therapeutic benefits of their products.
“We’re taking a risk-based approach where we’re going after places where CBD is being marketed in situations where we think the claims are either misleading to the point of encouraging a patient to forgo otherwise effective therapy for a medical condition or being marketed in a formulation and in a dose that’s at a level that creates significant safety concerns,” he said.
He also explicitly referenced reports that pharmacy chains CVS and Walgreens are moving to sell CBD products, noting that he expressed concerns about the prospect.
“We now see big box stores seeking to market CBD products for some uses where the claims seem to be potentially over-the-top claims for the treatment of pain, for example,” Gottlieb said. “We’re not allowing this. What’s happening is we see a burgeoning market and we can’t boil the ocean, so we’re trying to take a risk-based approach to our enforcement like we do on all matters.”
The hope is that taking “selective enforcement actions,” legitimate CBD manufacturers and retailers will voluntarily comply with existing FDA regulations on the substance as the agency works to create new regulations, per the will of Congress.
“I recognize Congress wants there to be a pathway here, so we’re trying to work at the same time expeditiously to create a viable pathway that can differentiate between potentially appropriate use of the product if we can have scientific evidence to support its appropriate use and use of the product that creates safety risks for the consumers,” he said.
Also during the hearing, Rep. Chellie Pingree (D-ME), who has pushed FDA on CBD issues, thanked Gottlieb for being so responsive to her concerns during his tenure.
There's been substantial disruption in the hemp market in #Maine + nationwide due to the regulatory limbo that #CBD products are in. In @AppropsDems committee, I thanked departing Commissioner @SGottliebFDA for taking this issue seriously + scheduling a public mtg on May 31. pic.twitter.com/iU8RJvbW0x
— Chellie Pingree (@chelliepingree) April 3, 2019
Photo courtesy of YouTube/House Appropriations Committee.
California Governor Approves Changes To Marijuana Banking And Labeling Laws
California Gov. Gavin Newsom (D) signed a handful of marijuana bills into law on Tuesday, making a series of small adjustments to the nation’s largest legal cannabis system. More sweeping proposals such as overhauling the state’s marijuana regulatory structure will have to wait until next year, the governor said.
Among the biggest of the new changes are revisions to banking and advertising laws. With many legal marijuana businesses are still unable to access financial services, Newsom signed a bill (AB 1525) to remove state penalties against banks that work with cannabis clients.
“This bill has the potential to increase the provisions of financial services to the legal cannabis industry,” Newsom wrote in a signing statement, “and for that reason, I support it.”
Democrats in Congress, meanwhile, have been working for months to remove obstacles to these businesses’ access to financial services at the federal level. A coronavirus relief bill released by House Democratic leaders on Monday is the latest piece of legislation to include marijuana banking protections. Past efforts to include such provisions have been scuttled by Senate Republicans.
In his signing statement on the banking bill, Newsom directed state cannabis regulators to establish rules meant to protect the privacy of marijuana businesses that seek financial services, urging that data be kept confidential and is used only “for the provision of financial services to support licensees.”
Another bill (SB 67) the governor signed on Tuesday will finally establish a cannabis appellation program, meant to indicate where marijuana is grown and how that might influence its character. The system is similar to how wine regions are regulated.
Under the new law, growers and processors under the new law will be forbidden from using the name of a city or other designated region in product marketing unless all of that product’s cannabis is grown in that region. Similar protections already apply at the county level.
For outdoor growers, the new law recognizes the importance of terrior—the unique combination of soil, sun and other environmental factors that can influence the character of a cannabis plant. For indoor growers, it provides a way to represent a hometown or cash in on regional cachet.
Most of the other new changes that the governor signed into law are relatively minor and will likely go unnoticed by consumers. One, for example, builds in more wiggle room on the amount of THC in edibles (AB 1458), while another would allow state-licensed cannabis testing labs to provide services to law enforcement (SB 1244).
The bills were approved by state lawmakers earlier this month, as the state’s legislative session drew to a close.
Other pieces of cannabis legislation passed by the legislature this session were met with the governor’s veto. On Tuesday, Newsom rejected a proposal (AB 1470) that would have allowed processors to submit unpackaged products to testing labs, which industry lobbyists said would reduce costs. Currently products must be submitted in their final form, complete with retail packaging. Newsom said the proposal “conflicts with current regulations…that prevent contaminated and unsafe products from entering the retail market.”
“While I support reducing packaging waste, allowing products to be tested not in their final form could result in consumer harm and have a disproportionate impact on small operators,” Newsom said in a veto statement.
Those changes to testing procedures should instead be considered next year, Newsom said, as part of a pending plan to streamline California’s cannabis licensing and regulatory agencies.
“I have directed my administration to consolidate the state regulatory agencies that currently enforce cannabis health and safety standards to pursue all appropriate measures to ease costs and reduce unnecessary packaging,” he wrote. “This proposal should be considered as part of that process.”
Newsom also last week vetoed a bill (AB 545) that would have begun to dissolve the state Bureau of Cannabis Control, which oversees the legal industry. In a statement, the governor called that legislation “premature” given his plans for broader reform.
“My Administration has proposed consolidating the regulatory authority currently divided between three state entities into one single department,” Newsom wrote, “which we hope to achieve next year in partnership with the Legislature.”
Earlier this month, the governor signed into law one of the industry’s top priorities for the year—a measure (AB 1872) that freezes state cannabis cultivation and excise taxes for the entirety of 2021. The law is intended to provide financial stability for cannabis businesses in California, where taxes on marijuana are among the highest in the nation.
The state’s leading marijuana trade group, the California Cannabis Industry Association (CCIA), applauded the governor’s moves. All the bills approved by Newsom this week had the industry group’s support.
“We thank Governor Newsom for prioritizing these bills, which seek to reduce regulatory burdens, improve enforcement, expand financial services and enhance the state’s cannabis appellation’s program,” CCIA Executive Director Lindsay Robinson said in a message to supporters on Wednesday. “Like so many, the cannabis industry has faced a series of unexpected challenges and setbacks in 2020. We look forward to continuing to work with the Newsom Administration, and the Legislature, as we pursue a robust policy agenda in 2021.”
Image element courtesy of Gage Skidmore
Mixed Arizona Marijuana Polls Raise Questions About Legalization Ballot Measure’s Prospects
Reform advocates are anxious to see how a marijuana legalization initiative in Arizona will fare this November. But predicting the outcome is complicated by a new pair of dueling polls that show mixed results.
The campaign behind the legalization measure, Smart and Safe Arizona, shared an internal poll on Wednesday with Marijuana Moment that showed 57 percent of likely voters in support for the effort, with 38 percent in opposition.
The survey, which was conducted September 24-29, shows that 83 percent of supporters say they are certain to vote for the measure. Opposition was just as certain, however, by a margin of 82 percent to 12 percent.
Seventy-two percent of Democrats support the legal cannabis initiative, as do 70 percent of independents and 42 percent of Republicans.
But while those results are largely consistent with several surveys this year have shown varying degrees of majority support for adult-use legalization among Arizona voters, a separate poll released on Tuesday that’s being touted by opponents indicates that the margin is slimmer than advocates would hope—with 46 percent of respondents saying they want the policy change and 45 percent saying they don’t.
n= 600 LVs, MOE +/- 4.0%, Survey Conducted 9/8- 9/10
— OHPI (@OHPredictive) September 29, 2020
When the same firm, OH Predictive Insights (OHPI), conducted a poll asking the same basic question about legalizing cannabis in July, 62 percent of likely voters said they favor legalization. The month prior, about 65 percent said they back the legal cannabis ballot measure in a survey from a different pollster, HighGround.
The notable dip based on the new OHPI poll appears to be largely attributable to declining support among people over 55, those who live in rural areas, independents and Republicans.
“As election day nears, voters appear to be focusing on what’s on the ballot. And while the campaign to oppose marijuana legalization is anemic compared to 2016, voters still have concerns about the effort,” OHPI Chief Mike Noble said in a press release, referring to an earlier legalization initiative that Arizonans rejected four years ago after a campaign in which the opposition received significant funding, including from a pharmaceutical company.
#AZPOP #POLL: “As election day nears, voters appear to be focusing on what’s on the ballot, and while the campaign to oppose marijuana legalization is anemic compared to 2016, voters still have concerns about the effort,” says @MikePNoble
— OHPI (@OHPredictive) September 29, 2020
But the reform campaign isn’t deterred. Far from it, actually. In addition to sharing their internal poll, a spokesperson told Marijuana Moment that the memo for the separate survey showing dwindling support actually bolstered its contributions by another $250,000—in the early part of the day alone.
“We’re giving this poll as much credence as we should—none. It’s absurd to think that while Arizona is on pace to sell a record amount of cannabis ($1.25B) to a record number of cardholders, popularity is waning,” Smart and Safe Arizona Campaign Manager Stacy Pearson told Marijuana Moment, referring to purchases in the state’s existing medical cannabis system. “Cash register receipts and internal polling do not align with OH’s prediction.”
“That said, their polling memo has certainly helped our cause. We have generated more than $250,000 in contributions today, and it’s not even noon,” she said on Tuesday morning.
In the campaign’s internal poll, 65 percent of those surveyed believe the measure, Prop. 207, would have a positive effect on the state’s economy, compared to 26 percent who said it would have a negative effect.
The OHPI poll involved interviews with 600 likely Arizona voters from September 8-10. The internal campaign poll involved 800 respondents.
Colton Grace, communications associate for the prohibitionist group Smart Approaches To Marijuana, told Marijuana Moment after viewing only the OHPI poll that it’s “great to see that the support for marijuana legalization—which is never as popular as the industry claims it is in the first place—is dropping rapidly ahead of the vote in Arizona.”
“This effort is no different than that of 2016 in that it is nothing more than a for-profit scheme that benefits a select group of investors while unleashing serious harms on the majority of the state,” he argued.
Another survey released this month from a separate firm showed that a slim majority of voters (51 percent) support the ballot measure.
Under the legalization initiative, adults could possess up to an ounce of marijuana at a time and cultivate up to six plants for personal use.
The measure also contains several restorative justice provisions such as allowing individuals with prior marijuana convictions to petition the courts for expungements and establishing a social equity ownership program
Cannabis sales would be taxed at 16 percent. Tax revenue would cover implementation costs and then would be divided among funds for community colleges, infrastructure, a justice reinvestment and public services such as police and firefighters.
The Department of Health Services would be responsible for regulating the program and issuing cannabis business licenses. It would also be tasked with deciding on whether to expand the program to allow for delivery services.
Read the full internal poll from the Arizona marijuana legalization campaign below:
Photo courtesy of Mike Latimer.
New Jersey Governor Works To Get Out The Vote For Marijuana Legalization Referendum
The governor of New Jersey is amplifying his support for a marijuana legalization referendum that will appear on the state’s November ballot.
In an email blast sent by the New Jersey Democratic State Committee on Wednesday, Gov. Phil Murphy (D) wrote that legalization was a priority of his as he campaigned for governor, and he emphasized racial disparities in cannabis enforcement.
“Legalization would right those wrongs while also spurring massive economic development opportunities, job creation, and new tax revenue,” he said. “Now, we have the opportunity to get this done and finally legalize adult-use marijuana here in the Garden State, and I need your help to make it happen. Vote Yes on Public Question #1 on your ballot.”
It’s clear that marijuana prohibition is causing serious, lasting damage to our state. Now, we have an opportunity to fix that and finally legalize adult-use marijuana in NJ. Vote Yes on Question 1. #TurnThePage https://t.co/dkq6zsHvVV
— Phil Murphy (@PhilMurphyNJ) September 30, 2020
“It has taken longer than we hoped to get to this point. Many well-meaning leaders have their reasons for opposing legalization, and we take their objections seriously,” he added. “But the overwhelming evidence points to a clear reality that this is something we must do to make our state both stronger and fairer.”
Murphy also wrote about the economic toll of enforcing prohibition, the long-lasting consequences of having a marijuana conviction on a person’s record and the fact that a growing number of states are legalizing cannabis for adult use.
“Voting Yes on Public Question #1 will legalize marijuana for adult use, while also creating a new regulatory structure to make sure operators are following the law and ensure that minors are not able to purchase the product. Legalization will not be the end of the story—there is more work to do, particularly in expunging past marijuana-related offenses. This is our chance to make history in New Jersey, and it’s all up to you.”
The governor said in July that legalizing cannabis is “an incredibly smart thing to do” both from an economic and social justice perspective.
Legalize it. pic.twitter.com/8gIbogvwW4
— Governor Phil Murphy (@GovMurphy) September 29, 2020
Legislators attempted to enact the policy change during the last session, but when negotiations stalled, they opted to put the question to voters in the form of a referendum. If the measure is approved on Election Day, the legislature will then have to pass implementing legislation containing details for how the legal cannabis market will work.
Recent polling indicates that the proposal has strong support among New Jersey voters. A survey from the law firm Brach Eichler that was released last week shows that 65 percent of likely voters are in favor of the policy change. That’s consistent with the results of a poll the firm published last month, signaling that support is steady.
The governor’s message to voters comes one week after NJ CAN 2020, a coalition of civil rights and drug policy reform groups, launched their first video ad promoting the legalization referendum.
In June, the state Assembly passed a cannabis decriminalization bill last month that would make possession of up to two ounces a civil penalty without the threat of jail time.
Read Murphy’s full email in support of approving the legalization measure below:
When I first announced my campaign for Governor, legalizing adult-use marijuana was one of my top priorities. It was as clear then as it is now — marijuana prohibition causes serious, lasting damage to our state, especially to the 35,000 mostly young, Black and Hispanic residents who are arrested for possession of marijuana every year. In fact, Black residents are 3.5 times more likely to be arrested for marijuana possession than White residents. Legalization would right those wrongs while also spurring massive economic development opportunities, job creation, and new tax revenue.
Now, we have the opportunity to get this done and finally legalize adult-use marijuana here in the Garden State, and I need your help to make it happen. Vote Yes on Public Question #1 on your ballot.
It has taken longer than we hoped to get to this point. Many well-meaning leaders have their reasons for opposing legalization, and we take their objections seriously. But the overwhelming evidence points to a clear reality that this is something we must do to make our state both stronger and fairer. Consider for example:
New Jersey spends about $147 million a year on the legal processing of marijuana possession and makes 35,000 annual arrests. Using our public safety dollars for marijuana arrests doesn’t make us any safer. By legalizing adult-use marijuana, we can free up police resources to focus on serious, violent and unsolved crimes, and reinvest those saved dollars into social services.
Our current marijuana laws can ruin lives based on one decision. Under current law, a person can land in jail over marijuana – with a criminal record that stigmatizes them for life and can make it harder to get a job, an apartment or a credit card; to adopt a child; or to visit one’s own children. Legalization has the potential to remove unfairly harsh punishments now suffered by entire families due to marijuana offenses.
Over the past decade, 11 other states and Washington, DC have all legalized adult-use marijuana. These states have not faced significant health or safety problems, have raised billions of dollars for vital public services, and have been able to focus law enforcement on more serious and violent crimes. We know that marijuana legalization works – and passing this ballot measure will allow New Jersey to take advantage of everything that we’ve learned from the states that went before us.
Voting Yes on Public Question #1 will legalize marijuana for adult use, while also creating a new regulatory structure to make sure operators are following the law and ensure that minors are not able to purchase the product. Legalization will not be the end of the story — there is more work to do, particularly in expunging past marijuana-related offenses.
This is our chance to make history in New Jersey, and it’s all up to you. Vote Yes on Public Question #1. You may need to turn over your Vote by Mail ballot or flip to the second page to find Public Questions, so make sure to examine your ballot carefully.