Search Results for: Epidiolex

Congresswoman Norton Requests HUD Permit Marijuana in Public Housing

DISTRICT OF COLUMBIA: Congresswoman Eleanor Holmes Norton (D-DC) wrote Secretary of Housing and Urban Development Marcia Fudge today asking her to use executive discretion to not enforce rules against marijuana use in federally assisted housing in compliance with the marijuana laws of the state where the property is located.

“Individuals should not be denied admission to or fear eviction from federally assisted housing simply for treating their medical conditions or using a substance legal under state law,” Norton said. “Increasingly, Americans are changing their views on marijuana. Marijuana is legal in 36 states and the District of Columbia, and nobody should fear being thrown out of their home for using a product legalized by their state.”

Norton is the sponsor of the Marijuana in Federally Assisted Housing Parity Act of 2021, which would permit the use of marijuana in federally assisted housing in compliance with the marijuana laws of the state where the property is located.

The letter follows:

 

May 25, 2021

The Honorable Marcia Fudge

Secretary

U.S. Department of Housing and Urban Development

451 Seventh Street SW

Washington, DC 20410

Dear Secretary Fudge:

I request that you use executive discretion to not enforce rules against marijuana use and possession in federally assisted housing, including public housing and Section 8 housing, in compliance with the marijuana laws of the state where the property is located.

Individuals living in federally assisted housing should not be denied admission, or face eviction, for using a legal product.  Adult use and/or medical marijuana is currently legal in 36 states and the District of Columbia, and over 90 percent of Americans support legalized medical marijuana.  The users of drugs that are illegal under federal law, including marijuana, are prohibited from being admitted into federally assisted housing.  Moreover, federal law allows landlords to evict residents of federally assisted housing for drug use.

The federal government has begun to change its approach to marijuana.  In 2018, the Food and Drug Administration approved Epidiolex, which is derived from marijuana.  Epidiolex is used to treat children who suffer from seizures.  For the last several years, Congress has prohibited the Department of Justice (DOJ) from using federal funds to prohibit jurisdictions from implementing their medical marijuana laws.  HUD, like DOJ, should not enforce federal marijuana laws where states have taken action to legalize marijuana.

Smoking marijuana in federally assisted housing should be treated in the same manner as smoking tobacco in federally assisted housing.

I ask that you respond in writing by June 21, 2021.

Sincerely,

Eleanor Holmes Norton

Jazz Pharmaceuticals To Acquire GW Pharmaceuticals, Creating An Innovative, High-Growth, Global Biopharma Leader

UNITED KINGDOM: Jazz Pharmaceuticals plc and GW Pharmaceuticals announced the companies have entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.

GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company’s lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex®, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.

Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.

“Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate a successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company.”

“Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Justin Gover, CEO of GW Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”

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 First Cannabis IP-Licensing Company, Breeder’s Best, Officially Launches

New company brings together cannabis industry leaders including attorney-scientist Dale Hunt, researcher-physician Ethan Russo, and botanist-author Robert C. Clarke

CALIFORNIA: Cannabis industry pioneers, Dale Hunt, PhD, JD, Ethan Russo, MD, and Robert C. Clarke have joined forces to create Breeder’s Best, the first cannabis company to focus on intellectual property (IP) protection for independent plant breeders and licensing IP for access to markets worldwide. Breeder’s Best brings a global plant-licensing model, proven successful in other agriculture industries, to cannabis.

The liberalization of global cannabis laws and growing public acceptance of cannabis have created a rapidly escalating demand for cannabis flower, as well as therapeutics and products made with cannabis. According to a report by Prohibition Partners, the international cannabis industry is projected to grow to more than $103.6 billion by 2024.

While the cannabis industry presents significant opportunity, there exists a critical disconnect that separates the creativity of breeders from the markets that are demanding products with unique and proven genetic profiles. Additionally, there is typically very little IP protection to support good partnerships between breeders and cannabis brands. Breeder’s Best will connect these two key stakeholders while legally protecting the genetic inventiveness of breeders.

Breeder’s Best founder and CEO Dale Hunt says, “Our mission is to connect the best Cannabis genetics to the greatest needs and most promising commercial opportunities. To do that, we have assembled an unparalleled team of experts with deep experience at every level of the cannabis supply chain. As the industry matures, Breeder’s Best will be positioned to meet the demands of the increasingly professional and GMP-oriented marketplace while doing business in a way that benefits breeders and directs profitable and reliable business to growers who may otherwise be left behind. With our vision, team, model, know-how, and relationships, Breeder’s Best is poised to become the global leader in patented cannabis genetics and related products.” Dr. Hunt has been practicing IP law for 23 years. He has a PhD in plant cellular and molecular biology and has obtained thousands of patents and plant variety rights for his clients in more than 30 countries.

“Cannabis use is finally normalizing. At Breeder’s Best, we present independent Cannabis breeders the opportunity to protect their unique varieties and assist them in placing those genetics in lucrative markets. This is a great service to breeders who would prefer to focus on the art and science of breeding, instead of dealing with the mechanics of commercialization,” said Breeder’s Best Director of Agronomy and Genetics, Robert C. Clarke. Mr. Clarke is a 40-year cannabis industry veteran, revered for his books Marijuana Botany, published in 1982, and Cannabis: Evolution and Ethnobotany, published in 2013.

The Cannabis plant produces over 450 chemical components, many of which are potentially therapeutic. However, decades of cannabis prohibition have resulted in a lack of genetic diversity worldwide and a predominance of only a small fraction of potential agents.

“We have just begun to scratch the surface of everything that cannabis can do to improve and enhance our lives,” said Dr. Ethan Russo. “That’s what Breeder’s Best will do. Identifying, selectively breeding for and utilizing specific chemical components will truly transform medicine in the coming decades.” Dr. Russo is a board-certified neurologist, preeminent medical cannabis expert, author of more than 50 peer-reviewed medical journal articles and a veteran of GW Pharmaceuticals where he served as Senior Medical Advisor as well as the Sativex® and Epidiolex® clinical trial Study Physician and Medical Monitor.


About Breeder’s Best:  Breeder’s Best is a privately held Cannabis IP genetics company organized as a B Corporation to demonstrate our commitment to independent Cannabis breeders and to meeting the worldwide needs of patients and consumers for superior products. To learn more about Breeder’s Best visit www.breedersbest.com.

Understanding The Medical and Recreational Benefits Of Cannabis

In 2012, the two states of Colorado and Washington sent shockwaves through the United States when they voted to legalize recreational cannabis. With these states legalizing, a domino effect has started around the country. As of 2019, the majority of states now have passed legalizations for recreational cannabis (11 states, including the District of Columbia), or medical cannabis (33 states).

People everywhere benefitted from these laws being passed. Consumers were able to go to the dispensaries for the first time to buy cannabis legally. Business owners set up dispensaries that people would flock to, and these businesses meant new employment opportunities for job seekers. Legal cannabis also saw revenue in cannabis-friendly states go nowhere but up.

With all of these new laws being passed in favor of cannabis comes a new awareness about the plant itself. More research about its medicinal qualities has come out in recent years. Cannabis is non-addictive and offers a variety of benefits for both medical and recreational users alike.

shutterstock_106154153The Medical Benefits of Cannabis

Cannabis offers many medicinal qualities to patients for all kinds of conditions. Recently, the DEA considered the reclassification of cannabis as a Schedule 1 Controlled Substance. While they regrettably didn’t reclassify cannabis, they did express their support to the further research of the plant, and worked on processes to make it easier for researchers.

Over the years, many studies have been made as to just what sorts of conditions cannabis can treat. Medical cannabis can help people with the following conditions:

  • People with epilepsy: Cannabis (notably the CBD found in the cannabis plant) can be a big helper for people suffering from epilepsy and seizures. Studies done on people taking Epidiolex (an FDA approved drug made of CBD) who were suffering from seizures experienced a mild drop in seizure occurrences.
  • People with severe pain and inflammation: Cannabis can help treat pain, as the effects felt after smoking may help to relieve the feelings of pain people with chronic issues experience.
  • People with eating disorders: Folks with eating disorders can benefit from cannabis, because it can increase a patient’s appetite and encourage them to eat more. 
  • Cancer patients: Not only can cannabis help control the feelings of nausea associated with chemotherapy, but it can also help control the vomiting. Research suggests that cannabis might also be able to reduce or even kill cancer cells, and possibly even slow the growth of tumors.
  • Depression: People who suffer from anxiety or depression can greatly benefit from cannabis. Cannabis can provide a feeling of happiness, and can help someone suffering from depression enjoy the little things more.

As you can see, cannabis offers medical patients a whole lot of healing qualities. What about recreational users, then?

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The Recreational Benefits of Cannabis

Recreational cannabis has taken many states by storm. In some of the states where cannabis is legal, law enforcement has even seen a drop in drug related stops and arrests, as well as drops in drinking and driving incidents and violent crimes.

Recreational users experience several benefits from being able to enjoy cannabis. Not every recreational user is looking to “get stoned,” but rather enjoy the benefits offered by one of the most versatile plants on the planet.

  • Liven up social gatherings. Someone having some friends over to their house might enjoy breaking out some cannabis and sharing it. Many friends and social circles were built on smoking together, and it is still a bonding experience among both friends and families today. 
  • Have a great nightcap! There are many people in the world who start drinking the minute they get home from work to deal with the day’s stress. Recreational cannabis users look forward to going home and sparking up, then just enjoying some music or a good show on the couch. Another bonus: there are no hangovers from smoking cannabis. 
  • Cannabis can bring out your creativity. Anyone who considers themselves creative can reap some benefits from cannabis. A lot of musicians, writers, artists, and actors get inspired after a good smoke. Certain strains can really unlock your creativity and get those neurons firing!

Now that you know some of the benefits offered by medical and recreational cannabis, you have to decide how you’re going to enjoy it.

Luckily, whether you choose to smoke or vape your weed, there are plenty of options around to enhance and personalize your cannabis experience.

Smoking Cannabis

Smoking is the tried and true method. It’s faster and a little cheaper initially than vaping. All you have to do is find your flower and put it in your preferred smoking device, and you’re off to the races.

Speaking of smoking devices, there is no shortage of them on the market. Beautiful glass pipes and water vases of all sorts of different designs, hookahs, and more are on offer for you to choose from at dispensaries and head shops. You can also just roll up a good old fashioned joint and pass it around.

volcano vapingVaping Cannabis

Vaping has been in the public eye for a while in the form of nicotine delivery systems. Lately, legal states have sold a lot of cannabis vapes, too. You can choose from cannabis oil vaporizers or dry herb vaporizers.

Cannabis oil vapes are refillable tanks with batteries. You can buy your favorite type of THC or CBD oil and refill your tank whenever it gets low. These can be super convenient and very discreet.

Dry herb vapes are devices that heat up dried herb. These are perfect for relaxing at home. Just insert some fresh cannabis and press the button, and you’re good to go.

No matter which type of vape you want, you will have plenty of options available at your local dispensary or online. Many reputable and popular brands offer more vapor devices than ever nowadays, with popular kits like the Volcano Vaporizer for sale and more, you’ll find something that will agree with your personality and your wallet!

Puff, Puff, Pass

As we become more and more aware of the medical and recreational benefits of cannabis, more people will have access to it and more states will continue to legalize it. This is good news for anyone who is a cannabis enthusiast, or for anyone who depends on it for medical reasons.

What’s your story with cannabis? Are you a recreational or medical user, or maybe a little bit of both? Do you prefer smoking or vaping, and what are some of your favorite products?

Hot Pot Stocks: Aurora Cannabis vs. GW Pharmaceuticals. Which Cannabis Stock To Buy?

By Cristine Felt 

Aurora Cannabis vs. GW Pharmaceuticals: Which Cannabis Stock To Buy?

In this time and age when cannabis industry is simply blooming, it appears even an inexperienced rookie could try their hand at buying cannabis stocks and shares without the slightest fear of losing. Indeed, the global market is thought to be worth some astonishing $150 billion, with the prognosis of hitting $272 billion by 2028. You may have envisioned that world popular “shut up and take my money” meme already, but it’s not that simple (as usual). Stocks rise and fall, so it’s best to rely on the companies that have been around for a while and are doing a pretty good job, to say the least – Aurora Cannabis and GW Pharmaceuticals.

But which one is a tad better? Let’s make a brief comparison.

Aurora-Cannabis-LogoAurora Cannabis

Aurora Cannabis is a Canadian cannabis producer which was founded in 2013. The company deals with the production and distribution of medical and recreational cannabis. Just saying their business is based in Canada speaks volumes. Ever since the country has legalized cannabis use in October last year, the sales have been rising, and it was excellent news for experienced players such as Aurora Cannabis.

They had a 20% market share in the last quarter of 2018. As one of the largest marijuana producers, and with expectations to produce astounding 500,000 kilograms in the near future, it appears they are a force to be reckoned with. Moreover, Aurora is Germany’s main cannabis supplier, and this European country is expected to follow Canada’s suit soon. In addition, it also exports products to 20 other countries in five continents. What is more, the announced shortage of cannabis supply is without a doubt an excellent opportunity for the company. Their latest market cap is $9.042B.

But, what about the drawbacks?

For one reason, their overall business in 2018 was not as stable as it may have seemed. Their general performance was quite disappointing, and they were listed as one of top five worst Canadian cannabis stocks. The last quarter turned out great due to the consequences of the messy legalization, which Aurora benefited from.

gwphGW Pharmaceuticals

On the other hand, we have a British biopharmaceutical company and a true pioneer in the industry. They are globally well-known due to a product of theirs called Sativex, an oral spray that is extensively used in the treatment of multiple sclerosis. They reaped huge success with it, and it is sold as a prescription drug in the UK, EU, New Zealand, Israel and Canada. GW Pharmaceuticals was set up in 1998, and their vast research experience is bearing fruit once again with the latest breakthrough in medical cannabis industry in the form of Epidiolex. In its essence, this drug is a purified CBD, and one of the reasons why Epidiolex is a revolutionary prescription drug is the fact that it was recently approved by the U.S. Food and Drug Administration for patients suffering from different types of seizure. Bearing in mind its CBD content, this is definitely an unprecedented event. Obviously, the company has made a huge step into the US market and was recognized as trustworthy (even 2-year-olds are can be prescribed Epidiolex). Naturally, the sales are expected to skyrocket and reach $1 billion per year, or even $2 billion. By the way, GW Pharmaceuticals market cap is 5.131B.

So, everything seems to be going great, but… What the company did not prepare for, and it is a bit surprising bearing in mind their experience, is the huge demand for the new drug which has surpassed the expectations and caused the shares to drop by 3% (!). Which is worse, the doubt in their business management was triggered by a simple tweet of a dissatisfied father. It makes one wonder if GW Pharmaceuticals can rise to the challenge.

Taking everything into consideration, we believe that GW Pharmaceuticals’ future shines a bit more brightly than Aurora Cannabis’. The latter is definitely a huge producer and distributor, but GW Pharmaceuticals seem to be producing medical cannabis of such high quality that even the FDA had to approve of it. After all, the winners have always been those who were able to offer something unique, extraordinary and extremely high-quality, no matter the industry, and GW Pharmaceuticals appear to be one of them.

CBD For Anxiety: The Best Products on the Market Today

Health enthusiasts attest to the broad range of CBD benefits that hemp-derived products provide. While more scientific research is encouraged, the existing research, as well as the anecdotal evidence from users, suggests that cannabidiol is an excellent pharmaceutical alternative for treating ailments like pain, anxiety, depression, and more–for example, the FDA has approved a CBD product called Epidiolex, which treats two kinds of pediatric epilepsy.

CBD products come in many forms, you can smoke CBD via vaporizer, apply it to the skin topically, ingest it in edible forms like gummies, and much more.

Arguably the most popular consumption methods are oils and tinctures, which you typically take sublingually. However, depending on how they are produced and what other ingredients are mixed in, oils and tinctures can carry earthy tastes that some customers are not fond of. Gummies, however, are a fun way to ingest CBD for pain relief and other maladies with an assortment of different flavors.

Here are a few of the best CBD products for anxiety on the market today.

Verma Farms

 

Verma Farms grows its own organic hemp and does not use pesticides. Because hemp is a bio-accumulator—meaning it absorbs other substances from its environment, such as toxins that may seep into the soil—unwanted and even harmful ingredients can sneak their way into CBD products. However, Verma does not use such toxins in its growing process and has a third-party lab test its products for purity and potency before selling them (the company also publishes the lab results online). If you want trustworthy CBD isolate products—including the best CBD oil on the market— Verma Farms is worth checking out.

Verma Farms Oil

Cannabidiol Life

 

Cannabidiol Life is based in Denver, Colorado, manufactures all of its products in-house, and is frequently inspected by the Denver Department of Health to assure quality and purity.

 

CBD Oil Geek recommends Cannabidiol Life because not only are they high-quality, but their gummies come in delicious flavors without hempy aftertastes–such as Golden Maple and Chocolate Bliss. In addition, their products come in a variety of dosages and are reasonably priced!

 

The company’s gummies use CBD isolate, but they also sell a range of other full-spectrum products. Cannabidiol Life is an excellent option if you want your CBD to come in playful shapes like worms or bears—but make sure to keep them away from children!

cbd-gummy-worms-for-sale

Green Roads

Green Roads is a renowned CBD company that sells high-quality, pharmacist-formulated products that are third-party lab tested and created from hemp grown in the US. Their website sums up what makes their gummies great,

“[Green Roads products have] universal appeal in that they offer a simple and discreet way to get your daily dose of CBD. Besides their fun and colorful appearance and fruity taste, these edibles contain all of the benefits of CBD, making them an excellent option for people looking for long-term relief over a short-term fix.”

Green Roads products are known to be highly effective and provide a host of options that range from gummies and syrups to pain cream and tea. If you want to make taking CBD a bit more fun and flavorful, Green Roads gummies are a good option.

 

CBD Edibles

Pure Kana

 

Pure Kana is a company that sells potent CBD isolate gummies—and they are vegan! An aspect that you can find with a variety of oils, but not always with edibles.

 

Each gummy has 25mg of cannabidiol and comes in natural fruit flavors. Experiencing symptoms of anxiety, depression, and pain is not limited to particular times, so Pure Kana gummies are perfect for taking CBD on the go–especially if you are hesitant or feel uncomfortable ingesting oil via a dropper in the middle of the day or in public.

CBD-Gummies-min

CBDistillery

CBDistillery offers gummies with 30mg of CBD per candy. They contain no THC, and independent test results are visible online.

CBDistillery-Gummies_DAY-1

Koi CBD

According to Koi CBD’s website:

“Unlike most CBD gummies—which spray CBD on their products—Koi takes the extra time to mix and roll our full-spectrum CBD blend into our gummies three times. Why? It evenly distributes the CBD throughout each piece, giving you the consistency and effectiveness that you deserve.”

Koi’s gummies come in flavors like tangerine, lime, and acai pomegranate. The company’s processes ensure that each piece is just as effective as any other, and their full-spectrum blend enhances the health benefits you are looking for.

Koi-CBD-Gummies

Why choose CBD Gummies?

If you are looking for the CBD for pain relief or other ailments but want to take doses whenever you want that don’t taste “hempy,” gummies might be the perfect option for you.

What are your favorite CBD gummies, and which ones are you interested in trying? Let us know in the comments below!

FDA Statement Statement From FDA Commissioner Scott Gottlieb, On Signing Of The Agriculture Improvement Act And The Agency’s Regulation Of Products Containing Cannabis And Cannabis-derived Compounds

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DISTRICT OF COLUMBIA: Today (December 20, 2018), the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.

Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.

We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD). This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products. In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act. To help members of the public understand how the FDA’s requirements apply to these products, the FDA has maintained a webpage with answers to frequently asked questions, which we intend to update moving forward to address questions regarding the Agriculture Improvement Act and regulation of these products generally.

In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area. We’ll also continue to closely scrutinize products that could pose risks to consumers. Where we believe consumers are being put at risk, the FDA will warn consumers and take enforcement actions.

In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.

We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.

These pathways include ways for companies to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis. For example, in June 2018, the FDA approved a drug, Epidiolex, that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies, which gives prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.

It should also be noted that some foods are derived from parts of the hemp plant that may not contain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. We are able to advance the lawful marketing of three such ingredients today. We are announcing that the agency has completed our evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.

Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products.

We’ll use this meeting to gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient. We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers.

At the same time, we recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities. We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

FSD Pharma Appoints Top GW Pharmaceuticals Executive As Chief Executive Officer

Management addition comes as FSD accelerates specialty cannabinoid pharmaceutical global expansion strategy

CANADA:  FSD Pharma announced today the appointment of Rupert Haynes as Chief Executive Officer. Mr. Haynes is a highly accomplished healthcare executive with nearly three decades of global pharmaceutical experience having most recently held the position of Head of Global Marketing at GW Pharmaceuticals in the United Kingdom. In his new role with FSD Pharma, Mr. Haynes will continue to work out of the United Kingdom, which will support FSD Pharma’s strategy of expanding its global footprint. Interim CEO and Co-chairman of the board, Dr. Raza Bokhari will remain in place as CEO until Mr. Haynes officially assumes the role.

“Mr. Haynes has an impressive track record in pipeline and product development which is directly relevant to FSD’s vision of becoming a global cannabinoid based pharmaceutical leader,” said Dr. Raza Bokhari, Co-chairman of the Board. “He blends world class specialty pharmaceutical experience with a fast-paced biotech mindset that will help accelerate FSD’s growth and global expansion strategy by assembling a top tier management team and pursuing targeted mergers & acquisitions. On behalf of the Board, I welcome him to the company.”

As head of Global Marketing at GW Pharmaceuticals, Mr. Haynes oversaw the strategic development of the firm’s cannabinoid portfolio including numerous cannabinoid pipeline products across dozens of therapeutic areas, but primarily neurological, neurodegenerative and neuropsychological conditions. Mr. Haynes was also involved in the strategic planning & development of Epidiolex®, an FDA-approved cannabidiol, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. Before GW, Mr. Haynes held numerous commercial roles, including senior leadership positions, at both large pharma and bespoke biotech firms which include Sobi, UCB Pharma, Bristol-Myers Squibb Ltd, UK, and Pharmacia & Upjohn Ltd, UK.

“This is an exciting time to be joining FSD,” said Mr. Rupert Haynes, CEO of FSD Pharma. “The company is advancing at a rapid pace having recently announced a pilot study for SCN-001 in irritable bowel syndrome through its collaboration with SciCann and intention to acquire Therapix Biosciences where there are active clinical trials evaluating cannabinoid combination therapies. I look forward to continuing this fast-paced pharmaceutical development which could lead to multiple significant new development programs in a very short timeframe.”

In October 2018, FSD announced its intention to acquire Therapix Biosciences to develop novel cannabinoid combination therapies in pain, migraine, and other CNS disorders. Therapix is currently evaluating THX-110, a proprietary combination drug based on dronabinol and PEA, in two ongoing Phase 2 studies in Tourette syndrome (Yale U. Medical Center) and obstructive sleep apnea (Assuta Medical Center) with a planned Phase 2 initiation in chronic back pain.

FSD partner SciCann Therapeutics, a company developing novel cannabinoid products for a range of diseases, recently announced initiation of a pilot study evaluating SciCann’s proprietary “Steady Stomach” cannabidiol combination product for the treatment of irritable bowel syndrome patients.

“We look forward to having Mr. Haynes at the helm of FSD as the company expands into the pharmaceutical industry,” said Anthony Durkacz, Co-chairman of the Board and Founder. “The Board believes that Mr. Haynes’ track record of product and pipeline development leadership on both a regional and international level, will support the transition of FSD into a global leader in the cannabinoid-based pharmaceutical space.”

“Mr. Haynes’ appointment as Chief Executive Officer builds on the incredible momentum at FSD Pharma this past year,” said Zeeshan Saeed, President and Founder. “We believe Mr. Haynes brings the vision and know-how to create long-term value for investors and new, effective treatments for conditions where there remains a need for therapeutic alternatives.”

FDA Approves Marketing Of Plant-Derived Marijuana Medicine

DISTRICT OF COLUMBIA:  Regulators at the US Food and Drug Administration on Monday granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The proprietary extract formulation – developed by the British biotechnology firm GW Pharmaceuticals – had demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. It is the fourth marijuana-based medicine to receive US FDA approval – joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.

Commenting on the agency’s decision, NORML Deputy Director Paul Armentano said: “We anticipate that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis – a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.”

Federal agencies have 90 days to determine the scheduling of Epidiolex under the US Controlled Substances Act. According to the New York Times, analysts expect Epidiolex to cost patients between $2,500 and $5,000 a month.

Despite the FDA’s approval of Epidiolex, the agency acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” FDA Commissioner Scott Gottlieb further added: “This is the approval of one specific CBD medication for a specific use. … [T]his is not an approval of marijuana or all of its components.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.