Cannabidiol oil, also known as CBD oil, reduces the frequency and severity of seizures in children and adults with severe, intractable epilepsy, according to findings presented by researchers from the University of Alabama at Birmingham at the American Epilepsy Society 70th Annual Meeting.
UAB researchers presented eleven abstracts, or research findings, at the meeting. A key finding was that CBD provided a significant reduction in frequency of seizures for a majority of the patients in the study, and that approximately two-thirds of patients saw a greater than 50 percent reduction in severity.
"It is encouraging that both frequency and severity of seizures appear to improve in the majority of patients in our study, patients who have limited treatment options," said Jerzy P. Szaflarski, M.D., Ph.D., professor in the Department of Neurology and director of the UAB Epilepsy Center. "Our research adds to the evidence that CBD may reduce frequency of seizures, but we also found that it appears to decrease the severity of seizures, which is a new finding."
The results were based on an open-label study of 81 patients — 42 children and 39 adults — who experienced four or more seizures per month. UAB launched the studies of CBD oil as a treatment for severe, intractable seizures in April 2015. The studies, an adult study at UAB and a pediatric study at Children's of Alabama, were authorized by the Alabama Legislature in 2014 by legislation known as Carly's Law.
After one month of beginning CBD therapy, 68 percent of the patients had experienced a greater than 25 percent reduction in seizure frequency; 58 percent had a greater than 50 percent reduction; 36 percent had a greater than 75 percent reduction and 9 percent were seizure-free. Those results were maintained at three and six months.
To assess seizure severity, researchers led by Jenifer DeWolfe, M.D., associate professor of neurology, used the Chalfont Seizure Severity Scale, a questionnaire given prior to therapy and re-administered at intervals throughout treatment. Fifty-seven patients were followed for three months: 67 percent experienced a more than 50 percent decrease in seizure severity, while 33 percent did not. Of 47 patients followed for six months, 64 percent had a greater than 50 percent decrease in seizure severity and 36 percent did not.
"These are encouraging results, but it is important to note that each patient may respond differently to CBD, and the dose for optimal seizures control varies," said Martina Bebin, M.D., professor of neurology and co-primary investigator of the CBD studies. "There appears to be an optimal CBD dose range where the patient achieves maximum benefit. If outside this CBD dosing range, the seizure frequency may not improve and may even increase. More research is needed, including determining why and how CBD helps some people with epilepsy but not others."
Among the other UAB abstracts presented at the AES meetings:
CBD oil was associated with an improvement in mood, an effect independent of the extent of seizure reduction. Lead author Pongkiat Kankirawatana, M.D., professor of pediatrics, says CBD oil may have overall positive effects on mood, which should be further investigated in patients with epilepsy and other chronic conditions in controlled studies.
A study led by Szaflarski and Bebin found that the optimum dose in both children and adults was between 20 and 25 mg/kg/day.
Jane Allendorfer, M.D., assistant professor of neurology, found that CBD, in a selected group of patients with epilepsy who experienced overall improved seizure control, has the potential for positive cognitive effects that are associated with corresponding fMRI signal changes.
One abstract reports on an interaction between warfarin, a drug used as an anticoagulant, and CBD. This underscores the importance of monitoring appropriate laboratory work in patients receiving CBD oil along with other medications, according to study lead Brannon Vines, M.D., a clinical neurophysiology fellow.
Significant drug interactions were identified between CBD and commonly-used medications for epilepsy, including clobazam, rufinamide, topiramiate, zonisamide and eslicarbazepine. This study, led by neurology fellow Tyler Gaston, M.D., emphasizes the importance of monitoring anti-epilepsy drug levels during treatment with CBD.
Electrical discharges measured by EEG decreased significantly after initiation and maintenance of CBD, particularly in pediatric patients, according to a study led by Leslie Grayson, M.D., a neurology fellow.
Using fMRI imaging, Amber Gregory, a graduate student in psychology, showed that persons with epilepsy showed gains in working memory that were associated with a shift in neural recruitment as examined with functional MRI.
An abstract aimed at examining associations between social determinants of health, such as age, gender and socioeconomic factors against health status, quality of life and mood states showed that higher age and low income were associated with lower health ratings among epilepsy patients, according to study led Magdalena Szaflarski, Ph.D., assistant professor of sociology.
The studies are designed to test the safety and tolerability of CBD oil in patients with intractable seizures. CBD oil, a derivative of the cannabis plant, is delivered orally as an oily liquid.
The oil used in the studies is produced under stringent requirements of the United States Food and Drug Administration by a licensed pharmaceutical company. It contains only traces of THC, the psychoactive component of marijuana. The process developed by GW Pharmaceuticals guarantees the consistency of the product that is provided to study participants.
In 1968, the Brown and Williamson Tobacco Company circulated an internal memo among colleagues where an executive of the company stated “What we want to do this morning is to take a summary look at the smoking and health question and then make a proposal to you for a B&W project to counter the anti-cigarette forces.” He continues “Doubt is our product, it is the best means of competing with the ‘body of fact’ that exists in the mind of the general public. It is also the means of establishing a controversy”. ( read the full memo here)
Big tobacco waged a war to discredit legitimate science as part of its overall effort to create controversy and doubt.
Fast forward to 2015 and the same type of controversial campaigns are being used to sow doubt and discredit science.
Only this time the source is our government, various health organizations and electronic cigarette critics.
Painting the Target
Electronic cigarettes (E-cigarettes) come in a variety of forms but all share a universal design of being a battery-powered device that heats a solution to produce an inhalable vapor. The devices do not contain tobacco, and do not burn it. E-cigarettes release a vapor that contains none of the carcinogenic tar present in cigarette smoke.
Despite the clear indication that these devices are less harmful than tobacco cigarettes, the Centers for Disease Control (CDC) and, independently, the California Department of Public Health launched “public education” (what could be considered borderline False Light) ad campaigns aimed at derailing the future of e-cigs. The ads being released are laden with half-truths, speculation and massive spin.
As the advocates and lobbyists for the e-cig/vaping industry have begun to fire back, critics of the industry have begun making accusations of astroturfing. That includes accusations that Big Tobacco is behind the push back against California Department of Public Health with the spin campaign at notblowingsmoke.org.
Which it’s not. That site was created in just a few days by a team of volunteers headed up by Stefan Didak – a known volunteer advocate for the vaping industry with no ties to Big Tobacco.
These, and many other individuals and organizations, are painting a target in an effort to eliminate e-cigarettes. Because they do not understand it, because they stand to lose revenue generated by tobacco tax, and because they have been unable to regulate it – they seek to end it.
Their misinformation has spread into the general public, and that needs to be corrected. Below we’ve compiled a list of common misinformation spreading around the world with evidence to refute their claims.
We don’t know anything about e-cigarettes
Dr. Thomas Frieden, CDC director, openly states “There are things we don’t know about e-cigarette toxicity.” On the contrary, there is quite a bit that we do know. The eliquid and vapor contains propylene glycol (PG), a substance regards as generally safe by the FDA. It is used in toothpaste, food, cosmetics as well as asthma and inhalers. That means that the FDA has already recognized it as safe for inhaling. In fact PG was first registered by the FDA for use in hospitals as air disinfectants. (proof of that one right here)
“E-cigarettes are getting kids hooked on smoking and are a gateway to tobacco”
There is absolutely no evidence to show this. The CDC’s own data show that the percentages of adolescent children who used e-cigs at least once within 30 days tripled from 1.5% to 4.5% percent between 2011 and 2013. Conversely, during the same period there was a decline in adolescent smoking from 15.8% to 12.7%. That’s the lowest it has ever been.
E-cigarettes produce formaldehyde
This is another drum beat of fear from California’s “Still Blowing Smoke” campaign. The bogus formaldehyde scare stems from a report in the New England Journal of Medicine ( read it here). The report described what happened when researchers used two different voltage settings on a vaping device.
When they tested the product at a realistic voltage of 3.3 volts, no formaldehyde was detected. Then they tested at 5.0 volts for an extended duration (100 seconds) which resulted in formaldehyde concentrations five to 15 times higher than that measured in tobacco cigarettes.
Here’s the problem: That study was done on a machine, at unrealistic levels that no human would sustain. There is no way a living person would or could physically force themselves to inhale such acrid vapor. At that point you’re not even measuring the contents of eliquid – you’re measuring the byproduct of burning the cotton or other wicking material. That doesn’t happen with normal day to day vaping.
E-cigarettes are more harmful than real cigarettes
This is a flatly absurd statement initiated by the StillBlowingSmoke.org campaign out of California. It claims that e-cigs are more harmful than real cigarettes because (and this is a direct quote) “ they contain more particles.”
This is false because particles alone are not a measure of whether or not something is harmful. Asthma inhalers also deliver particles to the lungs. If “particles” were dangerous, we would all develop cancer by the sheer volume of particles we inhale in our day to day lives.
E-cigs leave residue on everything
This is nothing more than trivial yet somehow presented by vaping critics as a threat. The concentrations of ambient are far below biologically meaningful levels ( here’s proof for you).
E-cigarette companies are targeting children
It’s easy for lawmakers to accuse eliquid and e-cig manufacturers of targeting children with their marketing because of the flavors that are used. This “think of the children” tactic is just one more way lawmakers are trying to demonize the industry.
There’s a surprising fact for you that requires no case study or research: adults like those flavors, too. People, by nature, like things that taste good. Nothing more even needs to be said about that.
Second hand vapor is harmful
Anti‐smoking groups claim the toxins and carcinogens in electronic cigarettes can be accidentally inhaled by bystanders, just like second‐hand tobacco smoke.
One study, reported byInhalation Toxicology, a peer-review journal focused on the evaluation of health risks associated with airborne chemicals, indicated that there was “no apparent risk to human health from e-cigarette emissions based on the [e-cigarette] compounds analyzed”.
In the study’s “non-cancer’ risk analysis, all vapor samples of e-cigarette liquids revealed to be of “No Significant Risk” to human health.
A separate test was performed on tobacco cigarette smoke.
The test results comparing the concentrations of pollutants between the two products produced two very different results in measuring the health risks of each.
In the study’s “non-cancer’ risk analysis, all vapor samples of e-cigarette liquids revealed to be of “No Significant Risk” to human health. Tobacco smoke, on the other hand, showed a “Significant Risk” of harm to human health.
Additionally, tobacco cigarettes burn constantly, creating continuous “side stream smoke,” which is the smoke that comes directly from the end of a lit cigarette and the smoke lingers in the air and travels a fair distance from the smoker.
Electronic cigarette vapor does not behave in the same manner as tobacco smoke. There is no vapor produced from the device, until the user activates it by inhaling, so no “side stream vapor” is created and the vapor dissipates very quickly. In the event that a bystander would pass through the vapor, since it doesn’t contain the irritating toxins of tobacco smoke, it would be barely detectable beyond the faint scent of the flavor and only for a fleeting moment.
Nic by itself is about as dangerous to your body as regular doses of caffeine. It’s not the nic in tobacco that causes cancer, it’s the tar created when tobacco and its preservatives (and lingering pesticides sprayed on the live tobacco plants) are burnt. This tar contains thousands of harmful chemicals including 70 known carcinogens. There is ZERO tar and none of the carcinogens in e-cig use because there is no combustion of tobacco.
E-cigarettes are Big Tobacco
Second to the “marketing to the kids” campaign, this is one of the most prominent messages coming out of California and other states.
We see the vaping industry as small business because that’s what it’s made of; start ups manufacturing mods, eliquid, accessories, distribution channels, vape shops. None of which are tied to big tobacco directly.
Big Tobacco does have a foot in the game though.
Lorillard: The 3rd largest cigarette manufacturer in the United States, Lorillard acquired BluCigs in April 2012. Lorillard, including the BluCigs line, was acquired by Reynolds American in July 2014.
Reynolds American : The 2nd largest cigarette manufacturer in the United States and the produce of Camel and Pall Mall. Released the Vuse cigalike and promptly sold the BluCigs line to Imperial Tobacco shortly after acquiring Lorillard.
Imperial Tobacco : A UK based tobacco company. Purchased the BluCigs line from Reynolds after acquiring the Dragonite in 2013 originally owned by Hon Lik, the Chinese inventor of the original e-cigarette.
British American Tobacco : A global tobacco group with brands sold in more than 200 markets worldwide. Also has a 40% stake in Reynolds American. Launched the Vype e-cigarette in the UK in August, 2013 manufactured under its subsidiary Nicoventures.
Japan Tobacco International : World’s 3rd largest international tobacco company headquartered in Switzerland. Owns minority shared in the Ploom, a loose-leaf vaporizer that heads tobacco pods. Acquired the e-cigarette brand E-lites in June 2014.
Altria/Philip Morris USA : Largest selling cigarette brand in the world (Marlboro). Nationwide rollout of the MarkTen cigalike in 2014.
Philip Morris International : The largest international tobacco company. Partnered with Altria to gain the exclusive right to sell Altria’s e-cigarettes outside the United States. In June 2014 acquired Nicocigs, owner of the Nicolites brand, to enter the UK e-cigarette market.
Big Tobacco may sell cigalikes, but they are not the vaping industry. They are not the vape shops, the eliquid manufacturers, the mod, atomizer or rebuildable manufacturers. Vaping is not Big Tobacco, it’s Small Business.
Vapers want nothing to do with Big Tobacco. Specialty vape shops generally don’t sell cigalikes as a rule. We’ve struggled with quitting cigarettes for years, we’re not in bed with Big Tobacco and we’re certainly done with giving them money.
E-cigarettes contain antifreeze
This has been blasted through the media countless times and each time it must be refuted as false. E-cigs do not contain anti-freeze. What they do contain is propylene glycol which is only one component in anti-freeze.
While the various uses of PG have already been listed, it needs to be reiterated: Propylene glycol is considerably less toxic than ethylene glycol (the other more toxic glycol used for years in antifreeze) and when used in antifreeze may be labeled as "non-toxic antifreeze". It is used as a component in antifreeze where ethylene glycol would be inappropriate, such as in food-processing systems or in water pipes in homes where incidental ingestion may be possible.
That’s right – propylene glycol is used in anti-freeze to make it LESS harmful.
As confirmation of its relative non-toxicity, the FDA allows propylene glycol to be added to a large number of processed foods, including ice cream, frozen custard, salad dressings and baked goods.
Propylene glycol is used as a primary component in antifreeze because of its low freezing point when compared to water.
For example: pure water freezes at 32 degrees Fahrenheit. A solution that is 25% propylene glycol to 75% water lowers the freezing point to 15 degrees Fahrenheit. A 50/50 mix of propylene glycol and water reduces the freezing point even further to -20 degrees Fahrenheit.
If all propylene glycol is antifreeze, because it’s used in antifreeze then all caffeine is coffee because it’s a component of coffee.
And that’s what you call “junk science.”
Only 8 percent of all former smokers have converted to vaping. That percentage needs to grow. But agencies such as the CDC and state of California are doing their best to halt the progression. It’s up to each of us to stay educated, and to pass that information along to educate everyone from other individuals in our social circles all the way up to those who influence legislation.
The CDC and the California Department of Health have ripped a page from the Big Tobacco playbook. “Strongly call out the point – Controversy! Contradiction! Other Factors! Unknowns!” as Hill and Knowlton, the PR firm that advised the tobacco industry, urged it to do in the 1950s and 60s.
By warping the perception of risk, these agencies will surely create enough doubt about the very real benefits of e-cigarettes that smokers will simply say to themselves, “Why switch?” And keep inhaling dangerous smoke. If there were such a thing as public health negligence, the nation’s flagship public health agency and California’s health department could rightly stand accused.
What this industry needs is advocacy to help push forward appropriate legislation and regulation; specifically for manufacturing standards and regulation prohibiting the sale to minors. What we don’t need are excessive sin taxes, flavor bans, product bans and smearing false-light campaigns that spread untruth.
Instead of focusing on lost taxes due to reduced tobacco sales and pushing through house bills that limit the industry, state legislators should be working with e-cig manufacturers & industry activists to help foster an innovative industry that - without a doubt - can change the lives of millions of people around the world.
Cannabis has been a friend to humankind since before the written word, providing fiber for cordage and cloth, seeds for nutrition, and roots, leaves and flowers for ritual and healing. During the Neolithic period, our ancestors discovered uses for every part of cannabis, which was one of the first agricultural crops, perhaps the first, ever to be grown and harvested some 12,000 years ago.
Agriculture, strictly speaking, is not a natural phenomenon. It is an expression of human ingenuity, an invention that has been described as the basis – literally the ground – of modern civilization. “The onset of agriculture was probably one of the most dramatic and important developments in human history,” writes Swiss scientist Jürg Gertsch, who explores the profound consequences of dietary changes brought on by food cultivation in a recent article in the British Journal of Pharmacology, entitled “Cannabimimetic phytochemicals in the diet – an evolutionary link to food selection and metabolic stress adaptation?”
Gertsch’s provocative thesis is that chronic metabolic disorders, currently a worldwide pandemic, are rooted in “a mismatch between ancient genes and high caloric diets” that ensued with the introduction of agriculture. “The multimillion year evolutionary process during which nearly all genetic change reflected the life circumstances of our ancestors [was] suddenly disturbed” when “carbohydrate farming” supplanted the “hunter-gatherer diet rich in animal food,” says Gertsch, who maintains that “the interplay between diet and the endocannabinoid system” is key to understanding today’s obesity/diabetes crisis and its potential remediation.
The endocannabinoid system, an ancient biological signaling network, regulates numerous physiological processes, including intestinal function, glucose metabolism, and the stress response. A dysregulated endocannabinoid system is implicated in metabolic and bowel pathologies and many other diseases. Gertsch discusses the different, yet complementary, roles of the cannabinoid receptors – CB1 and CB2 – pertaining to diet, digestion, and energy metabolism.
Mammalian CB1 receptors are concentrated in the brain and the central nervous system. They are also present in taste buds and the enteric nervous system (the gut-brain axis). Tetrahydrocannabinol (THC), marijuana’s main psychoactive component, boosts appetite and food intake by binding to the CB1 receptor – a phenomenon playfully known as “the munchies.” But CB1 receptors, as Gertsch points out, “can exert paradoxical effects on food intake,” facilitating essential nourishment as well as metabolic imbalance.
CB1 receptor signaling triggers a newborn’s suckling instinct. Mother’s milk is well endowed with arachidonic acid, a basic building block of the brain’s own marijuana-like compounds, anandamide and 2AG. These endogenous cannabinoid compounds bind to the same cell receptors – CB1 and CB2 – that mediate many of the effects of marijuana. Found in eggs, meat, and dairy products, arachidonic acid intake increases endocannabinoid levels in different tissues and is crucial for pre- and post-natal brain development.
Early hominids lived a precarious wilderness existence, requiring significant physical exertion (hunting and gathering) for survival. Famine, microbial infection, traumatic encounters with predators, fight or flight – all were hallmarks of a pre-agriculturist, subsistence lifestyle. Given the metabolic demands of their large brains and strenuous daily activities, our ancestors needed to consume energy-dense, nutrient-rich food.
In addition to heightening one’s sense of smell and stimulating appetite, CB1 receptor signaling “may facilitate survival after excessive physical activity, stress and trauma by restoring homeostasis, suppressing negative memories and reducing anxiety at the level of the central nervous system,” writes Gertsch, who explains that “CB1 receptor activation is associated with increased energy intake and decreased energy expenditure by controlling neural pathways.”
And CB1 taketh away
Combined with rigorous, day-to-day aerobics, the hunter-gatherer diet did not engender obesity, metabolic problems or cardiovascular disease. But the high-fat hunter-gatherer diet, which served our ancestors well, changed significantly with the advent of cultivated food. “Carbohydrate farming incited the most important dietary transition, which is still ongoing to the present day,” says Gertsch. There is a continuum, he maintains, between plant carbohydrate cultivation of yore and today’s over-starched, over-sweetened and over-processed Western diet.
Grain, carbs, sugar, alcohol, high fructose corn syrup: What started as the basis of civilization has spiraled into a mass-marketed refined sugar binge. “Dietary carbohydrates once essential for the cognitive and social development of Paleolithic humans gradually turned into a metabolic stress factor as a function of their glycemic indices,” Gertsch explains. “Epidemiological evidence points toward a pandemic diet-induced glucose toxicity due to excess sugar intake.”
The endocannabinoid system is deeply implicated in this unhealthy worldwide trajectory. Linked to both motivation and reward, CB1 receptor signaling encourages sugar consumption by enhancing neural responses to sweet flavors. It has been shown that chronic CB1 receptor activation in mice causes obesity-related insulin resistance. Aberrant CB1 activity reinforces a metabolically skewed feedback loop: In obese humans, high endocannabinoid levels are found in the liver, pancreas, adipose tissue, and skeletal muscle, where they contribute to insulin resistance, decreased glucose uptake, oxygen depletion, and cardiometabolic distress.
“The generation and excess use of sugars could be seen in analogy to the detrimental impact of the first distilled alcohol on humans. The sudden availability of excess sugars in combination with fats in diet may have led to a collision of genes that evolved to cope with high energy demands due to constant physical activity,” says Gertsch. “Excessive consumption of high-energy palatable food without physical activity contributes to obesity.” Which, in turn, leads to metabolic syndrome, heart disease, and other degenerative conditions.
CB2 to the rescue
CB1 receptors and CB2 cannabinoid receptors play different roles with respect to diet and nutrition. In animal studies, CB2 receptor activation generally causes the opposite effects of CB1. Whereas CB1 receptors promote appetite and food consumption, CB2 receptors tend to inhibit food intake.1
Expressed primarily in immune cells, adipose (fatty) tissue, and the peripheral nervous system, CB2 receptors confer broad anti-inflammatory effects in various disease models. Noting that obesity is a low-grade inflammatory condition, Gertsch discusses the “protective role of CB2 receptors in diet-induced metabolic malignancies.” Preclinical research indicates that CB2 receptor activity can prevent or ameliorate diabetes-associated peripheral neuropathy and pro-inflammatory obesity. CB2 signaling is also protective against brain damage from strokes, concussions, and neurodegenerative ailments.
Gertsch suggests that the contemporary “mismatch between ancient genes and high caloric diets” might be reconciled in part by CB2’s ability to mediate the effects of secondary plant metabolites (terpenes, flavonoids and other polyphenolic compounds) that are found in kitchen spices, leafy greens, and other vegetables. “Dietary secondary metabolites from vegetables and spices are able to enhance the activity of CB2 receptors and may provide adaptive metabolic advantages and counteract inflammation,” Gertsch reports.
Beta-caryophyllene (BCP), for example, is a seemingly ubiquitous aromatic terpene present in many spices (black pepper, cloves, rosemary, etc.) and bitter greens, as well as in numerous cannabis varietals. This versatile plant compound conveys significant health benefits by directly activating the CB2 receptor and via other molecular pathways. BCP has been shown to stimulate insulin production and inhibit tumor growth in human cell lines. Mounting evidence suggests that a steady diet of BCP-rich foods could prevent or mitigate non-alcoholic fatty liver disease through CB2-mediated channels. Eating green leafy vegetables and spices rich in essential oils “may counteract metabolic stress induced by excessive carbohydrate intake,” Gertsch advises.
Healthy fats, healthy people
Several scientific studies have explored the link between the intake of polyunsaturated fatty acids (PUFAs) and the endocannabinoid system. Docosahexaenoic acid (DHA), an omega-3 fatty acid, is the principal long chain PUFA found in the human brain. (Omega oils are considered “essential” fatty acids because they can’t be produced by the body in sufficient amounts and therefore must be ingested.) Dietary DHA and eicosapentaenoic acid (EPA), another long chain PUFA, support neurological function, retinal development, and overall health by up-regulating CB1 receptor gene expression.2 Preclinical research has shown that administering DHA and EPA prevented glucose intolerance and low-grade inflammation of white adipose tissue in obese mice.
The manifold health benefits of omega-3 PUFAs – prominent in oily fish, walnuts, flax and hempseeds, for example – include the prevention of heart disease, dementia, cancer cell proliferation, insulin resistance, and depression. Low levels of DHA and EPA can lead to premature aging, as well as mental illness. Nutritional omega-3 dietary deficiency “abolishes endocannabinoid-mediated neuronal functions” and is associated with neuropsychiatric disease, according to a 2011 report in Nature Neuroscience. Alzheimer’s sufferers and children with attention deficit hyperactivity disorder tend to be deficient in omega-3 fatty acids.
A healthy balance of omega-3 fatty acids and grain-derived omega-6 fatty acids is fundamental for preventing and managing obesity and metabolic syndrome. But a well-balanced ratio of PUFAs is typically lacking in a carb-heavy Western diet that favors greater omega-6 intake at the expense of omega-3. Gertsch suggests that it is possible “to reprogram energy metabolism” by increasing omega-3 and decreasing the amount of omega-6 in one’s diet: “Generally a lower omega-6 to omega-3 ratio is desirable in reducing the risk of many of the chronic diseases of high prevalence in industrial society or societies with high carbohydrate intake.”
A 2014 paper by Japanese scientists reported that the ratio of dietary omega-6 to omega-3 fatty acids influences how CB1 cannabinoid receptors regulate fear memory. The upshot is that altering the omega-6/omega-3 ratio in one’s diet could improve treatment regimens for anxiety and PTSD, as well as for metabolic disorders. Human beings have evolved in such a way as to have “an advanced capacity to digest and metabolize higher fat diets,” says Gertsch, who concludes that a “low-carb, high fat diet should be the most effective measure against obesity” – with the caveat that a high fat diet must be combined with regular physical exercise, much like in the hunter-gatherer days before agriculture.
Given what scientists know about how the endocannabinoid system functions, there is a strong basis for adopting a high fat, low carb diet with lots of fresh vegetables and spices, both as a general health practice and a remedy for many maladies.
1 THC binds directly to the CB2 receptor and activates it, but not as potently as THC binds to CB1, the “psychoactive” receptor.
2 When metabolized, fatty acids yield large quantities of mitochondria-mediated ATP, the main energy source for most cellular functions. Fatty acids are important components of phospholipids that form the phospholipid bilayers out of which all the membranes of cells and the membranes of organelles within cells, such as mitochondria and the nucleus, are created. In addition to modulating cannabinoid receptor activity, diet affects cell membrane fluidity and permeability, which, in turn, impacts the ability of fatty acid binding proteins to transport endogenous cannabinoids and plant cannabinoids through the cell's membrane and into the cell’s interior, where they activate nuclear and mitochondrial receptors.
Gertsch J. Cannabimimetic phytochemicals in the diet - an evolutionary link to food selection and metabolic stress adaptation?. Br J Pharmacol. 2016 Nov 27;PubMed PMID: 27891602.
Gertsch J, Leonti M, Raduner S, Racz I, Chen JZ, et al. Beta-caryophyllene is a dietary cannabinoid. Proc Natl Acad Sci U S A. 2008 Jul 1;105(26):9099-104. PubMed PMID: 18574142; PubMed Central PMCID: PMC2449371.
Gertsch J. Anti-inflammatory cannabinoids in diet: Towards a better understanding of CB(2) receptor action?. Commun Integr Biol. 2008;1(1):26-8. PubMed PMID: 19704783; PubMed Central PMCID: PMC2633791.
Lafourcade M, Larrieu T, Mato S, Duffaud A, Sepers M, et al. Nutritional omega-3 deficiency abolishes endocannabinoid-mediated neuronal functions. Nat Neurosci. 2011 Mar;14(3):345-50. PubMed PMID: 21278728.
Notarnicola M, Tutino V, De Nunzio V, Dituri F, Caruso MG, et al. Dietary ω-3 Polyunsaturated Fatty Acids Inhibit Tumor Growth in Transgenic ApcMin/+ Mice, Correlating with CB1 Receptor Up-Regulation. Int J Mol Sci. 2017 Feb 24;18(3)PubMed PMID: 28245562.
Rashid MA, Katakura M, Kharebava G, Kevala K, Kim HY. N-Docosahexaenoylethanolamine is a potent neurogenic factor for neural stem cell differentiation. J Neurochem. 2013 Jun;125(6):869-84. PubMed PMID: 23570577; NIHMSID: NIHMS465637; PubMed Central PMCID: PMC3775276.
Wood JT, Williams JS, Pandarinathan L, Janero DR, Lammi-Keefe CJ, et al. Dietary docosahexaenoic acid supplementation alters select physiological endocannabinoid-system metabolites in brain and plasma. J Lipid Res. 2010 Jun;51(6):1416-23. PubMed PMID: 20071693; PubMed Central PMCID: PMC3035504.
Yamada D, Takeo J, Koppensteiner P, Wada K, Sekiguchi M. Modulation of fear memory by dietary polyunsaturated fatty acids via cannabinoid receptors. Neuropsychopharmacology. 2014 Jul;39(8):1852-60. PubMed PMID: 24518289; PubMed Central PMCID: PMC4059893.
Photo Credits: BBC.com, Lena Guirguis, Health Staff, Brit & Co
VXL Distributors prides itself in providing the highest quality of the CBD on the market.
All of our manufacturers/partners import the CBD from the E.U., the letter attached to this link will provide a clear path to the legalities of our Industry and shine some light on the D.E.A announcement from 12/14/16.
I. INTRODUCTION The Drug Enforcement Administration (DEA) has, yet again, demonstrated its lawless recalcitrance for the prevailing law. A new Rule published in the Federal Register, and currently set to become effective on January 13, 2017, seeks to control all naturally occurring cannabinoids from the Cannabis sativa L plant. The DEA attempted something very similar in 2003, and the Ninth Circuit Court of Appeals rejected its efforts as unlawful and beyond the scope of the DEA’s delegated Congressional authorization. But, here we go again. Within the framework of existing laws, a robust cannabis industry, including consumer, textile and manufacturing industries based around non-psychoactive varieties of the Cannabis sativa L. plant and derivatives and cannabinoids derived therefrom, has evolved from the efforts of thousands of companies across the United States and globally. These industries, which already exist in the European Union, Latin America, Canada and China, among other countries, are rapidly growing, creating vast economic opportunities along with job creation. Absent a reversal or the striking of the DEA’s Rule, these businesses and industries stand to suffer a devastating impact from this Rule. To protect these individuals, businesses and this industry, the DEA’s actions cannot be overlooked. More specifically, on Tuesday, December 14, the Federal Register published information concerning a Final Rule enacted by the DEA pertaining to a change to 21 CFR 1308. In sum, the DEA has created a new Administration Controlled Substances Code Number for “Marihuana Extract.” According to the Federal Register, “[t]his code number will allow DEA and DEAregistered entities to track quantities of this material separately from quantities of marihuana” in order to comply with “relevant treaty provisions.” There are a number of unusual things about this DEA action; not the least of which is that it appears to be, yet again, outside of the scope of the DEA’s power and authority as it pertains to the legality and regulation of the Cannabis sativa L plant. The fact that the DEA, an unelected government body with no legislative authority, is attempting to outlaw all cannabinoids is concerning and problematic as it pertains to portions of the plant not legally defined as “marihuana,” and as it pertains to lawfully cultivated and processed Farm Bill-compliant industrial hemp. The discussion below addresses many of the salient reasons why the DEA’s most recent action cannot stand, and outlines an action plan accordingly. 2 II. DISCUSSION A. The DEA/Federal Register Issue The DEA’s new definition for “Marihuana Extract” includes: “an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.” The primary problem with this new definition is that it purports to broadly outlaw all 80-plus cannabinoids [such as cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), etc.] contained within this genus. And cannabinoids are not unlawful controlled substances. The only cannabinoid that has been specifically identified in the Controlled Substances Act (CSA) is tetrahydrocannabinol (THC), as set forth below. Per the Federal Register, the DEA previously established separate code numbers for marijuana and for tetrahydrocannabinols (THC), but not for “Marihuana Extract.” This is true, and directly related to the DEA’s Congressionally-delegated authority under the Controlled Substances Act (CSA) because "marihuana" (marijuana) and "tetrahydrocannabinols" (THC) are both listed on Schedule I. 21 U.S.C. §812(c)(Schedule I)(c)(10), (17)). B. CSA INCLUSION OF THC But even the CSA definition of THC, as an individually identified cannabinoid, does not appear to prohibit inclusion of THC in these extracts, as the Ninth Circuit determined when it stated that the definition of “THC” under the CSA includes only synthetic THC. 21 C.F.R. § 1308.11(d)(27). THC is defined there as "[s]ynthetic equivalents of the substances contained in the plant, or in the resinous extractives of Cannabis, sp. and/or synthetic substances, derivatives, and their isomers...." The lawful definition of THC expressly excludes THC that is naturally occurring in the stalks and fibers of a lawfully imported industrial hemp plant. And the controlled substances listing of THC is different from the listings for DMT, mescaline, psilocybin, and psilocyn, the definitions for which are not limited to synthetic forms of the drugs. See 21 C.F.R. § 1308.11(d). In Hemp Indus. Ass'n. v. DEA, supra, the court held that the DEA could regulate products containing natural THC if it is contained within marijuana, and can regulate synthetic THC of any kind. But they cannot regulate naturally-occurring THC not contained within or derived from marijuana, i.e., non-psychoactive hemp products, because non-psychoactive hemp from the stalks and fibers of such a plant is not included in Schedule I. The Court concluded that the “DEA has no authority to regulate drugs that are not schedule….” Id. at 1018. Furthermore, the Court concluded, “[I]f naturally-occurring THC were covered under THC, there would be no need to have a separate category for marijuana, which obviously contains naturallyoccurring THC. Yet Congress maintained marijuana as a separate category." Hemp Indus. Ass'n. 3 v. DEA, 357 F.3d 1012, 1014 (9th Cir. 2004) (quoting Hemp Indus. Ass'n v. DEA, 333 F.3d 1082, 1089 (9th Cir. 2003). In summary, under the CSA, the DEA can regulate foodstuffs and related products containing natural THC if it is contained within “marijuana,” and can regulate synthetic THC of any kind. But they cannot regulate naturally-occurring THC not contained within or derived from marijuana--i.e., non-psychoactive industrial hemp products--because non-psychoactive industrial hemp is not included in Schedule I, as set forth above. This is because statutes must be interpreted strictly and pursuant to their specific terms, and because the DEA has no authority to regulate drugs that are not scheduled. C. FEDERAL DEFINITION OF “MARIHUANA” It is clear that marijuana, or “marihuana,” is a controlled substance. But not all parts of the Cannabis sativa L plant are considered “marihuana” under the federal definition. Moreover, when it comes to industrial hemp, as set forth in the Agriculture Act of 2014 (commonly known as the Farm Bill), the entire industrial hemp plant is lawful, as set forth more fully below. To be clear, the federal definition of marihuana expressly excludes various portions of this plant. Yet, the DEA fails to recognize this express caveat. Under the CSA, "marihuana" is defined, not by the DEA, but by Congress, as follows: [A]ll parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination. 21 U.S.C. § 802(16)(emphasis added). By definition, the listing of "marihuana" in Schedule I excludes the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination. Hemp Indus. Ass'n., 357 F.3d at 1014 (quoting 21 U.S.C. § 802(16)). Thus, any extracts derived from the foregoing portions of a Cannabis sativa L plant lawfully cultivated outside of the United States remain lawful. 4 D. FARM BILL’S EXPRESS AUTHORIZATION OF INDUSTRIAL HEMP, INCLUDING CANNABINOIDS DERIVED THEREFROM The Farm Bill renders the entire industrial plant, including extracts, as lawful. On February 7, 2014, President Obama signed the Agricultural Act of 2014 into law. See P.L. 113-79 (§7606). Section 7606 of the act, Legitimacy of Industrial Hemp Research, defines industrial hemp as distinct from marijuana and authorizes institutions of higher education or state departments of agriculture in states that legalized hemp cultivation to conduct research and pilot programs across the country. Id. Importantly, the Farm Bill specifies that the entire “industrial hemp” plant is made lawful, in spite of, or notwithstanding, the CSA. As such, it expressly carves out an exception to the CSA for the entire industrial hemp plant and products/extracts therefrom. Id. Specifically, it states that “[n]otwithstanding the Controlled Substances Act (21 U.S.C. 801 et seq.), the Safe and DrugFree Schools and Communities Act (20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code, or any other Federal law, an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) or a State department of agriculture may grow or cultivate industrial hemp (with certain regulatory limitations).” Id. And industrial hemp has been defined, accordingly, as an exclusion/exception to the CSA, as, “the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” Id. There it is expressly clear that all parts of said plant, within this definition, are lawful, including but not limited to the extracts therefrom. E. CANNABINOIDS ARE NOT ILLEGAL CONTROLLED SUBSTANCES Cannabinoids are not illegal if they are derived from certain parts of the plant, and the Farm Bill expressly indicates that the entire plant is lawful, as set forth above. Moreover, naturally occurring cannabinoids are not unlawful substances per se. In Hemp Indus. Ass'n. v. DEA, 357 F.3d 1012 (9th Cir. 2004), the Ninth Circuit ruled that naturally occurring cannabinoids in industrial hemp foods, including oil, were never scheduled under the CSA; therefore, the DEA has no jurisdiction. This means that naturally occurring industrial hemp cannabinoids are federally legal in the view of the Ninth Circuit. In this case, the Court concluded: “[a]s in the case of poppy seeds commonly consumed on bagels and expressly exempted from the CSA, that come from a non-drug variety of, but the same species as, the opium poppy…non-psychoactive hemp seed products do not contain any controlled substance as defined by the CSA...” 357 F.2d at 1017. 5 F. DEA CITATION OF INTERNATIONAL TREATIES By citing reconciliation with international treaties as the premise for this Rule, the DEA appears to be seeking to invoke 21 CFR 1308.46, which, in theory, allows the DEA to bypass normal rulemaking procedures, effectively eliminating due process from the procedures set forth by Congress and through the Federal Register. This use of such procedure by the DEA is akin to emergency rulemaking and not only undermines the premise of due process afforded to adversely affected interested persons, but is essentially is an abuse of process and appears to be an attempt to circumvent Congressional restrictions upon the DEA’s authority. G. HEMP INDUS. ASS’N v. DEA CASE PRECEDENT Fundamentally, cannabinoids are not specifically or generally defined under the Federal Controlled Substances Act (the “CSA”). However, through its ruling, the DEA has improperly taken the position that all cannabinoids, even isolated and pure cannabinoids such as CBD, are unlawful under the CSA. Without an express provision under the CSA, it is questionable whether the DEA has any sort of authority to take this position. But more importantly, in the case of Hemp Indus. Ass'n v. DEA, 333 F.3d 1082 (9th Cir. 2003), the DEA attempted to initiate rules and interpretations concerning certain cannabinoid constituents of a Cannabis sativa L plant that were not expressly set forth under the CSA or the DEA’s own regulations (at the time), and the Ninth Circuit Federal Court of Appeals struck down its efforts, stating that: “[t]he petition requesting that we declare the rule to be invalid and unenforceable is GRANTED.” Hemp Indus. Ass'n v. DEA, 333 F.3d 1082 (9th Cir. 2003). In short, an agency – such as the DEA – is not permitted to change a legislative rule retroactively through the process of disingenuous interpretation of the rule to mean something other than its original meaning. Yet, here they go again, and, again this needs to be stopped. H. CONGRESSIONAL BUDGETARY APPROPRIATIONS ACTS DE-FUNDING DEPARTMENT OF JUSTICE PURSUANT TO FARM BILL To further confirm Congressional intent pursuant to the Farm Bill, Congress enacted the Consolidated and Further Continuing Appropriations Act of 2015 (Pub. L. 113-235, 128 Stat. 2130, §538 (2014)), and re-authorized such regulations in the Consolidated Appropriations Act, 2016, (Pub. L. No. 114-113, 129 Stat. 1175 (§763)), and most recently, this week extended the same through April 28, 2017 (collectively, the “Spending Bill”) (Pub. L. No. 114-254) . The Spending Bill effectively precludes block federal law enforcement authorities from interfering with conduct authorized by the Farm Bill, such state agencies and hemp growers, as well as to counter efforts to obstruct agricultural research. Accordingly, the Spending Bill sets forth: 6 None of the funds made available by this Act or any other Act may be used— (1) in contravention of section 7606 of the Agricultural Act of 2014 (7 U.S.C. 5940); or (2) to prohibit the transportation, processing, sale, or use of industrial hemp that is grown or cultivated in accordance with subsection section 7606 of the Agricultural Act of 2014, within or outside the State in which the industrial hemp is grown or cultivated. See Pub. L. No. 114-113, 129 Stat. 1175 (§763). The enforceable effect of the Spending Bill’s de-funding mechanisms have since been affirmed in multiple cases. See U.S. v. Marin Alliance for Medical Marijuana (MAMM), Case No. 98-00086; see also U.S. v. McIntosh, Case No. 15- 10122 (2016). Therefore, the DEA’s final rule regarding “Marihuana Extract” not only contradicts its own rulemaking authority, as otherwise discussed herein, but also explicitly conflicts with the Spending Bill provisions enacted by Congress, which disallows the DEA from expending resources that conflict with the Farm Bill. I. DEA FINAL RULE DISTINCTION BETWEEN “CANNABIS RESIN” AND “MARIHUANA EXTRACT” There is a positive aspect to this publication and the DEA’s position accordingly. Specifically, the new Rule defines “marihuana extracts” as distinct from its resins – “Marihuana Extract” is a new category and is “other than the separated resin (whether crude or purified) obtained from the plant.” It finds that the “use of the term ‘cannabinoid’ necessitates that the DEA clarify that the new marihuana extract category (drug code 7350) is not intended to include ‘cannabis resin’ as defined in the U.N. Single Convention (and under the CSA).” 21 CFR Part 1308, 81 FR 90194 This is an important distinction because it effectively acknowledges that cannabis extracts are not resins, but are something else altogether. This is a good sign because the CSA definition of marijuana makes any resins extracted from any part of the plant unlawful. 21 U.S.C. 802(16). And we have always known that resins are distinct from extracted oils; this Rule expressly makes that distinction and furthers the argument that the DEA has exceeded its jurisdiction here. J. CANNABINOIDS ARE NOT EXCLUSIVELY NATURALLY OCCURRING IN CANNABIS PLANTS The genus Cannabis sativa L. possesses over eighty distinct and naturally occurring cannabinoids. For example, research indicates cannabinoids also naturally occur in coneflower (Echinacea), oxeye (Heliopsis helianthoides), electric daisy (Acmella oleracea), Helichrysum umbraculigerum, liverwort (Radula marginata), black pepper (Piper nigrum) and even chocolate (Theobrama cacao) plants. 7 Importantly, the DEA has even admitted that cannabinoids naturally occur in other plants and/or can be derived from sources other than marijuana. See 21 CFR Chapter II, Docket No. DEA- 426, p. 53698 Further, the DEA also admits the tetrahydrocannabinol is the main psychoactive cannabinoid in marijuana – psychoactivity being the main impetus behind scheduling (synthetic) tetrahydrocannabinol – while also acknowledging that many of the other cannabinoids, specifically including CBD, do not possess psychoactive effects. See 21 CFR Chapter II, Docket No. DEA-426, p. 53698; Docket No. DEA-427 53778. K. ACTION PLAN There are administrative procedures, including requests for hearing, and/or the commencement of litigation seeking injunctive and declaratory relief that can be taken in response to the DEA’s Rule. Examples of such prior challenges include the HIA v. DEA case itself, along with recent challenges regarding the DEA’s ruling with regard to banning Kratom. Our team is diligently and expediently working to prepare a recommended strategy in response to the DEA’s Rule and looks forward to working on behalf of the continued success of the effected industries. /s/ Robert T. Hoban, Esq. Managing Partner, Hoban Law Group /s/ C. Adam Foster, Esq. Partner, Hoban Law Group /s/ Garrett Graff, Esq. Associate Attorney, Hoban Law Group, Hemp Attorney /s/ Dennis Brovarone, Esq. Senior Attorney, Hoban Law Group, Hemp Attorney /s/ Patrick Goggin, Esq. Counsel, Hoban Law Group, Hemp Attorney /s/ Lisa Sweeney, Esq. Counsel, Hoban Law Group, Hemp Attorney /s/ Matthew Smith, Esq. Counsel, Hoban Law Group, Hemp Attorney
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