Showing posts with label Edibles. Show all posts
Showing posts with label Edibles. Show all posts

Tuesday, November 9, 2021

Testimony to the NJ Cannabis Regulatory Commission 11-9-21


Testimony to the New Jersey Cannabis Regulatory Commission

By: Ken Wolski, RN, MPA

Executive Director, Coalition for Medical Marijuana--New Jersey, Inc.

November 9, 2021

The Commission is interested in hearing the Coalition’s thoughts on the following:

1. How can the Commission best protect public health while allowing for a greater variety of cannabis items?
2. How can food safety requirements work together with cannabis safety regulations?
3. What forms of edibles should or should not be permitted?
4. Are some edibles appropriate for the medicinal cannabis market and not the recreational cannabis market?
5. What important information should consumers and patients be aware of if they are interested in purchasing edible cannabis items?

1. The CRC can best protect public health while allowing for a greater variety of cannabis items by doing exactly what it is doing now--developing regulations for edible cannabis items including the: 

⦁ Production; 
⦁ Testing; 
⦁ Labeling; 
⦁ Packaging; and,
⦁ Distribution of these items.

This will ensure that cannabis items are safely produced, periodically tested for cannabinoid content and contaminants, accurately labeled because of these tests, securely packaged with appropriate warnings, and distributed to adults from licensed vendors. 

The CRC should quickly adopt Dosing and Administration guidelines and promulgate these guidelines to the cannabis consuming community and the healthcare community in order to increase the safety and appropriate use of edible products. In fact, the “Jake Honig Compassionate Use Medical Cannabis Act" was signed into law over two years ago, requiring these guidelines that have yet to be adopted in New Jersey: 
     “g.    The commission shall establish, by regulation, curricula for health care practitioners…:
     (1)   The curriculum for health care practitioners shall be designed to assist practitioners in counseling patients with regard to the quantity, dosing, and administration of medical cannabis as shall be appropriate to treat the patient’s qualifying medical condition.  Health care practitioners shall complete the curriculum as a condition of authorizing patients for the medical use of cannabis.”

Educational programs on the Endocannabinoid System for medical providers in New Jersey (now including physicians, Advanced Practice Nurses, and Physician Assistants) are required. Dosing and Administration guidelines and Endocannabinoid educational programs are readily available. 

For example, a company called “Cannabis Expertise” offers 2-hour and 4-hour Medical Cannabis educational courses with nationally accredited AMA credits at https://cannabisexpertise.com/. These modules were the basis for healthcare professionals to be certified as recommenders in the states of Ohio and Pennsylvania. The organization trained healthcare professionals from 38 states and 9 countries. The dosing recommendations in the training have been developed by physicians who kept track of every patient’s profile and reaction to cannabis.

The New Jersey Department of Health’s Executive Order 6 Report on 3/23/2018: 

DEVELOPMENT OF PROVIDER EDUCATION PROGRAM AND DOSING GUIDELINES With the expansion of authorized debilitating conditions, the Department recognizes the need to provide education and guidance to providers. To that end, the Department is exploring the creation of an education program for all physicians, with focus on the endocannabinoid system. The Department plans to leverage the expertise of the Medicinal Marijuana Review Panel to oversee the curriculum development for this program. This education program will serve to create best practices for the safe and effective administration of medicinal marijuana to the expanded universe of qualifying patients. In conjunction with the provider education program, there is also a need to develop standardized dosing and administrative protocols for medicinal marijuana products, including information on expected effects, side effects, and adverse effects. In addition to the provider education component above, the Department will charge the Medicinal Marijuana Review Panel, in an advisory role, to oversee the study of the efficacy of medicinal marijuana in treating New Jersey Medicinal Marijuana Program patients. This research will inform dosing and administration protocols to create best practices and improve health outcomes for qualifying patients. The Department believes that this refocusing of the Medicinal Marijuana Review Panel will make the best use of the expertise that the Panel provides to create best practices to inform health care providers and improve health outcomes for qualifying patients. https://www.state.nj.us/health/medicalmarijuana/documents/EO6Report_Final.pdf

Marijuana is mainstream medicine. The Medical Cannabis program in New Jersey is expanding rapidly, and the adult use industry will soon expose even more residents to the therapeutic benefits of cannabis. As more and more people experience these benefits, health care professionals in the state must become comfortable incorporating cannabis use into the therapeutic regimens of their patients. This can be done most efficiently by requiring education on the Endocannabinoid System for all health care professionals in the state of New Jersey as a condition for continued licensure in the state.

The Jake Honig Act also called for “Institutional caregivers” in the state. These caregivers are employees of a health care facility who are authorized to assist registered qualifying patients, who are patients or residents of the facility, with the medical use of cannabis, including obtaining medical cannabis and assisting these patients with the administration of medical cannabis. Currently, most health care facilities forbid the use of medical cannabis in the facility. This is a dangerous and potentially fatal situation. A patient who suffers from seizures may be admitted to a health care facility and then denied access to the only medicine that controls their seizures--medical cannabis. I was part of a team that tried unsuccessfully to save a patient in Status Epilepticus, an unrelenting seizure condition, at Trenton Psychiatric Hospital in the early 1970’s. It was a tragic experience that I have never forgotten. It should not happen again.

In addition to the expanding medical cannabis program and the anticipated increase in cannabis users through the adult use program, it is my sincere hope that the state will recognize its responsibility to the institutionalized patients in New Jersey. For 25 years, I have worked as a registered nurse (RN) in the state prison system and at a state psychiatric hospital. I know that many patients in these institutions qualify for medical cannabis and could benefit greatly from it. The staff there is already trained to administer, account for, and evaluate the effect of controlled substances. There is no reason to withhold this important medical therapy from these patients. In fact, courts have determined that inmates are entitled to “community standards” of healthcare. Edible medical cannabis products will improve health care in state institutions, group homes, hospices, etc., and will reduce the costs of running these programs.

2. Cannabis safety regulations must work in conjunction with food safety requirements to ensure consumer safety in using edible cannabis products. 

According to the NJ Department of Health: 
A person or entity that engages in the production, distribution, and/or sale of food to consumers shall:
1. Have a Cottage Food Operator Permit; or
2. Comply with applicable laws to retail food establishments.

The Food Innovation Center at Rutgers University supports established early-stage entrepreneurs and existing food companies from concept to commercialization. For more information, see: https://foodinnovation.rutgers.edu/

Additionally, the sale of edible cannabis products should require a license from the CRC to ensure compliance with production, testing, labeling, packaging, and distribution regulations.

3. Any form of edibles should be permitted as long as the regulatory procedures are followed in terms of their safe production, periodic testing, accurate labelling, secure packaging, and appropriate distribution. There should be no arbitrary exclusions placed on cannabis products.

Marijuana therapy is highly individualized. The amount that is used each day is determined by what is necessary to control the symptoms of the patient. Anything that patients need should be available to them. This includes a wide variety of edible products. 

Edibles are especially important for patients. Some patients simply cannot use inhaled types of cannabis either because of their medical conditions, or because of their living conditions.

The State of New Jersey has determined that cannabis has medically beneficial uses. It needs to be liberally available to those who are suffering due to lack of access to it. 

Dietary restrictions should also be taken into consideration for edible items. For example, sugarless products should be available (and not necessarily with a "sugar-free" sweetener alternative). Vegan products and hypoallergenic dietary edibles should also be available.

Public health and public safety can be improved by making the widest possible variety of products, including all potencies, legally available to patients who require them. This will diminish reliance on the unregulated market.

4. Edible products that are appropriate for the medicinal cannabis market are also appropriate for the recreational cannabis market.

Public safety can be improved not by banning edibles and other high potency products from the adult use markets, but by regulating the use of these products.

These are products that many New Jersey residents already want and use for their health and happiness. 

Many so-called recreational, or adult users experience medical benefit from cannabis products for undiagnosed or untreated conditions. Patients without health insurance may not be able to afford access to most American health care, including psychiatric care. Other patients may be on the spectrum of some disorder—Anxiety, PTSD, etc.--that negatively impacts the quality of their lives but does not rise to the level of a diagnosable condition. These patients know that cannabis can improve their quality of life, without them technically being considered medical marijuana patients. 

Edible and other high potency products are already in common use in the state. To ban them only recreates the very marijuana prohibition that voters overwhelmingly rejected in the November 2020 election.

To deter the unregulated market, the legal market should have all the products the black market does. Ideally, NJ residents should have access to the whole plant, full spectrum concentrates, the leaves, roots, and raw cannabinoids, all of which are used medicinally.

5. Important information that consumers and patients should be aware of when purchasing edible cannabis items include: 
⦁ Total dosage of THC per package; 
⦁ Strength of THC per unit dosage; 
⦁ Special dietary contents if included (e.g., sugar-free, vegan, hypoallergenic); 
⦁ Expiration date and storage recommendations; and,
⦁ Warning that the package contains cannabis (See https://www.dfcr.org/universal-cannabis-symbol); 

Thank you for the opportunity to address this commission. I would like to congratulate the CRC for the mission that it has taken on, to create this new cannabis industry in the state with social justice at its core. I want to acknowledge the progress you have made in fulfilling this mission and note that you are doing all this while managing the Medical Cannabis Program.

Having worked in NJ state government for 25 years, I am aware of some of the challenges that you face.

I would also like to congratulate Phil Murphy on his reelection as governor of New Jersey. I'm confident that we can look forward to four more years of continued cannabis reform in this state, and that means a great deal to me and to all the people in New Jersey.

Ken Wolski, RN, MPA

Executive Director, Coalition for Medical Marijuana--New Jersey, Inc.

219 Woodside Ave., Trenton, NJ 08618

609.394.2137 www.cmmnj.org

http://cmmnj.blogspot.com/

November 9, 2021


Tuesday, June 1, 2021

Testimony to the New Jersey Cannabis Regulatory Commission June 1, 2021


 Testimony to the New Jersey Cannabis Regulatory Commission

June 1, 2021

What non-oil-based concentrates and edible products would make medical cannabis easier to take, more effective, and more accessible?  Should similar products be available to recreational users?

How would new product types—particularly those with high potency—impact public health and safety?

What products would make medical cannabis easier to take, more effective, and more accessible?

Edible products were approved for New Jersey’s Medicinal Marijuana Program (NJ MMP) patients during the Christie administration, but for minors only(!) Edible products were approved for all NJ MMP patients during the Murphy administration but have never become available through the Alternative Treatment Centers (ATCs). Only lozenges are currently available for sublingual use. Patients and caregivers have been forced to create their own edible cannabis products from the flower purchased at the ATCs. Alternately, edible products are also available on the unregulated black market. 

To assist patients and caregivers, the Coalition for Medical Marijuana--New Jersey, Inc. (CMMNJ) produced the “Patient Handbook 2015” that contained easy to follow recipes, with photos, that were submitted by three CMMNJ Board members. These recipes included “Making brownies—How to prepare edibles with consistent amounts of THC,” “Cannabis butter: Crockpot small batch cannabutter,” and, “Butter and…salad dressing?” 

CMMNJ also produced a 28-minute YouTube video, “CMMNJ TV with Amanda Hoffman.” CMMNJ Board member Hoffman demonstrated the process for making edible forms of cannabis. The video is available at: https://www.youtube.com/watch?v=NApjPNDAyyo

Marijuana therapy is highly individualized. The amount that is used each day is determined by what is necessary to control the symptoms of the patient.

New marijuana types have the potential to improve public health and safety. Safety can be addressed by doing exactly what the CRC is now doing—appropriately regulating the production, testing, labeling, packaging, and distribution of cannabis products, including high potency products. 

Any edible, inhaled or topical product of any strength should be allowed as long as it is properly produced, tested, labelled and packaged. 

CMMNJ endorses the labeling recommendations of Doctors for Cannabis Regulation (DFCR). These recommendations can be found at “Setting the Standard for Cannabis Labeling” https://dfcr.org/labeling

Edibles are especially important for patients. Some patients simply cannot use inhaled types of cannabis either because of their medical conditions, or because of their surroundings, or because of their living conditions such as at health care facilities. Other patients may have a cultural prejudice against the inhalation method of drug administration (“No drug is smoked!”)

High potency edibles get a bad reputation when an inexperienced user tries them. Patients must be made aware of the delayed onset of action of edible products along with the prolonged duration of effect compared to the inhaled method of administration. Otherwise, these patients may inadvertently consume more than is necessary for symptom control and become over sedated.  The good news is that no overdose of cannabis has ever produced a fatal result. Dosage levels, generally in 10 mg portions of edible products, should be clearly labelled. Patients who are new to this type of therapy should be instructed to “start low and go slow” with their dosage titration.

On the other hand, patients with high tolerances, or patients with severe medical conditions, or multiple medical conditions, or terminal medical conditions, may need more potent edibles. When tolerance is high, patients may need 50mg or more to feel the desired effects.

In addition, some patients use a combination of edible products for their long-lasting effects while using inhaled cannabis for breakthrough pain or other noxious symptoms. Some patients may need a consistent bioavailability of cannabinoids that can most readily be achieved by edible products. 

Anything that patients need should be available to them. This includes a wide variety of edible products. 

Marijuana is legal and the State of New Jersey has determined that it has medically beneficial uses. It needs to be liberally available to those who are suffering, and who need it, in the widest possible array of products.

The CRC must be flexible in providing approvals as patients, medical personnel or advocacy groups bring issues to it. The CRC is encouraged to provide liberal authorizations as it develops the required regulations, as opposed to the overly restrictive regulations that were adopted for the MMP during the Christie administration.

With concentrates, medical marijuana should be tested more frequently, ideally after each harvest to allay patient concerns about contaminants.

Patients are also looking for Full Extract Cannabis Oil (FECO), suppositories, and sugar-free edibles.

Public health can be improved by making the widest possible variety of products, including all potencies, legally available to patients who require them. 

Should similar products be available to recreational users?

Yes. Public safety can be improved not by banning edibles and other high potency products from the adult use markets, but by regulating the use of these products.

These are products that many New Jersey residents already want and use for their health and happiness. Many so-called recreational, or adult users experience medical benefit from cannabis products for undiagnosed or untreated medical, mental health, or emotional conditions. Patients without health insurance may not be able to afford access to most American health care, including psychiatric care. Other patients may be on the spectrum of some disorder—Anxiety, Bipolar, PTSD, etc.--that negatively impacts the quality of their lives but does not rise to the level of a diagnosable condition. These patients know that cannabis can improve their quality of life, without technically being considered medical marijuana patients. 

Edible and other high potency products are already in common use in the state. To ban them only recreates the very marijuana prohibition that voters overwhelmingly rejected in the November 2020 election.

To deter the unregulated market, the legal market should have all the products the black market does. Ideally, NJ residents should have access to the whole plant, full spectrum concentrates, the leaves, roots, and raw cannabinoids, which are all medicinal.

Of course, as with flower products, the CRC should ensure that such products are sufficiently available to patients before being made available to the adult use market. 

How do high potency types of marijuana impact public health and safety?

Marijuana has been used throughout the world for thousands of years. It was in the U.S. Pharmacopeia for almost 100 years before it was banned. It was not banned for medical or scientific reasons. It was banned after a campaign of misinformation. 

In the 1930’s prohibitionists associated marijuana with insanity, criminality and death. In the 1960’s prohibitionists said that marijuana damaged the immune system and made men grow female breasts. In the 1990’s prohibitionists said marijuana was 10 times stronger than the marijuana of the 1960’s and that now it was REALLY dangerous. (Meanwhile, they would not allow you to have the weaker stuff, either.) 

Now prohibitionists are saying there are new dangers associated with high potency marijuana, including mental illness. This is one of the most studied of all cannabis issues, going back to the 19th Century India Hemp Drug Commission report. That report, and most subsequent reports, found no causal connection between marijuana use and mental illness. Just think about it. The rates of schizophrenia in the adult population are stable at about 2% worldwide. The rate is the same in countries like Canada, that has one of the highest percentages of marijuana users, and countries like Japan that has one of the lowest percentages of marijuana users. Moreover, the rate of mental illness was the same in the U.S. before and after the 1960’s when there was an explosion of marijuana use.

It is true that marijuana can precipitate a psychotic episode in a person who is predisposed to mental illness. But so can alcohol and other substances and events in the person’s life. That is not the same thing as being a cause of mental illness.

No, the reality is that marijuana can help many people who suffer from mental illness. That is why there is an increased rate of marijuana use in this population. I am an RN, and I worked in psychiatric hospitals for over five years. It is no surprise to me that patients with mental illness seek out alternatives to currently prescribed anti-psychotic drugs that are often ineffective, often have undesirable side effects, and are often expensive to boot.

Much of the marijuana of today has greatly increased potency when compared to the marijuana of the 1960’s. However, it is a groundless fear that there are new risks associated with this stronger marijuana. 

I know from personal experience that the East and West coasts of the United States were saturated with high-grade marijuana by the late 1960’s. (I attended colleges and universities in California and New Jersey from 1967 through 1976 and during that time I earned three undergraduate degrees—Associate in Arts, Bachelor of Arts, and Associate in Applied Science.) 

On college campuses, there was Columbian Gold, Panama Red, Thai Sticks, various Jamaican strains, and high-grade Mexican marijuana from the state of Michoacán, to name just a few, that were the equal in THC potency to many of the strains available today. 

In addition, there was a wide variety of hashish (hash) on the campuses. Hash was available from Morocco, Lebanon, and Afghanistan. Hash, which is a collection of the resin of the cannabis (marijuana) plant, typically had a THC content of 15% - 20% which made it stronger than most of the marijuana that was available then and equal to some of the stronger marijuana available now. 

Hash was desirable precisely because of its potency. A supply of hash would last longer than a supply of marijuana because less was required to produce the desired effect. Also, fewer toxins were introduced into the body because less smoking was required. 

A commonly observed phenomenon in the 1960’s was, “Good pot drives out bad pot.” That is, when marijuana of superior quality was introduced in an area, the more inferior marijuana was less sought after and hence became less available. The same is true today. 

The explosion of sophisticated cultivation techniques has greatly increased the potency and variety of homegrown marijuana. Now, U.S. homegrown is the equal to any of the legendary international strains of the late 1960’s. This represents progress and the maturity of the U.S. marijuana market. It does not represent the introduction of a new product or a new threat. 

With legalization and regulation of marijuana, consumers can have available to them products that are laboratory tested with accurately labeled contents, including cannabinoids and terpenes. Consumers will know exactly what strength they are getting in order to use the substance more safely.

I am also including a brief from the U.S. Cannabis Council on “THC Cap and Ban.” The USCC says capping and banning cannabis products:

⦁ Is not supported by scientific consensus as effective public health policy;

⦁ Have been unanimously rejected by states and state regulators;

⦁ Have negative unintended consequences in criminal justice reform;

⦁ Are pharmaceutically and therapeutically undesirable; and,

⦁ Decrease public safety and increase harms.

Thank you for the opportunity to address this commission.


Ken Wolski, RN, MPA

Executive Director

Coalition for Medical Marijuana--New Jersey, Inc.

219 Woodside Ave.

Trenton, NJ 08618

609.394.2137

www.cmmnj.org

http://cmmnj.blogspot.com/


CMMNJ TV, process for making edible forms of cannabis, with Amanda Hoffman https://www.youtube.com/watch?v=NApjPNDAyyo 

Doctors for Cannabis Regulation, “Setting the Standard for Cannabis Labeling” https://dfcr.org/labeling/

U.S. Cannabis Council “THC Cap-and-Ban Policy Brief” http://www.uscannabiscouncil.org/