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Delta, Kelowna, BC, December 5th, 2019 (Investorideas.com
Newswire) www.Investorideas.com, a global news source covering leading sectors
including marijuana and hemp stocks and its potcast site, www.potcasts.ca release today’s podcast
edition of cannabis news and
stocks to watch plus insight from thought leaders and experts.
Listen to the podcast:
Today’s podcast overview/transcript:
Good
afternoon and welcome to another episode of Investorideas.com
"Potcast" featuring cannabis news, stocks to watch as well as insights
from thought leaders and experts.
In today’s podcast
we look at a few early announcements.
But first, 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.
Dixie
Brands Inc. (CSE: DIXI.U) (OTCQX: DXBRF) today announced that the United States Patent and
Trademark Office will issue its wholly-owned subsidiary, Aceso Wellness, LLC, a
patent for a unique range of formats providing for the delivery of
cannabinoids, along with nutrients, in effervescent powder and/or aqueous
liquid forms.
The patent
application, entitled 'Cannabinoid Emulsion Product and Process for Making the
Same', encompasses a broad set of popular formats and formulations that provide
for various nutraceutical compositions including cannabinoids, supplements and
vitamins. These compositions have been configured for specific uses such as the
promotion of the immune system, improved energy levels, joint and bone health,
reduced inflammation, and more efficient cellular energy metabolism.
"This patent
is the culmination of a 3-year process and demonstrates our commitment to, and
investment in, the potential power of the inclusion of cannabinoids to help
support healthy lifestyles." says Jay Denniston C.F.S., Director of
Science, Dixie Brands. "It provides proven, efficacious formats for
consumers as they continue to explore cannabis as a plant-based, healthy
alternative to traditional pharmaceutical products."
The Company's
patented technology provides an extensive and protected platform to further
access the burgeoning US Dietary Supplement market in addition to the rapidly
emerging hemp-derived category. The US Dietary Supplement market is expected to
grow to nearly US$57 billion by 2024 (Source: Matej Mikulic, Sep 19, 2019) lead
by non-pill formats and fueled by increasing consumer awareness of nutrition, a
focus on preventative health care and a desire for solutions that are perceived
to be more natural.
"This is an
incredibly exciting development for Dixie Brands, reflecting the depth of our
R&D heritage, established over nearly a decade." said Chuck Smith,
President and CEO, Dixie Brands. "As the FDA provides positive guidance
and the category continues to grow, securing patents for our scientific
intellectual property not only provides protection for key elements of our
portfolio and optimizes shareholder value but also further supports the
continued legitimization and normalization of the cannabis industry."
The patented
technology has been commercialized by Aceso's range of hemp-derived sprays,
dissolvable tablets and powder sachets. The effervescent powder lies at the
center of the company's growth strategy in the hemp-derived CBD market due to
the existing popularity of that format in the broader health and wellness
category. The portfolio currently includes Calm, Soothe and Wellness variants
and is available in more than 1,000 brick and mortar stores across the country.
The breadth of the forthcoming patent protects the inclusion of cannabinoids in
products across a broader range of formats and channels including the regulated
cannabis marketplace.
MYM
Nutraceuticals Inc. (CSE: MYM) (OTCBB: MYMMF) announced that it has paid back the Trichome loan in
full, is now completely debt-free, and maintains a healthy cash-positive bank
balance.
Although the
Trichome loan has been fully paid and there are no further obligations from MYM
to Trichome with respect to the loan, Trichome remains supportive of the
Company exploring potential acquisitions in the future. As such, the Company
will continue its exploration to find great value, given current market
conditions, and looks forward to working with Trichome on future projects.
"We are
committed to our strategy of focused opportunistic acquisition. We remain
debt-free with the ability to potentially access additional capital should the
right opportunity present itself," said Howard Steinberg, CEO of MYM.
"With the increasingly complex capital market environment in the cannabis
industry, we believe there are companies with valuable core assets that are
poised to benefit from the restructuring expertise our team can bring, in terms
of both capital and management support."
"While we are
pleased to have been repaid on our loan, we remain supportive of MYM as they
pursue strategic options that may arise," said Michael Ruscetta, Trichome
Financials' Chief Executive Officer.
GB
Sciences, Inc. (OTCQB: GBLX) announced the execution of a Binding Letter of
Intent for the Sale of 75% of its membership interests in the Company's Las
Vegas, Nevada cultivation and production operation. This transaction will significantly reduce
the Company's operating expenses, generate near-term working capital, and
provide ongoing cashflow to enable the Company to focus solely on its
biopharmaceutical and wellness assets.
The transaction is
the next step in the Company's exit from cannabis cultivation and production.
The Company is pivoting to focus all of its capital and efforts on advancing
GBS Global Biopharma, Inc.'s scientific programs including its three patents,
four patent applications and four provisional patent applications. This is in
anticipation of interim data on the Parkinson's Disease animal studies expected
later this month, which will be readying the Parkinson's formulation for a
first-in-human trial. The Company is also developing a wellness business,
utilizing its formulations for licensing as nutraceuticals and natural health
supplements which allows earlier monetization of its patent portfolio.
At Closing, the $6
million sale of its interests in the Las Vegas operation shall include a $3
million cash payment and a $3 million promissory Note to GB Sciences with the
opportunity to sell the remaining 25% interest to the Purchaser in 18 months
from Closing. Due to the moratorium on
license transfers in Nevada, a Closing date will be set when the moratorium is
lifted. The Purchaser will immediately manage the Las Vegas facility relieving
GB Sciences from those operational expenses, provide a $500,000 credit line to
operations and GB Sciences shall benefit from any available cash flow. The Sale immediately eliminates $5.77 million
of annual operating expenses and $5 million for construction to expand the
facility's capacity to approximately 300% of its current output. After Closing, GB Sciences will continue to
receive 25% of the net profits with none of the expenses.
Andrea
Small-Howard, Chief Science Officer of GB Sciences, stated: "We think this
transaction is important to the continued success of the Company and its
shareholders. It will free-up capital to
focus on our most valuable assets through continued development of clinical
cannabis and wellness formulations for which the Company has filed numerous
patents, progressing the research on our Parkinson's Disease and Chronic
Neuropathic Pain formulations towards clinical trials and allowing us to build
a robust portfolio of nutraceutical formulations for global licensing. The Company's pivot offers tremendous
opportunity to create substantial shareholder value in this untapped segment of
the cannabis sector."
Tauriga Sciences,
Inc. (OTCQB: TAUG) today announced its plans to develop a Cannabigerol
(“CBG”) Infused product to complement its existing Cannabidiol (“CBD”) Isolate
Infused product line(s): Tauri-Gum™ and Tauri-Gummies™. The Company may,
alternatively, decide to acquire a CBG Infused product or product line – should
such opportunity prove synergistic with existing business activities and
infrastructure.
Cannabigerol
(“CBG”) is a non-psychoactive cannabinoid that plays an important role in the
biochemistry of the cannabis plant. CBG acts as a chemical precursor to other
cannabinoids such as THC and CBD. This conversion typically takes place 6-8
weeks in the flowering cycle. CBG is present only in trace amounts in most
cannabis strains, however some hemp strains are specifically cultivated to
generate higher yields of this cannabinoid.
CBG
holds promise to be a key constituent in the overall medicinal benefits
cannabis may provide. As cannabis research continues to rapidly evolve, CBG may
emerge as one of the most therapeutically applicable and diverse cannabinoids
to offer a wide range of possible remedies.
CBG
is not scheduled by the UN Convention on Psychotropic Substances. In the United States, it is not a controlled
substance under the Controlled Substances Act as long as it is not produced
from the controlled parts of the cannabis plant.
Tauriga’s
CEO Seth M. Shaw expressed, “Over the past 18 months, the Company has
established a considerable Research and Development infrastructure and
capacity. With respect to the industry
landscape and overall retail marketplace, the Company believes that the timing
is prudent to develop or acquire a CBG Infused product offering as a
diversification to Tauriga’s existing product lines. The Company places great emphasis on staying
ahead of the curve and being innovative as opposed to reactionary.”
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