Tag Archives: FDA

The Most Misunderstood Plant

Cannabis must be the most misunderstood plant on the face of the planet.  Even among it’s supporters there is a great deal of misunderstanding.

It’s detractors would have you believe that the plant or it’s use is at it’s worst akin to being in league with the devil himself.  Among the many things it is said to have caused is Rape, Murder, Child Abuse, Mental Illness, among a slew of medical ailments.

It’s proponents are generally falling into one of three camps.   Industrial Hemp,  Medical Marijuana, and Recreational Marijuana.  While each of the groups would like to see the other succeed in their actions many times they oppose each other when they shouldn’t be.

The problem comes from a single chemical found in the Cannabis Plant  THC.  THC is the active psychoactive chemical associated with the high that people get from ingesting or smoking the plant or it’s extracts.  THC is a drug that has been made synthetically pure in a pill or liquid form, is FDA approved, and is available from the pharmacy for certain medical conditions.  The DEA doesn’t even really track how much THC is made or used in the US, it’s a low schedule drug.  However when it comes to the plant well it’s a totally different situation.

So what’s the problem.  Hemp proponents would have you believe that Cannabis with a THC content below a certain percentage is “Hemp” and not Marijuana.  They believe that by reducing the THC content of the plant to a point that it isn’t desirable for medical or recreational purposes that they will be able to grow the plant and use if for it’s industrial purposes.  They hope that this will allow the mass cultivation of Cannabis across the United States and world.

While it’s true that Cannabis can be breed to have a low THC content, it’s the fiber and other parts of the plant including the tops that contain the multi-level value that farmers need to succeed with the crop.  Fiber content can be breed into the plant just as THC can be breed out, but no one knows if the fiber is being affected by the concentration on THC content.  Look at it this way, Breeders of plants for cultivation do not look at the chemical makeup of the plant they look at what it is their customers want.  In the case of Cannabis there are customers for all parts of the plant from it’s fiber to it’s various Cannabinoids.

Cannabis is a unique plant.  You can grow Cannabis in a manner similar to how industrial Cannabis is grown and produce not only high quality fiber, hurds, but also the top itself for medical and recreational purposes.  Looking at a field of Cannabis you can not determine if it is low THC Cannabis or High THC Cannabis.  It’s simply not possible.   So the THC content of the field only is important to law enforcement.  This would be absurd if applied to other crops.  There is no evidence that the THC content of Cannabis produces anything better than any other variety of Cannabis.

There is no reason to breed out the THC from Cannabis for the crop to be successful.  Actually the cultivation of large quantities of low THC Cannabis near medical or recreational Cannabis will result in crossbreeding.  This crossbreeding will result in seed stock of each grower that has a THC content different from that of it’s original plants and presents all kinds of problems.

There is no reason, other than political, to regulate the amount of THC that can be produced by a Cannabis plant to determine it’s use.  Cannabis is Cannabis, while there might be varietal differences just as there is with all other crops and plants, doesn’t change the fact that it is still Cannabis.

For government to set an arbitrary limit on the THC content for it to be “Industrial Hemp” is insanity at it’s finest.   For proponents of the use of Cannabis for it’s industrial applications to allow this is even more insane.  It’s not known how THC interacts with the fiber quality, quantity and other factors of the plants ability to survive diseases.  For THC to be used as something that needs to be controlled is simply not going to work in the long run.

It’s time for Industrial Cannabis people to stop hiding behind the word Hemp and make any attempt to discriminate themselves into legalization.  I say this from being an Industrial Hemp Advocate.  For years I focused on it’s industrial applications.  When pushed I said it’s possible to breed out THC and that many countries had, but it wasn’t necessary.  It gave me an opportunity but the opportunity has been used and worked.  I personally talked more about Industrial use than even Medical use.  Now, Cannabis is Cannabis, is Cannabis you simply can’t have one without the other as they are so inter-related that the more we discover the more we may regret allowing low THC Cannabis to be something different than the Medical and Recreationally used Cannabis.

 

 

DEA says Inhaled is Better

Today the DEA announced that they have a new FDA approved form of THC called Syndros.  Syndros is the result of work of Insys Therapeutics to create a new oral THC that has 5mg per ML of solution. – FEDERAL REGISTER LINK

In the DEA’s findings they are planning to schedule this as a Schedule II drug because.

Dronabinol is a generic name for the (-) delta-9-trans isomer of tetrahydrocannabinol (THC). THC is the primary psychoactive substance in marijuana. Dronabinol is the active pharmaceutical ingredient in Syndros. As stated by HHS, Marinol (synthetic dronabinol in sesame oil and encapsulated in a soft gelatin capsule) was approved by the FDA for medical use on May 31, 1985 and placed in schedule II based on its accepted medical use and high abuse potential. On July 2, 1999, Marinol was rescheduled from schedule II to schedule III because of the findings of the DEA that the difficulty of separating dronabinol from the sesame oil formulation and the delayed onset of behavioral effects due to oral route administration supported a lower abuse potential of Marinol as compared to substances in Schedule II. 64 FR 35928.

Going on to state:

HHS indicated that the formulation of Syndros (oral solution) is easier to abuse than Marinol because this liquid formulation can be manipulated to produce concentrated extracts of dronabinol for abuse by inhalation (smoking or vaping) or through other routes of administration. Because of the large amount of dronabinol in Syndros oral solution it has a greater potential for extraction than Marinol and thus has a greater abuse potential.

Based on the use of Cannabis by the general public DEA feels that this form of THC needs to be a Schedule II drug.

What you find when reading further down is that it appears DEA would rather people smoke it because of the onset of effects are easier to control.

Oral consumption of dronabinol, compared to inhaled THC, may result in psychoactive effects that are delayed and stronger with an increased risk of experiencing serious adverse events.

But then they quickly add:

When dronabinol (THC) is smoked, the drug rapidly reaches the brain and psychoactive effects are felt within minutes of inhalation, which allows the subject to control the dose more readily.

The DEA is full of contradictory things but this just about takes the cake.  Using a substance via oral methods pose issues that smoking or inhalation don’t and is better at controlling the dose.  However they are afraid that people will do just that.  Take this new drug and turn it into something they can control the dose better.

There is a time that this potential rule can be commented on, see the link at the top of the page to the federal register.

Congressional Research Service Report on Cannabis

On March 10th the Congressional Research Service released it’s report on “The Marijuana Policy Gap and the Path Forward”

“Given the current marijuana policy gap between the federal government and many of the states, there are a number of issues that Congress may address. These include, but are not limited to, issues surrounding availability of financial services for marijuana businesses, federal tax treatment, oversight of federal law enforcement, allowance of states to implement medical marijuana laws and involvement of federal health care workers, and consideration of marijuana as a Schedule I drug under the CSA. The marijuana policy gap has widened each year for some time. It has only been a few years since states began to legalize recreational marijuana, but over 20 years since they began to legalize medical marijuana. In addressing state – level legalization efforts and considering marijuana’s current placement on Schedule I, Congress could take one of several routes. It could elect to take no action, thereby upholding the federal government’s current marijuana policy. It may also decide that the CSA must be enforced in states and not allow them to implement conflicting laws on marijuana. Alternatively, Congress could choose to reevaluate marijuana’s placement as a Schedule I controlled substance.”

Here is the document – R44782

And a link to the CRS report

World Health Organization to Review Cannabis

It is going largely unknown, unreported and ignored that the World Health Organization (WHO) the arm of the UN that controls the schedule of substances is looking at Cannabis.

As part of the UN the US and the FDA is looking for input from people and organizations about the changes and surprisingly no one is commenting.  The comment period ends Feb 10th at midnight eastern time and so far they have gotten 3 comments.

https://www.regulations.gov/docket?D=FDA-2016-N-4619

3 comments, that is really pretty sad considering a change in the scheduling of Cannabis on an international level could lead to changes in scheduling on a federal level here in the US.

The United States is also a party to the 1961 Single Convention on Narcotic Drugs (1961 Single Convention). The Secretary of State has received a notification from the Secretary-General regarding two substances to be considered for control under this convention. The CSA does not require HHS to publish a summary of such information in the Federal Register. Nevertheless, in an effort to provide interested and affected persons an opportunity to submit comments regarding the WHO recommendations for narcotic drugs, the notification regarding these substances is also included in this Federal Register notice. The comments will be shared with other relevant Agencies to assist the Secretary of State in formulating the position of the United States on the control of these substances. The HHS recommendations are not binding on the representative of the United States in discussions and negotiations relating to the proposal regarding control of substances under the 1961 Single Convention.

Of the substances being considered

The Committee recommended that a specific ECDD meeting dedicated to cannabis and its component substances should be held within the next eighteen months from the 38th meeting, and will carry out pre-reviews for the following substances:

—Cannabis plant and cannabis resin;

—Extracts and tinctures of cannabis;

—Delta-9-tetrahydrocannabinol (THC);

—Cannabidiol (CBD);

—Stereoisomers of THC.

The recommendations and the assessments and findings on which they are based are set out in detail in the Report of the 38th Expert Committee on Drug Dependence, which is the Committee that advises me on these issues. An extract of the Committee’s Report is attached in Annex 1 to this letter.

 

Here is a copy of the WHO Review Report – WHO-cannabis-report

 

 

DEA/DOJ not the Problem

I’m sorry but the DEA/DOJ are not the problem with Cannabis legalization on a federal level or even Scheduling of Cannabis.  The real problem is with HHS, FDA, NIDA and other “Medical” organizations that continue to feed DEA/DOJ faulty information.

While I’m not going to say that the DEA doesn’t want to have Cannabis in Schedule I for ease of prosecution, they are not to blame for failed Petitions.  The problem is in the petition process.  First the DEA is required to ask the FDA, NIH for a recommendation.  Well they both ask NIDA to give them the information and everyone knows that NIDA is opposed to Cannabis.

NIDA provides FDA and NIH with information about Cannabis and all it’s “Hazards”.  Rather than do a real investigation like it’s own PubMed and other resources it barfs up NIDA information and gives it to the DEA.

DEA then takes that information and says sorry not going to change anything.

There is also the fact that the petitions in the past 6-7 years have been faulty in their filing and haven’t been really challenged in court.

HIA has offered DEA resistance and met with success.  ASA is currently suing the DEA for it’s compliance with the little known “INFORMATION QUALITY ACT”.  This requires agencies to provide Quality Information when they give it out.  Frankly NIH, NIDA and any other agency that has information opposing Cannabis should be challenged.

If your not following on social media NIH, FDA, and NIDA then you should be:

FDA https://www.facebook.com/FDA/

NIDA https://www.facebook.com/NIDANIH/

NIH https://www.facebook.com/nih.gov/

USDA https://www.facebook.com/USDA/

Cannabis Extract Opens New Door

Everyone is talking about how terrible it was of the DEA to create a number for Cannabis Extracts.  Well there is an upside to the situation.

All the attention is being made to the single mention of CBD being made a Schedule I substance.  Nothing is further from the truth, CBD is not a scheduled substance by the federal government.  NO Cannabinoid, with exception to THC, is a controlled substance according to the federal government.

What has been missed by everyone is the DEA’s statement about CBD extracted from the Cannabis Plant.  That they see no way for it to be extracted without extracting other Cannabinoids like THC which is a scheduled substance.   So there is no change in the stance of the DEA, there has actually been clarification that mixtures of CBD that contain THC and are extracted from the cannabis plants are extracts, those without are not.

What people have been missing is the opportunity to petition the DEA to De-schedule Extracts.  As extracts now have their own ID number they can be scheduled differently than Cannabis just as THC is scheduled differently.

The science is clear and evident that Extracts are by far safer than raw cannabis.  It’s easier to maintain dosage and test lots.  You can take a ton of cannabis and create and extract, test that batch for purity and level of cannabinoids and have a uniform product.  Unlike a plant which changes from plant to plant, even if cloned, extracts offer uniformity which is what the FDA likes.

Extracts make sense and it makes sense to De-schedule them or Re-schedule them into another schedule like THC has.

DEA and Marijuana Extract Means.. NOTHING

On Dec 14th the DEA announced a new drug code for “Marijuana Extract” and there has been a lot of furor over the decision.  For those that have read the CSA and understand the meaning of the definition of “Marijuana” it already meant:

The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Prior to this announcement everything other than THC, which already has it’s own drug code, all other Cannabinoids were classified under the Marijuana Code.  What this does is separate out for purposes of clerical and data collection a difference between raw Cannabis plant material and Extractions made from the plant.

NOTHING has changed, no substance scheduling has changed, no laws have been changed.

So what does it really mean?  What it really means is that now the extracts that researchers have been getting from the Mississippi Farm now have a separate code.  This allows the DEA, FDA, HHS, NIDA to track what kind of research is being done.  Is it whole plant or an extract that is being used.

Frankly it wouldn’t be a bad idea to put each cannabinoid it’s own drug code.  This could do two things.  First it would track what research is being done with what cannabinoids.  It could also lead to many more cannabinoids being put into different schedules like THC is in a different schedule.  One by one move the cannabinoids to other schedules and you less reason to keep the whole plant scheduled in schedule I

 

Social Media and Cannabis

Everyone knows that you can follow all kinds of groups, organizations and such that are in favor of Cannabis but are you using social media to it’s full extent?  What about all those Representatives in Congress?  How about the FDA, Department of Justice, NIDA, NIH, and countless others?

It’s easy to follow them and depending on who they are they may send out lots of information or very little.  In any case it gives you an opportunity like we saw in a recent FDA post about Opiate addiction.

fda-faceHere the FDA is talking about the Surgeon General and the national Opiate Epidemic sweeping the United States.

This gives more than one person an opportunity to confront the FDA about the medical use of cannabis.  Present information that the use of opiates is down in states that have legalized cannabis.

Surprisingly the FDA responded to at least one of the comments with a link to their website.  Interestingly enough the information the FDA provides on it’s website link is both wrong and also opens new questions.

Are you using your use of Social media like Facebook to keep yourself informed and also have an opportunity to present information to the millions of people who also follow these groups?

Then there are your representatives both locally and federally.  All of them have Facebook Pages.  Follow them, look for opportunities to make intelligent comments that deal with Cannabis.  You would be surprised the number of opportunities you can have to not only educate your representatives but also those who are also following them.

This tactic also works great with Call in Radio programs, which is frankly where we got the idea.  Our founder used to call into one Talk Radio program so often he had his own theme music.  He looked for opportunities to be able to call into the program and turn the conversation to Cannabis.

fda-face2Social media gives you another opportunity to educate people about Cannabis.  Get out there and like pages of those who represent you and also the agencies that regulate you and get an opportunity to express your voice about Cannabis.

 

PTSD Clinical Trials Recruiting

clinicalEugene Applebaum College of Pharmacy and Health Sciences is currently recruiting patients for a Therapeutic Cannabinoid Research program for treatment of PTSD.

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.
This study which has been waiting to start since Feb of 2014 is currently recruiting patients.  You can find more information on how you qualify, and who to contact at the following link.  This link takes you to ClinicalTrials.Gov a site not affiliated in any many with us.

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Therapeutic Cannabinoid Research

 

Mission of the FDA and Cannabis

FDAIs the FDA meeting it’s stated mission?  When it comes to Cannabis, and other medications, it would seem not.

The stated mission of the FDA is:

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Protecting the Public Health by assuring the safety, efficacy of drugs and devices.

When it comes to Cannabis they are not assuring that what is being sold is safe.  It’s been found that the cannabis sold in CO, WA and OR have had issues with mold, heavy metals, and non-organic grown cannabis making it’s way to the market.  If the FDA was doing it’s job it would be demanding the DEA re-schedule cannabis so that they can control production.

fda-otcAdvancing the public health

Again when it comes to Cannabis they are not advancing public health.  In fact they are actually hindering the public health by not allowing it to be monitored or even determining what needs to be monitored.

Speed Innovations that make medications more effective, safer, and more affordable.

Again they are failing.  It’s been well documented that in states where Cannabis medications are allowed the use of other medications have been reduced.  In most instances these medications are not as effective, not as safe or as affordable than Cannabis.  The research that has already been done, showing safety, shows that a variety of products are not being sped to market.

fda-safeHelping the Public get Information they need

They seem ready to promote new drugs made from chemical processes but when it comes to herbal items like Cannabis they fail.  Instead all you really hear from the FDA is when there is a problem with an approved medication.  Even “safe” over the counter medications the FDA is failing to protect the public.

It’s time for the FDA to turn itself around and become the organization it was meant to be.

The first step is to put then FDA in charge of the Controlled Substance Schedules.  Why the DOJ is in charge of what substances are on the various schedules simply doesn’t make sense from any aspect.  Having the DOJ enforce the substance laws makes sense, but why are they the ones to schedule a substance, is it logical?  Wouldn’t it make greater sense for a properly run FDA to be in charge of scheduling substances?  They are supposed to have all the information or are able to research and determine the information for substances that might be used as either a medication or as a food.  Doesn’t that make the FDA the logical people to determine if a substance can be sold and distributed?

The second step would be for the FDA to then approve Cannabis to be sold in the United States under the CSA.  Under the CSA there already is in place a registration process for manufacturers of substances including Cannabis.  It’s how so many pharmaceutical companies, the Mississippi Farm, the University of MN do research.  There is nothing in the CSA that says substances on Schedule I can’t be manufactured, distributed, it simply says there needs to be controled so that it doesn’t end up in the illicit market.  By licensing those, in states that allow it, to register and document what they produced and where it went would allow for recalls and other things that would benefit the consumer.

Let’s face it with 60-65% of the United States saying that we should legalize cannabis it’s time to change the system.  The FDA could make public sales controlled and the products safer for consumers which is what their mission is.