Research
If there’s one thing holding cannabis nonbelievers back from the realm of acceptance, it’s the lack of research. In-vivo, observational studies measuring the impact of cannabis. Unfortunately, due to the current label of cannabis as a Schedule 1 Drug by the Drug Enforcement Agency, finding research studies supporting cannabis as medicine is easier said than done.
But the research is out there for those willing to find it.
With the help of Florida patients and Strainprint, MÜV has gained invaluable insights regarding cannabis as medicine – and the use of specific products for specific symptoms.
The Strainprint App – By Patients, For Patients
Stephanie Karasick had tried everything to help with her depression and anxiety and, after years of struggling with traditional pharmaceuticals, decided to explore alternative medicine in the form of medical cannabis. A week into this new path, Karasick noticed her uptick in mood – and that strains affected her differently. She took detailed notes of how she felt before and after medicating, how many doses it took of the product to achieve the desired effect, and how long the effects lasted.
After journaling and dialing in her own routine, Karasick had a thought – if I can track every step I take with a smart watch, why isn’t there a solution for tracking my medical cannabis sessions?
Karasick took this question and, with the help of passionate data experts, developed Strainprint, the first medical cannabis journaling app created by patients, for patients.
Upon signup of the app, patients indicate the ailment they have and the symptoms tied to that ailment. Tracking a medicating session with cannabis products is as simple as tapping buttons within the app, with the beauty of tracking resulting in efficacies for symptom management.
1. Indicate the symptom(s) they are seeking to ease
2. Indicate the severity of symptom(s) on a scale of 1-10
3. Select the MÜV strain/product being used (populated from “My Products”)
4. Record the dosage used (1 puff of vape, 1 dropper of tincture, etc.)
5. After 20 minutes (or more, depending on method of onsumption), the app notifies the patient to record their symptom level post-medicating.
The change in the symptom from before and after medicating is calculated as the product’s efficacy for that specific symptom. While patients can view their personal efficacies from tracked sessions, an average efficacy is calculated for all symptoms. An average efficacy, too, is calculated for products by averaging the outcomes of all patients that tracked a specific product for a specific symptom.
Strainprint gives patients the power to take control of their symptom management; to identify the products that work best for their individual needs. The app takes these insights a step further, as the anonymized data is shared throughout the platform, guiding patients make informed decisions on the best products to add to their routine.
MÜV & Strainprint: Revolutionizing Florida Medical Cannabis
MÜV saw the immense value in this platform. The app was added into the robust toolset utilized at the dispensaries in October of 2020. In the past year, 7,300 MÜV Patients enrolled with Strainprint and have recorded 49,000 medical cannabis tracking sessions.
“The partnership with MÜV is one that we at Strainprint highly value,” said Andrew Mulnoff, Co-Founder and Chief Executive Officer at Strainprint. “Their commitment to furthering their understanding of strains and products to improve the health and wellness of their patients is palpable, and their patient base interaction with the app is a true testament to this.”
These patients are lovingly referred to as Patient Pioneers, Florida medical cannabis patients who are pioneers in self-reported cannabis research. MÜV Patient Pioneers are helping to gather real data about medical cannabis for symptom management through the Strain Assessment Program, and are rewarded with discounts upon completing 5 tracked sessions of an eligible strain or product.
With their help, MÜV has made great strides in recommending products to patients.
MÜV Cannabis And Mental Health: The Data
Anxiety, depression, stress and other mental disorders are arguably pervasive issues in America. In fact, the Anxiety and Depression Association of America reports 40 million adults suffer from anxiety, depression, and stress each year.
Cannabis has shown to be efficacious in quelling several mood disorders, and according to MÜV Patients, several products have been adept at easing symptoms*:
Anxiety (47% average efficacy across all cannabis data)
Cherry Punch Flower: 60% efficacious
Püre Maui Wowie Cartridge: 59% efficacious
Depression (51% average efficacy across all cannabis data)
Püre Maui Wowie Cartridge: 71% efficacious
Durban Dream Flower: 61% efficacious
Stress (55% average efficacy across all cannabis data)
London Pound Mints Flower: 60% efficacious
Slurricane Flower: 68% efficacious
*Patient-reported data as of December 2021
MÜV Cannabis And Pain Management: The Data
Chronic pain, too, is highly prevalent in the United States. The CDC puts estimates at 11-40% of the U.S. population, and is often linked to mental health conditions. The current estimates of efficacies of cannabis for pain management are highly promising, particularly due to its minimal side effects when compared to opioids.
MÜV Patients have confirmed what early research has shown*:
Upper Back Pain (50% average efficacy across all cannabis data)
Püre Canna-Tsu Cartridge: 68% efficacious
Strawberry Cough Flower: 56% efficacious
Joint Pain (49% average efficacy across all cannabis data)
Wana Strawberry Lemonade 1:1 Soft Chews: 65% efficacious
Wana Watermelon Hybrid Soft Chews: 67% efficacious
Headache (54% average efficacy across all cannabis data)
Guru Flower: 71% efficacious
Ice Cream Cake Flower: 65% efficacious
*Patient-reported data as of December 2021
MÜV Cannabis And Insomnia: The Data
Insomnia is a symptom that can be brought about by a host of underlying issues, such as pain, or occur on its own. Short-term insomnia is prevalent in the U.S., reported by approximately 30% of Americans, according to the Sleep Association, and 10% of Americans experiencing chronic insomnia. Thankfully, cannabis has shown to ease the sleep issue. At MÜV, these strains and products include*:
Insomnia (53% average efficacy across all cannabis data)
Püre Blueberry Cartridge: 75% efficacious
THC EnCaps: 73% efficacious
*Patient-reported data as of December 2021
Mood disorders, pain, and insomnia are not all that is tracked within Strainprint. Patients can track up to three symptoms per medicating session, ranging from appetite issues to insomnia, seizures to bladder issues, allowing patients to truly customize their medicating experience. Of course, MÜV is not alone in seeing the value in this app.
Strainprint In Peer-Reviewed Studies
Strainprint data has been leveraged in several peer-reviewed research studies, a true testament to the app itself. These studies include:
• Short- and Long-term Effects of Cannabis on Headache and Migraine, published in the Journal of Pain. Washington State University researchers examined a total of 19,000 Strainprint self-reported medicating sessions. Researchers found that cannabis reduced headaches and migraines by 50%.
• Short- and Long-term Effects of Cannabis on Symptoms of Post-Traumatic Stress Disorder, published in the Journal of Affective Disorders. Researchers at Washington State University and the University of Pennsylvania Perleman School of Medicine analyzed over 11,500 tracked sessions recorded in the Strainprint app and found patients reported an average of 67% reduction in irritability, 62% reduction in intrusive thoughts, and 57% reduction in anxiety, and 51% reduction in flashbacks.
• Acute Effects of Cannabis on Symptoms of Obsessive-Compulsive Disorder, published in the Journal of Affective Disorders. Researchers at Washington State University examined the effects of cannabis on symptoms of OCD, finding that inhaling cannabis reduced intrusive thoughts by 49% and compulsions by 60%.
This peer-reviewed research confirms what anecdotal evidence has claimed – that cannabis holds therapeutic value. Thanks to the Strainprint app, patients that track, and researchers, the results further support the calls for double-blind, placebo-controlled studies on the plant.
Be The Research
The partnership between MÜV and Strainprint has furthered our knowledge of the plant as medicine in Florida, leading to helpful and data-backed recommendations to further well-being. Each day we inch closer to a wide acceptance of cannabis because of apps like Strainprint and the knowledge they bring forth.
This knowledge, however, would truly not be possible without our Patient Pioneers. Thank you for being pioneers in cannabis research, confirming the anecdotal stories, and for helping other patients like you in their own journeys with cannabis.
The commitment to diversity, equity and inclusion continues to be a focal point for many across the country considering the tragic events that have marred American history and recently sparked a wave of activism across minority groups striving for change. While change has many faces, the change facing Florida’s marijuana market comes through releasing the Black Farmer License Application. Although many believe Florida doesn’t go far enough to move its marijuana market towards equitable ownership, the long-awaited process of issuing a Medical Marijuana Treatment Center License (MMTC) is a small step in the right direction.
On October 14, 2021, the Florida Department of Health’s Office of Medical Marijuana Use (“OMMU”) released Emergency Rule 64ER21-16, titled, Application for Pigford/BFL MMTC Licensure. The release of this Rule has been over 4 years in the making and paves the way for class members of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999) and In re Black Farmers Litigation, 856 F. Supp. 2d 1 (D.D.C. 2011) to apply for a coveted Medical Marijuana Treatment Center License, which some regard as one of the country’s most sought-after cannabis licenses. The Rule also comes with a 70-page application instruction form and 18-page application-evaluator instructions and manual. Additionally, on December 2, 2021, OMMU also released Emergency Rule 64ER21-10, titled, Application Window for the Pigford/BFL Batching Cycle. The release of this Rule establishes that the batching cycle opens on Monday, March 21, 2022, at 9:00 a.m. and closes on Friday, March 25, 2022, at 5:00 p.m.
Although Florida is heading in the right direction, the impact of injustice the Pigford and In re Black Farmers Litigation class members suffered from by the USDA’s failed efforts to investigate and resolve discrimination complaints still lives on today. For example, farms run by African Americans make up less than 2% of all of the nation’s farms today, and over the course of the 20th century, black farmers have lost over 20 million acres of farmland in total. That’s largely in part due to the decades of racial violence and unfair lending and land ownership policies.
In 1997 and 1998, two class-action lawsuits entitled Pigford v. Glickman (“Pigford”) and Brewington v. Glickman (“Brewington”), respectively, were filed on behalf of groups of African American farmers. Those lawsuits asserted that the U.S. Department of Agriculture (“USDA”) had systematically discriminated against African American farmers based on race, in violation of the Fifth Amendment to the United States Constitution, the Equal Credit Opportunity Act, Title VI of the Civil Rights Act, and the Administrative Procedure Act.
More than 60,000 people sought to enter Pigford but filed too late and were not permitted into the case.[1] Two statutory provisions made In re Black Farmers possible. First, in 2008 Congress permitted claimants in Pigford who did not receive a determination on the merits to bring a new civil action.[2] This provision, which was part of the 2008 Farm Bill, also provided $100 million of funding for these claims.[3] In 2010, Congress provided an additional $1.15 billion to fund an agreement reached between the plaintiffs and the government earlier that year.[4]
The history of the two class action cases plays a pivotal part in Florida’s Medical Marijuana Treatment Center (MMTC) licensure. To submit applications for licensure as an MMTC, applicants must provide documentation establishing that the applicant is a Pigford member or BFL member.
The release of these Emergency Rules by OMMU provides a glimpse into how the state will likely handle an upcoming batch of applications, which overall will almost double the number of the state’s cannabis operators. However, this process will undoubtedly be stiffened with litigation, so much so that in its most recent preliminary budget request, The Florida Department of Health sought nearly $13 million to more than double OMMU’s current 80-person staff to 165 employees to handle what it anticipates will be a dramatic surge in state medical marijuana sales in the coming years and of that $2.15 million would be used for litigation-related expenses.
There is little doubt Florida will issue more licenses; the question remains how soon. For more information on Florida’s licensing rollout, contact the author Vijay Choksi at vchoksi@foxrothschild.com
[1] Settlement Agreement, In re Black Farmers Discrimination Litig. No. 08-MC-0511 (D.C.C. 2011).
[2] Food, Conservation, and Energy Act of 2008, H.R. 2419,
110th Cong. § 14012(b) (2008).
More than 120,000 pounds of hemp fiber was needed to rig the 44-gun USS Constitution, America’s oldest Navy ship affectionately called “Old Ironsides.”
Nearly 55 tons of fiber was needed for the lines and rigging on that USS Constitution alone. Even more hemp fiber went into making canvas for sails and caulking for the wooden hull.
Where did all of that hemp fiber come from? It came from the cannabis sativa fields of patriotic Revolutionary War-era farmers who originally grew the fibrous crop for the British Crown. Strong fibers formed strong nations in the pre-industrial age, and hemp was strategically important during the Revolutionary War.
Yet, hemp is no longer purposefully grown in the U.S. in any significant amount. The forgotten history of this lowly “ditch weed” – now hugely important as a food for migratory birds – reveals that hemp was an important crop from Colonial times through World War II, when it was last widely planted across the country for the war effort.
Hemp arrived in Colonial America with the Puritans in the form of seed for planting and as fiber in the lines, sails and caulking of the Mayflower. British sailing vessels were never without a store of hemp seed, and Britain’s colonies were compelled by law to grow hemp.
Hemp was the fiber of choice for maritime uses because of its natural decay resistance and its adaptability to cultivation. Each warship and merchant vessel required miles of hempen line and tons of hempen canvas, which meant the Crown’s hunger for the commodity was great. Ship captains were ordered to disseminate hemp seed widely to provide fiber wherever repairs might be needed in distant lands.
By the mid-1600s, hemp had become an important part of the economy in New England, and south to Maryland and Virginia. The Colonies produced cordage, cloth, canvas, sacks and paper from hemp during the years leading up to the Revolutionary War. Most of the fiber was then destined for British consumption, although at least some was used for domestic purposes. Ironically, the first drafts of the Declaration of Independence were penned on hemp paper.
Hemp fiber was so important to the young Republic that farmers were compelled by patriotic duty to grow it, and were allowed to pay taxes with it. George Washington grew hemp and encouraged all citizens to sow hemp widely. Thomas Jefferson bred improved hemp varieties, and invented a special brake for crushing the plant’s stems during fiber processing.
Shortly thereafter, Robert McCormick (father of Cyrus McCormick, who invented the first successful reaper) patented a hemp fiber-processing device. Through the International Harvester Co., Cyrus’ descendants later contributed additional labor-saving harvesting tools to hemp farmers in the 20th century.
Hemp crops quickly spread, and arrived in Kentucky with settlers from Virginia just prior to the Revolutionary War, according to a 1919 article in the Kentucky Agricultural Experiment Station Bulletin no. 22. These settlers set the stage for what would become one of the most important and long-standing hemp industries in America.
Along with Missouri and Illinois, Kentucky farmers produced most American hemp until the late 1800s, when demand for sailcloth and cordage began to wane as steam ships dominated the seas. By the end of the Civil War, Kentucky was the only state with a significant hemp industry until World War I, and that state remained the nation’s leading producer of hemp seed.
In 1918, virtually all stages of hemp growing and processing in the U.S. still relied on hand labor. In Nebraska, a mechanical fiber-processing machine had been tried, but the resulting fiber was not of the quality desired by the growers, so they imported laborers to process it the age-old way: by hand. In 1919, G.W. Schlichten was awarded a patent for a fiber-processing machine called a decorticator. This machine looked promising but, for unknown reasons, never went into production.
It took the directed efforts of Wisconsin State Department of Agriculture and local hemp growers like Matt Rens of Waupun to convince the International Harvester Co. and others to embrace the task of mechanizing the hemp harvest and processing.
Matt went on to build a highly successful hemp-milling business that included several plants, and contracts with Wisconsin farmers for thousands of acres of hemp. His steam-driven mills were the state-of-the-art in hemp processing through the 1950s, and one of his employees played a role in building another important hemp-processing machine that turned the stalks where they lay in the fields during the retting process.
Despite those new hemp-handling tools, which lowered production costs, the demand for high-quality domestic hemp fiber steadily declined after World War I. Kentucky still produced much of the hemp seed and Matt’s Wisconsin mills produced most of the fiber.
Ultimately, hemp’s use as a fiber crop was crippled by politics. In 1937, the federal government passed the Marijuana Tax Act, aimed at regulating the narcotic varieties of cannabis. Interestingly, this law turned over the regulation of hemp production to the Department of Revenue, which was then responsible for licensing all hemp growers.
“(The Marijuana Tax Act) didn’t really affect us as growers, other than we had to pay a small tax and sign a paper stating that we wouldn’t use the plant as a drug,” explains hemp farmer and Matt’s nephew, Junior Prange. “What really killed the hemp industry in the 1950s was the availability of cheap synthetic fibers.”
World War II brought on the final burst in American hemp-fiber production. The USDA’s Hemp for Victory campaign successfully convinced growers to again embrace hemp. The federal government consulted with Matt and embarked on an ambitious project that involved construction of many new hemp processing plants.
But before the project was fully realized, the war ended, along with demand for domestic hemp fiber. Many Midwestern towns (and farmers) were left high and dry with empty or partially constructed plants, and cancelled hemp contracts. By 1958, the last significant hemp crop in the U.S. had been harvested and processed.
Hemp has been cultivated and used for thousands of years. It was in widespread use in ancient China and Mesopotamia. Taking advantage of its sturdy fibers, ancient peoples made clothing, shoes, rope, and sailcloth. It was a key economic engine for pre and post-revolutionary America, and has even served key roles for the US military: on the deck of the USS Constitution, the oldest still-commissioned warship in the Navy, and during the “Hemp for Victory” campaign in World War II.
However, as part of the cannabis sativa family, hemp fell under the definition of “Marihuana” under the Marihuana Tax Act of 1937, 50 Stat. 551, making its cultivation and sale an economically problematic affair. When the Controlled Substances Act (CSA) made hemp a Schedule I controlled substance in 1970, there appeared to be no hope for the industry.
But after a sea change in public opinion on cannabis, and for the first time in many decades, hemp was removed from the Controlled Substances Act, 21 USC 802(16)(B)(ii), by the 2018 Farm Bill. A new statute, 7 USC 1639o, provided a detailed definition:
The term “hemp” means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.
The excitement of a “new” American cash crop, however, very quickly met harsh reality. Rulemaking at the federal level proceeded at a glacial pace, and the regulations that were promulgated (such as the testing regulations) were loudly criticized in public comments. And just when the industry felt it was starting to make some sense of the new regulations, the COVID-19 pandemic demolished fledgling businesses, disrupted business conditions, and de-prioritized hemp regulation as governments focused squarely on the public health emergency.
Hemp industry participants still face many unanswered questions in 2022: navigating changing state and international tetrahydrocannabinol (THC) standards, use of cannabidiol (CBD) in food products and supplements, and the means of getting one’s products to market are just some of them. Further, states like California have moved forward with their own laws on hemp, in response to Federal paralysis on CBD, setting up conflicts with the Federal government even as Federal legislation moves forward. 2022 could see some pivotal developments for the industry.
Perhaps the most daunting task faced by the hemp business owner is ensuring that their hemp products meet the federal standards for THC content. Although it is often said that the 2018 Farm Bill “legalized” hemp, such a conclusion is a misconception. Any “hemp” with a greater than .3% delta-9 THC concentration by dry weight is “Marihuana,” and federally illegal under the CSA—as are any products derived from those plants.
While the .3% THC standard is “old news,” the testing requirements to make that determination still generate confusion. For example, the United States Department of Agriculture’s (USDA’s) regulations technically require the use of Drug Enforcement Administration (DEA) approved laboratories to complete such testing, but due to the small number of labs currently in the program, delayed implementation of this requirement until January 1, 2023. Additionally, in promulgating their final rule, the time at which a grower must test was increased from 15 to 30 days before harvest, but many growers note that such timing still creates an undue hardship. Lastly, 7 CFR § 990.6 requires sampling of the flowering tops of the plants when those flowing tops are present. Growers, however, have expressed concern that USDA targets the most THC-rich part of the plant, and mandating testing of flowers thus artificially inflates “whole-plant” THC. To address this concern, the final regulations allow growers to request alternative testing methods—but growers must obtain pre-approval of such methods.
Moreover, legal THC standards themselves differ internationally, even as they continue to change and evolve. While the United States has embraced a .3% delta-9 THC standard in the Farm Bill, the European Union had previously authorized only a .2%. A recent vote by the European Parliament increased the authorized THC level from .2 to .3% total THC in the Common Agricultural Policy (CAP), bringing it largely in line with the United States. But as some hemp business owners noted in 2018 Farm Bill regulatory comments published on January 19, 2021, in the Federal Register, the EU’s use of total THC standards differs from computations using American delta-9 THC standards. Moreover, other hemp-producing countries (such as Uruguay in South America) have defined hemp more liberally, legalizing dry weight THC percentages as high as 1%. American hemp producers have argued that their hemp and hemp products—limited to the .3% standard—are less attractive on the international market. Lastly, the patchwork of international standards makes the import or export of hemp and hemp-derived products confusing at best and at worst could subject even the most diligent hemp business owner to a drug trafficking charge.
Much to the chagrin of the hemp industry, the FDA has moved at a snail’s pace to approve any meaningful use of CBD in food products or supplements in interstate commerce. More than two years after the passage of the 2018 Farm Bill, only hulled hemp seed, hemp seed protein powder, and hemp seed oil have been generally recognized as safe (GRAS) by FDA, which issued GRAS notices GRN 765m 771 and 778 as to each of these products. Critically, only trace amounts of naturally occurring CBD and THC are contained in these products.
The industry, along with several US states, has been getting impatient, setting up potential conflicts between the states and the federal government as states step in to fill the void. For example, on October 6, 2021, California Governor Gavin Newsom signed Assembly Bill 45 into law, which expressly recognized and regulated the use of CBD in beverages, supplements, and food products in the state. It did so by modifying California’s Health & Safety Code (§§ 111920 et seq.) and Business and Professions Code (§ 26013.2). California’s new laws do not consider products “adulterated” if they incorporate CBD and instead impose requirements on CBD-containing products such as registration with the state, rules on advertising and labeling, and taxation. California Health & Safety Code § 111921.5 also prohibits the use of industrial hemp in medical devices, prescription drugs, “processed smokable products,” and alcoholic beverages. Notably, California’s law appears to be in direct conflict with FDA’s prohibition on CBD in food products and supplements.
At the federal level, multiple bills have been introduced that could potentially remedy the issues facing the industry. Among the most significant is a bill from Senator Rand Paul (R-KY), S.1005, the HEMP act of 2021, which would change the legal definition of hemp from .3% THC by dry weight and increase it to 1% THC by dry weight. Others are aimed directly at the FDA’s inaction on CBD. HR 6134, the CBD Product Safety & Standardization Act of 2021 was introduced by a bipartisan group of representatives including Kathleen Rice (D-NY), Angie Craig (D-MN), Morgan Griffith (R-VA), and Dan Crenshaw (R-TX). That bill would require the FDA to regulate CBD as a food additive. A similar Senate bill, the Hemp Access and Consumer Safety Act, seeks to do the same thing. But as in past years, whether there is sufficient momentum to carry these bills over the finish line in 2022 is an open question.
Hemp is a multi-billion dollar industry after just three years, notwithstanding regulatory and legal uncertainty and a devastating global pandemic. The only certainty about the industry is that the regulations will continue to change and develop. Having a grasp of these evolving issues will enable the industrial hemp business owner to remain flexible and quickly adapt to the changing legal landscape.