FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

The Benefits Of CBD Oil For Sleep Disorders And Insomnia

One of the most important components of life is sleep. The way we sleep at night largely influences the behavior and performance we provide the next day. More and more people are suffering from a form of chronic sleep disorder. Specialists believe that certain medication can  contribute to insomnia, especially as this disorder is a frequent side effect of antidepressants.

On the other hand, people who are taking sleeping pills, to get rid of insomnia, can become addicted to these drugs. This state of dependence appears when the treatment is stopped. Symptoms like tremors, nausea, anxiety, changes in blood pressure, muscle cramps may then occur.

Since drugs generate addiction and can lead to abuse, people are looking for natural options to minimize the negative effects. In this sense, cannabidiol has become a viable medical alternative. Here is how CBD is not only a healthy alternative to sleeping pills but it can counteract many factors that cause sleep disturbances.

What is Insomnia?

Insomnia is the sensation of inadequate or poor repose due to problematic sleep, frequent night awakening with difficulty in falling asleep again.

Insomnia is classified as:

  • Transient (short-term) – lasting from one night to a few weeks;
  • Intermittent (appears and disappears) – where the episodes appear from time to time;
  • Chronic (constant) – insomnia occurs in most nights, at least three times a week for more than a month.

Insomnia may occur due to emotional, neurological or medical disorders as well as a result of stimulant medications or alcohol/drug addiction. 

insomnia too

What Illnesses Can Insomnia Hide?

In most cases, insomnia is based on psychiatric pathology, ie neurosis (depression, anxiety) or psychosis (schizophrenia and related disorders). Insomnia also occurs in thyroid disorders, alongside depression and appetite disorders.

Insomnia may appear in patients with adrenal gland disorders, as well as patients with advanced cirrhosis when hepatic encephalopathy occurs. Last but not least, this disease occurs in patients with cardiac pathology, especially due to decompensation in the evening or at night.

How Does CBD Work?

CBD works through the endocannabinoid system (ECS). In our body, this system produces its own cannabinoids. ECS regulates processes such as our mood and appetite, as well as our perception of pain.

CBD interacts with the endocannabinoid system and its receptors having numerous beneficial effects as research results suggest.

CBD Oil

Image source: Pexels.com

The Effects of CBD on Sleep

CBD is a constituent of the plant called cannabis. Another constituent of this plant is THC. Both substances are known for their beneficial effects. However, THC also has a psychoactive effect, unlike CBD. Hemp plants contain a high CBD concentration.

Several studies have shown that CBD can have a medicinal effect on a wide range of health problems. One of these problems is insomnia. CBD not only makes sleeping easier but also influences the sleep cycle.

Sleep divides into several cycles with different phases. Insomnia occurs during the rapid eye movement (REM) stage, called REM parasomnia. In this phase, active behavior and nightmares will take place during dreams. This is a category of sleep disorders that involves behaviors, emotions and abnormal movements. It is also characterized by loss of muscles’ capacity to relax during REM sleep.

Cannabidiol has strong anxiolytic, anticonvulsant and sedative effects. CBD oil has the ability to control these disturbing symptoms because it directly affects CB1 receptors in the brain, an important receptor that is responsible for multiple actions of the central nervous system.

In addition, CBD decreases the duration of REM sleep. By reducing this phase, people dream less, memory improves and symptoms of depression are lowered. Blood tests have shown that CBD oil influences dopamine levels in the blood during sleep. This leads to a better, relaxed sleep alongside lower destructive behavior.

In sleep disturbance, the same component called CBD, by its anxiolytic effect, blocks anxiety states induced in REM sleep state, which makes a person suffering from this disorder have a longer sleeping time; therefore, recover fast from damages provoked by previous insomnia episodes.

Recommended CBD Oil Dosage in Sleeping Disorders?

The first thing to look for, when decided to consume CBD oil, is its purity. This applies in any case, regardless of the medical disorder encountered. If it is not in its pure state, containing 100% CBD oil, this treatment may have weaker results. Moreover, when it is not in a pure state, this oil may comprise other chemicals which promote allergies.

Hellomello.life offers lab-tested, 100% natural CBD oil which may come in handy in treating sleep disorders and insomnia. Unlike other medical treatments, this CBD oil does not give addiction and does not have other side effects on brain chemistry, in neither short or long-term.

For sleep disorders, the recommended CBD oil dosage shall fall between 40 mg-160 mg of CBD taken orally. The exact amount taken depends on the user’s body weight and tolerance, as well as the concentration of CBD per ml of oil. The higher the body weight, the greater is the dosage of CBD oil.

In some cases, users develop a tolerance to the consumption of CBD oil, meaning that once ingested effects take longer to appear. In this case, it is advisable to increase the usual dosage.

Final Thoughts

Cannabidiol (CBD) is a component of Cannabis sativa plant that has an extensive range of potential beneficial effects in neuropsychiatric and other disorders. Insomnia is among disorders that finds its cure in CBD oil.

Sleep is very important for the body’s recovery and if this becomes insufficient it can affect your health. The main cause of insomnia today stays the stress, which in the long run remains harmful to the body.

Among the most common reasons for using CBD oil is the effect of relieving stress and anxiety. Cannabidiol has great efficacy in relaxing the mind, reducing stress and inducing calmness, being a good solution to combat insomnia and sleep disorders.

How To Use CBD Oil For Fibromyalgia

According to the NFA (National Fibromyalgia Association), about 10 million people in the States suffer from fibromyalgia. This chronic condition is manifested through pains, aches, exhaustion, stiffness, tender areas, and sleeping issues.

The standard treatment for fibromyalgia includes several types of prescription medications including pain relievers, antidepressants, and anti-seizure medications. However, these drugs are known to result in unwanted side effects or, in some cases, they prove to be completely inefficient.

For these reasons, many people suffering from fibromyalgia turn to alternative solutions such as CBD.

CBD for Firbro

What Exactly is Fibromyalgia

Fibromyalgia is a chronic condition which manifests through pains in the bones and muscles, chronic fatigue, and tender areas. The symptoms of fibromyalgia are subjective and the causes are not yet clear and, for that reason, it is often incorrectly diagnosed as another disease.

Doctors and medical researchers still don’t know the exact cause of fibromyalgia, but they have been able to determine several factors that might work together to cause it: genetics, stress, trauma, infections, as well as certain diseases like rheumatoid arthritis and lupus. Gender can be another risk factor since 80%-90% of all fibromyalgia patients are women.

Since there aren’t any objective, reproducible tests, many medical professionals deny the existence of fibromyalgia as a separate disease. Still, the number of doctors who accept it as a real disorder is growing and researchers are working actively to understand it and find a more effective treatment.

While there is still no pharmaceutical drug specifically made for fibromyalgia, the FDA has approved 3 pre-existing prescription drugs for treating moderate to severe fibromyalgia symptoms: the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), as well as the anti-seizure medicine pregabalin (Lyrica).

Additionally, doctors may also write “off-label” prescriptions, which aren’t officially approved, but may treat specific fibromyalgia symptoms in certain patients.

While these often work as effective pain treatments, they still don’t always pinpoint patients’ symptoms. Plus, they often come with undesirable side effects, and patients might quickly build a tolerance to them.

Many doctors believe that certain lifestyle changes and natural supplements may be even more effective in treating fibromyalgia than prescription drugs. One of these alternative solutions is CBD oil. CBD oil is appealing to fibromyalgia patients because of their anti-inflammatory properties and less frequent occurrence of side effects.

What is CBD?

CBD (cannabidiol) is one of the 100+ compounds found in the cannabis plant. When used in very concentrated forms, like CBD oil, cannabidiol offers a number of health benefits.

Still, many people refuse to use CBD due to previous negative experiences with marijuana. It’s important to note that CBD is not psychoactive and won’t make users high. The compound that has mind-altering properties is actually THC (tetrahydrocannabinol), another compound found in the cannabis plant.

While THC triggers a release of dopamine, CBD interacts with the endocannabinoid system, which helps regulate mood, pain sensitivity, and sleep.

Can CBD Help with Fibromyalgia?

Even though extensive research regarding the efficiency of CBD for treating fibromyalgia is lacking, the initial results are quite promising.

Research conducted in 2013 suggests that CBD can relieve pain caused by various conditions that involve chronic pain including fibromyalgia, multiple sclerosis, migraine, irritable bowel syndrome, and arthritis.

The effectiveness of CBD in relieving pain is explained by its ability to interrupt the pathways that send pain signals to the brain. In addition, CBD binds with neurotransmitters in the human body called endocannabinoids, thus changing the way humans process pain.

CBD also has anti-inflammatory properties which help reduce swelling and heat caused by diseases or injuries which, in turn, alleviates pain.

These anti-inflammatory properties leave a huge connection between CBD and fibromyalgia, as it is generally regarded as an inflammatory disease and, as such, experts advise the use of treatments that specifically target inflammation.

Evidence proving CBD’s anti-inflammatory properties have spurred more research on how it affects symptoms of chronic and acute pain, as well as how it impacts inflammation and neuropathic pain. For instance, one 2012 study found that CBD reduces inflammation by turning off receptors that would sharpen pain sensitivity, while one 2009 review concluded that CBD was a strong enough source of pain relief that it could be used as a powerful adjunct to pain medications.

Plus, as chronic pain has become the biggest reason why people use CBD, quality brands are recognizing that this condition can refer to a variety of conditions by creating specialty CBD products. In this case, CBD specifically formulated for fibromyalgia is an option.

For example, Every Day Optimal offers Fibromyalgia Relief CBD Capsules, which are made with 25 mg pure CBD per capsule, along with 60 different vitamins and minerals proven to help the onset of fibromyalgia symptoms, including alpha lipoic acid, magnesium, and Acetyl L-Carnite.

This product is ingested in capsule form, making it a convenient way to naturally boost the endocannabinoid system with beneficial phytocannabinoids.

Still, more research is necessary to understand how CBD can help with fibromyalgia. Scientists are trying to understand why CBD works in some patients while it fails to help others. They’re also debating whether the compound should be used alone or in combination with THC in order to boost its health benefits.

How to Use CBD Oil for Fibromyalgia

Since the FDA hasn’t approved the use of CBD for medical purposes, there is no official RDA (recommended daily allowance) or prescribed dosage of CBD for fibromyalgia. The dosage depends on various factors including the person’s weight, age, metabolism, diet, genetics, as well as the severity of the condition and the consistency of the CBD oil itself.

As with any supplement or medication, it’s recommended to start with a small dosage and increase gradually.  Begin with a single drop of CBD oil on the first day of use to allow the body to adapt. Carefully observe if there are any negative reactions and, if that’s not the case, increase the dosage to two drops. Continue increasing every week or so until you notice the desired results.

It’s also recommended to discuss the use of CBD for fibromyalgia with a medical professional who is knowledgeable about both the condition and CBD.

Finally, make sure to obtain your CBD oil (or any other CBD product) from a quality source. Ideally, this would be your health provider but if you’re ordering online, look for brands that offer certificates of lab tests and list the amounts of CBD and THC on their label. This way, you’ll maximize the health benefits and minimize the side effects.

Are There Any Side Effects from CBD

Even though the side effects of CBD are rare, some people have reported the following:

  • nausea
  • dizziness
  • drowsiness
  • dry mouth
  • diarrhea
  • fatigue
  • changes in appetite
  • anxiety
  • mood swings

Is the Use of CBD Legal?

Even though several US states have legalized the use of CBD, it’s still illegal at the federal level.

All CBD products derived from industrial hemp are legal in all 50 US states, whereas CBD products obtained from marijuana are legal for recreational use in only 8 US states.

Since CBD is considered a byproduct of marijuana (which is rich in psychoactive THC), it is legal only for medicinal use in forty-six US states. In Idaho, Kansas, Nebraska, and South Dakota all CBD products are illegal.

If you’re considering CBD as a fibromyalgia treatment, make sure to check its legal status in your state. Taking CBD in a state where it is illegal can put you in legal jeopardy.

CBD Oil

In Conclusion

Fibromyalgia is a chronic condition and CBD oil won’t cure it. However, it may be effective in mitigating and even eliminating its symptoms.

The efficiency of CBD depends on a number of factors including the severity of the condition, as well as the individual being treated. In some cases, CBD can be more effective when combined with prescription medication and/or other alternative remedies.

However, if you’re suffering from fibromyalgia, make sure to consult your doctor before you begin using CBD, especially if you’re already taking prescription medications, to avoid any negative reactions.

The legal status of CBD varies and it is advised that you check the local laws before buying any CBD products.


Every Day Optimal CBD is the nation’s leading supplier of USA made CBD products. Our Fibromyalgia product is Derived From Non-GMO, CBD-Rich Hemp and has 25mg of CBD and 17 essential vitamins in each recommended serving. Each bottle contains 60 capsules, 1 capsule per serving. This product is available in all 50 states. Order today!

Fibro_Relief_CBD

Case Report: Daily CBD Administration Associated With Remission Of Schizophrenic Symptoms

GERMANY: The adjunctive use of cannabidiol is associated with a remission in schizophrenic symptoms in a patient previously unresponsive to conventional treatment, according to a case report published in the Australian & New Zealand Journal of Psychiatry.

Investigators from the University of Leipzig in Germany assessed the use of twice-daily dosing of 750mg of CBD in conjunction with clozapine in a patient with treatment-resistant schizophrenia. Cannabidiol dosing was associated with remission criteria and improvements remained consistent over eight months.

“Our case report contradicts the assumption that CBD is not likely to be any superior than existing antipsychotics,” authors concluded. “In fact, CBD might be particularly suitable for those patients [who are] resistant to antipsychotics due to its different mode of action.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Remission of severe, treatment-resistant schizophrenia following adjunctive cannabidiol,” appears in the Australian & New Zealand Journal of Psychiatry.

Study: CBD Effective As Adjunctive Therapy For Schizophrenia

UNITED KINGDOM: The daily administration of CBD (cannabidiol) as an adjunctive therapy mitigates psychotic symptoms in patients with schizophrenia, according to clinical trial data published online ahead of print in The American Journal of Psychiatry.

British researchers assessed the adjunctive use of CBD compared to placebo over a six-week period in a randomized trial of 88 schizophrenic patients. Participants ingested 1000mg of plant-derived CBD per day in addition to their conventional medications.

Subjects in the CBD treatment group “had lower levels of positive psychotic symptoms and were more likely to have been rated as improved and as not severely unwell by the treating clinician” at the conclusion of the trial. CBD administration was also associated with “improvements in cognitive performance and in the level of overall functioning,” although these changes did not reach statistical significance.

“These findings suggest that CBD has beneficial effects in patients with schizophrenia,” authors concluded. “As CBD’s effects do not appear to depend on dopamine receptor antagonism, this agent may represent a new class of treatment for the disorder.”

Results of a prior clinical trial published in the journal Translational Psychiatry determined that CBD is superior to amisulpride, a potent anti-psychotic agent, in mitigating psychotic symptoms in schizophrenic patients.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Cannabidiol (CBD) as an adjunctive therapy in schizophrenia: A multicenter randomized controlled trial,” appears in The American Journal of Psychiatry.

Pharmacist Launches New CBD Company, Honest Herbal; Takes Top Honors in DOPE Competition

COLORADO: Kristy Redmon, Honest Herbal president, founder and a registered pharmacist, announced that the company is the recipient of two DOPE Cup Colorado awards. The full-spectrum CBD hemp company placed first in the Best CBD Edible category for its capsules and took second place for Best Transdermal Cream.

“We were thrilled to have our products recognized in the DOPE Cup competition,” said Redmon. “As a new company, we had no idea what to expect. To have won a first and second place was an honor and an affirmation to our philosophy of providing consistent, fully tested and trustworthy CBD hemp products.” The awards are especially impressive as they come just a few months after Honest Herbal’s official launch.

All of Honest Herbal’s products are pharmacist formulated from cannabinoid rich industrial hemp, making them legal in all 50 states. Honest Herbal’s in-house breeding program has produced strains of CBD flower that are high in CBD yet low in THC. The results are products with all the beneficial health and wellness properties, yet without the psychoactive elements inherent in cannabis, with which most people are familiar.

Honest Herbal offers CBD Hemp Oil Capsules available in strengths of 12.5mg. and 25mg. For pets or those who prefer a liquid form, Honest Herbal offers a 30ml CBD Hemp Extract, complete with a calibrated dropper for accurate dosing.

Honest Herbal’s CBD Muscle & Joint Cream is a transdermal formulation that is easily and quickly absorbed through the skin and is one of the most potent CBD topicals in the industry. Consumers can also take advantage of the company’s luxurious and nourishing CBD Infused Hand and Body Lotion that can be used every day.

Honest Herbal grows, processes, and produces its entire product line giving the company the unique ability to ensure the quality of its products from their inception all the way to store shelves. Wholesaler inquiries are now being accepted on the company website.

 

Report: CBD Interacts with Anti-Epileptic Drugs

New research published in Epilepsiaa journal of the International League Against Epilepsy (ILAE), suggests that an investigational neurological treatment derived from cannabis may alter the blood levels of commonly used anti-epileptic drugs. It is important for clinicians to consider such drug interactions during treatment of complex conditions.

Cannabidiol (CBD), a compound developed from the cannabis plant, is being studied as a potential anticonvulsant, and it has demonstrated effectiveness in animal models of epilepsy and in humans. An ongoing open label study (Expanded Access Program) conducted by investigators at the University of Alabama at Birmingham is testing the potential of CBD as a therapy for children and adults with difficult to control epilepsy. The study includes 39 adults and 42 children, all of whom receive CBD.

Because all of the participants are also taking other seizure drugs while they are receiving the investigational therapy, investigators checked the blood levels of their other seizure drugs to see if they changed. “With any new potential seizure medication, it is important to know if drug interactions exist and if there are labs that should be monitored while taking a specific medication,” said lead author Tyler Gaston, MD.

Dr. Gaston and her colleagues found that there were significant changes in levels of the drugs clobazam (and its active metabolite N-desmethylclobazam), topiramate, and rufinamide in both adults and children, and zonisamide and eslicarbazepine in adults only. Except for clobazam/desmethylclobazam, however, the drug levels did not change outside of the normally accepted range. In addition, adult participants in the study taking clobazam reported sedation more frequently.

Tests also showed that participants taking valproate and CBD had higher ALT and AST (liver function tests) compared with participants not taking valproate. Very high ALT and AST indicate abnormal liver function, but significant ALT and AST elevation occurred only in a mall number of participants (4 children and 1 adult), and the levels returned to normal after discontinuation of valproate and CBD.

“While the interaction between CBD and clobazam has been established in the literature, there are currently no published human data on CBD’s potential interactions with other seizure medications,” said Dr. Gaston. “However, given the open label and naturalistic follow-up design of this study, our findings will need to be confirmed under controlled conditions.”

The findings emphasize the importance of monitoring blood levels of antiepileptic drugs as well as liver function during treatment with CBD. “A perception exists that since CBD is plant based, that it is natural and safe; and while this may be mostly true, our study shows that CBD, just like other antiepileptic drugs, has interactions with other seizure drugs that patients and providers need to be aware of,” said Dr. Gaston.

 

The Cannabrander: CBD + Co. A First Product Case Study

By Ben Weinberg 

CBD + Co. produces pharmaceutical grade cannabidiol (CBD) in a well-equipped laboratory northeast of Boulder, Colorado.  “Our chief innovation is a water-soluble isolate that can be ingested sublingually,” relates Founder Stephen Bernard, a mechanical engineer who has spent more than a decade in the cannabis industry.  This means it continues to release active ingredients in a biocompatible way even after being swallowed.  It’s a major step, and given his company’s focus it makes no sense to follow the branding practices of stoner subculture, “not if we want to reach serious people while providing legitimacy to the business of cannabis.”

Bernard and Alex Cullota, the company’s Cofounder, first looked at other available CBDs, which are most popular as tinctures (alcoholic extracts that don’t fit everyone’s taste).  They then incorporated their water-soluble isolate into honey, a natural product with positive health connotations.  Another critical decision was to package Honey Drops in blue glass, representative of laboratory packaging, instead of subculture-standard colors and materials.

According to Cullota, a veteran consultant in chemicals, oil, gas, and construction, such tactics build on CBD + Co.’s reputation for bringing the science of cannabis front-and-center.  “We cater to ‘Productive Potheads’, people who use cannabis to do creative things, and our branding proposition reflects this.”

The Hard Part

Of course, there have been stumbles along the way.  Facebook shut down Bernard’s personal page, and early on there were misunderstandings about online marketing.  “We originally built big,” explains Douglas Wilson, a former military man who now consults for CBD + Co. in IT and cybersecurity, “with an expensive website that wasn’t exactly turnkey.  But we had no effective content management and we weren’t sure if we could actually sell something about which we couldn’t openly converse.”

Wilson bursts through this paradigm via the clever use of pictures and videos depicting bright, sunny places where consumers engage in productive activities such as yoga, gaming, and athletics.  “We’re changing the image of the cannabis user by showing off the science behind a healthy lifestyle that includes our products.”

Cullota believes that the closest space in this regard is Big Pharma, and that many branding problems can be solved by looking there.  “Drug companies sell their most controversial products by socially engineering their target markets.  This usually involves aligning the general perception of their drugs with productive lifestyle choices.”

Wilson also believes that simply pointing out the government’s acceptance of CBD and other compounds via U.S. patent can help people accept life empowering solutions.  To quote the patent abstract, “Cannabinoids have been found to have antioxidant properties… This newfound property makes cannabinoids useful in the treatment and prophylaxis of a wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune…”  Spreading awareness via the major actors in CBD-manageable illnesses, primarily chronic pain issues such as fibromyalgia and arthritis, and neurodegenerative quirks like cerebral palsy and epilepsy, also make intuitive sense.

The Future

The company continues to innovate as a major part of its value proposition.  “We’re currently isolating tetrahydrocannabinol (THC) and THCA,” says Bernard, “and we’re working on THCV, cannabigerol (CBG), and cannabinol (CBN).”  It’s taken CBD + Co. three years to get to this point, and the plan is to continue to improve incrementally while creating qualitative differences versus the competition.  A long-term goal is to eventually sell to Big Pharma and anyone else who needs high quality, cannabis derived compounds.

The Bottom Line

Branding a cannabis related product, particularly a company’s first foray into the marketplace, can be a distinct challenge.  One way to cut through the chaff of subculture is to focus on pictures and especially video as a form of social engineering that leans toward the customers who represent the best of your targeted market.

 


Ben Weinberg, JD, MBA, the President of Ben Weinberg Consultants, has more than 30 years of experience in harnessing his creativity to tell your company’s story, including strategic and tactical marketing, sales, operational, and administrative consulting for small- and medium-size businesses across diverse industries such as law, medicine, wellness, leisure, and hospitality. Ben has written professionally for many international magazines and newspapers, online and in print, including as a contributing editor and Editor-in-Chief, is a member of the American Society of Journalists and Authors, and has won multiple awards for creative writing.

Hoban Law Group Files Ninth Circuit Petition To Challenge Recent DEA Classification of “Marihuana Extracts”

COLORADO: In an overreach of authority and without consulting Congress, the Drug Enforcement Administration (DEA) issued its Final Rule, the “Establishment of New Drug Code for Marihuana Extract,” on Dec 14, 2016. In response to the change, which serves to potentially devastate developing businesses and consumer, textile and manufacturing industries related to industrial hemp and other lawfully derived cannabinoids, Hoban Law Group has filed a petition in San Francisco’s United States Court of Appeals for the Ninth Circuit to challenge what appears to be the DEA’s attempt to control an otherwise lawful substance.

The petition, filed on January 13, 2017 in California’s United States Court of Appeals for the Ninth Circuit, is on behalf of three Petitioners: the Hemp Industries Association (an industrial hemp trade organization representing an array of industrial hemp industry actors); RMH Holdings, LLC (which sources its products from industrial hemp lawfully cultivated pursuant to the Agricultural Act of 2014 (also known as the Farm Bill)); and Centuria Natural Foods, Inc. (which lawfully imports certain exempted parts of the Cannabis plant, and oils and derivatives there from, such as stalks and fibers). The recent Final Rule substantially impacts businesses long operating in compliance with existing laws that now could be facing significant change in existing policy. These adverse impacts are caused by the Final Rule’s attempt to create a drug code encompassing all cannabinoids as Schedule 1 substances without reflecting the parts of the Cannabis plant which are Congressionally exempted from the definition of “marihuana” under the Controlled Substances Act and/or are exempted from treatment as a controlled substance.

“This is an action beyond the DEA’s authority. This Final Rule serves to threaten hundreds, if not thousands, of growing businesses, with massive economic and industry expansion opportunities, all of which conduct lawful business compliant with existing policy as it is understood and in reliance upon the Federal Government.” -Hoban Law Group Managing Partner Bob Hoban.

Unfortunately, the DEA’s Final Rule exceeds the authority granted it by Congress and is inconsistent with the language of the Controlled Substance Act and other laws applying to industrial hemp. The genus Cannabis sativa L. contains over 80 cannabinoids, such as those commonly known as tetrahydrocannabinol (THC) and cannabidiol (CBD). The DEA’s Final Rule takes the position that the mere presence of any cannabinoid extracted from the Cannabis plant automatically renders that substance a “marihuana extract,” despite no cannabinoid except for (synthetic) THC being expressly scheduled under the Controlled Substances Act. This reclassification contradicts the DEA’s acknowledgement in the past that certain cannabinoids exhibit different effects: THC is known for psychoactive properties, whereas CBD, CBG and other cannabinoids are not commonly associated with psychoactive properties. In addition, the DEA’s Final Rule fails to recognize that cannabinoids can be derived from sources other than the Cannabis plant, such as a certain South African daisy, some chocolates, human breast milk and black pepper, highlighting the point that where or from what plant the cannabinoids originated is very difficult to prove.

Though the DEA has referred to their recent Final Rule as a “mere recordkeeping measure,” Hoban Law Group is acting swiftly on behalf of the Petitioners to ensure that continued lawful pathways remain available for industrial hemp companies seeking to remain compliant with federal law. The Final Rule raises concern that this type of overreach could become more commonplace, continuing to widely affect many industrial hemp companies and a wide variety of products currently marketed for sale. Whether the DEA’s motives are negligent or intentional, a primary concern is that this “mere recordkeeping” is a misuse of the drug code that could lead to abuse and misunderstanding of the law by other local, state and federal agencies and an unwarranted chilling effect upon the industrial hemp industry.

Notably, the DEA has sought to unilaterally reclassify cannabinoids before, and lost. See Hemp Indus. Ass’n. v. DEA357 F.3d 1012, 1014 (9th Cir. 2004); Hemp Indus. Ass’n v. DEA333 F.3d 1082, 1089 (9th Cir. 2003).

Texas Department of Public Safety Releases Confiscated Hemp CBD Oil

TEXAS: On September 7, Texas Hemp Industries Association (TXHIA) received notice that the Texas Department of Public Safety (DPS) arrived at People’s Pharmacy’s four (4) Austin locations to confiscate various industrial hemp Cannabidiol (CBD) products.  On October 11, DPS reported to People’s pharmacy’s attorney the following:

“Attached is the lab report regarding the ‘CBD hemp oil’ from People’s Pharmacy.  The report indicates the presence of cannabidiol (CBD). The report does not indicate any detectable tetrahydocannabinol (THC).  Given certain ambiguities regarding the status of CBD under the Texas Controlled Substances Act (CSA), the department, after consulting with prosecutors, does not intend to pursue enforcement action based on the tested substance.  This discretionary enforcement decision does not constitute a general opinion about the legality of any product,” wrote D. Phillip Adkins, General Counsel, Texas Department of Public Safety.

Sheila Hemphill, Policy Director for TXHIA states, “Since January of 2016, we are aware of seven known conflicts with law enforcement, fortunately none have resulted in a conviction. Ambiguity in the law related to the status of CBD under the TCSA has caused general confusion, unnecessary expenditures by law enforcement, legal expenses and untold stress to innocent consumers and businesses. This event with People’s pharmacy demonstrates the necessity for our upcoming Texas Legislature to define industrial hemp as an agriculture crop separate from the marijuana definition in the CSA.”

Industrial hemp is not new to Texas and prior to prohibition, a 1938 Popular Mechanics article stated, “hemp grows luxuriously inTexas.”  At a recent Cochran County Farm Bureau meeting near Lubbock, attendees interested in growing this historical crop adopted a resolution approving the cultivation of industrial hemp suitable for seed, oil, fiber, and CBD, with a vote of seventy to one.  Coleman Hemphill, TXHIA Executive Director emphasized that, “our farmers are expressing a need for new beneficial crops to remain solvent through drought and profitable in down markets.  Industrial hemp needs half the water required by cotton and historically cotton has been Texas’ largest cash crop.  Lowered market prices for commodities and the loss of subsidies are jeopardizing our Texas farmer’s viability.”