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FDA Is Taking Public Comments On CBD. Here’s How To Make Your Voice Heard

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Do you have feelings about how the federal government is handling the regulation of CBD products? Now you can share those thoughts—along with studies, data and other important information—with the Food and Drug Administration (FDA).

On Wednesday, the agency published an official notice announcing a public hearing for next month on its approach to regulating products, including dietary supplements and foods, that contain cannabidiol.

But you don’t have to participate in the meeting itself to make your voice heard. In conjunction with the May 31 event, regulators have also opened up an official docket to take feedback on the issue. The public comment period is open through July 2.

Specifically, FDA is requesting information related to health and safety risks, manufacturing and product quality and the way in which products containing cannabis or cannabis-derived compounds are marketed and sold.

As the agency writes in its notice: “While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.”

Broadly, the FDA wants to see information concerning the notion that hemp-derived CBD is safe to consume in food, what kind of standards need to be put into place to ensure product quality and consistency and what information needs to be included on labels to ensure consumers know exactly what risks they’re taking, if any.

FDA Announces Details On CBD Public Hearing

Other questions include:

  • What levels of cannabis and cannabis-derived compounds cause safety concerns?
  • How do cannabis and cannabis-derived compounds interact with other substances (e.g., drug ingredients)?
  • What validated analytical testing is needed to support the manufacturing of safe and consistent products?

David Mangone is the director of government affairs at Americans for Safe Access (ASA). He told Marijuana Moment that submitting comments to the FDA is an opportunity for the general public to help shape policy—and that every comment is read.

“The federal government is anywhere from 10 to 15 years behind the American public and the state-level politics on this issue,” he said in a phone interview. “It’s important for people to be able to use their voice,” and this is one way to do that.

If you’re planning to submit a public comment on the issue, here are a few things to keep in mind:

Be thoughtful about your comment. 

“When you see comments particularly on this issue from the general public, you see a lot of brief comments that are very opinionated,” Mangone said.

Last month, another cannabis-related docket was opened to gauge public interest in how the United States should vote on World Health Organization recommendations to reschedule cannabis and its compounds. Nearly 2,000 comments were filed, and an overwhelming number of them support marijuana reclassification.

But, Mangone pointed out, many of those comments were brief, boiling down to “Legalize it” or offering stories about how medical cannabis helps people who are struggling with debilitating conditions.

“That’s not really what the FDA is ever looking for,” he said. “I wish we could sway federal policy with patient stories—and, to a degree, we can on Capitol Hill—but with a regulatory body like the FDA, they’re looking for very specific answers to very specific questions.”

As such, Mangone suggested picking one question from the public notice document on CBD and focusing on it.

Include scientifically sound research.

“This is not a popularity contest. It’s not like an up/down vote on how many comments in favor and how many comments against [CBD products],” he explained. “It’s based off the quality and content of the comments.”

That’s why including studies and data in your submissions is so important. Start by looking for scientific studies that include a large number of people in the sample. Pay attention to who it was conducted by (a university or international body is ideal) and whether or not the authors have a financial interest in the outcome of the study, Mangone said.

PubMED, Health Affairs and other medical journals are great places to start, he added. ASA has also compiled peer-reviewed research that may be helpful.

Remember who your audience is.

“You’re writing to a government regulatory body that for the past 40 to 50 years has worked actively against allowing CBD—and cannabis largely—as a medicine,” Mangone said. “You have to be respectful in your comments, but you also can’t leave anything on the table.”

FDA Chief Warns CBD Rulemaking Could Take Years Without Congressional Action

Photo courtesy of Rick Proctor.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kimberly Lawson is a former altweekly newspaper editor turned freelance writer based in Georgia. Her writing has been featured in the New York Times, O magazine, Broadly, Rewire.News, The Week and more.

Business

State Of Montana Launches Online Hemp Marketplace To Connect Buyers And Sellers

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Say you’re a Montana farmer who has planted acres of industrial hemp. As harvest nears, you’re looking to offload it. Where do you go to find a buyer?

Montana’s Department of Agriculture says it has the answer.

The state this week announced the launch of an online “Hemp Marketplace,” unveiling an online portal meant to connect the hemp farmers with buyers in search of seeds, fiber and derivatives such as cannabidiol, or CBD.

“The Hemp Marketplace concept originated from the same idea as the department’s Hay Hotline,” the Agriculture Department says on its website, “only instead of hay and pasture, the online tool connects buyers and sellers of hemp and hemp derivatives.”

Listings are free of charge.

Montana online Hemp Marketplace screenshot

Montana Department of Agriculture

Montana farmers have embraced industrial hemp since the state legalized its production under a federal pilot program. The first legal crop was planted in 2017, and in recent years the state has led the country in terms of space dedicated to the plant. In 2018, for example, licensed farmers in Montana grew more acreage of hemp than any other U.S. state. While other states have since eclipsed the state’s hemp production—the crop became broadly federally legal through the 2018 Farm Bill—Montana remains an industry leader.

But to make revenue, farmers have to be able to sell their crop. That’s where the new hemp marketplace comes in. The online portal is essentially a sophisticated bulletin board for buyers and sellers, split into “Hemp for Sale” and “Hemp to Buy” categories.

“With hemp being a relatively new crop grown in Montana, the department recognizes that these markets are still developing,” Department of Agriculture Director Ben Thomas said in a statement. “The Hemp Marketplace was designed to help facilitate connections between buyers and sellers. I’m looking forward to seeing how the marketplace will continue to advance the industry.”

Listings include what type of products are on offer (or being sought), whether a given crop is organic and even whether laboratory testing data is available. The portal also organizes products into one of four varieties based on whether the hemp seeds have been certified by regulators. None of the products may contain more than 0.3 percent THC—the upper limit for what qualifies as hemp under both state and federal law.

Meanwhile, Montana voters are set to decide on Tuesday whether the state will legalize hemp’s more infamous cousin, high-THC marijuana. According to a poll released this week, passage looks likely: The survey, conducted by Montana State University at Billings, found that 54 percent of likely voters plan to support legal cannabis on the ballot. Another 38 percent said they were opposed, while 7 percent remained undecided.

At the federal level, officials at the Drug Enforcement Administration are still working to revise rules around marijuana and hemp to reflect Congress’s move to legalize hemp broadly in 2018. While the public comment on the proposals closed earlier this month, nine members of Congress cautioned the agency against adopting its proposed changes, warning some could put hemp producers at risk of criminal liability. Already a number of arrests and seizures have been made by law enforcement officers confused whether products were legal hemp or illicit marijuana.

The U.S. Department of Agriculture (USDA), meanwhile, has faced separate criticism over its own proposed hemp rules, though it has been more proactive in addressing them. Following significant pushback from the industry over certain regulations it views as excessively restrictive, the agency reopened a public comment period, which closed again this month.

USDA is also planning to distribute a national survey to gain insights from thousands of hemp businesses that could inform its approach to regulating the market.

Montana Marijuana Legalization Ballot Measure Has Solid Lead In New Poll

Photo courtesy of Brendan Cleak

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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Politics

New Jersey Governor Steps Up Marijuana Legalization Push As New Ad Touts Economic Benefits Days Before Election

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With just a few days to go before Election Day, New Jersey Gov. Phil Murphy (D) is continuing to stump for marijuana legalization in that state, extolling the economic and social justice benefits he says the change would bring. His latest comments came shortly after the release of a new campaign ad focusing on legalization’s economic impact.

“We’ll build an industry, it would be a revenue-generator,” Murphy said in an interview with Yahoo Finance. “I think at first it would be modest, but ultimately will grow, I think, into several hundred million dollars in the state budget.”

“Along with social justice,” he added, “that’s a pretty good, winning combination.”

Recent polling suggests voters are mostly on board with legalization, with surveys showing upwards of 60% support for Public Question 1, a referendum to legalize and establish a commercial industry around the drug. If it passes, some lawmakers hope legal sales to adults 21 and older could begin as soon as next month, though regulators and some advocates have pushed back on the plan to start sales in existing medical cannabis dispensaries, saying that it could lead to access and supply issues for patients.

Legalization would indeed likely bring in millions of dollars to the state budget, hit hard by the coronavirus pandemic and ensuing economic downturn. But Murphy claims his chief motivation for supporting the measure is racial justice.

“When I became governor, we had the widest white–nonwhite gap of persons incarcerated, believe it or not, of any American state. The biggest reason was low-end drug offenses,” he said. “So I get there first and foremost because of social justice.”

Meanwhile, on Wednesday, one of the campaign committees behind New Jersey’s legalization effort, NJ CAN 2020, released a new 30-second ad emphasizing the economic benefits legalization could bring the cash-strapped state.

“At a time when this crisis has created challenges we all face—a budget deficit and a lack of funding for services we need—New Jersey could raise hundreds of millions of dollars to support our local schools, vital health care services and community programs, by simply voting yes on Public Question 1,” the ad says.

Earlier this week, U.S. Sen. Cory Booker (D-NJ) also filmed a video in support of the measure. Appearing in a NJ CAN campaign video released Wednesday, he said prohibition “has not been a war on drugs, but a war on people.”

“Veterans, for example, are more likely to be arrested for drug use or possession of marijuana. Instead of getting help, they’re often hurt by a system that piles upon them criminal charges for doing things that two of the last three presidents admitted to doing,” he said.

Black, Latino and low-income communities are also disproportionately targeted by enforcement of drug laws, Booker added. “We can do this as a state so much more responsibly, and instead of destroying lives we can get more resources to help to empower the well-being of all New Jerseyans.”

In other legal states, cannabis has been a rare bright spot in terms of tax revenue. Oregon, for example, saw record sales this summer even as other areas of the economy slowed. State budget analysts said last month that they expect the strong sales to continue.

“Since the pandemic began, the increase in recreational sales have been more than 30 percent above forecast,” Oregon’s Office of Economic Analysis said in a recent report. “Expectations are that some of these increases will be permanent.”

Other established markets, such as Washington state, Colorado and Nevada, have also seen “strong gains” in marijuana sales amid the pandemic, Oregon’s budget office noted.

Big money has also been flowing into New Jersey’s legalization campaign itself. A report released Thursday by the state Election Law Enforcement Commission (ELEC) shows that committees supporting the referendum have raised more than $2 million in campaign contributions. That’s compared to just $9,913 brought in by opponents.

“Assuming all available funds are spent, the marijuana ballot question already ranks eighth among the top ten most expensive public referenda in the Garden State,” ELEC Executive Director Jeff Brindle said. “Keep in mind that marijuana interests already have spent $4.1 million on lobbying between 2017 and 2019. So the industry’s overall political investment in New Jersey already has topped $6 million.”

If voters approve the referendum, lawmakers will still need to pass a bill to establish a framework for the state’s legal marijuana market. A legislative hearing to get a head start on planning was scheduled for last week, but that was canceled when a state senator leading the proposal went into quarantine after being exposed to the coronavirus.

Friday’s appearance by Murphy is the latest effort by the governor to encourage voters to back legalization. He also recorded a video that was released by NJ CAN 2020 earlier this month and recently called on voters to support the proposal in an email blast circulated by the New Jersey Democratic State Committee.

In July, Murphy described legalizing cannabis is “an incredibly smart thing to do” both from an economic and social justice perspective.

The governor isn’t alone in his attempts to get out the vote for cannabis reform. Filmmaker Kevin Smith earlier this month urged his Twitter followers to “VOTE YES when you see State Public Question Number 1: Constitutional Amendment to Legalize Marijuana.”

Also this month, the NJ CAN campaign scaled up its advertising push, releasing a series of English- and Spanish-language videos.

In June, the state Assembly passed a cannabis decriminalization bill that would make possession of up to two ounces of marijuana a civil penalty without the threat of jail time. The bill hasn’t advanced in the Senate.

Arizona Marijuana Opponents Release Five Misleading Attack Ads Ahead Of Legalization Vote Next Week

Photo courtesy of Gov. Phil Murphy

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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Oregon Psilocybin Ballot Measure Can Help Dying People Find Peace, Doctor Says In TV Ad

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Oregon’s first-of-its-kind ballot measure to legalize psilocybin therapy has the potential to help ease mental suffering for terminally ill people, a medical doctor says in a new TV ad for the initiative.

“I’ve worked in end-of-life care for 28 years. In hospice, we believe when people are dying, we should treat their pain—physical or mental distress,” Dr. Nick Gideonse says in the 30-second spot. “There’s often mental suffering that comes with a terminal diagnosis.”

“So I support Measure 109 to allow psilocybin therapy for terminally ill people suffering from depression. It’s humane,” he said. “Yes on 109 will help those near death come to terms with their diagnosis and find peace.”

If approved by voters, adults would be able to access the psychedelic in a medically supervised environment. There aren’t any limitations on the types of conditions that would make a patient eligible for the treatment.

A previous ad released earlier this month by the campaign featured a state senator who is also a medical doctor saying that the measure “promotes safety for a therapy that can help people who are suffering.”

That followed an independent spot by the nonprofit Heroic Hearts Project going on the air in Oregon to tout the benefits of psilocybin therapy, but it didn’t mention the specific ballot measure.

A campaign working to pass a separate measure on the Oregon ballot to decriminalize drug possession and expand substance misuse treatment also recently released a series of ads.

The Oregon Democratic Party formally endorsed both measures last month.

Meanwhile, the psychedelic reform measure has drawn opposition from an unlikely source. Decriminalize Nature, which has led efforts to pass local policies reducing criminal enforcement against psilocybin and other entheogens, has argued that it could threaten equitable access to the substance.

Rep. Earl Blumenauer (D-OR) told Marijuana Moment in January that he was in favor of the psilocybin reform proposal and that he would be working to boost the campaign as the election approaches. In August, he wrote in an email blast that passing the measure is necessary “because it tackles an important issue in our community, mental health, and it does so in an innovative and responsible way.”

Arizona Marijuana Opponents Release Five Misleading Attack Ads Ahead Of Legalization Vote Next Week

Photo courtesy of Wikimedia/Workman.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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