This Week in Cannabis Investing December 6th

This Week in Cannabis Investing December 6th

As we move into the first week of December, The Seed Investor’s coverage was an even mix. We covered some of the biggest news items this week, but we also stepped back to take a hard look at cannabis laws and cannabis politics.

It’s been a disappointing year for the legal cannabis industry, but clearly the reasons for this have much more to do with government regulations and government effort to roll out legalized cannabis than with the execution of legal cannabis companies.

Monday, we started the week by once again making an obvious point: cannabis taxes need to be low. The only way in which the legal cannabis industry can phase out the cannabis black market (that was created by our governments) is if it can compete with the black market in the price of cannabis products.

With governments already undermining the legal industry with excessive regulation, high taxes make it virtually impossible for Canadian LP’s to compete with the black market on equal terms.

That said, we took a look at one Canadian cannabis retailer that has been making steady progress in expanding it retail store network and building its revenue. Fire & Flower Holdings (CAN:FAF / US:FFLWF). Fire & Flower now has a total retail network of 38 cannabis stores, ranking it as Canada’s new industry leader.

The Company also boasts strong financial backing. Strategic shareholder Alimentation Couche-Tard (CAN:ATD.A / US:ANCTF) has expressed a willingness to commit up to CAD $380 million in growth capital. Couche-Tard can potentially acquire majority control of Fire & Flower.

Tuesday, it was back to politics, specifically the U.S. “politics of cannabis”. The general picture is well understood. Roughly 70% of Americans support full cannabis legalization (which now includes a majority of Republican voters). Yet full legalization – at the federal level – is nowhere in sight.

Republicans are generally perceived as the primary Obstructionists with respect to overhauling the U.S.’s archaic (and unjust) cannabis laws. However, we pointed out that the Democrats have done more than enough “playing politics” with the legal cannabis industry to earn the contempt of cannabis investors.

Wednesday, we focused on specific facet of federal inaction on cannabis reform: addressing the vaping crisis. As the deaths and illnesses mount, the U.S. federal government continues to do absolutely nothing to address this serious health issue.

We pointed out that cannabis lawyers have taken note of this and have put the government on notice. There is only one real way to address the cannabis vaping deaths/illnesses from black market vaping products: legalize and regulate the cannabis industry – at the federal level.

If the federal government continues to choose to do nothing to address these mounting deaths and illnesses? We connected the dots on how and when this failure to act may lead to legal liability for the government.

Thursday, we reported on some big news in the cannabis industry this week – on the international front. Brazil, South America’s largest nation, has announced the official approval of a legal market for medicinal cannabis.

This adds a population of 211 million (potential) new cannabis consumers. That’s roughly the same size population as the number of Americans that currently have legal access to medicinal cannabis. Obviously, this market won’t get off the ground overnight.

However, Brazil is continuing its ban on cannabis cultivation. This makes this huge population base a potential export market for whatever countries (and companies) are first to capitalize.

Friday, we thought we would end the week on an upbeat note: how and why “cannabis will be everywhere”. With so much cannabis disinformation still in circulation, we continue to see a need to educate and clarify.

Cannabis is an incredibly versatile and incredibly potent medicine. But it has an unparalleled safety/tolerance profile. For precisely these reasons, governments should be encouraging cannabis use as a safe alternative to alcohol or nicotine products. The potential savings in both human lives and healthcare dollars are astronomical.

Cannabis will (eventually) be everywhere as medicine. It will be everywhere as a recreational drug, with the possible exception of societies that already outlaw alcohol use. As cannabis investors view their battered portfolios, there is plenty of cause for future optimism.

Next week, with Cannabis 2.0 products in Canada only days away from appearing on retail store shelves, we’ll spend extra time focusing on this new market. With a potential 3 million new cannabis consumers added to the legal market (an approximate 50% increase), this really is a big industry and investment driver for 2020.
 

Published at Fri, 06 Dec 2019 22:08:35 +0000

11 States That Could Legalize Cannabis in 2020

11 States That Could Legalize Cannabis in 2020

While cultivating hemp is now fully legal at the federal level, recent actions from the FDA may have the booming cannabidiol (CBD) product market pumping its brakes.

The U.S. Food and Drug Administration (FDA) recently published a revised Consumer Update, titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” where it clarifies the legality of marketing CBD products and airs its concerns about the hemp-derived compound’s prolonged health effects. 

In the Consumer Update, the FDA emphasizes that of all the oils, lotions, food, beverages and numerous other CBD products on store shelves, only one has been approved by the FDA—Epidiolex, a prescribed oral solution used to treat two rare, severe forms of epilepsy.

Otherwise, CBD that is marketed as a dietary supplement, added to food or labeled as any sort of cure or treatment for an ailment is technically illegal, as CBD products are subject to FDA regulations.

The regulatory crackdown comes on the heels of the FDA issuing warning letters to 15 companies in late November for illegally selling CBD products in ways that violate the Federal Food, Drug, and Cosmetic (FD&C) Act. The companies are required to respond with plans to correct the violations within 15 working days.

Many of the companies that received letters now have disclosures on the bottom of their web pages that explain the products were not evaluated by the FDA and are “not intended to diagnose, treat, cure or prevent any disease.”

The warning letter left some wanting answers, including Shiloh Thibodeaux, a founding member of Organix Industries Inc., doing business as Plant Organix.

“We are left with several questions regarding the warning letter. Why were we, along with 14 other companies, singled out while hundreds are left to continue business as usual? Why would the federal government legalize production and sale if only to be derailed by its own agency?” Thibodeaux says. “We are duly licensed to conduct CBD business and will respond to the FDA with legal ingredients in our products, ensuring required labeling is in place.”

Dr. Gregory Smith, the CEO of Red Pill Medical Inc., another company that received a warning letter from the FDA, tells Hemp Grower he was “pleased” to receive guidance from the agency. “There is so much confusion in the marketplace that I see this as an opportunity to work with the FDA to give companies clear guidance on what they can and cannot say. At this point, the industry simply gets told what they can’t say or do, but what we need is exact guidelines on what we can say and do,” Smith says.

In its consumer update, the FDA says it recognizes the “significant public interest” in CBD but warns of the numerous unknowns involved with using the compound in products. It adds that it is working to answer the unknowns through ongoing efforts, such as feedback from a recent FDA hearing and information through a public docket.

“As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended,” the FDA says in the Consumer Update. 

With limited data available on CBD’s health effects so far, the FDA says its chief concerns include:

  • CBD’s potential to harm users before they become aware of its effects.
  • Noticeable side effects of CBD, which include “changes in alertness” (or drowsiness), gastrointestinal issues and changes in mood.
  • The unknown aspects of CBD, which include:
    • Its effect with prolonged use.
    • Its effect on the developing brains of children.
    • Its effects on developing fetuses or breastfed newborns.
    • Its effect on others in special populations, such as the elderly, adolescents, pregnant women and pets.
    • How it interacts with other herbs, botanicals and medications.
    • Its effect on the male reproductive system.

Of notable concern is CBD’s potential for liver injury, which the FDA says it discovered during its review of the marketing application for Epidiolex. FDA says the risk can be managed under medical supervision, but its effects on general CBD users who aren’t monitored are unknown.

Another concern cited by FDA is CBD’s potential effects on the male reproductive system. FDA says studies in laboratory animals showed male reproductive toxicity, including in the male offspring of CBD-treated pregnant females. 

For some, the FDA’s concerns stir up outlandish claims not yet backed by solid evidence.

“It’s ironic that the FDA sends warning letters to CBD companies for allegedly making false claims, or medical claims, while the FDA is arguably making inaccurate, scientifically insufficient, and evidence-lacking claims about CBD and its effect on human health,” Morris Beegle, the co-founder and president of a group of hemp companies called We Are For Better Alternatives, tells Hemp Grower. “What the FDA has suggested lacks facts. This is the same fear-mongering approach governments have been using for 80-plus years.”  

Smith agrees that the FDA’s concerns regarding CBD are “a little misleading.”

“The studies showing these problems were mainly done in animals who were given incredibly high doses of cannabis (if extrapolated to humans, no one under normal conditions could consume that much cannabis or CBD) that lead to liver issues. Also, the metabolism and absorption of CBD in the mice/rat model is very different than in humans,” Smith says. “I have maintained that clinically, the safety profile of CBD is excellent, especially when compared to any prescription medication. This is not to say that consumers with medical problems taking prescription medications should not use CBD with caution. Our model since day one was to make sure that consumers that are being treated for chronic illnesses, taking prescription medications, not take CBD without consulting a physician who is educated in cannabinoid medicine.”

The FDA says it is continuing to evaluate its regulatory framework regarding CBD based on information it receives, but concrete answers from the agency may be far off. 

As the agency works to wrap its head around the increasingly popular product, it’s unclear how its stance will shape the industry. CBD products, however, are still fully marketable as long as they aren’t added to food, aren’t labeled as a dietary supplement and don’t make false claims.

Brightfield Group, a CBD and cannabis research firm, estimates the CBD market, currently worth $5 billion, will reach $23.7 billion by 2023.

Published at Fri, 06 Dec 2019 13:00:00 +0000

Akers Bio Forms Advisory Board to Explore Involvement in the Hemp and Minor Cannabinoid Market

Akers Bio Forms Advisory Board to Explore Involvement in the Hemp and Minor Cannabinoid Market

While cultivating hemp is now fully legal at the federal level, recent actions from the FDA may have the booming cannabidiol (CBD) product market pumping its brakes.

The U.S. Food and Drug Administration (FDA) recently published a revised Consumer Update, titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” where it clarifies the legality of marketing CBD products and airs its concerns about the hemp-derived compound’s prolonged health effects. 

In the Consumer Update, the FDA emphasizes that of all the oils, lotions, food, beverages and numerous other CBD products on store shelves, only one has been approved by the FDA—Epidiolex, a prescribed oral solution used to treat two rare, severe forms of epilepsy.

Otherwise, CBD that is marketed as a dietary supplement, added to food or labeled as any sort of cure or treatment for an ailment is technically illegal, as CBD products are subject to FDA regulations.

The regulatory crackdown comes on the heels of the FDA issuing warning letters to 15 companies in late November for illegally selling CBD products in ways that violate the Federal Food, Drug, and Cosmetic (FD&C) Act. The companies are required to respond with plans to correct the violations within 15 working days.

Many of the companies that received letters now have disclosures on the bottom of their web pages that explain the products were not evaluated by the FDA and are “not intended to diagnose, treat, cure or prevent any disease.”

The warning letter left some wanting answers, including Shiloh Thibodeaux, a founding member of Organix Industries Inc., doing business as Plant Organix.

“We are left with several questions regarding the warning letter. Why were we, along with 14 other companies, singled out while hundreds are left to continue business as usual? Why would the federal government legalize production and sale if only to be derailed by its own agency?” Thibodeaux says. “We are duly licensed to conduct CBD business and will respond to the FDA with legal ingredients in our products, ensuring required labeling is in place.”

Dr. Gregory Smith, the CEO of Red Pill Medical Inc., another company that received a warning letter from the FDA, tells Hemp Grower he was “pleased” to receive guidance from the agency. “There is so much confusion in the marketplace that I see this as an opportunity to work with the FDA to give companies clear guidance on what they can and cannot say. At this point, the industry simply gets told what they can’t say or do, but what we need is exact guidelines on what we can say and do,” Smith says.

In its consumer update, the FDA says it recognizes the “significant public interest” in CBD but warns of the numerous unknowns involved with using the compound in products. It adds that it is working to answer the unknowns through ongoing efforts, such as feedback from a recent FDA hearing and information through a public docket.

“As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended,” the FDA says in the Consumer Update. 

With limited data available on CBD’s health effects so far, the FDA says its chief concerns include:

  • CBD’s potential to harm users before they become aware of its effects.
  • Noticeable side effects of CBD, which include “changes in alertness” (or drowsiness), gastrointestinal issues and changes in mood.
  • The unknown aspects of CBD, which include:
    • Its effect with prolonged use.
    • Its effect on the developing brains of children.
    • Its effects on developing fetuses or breastfed newborns.
    • Its effect on others in special populations, such as the elderly, adolescents, pregnant women and pets.
    • How it interacts with other herbs, botanicals and medications.
    • Its effect on the male reproductive system.

Of notable concern is CBD’s potential for liver injury, which the FDA says it discovered during its review of the marketing application for Epidiolex. FDA says the risk can be managed under medical supervision, but its effects on general CBD users who aren’t monitored are unknown.

Another concern cited by FDA is CBD’s potential effects on the male reproductive system. FDA says studies in laboratory animals showed male reproductive toxicity, including in the male offspring of CBD-treated pregnant females. 

For some, the FDA’s concerns stir up outlandish claims not yet backed by solid evidence.

“It’s ironic that the FDA sends warning letters to CBD companies for allegedly making false claims, or medical claims, while the FDA is arguably making inaccurate, scientifically insufficient, and evidence-lacking claims about CBD and its effect on human health,” Morris Beegle, the co-founder and president of a group of hemp companies called We Are For Better Alternatives, tells Hemp Grower. “What the FDA has suggested lacks facts. This is the same fear-mongering approach governments have been using for 80-plus years.”  

Smith agrees that the FDA’s concerns regarding CBD are “a little misleading.”

“The studies showing these problems were mainly done in animals who were given incredibly high doses of cannabis (if extrapolated to humans, no one under normal conditions could consume that much cannabis or CBD) that lead to liver issues. Also, the metabolism and absorption of CBD in the mice/rat model is very different than in humans,” Smith says. “I have maintained that clinically, the safety profile of CBD is excellent, especially when compared to any prescription medication. This is not to say that consumers with medical problems taking prescription medications should not use CBD with caution. Our model since day one was to make sure that consumers that are being treated for chronic illnesses, taking prescription medications, not take CBD without consulting a physician who is educated in cannabinoid medicine.”

The FDA says it is continuing to evaluate its regulatory framework regarding CBD based on information it receives, but concrete answers from the agency may be far off. 

As the agency works to wrap its head around the increasingly popular product, it’s unclear how its stance will shape the industry. CBD products, however, are still fully marketable as long as they aren’t added to food, aren’t labeled as a dietary supplement and don’t make false claims.

Brightfield Group, a CBD and cannabis research firm, estimates the CBD market, currently worth $5 billion, will reach $23.7 billion by 2023.

Published at Fri, 06 Dec 2019 18:05:00 +0000

Puration Inc. (OTCMKTS:PURA) Finalizes Acquisition To Bring Bottling of CBD Beverage to Europe

Puration Inc. (OTCMKTS:PURA) Finalizes Acquisition To Bring Bottling of CBD Beverage to Europe

Puration Inc.
(OTCMKTS:PURA)
has announced that it has finalized
the acquisition of a Germany company. This will enable Puration to bottle its
CBD drinks locally and supply them throughout Europe.

Puration takes
EVERx CBD Sports Water to Europe

The acquisition comes at the back of Puration, entering
a distribution agreement to supply its EVERx CBD Sports water and other
beverages in Europe. The distribution agreement will add approximately $4
million in sales in 2020.according to the management, the European market is
huge, and the sales projection needed the establishment of a local bottling
capacity.

By 2023 the CBD market in Europe will be around $17 billion. The expansion to Europe is part of the company’s strategy to expand the bottling of beverages outside Latin America and Canada. The company has indicated that it will close the acquisition on November 14.

The company has already started marketing the EVERx CBD
Sports Water in Europe. The company launched the beverage at the Arnold
Schwarzenegger Sports Festival In Barcelona. The water was introduced first in
2017 at the Arnold Classic in Ohio in 2017. It has grown to be part of the
global Arnold Sports Festival events.

EVERx Sports Water is a leading CBD infused beverage that is growing sales rapidly. In the first half of this year, the company generated sales of $1 million from the water, and it is targeting sales of around $4 million by the end of 2019. This will be different from the current anticipated $4 million from the distribution agreement.

Puration
Announces LOI for an acquisition in Latin America

Besides the acquisition in German, the company also announced a possible acquisition in Latin America same as that of Germany. The acquisition is designed to enhance foothold for the company to bottle the CBD infused beverages locally in Latin America. The Latin America CBD market is budding, and it is showing signs of massive potential. By 2028 it is estimated that the market will hit $9 billion.

Published at Fri, 22 Nov 2019 13:05:11 +0000

Atalo Holdings Launches New Consultation Subsidiary

Atalo Holdings Launches New Consultation Subsidiary

MINNESOTA DEPARTMENT OF HEALTH, Dec., 2, 2019–PRESS RELEASE– The Minnesota Department of Health (MDH) announced Monday it will add chronic pain and age-related macular degeneration as new qualifying conditions for the state’s medical cannabis program. Under state law, the new conditions will take effect in August 2020.

MDH also approved two new delivery methods to give patients more options. The new methods being added are water-soluble cannabinoid multi-particulates (for example, granules, powders and sprinkles) and orally dissolvable products such as lozenges, gums, mints, buccal tablets and sublingual tablets.

The program’s two medical cannabis manufacturers will double the number of patient cannabis treatment centers in accordance with legislation passed during the 2019 Minnesota Legislative Session. These new sites will mean greater access to cannabis treatment centers. The manufacturers selected eight locations for additional centers. Leafline Labs has proposed centers in Willmar, Mankato, Golden Valley and Rogers, while Minnesota Medical Solutions has proposed centers in Woodbury, Blaine, Duluth and Burnsville.

Minnesota Commissioner of Health Jan Malcolm said the changes give patients more options, particularly in light of concerns about potential health impacts of e-cigarettes and vaping.

“We hope the addition of new delivery methods will provide a potential alternative to vaping for some patients and that the additional centers will provide more convenient access,” Commissioner Malcolm said.

Commissioner Malcolm explained that the two new qualifying conditions were added to allow patients more treatment options for conditions that can be debilitating.

“Minnesota’s medical cannabis program tracks patient experiences so we can learn about the real-world benefits and downsides of using medical cannabis for various conditions,” Commissioner Malcolm said. “The generally positive experience patients have had using medical cannabis to treat intractable pain prompted us to add chronic pain as a qualifying condition. Meanwhile, the decision to add age-related macular degeneration was due to a lack of good treatment options for managing symptoms.

“The bottom line is that people suffering from these serious conditions may be helped by participating in the program, and we felt it was important to give them the opportunity to seek that relief,” Commissioner Malcolm said.

Adding chronic pain will allow patients with pain to more easily access medical cannabis as an earlier treatment option. In 2016, MDH added intractable pain to the program. As defined by state law, intractable pain is pain whose cause cannot be removed and, according to generally accepted medical practice, the full range of pain management treatments appropriate for the patient have been used without adequate result or with intolerable side effects.

As in years past, MDH used a formal petitioning process to solicit public input on potential qualifying conditions. Throughout June and July, Minnesotans submitted petitions to add qualifying conditions. Following this petition period, the process included public comments and a citizens’ review panel. MDH staff also prepared a set of documents summarizing the available research pertaining to the use of medical cannabis for each prospective condition.

In addition to the newly approved conditions, MDH received petitions for four other conditions: anxiety, insomnia, psoriasis and traumatic brain injury. The petitions were rejected because the conditions had been petitioned previously and this year’s petitions did not include new scientific evidence.

Under current state rules, patients certified to chronic pain or age-related macular degeneration will become eligible to enroll in the program on July 1, 2020, and receive medical cannabis from the state’s two medical cannabis manufacturers beginning Aug. 1, 2020. As with other qualifying conditions, patients will need advance certification from a Minnesota health care provider. More details on the process are available on the Medical Cannabis website.

When the 2014 Minnesota Legislature authorized the creation of a medical cannabis program, the law included a set of nine conditions qualifying a person to receive medical cannabis. State rules direct the commissioner of health to consider each year whether to add other qualifying conditions and delivery methods. The current list of qualifying conditions includes:

  • Cancer associated with severe/chronic pain, nausea or severe vomiting, or cachexia or severe wasting
  • Glaucoma
  • HIV/AIDS
  • Tourette’s syndrome
  • Amyotrophic lateral sclerosis (ALS)
  • Seizures, including those characteristic of epilepsy
  • Severe and persistent muscle spasms, including those characteristic of multiple sclerosis
  • Inflammatory bowel disease, including Crohn’s disease
  • Terminal illness, with a probable life expectancy of less than one year
  • Intractable pain
  • Post-traumatic stress disorder
  • Autism spectrum disorders
  • Obstructive sleep apnea
  • Alzheimer’s

Currently permitted delivery forms include liquid (including oils), pills, vaporizable liquids or oils, and topical applications. The two new delivery methods will become effective Aug. 1, 2020. Minnesota law does not permit smokable or edible forms of medical cannabis.

Published at Fri, 06 Dec 2019 21:25:00 +0000

Minnesota Increases Medical Cannabis Program Access

Minnesota Increases Medical Cannabis Program Access

While cultivating hemp is now fully legal at the federal level, recent actions from the FDA may have the booming cannabidiol (CBD) product market pumping its brakes.

The U.S. Food and Drug Administration (FDA) recently published a revised Consumer Update, titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” where it clarifies the legality of marketing CBD products and airs its concerns about the hemp-derived compound’s prolonged health effects. 

In the Consumer Update, the FDA emphasizes that of all the oils, lotions, food, beverages and numerous other CBD products on store shelves, only one has been approved by the FDA—Epidiolex, a prescribed oral solution used to treat two rare, severe forms of epilepsy.

Otherwise, CBD that is marketed as a dietary supplement, added to food or labeled as any sort of cure or treatment for an ailment is technically illegal, as CBD products are subject to FDA regulations.

The regulatory crackdown comes on the heels of the FDA issuing warning letters to 15 companies in late November for illegally selling CBD products in ways that violate the Federal Food, Drug, and Cosmetic (FD&C) Act. The companies are required to respond with plans to correct the violations within 15 working days.

Many of the companies that received letters now have disclosures on the bottom of their web pages that explain the products were not evaluated by the FDA and are “not intended to diagnose, treat, cure or prevent any disease.”

The warning letter left some wanting answers, including Shiloh Thibodeaux, a founding member of Organix Industries Inc., doing business as Plant Organix.

“We are left with several questions regarding the warning letter. Why were we, along with 14 other companies, singled out while hundreds are left to continue business as usual? Why would the federal government legalize production and sale if only to be derailed by its own agency?” Thibodeaux says. “We are duly licensed to conduct CBD business and will respond to the FDA with legal ingredients in our products, ensuring required labeling is in place.”

Dr. Gregory Smith, the CEO of Red Pill Medical Inc., another company that received a warning letter from the FDA, tells Hemp Grower he was “pleased” to receive guidance from the agency. “There is so much confusion in the marketplace that I see this as an opportunity to work with the FDA to give companies clear guidance on what they can and cannot say. At this point, the industry simply gets told what they can’t say or do, but what we need is exact guidelines on what we can say and do,” Smith says.

In its consumer update, the FDA says it recognizes the “significant public interest” in CBD but warns of the numerous unknowns involved with using the compound in products. It adds that it is working to answer the unknowns through ongoing efforts, such as feedback from a recent FDA hearing and information through a public docket.

“As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended,” the FDA says in the Consumer Update. 

With limited data available on CBD’s health effects so far, the FDA says its chief concerns include:

  • CBD’s potential to harm users before they become aware of its effects.
  • Noticeable side effects of CBD, which include “changes in alertness” (or drowsiness), gastrointestinal issues and changes in mood.
  • The unknown aspects of CBD, which include:
    • Its effect with prolonged use.
    • Its effect on the developing brains of children.
    • Its effects on developing fetuses or breastfed newborns.
    • Its effect on others in special populations, such as the elderly, adolescents, pregnant women and pets.
    • How it interacts with other herbs, botanicals and medications.
    • Its effect on the male reproductive system.

Of notable concern is CBD’s potential for liver injury, which the FDA says it discovered during its review of the marketing application for Epidiolex. FDA says the risk can be managed under medical supervision, but its effects on general CBD users who aren’t monitored are unknown.

Another concern cited by FDA is CBD’s potential effects on the male reproductive system. FDA says studies in laboratory animals showed male reproductive toxicity, including in the male offspring of CBD-treated pregnant females. 

For some, the FDA’s concerns stir up outlandish claims not yet backed by solid evidence.

“It’s ironic that the FDA sends warning letters to CBD companies for allegedly making false claims, or medical claims, while the FDA is arguably making inaccurate, scientifically insufficient, and evidence-lacking claims about CBD and its effect on human health,” Morris Beegle, the co-founder and president of a group of hemp companies called We Are For Better Alternatives, tells Hemp Grower. “What the FDA has suggested lacks facts. This is the same fear-mongering approach governments have been using for 80-plus years.”  

Smith agrees that the FDA’s concerns regarding CBD are “a little misleading.”

“The studies showing these problems were mainly done in animals who were given incredibly high doses of cannabis (if extrapolated to humans, no one under normal conditions could consume that much cannabis or CBD) that lead to liver issues. Also, the metabolism and absorption of CBD in the mice/rat model is very different than in humans,” Smith says. “I have maintained that clinically, the safety profile of CBD is excellent, especially when compared to any prescription medication. This is not to say that consumers with medical problems taking prescription medications should not use CBD with caution. Our model since day one was to make sure that consumers that are being treated for chronic illnesses, taking prescription medications, not take CBD without consulting a physician who is educated in cannabinoid medicine.”

The FDA says it is continuing to evaluate its regulatory framework regarding CBD based on information it receives, but concrete answers from the agency may be far off. 

As the agency works to wrap its head around the increasingly popular product, it’s unclear how its stance will shape the industry. CBD products, however, are still fully marketable as long as they aren’t added to food, aren’t labeled as a dietary supplement and don’t make false claims.

Brightfield Group, a CBD and cannabis research firm, estimates the CBD market, currently worth $5 billion, will reach $23.7 billion by 2023.

Published at Wed, 04 Dec 2019 17:45:00 +0000

Auxly Clears Key Milestones for Phase Two Cannabis Product Sales: Agreements in Place and Listings Secured for Derivative Product Sales Across Canada Beginning December 16

Auxly Clears Key Milestones for Phase Two Cannabis Product Sales: Agreements in Place and Listings Secured for Derivative Product Sales Across Canada Beginning December 16

Auxly Cannabis Group Inc. (TSX.V – XLY) (“Auxly” or the “Company”) today announced that it has entered into an agreement with every Canadian province (except Quebec) to commence sales of cannabis 2.0 products (extracts, edibles and topicals) and has secured in excess of 250 listings in the aggregate for its vape, chocolate and chewable products across nine provinces. This development, following the Company’s submission to Health Canada of new product notifications for 83 derivative cannabis products announced in October, means that Auxly will be ready to sell vapes, chocolates and chewables beginning December 16 when the sale of those products becomes legally permitted. These new product formats will be added to the oil-based products in bottle and spray formats that the Company recently began shipping for sale in certain provinces, all of which are produced at Auxly’s wholly owned, state-of-the-art, 52,000 square foot facility, Dosecann.

“This is a major milestone for us,” said Hugo Alves, CEO of Auxly. “Our team has been working toward the launch of our derivative product portfolio for over 20 months and seeing the hugely positive reactions to our thoughtfully developed brands and products from provincial purchasers, our distribution partner, Kindred, and consumer focus groups has been immensely satisfying and motivating for the entire Auxly family. It is a huge accomplishment to be ready for commercialization on day one, right across the country – it speaks to the talent and dedication of our people and our organization-wide focus on winning in the cannabis 2.0 market. We are very much looking forward to bringing our branded cannabis products to Canadian consumers from coast to coast and we are committed to winning consumer confidence and trust through the quality, consistency and efficacy of our products.”

Led by Dosecann’s Chief Product Innovation Officer Peter Crooks, founder and former CEO of Canada’s Smartest Kitchen, the Company has formulated what it believes will be some of the highest quality and best tasting cannabis chocolates and chewables available to consumers anywhere in the world. Together with Peter and his team, Auxly is committed to being a category leader in cannabis 2.0 by leveraging the powerful combination of Dosecann and its clinical capabilities at KGK Science to bring consumers new and innovative product formats backed by research and science.

Similarly, the Company is confident that its branded vape products, produced using quality hardware tuned specifically to Auxly’s proprietary in-house formulations and made using Dosecann’s validated processes, will provide Canadian consumers with a differentiated and unique user experience. Like all of Auxly’s derivative products, its vapes have been developed with consumer safety at the heart of the product development process. The Company has gone above and beyond applicable regulatory requirements with both its hardware and its formulations to earn the trust of Canadian consumers.

The Company’s launch of 2.0 derivative products will be sold under the Kolab, Foray and Dosecann brands. Auxly anticipates launching tablet, capsule and lozenge formats beginning the first half of 2020 and topical formats in Q3 of 2020, and entering the Quebec market as soon as required regulatory approvals have been obtained.

ON BEHALF OF THE BOARD

Hugo Alves” CEO

About Auxly Cannabis Group Inc. (TSX.V: XLY) (OTCQX: CBWTF)

Auxly is an international cannabis company dedicated to bringing innovative, effective, and high-quality cannabis products to the medical, wellness and adult-use markets. Auxly’s experienced team of industry first-movers and enterprising visionaries has secured a diversified supply of raw cannabis, strong clinical, scientific and operating capabilities and leading product research and development infrastructure in order to create trusted products and brands in an expanding global market.

Learn more at www.auxly.com and stay up to date at Twitter: @AuxlyGroup; Instagram: @auxlygroup; Facebook: @auxlygroup; LinkedIn: company/auxlygroup/.

Investor Relations:

For investor enquiries please contact our Investor Relations Team:
Email: IR@auxly.com
Phone: 1.833.695.2414

Media Enquiries (only): 

For media enquiries or to set up an interview please contact:
Sarah Bain, VP External Affairs
Email: sarah@auxly.com
Phone: 613.230.5869

Notice Regarding Forward Looking Information:

This news release contains certain “forward-looking information” within the meaning of applicable Canadian securities law. Forward-looking information is frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or information that certain events or conditions “may” or “will” occur. This information is only a prediction. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking information throughout this news release. Forward-looking information includes, but is not limited to: the successful production and launch of the Company’s new derivative products; the timeline for the launch of additional product formats; the timeline and ability of the Company to enter the Quebec market; the Company’s execution of its product development and commercialization strategy; consumer preferences; political change, future legislative and regulatory developments involving cannabis and cannabis products; and competition and other risks affecting the Company in particular and the cannabis industry generally.

A number of factors could cause actual results to differ materially from a conclusion, forecast or projection contained in the forward-looking information in this release including, but not limited to, whether: Kolab and Dosecann are able to maintain their sales licenses and are able to obtain and maintain all other necessary governmental and regulatory authorizations and permits to conduct business; the acceptance and demand for future Company products by consumers and provincial purchasers; and general economic, financial market, regulatory and political conditions in which the Company operates will remain the same. Additional risk factors are disclosed in the revised annual information form of the Company for the financial year ended December 31, 2017 dated May 24, 2018.

New factors emerge from time to time, and it is not possible for management to predict all of those factors or to assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking information. The forward-looking information in this release is based on information currently available and what management believes are reasonable assumptions. Forward-looking information speaks only to such assumptions as of the date of this release. In addition, this release may contain forward-looking information attributed to third party industry sources, the accuracy of which has not been verified by the Company. The purpose of forward-looking information is to provide the reader with a description of management’s expectations, and such forward-looking information may not be appropriate for any other purpose. Readers should not place undue reliance on forward-looking information contained in this release.

The forward-looking information contained in this release is expressly qualified by the foregoing cautionary statements and is made as of the date of this release. Except as may be required by applicable securities laws, the Company does not undertake any obligation to publicly update or revise any forward-looking information to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or results, or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Published at Thu, 05 Dec 2019 12:32:32 +0000

Does U.S. Government Face Potential LIABILITY For Vaping Deaths?

Does U.S. Government Face Potential LIABILITY For Vaping Deaths?

The death (and illness) toll continues to rise.

As of the most recent update from the CDC, 47 U.S. vaping-related deaths have now been confirmed, with 2,290 cases of “associated lung injury reported”. Almost all of these deaths/illnesses have been attributed to black market cannabis and tobacco vaping devices.

The CDC has identified vitamin E acetate as a suspected cause of these deaths and illnesses. Vitamin E acetate is banned from legal vaping products.

When the U.S. government abandoned its disastrous experiment with alcohol Prohibition, one of the main reasons for doing so was to protect U.S. alcohol consumers from deaths and injuries from black market alcohol – moonshine.

But when it comes to cannabis consumers?

Nero continues to fiddle while Rome burns.

Here investors need to understand that governments are not immune from the consequences of their own reckless behavior.

While the U.S. government has general immunity from legal liability (for mere negligence), there is an extensive statutory list of “exceptions” to this immunity from liability.

When the “vaping crisis” first arose, the U.S. federal government was exposed as being negligent. Had cannabis already been federally legalized and regulated, arguably none of these deaths/illnesses would have occurred. At worst, casualty figures would have been slashed.

There are now mountains of empirical evidence that there was never any medical or legal justification for criminalizing cannabis. Conversely, as cannabis has been legalized – piecemeal – across the United States, cities and states have experienced only positive benefits from legalization.

In short, there is no legal excuse for the U.S. government (or any other government) in continuing to criminalize cannabis.

As more and more Americans sicken and die from black market vaping products, the U.S. federal government is refusing to address its own negligence. And it has no legitimate excuse of any kind for this omission.

This escalates the culpability of the federal government from mere negligence to recklessness: choosing to ignore the obvious danger to U.S. consumers.

Arguably, this already meets the threshold necessary for U.S. courts to contemplate waiving U.S. sovereign immunity. And U.S. lawyers are starting to take note.

A new article in Insurance Journal is revealing.
 

Vape Crisis Prompts Calls for Greater Clarity in Cannabis Regulation

Cannabis industry lawyers are calling for greater clarity around regulation of the cannabis industry.

Panelists at the 2019 Professional Liability Underwriting Society (PLUS) Conference in Washington D.C. this month said the ongoing vape crisis in particular highlights the need for better regulation.

“I think the [cannabis] industry is saying to the federal government, ‘Look, the time of the federal government’s only policy response to marijuana being criminal enforcement is over,’” said Ian Stewart, co-chair of Wilson Elser’s Cannabis Law practice. “This is now a public health crisis, people are dying because it’s not regulated.” [emphasis mine]

If federal politicians and regulators were to pull their heads out of their asses long enough to look around, they might perceive this as a threat.
 

Your time is up. This is now a public health crisis. People are dying because cannabis is not legal and regulated.

A clear causal connection has been established between this political failure (at the federal level) and the rising death toll among the American people.

What is being done in Washington? Nothing at all.

The House just voted on what Democrat’s are calling “marijuana legalization”. It’s not.

It’s mere decriminalization. This (partisan) bill has zero chance of being passed. Decriminalization does nothing at all to protect Americans from tainted black market vaping products. Mere decriminalization actually makes it easier for the cannabis black market to operate.

The U.S. government is now refusing to address its own recklessness on the vaping crisis. The NY Times has already described this health threat as “an epidemic”.

What comes (legally) after recklessness? Malice.

In this context, legal malice would be defined as “a callous disregard for human life” on the part of the U.S. federal government: ignoring the loss of American lives because it simply doesn’t care.

Today, cannabis lawyers are starting to fire salvos in the direction of the U.S. federal government.

Tomorrow? If at any point, litigation lawyers perceive the federal government as being malicious in its refusal to legalize and regulate cannabis nationally, the lawyers will be lining up to file suit against the United States government.

 

Published at Wed, 04 Dec 2019 11:00:01 +0000

Natural Cannabis Odor Control: Q&A with OMI Industries’ Dr. Laura Haupert

Natural Cannabis Odor Control: Q&A with OMI Industries’ Dr. Laura Haupert

Whether a cannabis cultivator is growing outdoors, in a greenhouse or in an indoor facility, odor can quickly become an issue. It’s imperative for operations to consider and implement odor control technology in the initial buildout, before neighbors are affected.

Equally important is finding an odor control solution that is both safe and effective for the community, employees and the plants.

Dr. Laura Haupert is the Director of Research and Development for OMI Industries, a provider of natural odor-eliminating technology specific to the cannabis market. She explains how OMI’s solution works, why it’s safe and effective and how cultivators can work with their local communities to mitigate odor issues before they arise.

Cannabis Business Times: How does OMI’s odor control solution work? Can you provide a brief overview of the science behind it?

Dr. Laura Haupert: We developed Ecosorb CNB 100 specifically for control of cannabis grow odors. Like all our products, Ecosorb CNB 100 is a blend of natural plant oils, which is the part of the plant that gives it its odor. We only use steam-distilled plant oils, which means, for example, if you had a pine tree and you had a pine cone, you would take that pine cone and heat it with water to pull the oil off. That’s a simplified version, but it’s essentially what we do to isolate the natural oils. We only use plant oils that are removed that way. You can also extract the plant oils using solvents, but solvents can react with the plant oils, producing new hazardous compounds, and we don’t want to affect the natural plant oils.

Then we blend bio-based surfactants with the natural plant oils. Bio-based surfactants means that it is derived from plants and other renewable materials. With bio-based surfactants, you have to use more than one chemical from a plant, you put them together, and you have a new compound (the bio-based surfactant). So, it’s not natural anymore because you altered it by putting two chemicals together (as a note, water is a chemical), but every part of the surfactant comes from plants. We also use a reverse osmosis system so that we have highly purified water.

Our products have to make contact with the odors in order to neutralize the odor itself. If you’re at a greenhouse, both indoor and outdoor, cannabis plants are going to release odors in the form of volatile organic compounds (VOCs). Even if it’s an outdoor grow, you have odors that are coming off of those cannabis plants. The VOCs being released from the plants smell, and that’s where we step in. The first step to our odor control working is making contact with the odor-causing chemical compounds. You have to make sure that our product, Ecosorb CNB 100, gets released in the air in droplet form and can attach to the odor molecule. We call this process adsorption. It’s a binding of the odor molecule to the surface of the droplet. This is done by using our vapor phase systems that allow for small droplets of to be released in the same location as the odors (vents of grow house for example). We use vapor phase technology, which is convenient and durable for any condition. To do this, we run PVC piping around the perimeter of your facility so when that odor comes out and is exhausted out, the Ecosorb CNB 100 product is right there to make contact with it

As soon as our product is vaporized into the air and makes contact (adsorbed), it is then absorbed, which means that odor molecule gets absorbed into the droplet. Once the odor molecule is inside of the droplet, the odor is under control and the odor molecule is not released. You’re not going to smell the odorous chemical compound anymore. In addition, acid/base reaction can take place between the Ecosorb CNB 100 and the odor-causing chemicals, resulting in an organic salt that does not smell.

CBT: What is the significance of using natural ingredients in an odor control solution? Why are these ingredients safe and effective?

LH: We use natural plant oils because they are very effective at removing odors. We also use plant-based ingredients to ensure a level of safety for all those who may use or come into contact with our products. Because we use plant-based ingredients, our products are non-toxic.

If you’re standing outside in a forest, that’s the feeling you want to get when you’re using our products. We don’t use any synthetic fragrances at all—that’s not in our vocabulary.

CBT: How can cannabis cultivators effectively explain their odor control efforts to regulators? How can they work with the community and key stakeholders on the issue?

LH: We have a team internally that does odor testing. This team goes out into the field to measure odor units and give customers a real-time analysis of their current odor unit level. If you’re at a greenhouse and your nearest neighbor is 100 feet away, we could send that team out to your nearest neighbor and show them how much of the odor is being reduced.

Our team has helped customers share this information in hearings before, and we’ve also helped customers get permits if need be. Regulatory guidelines change frequently, and our team is always available and willing to help our customers with these issues. Many local regulators require air permits, and if this is the case, having an odor control plan in place from the beginning will help ensure you are given an air permit and experience less issues down the road.

Regulatory issues aside, many times it comes down to neighbors complaining about odor, which pushes the city council to step in and require documentation to prove that odor control practices are in place and that they’ve both safe and effective. This is where our team steps in to help.

The key is to be a good neighbor, and controlling odor allows you to do that.

CBT: How can cultivators prevent complaints initially?

LH: The key is to implement an odor control solution from the start because you know the plant is going to create odor. You can’t stop that from happening. Every plant gives off its natural essence, and that’s going to happen no matter what strains of cannabis you grow. If your nearest neighbor is 20 miles away, sure, you might not need odor control, but most of the time, your nearest neighbor is a lot closer than that.

Editor’s Note: This interview has been edited for style, length and clarity.

Published at Tue, 03 Dec 2019 18:44:00 +0000

Cannabis Business Times’ Top 10 Articles of 2019

Cannabis Business Times’ Top 10 Articles of 2019

The past year saw continued growth for the cannabis industry, with Illinois legalizing adult-use and new opportunities in hemp after the passage of the 2018 Farm Bill last December. 2019 wasn’t without its challenges, however, as an outbreak of vape-related lung injuries swept the nation at the end of the summer and states wrestled with cannabis policy reform and regulation.

With 2020 rapidly approaching, we rounded up Cannabis Business Times’ top 10 most popular articles of 2019.

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10. Patient Access Dwindles in Michigan After Closure of More Than 70 Unlicensed Medical Marijuana Dispensaries

In early 2019, Michigan forced more than 70 unlicensed medical cannabis dispensaries to close after a state-issued Dec. 31 licensing deadline, severing many patients’ access to their medication. The story didn’t end there, however, as the state’s licensing board then extended the licensing deadline to March 31 and allowed the retailers to reopen, at the recommendation of Gov. Gretchen Whitmer. Read more

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9. Illinois Lawmakers Consider Two Adult-Use Cannabis Legalization Proposals

At the beginning of the year, Illinois lawmakers were presented with two proposals to legalize adult-use cannabis—one introduced by Rep. Carol Ammons (D-Urbana) and one introduced by Sen. Heather Steans (D-Chicago) and Rep. Kelly Cassidy (D-Chicago). The legislation drafted by Steans and Cassidy ultimately became the Cannabis Regulation and Tax Act (CRTA), which passed the legislature in May and was signed into law by Gov. J.B. Pritzker in June. Read more

JuditaJurkenaite | Adobe Stock

8. 2018 Farm Bill: Opportunities in Hemp

The 2018 Farm Bill federally legalized industrial hemp and its derived products, and states were charged with developing new regulatory plans. In our January 2019 issue, Husch Blackwell’s Steve Levine and Benjamin Jones outlined next steps for businesses looking to cash in on opportunities in the newly legal industry. Read more

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7. CVS and Walgreens Plan to Carry CBD Products: What’s Next for the Rapidly Growing Market?

CVS Pharmacy and Walgreens announced plans in March to carry CBD-infused products in select stores, bringing to life Brightfield Group’s 2018 prediction that chain retailers would support the rapid growth of the hemp-derived CBD market in 2019. We spoke with Brian Baum, CEO of CBD product manufacturer Cannovia, and Celeste Miranda, CEO of the CBD Expo Tour, about how small businesses could find their niche and continue educating customers as big box stores entered the space. Read more

6. What Is the Science Behind White Ash and Black Ash?

In our June 2019 issue, we explored whether the longstanding popular belief that white ash is “good” was nothing more than a myth. Dr. Allison Justice, co-founder of SC Botanicals and founder of The Hemp Mine, and Dr. Markus Roggen, founder of Complex Biotech Discovery Ventures, concluded that the manipulation of temperature and light with the goal of chlorophyll degradation and sugar transformation are major contributors to a pleasant smoke and “white” ash, not a good pre-harvest “flush.” Read more

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5. Yellowing Leaves?

In our May 2019 issue, we explored how to meet the nitrogen needs of cannabis for each life stage, from rooting to flowering. As “Nutrient Matters” authors Brian Whipker, James Turner Smith, Paul Cockson and Hunter Landis laid out, nitrogen is needed in the largest quantity of all the nutrients provided by growers to stimulate plant growth. Read more

Courtesy of Cresco Labs

4. 10 Cannabis Harvesting and Post-Harvest Tips

Cresco Labs Cultivation Manager Jessica Ryan outlined her top pointers for the processing, drying and curing stages in our January 2019 issue to help cultivators achieve connoisseur-grade cannabis every crop cycle. Depending on the strain, it’s time to harvest when the pistils have turned amber and the trichomes are no longer translucent, Ryan wrote. Read more

Ryland Zweifel | Adobe Stock

3. 2019 State Cannabis Legislation: The Bills to Watch

State lawmakers from New Hampshire to New Mexico introduced legislation to decriminalize and legalize cannabis at the start of the year. Which ones came to fruition? Read more

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2. New Research Results: Optimal pH for Cannabis

Although the recommended substrate pH for cannabis varies widely, a recommended substrate pH of 6.0 to 6.5 often is cited as the standard, according to “Nutrient Matters” columnists Brian Whipker, James T. Smith, Paul Cockson and Hunter Landis in our March 2019 issue. In this column, the North Carolina State University researchers explore the underlying factors affecting pH in substrates and how those fluctuations impact the cannabis plant in order to determine the optimal pH range for cannabis. Read more

capjah | Adobe Stock

1. What’s In Your Vape Cartridge?

Cartridge contents are produced in a multitude of ways, resulting in extracts that can contain many different ingredients, both cannabis-derived and not. In our February 2019 issue, Trichome Technologies’ Kenneth Morrow examined both cartridges and their contents. As the year went on, this cartridge primer only became more relevant and vital for the industry. Read more

Published at Mon, 02 Dec 2019 13:00:00 +0000

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