Connect with us

Politics

Key Takeaways From FDA’s Historic CBD Regulations Meeting

Published

on

Advocates, industry representatives, regulators, health professionals and marijuana legalization opponents stood up before the Food and Drug Administration (FDA) on Friday to share their perspectives on how to best approach regulating the cannabis compound CBD.

The first-of-its-kind public meeting is meant to inform the FDA’s approach as it considers developing alternative pathways to regulate cannabidiol, which is not currently permitted in the food supply or as a dietary supplement.

Here’s a look at the discussions that took place at the event:

Advocates and opponents

Jonathan Miller, general counsel at U.S. Hemp Roundtable, said there is “an urgent need for an efficient regulatory framework for CBD” and noted that it was the intent of Congress to provide for the marketing of hemp-derived CBD products when it passed the 2018 Farm Bill, federally legalizing the crop and its derivatives.

Interestingly, Miller said his organization has been working with lawmakers in recent weeks to draft standalone legislation to regulate CBD if the FDA determines that the task is too complicated for the agency to complete on its own. Senate Majority Leader Mitch McConnell (R-KY), who led the charge on hemp legalization, previously suggested that further legislative action may be necessary to unlock the full potential of the hemp economy.

The National Cannabis Industry Association (NCIA), which represents a wide range of industry stakeholders, made a similar argument in its testimony.

Andrew Kline, the group’s director of public policy, said “we strongly recommend [that] FDA act quickly to clarify the regulatory environment.”

“Because there are significant confusions in the market, businesses don’t know what is legally permissible and some are making health claims in the absence of clear regulatory guidance,” he said. “Most significantly, banks and payment processors don’t understand [the regulatory rules] and as a result many CBD companies are at risk of losing financial services.”

NCIA also provided the panel with extensive written testimony it compiled from more than 100 industry representatives, scientists and attorneys in support of establishing clear regulatory guidelines for CBD.

“The bottom line is this: an overwhelming preponderance of evidence indicates that cannabis and cannabis-derived compounds present minimal safety concerns,” Kline said. He added that the FDA should create universal testing and labeling requirements to “help protect the public from health and safety risks.”

On the opposing side, members of the anti-legalization group Smart Approaches to Marijuana (SAM) Canada and the Marijuana Victims Alliance offered testimony that touched on CBD regulations but mostly served to express opposition to marijuana reform more broadly.

“The public is up against a narrative that is at war with science,” SAM Canada’s Pamela McColl said. She claimed that marijuana is addictive, leads people to harm themselves and damages DNA.

“The subversion of truth and science and what is going on in North America [is a source of] great concern and reason to pause and do risk assessments on these drugs and analyze the influence of the billionaires and in the industry that have influenced public sentiment and dictated a very deceitful campaign,” she said.

Sally Schindel, the representative from Marijuana Victims Alliance, said that her son committed suicide, which she attributed in large part to his cannabis use.

“What we need is our federal government enforcing federal laws,” she said. “We need FDA to be more involved and take a leading role in marijuana research and policy formation.”

Shawn Hauser, a hemp and cannabinoid attorney with the law firm Vicente Sederberg LLP, represented the Cannabis Trade Federation at the hearing. “The appropriate regulation of products containing lawful cannabinoids already exists, and that data arising out of the state-regulated regime supports such regulation,” she said.

But “whether right or wrong, the current situation has created a vacuum. It opens the door to bad actors,” which ought to inform the FDA’s next steps.

“Cannabis products can be safely regulated under the existing dietary supplement framework and where products are intended for non-medicinal purposes, it is appropriate to regulate them as such,” she said. “The years of data from these state regulatory regimes are an important source of data for the agency to consider in determining the regulatory pathway. We stand ready to advance to the next level as a partner with FDA in effective federal regulation of cannabinoid products.”

Regulators

Represents from state regulatory agencies in Virginia, Florida, North Carolina and Pennsylvania also addressed the uncertainty that’s prevalent throughout the industry without updated FDA guidelines.

“Currently, states are struggling with the lack of sound scientific research available in CBD and long-term health impacts, including those to children,” Pam Miles of the Virginia Department of Agriculture, said. She added that her department “is hopeful that FDA will begin to supply significant leadership as it related to CBD, including research related to its health impacts.”

Brenda Morris, representing the Florida Department of Agriculture and Consumer Services, talked about the “patchwork of laws” surrounding CBD and how that has fostered an environment where “anything is allowed.”

“Without the FDA’s guidance and leadership, individual states may carve out their own regulatory exceptions for CBD,” Joseph Reardon of the North Carolina Department of Agriculture and Consumer Services, said, noting that his state’s hemp industry has greatly expanded in recent years. “We urge the FDA to resolve the statutory issues and properly establish a legal pathway for CBD products to enter the market place.”

Health and consumer advocates

The Alzheimer’s Association argued that existing research is insufficient to substantiate claims about the therapeutic potential of cannabis for Alzheimer’s and dementia. The group said the “lack of evidence creates a substantial risk for individuals and their families.”

The American Epilepsy Society expressed similar concerns, despite CBD being an FDA-approved drug in the treatment of seizures in the form of Epidiolex.

“We support reducing regulatory barriers to research of cannabis-derived compounds,” a representative for the group said. “We strongly urge the FDA to classify the compounds and drugs under the complete jurisdiction of the FDA. We also advocate for ongoing studies on the efficacy of cannabis drugs.”

Ashley Morgan of the American Veterinary Medical Association told the FDA panel that “we believe there is therapeutic potential in the development of cannabis-derived and cannabis-related compounds and we would like to see the potential realized.”

“We believe FDA must seriously consider the need for efficacy and safety data when therapeutic claims are made” about CBD products, she said. “To facilitate the development of such products for veterinary use is imperative [for the FDA to] provide pathways to ensure the regulatory clarity and predictability and economic viability of the industry. The agency must make enforcement priorities known and consistently and intentionally act on the priorities.”

Another interesting testimony came from Larry Walker at the University of Mississippi, which is currently the site of the nation’s only federally authorized marijuana manufacturer for research purposes. He raised some concerns about potential adverse effects of CBD but made a series of recommendations to the FDA about how to minimize risks.

“A possible path forward, it seems to us, is prudent to have a multitrack approach with these products that are cannabis-related,” Walker said.

“It would be outstanding if the FDA could conduct some basic studies in this realm. It is a national need,” he said. “We need a national testing program for cannabinoid quality and standardization, a national adverse reporting program for whatever products are out there and a rapid response program for products where there are serious incidents. We need analytical backup on many of these things where the serious incidents have occurred. Finally, if possible, together research outcomes in the state medical programs.”

Sue Sisley, an internal medicine physician at the Scottsdale Research Institute, expressed frustration over the fact that the DEA “has not processed” applications to increase the number of authorized manufacturers for research-grade cannabis “despite members of Congress repeatedly urging” the agency to do so.

“Sadly, because of the limitations with the current drug supply, we are forced to import study drugs from a Canadian manufacturer and that is disappointing to us,” she said. “We would like to see our own domestic variety of domestic manufacturers. The point is that researchers need access to options. Scientists need options when it is to embolden scientific freedom.”

James Beck, representing the Parkinson’s Foundation, noted that while traditional pharmaceuticals can treat some of the symptoms Parkinson’s patients experience, many remain unaddressed, leaving the community “seeking alternative ways in which to control the symptoms.”

He said that marijuana doesn’t seem to treat tremors, but “it may be helpful on a targeted level for nonmotor symptoms, sleep, anxiety.”

“Bottom line, we really need more research to understand the utility of cannabis for Parkinson’s disease,” Beck said. “I don’t know that there’s very other circumstances we have a drug that is life-saving.”

Jacqueline French of the Epilepsy Foundation said that the group wants the FDA to “preserve access to CBD for those who need it as a life-saving medication.” However, she emphasized the need to create “manufacturing standards” to avoid contamination from mold and other contaminants.

Americans for Safe Access’s Heather Despres talked about standards that her organization has developed, recommending that the FDA consider integrating some of their best practices on “cultivation, manufacturing, distribution and laboratory operations.”

“There are many challenges facing the cannabis industry. There are solutions available,” she said. “We have worked with state regulators to develop and implement a standard, [and] we look forward to working with you, together, to help implement those standards.”

FDA reaction

Amy Abernethy, the FDA principal deputy commissioner who helped organize the public meeting, identified several themes that emerged during the talks.

In general, there is a need to “further clarify the regulatory framework to reduce confusion in the market,” to provide that clarification in timely manner, to collect data on CBD to ensure that the products are safe and to create labeling standards so consumers know what they’re getting.

Another theme that seemed to develop is the lack of information about dosing guidelines. Several experts who testified were unable to give clear answers to the FDA panel when asked about what the proper doses are in different contexts, and what their affects on consumers are.

Interested parties can submit public comments to FDA’s docket on CBD issues through July 2.

This story was updated to include testimony delivered later in the day. 

Federal Court Orders DEA To ‘Promptly’ Consider Marijuana Rescheduling…Or Else

Photo by Kimzy Nanney on Unsplash.

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.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

Watch Live: Congressional Committee Discusses Medical Marijuana And Military Veterans

Published

on

A congressional committee held a hearing on four bills that concern veterans and medical marijuana on Thursday.

The House Veterans’ Affairs Committee discussed one piece of legislation that would allow doctors at the U.S. Department of Veterans Affairs (VA) to issue medical cannabis recommendations in states where it’s legal. That bill was introduced by Rep. Earl Blumenauer (D-OR).

The panel also took up a bill sponsored by Rep. Lou Correa (D-CA) that would require VA to conduct clinical trials on the therapeutic potential of cannabis in the treatment of conditions such as post-traumatic stress disorder and chronic pain.

“The men and women that I meet back home vouch for the therapeutic benefits of medical cannabis and support further research into the issue,” Correa said in testimony prepared for the hearing. “The legislation provides a framework for that research to ensure a scientifically-sound study on the issue.”

“Cannabis must be objectively researched. Period,” Rep. Mark Takano (D-CA), chair of the committee, said in support of the legislation. “Medicinal cannabis may have the potential to manage chronic pain better than opioids and treat PTSD.”

Rep. Phil Roe (R-TN), ranking member on the committee, agreed that VA should be studying the therapeutic potential of cannabis for veterans but complained that the proposed bill is excessively prescriptive. The congressman, who introduced a similar piece of legislation in January, said lawmakers shouldn’t “be telling the scientists how to design their studies.”

Other legislation that came up for consideration was a bill from Rep. Seth Moulton (D-MA), a 2020 presidential candidate, that would provide training on medical cannabis for VA health practitioners.

Finally, the committee heard testimony on another Moulton proposal that would require VA to conduct a survey to “measure cannabis use by veterans.”

Watch the hearing below:

Witnesses who testified before the committee include Adrian Atizado, deputy national legislative director of Disabled American Veterans (DAV), Travis Horr, director of government affairs with Iraq and Afghanistan Veterans of America (IAVA) and Carlos Fuentes, director of national legislative service for Veterans of Foreign Wars (VFW).

The VFW representative said the organization supports all but one of the cannabis bills. While the group agrees with the intent of allowing VA doctors to recommend cannabis, it “believe it is unacceptable for VA providers to recommend a treatment that they are unable to provide veterans and force patients to pay for the full cost of such care.”

DAV voiced support for legislation requiring VA to study medical cannabis and also to survey veterans on their marijuana usage.

And IAVA came out in strong support for the research bill. In testimony, the group said that “without research done by VA surrounding cannabis, veterans will not have conclusive answers to ways cannabis might aide their health needs. This is unacceptable.”

“VA houses some of the most innovative and best-in-class research this country has to offer. It should not be shutting its doors on a potentially effective treatment option because of politics and stigma,” the group said. “Our nation’s veterans deserve better.”

Larry Mole, chief consultant of population health services at the federal Veterans Health Administration, testified that VA opposes all four of the cannabis bills.

He expressed concerns that VA doctors would be penalized if they recommend medical cannabis, that the research requirement would be excessively onerous and that VA is already studying marijuana, that VA doctors already have access to training materials on the subject and that the proposed anonymous survey would require veterans to disclose information that could make them identifiable.

“The legislation would prescriptively define how the surveys would be conducted, but it does not provide the purpose, goals, or objectives for the surveys,” he said. “We have significant concerns that veterans will not want to participate, despite the survey being anonymous.”

Several committee members pressed Mole on VA’s current research efforts, noting the widespread support among veterans to study the medicinal benefits of marijuana.

Rep. Mike Levin (D-CA) said that he meets with veteran constituents each week and asked the VA representative, “[w]hat am I to tell them when they ask when is this [research] actually going to happen?”

“When is this research going to occur? When is the VA going to listen to the 92 percent of veterans across all political stripes and ideologies that want to see this done?” he said.

Mole pointed to the single ongoing VA clinical trial that just recently recruited its first participant focusing on the benefits of CBD for post-traumatic stress disorder. He encouraged Levin to tell his constituents to look up the study and apply to participate if they were interested.

Rep. Andy Barr (R-KY) characterized the VA’s study as “a baby steps approach” to the issue given that CBD alone isn’t representative of the products that veterans are using in the commercial market.

After the House Veterans’ Affairs Subcommittee on Health held a hearing on several of the cannabis proposals in April, the full committee was set to vote on two marijuana measures last month. That hearing was cancelled, however.

Blumenauer is also pursuing cannabis reform for veterans through a different vehicle: an appropriations bill that’s being debated on the House floor this and next week. He introduced an amendment that would prohibit VA from “interfering with a veteran’s participation in a state medical cannabis program, denying a veteran who participates in a state medical cannabis program from being denied VA services, and interfering with the ability of VA health care providers to recommend participation in state medical cannabis programs.”

This was the second congressional committee hearing on marijuana-related issues this week. On Wednesday, the House Small Business Committee met to discuss challenges and opportunities for entrepreneurs in the emerging cannabis industry.

This story has been updated to include additional testimony from witnesses.

House Passes Amendments Stripping DEA Funding And Pushing FDA To Regulate CBD

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.
Continue Reading

Politics

House Passes Amendments Stripping DEA Funding And Pushing FDA To Regulate CBD

Published

on

Two drug policy amendments cleared the House of Representatives on Thursday, building on reform victories in the chamber the day before.

One measure addresses funding for the Drug Enforcement Administration (DEA) and the other would direct the Food and Drug Administration (FDA) to establish regulations for adding CBD to foods and dietary supplements.

The first amendment, introduced by Rep. Alexandria Ocasio-Cortez (D-NY), would transfer $5 million from the DEA to an opioid treatment program. It passed without opposition on a voice vote and is now be attached to the House version of a large-scale spending bill, but it remains to be seen how the Senate will set funding levels for the agency in its own version of the funding legislation.

“I offer this amendment because ending the war on drugs has to mean changing our priorities in order to keep all communities safe and healthy,” Ocasio-Cortez said. “The best way we do that is by offering people the help and support they need before arrest and criminalization should be considered in the first place.”

She added that the DEA is still receiving $2.36 billion in funding, which is $90 million higher than was appropriated for the last fiscal year. It’s also about $78 million higher than President Trump requested in his budget.

Rep. Jose Serrano (D-NY), the chairman of an appropriations subcommittee that handles Justice Department funding, rose in support of the amendment, stating that opioids “are a serious threat to the health and wellbeing of our communities, and we must do everything we can to combat this epidemic.”

Michael Collins, director of national affairs for the Drug Policy Alliance, told Marijuana Moment that the successful vote “should send a message to the DEA—it’s not business as usual anymore.”

“We want to end the drug war and we will fight for it. We will drain you dollar-by-dollar, cent-by-cent, if that’s what it takes,” he said.

Rep. Robert Aderholt (R-AL) claimed time designated for the opposition on the floor but said he supports the amendment. The congressman did note, however, that funding for opioid abuse prevention grants has increased by 360 percent since 2017 and that “we want to work with both sides to make sure we have the appropriate funds necessary to make sure we fight this opioid addiction that has taken over so many parts of the country.”

In closing, Ocasio-Cortez said “just as the epidemic is exploding so should our commitment to address this problem.”

“We have overfunded one agency and we should move that to make sure that we are getting people the care they need,” she said.

Dan Riffle, senior counsel and policy advisor in Ocasio-Cortez’s office told Marijuana Moment that the amendment is “a good start, but it’s not enough.”

“Every dollar we waste trying and failing to reduce supply is a dollar that should be spent on treatment and demand reduction,” he said.

This is the second drug policy amendment the freshman congresswoman has introduced that’s been brought to the House floor. However, her earlier proposal, which was meant to lift barriers to research for psychedelic substances such as psilocybin and MDMA, was rejected when it came up for a vote as part of separate appropriations legislation last week.

The FDA amendment, introduced by Rep. Jerry McNerney (D-CA), was approved as part of an en bloc voice vote combining other relatively noncontroversial measures and it did not receive debate on the floor. The measure aims to resolve a problem that the FDA has repeatedly raised since hemp and its derivatives were federally legalized under the 2018 Farm Bill.

Because CBD exists as an FDA-approved drug and has never been allowed in the food supply before, the agency’s former commissioner said Congress may have to pass separate legislation to provide for its lawful marketing.

The amendment’s description directs FDA to “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.”

Two other drug policy amendments were debated in the chamber on Wednesday. A measure that would block the Justice Department from using its funds to intervene in state marijuana laws was approved on a voice vote but still needs to pass in a recorded vote; another that extends similar protections to tribal cannabis programs passed without a request for a recorded vote.

Congress Clashes On Marijuana Amendments In Floor Debate

This story was updated to include comment from Riffle.

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.
Continue Reading

Politics

Cory Booker Unveils Plan To Commute Sentences For Thousands Of Drug War Prisoners

Published

on

If elected president next year, Sen. Cory Booker (D-NJ) said that he would immediately exercise his powers to grant clemency to an estimated 17,000 individuals serving time in federal prison for nonviolent drug offenses—more than half of whom would be people with marijuana-related convictions.

The 2020 Democratic presidential candidate unveiled his “Restorative Justice Initiative” on Thursday, outlining a plan to right the wrongs of the war on drugs and promote fairness in a criminal justice system that has historically disproportionately punished people of color even though drug use rates are virtually identical across racial lines.

“The War on Drugs has been a war on people, tearing families apart, ruining lives, and disproportionately affecting people of color and low-income individuals — all without making us safer,” Booker wrote. “Granting clemency won’t repair all the damage that has been done by the War on Drugs and our broken criminal justice system, but it will help our country confront this injustice and begin to heal.”

Starting on his first day in office, Booker would start the clemency process by signing an executive order instructing the Bureau of Prisons, the Defender Services Division of the U.S. Courts and the U.S. Sentencing Commission to identify individuals in prison who would be eligible for clemency under his initiative.

Three broad classes of inmates would be eligible: those convicted of marijuana-related offenses, those serving sentences that would have been reduced had the bipartisan First Step Act been applied retroactively and those who received lengthier sentences for a crack cocaine-related offense than a person would have for powder cocaine.

Via Cory Booker.

The announcement builds on Booker’s criminal justice reform-focused presidential campaign. The senator, who introduced a comprehensive cannabis legalization bill in February, has drawn a line in the sand on the issue, stating that he won’t consider marijuana reform legislation unless it also contains measures aimed at restorative justice for those disproportionately impacted by prohibition.

His new plan would also reform the clemency system itself, establishing a federal interagency council that would advise his administration and Congress on policies including “identifying job and training opportunities, investing in rehabilitation programs, and targeting evidence-based social services” for those granted clemency.

Via Cory Booker.

“Progress has been far too slow, and thousands of people continue to languish in prison — brick-and-mortar warehouses of human potential,” Booker said. “The impact of the failed War on Drugs is not limited to those presently incarcerated; across the country, families and communities have been hollowed out by missing fathers, sons, mothers, and daughters.”

While it’s still early in presidential campaign season, the first Democratic debates are set for next week and candidates are increasingly willing to call out their opponents’ records. Booker is no exception, taking subtle swipes at Sen. Kamala Harris (D-CA) for making cavalier statements about her past cannabis use and urging Joe Biden to apologize for waxing poetic about the “civility” of his time in the Senate while working with segregationist lawmakers.

Presidential Candidate Calls On Federal Financial Regulators To Clarify Hemp Rules

Photo courtesy of Facebook/ABC News.

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.
Continue Reading
Advertisement

Stay Up To The Moment

Marijuana News In Your Inbox


Support Marijuana Moment

Marijuana News In Your Inbox

Do NOT follow this link or you will be banned from the site!