Click here to see the first issue of Cannabis Patient Care

Cannabis Patient Care

How can cannabis enterprise resource planning software help organize your data?

Integrated Data in Cannabis ERP: From Greenhouse to Production

Cannabis Science and Technology®, Cannabis Patient Care™,

The Tragedy Assistance Program for Survivors

 (TAPS) today announced the Veterans Day webcast raised $1548 to support the families of America’s fallen military heroes.

“We are so grateful for the opportunity to raise awareness and money for families who have lost loved ones during military service,” said Mike Hennessy Jr., president and CEO of MJH Life Sciences™, the parent company of 

. “The services TAPS offers to the families of our nation’s fallen heroes are truly life-changing, and we thank our partners, sponsors and, most importantly, our readers, who participated in our Veterans Day webcast and honored our country's servicemen and women for their endless service and sacrifice.”

aunched its first issue this November focused on how veterans are using medical cannabis to treat post-traumatic stress disorder (PTSD). To complement the publication launch, 

 hosted a free Veterans Day webinar titled, 

“From Post-Traumatic Stress to Post-Traumatic Growth: How Medical Cannabis Is Helping Veterans with PTSD.”

Findings from the 2019 Veterans Health and Medical Cannabis Study were presented by 

, with a highlight of veterans who report that cannabis is helpful for treating PTSD. The webcast also featured a special panel discussion organized by veteran and advocate 

 with a group of veterans from across the country who shared their unique experiences with medical cannabis.

"With the holidays approaching, our military families need the support and services TAPS provides,” said Katie Maness, senior adviser and director of development at TAPS.org. “We are so grateful for the support of 

 and the opportunity to share our mission at their event, ‘From Post-Traumatic Stress to Post-Traumatic Growth: How Medical Cannabis Is Helping Veterans with PTSD.’”

 and to register for the on-demand webinar click 

® is a multimedia platform that focuses on educating the legal cannabis industry about the science and technology of analytical testing, quality control, extraction and cultivation. The magazine is accompanied by an online component that provides relevant information and tutorials for all members of the cannabis industry.

 magazine is an educational resource for patients, doctors, nurses, pharmacists, and caregivers on the latest research, benefits, and treatment options cannabis provides for a variety of illnesses. Each issue of the publication will focus on a specific disease or ailment that cannabis has been shown to be an effective remedy for. The brand will cover the current research, patient testimonials, medical perspectives and advocacy work. Our mission is to educate the medical community on the viable treatment options patients are experiencing with cannabis and the ongoing research into cannabis and cannabinoids worldwide. 

™, the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels.

The Tragedy Assistance Program for Survivors (TAPS) is the leading national organization providing compassionate care and survivor support services for the families of America’s fallen military heroes. Since 1994, TAPS has offered support to more than 90,000 survivors of fallen military in the form of peer-based emotional support, grief and trauma resources, grief seminars and retreats for adults, Good Grief Camps for children, casework assistance, connections to community-based care, online and in-person support groups and a 24/7 resource and information helpline for all who have been profoundly affected by a death of a military loved one. Services are provided free of charge. For more information go to 

 or call the toll-free TAPS resource and information helpline at 1.800.959.TAPS (8277).

Articles

The proceeds raised from the special Veterans Day webcast will help support the families of America's fallen military heroes.

Cannabis Science and Technology® and Cannabis Patient Care™ Raised More Than $1,500 for The Tragedy Assistance Program for Survivors (TAPS)

In a recent press release (1), Foxx Life Sciences announced that their custom single-use systems (SUS) company will be opening their new international Asia headquarters in Medchal, Hyderabad, India. With this new location, Foxx will bring continued expansion of biopharmaceutical manufacturing to the region.

"Foxx is proud to expand in Asia to offer innovative products to the Indian and Asian markets,” said Vikram Mahapatra, vice president of Foxx Life Sciences (1). “We are happy to be committed to providing our customers with high-quality products with exceptional global customer service.”

Foxx Life Sciences will maintain its initiative to invest in the strong demand growth forecasted in the India and Asia markets for Foxx Custom (SUT), which is specifically designed to support biopharmaceutical and bioprocess companies.

Following the addition of Foxx Life Sciences new facility, they launched a new website, 

, regarding product knowledge and online purchasing of their products for Asia customers.

"Foxx is recognized as the bridge to India in the USA" stated Thomas Taylor, President and CEO.

The new headquarters will also include warehouse inventory and manufacturing for the Asian-Pacific region.

https://www.prnewswire.com/news-releases/foxx-life-sciences-announces-opening-of-new-asia-headquarters-in-india-301173886.html

Foxx Life Sciences announce new Asia headquarters in India.

Foxx Life Sciences Adds New Asia Headquarters in India

BUCHI Corporation has announced a new expansion into Spain, with the establishment of BUCHI Ibérica S.L. in Barcelona. According to the company, direct and close customer support has always been a focus of theirs so they wanted to expand their direct distribution network to cover the Spanish market. The new organization will build on the 25 years of experience their current exclusive distributor, Massó Analítica S.A., has built up. BUCHI plans for a smooth transition, with their team from Massó Analítica transitioning to the new BUCHI market organization.

The new organization will be in place January 1, 2021, and will take over all current projects and activities related to BUCHI products and services from Massó Analítica S.A.

Recently the BUCHI Corporation announced a new expansion into Spain, with the establishment of BUCHI Ibérica S.L. in Barcelona.

BUCHI Announces New Location in Spain

® is excited to announce a new sister publication, 

, dedicated to medical cannabis coverage.

 will focus on a single disease or ailment for which medical cannabis has proven effective for treating and provide research, patient stories and insights from medical professionals to further educate the medical cannabis community.

® has established itself as a thought leader in the cannabis industry by delivering accurate and relevant scientific information to the community,” said Mike Hennessy Jr., president and CEO of MJH Life Sciences™, the parent company of 

®. “As we strive to grow that brand, we continue to look for opportunities to educate the cannabis community in new ways, and 

 will be the next chapter in our success by educating health care providers and improving patients’ lives.”

 focuses on veterans using medical cannabis to treat post-traumatic stress disorder (PTSD). It was created in partnership with 

 president of Cannabis Center of Excellence, INC.; 

, founder and CEO of Joint Venture & Co.; and 

, veteran, cannabis patient and advocate — who together conducted the 2019 Veterans Health and Medical Cannabis Study to raise awareness and help change policy surrounding veteran access to medical cannabis in Massachusetts.

™, McNabb highlights some of their data and insights, Brum details her story as an advocate for veteran access and Mandile shares his personal story as a veteran patient. The issue also features an interview with 

, the director of Marijuana Investigations for Neuroscientific Discovery (MIND) at McLean Hospital who's been studying the impact of cannabis on the brain for more than two decades, as well as conversations with a hospice nurse who works with veterans, a Veterans Affairs caregiver and a veteran advocate.

“This research study examined the use of medical cannabis among U.S. military veterans and found cannabis is most commonly used to address PTSD, chronic pain, anxiety, and depression,” said McNabb. “In our sample, 76% of veterans report actively using cannabis to replace or reduce the use of over the counter or prescription medications. Given the self-reported benefits of using medical cannabis among veterans, further inquiry into the benefits and risks of use for specific health conditions and symptoms should be prioritized.”

 will host a free Veterans Day webinar on Nov. 11 at 11 a.m. EST titled, 

 For more information and to register for the webinar, click 

 will donate a portion of its first-edition proceeds to 

, a national nonprofit 501(c)3 veterans service organization that provides comfort, care and resources to all those grieving the death of a military loved one. To donate, visit 

® is a multimedia platform that focuses on educating the legal cannabis industry about the science and technology of analytical testing, quality control, extraction and cultivation. The magazine is accompanied by an online component that provides relevant information and tutorials for all members of the cannabis industry. 

 (CCOE, INC.) is a registered 501c3 non-profit organization based in Massachusetts that conducts citizen-science focused population studies and programs in the areas of community engagement, medical cannabis, adult-use cannabis, and social justice in the cannabis industry. The CCOE serves as a virtual resource and network of cannabis industry professionals, academics, policy makers, healthcare providers, consumers, and patients who aim to break the stigma and advance social justice in the cannabis industry.

 is a New England growth agency helping cannabis and wellness brands intentionally expand their audience and exceed the expectations of growing demand.

Cannabis Patient Care™ will launch in November with a first-issue focus on how medical cannabis is helping veterans with PTSD

Cannabis Science and Technology® Launches New Dedicated Medical Cannabis Sister Brand

The Association of Official Agricultural Chemists (AOAC International) recently announced their new initiative to develop technical requirements, evaluate, and certify the performance of test kits that calculate total yeast and mold organisms in cannabis flower (1).

This new project will apply the Emergency Response Validation option of the AOAC Research Institute’s Performance Tested Methods (PTM) and AOAC International’s Official Methods of Analysis (OMA) programs with oversite from the Cannabis Analytical Science Program (CASP) advisory council. CASP reportedly brings together leaders from state and federal government, industry, academia, and contract laboratories to develop consensus-based standards and scientific methods for cannabis microbiological and chemical analysis (2).

For this joint program, it will allow for the rapid development of emergency Standard Method Performance RequirementsSM (SMPRs) through CASP to provide acceptance criteria for method validation while also conducting an evaluation and review of multiple test kit models in parallel through the PTM and OMA Programs to ramp up the availability and variety of certified test kits.

Yeasts and molds are able to grow in a large variety or environmental conditions, which can result in contamination of products and significant economic loss. With the absence of a federal framework of regulations for cannabis, states have been individually developing microbial testing requirements and setting action limits for approving or rejecting batches. According to the press release, most states have set action levels at one of two concentrations for total yeast and mold analysis: < 103 or 104 CFU/g (1). Between 10–20% of cannabis batches are estimated to fail these microbial contaminant requirements (3). Recent surveys of cannabis products were able to determine the presence of more than 4000 different fungal taxonomic classifications in cannabis flower, which included several pathogenic fungal agents.

Regulators with states have requested that testing facilities use AOAC validated methods to ensure safer products reach consumers. Currently, there are no AOAC certified methods for mold and yeast enumeration in cannabis products available. With this new endeavor, the main goal will be to create an emergency SMPR while also concurrently performing a matric extension to cannabis flower for PTM or OMA certified yeast and mold methods or be able to grant an Emergency Response PTM status for new methods.

The project began in mid-October 2020. Regulators, method developers, and cannabis or hemp laboratories interested in becoming a part of CASP or wanting to submit a method as part of the validation study are highly encouraged to get involved.

For more information about submitting a method or becoming involved in CASP, contact Scott Coates at 

https://www.aoac.org/news/aoac-international-activates-accelerated-program-to-evaluate-test-kits-that-measure-yeast-and-mold-in-cannabis/

https://www.einnews.com/pr_news/527233190/aoac-international-announces-accelerated-program-to-evaluate-test-kits-that-measure-yeast-and-mold-in-cannabis

https://drive.google.com/file/d/1rCWw9AquV9Pr1STMbv8dySrU6L2wJHfI/view

The Association of Official Agricultural Chemists (AOAC International) announced their new project to develop technical requirements, evaluate, and certify the performance of test kits that calculate total yeast and mold organisms in cannabis flower.

AOAC International Launches Accelerated Program Evaluating Test Kits that Measure Yeast and Mold in Cannabis

A recent study from the Dental College of Georgia (DCG) (Augusta, Georgia) and the Medical College of Georgia (Augusta, Georgia) produced results showing that cannabidiol (CBD), a non-psychoactive cannabinoid found in cannabis, reduces damage in the lungs spurred by cytokine storms caused by coronavirus (COVID-19) (1). In an earlier study (2), the researchers illustrated that CBD can reduce inflammation and physical lung damage associated with adult respiratory distress syndrome (ARDS), along with improved oxygen levels. The new study revealed the mechanisms behind these earlier results, exhibiting that CBD normalizes levels of apelin, a peptide known to reduce inflammation. During a COVID-19 infection, levels of the apelin peptide are low. Results of this study have been published in the 

Journal of Cellular and Molecular Medicine

In the authors ARDS model, blood levels of apelin (a crucial piece in regulation, bringing both blood pressure and inflammation down) had dropped close to zero and increased 20 times with CBD. In the instance that blood pressure gets too high, apelin levels rise up to help alleviate the pressure. It is assumed that apelin should also help normalize inflammation in the lungs and other related breathing difficulties linked to ARDS. “Ideally with ARDS it would increase in areas of the lungs where it’s needed to improve blood and oxygen flow to compensate and to protect,” said Dr. Babak Baban, DCG immunologist (1). In their ARDS model, apelin did neither of these. When CBD was administered, apelin increased.

Although with their current study, the authors reiterated that much more is still being studied and there is some animosity in regard to whether CBD or COVID-19 have a direct effect on apelin but they are continuing on their mission to find out. “It is an association; we don’t know yet about causative, but it is a very good indicator of the disease,” Baban said (1). What they have found so far is that the reductions in apelin could potentially be an early biomarker for ARDS and response to treatment efforts.

Based on their earlier study, the authors mentioned that the data supported the idea that the anti-inflammatory function of CBD may assist in reducing cytokine storm and mitigate the effects of exaggerated inflammation (2). Further adding that, “considering all potential regulatory effects of CBD as well as the vast distribution of endocannabinoid system in the body, it is plausible that CBD may be used as a therapeutic candidate in the treatment of various inflammatory conditions including COVID-19 and other virus-induced ARDS.”

Expanding from the researchers’ newest study, the next steps for their research would be to comprise a stronger understanding of the interactions between apelin, CBD, and COVID-19 as well as studying why apelin decreases during COVID-19 infections and how CBD increases those numbers. They will explore how eliminating apelin affects ARDS and if CBD is able to produce the same lung benefit without the peptide. It is assumed that COVID-19 suppresses some sort of reaction that then suppresses apelin and CBD interferes with this process. Nonetheless, the authors doubt the apelin-CBD interaction is the only means by which the compound works in this or other scenarios.

Moving forward with their studies, the authors have refined a safe, relatively inexpensive model of ARDS by giving a synthetic analogue of double-stranded ribonucleic acid (RNA) called POLY (I:C). COVID-19 has double-stranded RNA, while human deoxyribonucleic acid (DNA) is single-stranded. The researchers’ model propagated a response similar to the virus, along with the extreme lung damage and cytokine storm, reflecting an overactive immune response in the lungs.

Gathering data for these studies, a control group received intranasal saline consecutively for three days while the COVID-19 model received POLY (I:C) intranasally for three days. Then there was a third group, known as the “treatment group,” who received POLY (I:C) and CBD over the same timeframe. The results produced significantly reduced apelin levels in the mice who had developed COVID-19-like symptoms compared to controls, and treatment with CBD normalized the immune response, apelin levels, oxygen levels, swelling, and scarring in the lungs.

CBD has shown itself to be a natural apelin agonist. Apelin levels are consistently measurable in the lungs, which is one of the reasons it proves to be a good biomarker. Aside from CBD, other cannabinoids, such as tetrahydrocannabinol (THC), are proving themselves beneficial in the fight against COVID-19 by decreasing the risk of cytokine storms, ARDS, and mortality (4,5). With future research, cannabis may prove itself useful in strengthening the side of those battling the virus and others fighting to rid the world of COVID-19.

https://www.healtheuropa.eu/cbd-reduces-covid-19-lung-damage-with-protective-peptides/103374/#:~:text=In%20a%20new%20study%2C%20scientists,levels%20of%20a%20natural%20peptide

https://www.cannabissciencetech.com/view/evidence-grows-for-cbd-as-potential-covid-19-treatment

https://onlinelibrary.wiley.com/journal/15824934

https://www.cannabissciencetech.com/view/a-storm-of-research-activity-into-cannabis-and-coronavirus-a-closer-look-at-expanding-research-of-cannabinoids-and-terpenes-in-covid-19

https://www.cannabissciencetech.com/view/treating-immunocompromised-patients-during-the-covid-19-pandemic-a-conversation-with-dr-bonni-goldstein

The Dental College of Georgia (DCG) and the Medical College of Georgia, recently performed a study which produced results showing that cannabidiol (CBD), a non-psychoactive cannabinoid found in cannabis, reduces damage in the lungs spurred by cytokine storms caused by coronavirus (COVID-19).

COVID-19 Lung Inflammation Reduced by CBD

The cannabis plant was used as a medicinal herb for thousands of years before its prohibition in the 20th century. As legalization for cannabis and hemp has spread across the US and globe since 1996, medical professionals are left to fill in the gaps of knowledge with their patients on its use. For instance, cannabidiol (CBD) is hailed as a treatment option for many conditions but many doctors are not taught about it or the endocannabinoid system in medical school. Dr. Junella Chin, the Founder of MedLeaf RX and the Chief Medical Advisor for 

 (1), recently spoke to us about the beneficial aspects CBD and how the medical field is beginning to incorporate the concept of medical cannabis into patient treatments.


What inspired you to pursue CBD as a treatment option for your patients?

 As a teenager, I was diagnosed with ankylosing spondylitis (AS), a progressive type of arthritis that affects the spine, pelvis, hips, and back and causes extreme stiffness and nerve pain. 

I spent my younger years trying conventional treatments— epidurals, narcotics, muscle relaxants, acupuncture, physical therapy—but the pain was unrelenting. By the time I got to medical school in San Francisco, I was having difficulty standing for long periods in the operating room. One of the attending physicians saw this and asked me about it. I told him I had AS but that I couldn't take the meds I needed for relief while doing rounds or while attending a four-hour hip-replacement surgery because they made me drowsy and foggy.

Here, I was in a hospital surrounded by great medical minds, but I was disheartened to find nothing could help my condition. The attending physician and my mentor Dr. Levine pulled me aside and handed me a bottle containing a tincture. "This is marijuana," he told me, "but it won't make you high."

He didn't call it CBD oil. He just said it was a different type of cannabis plant. I was mortified but desperate. As a medical student, training to be a doctor, my first thought was, "You are offering me pot? You want to make me a drug addict?" I grew up in the Bronx, where there was a huge social stigma around marijuana. Kids that smoked weed were either the dropouts or involved in gangs. I also grew up in a very traditional Chinese household. My parents believed in “Reefer Madness”—that weed would led to psychosis and schizophrenia.

The little brown dropper bottle Dr. Levine handed me smelled like a combination of alcohol, wet dog, and grass, and I didn't know what to think. To my amazement, the tincture worked very well. The pain and inflammation of my arthritis decreased dramatically, my AS stopped progressing, and my health improved.

Even though California legalized medical cannabis in 1996, I didn't dare tell anyone I was using it. I was a young physician and didn't want to jeopardize my career. But once I got my health back, I decided to learn more about cannabis and how it helps manage pain and improve people's overall health and wellness.

Having suffered in pain for so long, I know what it feels like to say to your doctor, "I've tried everything, and nothing has helped."

I have been helping patients integrate medical cannabis into their health and wellness for more than a decade. Cannabis changed the trajectory of my life. I would not have been able to finish medical school and become a doctor had it not been for cannabis treatment. I had an educational advantage in doing my medical school training in California. California legalized medical cannabis in 1996. I was in the middle of a switch box and was able to engineer my circumstances to learn holistic and integrative cannabis medicine.

Do you face any scrutiny or stigma from other medical professionals for using medical cannabis or CBD as a treatment option?

 In medical school, there is a "this is how we've always done it" syndrome. That is the conventional, allopathic medicine model. How did we come to believe that prescription medication is the only or most effective way to treat disease? We are taking a reductive approach. In medical school, we are trained in identifying what's bad in your body and then to get rid of it. This is only part of the puzzle. We often get locked into this one-size-fits-all thinking. There is no one-size-fits-all when it comes to working with plant medicine like cannabis. Botanical remedies have been mainstays of folk medicine in many cultures throughout history. Phytocannabinoid medicine is on that list. We also have to remember there are synergistic effects of the complex compounds found in plants. When we try to isolate one of those molecular compounds and take its’ pure form, not only may you not get all the benefits, but you increase risk by taking them out of context.

What resources do doctors and other medical professionals have to learn more about cannabis as a treatment option?

 Unfortunately, there are very little resources since it’s still not taught in medical schools.

What benefits have you seen with CBD in your patients?

 Over the last 15 years, my medical cannabis career has been based on anecdotal and clinically applied evidence. I help patients integrate medical cannabis in the context of a full-scope general and holistic medical practice. CBD is an empowering medicine. The cannabis plant is unique. There is no precedent, no other drug in the world that we are using recreationally and medicinally for therapeutic uses. The historical record of safe use is unparalleled.

The endocannabinoid system (ECS) modulates and interfaces with all of the other systems throughout your body. It regulates physical functions, such as movement, pain sensation, immune responses, and cognitive or mental capacities, such as perception, mood, and memory. The ECS naturally produces cannabinoid-like molecules that stimulate the body's endocannabinoid receptors. These receptors are in the brain, muscles, and fat (adipose tissue). There is a galaxy of cannabinoid receptors in the digestive system.

How does CBD affect the way the brain processes emotional memories (for example, in patients suffering from PTSD and other psychiatric disorders)?

 Anxiety, stress, and chronic sleep deprivation all inhibit Gamma-Aminobutyric acid (GABA), a naturally occurring brain chemical that directs neurons to slow down or stop firing. This neurotransmitter also helps to induce sleep, relax muscles, and calm us down. In essence, GABA directs the body to chill out. 

Cannabis modulates GABA, helping return the body to its more normal functions. Careful dosing may help stem the racing thoughts that cause disrupted sleep and panicked awakenings during the night. It can also be used to treat what are called “parasomnias,” sleep disorders such as jaw grinding, sleepwalking, or nightmares.

The “cannabis molecules” produced by your own body (endogenous cannabinoids) make you resistant to stress, similar to the way endorphins provide natural relief from pain. Integrating optimally-dosed cannabis products can help bring the body back into balance.

 (2). CBD directs the brain to activate the parasympathetic nervous system, which induces a state of calm. It works well for social anxiety and everyday stress, plus more extreme forms of anxiety such as panic attacks. 

 (3) showed it even “reduced anxiety in public speakers” so if you’re gearing up for that online TED Talk, take note!

How do the different state regulations the US impact your work? For instance, is it more difficult to treat patients in New York compared to California?

 Every state has its own medical cannabis laws that we have to adhere to as MDs. I have not found it more challenging to practice in New York versus California.

Do you feel that CBD may become more sought out and the future for treating not only neurological disorders but other ailments as well? Have you studied any other cannabinoids?

 At last count, the cannabis plant contains more than 500 chemical compounds, many of them only in trace amounts. We need more research, but the research needs to focus on the fundamental understanding of what is going on with the whole plant and not selecting out individual molecules like we know what we are doing. Again, we are looking at this field from a "disease-target-kill model." Allopathic medicine takes the reductive approach. We are separating disease into its parts, element by element, component, and subpart, and then using drugs to attack these separate targets. CBD is part of a whole plant. There's a whole universe of regenerative medicine, nutritional medicine, preventative, and integrative medicine. Cannabinoid science and the push for cannabis legalization is teaching us a vital lesson. It is reframing our thinking about medicine and healthcare. It also raises some of the most critical questions about how we think about medicine in the future. 

What would you like to see change in medical cannabis regulations in the United States?

 I think we needed a guide to cannabis and CBD a while ago—it almost feels like we are racing to keep up with the explosion in popularity of CBD in particular and nobody understands what it is, how to use it, or even what they are actually getting. As states legalize and as the federal government is trying to figure out what a "legal CBD market" looks like, the general public is caught in the middle with very little quality information about cannabis. 

For example, most people don't realize that CBD comes from the cannabis plant, it is a chemical compound extracted from the

 plant. In the US, the CBD we can "legally" purchase is defined as coming from "industrial hemp," however, the hemp plant is 

, it is just a cultivated variation of the plant that is being farmed and used in legal medical and recreational states to produce the cannabis containing THC, another chemical compound in the cannabis plant. The main difference is that the hemp plant is a low resin plant containing very low amounts of THC.

Of course, there is, and will continue to be, stigma around cannabis. First, it is still federally illegal and most people don't realize that it isn't illegal because it is dangerous but it was made illegal for economic reasons. There were decades of deliberate propaganda that resulted in movies like "Reefer Madness" in the 1930s and the "Just Say No" campaign in the 1980s.

Fear, bigotry, and greed led to the vilification of the medicinal cannabis plant and the versatile hemp plant. It is hard to abolish decades of misinformation, not to mention the decades of criminalization of cannabis and the imprisonment of mostly people of color for possessing cannabis. As long as the plant is federally illegal and people believe the misinformation, there will still be a stigma.

Patients are looking for reliable information but there are few, trusted healthcare-provided resources. Healthcare practitioners receive little or no education regarding medical cannabis.

As doctors, we need to be capable of engaging in meaningful discussions with patients regarding the potential harms and the benefits of cannabis and safely help them manage their diseases and improve their quality of life.

I always say I'd like to see "cannabis in every medicine chest"—that it is accessible to all people who need it. But we still have a long way to go. We do have to remember that there are counter indications and cross reactions of CBD and cannabis with other prescription medications and certain health conditions. Cannabis is not a cure-all, and it works differently for each person so just because it helped their friend or neighbor with a particular ailment or condition doesn't mean it will work the same way for them.

Rescheduling of cannabis to Schedule II, III, IV, or V presupposes that there is an FDA-approved pharmaceutical that can be prescribed. That is not the case. Even with Epidiolex (CBD extract) approval for severe epilepsy in 2018, it does not carry over to other forms of CBD or cannabis in any way.

In the University of London’s study (4), what are your opinions and hopes of their findings?

 I think this UL study is promising and more research is needed. When vessels that supply blood to the brain are too clogged or damaged, this can result in a decline in cognitive function, memory loss, and difficulty making executive decisions. In addition, mobility and balance get impaired, too. Increasing blood flow to areas in the brain help to maintain cognitive faculties as we age and perhaps increasing memory in Alzheimer’s disease patients.

How does CBD increase the cerebral blood flow throughout the brain?

 The mechanism of action with respect to increase cerebral blood flow on the brain is unclear.

https://pubmed.ncbi.nlm.nih.gov/28249817/

https://pubmed.ncbi.nlm.nih.gov/21307846/

https://medicalxpress.com/news/2020-08-cannabidiol-blood-brain-hippocampus.html

Dr. Junella Chin, the Founder of MedLeaf RX and the Chief Medical Advisor for Yesterday Wellness, discusses with us the beneficial aspects CBD and how the medical field is beginning to incorporate the concept of medical cannabis into patient treatments.

Medical Cannabis and Better Patient Care: Breaking the Stigma with Science and Education

, is excited to be hosting “From Post-Traumatic Stress to Post-Traumatic Growth: How Medical Cannabis Is Helping Veterans with PTSD” webcast on Veterans Day, November 11, 2020 at 11am EST. This event will highlight how cannabis helped improve the quality of life for our veterans suffering from various mental health conditions, such as post-traumatic stress disorder (PTSD). Dr. Marion McNabb will be presenting her findings from the 2019 Veterans’ Health and Medical Cannabis Study. The research study highlights the veterans who reported that cannabis has been helpful for treating PTSD.

The event will also feature a special panel discussion organized by veteran and advocate Stephen Mandile. The panelists chiming in with their unique experiences with medical cannabis include veterans Dan Moynihan, Daniel Vela, and Hether Zeckser.

 Veterans Day event will be presented in partnership with Cannabis Center of Excellence, Cannabis Advancement Series, and Joint Venture & Co.

http://www.cannabissciencetech.com/cst_w/veterans

Cannabis Science and Technology, is thrilled to be hosting “From Post-Traumatic Stress to Post-Traumatic Growth: How Medical Cannabis Is Helping Veterans with PTSD” webcast on Veterans Day, November 11, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET.

Cannabis Science and Technology to Host Special Veterans Day Webcast

PerkinElmer, Inc., recently launched a fully automated liquid handling sample preparation and liquid chromatography–tandem mass spectrometry (LC–MS/MS) analysis workflow for pesticide residue testing of cannabis and hemp flower samples (1). This new solution reportedly includes cannabis-optimized reagents and sample prep consumables as well as proprietary cannabis standard operating procedures (SOPs) and cloud-based tracking and reporting software. According to the company’s press release (1), with this workflow, in house and contract laboratories can increase pesticide analysis throughput with improved data quality, decrease laboratory waste, reduce the likelihood of operator error, and slash sample prep times to 2 hours from 6-8 hours when performed manually.

 The fully automated liquid handling sample preparation workflow starts with an integrated micro balance that captures and conveys sample ID and weight data. After, a multi-step sample preparation procedure is executed automatically by PerkinElmer’s liquid and sample handling system, the Janus® G3 420 Workstation which conducts sample vortexing, centrifuging, filtering, and diluting. It also includes integrated barcoding and scanning. The new One Pesticide420TM Reagent Kit offers calibration and quality control reagents along with the sample preparation consumables needed for consistent implementation of the new application-dedicated SOPs. Once the sample preparation is complete, the sample is then analyzed on PerkinElmer’s QSight® 420 LC–MS/MS instrument in sync with regulation frameworks, such as California’s meticulous ISO 17025:2017 and the Bureau of Cannabis Control (BCC) pesticide regulation requirements.

 Lastly, the full sample traceability and instrument connectivity is delivered with the company’s new cloud-based SimplicityLab420TM software. With this technology, it is able to support easy batch creation and method transfer, regulation-ready reporting, integration with laboratory information management system (LIMS) systems, and remote workflow monitoring.

“On average, cannabis labs perform up to 1000 pesticide analyses per month and 60% of testing time is spent on manual sample preparation,” said Greg Sears, Vice President and General Manager, Food & Organic Mass Spectrometry, PerkinElmer (1). “By bringing together and automating all of the pieces a lab needs to tackle pesticide analysis, our new workflow solution provides a streamlined approach that helps increase productivity, compliance and consumer protection while also saving time and money.”

The innovations in cannabis testing and analysis are part of PerkinElmer’s broader safety and quality solutions for food.

https://ir.perkinelmer.com/news-releases/news-release-details/perkinelmer-launches-industry-first-fully-automated-workflow

Recently, PerkinElmer, Inc., announced a fully automated liquid handling sample preparation and liquid chromatography–tandem mass spectrometry (LC–MS/MS) analysis workflow for pesticide residue testing of cannabis and hemp flower samples.

PerkinElmer Introduces Fully Automated Workflow for Cannabis and Hemp Pesticide Residue Testing

The United States Food and Drug Administration (FDA) plans to further regulate the cannabis industry (1), specifically cannabidiol (CBD) products. These regulations will undoubtedly reflect how the FDA currently regulates pharmaceutical and nutritional supplement products. Is FDA oversight necessary? What is the current state of the industry with respect to anticipated regulations? What does FDA oversight mean for cannabis businesses and the industry as a whole? In this, the first of a two-part series, I will give my view on the need for FDA involvement in our industry, and discuss the current state of things. In Part II, to be published in the next issue, I will discuss the specifics of what FDA regulation will mean for cannabis businesses.

The Federal Food, Drug, and Cosmetics Act, passed by the United States Congress in 1938, gives the US Food and Drug Administration (FDA) the power to regulate the manufacture and sale of food, medicines, and cosmetics (2). The act was passed to protect the public from things such as dangerous patent medicines and tainted food. In essence, the FDA regulates any product that goes into or onto a human being. These products undergo greater scrutiny than others because of their potential to cause harm to us if not made properly. There is also an economic aspect to FDA regulation; people should get what they pay for.

The regulatory goal for the manufacture of medicines is that they be “safe and effective” (2). The first burden, safety, is always the minimum standard, part of the “above all else do no harm” idea enshrined in the Hippocratic Oath (3). The second burden, efficacy, is defined as (4): “Capacity for producing a desired result or effect.” This simply means that the drug must treat the disease for which it is being used.

The FDA has already approved the use of a cannabidiol (CBD)-based medicine called Epidiolex for treatment of certain types of epilepsy (5). This cannabis medicine is one of the first to undergo the rigors of the FDA’s drug approval process and come out the other side with the stamp of approval. This is the best proof yet that cannabis truly is medicine.

The challenge we face now is there's one CBD medicine with FDA approval, but thousands of companies are selling CBD containing products without FDA approval. This situation is—to the best of my knowledge—unprecedented; that an active pharmaceutical ingredient is made available to the general public before FDA approval. In a sense then, the horse is out of the barn. How does the FDA go about regulating an industry that has sprinted ahead of it in terms of product development and sales?

Is FDA Regulation of the Cannabis Industry Necessary?

At the Federal level, cannabis products with 0.3 weight percent or less total tetrahydrocannabinol (THC) are legal, but anything above this is illegal (6,7). States such as California and Colorado have full legalization of cannabis, other states allow some cannabis products but not others, and still others ban all cannabis products (8). This means there are numerous, overlapping, and competing sets of regulations the cannabis industry must comply with. This uneven regulatory landscape is a financial and logistical burden for cannabis businesses, particularly ones doing business in multiple states. An argument for FDA regulation is that with one overarching regulatory body there will hopefully be only one set of regulations all cannabis businesses must abide by, reducing the time and cost needed to comply with those regulations, hopefully boosting profitability.

I have been a longtime advocate that cannabis is medicine and that it should be tested like medicine (9). FDA regulation will require more and better testing at all steps in the cannabis product supply chain. My own work consulting with extractors has shown that implementation of in-house testing and quality control programs, though not necessarily cheap, reaps big benefits by increasing the control and understanding of manufacturing processes so more product can be made with less input, maximizing safety, quality, productivity, and profits. Believe or not, more regulation can lead to bigger not smaller profits.

What is the current state of industry compliance with potential FDA regulations?

I have been involved in the cannabis industry since it first became legal in Colorado in 2014. I have developed cannabis testing methods, sold equipment to cannabis businesses, worked as a laboratory director for an extractor, and now consult for cannabis businesses. I have visited dozens of cannabis businesses across the country including farms, extractors, and dispensaries. My firsthand observation is that the current state of the industry's compliance with potential FDA regulations is mixed at best.

I have seen cannabis businesses that are familiar with FDA regulations and are making a good faith effort to abide by these rules. But I have also seen true horror stories. I see people jumping into growing cannabis with no idea what strains to grow, how to prepare the soil, manage pests, or know when to harvest. I have seen extractors with no process control programs in place who have no understanding of what they are making, how they made it, and are unable to make the same thing twice. I see dispensaries selling products with completely different potency than claimed on the label (10). I see sectors of the industry refuse to listen to any arguments for the expansion of in-house testing and other regulations. I have had cannabis company executives say to me with a straight face that, “We don’t need to do in-house testing, the state takes care of that for us.”

One reason the FDA is taking a closer look at our industry is the extent of the product mislabeling problem. A recent report the FDA sent to the US Congress found a disturbing number of CBD products contain significantly less CBD than stated on their label, and some contained no CBD at all (11). This problem has been previously documented (12). This means cannabis patients are not getting the correct dose of medicine.

What would happen if something like this occurred in the pharmaceutical industry? Imagine the Dewey, Cheatham, and Howe (13) pharmaceutical company sold 100,000 antibiotic tablets that contained no antibiotic. Doctors would prescribe these pills in good faith, but their patients would not get better, instead getting sicker or possibly die since they are not receiving any medicine. Once it was discovered the pills were fake, imagine the bad press and billions of dollars in lawsuits that would be filed. The company would probably be shut down, and company executives may go to jail. We as a society do not tolerate this situation, which is why the FDA exists. And yet every day cannabis patients are taking medicine with the wrong dose of CBD in it. This threatens the health of our most important asset, our customers, and damages the credibility of our industry. The extent of this problem indicates to me that the current regulatory regime is not working. FDA regulation would standardize manufacture, testing, and labeling of cannabis products and would go a long way towards solving the mislabeling problem.

Besides the public health threat from mislabeling, there’s the economic threat as well. When people buy mislabeled CBD products they are not getting what they are paying for. If you bought a carton of milk at the grocery store and found upon getting it home it was half full would you be happy? Of course not. You would march right back to the grocery store with the offending carton in hand and ask for a refund. If this situation occurred regularly the grocery store may start losing customers. And yet people are buying CBD products with less than the stated potency on a regular basis. If we don’t tolerate this type of rip off in our own lives, why do we tolerate it in our industry? Since the current regulatory regime has failed to solve this problem, I believe oversight by the FDA is needed.

Another problem the FDA can help with is inter-laboratory error. This is the well documented problem where third party cannabis laboratories obtain significantly different results on the same samples (14–16). There are a number of causes for this problem including lack of standard analytical methods, lack of standard reference materials, and lack of training (15). At the moment, individual states are tasked with licensing third party cannabis laboratories, and many of these laboratories are certified by the International Standards Organization (ISO). This level of regulation is not working. In a study by myself and others published in this journal (14), distillate samples sent to five different state licensed, ISO certified laboratories returned THC values from 77% to 94%. This is unacceptable. FDA oversight will help with this problem by implementing the development of standard methods, standard reference materials, and training regimens.

There are numerous organizations working on developing standard cannabis analysis methods, including the American Herbal Products Association (AHPA) (17), American Society for Testing Materials (18), AOAC International (19), the United States Pharmacopeia (USP) (20), and the National Institutes of Standards and Technology (NIST) (21). The work of these organizations is important, and I admire them for doing it. A problem I forsee is with so many organizations involved a number of different standard methods may be developed. From draft methods I have seen I find differences in proposed methods between these groups. We really need one agreed upon analytical method, or some kind of oversight to harmonize these methods with each other. The FDA can do that for us.

What Level of Regulation is Needed: Medicine or Dietary Supplement?

There are two levels of FDA regulation that cannabis products could be placed under—medicines or dietary supplements. Both types of regulation are stringent, but medicines must jump over a higher regulatory bar than dietary supplements to get to market. So, which of these levels of regulation are appropriate for the cannabis industry?

For decades, a large part of the justification for cannabis legalization is that it is medicine. I believe a reason the general public who are not recreational cannabis users have bought into cannabis legalization is that we believe it is medicine and that people should have access to the medicinal benefits of cannabis. If we are going to claim cannabis is a medicine we must be consistent and ask that it be regulated like medicine.

There are people in this industry trying to push for cannabis to be regulated as a dietary supplement. From an economic point of view that makes sense, it will be cheaper and easier to abide by dietary supplement regulations than medicinal ones. However, the main argument for cannabis legalization was that it is a medicine. We cannot now argue that cannabis is not a medicine, but a dietary supplement. If the general public is to believe we are a legitimate industry, we must give them a clear message as to why cannabis should be legal. Going back on what we said to gain legalization will not help our cause.

It is in everyone’s best interest to maintain as positive a public image as possible for the cannabis industry. The problems I have discussed above all damage our industry's reputation, resulting in lost sales and roadblocks to further legalization. The American public will not get behind us unless we can convince them that we can, as an industry, provide them with safe and effective medicines on a consistent basis. The current regulatory regime is clearly not giving us this outcome. FDA regulation will help the cannabis industry do a better job of making medicines and improve our public image, which will lead to a growing and prospering industry. FDA regulation is the right and profitable thing to do.

https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act

https://en.wikipedia.org/wiki/Hippocratic_Oath

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

115th United States Congress, Senate Bill S.2667,” Hemp Farming Act of 2018.

https://www.federalregister.gov/documents/2019/10/31/2019-23749/establishment-of-a-domestic-hemp-production-program

https://www.businessinsider.com/legal-marijuana-states-2018-1

https://hempindustrydaily.com/wp-content/uploads/2020/07/CBD-Marketplace-Sampling_RTC_FY20_Final.pdf

M.O. Bonn-Miller, M.J.E. Loflin, B.F. Thomas, J.P. Marcu, T. Hyke, and R. Vandrey, 

Journal of the American Medical Association

https://en.wikipedia.org/wiki/Dewey,_Cheatem_%26_Howe

https://www.aoac.org/scientific-solutions/casp/

https://www.usp.org/sites/default/files/usp/document/about/public-policy/2019-07-05-comment-from-usp-cannabis.pdf

https://www.nist.gov/programs-projects/nist-tools-cannabis-laboratory-quality-assurance

, is Founder, CEO, and Chief Technical Officer of Big Sur Scientific. He is the inventor of the BSS series of patented mid-infrared based cannabis analyzers. Dr. Smith has done pioneering research and published numerous peer-reviewed papers on the application of mid-infrared spectroscopy to cannabis analysis, and sits on the editorial board of 

. He has worked as a lab director for a cannabis extractor, as an analytical chemist for Waters Associates and PerkinElmer, and as an analytical instrument salesperson. He has more than 30 years of experience in chemical analysis and has written three books on the subject. Dr. Smith earned his PhD on physical chemistry from Dartmouth College.

What does FDA oversight mean for cannabis businesses and the industry as a whole?

Featured Content

Cannabis Patient Care

Integrated Data in Cannabis ERP: From Greenhouse to Production