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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

Congressional Committee Asks JUUL For Documents On Marijuana Partnerships

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Is the e-cigarette company JUUL planning on expanding its stake in the marijuana industry?

That’s one question the chair of a congressional subcommittee asked the company in a letter concerning JUUL’s role in the “youth e-cigarette epidemic” earlier this month.

Lawmakers have frequently criticized JUUL for making products—specifically flavored e-cigarette cartridges—that allegedly appeal to young people at a time when rates of cigarette use are steadily declining. But while JUUL was developed by the cannabis vaporizer company PAX, it hasn’t announced plans to further partner with marijuana companies.

Rep. Raja Krishnamoorthi (D-IL), who chairs the House Subcommittee on Economic and Consumer Policy, apparently sees the possibility on the horizon, though.

In a letter sent to JUUL on June 7, the congressman said his panel was investigating youth e-cigarette usage and, specifically, how the company’s marketing tactics might be exacerbating the issue. He requested documents on everything from clinical trials on how JUUL devices divert people away from traditional cigarettes to communications on the company’s rationale for the nicotine concentration of JUUL pods.

Tucked within the extensive request is a question about potential marijuana partnerships. Krishnamoorthi asked for:

“All documents, including memoranda and communications, referring or relating to proposals, plans, and/or intended partnerships or collaborations between JUUL and any cannabis-related companies, including but not limited to Cronos Group.”

It’s not clear where the Cronos-specific mention comes from, but the company has perviously caught the interest of the tobacco industry. The maker of Marlboro cigarettes, Altria Group, invested almost $2 billion in the Canada-based cannabis company in December. Two weeks later, Altria invested $13 billion in JUUL.

Marijuana Moment reached out to JUUL, Cronos and Krishnamoorthi’s office for comment, but representatives did not respond by the time of publication.

If a partnership does emerge, it would likely be met with some controversy, as opponents and proponents of marijuana reform alike have long expressed concern that the tobacco industry would take over the cannabis market and commercialize it in a way that mirrors how it peddled cigarettes.

Of course, given that tobacco use is declining and tobacco companies generally have the infrastructure that would make a pivot to cannabis relatively simple, such a partnership would not be especially surprising.

Senate Majority Leader Mitch McConnell (R-KY) has made the case several times that tobacco farmers in his state could leverage the federal legalization of industrial hemp and its derivatives by growing the crop to offset profit losses from declining tobacco sales.

Read Rep. Krishnamoorthi’s full letter to JUUL below:

2019-06-07.Krishnamoorthi t… by on Scribd

Americans Want CBD Available Over-The-Counter, Poll Finds

Photo courtesy of Wikimedia.

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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New York Lawmakers Might Actually Vote On Marijuana Legalization This Week

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With just days left before the end of the legislative session, efforts to legalize marijuana in New York have been revived, with a possible vote this coming week.

Though momentum to pass a legalization measure seemed to largely die off after lawmakers in neighboring New Jersey announced they wouldn’t move forward with plans to end cannabis prohibition through the legislature, advocates are increasingly optimistic that a deal in the Empire State is imminent.

Democratic members in both the Senate and Assembly held conferences last week to discuss details of the legislation. Spectrum News reported that the meetings went well, with members indicating that there’s support for the measure.

That’s just one of several positive signs that a proposal many observers thought was dead for the year has new life.

On Saturday and Sunday, staff for legislative leaders from both chambers and Gov. Andrew Cuomo (D) met to negotiate provisions of a revised legalization plan.

On Wednesday, an earlier Senate version of the bill was assigned “same as” status in the Assembly version. That means the current proposals in each chamber lined up with identical language and is considered to be an indicator that the legislation could pass.

Assembly Speaker Carl Heastie (D) said on Friday that his party has yet to determine whether they’ll bring the bill to the floor, but he added that “I think there is support in the conference.”

He also characterized the window of time until the end of the session on Wednesday as “an eternity.”

Cuomo, who said late last month that passing legalization remains a top 10 priority, has said that lawmakers who fail to approve items on his agenda, including ending cannabis prohibition, “should all be primaried, because that is a failure of a basic progressive agenda.”

On the flip side, the chairman of New York’s Democratic Party said earlier this month that if the Senate approves the legalization bill, they run to risk of alienating voters in certain areas such as Long Island and upstate New York. But that argument neglects to account for recent polling that shows voters in those regions strongly support legalization.

Notably, the measure’s most vocal opponents with the anti-legalization Smart Approaches to Marijuana have been sending email blasts in recent days urging their supports to call senators and voice opposition to the bill, giving the impression that the group is anticipating a vote.

Assembly Majority Leader Crystal Peoples-Stokes (D), sponsor of the legalization legislation, seemed to confirm that suspicion on Friday, stating that after “conversations with my co-sponsor and colleague in the Senate, I am even more confident of a path for victory.”

But despite that confidence, the fate of legalization in New York remains murky. An analysis earlier this month found that legalization was two votes short of a needed majority in the Senate.

Meanwhile, a number of key elected officials are calling on the governor and lawmakers to not only push legalization over the finish line but to include certain key provisions in the final legislation.

State Attorney General Letitia James (D) sent a letter urging that the bill expunge prior cannabis records.

“Before we create a booming business for legal marijuana, we must provide relief to those individuals that have paid much more to society than what was due,” she wrote.

New York City Mayor Bill de Blasio (D), a 2020 presidential candidate, also pushed for expungements and said in a Twitter thread that legalization should “empower local business and not big corporations.”

And the Manhattan and Albany County district attorneys co-authored an op-ed calling leaders to “correct staggering inequities and promote public safety by passing” legalization.

 

The Buffalo News reported on Sunday afternoon that there were still a number of outstanding issues left to be settled between lawmakers, including whether or not home cultivation of cannabis would be allowed, how tax revenue would be allocated and whether localities would have to proactively opt in to allowing marijuana businesses or if there would instead be an opt out provision for those wanting to ban cannabis commerce.

The session ends on Wednesday, and so far no vote has been scheduled in either chamber.

Meanwhile, lawmakers early on Monday morning filed what appears to be backup legislation to expand the decriminalization of marijuana and to provide a process to expunge or vacate prior cannabis convictions. And others support putting legalization on the ballot through a referendum that voters can decide on.

The situation is very fluid, and over the next few days advocates will be stepping up the push for action in Albany. On Sunday, they held a rally outside Cuomo’s Manhattan office.

Bill Allowing Interstate Marijuana Commerce Heads To Oregon Governor’s Desk

This post has been updated to include the latest developments as well as comment from a number of elected officials.

Photo courtesy of Philip Steffan.

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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Texas Governor Signs Bill To Expand State’s Medical Marijuana Program

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The governor of Texas signed a bill into law on Friday that significantly expands the state’s medical cannabis program.

The legislation, which was overwhelmingly approved by lawmakers last month, adds multiple medical conditions to the list of disorders that qualify patients of low-THC marijuana. Currently only patients with intractable epilepsy qualify under the CBD-focused program.

New qualifying conditions include epilepsy, multiple sclerosis, terminal cancer, autism, spasticity and amyotrophic lateral sclerosis.

Gov. Greg Abbott (R) signed the bill with little fanfare.

Reform advocates said the legislation is a big step in the right direction, even though it doesn’t go as far as they’d hoped. A 0.5 THC cap on marijuana products remained in the bill, for example, and a section that would have established a research program to study the therapeutic potential of cannabis was removed.

“Cannabis is effective medicine for many patients suffering from debilitating medical conditions,” Heather Fazio, director of Texans for Responsible Marijuana Policy, told Marijuana Moment. “HB 3703 represents a positive step toward a functional medical cannabis program, but sadly, it still leaves behind millions of Texas families that could benefit from legal access.”

Also this legislative session, the House of Representatives approved bills to more comprehensively expand the medical cannabis program and to decriminalize marijuana possession, but they died in the Senate.

Abbott signed a hemp legalization bill earlier this week.

Bill Allowing Interstate Marijuana Commerce Heads To Oregon Governor’s Desk

Photo courtesy of Brian Shamblen.

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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