Self-Affirmed GRAS status and recent regulatory
achievements position HempFusion to meet or exceed US & global
standards for CBD products
HempFusion Wellness Inc. (TSX:CBD.U) (OTCQB:CBDHF) (FWB:8OO)
(“HempFusion” or the “Company”), a leading health and wellness
Company offering premium probiotic supplements and products
containing CBD, announces that its exclusive and proprietary
hemp-derived CBD extract has achieved self-affirmed Generally
Recognized as Safe (GRAS) status. The Company expects this to drive
significant incremental revenue growth at retail.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20220112005134/en/
The HempFusion Family of Brands Include
HempFusion, Probulin Probiotics, Sagely Naturals and Apothecanna.
(Photo: Business Wire)
“Self-affirmed GRAS status is a major milestone that only a
select few highly responsible CBD companies have achieved,” said
Jason Mitchell, N.D., HempFusion’s co-founder and Chief Executive
Officer. “Today, HempFusion and its family of brands are one of the
select few CBD companies that stand fully prepared to meet or
exceed US & global compliance standards. This puts the business
in a position to win with large retailers, and we expect this could
open new retail opportunities,” Dr. Mitchell continued.
Under the federal Food, Drug, and Cosmetic Act (FD&C Act),
an expert panel can determine a substance is generally recognized
as safe using scientific procedures. In accordance with FDA
requirements, an independent panel of qualified experts reviewed
HempFusion’s safety dossier on its hemp-derived CBD extract, which
included safety and toxicology studies, the published results of
these studies, and a comprehensive review of the scientific
literature on CBD. HempFusion is one of the only select few
companies to achieve a status of this kind, whereby the expert
panel deemed HempFusion’s hemp-derived CBD extract safe for human
consumption, thus providing a legal pathway for use in foods and
beverages and making the extract eligible for use in dietary
supplements.
“HempFusion has gone to extraordinary lengths to earn the trust
of consumers and retailers by providing scientific data
demonstrating our hemp-derived CBD extract is safe when used as
intended. We achieved this through an exclusive joint-venture with
our hemp extract supply partner Verdant Nature, LLC. HempFusion and
this extended team of esteemed research partners spent nearly three
years performing all necessary toxicology studies and conducting
additional studies using our exclusive and proprietary USDA Organic
DNA-verified industrial hemp from Verdant Nature, LLC. This data
provides the necessary safety basis to show that our proprietary
hemp extract including CBD is safe for human consumption,”
commented Dr. Mitchell.
New Dietary Ingredient Notification Readies HempFusion for
Anticipated FDA Changes
In addition to this self-GRAS status, HempFusion has also
prepared a New Dietary Ingredient Notification (NDIN) and will
submit the dossier when a regulatory pathway for the use of CBD as
a dietary supplement is established. Currently, there are three
Bills in front of Congress that could open this pathway:
- H.R. 841, which would legalize hemp-derived cannabinoids
including CBD in dietary supplements.
- H.R. 6134, which would legalize hemp-derived CBD in foods and
beverages.
- S. 1698, which would legalize hemp-derived cannabinoids
including CBD in food, beverages, and dietary supplements.
“GRAS status and a successful NDIN will likely be the standard
by which major retailers and big box companies vet brands for the
safety of their billions of loyal consumers, and HempFusion is one
of the few CBD companies with a completed dossier and ready to
act,” said Dr. Mitchell. “It’s a common misconception in the
industry that when one company achieves this level of compliance,
it applies to all other companies. In fact, every validation is
unique, requiring every company to independently evaluate whether a
dossier should be prepared and submitted, based on the specific
ingredient they are using and the raw material source.”
With self-affirmation of GRAS, upcoming NDIN, and the recent
publishing of our toxicology manuscript, HempFusion is now poised
to address major compliance issues that large retailers and online
sellers seek to overcome. International conglomerates, many of whom
have been anxiously waiting for clarity, will likely begin
acquiring compliant brands to move quickly to market.
Investors can learn more in the November 29, 2021 edition of
Hemp Industry Daily where Dr. Mitchell details Why Every Company
Should Prepare Their Own NDIN.
ABOUT HEMPFUSION
One of a select few hemp-derived CBD companies that are today
fully prepared to meet or exceed expected global guidance.
HempFusion Wellness Inc. is a leading health and wellness company
whose family of premium consumer brands include HempFusion™, Sagely
Naturals™, Apothecanna™, and Probulin Probiotics™, one of the
fastest-growing probiotics companies in the United States according
to SPINs reported data.
One of only a few CBD companies to have achieved Self-Affirmed
GRAS status, the HempFusion family of brands’ product portfolio
comprises 112 SKUs including USDA Organic Certified Tinctures,
proprietary FDA Drug Listed Over-The-Counter (OTC) Topicals,
probiotic supplements and skin care products, a Doctor/Practitioner
line, a White Label division and more. With a strong focus on
research and development, HempFusion Wellness has 43 products under
development.
Available from more than 18,000 US retail locations across all
50 states, HempFusion Wellness products are also available in
China, Mexico, Ireland, United Kingdom, United Arab Emirates, South
Korea and Canada and may be purchased online from each brand’s
website, The Probulin Store on Amazon.com, Alibaba’s Tmall.com, the
world’s largest cross-border online marketplace, and a multitude of
additional e-commerce sites.
For more information, visit www.hempfusion.com. Follow
HempFusion on Twitter, Facebook and Instagram.
FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements and
forward-looking information within the meaning of Canadian
securities legislation (collectively, “forward-looking
statements“) that relate to HempFusion’s current expectations
and views of future events. Any statements that express, or involve
discussions as to, expectations, beliefs, plans, objectives,
assumptions or future events or performance (often, but not always,
through the use of words or phrases such as “will likely result”,
“are expected to”, “expects”, “will continue”, “is anticipated”,
“anticipates”, “believes”, “estimated”, “intends”, “plans”,
“forecast”, “projection”, “strategy”, “objective” and “outlook”)
are not historical facts and may be forward-looking statements and
may involve estimates, assumptions and uncertainties which could
cause actual results or outcomes to differ materially from those
expressed in such forward-looking statements. No assurance can be
given that these expectations will prove to be correct and such
forward-looking statements included in this news release should not
be unduly relied upon. These statements speak only as of the date
of this news release. In particular and without limitation, this
news release contains forward-looking statements relating to the
Company’s brand and retail expansion plans, future opportunities
around hemp-derived CBD products and the Company’s other plans,
focus and objectives.
Forward-looking statements are based on a number of assumptions
and are subject to a number of risks and uncertainties, many of
which are beyond HempFusion’s control, which could cause actual
results and events to differ materially from those that are
disclosed in or implied by such forward-looking statements. Such
risks and uncertainties include, but are not limited to, the impact
and progression of the COVID-19 pandemic and other factors set
forth under “Cautionary Note Regarding Forward-Looking Statements”
and “Risk Factors” in the annual information form of the Company
dated March 31, 2021, and available under the Company’s profile on
SEDAR at www.sedar.com. HempFusion undertakes no obligation to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
may be required by law. New factors emerge from time to time, and
it is not possible for HempFusion to predict all of them or assess
the impact of each such factor or the extent to which any factor,
or combination of factors, may cause results to differ materially
from those contained in any forward-looking statement. Any
forward-looking statements contained in this news release are
expressly qualified in their entirety by this cautionary
statement.
Neither the TSX nor its Regulation Services Provider (as that
term is defined in the policies of the TSX) accepts responsibility
for the adequacy or accuracy of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220112005134/en/
Investor Relations: Eric Balshin +1 437-826-9911
eric@sophiccapital.com
Company Contact: Jason Mitchell, N.D. Chief Executive Officer
and Director ir@hempfusion.com
HempFusion Wellness (TSX:CBD.U)
Historical Stock Chart
From Dec 2024 to Jan 2025
HempFusion Wellness (TSX:CBD.U)
Historical Stock Chart
From Jan 2024 to Jan 2025
