HempFusion Wellness Submits Novel Foods Dossier to the United Kingdom’s Regulatory Food Safety Agency
March 03 2021 - 7:05AM
Business Wire
HempFusion Wellness Inc. (TSX:CBD.U) (OTCQX:CBDHF) (FWB:8OO)
("HempFusion" or the "Company"), a leading health and wellness CBD
company utilizing the power of whole-food hemp nutrition, is
pleased to announce that it has submitted its dossier to the United
Kingdom's Regulatory Food Safety Agency (the "FSA").
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HempFusion, in conjunction with its strategic and exclusive
supply chain partner, has submitted its novel foods application to
the FSA with the coordination of a leading regulatory agency in
Europe. This submission represents the first step in the United
Kingdom’s (the “UK”) regulatory approval process required to allow
products that contain CBD to be sold on the shelves of retailers in
the UK. The submission includes a detailed analysis of the quality,
stability and safety of HempFusion's raw ingredients and many
unique product formulations. In addition to proprietary heirloom
hemp-sourcing and state-of-the-art low pressure and low-temperature
C02 extraction methods, the submission also includes compliant
labeling and testing requirements and complete toxicology data.
The Company's focus on compliance and sourcing premium raw
materials further substantiates the quality of HempFusion's
exclusive Organic Panoramic Hemp Extract and strategically
positions HempFusion for continued sales within one of the largest
markets in Europe, the UK. HempFusion believes the submission is an
essential step in preparing for anticipated European Union (the
“EU”) regulations.
"We believe the UK's decision to allow CBD companies to obtain a
Novel Food Authorization from the FSA is a tremendous step forward
for the global CBD industry," commented Jason Mitchell, N.D.,
HempFusion's Co-Founder and Chief Executive Officer. "HempFusion
was built on the pillars of regulatory compliance. We have invested
significant time, resources, and energy to ensure our products meet
the highest standards, and we are pleased to report our submission
includes completed toxicology data, which may represent one of the
most complete submissions to date. We look forward to working with
the FSA as regulations continue to evolve within the UK. This
submission firmly establishes HempFusion as a future leader within
the UK market,” continued Dr. Mitchell.
The novel food application's primary function is to assess CBD
product safety, including detailed toxicology studies. HempFusion
places significant importance on safety for its consumers as
evidenced by its participation and co-sponsoring of many studies
and clinical trials, such as the Company’s participation in
ValidCare’s liver and reproductive toxicity study, believed to be
the largest CBD human observational study to date.
The Company has recently entered Europe through Ireland and
looks forward to maintaining its long track record of compliance by
meeting the requirements of the FSA ahead of its broader planned
expansion throughout the UK and the EU to further establish it as a
global leader.
ABOUT HEMPFUSION
HempFusion is a leading health and wellness CBD company
utilizing the power of whole-food hemp nutrition. HempFusion
distributes its family of brands, including HempFusion, Probulin
Probiotics, Biome Research, and HF Labs, to approximately 4,000
retail locations across all 50 states of the United States and
select international locations. Built on a foundation of regulatory
compliance and human safety, HempFusion’s diverse product portfolio
comprises 48 SKUs including tinctures, proprietary FDA Drug Listed
Over-The-Counter (OTC) Topicals, Doctor/Practitioner Lines and
more. With a strong focus on research and development, HempFusion
has an additional 30 products under development. HempFusion is a
board member of the US Hemp Roundtable, and HempFusion’s
wholly-owned subsidiary, Probulin Probiotics, is one of the
fastest-growing probiotics companies in the United States,
according to SPINs reported data. HempFusion’s CBD products are
based on a proprietary Whole Food Hemp Complex™ and are available
in-store or by visiting HempFusion online at www.hempfusion.com or
www.probulin.com.
Follow HempFusion on Twitter, Facebook and Instagram and
Probulin 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 continued sales within the UK, preparation for
anticipated EU regulations, compliance with the requirements of the
FSA, planned expansion throughout the UK and the EU 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 “Forward-Looking Statements” and “Risk Factors” in the
final long form prospectus of the Company dated December 17, 2020
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/20210303005322/en/
Jason Mitchell, N.D. Chief Executive Officer and Director Email:
ir@hempfusion.com Phone: 416-803-5638
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