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VALBIOTIS SA
Valbiotis announces that it has received Food and Drug Administration (FDA) approval for New Dietary Ingredient (NDI)
status
11-Dec-2023 / 20:02 CET/CEST
Dissemination of a French Regulatory News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.




Press Release



Valbiotis announces that it has received Food and Drug Administration (FDA) approval for New Dietary Ingredient (NDI)
status for a plant extract present
in all its TOTUM products

La Rochelle, December 11, 2023 (08:00 p.m. CEST) - Valbiotis (FR0013254851 - ALVAL, PEA/SME eligible), a
commercially-oriented company specializing in dietary supplements, committed to scientific innovation for preventing
and combating metabolic and cardiovascular diseases, announces that it has received approval from the Food and Drug
Administration (FDA) for New Dietary Ingredient (NDI) status for a plant extract present in all its TOTUM products.

The US Food and Drug Administration (FDA) imposes specific requirements on manufacturers and distributors wishing to
market dietary supplements containing "new dietary ingredients". These players must notify the FDA of all information
relating to the quality and safety of the new ingredient, enabling them to conclude that a dietary supplement
containing this new ingredient is safe under the conditions of use recommended or suggested on the label.

Sébastien PELTIER, CEO and co-founder, emphasizes: "Obtaining the New Dietary Ingredient (NDI) status for this plant
extract is a gratifying milestone, albeit expected, marking the conclusion of a standard authorization process. As the
U.S. market stands as the world's leading market for dietary supplements, we are thrilled to be able to commercialize
all our TOTUM products there, considering that all their individual ingredients are already authorized. We extend our
sincere thanks to the Nestlé Health Science teams, with whom a fruitful collaboration has been established to secure
this FDA notification, thereby strengthening our international presence."

Murielle CAZAUBIEL, member of the Executive Committee and Director of Medical, Regulatory and Industrial Affairs at
Valbiotis, comments: "Obtaining New Dietary Ingredient (NDI) status for this plant extract present in all our TOTUM
products, including TOTUM.63, reflects Valbiotis' determination and ability to develop safe, high-quality active
substances. This approach guarantees widespread access to our products, reinforcing our commitment to take action
before a person identified as being at risk becomes a confirmed patient. This comes at a time when the growing
incidence of metabolic and cardiovascular diseases worldwide poses a public health challenge."

The FDA's no-objection letter was granted to Valbiotis before the end of the standard 75-day review period, testifying
to the diligence and quality of the steps taken by the Company.

About Valbiotis
Valbiotis is a commercially-oriented company specializing in dietary supplements, committed to scientific innovation
for preventing and combating metabolic and cardiovascular diseases in response to unmet medical needs.
Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health
nutrition products designed to reduce the risk of major metabolic diseases, relying on a multi-target strategy enabled
by the use of plant-based terrestrial and marine resources.
Internationally, its products are intended to be the subject of licensing or distribution agreements with global and
regional health and nutrition players. In France, Valbiotis will be responsible for marketing its own products.
Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic
centers. The Company has established three sites in France - Périgny, La Rochelle (17) and Riom (63) - and a subsidiary
in Quebec City (Canada).
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI
label. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from
the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a PEA-SME
eligible company.
For more information about Valbiotis, please visit: www.valbiotis.com


Contacts
Corporate communication / Valbiotis
Carole ROCHER
Communications and Public Affairs Director
+33 6 77 82 56 88
media@valbiotis.com

Financial communication / Seitosei Actifin
Marianne PY
Senior consultant
+33 1 80 48 25 31
mpy@actifin.fr



Name: Valbiotis
ISIN code: FR0013254851
Ticker symbol: ALVAL
EnterNext© PEA-PME 150


The present press release contains forward-looking statements about Valbiotis' objectives. Valbiotis considers that
these projections are based on rational hypotheses and the information available to Valbiotis at the present time.
However, these are in no way guarantees of future performance and may be affected by changes in economic conditions,
financial markets, and a number of risks and uncertainties, including those described in Valbiotis' Universal
Registration Document filed with the French Financial Markets Authority (AMF) on April 26, 2023, under No. D.23-0347,
as well as in its Amendment filed with the AMF on December 11, 2023, under No. D.23-0347.A01. This document is
available on the Company's website (www.valbiotis.com). This press release and the information it contains do not
constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to Valbiotis' shares or financial
securities in any country.

Regulatory filing PDF file

File: 2023-12-11-PR_VALBIOTIS_NDI_FDA  
Language:        English 
Company:         VALBIOTIS SA 

12F, Rue Paul Vatine
17180 Périgny
France

Phone:           0546286258 
E-mail:          contact@valbiotis.com 
Internet:        www.valbiotis.com 
ISIN:            FR0013254851 

Euronext Ticker: ALVAL

AMF Category:    Inside information / Other releases 
EQS News ID:     1794511 

End of Announcement EQS News Service
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1794511 11-Dec-2023 CET/CEST

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END) Dow Jones Newswires

December 11, 2023 14:02 ET (19:02 GMT)