cbdMD Files Novel Foods Dossier With UK and European Regulators
April 21 2021 - 12:15PM
Business Wire
cbdMD, Inc. (NYSE American: YCBD, YCBDpA) (the “Company”), one
of the leading, and most highly trusted and recognized cannabidiol
(CBD) brands, announced today that on March 26th, it officially
filed its Novel Food Application (“Application”) with the United
Kingdom’s Food Standards Agency (“FSA”). The Application included
all of the requisite data to allow for a validated submission and
thorough scientific assessment. A similar submission was
simultaneously made to the European Food Safety Authority (EFSA) to
ensure compliance for the European markets. The Company’s products
have been offered for sale in the UK since mid 2019.
The Application is currently undergoing an administrative check
for appropriateness and will then move to the validation process.
Upon the successful validation of the Application, the FSA and the
EFSA will each individually undertake a suitability review of the
data in the Application. The Company estimates this suitability
review to be completed by the end of 2021, although no assurance
can be made that the Company will pass the administrative check,
receive validation for its Application or a favorable result from
the suitability review.
“This Application includes detailed analysis of the ingredient
characterization, quality and stability of our product, hemp
sourcing and extraction controls, labelling and testing
requirements, and the underlying intake and toxicological data
related to the safe consumption of the proprietary cannabinoid
blend ingredients in our cbdMD product line. cbdMD believes this
step is important as a precursor for its preparation of its FDA
NDIN submissions, Australian TGA submissions, various Sanitary
Registrations in Latin America and other regulatory submissions
throughout the world. Completion of the extensive pre-clinical
research required to support the Application provides cbdMD with a
valuable tool for other regulatory approvals around the world,"
said Dr. Sibyl Swift, Scientific & Regulatory Affairs advisor
to cbdMD and Co-Chair of cbdMD Therapeutics.
About cbdMD, Inc.
cbdMD, Inc. is one of the leading and most highly trusted and
most recognized cannabidiol (CBD) brands with a comprehensive line
of U.S. produced, THC-free1 CBD products. Our cbdMD brand currently
includes over 130 SKU’s of high-grade, premium CBD products
including CBD tinctures, CBD gummies, CBD topicals, CBD capsules,
CBD bath bombs, CBD bath salts, CBD sleep aids and CBD drink mixes.
Our Paw CBD brand of pet products includes over 45 SKUs of
veterinarian-formulated products including tinctures, chews,
topicals products in varying strengths, and our CBD Botanicals
brand of beauty and skincare products features 15 SKUs, including
facial oil and serum, toners, moisturizers, clear skin, facial
masks, exfoliants and body care. Please visit www.cbdMD.com, follow
cbdMD on Instagram and Facebook, or visit one of the 6,000 retail
outlets that carry cbdMD products. To learn more about cbdMD and
their comprehensive line of U.S. grown, THC-free1 CBD oil products,
please visit www.cbdmd.com.
Forward-Looking Statements
This press release contains certain forward-looking statements
that are based upon current expectations and involve certain risks
and uncertainties within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995. Such forward-looking statements can
be identified by the use of words such as ''should,'' ''may,''
''intends,'' ''anticipates,'' ''believes,'' ''estimates,''
''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and
''proposes.'' These forward-looking statements are not guarantees
of future performance and are subject to risks, uncertainties, and
other factors, some of which are beyond our control and difficult
to predict. You are urged to carefully review and consider any
cautionary statements and other disclosures, including the
statements made under the heading "Risk Factors" in cbdMD, Inc.'s
Annual Report on Form 10-K for the fiscal year ended September 30,
2020 as filed with the Securities and Exchange Commission (the
"SEC") on December 22, 2020 and our other filings with the SEC. All
forward-looking statements involve significant risks and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements, many of which are
generally outside the control of cbdMD, Inc. and are difficult to
predict. cbdMD, Inc. does not undertake any duty to update any
forward-looking statements except as may be required by law. The
information which appears on our websites and our social media
platforms, including, but not limited to, Instagram and Facebook,
is not part of this press release.
1 THC-free is defined as below the level of detection using
validated scientific analytical tools.
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version on businesswire.com: https://www.businesswire.com/news/home/20210421005725/en/
PR: 5W Public Relations cbdMD@5wpr.com (212) 999-5585
Investors: cbdMD, Inc., John Weston, Director of Investor
Relations John.Weston@cbdMD.com (704) 249-9515
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