cbdMD Requests the Food and Drug Administration (FDA) Remove the Drug Exclusion for CBD and Review cbdMD’s Extensive Safety Submission
2022年2月23日 - 12:45AM
ビジネスワイヤ(英語)
cbdMD, Inc. (NYSE American: YCBD, YCBDpA) (the “Company”), one
of the world’s leading and most highly trusted and recognized
health & wellness CBD companies, today announced that the
Natural Products Association (NPA) filed a Citizen’s Petition on
cbdMD’s behalf with the Food and Drug Administration (FDA)
requesting the FDA to remove the drug exclusion for CBD and to
review the Company’s extensive dossier of identity, safety and
quality data.
Removing the drug exclusion for CBD will achieve clarity in the
market and create a level playing field for all participants. The
final outcome of this process is expected to result in the ability
of the Company to submit and receive acknowledgement for a New
Dietary Ingredient Notification (NDIN). This will finally allow the
Company to inform consumers of the benefits of its cannabinoid
products and expand its sales in the United States by opening up
mass retail channels. Since passage of the Farm Bill 2018, the FDA
has not provided any clear regulation on the CBD market. The lack
of a clear, regulated framework has allowed an expanding pool of
producers, manufacturers and marketers to flood the market with
substandard products and an abundance of questionable advertising
tactics. Creating and enforcing industry-wide standards would help
create a necessary roadmap for all CBD products and bring
organization to an industry that has otherwise been operating
without order.
“FDA has asked for good science and solid safety data. We
offered it to them in our pre NDI submission meeting and the FDA
was excited to review our data, but fell back on the drug
exclusion. We want them to review our science, which we believe
contains the requisite studies to clearly demonstrate the safety of
our products for consumers. We want a scientific path to market
consistent with the Dietary Supplement Health and Education Act
(DSHEA), one that does not bureaucratically reward companies that
aren’t putting consumers first with safety and science. Our science
is so strong that we are confident when we are given the
opportunity to submit an NDIN we will achieve another first, the
first acknowledgment letter for a NDIN for CBD,” said Sibyl Swift,
Ph.D., Vice President of Scientific & Regulatory Affairs for
cbdMD.
For more information on NPA's filing,
https://www.npanational.org/news/npa-files-citizens-petition-with-fda-on-specific-cbd-relief-requests-enforcement-discretion-on-drug-exclusion-clause-for-a-single-product-to-review-premarket-notifications-of-cbd-consistent/
The Company submitted its dossier of identity, quality and
safety data as a novel food ingredient for the European Union (EU)
Food Safety Authority (EFSA) and the United Kingdom (UK) Food
Standards Agency (FSA). The UK FSA has already begun to review this
data and EFSA is on track to begin shortly. “cbdMD is an industry
leader with exceptional quality and scientific standards. We
believe that our studies will withstand the rigorous review in the
EU and UK. We are asking for the FDA to give us the same
opportunity as other government agencies have done. cbdMD sets the
bar within the industry for safety and quality. This citizen’s
petition is yet another example of why cbdMD is the market leader.
We stand behind our science and our quality and look forward to the
day when we are no longer precluded from sharing our data with our
customers,” says Martin A. Sumachrist, Chairman & co-CEO of
cbdMD.
About cbdMD, Inc.
cbdMD, Inc. is one of the leading and most highly trusted and
recognized cannabidiol (CBD) brands with a comprehensive line of
U.S.-produced, THC-free1 CBD products. The cbdMD brand currently
includes over 130 SKUs of high-grade, premium CBD products
including CBD tinctures, CBD gummies, CBD topicals, CBD capsules,
CBD bath bombs, CBD bath salts, CBD sleep aids, CBD drink mixes and
full spectrum CBD options. Our Paw CBD brand of pet products
includes over 45 SKUs of veterinarian-formulated products including
tinctures, chews and topical products in varying strengths, and our
cbdMD Botanicals brand of beauty and skincare products features 15
SKUs, including facial oil and serum, toner, moisturizers, facial
masks, exfoliants and body care. To learn more about cbdMD and
their comprehensive line of U.S.-grown, THC-free1 CBD oil and full
spectrum products, please visit www.cbdmd.com, follow cbdMD on
Instagram and Facebook or visit one of the 6,000 retail outlets
that carry cbdMD products.
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 and could cause actual results to differ materially from
those expressed or forecasted in the forward-looking statements,
including, without limitation, statements made with respect to
results of reviews by the FDA, EFSA, and FSA; our ability to
increase our market share; our ability to expand our business and
significantly increase our revenues; our ability to effectively
leverage our brand partnerships and sponsorships, our ability to
effectively compete in our market; and our ability to report
profitable operations in the future. 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, 2021 as filed with the Securities and
Exchange Commission (the "SEC") 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 methods.
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version on businesswire.com: https://www.businesswire.com/news/home/20220222005877/en/
PR: cbdMD, Inc. Robert Pettway Director of Paid Media
rpettway@cbdmd.com (423) 503-5225
Investors: cbdMD, Inc. John Weston Director of Investor
Relations john.weston@cbdmd.com (704) 249-9515
cbdMD (AMEX:YCBD)
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