The FDA Just Got A Truckload Of Marijuana Comments Delivered To Them

The FDA Just Got A Truckload Of Marijuana Comments Delivered To Them

Last month, the Food and Drug Administration (FDA) requested public input on the international classification of marijuana and other drugs. Well, ask and you shall receive.

More than 20,000 people submitted comments ahead of the Wednesday deadline. And about half of those were gathered and hand-delivered to FDA headquarters by NORML, which created an online tool to streamline comments.

That’s about how many comments the organization delivered in April, in response to a similar FDA open comment period on cannabis.

The organization posted a video of the new delivery on Facebook, so you can watch it for yourself below:

https://www.facebook.com/norml/videos/195700877994990/

“In just over two weeks, we received more than 10,000 comment submissions from our supporters,” NORML Political Associate Carly Wolf told Marijuana Moment. “It’s so important for everyday American citizens to speak up and participate at every opportunity because when it comes down to it, our communities are being directly impacted by the discriminatory and destructive policies our government has unjustly implemented.”

“The sooner these supposedly ‘fact-based’ bureaucracies acknowledge the actual realities of marijuana’s effects, widespread medical uses and very low potential for abuse, the sooner we will end the criminalization of cannabis.”

Another 10,591 comments were submitted online via the federal regulations.gov portal.

Altogether, the comments are aimed at informing the United States’s position on drug scheduling requirements under international treaties that prohibit member countries from legalizing cannabis. Marijuana is currently included in the most restrictive category under international treaties, similar to its placement in Schedule I under U.S. law.

The World Health Organization (WHO) is actively reviewing the global scheduling system to see if it should be amended. In August, WHO determined that one ingredient in cannabis, CBD, was a relatively safe and therapeutic substance that doesn’t deserve to be scheduledunder international treaties.

While the comments from this round varied somewhat in terms of how each individual framed their argument, the vast majority published so far seem to be supportive of either loosening or eliminating international restrictions on marijuana.

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

See the original article published on Marijuana Moment below:

The FDA Just Got A Truckload Of Marijuana Comments Delivered To Them

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

It’s not every day that the federal government requests public input on international marijuana laws, but that’s exactly what the Food and Drug Administration (FDA) did last week. And the comments are pouring in.

So far, the agency says it has received more than 2,100 comments—a small fraction of which have been published. The comments range from personal anecdotes about how cannabis has helped patients to arguments about the economic benefits of legalization. Others put the issue more bluntly:

“Just legalize it already.” —Anonymous

The comment period is fairly open-ended, so there’s not necessarily a “right” way to express your views. What the agency requested is input on the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use” of cannabis and several other substances.

The comments will be considered as the United States responds to the United Nations World Health Organization. That response will help inform the international group on “whether to recommend that certain international restrictions be placed on these drugs” or whether that should be reclassified under international drug treaties.

For reference, here are a few other comments to FDA that stand out:

“I am a 25-year old male working in finance in NYC, please legalize marijuana — it is one of the few answers to budget deficits across the nation in the form of billions in tax revenue, and it is a scientifically “safer” drug than both alcohol and nicotine, the latter two of which are currently legal and causing billions of dollars in healthcare related costs.”

“The benefits of Cannabis Plant and Resin far outweigh its health risks. All forms of THC and CBD should be made completely legal for medicinal and recreational use immediately, and taxed accordingly.”

“I am writing to voice my support for full cannabis descheduling. It is clear that the current policy is a failure in controlling a substance that is dramatically less harmful than currently legal products. This injustice to the American people has gone on for far too long. “

“Marijuana has been legalized for medical use in 31 states. Additionally, it is legal for recreational use in 9 states with more voting on it this mid-term election. Canada is also legalizing marijuana federally on October 17th. The United States needs to get its head out of the sand and take a more progressive approach to marijuana use and research.”

“I am a combat veteran of the Iraq war, and I am ASHAMED of the way that the United States Government is treating veterans like myself who know firsthand the positive effect that cannabis can have for people suffering from PTSD. I know that it has helped me. Stop standing in the way of our potential happiness.”

The FDA isn’t just asking about marijuana—there are 16 substances included in this comment period—but it’s clear that cannabis is the primary subject of interest, at least in the submissions that have been published so far. The comments overwhelmingly support de-scheduling or legalizing cannabis, with rare exceptions.

For example, one anonymous commenter who claimed to be representing a “major corporate client” lamented reportedly declining property values in a Massachusetts jurisdiction where a marijuana dispensary operates. The losses, the commenter claimed, amounted to more than $29 million.

Another reform critic who identified himself as Eric R. Eliason from Utah said he “took two puffs of a joint” in college and suffered academically.

“I usually get As in math but the next semester I got Fs in all my classes (except an A in tennis where I cheated). Marijuana impairs judgment and stays in your system for a very long time. Drugs are bad for you. We need critical thinkers for our economy.”

Eric R. Eliason is also the name of a U.S. House candidate in Utah, running as a United Utah Party member. The candidate denied having written the comment in a tweet, noting that he knows several other individuals with the same name.

“LOL. I’ve never had an F, never had a tennis class, and never had a toke,” Eliason wrote on Twitter. “Based on writing style, I would nix the professor and the gastro surgeon as well.”

For those who are supportive of changing international treaties to free up countries to set their own marijuana policies—but perhaps aren’t sure how to articulate their views to the FDA—NORML launched an online tool on Tuesday that offers editable, pre-written letters that the organization will submit to the FDA.

“In April, in response to a similar FDA request, NORML collected and hand-delivered over 10,000 comments to the agency calling on it to recommend a lifting of international restrictions criminalizing the plant,” the organization wrote.

“It is imperative that rational, evidence-based policies are what our policy makers review, and the FDA public comment period provides a terrific opportunity for citizens to make their voices heard,” NORML Political Director Justin Strekal told Marijuana Moment.

“Here at NORML, we made it easy with a pre-written letter with recent studies, which commenters can easily edit as they see fit to include additional context. In April, during the first round of public comment, over 60 percent of all submissions came from NORML members and we hope to continue to dominate the discussion in October.”

For those who want to submit comments to the FDA through the official government channel, Marijuana Policy Project general counsel Kate Bell shared some advice with Marijuana Moment.

“1. Submit something. Don’t worry about whether others might submit similar comments or make them in a more compelling fashion. The sheer volume of comments makes a statement.
2. Explain your expertise. It’s okay if you’re not a policy expert or medical researcher. For example, if you are a medical cannabis patient or you have a marijuana-related conviction on your record, let them know how marijuana’s current classification has personally affected you.
3. Make sure you address the questions that are being asked. In this case, review the issues that the WHO is considering, which are listed in the FDA’s request for comment.”

Whatever your individual stance is, and whatever method you choose to submit your comment, there’s one date to keep in mind: October 31 is the deadline to make your voice heard.

See the original article published on Marijuana Moment below:

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

U.S. Senators Demand Update On Federal Cannabis Research

U.S. Senators Demand Update On Federal Cannabis Research

In late December 2015, lost amongst the hustle and bustle of holiday shopping, office parties, and spiked egg nog, a group of eight U.S. senators, all Democrats, sent a letter to three high-level bureaucrats in Washington, D.C., one each at the Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), and the Drug Enforcement Administration (DEA).

Senators Barbara Boxer (California), Elizabeth Warren and Edward Markey (Massachusetts), Cory Booker (New Jersey), Kirsten Gillibrand (New York), Jeff Merkley and Ron Wyden (Oregon), and Barbara Mikulski (Maryland) sent a nearly four-page letter to the acting officers of these government agencies. Conspicuously absent from the author list was Republican senator and libertarian torch bearer Rand Paul (Kentucky), possibly due to his presidential campaign.

US-senators-query-status-of-federal-cannabis-research-2b

Paul, along with junior senators Booker and Gillibrand, in early 2015 sponsored the CARERS Act, bi-partisan legislation that would further force the federal government to recognize a state’s right to legalize cannabis for any reason, reclassify the herb as Schedule II (it is currently Schedule I), eliminate several barriers to research, and — most important — make it easier for military veterans to obtain recommendations for medical cannabis from Veterans Affairs doctors (most notably for PTSD, depression, and anxiety).

More specifically, the target of the letter was Chuck Rosenberg, the Acting Administrator of the DEA, Michael Botticelli, Director of the ONDCP, and Sylvia Mathews Burwell, the Secretary of HHS. Rosenberg made headlines in late 2015 when he discounted the medicinal properties of cannabis and the efficacy gained by millions of patients nationwide, calling med pot a “joke” and saying that cannabis “never has been shown to be safe or effective as a medicine.”

Call for Collaboration

The letter pointed out the need for a wide range of government agencies and research organizations to somehow combine their efforts to reach the goal of more comprehensive medical cannabis research. Wrote the senators in the opening of their letter:

“…there is a need and unique opportunity for federal agencies to collaborate with each other…”

The letter stressed the “unique opportunity” for states to conduct population-based, clinical, “and other basic research on the risks and benefits of medical marijuana.” The letter went on to note the hurdles and barriers to federally-authorized cannabis research that are supported or maintained by a variety of government agencies. It identified the current regulatory scheme for medical cannabis research as “outdated and in desperate need of serious and immediate review.”

US-senators-query-status-of-federal-cannabis-research-1

Areas of Focus

The letter focused on five key points, as summarized below:

  1. Supply Limits. The senators questioned the ability of a single farm at the University of Mississippi to produce an adequate supply of high-quality, “medical grade” cannabis for multiple research studies nationwide. The pot farm at the University of Mississippi holds the only bulk manufacture permit issued by the DEA and has cultivated and produced cannabis that many patients, physicians, and experts have labeled low-quality and as offering relatively little medicinal benefit. Thus, any study conducted in the United States using this low-quality herb would result in lower efficacy rates among participants — in essence, rigging the game for those who oppose medical pot.
  2. Rescheduling. Cannabis, which currently is part of Schedule I under the Controlled Substances Act, has been argued as a logical candidate for a lower ranking, such as Schedule II or III. The Food and Drug Administration has completed an analysis of the rescheduling of cannabis, and, it appears, HHS has provided “scientific and medical evaluations, as well as a scheduling recommendation” to the DEA. The query from the senators: What was the recommendation, and what is the timetable for review of the recommendation? This section of the letter also calls for the rescheduling of CBD oil.
  3. Interagency Coordination. Echoing one of the primary themes of the letter, coordination and cooperation, its authors cite a research application approval process that is “long, cumbersome, and difficult to navigate.” The senators request that the recipients explain how they “plan to work together to encourage qualified research applications” and asks them to describe the application process for qualified cannabis researchers.
  4. Surveillance and Epidemiological Studies. Such studies would gather data regarding how cannabis is actually being used, both medically and recreationally. The letter specifically calls for an investigation of cannabis use in “diverse populations and with multiple modes of administration.” If this actually occurred, government authorities would gather some rare insight into the economic and social aspects of cannabis consumption among a wide variety of demographic groups.
  5. Coordination with States. The senators would like to see “regular and organized communication” between agencies like HHS and state organizations such as public health departments — especially those in legal medical or recreational states like Michigan, California, Colorado, and Oregon — from which invaluable data can be obtained for further analysis or consideration from a national perspective.

The senators requested responses to their inquiries by January 31, 2016.

Photo credit: MSNBC, CBS News

FDA Approves Study for Cannabis Oil as Seizure Treatment

FDA Approves Study for Cannabis Oil as Seizure Treatment

The number of clinical studies that have been conducted on the use of cannabis oil in the treatment of different forms of epilepsy and other seizure disorders far under-represents the public want and need for such research. Parents of children suffering from such conditions in the United States, South America and the rest of the world have even rallied to draw attention to this crime against humanity. Being granted cannabis research permission is the United States is nearly impossible due to the current classification of marijuana as a Schedule I drug under the Controlled Substances Act. Until the federal government removes cannabis from this classification all together, like alcohol, more people, including children, will continue to suffer.

Last year, a coalition of parents with children suffering from different forms of epilepsy and seizure disorders was able to convince legislators in Alabama to approve a bill allowing such research. The study is to be conducted at the University of Alabama at Birmingham, and now, the Food and Drug Administration is officially approving the study.

Permission for this research has been granted to the UAB Neurology department, and reportedly aims to test the effectiveness of the marijuana cannabinoid, known as cannabidiol (CBD), as a treatment for seizure disorders. This study will be different than others conducted because there will be no placebo group. All participants will receive the cannabidiol rich extract during clinical trials. However, there is a catch. A university representative told ABC 3340 that the FDA approved the study with a few alterations. These modifications are expected to be discussed by a review board in January 2015, and hopefully the study will be able to begin soon thereafter.


photo credit: dr-bonni.bitnamiapp

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