Niagen Bioscience, Inc 8-K, filed Nov 23, 2020
Niagen Bioscience, Inc. (NAGE)
8-K
2020-11-23
For: 2020-11-17
View Original
Added on
April 10, 2026
About this 8-K
Niagen Bioscience, Inc filed this 8-K on November 23, 2020, reporting on events of November 17, 2020.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
____________
FORM 8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported): November 17,
2020
(Exact name of registrant as specified in its
charter)
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(State
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(Commission
File Number)
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(IRS
Employer Identification No.)
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(Address
of principal executive offices, including zip code)
(310 ) 388-6706
(Registrant's telephone number, including area
code)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
Securities
registered pursuant to Section 12(b) of the Act:
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each exchange on which registered
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The
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Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the
Securities Act of 1933 (§230.405 of this chapter) or
Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this
chapter).
Emerging growth
company ☐
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On
November 17, 2020, ChromaDex Corporation (the
“Company”) received a warning letter (the
“Letter”) from the United States Food and Drug
Administration (“FDA”) and Federal Trade Commission
(“FTC”). The Letter references statements related to
preclinical and clinical research and data involving nicotinamide
riboside (“NR”) and COVID-19 that were included in
certain press releases and social media posts issued by the Company
(the “Company Disclosures”). The Letter asserts that
the Company’s TRU NIAGEN® products are intended to
mitigate, prevent, treat, diagnose or cure COVID-19 in violation of
certain sections of the Federal Food, Drug, and Cosmetic Act (the
“FD&C Act”) and the Federal Trade Commission Act
(the “FTC Act”).
On
November 18, 2020, the Company provided a response (the
“Response”) to the Letter stating that the Company
disagrees with the assertion in the Letter that the Company’s
products are intended to mitigate, prevent, treat, diagnose or cure
COVID-19 in violation of certain sections of the FD&C Act and
the FTC Act. The Response notes that the Public Disclosures
accurately describe the scientific research regarding NR and
COVID-19, and that such Public Disclosures were not intended to
suggest the use of the Company’s products for therapeutic
purposes. However, in order to address the concerns from the
Letter, the Company has deleted certain social media posts and
removed certain press releases from its website, including the
Public Disclosures. The Company believes that such corrective
actions address the Letter in full, and the Company intends to seek
guidance, as needed, from the FDA and FTC to ensure that statements
made about the scientific research related to the Company’s
products are appropriately disseminated in the future.
This Current Report on Form 8-K contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, that are intended to be covered by the “safe
harbor” created by those sections. These forward-looking
statements include the possible resolution of the issues identified
in the Letter and the Company’s intention to seek guidance
from the FDA and FTC to ensure that statements made about the
scientific research related to the Company’s products are
appropriately disseminated. Forward-looking statements, which
describe future plans, strategies, expectations and events, can
otherwise generally be identified by the use of forward-looking
terms such as “believe,” “expect,”
“may,” “will,” “should,”
“would,” “could,” “seek,”
“intend,” “plan,” “goal,”
“project,” “estimate,”
“anticipate” or other similar terms. These
forward-looking statements are based on current beliefs,
expectations and assumptions that are subject to significant risks,
uncertainties and changes in circumstances that could cause actual
results to differ materially from the forward-looking statements,
including those risks and uncertainties discussed under the heading
“Risk Factors” in the Company’s most recent
Annual Report on Form 10-K and Quarterly Report on Form 10-Q as
filed with the Securities and Exchange Commission. You should not
rely upon forward-looking statements as predictions of future
events. The forward-looking statements included in this Current
Report on Form 8-K speak only as of the date hereof, and except as
required by law, the Company expressly disclaims any intent,
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements to reflect any change
in the Company’s expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statements are based.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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CHROMADEX CORPORATION
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Dated:
November 23, 2020
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By:
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/s/
Kevin M.
Farr
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Name:
Kevin M. Farr
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Chief
Financial Officer
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