Important Memo: FDA Accepting Comment On Scheduling of CBD

Your Opinion Matters

It is a critical time for the hemp industry. In order to avoid CBD being scheduled as a drug, thus limiting or eliminating access to it, we ask that you take a few minutes to comment on CBD to the FDA. Your comments will help keep CBD available to everyone who uses it. This informative memo will assist you with your comment.

What’s Going On?

The Food and Drug Administration (FDA) is accepting comments from the public about cannabidiol (CBD). We strongly encourage you to comment as soon as possible. The available period to comment ends on Wednesday, September 13, 2017. Specifically, the FDA is soliciting comments about CBD that address (a) abuse potential, (b) actual abuse, (c) medical usefulness (This comment request should be avoided since CBD is not medicine) (d) trafficking, and (e) the impact of scheduling changes on CBD’s availability for medical use. Comments are required by the Controlled Substances Act (CSA) and will be considered in the FDA’s upcoming response to the World Health Organization (WHO) regarding abuse and trafficking of CBD.

Goals

Our objective is to convince the FDA that CBD should not be regulated as a drug because it is a naturally occurring nutraceutical that promotes well-being, it has no history of abuse, and it may be lawfully transported, processed, sold, and/or used when it is derived from industrial hemp cultivated pursuant to the 2014 US Farm Act. In accomplishing our objective we need a large number of people to comment on the  online portal set up for this purpose. This memo provides information on how best to comment in a way that will promote CBD’s safety and usefulness while preserving its availability to the public without prescription.

When Is The Deadline For Comment Submission?

All forms of comment must be submitted by September 13, 2017.

Link To Submit Comment

The FDA comment portal can be found by clicking here. The comment box is open-ended and allows up to 5000 characters. Including spaces, that’s approximately 833 words. For comparison, this memo has 782 words. The portal also allows you to upload files such as documents and images. You may provide your contact information. If you are commenting for others you may provide their contact information. Finally, you must identify your relationship to CBD by category, such as “individual consumer”, “academia”, “food industry”, “health professional”, et cetera. The available categories are provided. You simply choose the most appropriate one.

 

Suggestions For Comments

Comments should address one or more of the following regarding CBD:

  • potential for abuse;
  • evidence of any actual abuse;
  • improvement in quality of life through health and wellness;
  • evidence of illegal trafficking;
  • impact of scheduling changes (ie, what impact it would have if it were scheduled as a
    controlled substance under the CSA).

Although you do not need to discuss each of these issues in your comment, it is important that you discuss as many as you can based on your knowledge and experience. These are the specific issues the FDA is looking to address in its response to the WHO. Unfortunately, the FDA has couched its request for comments in terms that make it appear that CBD is a psychotropic drug (ie, one that “gets you high”) with a potential for abuse. We want to make it clear that neither of these is true.

It is important that your comment discuss CBD’s health benefits. This is a little tricky. On one hand, we want to make it clear to the FDA that CBD promotes health and well-being. On the other hand, we do not want to claim that CBD cures any specific disease since this may encourage the FDA to schedule CBD as a drug. In other words, comments should stress CBD’s effects on general wellness and not focus on curing disease. You should discuss the ways in which CBD has improved your quality of life and/or the well-being of your family and friends.

We want the FDA to know about the legitimate studies demonstrating CBD’s positive effects on health with no potential for abuse. In addition to commenting on your personal experiences with CBD, you should consider referencing one or more of these studies. (Please limit your references to no more than three studies so that the ones you reference have the most impact.) Below is a list of studies with hyperlinks to the actual reports. We suggest that you read a few of them so you may reference the ones that are most applicable to your personal situation and can do so with authority.

Length Of Use

Finally, it is important for you to state how long you have been using CBD and/or hemp based products that contain CBD. The longer the better. The rules that govern nutraceuticals and dietary supplements make it difficult to classify hemp based CBD as a dietary supplement unless there is sufficient evidence that it has historically been used for that purpose. You can be immensely helpful in providing that evidence.

Informative Studies

1) [MARCH 2012] Cannabidiol, a non-psychotropic plant-derived cannabinoid, decreases inflammation in a murine model of acute lung injury: role for the adenosine A(2A) receptor

https://www.ncbi.nlm.nih.gov/pubmed/22265864

– Thus, we show that cannabidiol has anti-inflammatory effects in a murine model of acute lung injury and that this effect is most likely associated with an increase in the extracellular adenosine offer and signaling through adenosine A(2A) receptor.

– Immunosuppressive & anti-inflammatory properties

2) [DEC 5 2009] Cannabidiol reduces Aβ-induced neuroinflammation and promotes hippocampal neurogenesis through PPARγ involvement

https://www.ncbi.nlm.nih.gov/pubmed/22163051

– Moreover, due to its interaction at PPARγ, CBD was observed to stimulate hippocampal neurogenesis. All these findings report the inescapable role of this receptor in mediating CBD actions, here reported

– Alzheimer’s specifically

3) [MARCH 2009] Cannabidiol attenuates cisplatin-induced nephrotoxicity by decreasing oxidative/nitrosative stress, inflammation, and cell death

https://www.ncbi.nlm.nih.gov/pubmed/19074681

– Treatment of mice with cannabidiol markedly attenuated the cisplatin-induced oxidative/nitrosative stress, inflammation, and cell death in the kidney, and it improved renal function. Thus, our results suggest that cannabidiol may represent a promising new protective strategy against cisplatin-induced nephrotoxicity.

– Reduce oxidative/nitrosative stress associated with chemotherapy [Nephrotoxicity]

4) [APRIL 15 2015] CBD as an Intervention for Addictive Behaviors

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4444130/pdf/sart-9-2015-033.pdf

– CBD thought to modulate various neuronal circuits involved in drug addiction

– CBD may have therapeutic properties on opioid, cocaine, and pschyostimulant addiction, and preliminary data suggests it may be beneficial in cannabis and tobacco addiction in humans

5) [SEPTEMBER 2013] CBD reduces cigarette consumption in tobacco smokers

https://www.ncbi.nlm.nih.gov/pubmed/23685330

– We conducted a pilot, randomised double blind placebo controlled study set out to assess the impact of the ad-hoc use of cannabidiol (CBD) in smokers who wished to stop smoking.

– treated CBD significantly reduced the number of cigarettes smoked by ~40% during treatment

– Potential treatment for nicotine addiction

 

6) [MARCH 2013]  CBD inhibits the reward-facilitating effect of morphine

https://www.ncbi.nlm.nih.gov/pubmed/22862835

  • Therefore, we investigated the effects of cannabidiol on brain reward function and on the reward-facilitating effect of morphine and cocaine using the intracranial self-stimulation (ICSS) paradigm
  • Cannabidiol inhibited the reward-facilitating effect of morphine, but not cocaine.
  • Our results suggest that cannabidiol interferes with brain reward mechanisms responsible for the expression of the acute reinforcing properties of opioids, thus indicating that cannabidiol may be clinically useful in attenuating the rewarding effects of opioids.

 

7) [AUGUST 2013]  Transdermal delivery of CBD attenuates binge alcohol-induced neurodegeneration in a rodent model of an alcohol use disorder

http://www.sciencedirect.com/science/article/pii/S0091305713002104

  • Alcohol-induced neurodegeneration is a novel target for alcoholism pharmacotherapy.
  • Transdermal cannabidiol prevents alcohol-induced neurodegeneration similar to i.p.
  • Transdermal systems for treating alcoholism may improve patient compliance.

8) [MARCH 2017]  CBD regulation of emotion and emotional memory processing: relevance for treating anxiety-related and substance abuse disorders

https://www.ncbi.nlm.nih.gov/pubmed/28268256

  • There is also accumulating evidence from animal studies investigating the effects of cannabidiol on fear memory processing indicating that it reduces learned fear in paradigms that are translationally relevant to phobias and post-traumatic stress disorder. Cannabidiol does so by reducing fear expression acutely and by disrupting fear memory reconsolidation and enhancing fear extinction, both of which can result in a lasting reduction of learned fear. Recent studies have also begun to elucidate the effects of cannabidiol on drug memory expression using paradigms with translational relevance to addiction. The findings suggest that cannabidiol reduces the expression of drug memories acutely and by disrupting their reconsolidation.

 

9)  [JULY 2014]  Cannabidiol Promotes Amyloid Precursor Protein Ubiquitination and Reduction of Beta Amyloid Expression in SHSY5YAPP+ Cells Through PPARγ Involvement

https://www.ncbi.nlm.nih.gov/pubmed/24288245

  • Cannabidiol (CBD), a Cannabis derivative devoid of psychotropic effects, has attracted much attention because it may beneficially interfere with several Aβ-triggered neurodegenerative pathways
  • Results indicated the CBD capability to induce the ubiquitination of APP protein which led to a substantial decrease in APP full length protein levels in SHSY5Y(APP+) with the consequent decrease in Aβ production. Moreover, CBD promoted an increased survival of SHSY5Y(APP+) neurons, by reducing their long-term apoptotic rate.

10) [JULY 2016]  Neurological aspects of medical use of CBD

https://www.ncbi.nlm.nih.gov/pubmed/28412918

  • Pre-clinical evidence largely shows that CBD can produce beneficial effects in AD, PD and MS patients, but its employment for these disorders needs further confirmation from well designed clinical studies.
  • potential use in children and young adults affected by refractory epilepsy.

 

11)  [FEBRUARY 2004]  Effects of CBD on regional cerebral blood flow

https://www.ncbi.nlm.nih.gov/pubmed/14583744

  • CBD significantly decreased subjective anxiety and increased mental sedation, while placebo did not induce significant changes.
  • These included a medial temporal cluster encompassing the left amygdala-hippocampal complex, extending into the hypothalamus, and a second cluster in the left posterior cingulate gyrus.
  • These results suggest that CBD has anxiolytic properties, and that these effects are mediated by an action on limbic and paralimbic brain areas

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4 thoughts on “Important Memo: FDA Accepting Comment On Scheduling of CBD

  1. Nina Simmons says:

    CBD has reduced my sons seizures thus improving his quality of life and gave him the ability to attend school. My son recently had a normal EEG which was not the case before CBD oil. CBD gave our family back it’s joy!

  2. Sanura Moon says:

    CBD oil helps me daily with anxiety, feeling nautious, pain, and gives me energy each day. I take a few drops under my tongue each morning. I can’t imagine my life without this healing plant and plant oils. I believe it a healing plant gift God created for us all.

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