The American Kratom Association (AKA) has petitioned the US Food and Drug Administration (FDA) to “review and correct” the agency’s public health advisory on kratom.
On November 14, the FDA warned against the use of kratom, a plant with opioid properties, noting it is addictive and has been linked to 36 deaths.
The AKA, a consumer-based nonprofit organization, said the advisory is based on “discredited, incomplete, and mischaracterized scientific claims” and should be rescinded.
The organization has initiated a formal dispute resolution petition with the US Department of Health and Human Services challenging the “weak scientific basis” of the FDA advisory and seeking to have it overturned, according to a statement from the organization.
“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA [Drug Enforcement Administration], states, and various local government entities. AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims,” the statement reads.
Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. Its popularity is increasing in the United States, with users claiming the botanical helps treat pain, anxiety, depression, and, more recently, opioid withdrawal.
But it is an unapproved drug and is being illegally promoted for those conditions, FDA Commissioner Scott Gottlieb, MD, said in the public health advisory. He added that current evidence shows that kratom “has similar effects to narcotics like opioids and carries similar risks of abuse, addiction, and in some cases, death.”
The AKA disagrees, stating that, contrary to the statement that kratom has narcotic opioid like abuse potential and other effects, kratom is primarily used by millions of Americans not to get “high” but because it is beneficial.
The organization says it is “well documented” that kratom does not cause the lethal respiratory depressing effects that are a hallmark of narcoticlike opioids. “In stark contrast, among millions of users of kratom in America, probably dating back to the 1990s and earlier, there has not been a single documented actual kratom-caused overdose death.
“The handful of possible kratom-associated deaths in the US involved people taking multiple drugs, with apparent causes of death varying widely, quite unlike what is seen with narcoticlike opioids,” the AKA said.
“We care very much about the health and well-being of the kratom community and that is why we welcome a full-scale review and the eventual rescinding of the FDA’s latest attack on kratom,” said AKA President and Board Chair Dave Herman.
“We know from surveys that kratom consumers are concerned about being forced to seek relief by using illegal opioids in the event that kratom is banned. It would be an outrageous and unacceptable public health outcome if the effect of the FDA assault on kratom backfires and leads to more opioid addiction and death.
“The very real possibility of this kind of unintended consequence happening in the wake of FDA-inspired restrictions on kratom should give any responsible legislator or regulator real pause,” Herman stated.
This is going to be short and to the point…
Any migraine sufferer can attest to the truth that once this condition gets beyond its earliest stages, over the counter medication can’t stop it. Additionally, migraine is not a normal headache because its pain is usually excruciating. In fact, the pain can compel a patient to commit suicide. The fact that CBD is being proven effective in improving the symptoms of a migraine is, therefore, good news to migraine sufferers.
Studies show that marijuana has been used to relieve headaches or migraines for more than a hundred years. There are also cases when cannabis has been used in the ancient Chinese medical context. In the 1800s and beginning of the 1900s, medical marijuana was preferred over other therapeutic aids by some physicians. And, several modern studies have pointed out that CBD may help with a migraine and/or relieve its symptoms. There are also stories of patients that have used CBD and resulted in successful migraine relief.
Medical Study #1
“Although the exact ECS-dependent mechanisms underlying migraine are not fully understood, the available results strongly suggest that activation of ECS could represent a promising therapeutical tool for reducing both the physiological and inflammatory components of pain that are likely involved in migraine attacks.” – https://www.ncbi.nlm.nih.gov/pubmed/20353780
Medical Study #2
“The literature suggests that the medicinal use of cannabis may have a therapeutic role for a multitude of diseases, particularly chronic pain disorders including headache. Supporting literature suggests a role for medicinal cannabis and cannabinoids in several types of headache disorders including migraine and cluster headache…” – https://www.ncbi.nlm.nih.gov/pubmed/26015168
The presence of an endocannabinoid system in the human body explains the efficacy of CBD in improving the symptoms of a migraine. The endocannabinoid system comprises of cannabinoid receptors and cannabinoids that the body produces naturally. When the natural cannabinoids bind to the cannabinoid receptors, they block pain while providing system-wide events that eliminate factors that cause a migraine. CBD from the hemp plant acts like the natural body cannabinoids. Thus, CBD essentially inhibits neurotransmission of pain signals while reducing the inflammatory response that is associated with a migraine.
Scientists suggest the use of CBD as a preventative therapeutic aid for a migraine. Using CBD on daily basis has been proven effective in relieving migraine in some people. Some of the CBD products that have been used to relieve a migraine include CBD oil, CBD cream, and CBD edibles. People have used CBD vaporizer or added it to drinks and food, or even applied it under their tongue to relieve a migraine. Most people recommend CBD wax and CBD oil that can be inhaled or vaporized to provide a more immediate effect or relief.
CBD is a non-psychoactive product that has many medicinal properties. It’s an excellent pain reliever that provides natural healing effects without causing a high feeling that is associated with cannabis. And, though CBD has not been declared conventional in the therapeutic aid of a migraine headache, many patients have used it to relieve pain. Nevertheless, if you or a loved one is considering taking CBD as a dietary supplement for headaches or migraine relief, we highly recommend that you speak with your physician about it first.
During the last week of June, more than 400 scientists from 25 countries met in Montreal for the 27th annual symposium of the International Cannabinoid Research Society (ICRS). Several presentations and posters showcased new findings about cannabidiol (CBD), the non-euphoric component of the cannabis plant that is transforming the medical marijuana landscape.
In her Young Investigator Award Presentation, Saoirse O’Sullivan, associate professor at the University of Nottingham in the United Kingdom, discussed the cardiovascular effects of cannabidiol: “CBD causes both acute and time dependent vasorelaxation of rat and human arteries … and can improve endothelial function and vasodilator responses in a rat model of type 2 diabetes.” Moreover, a single dose of CBD was found to decrease “resting blood pressure and the blood pressure response to stress.” Other studies indicate that CBD limits brain damage in animal models of stroke. “Collectively, these data suggest that CBDis a compound of interest in the cardiovascular system and in cardiovascular disorders, which need to be tested in relevant patient groups,” O’Sullivan concluded.
A poster by Dr. Paula B. Dall’Stella, a neuro-oncologist with Sirio Libanes Hospital in San Paulo, Brazil, documented the antitumoral effects of CBD in two patients with Glioblastoma Multiforme (brain cancer) that were resistant to other therapies. Before and after MRI scans showed “a marked remission … not commonly observed in patients only treated with conventional modalities … that could impact survival.”
Several presentations focused on CBD and treatment-resistant epilepsy. Dr. Fabricio A. Pamplona, scientific director of of Entourage Phytolab in San Paulo, Brazil, compared the efficacy of a purified CBD isolate to a whole plant CBD-rich oil extract. Pamplona found the whole plant extract to be a superior option with higher potency and fewer adverse side effects than single-molecule CBD: “There were more reports of ‘improvement in seizures frequency’ in CBD-enriched extract compared to purified CBD,” a result that he attributed to the “additional compounds available in extracts (other than CBD) that may interact synergistically.”
Israeli researchers at the Technion institute in Haifa found that “not all high CBD extracts have the same anticonvulsant ability.” The Israelis noted that “the terpenoid content in the cannabis extracts are important for the anticonvulsant effect.” (Terpenoids are derived from terpenes, the aromatic botanical compounds that endow cannabis with a unique smell and confer specific medicinal effects.) “Not all cannabis extracts will be useful as a treatment for epilepsy,” the Technion researchers concluded, adding: “[T]he exact cannabinoid and terpenoid profiles are needed to evaluate the potential anticonvulsant properties of a cannabis extract.”
Another poster drew attention to the fact that daily use of CBD-rich cannabis oil extracts may lead to a positive THC finding in a drug test, a concern for many U.S. patients in so-called “CBD-only states” that have legalized CBD but not the whole plant. Unfortunately, this poster resurrected the thoroughly discredited (and financially motivated) theory that CBD may convert to THC in the stomach. A more likely explanation is that any whole cannabis plant extract that includes even a small amount of THC could generate a positive result from a drug test. Given the unregulated CBD products that proliferate online, it’s not surprising that some “CBD” oils contain higher THC concentrations than advertised.
Other scientists probed CBD’s mechanism of action with respect to nausea, neuropathic pain, anxiety, and other mood disorders. Researchers at McGill University in Montreal found that analgesic effects of acute and chronic CBD treatment are mediated by the serotonin 5HT1a receptor, but this is not the case for CBD’s antidepressant effects, which seem to be regulated via other molecular pathways.
The complex role of the 5HT1a receptor with respect to CBD’s therapeutic properties was addressed in a poster by Aidan J. Hampson and his colleagues at the National Institute of Drug Abuse. It was Hampson’s work, published in 1998, that formed that basis for the U.S. government’s patent on the antioxidant and neuroprotectant properties of cannabinoids (both THC and CBD). More recently, Hampson has shown that the anxiety-relieving effect of CBD can be blocked in vivo (in a living animal) by a 5HT1a antagonist, indicating that this receptor is in part responsible for mediating the anxiolytic effects of cannabidiol. Curiously, Hampson’s current data suggests that in addition to binding directly to 5HT1a, cannabidiol may also act as a positive allosteric modulator of 5HT1a – meaning that CBD can alter the functionality of this receptor (and other serotonin receptor subtypes) in such a way as to enhance its binding efficiency with the endogenous serotonin neurotransmitter. In other words, CBD may actually magnify the effect of serotonin, in addition to directly activating the 5HT1a receptor.
Scientists at the University of Louisville School of Medicine in Kentucky have identified two new molecular targets of CBD – the receptors designated “GPR3” and “GPR6.” (GPR refers to G-coupled protein receptor, the family of receptors that includes cannabinoid, opioid, and several serotonin receptor subtypes.) GPR3and GPR6 are both known as “orphan receptors” because the principal endogenous compounds that bind to these receptors have yet to be identified. Some of the potential therapeutic effects of CBD for Alzheimer’s disease, Parkinson’s disease and schizophrenia may be mediated by GPR3 and GPR6.
Amyloid beta plaque and tau protein tangles in the brain are hallmarks of Alzheimer’s dementia. Tim Karl from the Western Sydney University School of Medicine in Australia elaborated on CBD’s therapeutic potential for this neurodegenerative brain disease: “The phytocannabinoid cannabidiol possesses antioxidant, anti-inflammatory and neuroprotective properties and prevents amyloid beta-induced neuroinflammation, and tau hyperphosphorylation in vitro. CBD also reverses cognitive deficits of pharmacological amyloid beta models. Thus, CBD may offer therapeutic value for Alzheimer’s disease.”
Another receptor, known as GPR55, is inhibited by CBD. This is significant because preclinical research has linked GPR55 activation to several aberrant conditions, including colon cancer and Dravet Syndrome, a severe seizure disorder. By functioning as a GPR55 “antagonist,” CBD may confer a tumor-suppressing and anti-epileptic effect, although clinical studies have yet to confirm whether this mechanism of action is applicable to humans as well as animals.
At the 2017 ICRS conference, numerous presentations focused on other areas of cannabinoid science that do not involve CBD but are nonetheless relevant for cannabis clinicians and patients. Some highlights:
Martin A. Lee is the director of Project CBD and the author of Smoke Signals: A Social History of Marijuana – Medical, Recreational and Scientific.
With more studies, fewer regulations and increased acceptance, CBD hemp oil is gaining in popularity – with good reason. Shown to decrease seizures, alleviate anxiety, reduce inflammation and help with PTSD symptoms, CBD hemp oil is attracting entrepreneurs who want to make a quick buck on the heady crop. These capitalists tend to source their hemp from less-than-organic farms, use cheaper petroleum-based extraction methods, and provide no lab results or testing of their product to ensure potency. This makes it difficult for the consumer to decide what is high quality CBD oil and what isn’t. Below are our recommendations for five ways to identify high-quality CBD:
As any New Yorker will tell you, bagels are better in Manhattan. Why? Because of the water. A very precise combo of minerals in New York metro water makes it perfect for producing delicious bagels. The same goes for industrial hemp.
We source our hemp locally — in Europe, the U.S. and Australia — from organic farmers who are committed to quality hemp. It’s more expensive than hemp from China, but it’s worth it. Our specially bred industrial hemp plants are primarily grown as an agricultural crop, by farmers we have relationships with and who care about the plants they tend. This is important. If there’s ever an issue with a harvest, we know about it and make decisions that maximize the quality of the products we produce.
That care doesn’t stop at the farm. How CBD hemp oil is extracted from the plant is crucial. While our specially bred industrial hemp plants have a naturally higher level of CBD, the direct plant extracts are still low. To obtain a higher concentration of CBD, we use a Super critical CO2 extraction method. This chemical-free “cold” CO2 extraction method is more expensive, uses safer solvents and ensures a highly potent and pure extract. It’s also eco-friendly, non-toxic and has negligible environmental effects.
Contrary to the safer CO2 method, the Rick Simpson extraction method uses petroleum solvents to extract the active compounds from the cannabis plant. These solvents leave petroleum-based residues, which end up in the CBD oil and have been shown to impact all sorts of our body’s biological functions. Additionally, while this method is efficient (and cheaper), it generally produces products with a lower concentration of CBD.
High quality CBD hemp oil contains less than .03% of THC. Speaking of bagels, that low amount of THC can be equated to the same amount of opiates found on a poppy seed bagel. While both poppy seeds and heroin come from the poppy plant, eating fifteen bagels will not get you high. (It’ll probably make you sick to your stomach, however!) Similarly for CBD, while hemp and marijuana are related, industrial hemp is, “… low in resin, does not produce a natural abundance of THC and can be sold and imported in all 50 states (according to the 2014 US Farm Bill).”
Additionally, we use “whole plant” CBD oil. Whole plant CBD oil is extracted from the stem, seeds and stalks of the hemp plant. This oil includes not only CBD, but the full range of other natural constituents (terpenes, sugars, flavonoids, and secondary cannabinoids) that are found in all parts of hemp and are believed to work better together.
PTSD shows no bias. It affects women in abusive relationships, children in traumatic homes and veterans, post-service. Associated with chronic pain, anxiety, addiction and suicide, PTSD treatment has eluded many of the 3.5 Million Americans searching for relief.
Dr. Philip Blair, is a former military doctor conducting pre-clinical trials, has seen the positive impact CBD has made on the lives of those with PTSD. From improving quality of sleep to decreasing feelings of pain, CBD Hemp Oil has shown to improve quality of life with no significant side effects.
Presenting at the recent Cannabis World Congress & Business Expo, Dr. Blair discussed his trial with nine veterans with PTSD and their success with CBD. But before you can understand Dr. Blair’s findings, you must understand what CBD is and how it works.
CBD Hemp oil is non-psychoactive, it will not get you high. This “whole plant hemp oil,” contains CBD and the variety of other natural plant constituents (terpenes, sugars, flavonoids, and secondary cannabinoids) that are found in all parts of hemp and are believed to work better together with the endocannabinoid system.
The endocannabinoid system is a series of cannabinoid receptors involved in maintaining the body’s homeostasis, with a strong impact on feelings, mood, pain perception and movement. CBD helps to relieve the effects of PTSD by way of this system.
Of the nine veterans in Dr. Blair’s trial, 100% of them reported some sort of relief from their “repeated, disturbing memories of their stressful military experience,” after three weeks of twice a day, 5 mg servings of our Liposomes 300 CBD Hemp oil. Referred to as “extinction of fear,” these results display how a small serving of legal CBD oil can have a large effect.
With nearly 8% of the population suffering from PTSD at some point in their lives, treating it without extensive therapy and synthetic medications is of interest to many people. That’s how we believe in the power of CBD oil to heal and provide relief to so many that suffer.#