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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

Trade Associations And Civil Rights Groups Send Mixed Messages On Marijuana Banking To Senate

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A coalition of trade associations sent a letter to Senate Banking Committee leadership on Thursday, urging a vote on legislation to protect financial institutions that service state-legal marijuana businesses.

But those senators are also feeling pressure from leading civil rights groups like the ACLU and Human Rights Watch, which sent an earlier letter insisting that they not allow cannabis banking to detract from more comprehensive reform that addresses social equity.

The organizations involved in the latest letter—including the American Bankers Association and Credit Union National Association—said that advancing the Secure and Fair Enforcement (SAFE) Banking Act or similar legislation is pivotal to ensuring that stakeholders receive needed clarity and are shielded from being penalized by federal regulators.

The letter, addressed to Banking Chair Mike Crapo (R-ID) and Ranking Member Sherrod Brown (D-OH), emphasized the bipartisan nature of the House passage of the bill in September and the growing movement at the state level to legalize cannabis for medical or recreational purposes.

“Our organizations support an initial legislative step that allows the legal cannabis industry into the banking system,” the groups, which also include the Council of Insurance Agents and Brokers, International Council of Shopping Centers and National Association of REALTORS, wrote. “Ultimately, protecting law-abiding financial institutions and ancillary businesses from their currently untenable position and addressing increasing public safety concerns.”

As more states reform their marijuana laws, however, “distribution, sale, possession, research, transaction, housing, employment, and a broader landscape of cannabis is becoming increasingly problematic” for stakeholders under federal prohibition.

“Ultimately, this creates more legal and security concerns that impact the operations and safety of businesses and consumers,” they said. “Finally, the lack of an available safe harbor for cannabis will continue to challenge the full adoption and deployment of the legal hemp and CBD products market in the U.S. due to the inextricable link between hemp and cannabis.”

“To resolve this, we urge the Committee to vote on the SAFE Banking Act or similar measures. Such measures are meant to create a safe harbor for depository institutions that provide a financial product or service to businesses in a state permitting the use of cannabis. A safe harbor will enable law enforcement and states to effectively monitor and regulate businesses while simultaneously bringing billions into the regulated banking sector.”

The letter, also signed by Americans for Prosperity and R Street, recognizes that creating a federal regulatory scheme for marijuana will take time but says that the SAFE Banking Act represents “a critical first step to ensure that legal cannabis marketplaces are safe, legal, and transparent.”

Crapo has said that he’s interested in holding a vote on resolving the cannabis banking issue in his panel before the year’s end, but so far nothing has been scheduled. The chairman told Marijuana Moment in earlier interviews that there are several changes to the House-passed bill that he’d like to see but that he’s worried impeachment proceedings against the president will interfere with plans to hold a vote.

All that said, pressure from civil rights advocacy groups could complicate congressional efforts to get the banking bill approved. In October, several organizations including the ACLU, Drug Policy Alliance, Human Rights Watch and Center for American Progress sent a letter to Senate leadership, as well as Crapo and Brown, demanding that “marijuana legislation considered in the Senate include provisions that will guarantee equity in the industry.”

The letter, which doesn’t appear to have been previously reported and was obtained by Marijuana Moment, states that while the coalition agrees the SAFE Banking Act “is an incremental step toward rolling back the federal prohibition of marijuana, it fails to help communities that have been historically and disproportionately devastated by United States’ punitive drug laws.”

“As the Senate Committee on Banking, Housing, and Urban Affairs considers similar legislation, we insist that the legislation include provisions that ensure equity in the marijuana industry by creating opportunities for individuals who have been prohibited from this growing business either by legal or financial means,” the letter, which was also signed by the Immigrant Legal Resource Center, Leadership Conference on Civil and Human Rights and National Association of Social Workers, states.

“Indeed, this Congress has shown it understands the economic impact of legalization. But while progress on the business side of legalization is promising, it is not sufficient. Federal marijuana legislation must be comprehensive and lead with equity, addressing past and current harms to communities of color and low-income communities who bore the brunt of the failed war on drugs. We demand that any marijuana reform or legalization bill considered by the Senate] include robust provisions addressing equity. More than simply adding equity provisions to bills that address industry concerns, we need comprehensive reform that deschedules marijuana and addresses the inequities and harms continually inflicted by the failed war on drugs.”

In other words, the groups are insisting on broad reform prior to a vote on a bill viewed as largely beneficial to the cannabis industry—similar to a request they made of House members prior to the legislation’s passage in the chamber.

Read the marijuana banking letters from the trade associations and civil rights groups below:

Industry SAFE Senate Bankin… by Marijuana Moment on Scribd

Senate Leadership Letter Re… by Marijuana Moment on Scribd

Senators Demand Update From DEA On Marijuana Growing Applications

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

GOP Congressman Knocks His Party For Failing To Pass Marijuana Reform

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A Republican congressman says that whichever party is responsible for passing federal marijuana reform will “instantly” shoot up in the polls, while lamenting the fact that the GOP failed to do so when they controlled the House.

Rep. Thomas Massie (R-KY), a vocal advocate for hemp, was asked by Fox Business host Kennedy on Wednesday whether cannabis should be rescheduled under federal law.

“Absolutely,” he said. “The first party that does this—and I don’t understand why either party won’t do it—is going instantly gain 10 points in the general poll on which party versus the other.”

“We should have done it when we were in the majority,” he added. “The liberals should be asking Pelosi why she hasn’t put it on the floor yet.”

The House Judiciary Committee approved legislation last month to end federal marijuana prohibition, but it hasn’t yet been scheduled for floor action.

Massie made similar points during an interview with Marijuana Moment earlier this year, stating that if Republicans had advanced states’ rights-focused marijuana legislation, “I think we might still be in the majority.”

Of course, while Massie has supported legislation to allow states to set their own cannabis policies without federal intervention, as well as other more modest reform measures such as protecting banks that service marijuana businesses, he’s so far declined to cosponsor any bills that seek to deschedule cannabis.

The congressman has also expressed interest in changing federal gun control laws to allow cannabis consumers to purchase firearms.

Though it’s not clear exactly how much of a boost either party would get by passing a marijuana reform bill, a Pew poll released last month does show that there’s majority support for legalization among those who lean Republican (55 percent) as well those who lean Democratic (78 percent).

Senators Demand Update From DEA On Marijuana Growing Applications

Photo courtesy of YouTube/Rep. Massie.

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

State Department Warns Travelers About Flying With Cannabis Oil Internationally

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The U.S. State Department is warning international holiday travelers that while hemp-derived CBD might be legal in the U.S., it can land you in trouble if you take it certain places abroad.

“Make sure your gift isn’t a fa la la la la la la la la fail,” the department said in a tweet on Thursday. “Bringing along gifts like drones, CBD oils, and firearms can land you in trouble in foreign countries. Research what is and isn’t allowed before you travel.”

Please visit Forbes to read the rest of this piece.

(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)

MLB Officially Removes Marijuana From Banned Substances List For Baseball Players

Photo courtesy of Flickr/DHS.

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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