VANCOUVER, BRITISH COLUMBIA / ACCESSWIRE / December 16, 2019 / ELSE NUTRITION HOLDINGS INC. (TSX-V: BABY, OTCQB: BABYF) ("Else" or the "Company"), a developer of plant-based alternatives to dairy-based baby nutrition, announces that it has received a favorable regulatory assessment of its toddler formula ingredients from EAS Consulting Group, LLC, which conducted a preliminary review of the Else formula in view of the FDA (Food and Drug Administration) requirements.
With vast, global expertise in regulatory approvals, and specialty in FDA requirements, EAS has unique experience and capability pertaining to the introduction of food, drinks and new infant formulas.
"The EAS Infant Formula Team has confirmed that Else toddler formula intended to be marketed in the U.S. meets the regulatory requirements for general food as required for a toddler formula," stated Dr. Fabiana Bar-Yoseph, Else's Director of Clinical Development, Regulatory and Scientific Affairs. She added, "This regulatory validation marks a significant step as we look to bring a nutritious, plant-based toddler formula to the U.S. market."
Else Nutrition's 100% plant-based toddler formula is set to launch in the U.S. market in the second quarter of 2020.
About Else Nutrition Holdings Inc.
The Company is a food and nutrition company focused on research, development, manufacturing, marketing, sale and/or license of innovative plant-based food and nutrition products to the infant, toddler, children and adult markets. Its revolutionary 100% plant-based non-soy alternative to dairy-based baby formula received the "Best Health and Diet Solutions" award in the Global Food Innovation Summit in Milan in May 2017. For more information, visit: elsenutrition.com.
About EAS Consulting Group, LLC (EAS)
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout North and South America, Europe, and various Pacific Rim counties, EAS Consulting Group is a sought-after expert in regulatory matters, assisting firms with highly technical submissions such as GRAS, DMF, NDI, ANDA, 510(k) and others, as well as the development of quality systems, label reviews, structure-function claims, GMP audits, and US Agent assistance and more. EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. For more information, visit: easconsultinggroup.com.
For more information, contact:
Chelsie Hodge, Director of Corporate Relations
ELSE Nutrition Holdings Inc.
E: [email protected]
P: (604)360-2977
Hamutal Yitzhak, CEO, Co-Founder & Director
ELSE Nutrition Holdings Inc.
E:[email protected]
P: +972(0)52-447-9931
TSX Venture Exchange
Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Caution Regarding Forward-Looking Statements
This press release contains statements that, to the extent they are not recitations of historical fact, constitute "forward-looking statements" within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as "will", "plan", "hope to", "intend" or similar expressions. Forward-looking statements in this press release include, but are not limited to, statements with respect to: the Company's commercialization of its products and expected timing, expected go-to-market strategy (including marketing, proposed markets, sales, customer growth and market position), and industry conditions.
Such forward-looking statements reflect current estimates, beliefs and assumptions, which are based on management's perception of historical trends, current conditions and expected future developments, as well as other factors management believes are appropriate in the circumstances. No assurance can be given that the foregoing will prove to be correct.
Forward-looking statements made in this press release assume, among others, the successful completion of Else's proposed scale-up for its products, and such statements are intended to apply only to the infant formula market for ages 12 months and above, and having all necessary regulatory approval as required by each target market.
Numerous risks and uncertainties could cause the Company's actual results to differ materially from the estimates, beliefs and assumptions expressed or implied in the forward-looking statements, including, but not limited to: consumer demand for the Company's products, whether the Company's current and future products achieve commercialization, uncertainty regarding material changes in laws and regulations, retention of key personnel, the Company's ability to expand into global markets and competitive developments.
The foregoing list of factors is not exhaustive, and other risks and uncertainties not presently known, or believed to be material, to management Additional information and other factors that could affect the operations or financial results of the Company are set out in the Company's Filing Statement dated May 14, 2019 under the heading "Risk Factors" and may be accessed through the SEDAR website (www.sedar.com).
Readers are cautioned not to place undue reliance on any forward-looking statements, which reflect management's expectations only as of the date of this press release. The Company disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE: ELSE Nutrition Holdings