Else Nutrition CEO Highlights Urgent Need for Infant Formula Alternatives in The Washington Times Op-Ed

Rhea-AI Summary

Else Nutrition (BABYF) CEO Hamutal Yitzhak published an op-ed in The Washington Times discussing Operation Stork Speed, an initiative aimed at modernizing infant formula regulations and increasing access to innovative nutrition options. The company has developed a plant-based infant formula as an alternative to dairy and soy-based products, targeting families with dietary restrictions and allergen sensitivities.

The company has completed pre-clinical studies and received IRB approval for its infant growth clinical study protocol. Else Nutrition is currently awaiting FDA authorization to begin clinical trials in the United States, which may be expedited through Operation Stork Speed. The initiative, launched by the Trump administration and HHS Secretary Robert F. Kennedy Jr., focuses on improving regulatory review and safety of infant formula while encouraging innovation.

Positive

• Successful completion of pre-clinical studies and IRB approval for clinical study protocol
• Strategic publication in The Washington Times, reaching key policymakers and regulators
• Potential acceleration of FDA approval process through Operation Stork Speed initiative
• Active engagement with policymakers and bipartisan advocacy efforts

Negative

• Still awaiting FDA authorization to begin clinical trials
• Product launch timeline dependent on regulatory modernization
• Current regulatory environment poses barriers to market entry

VANCOUVER, BC, May 28, 2025 /PRNewswire/ - ELSE NUTRITION HOLDINGS INC. (TSX: BABY) (OTCQX: BABYF) (FSE: 0YL) ("Else" or the "Company"), a pioneer in wholefood, Plant-Based nutrition for babies, toddlers, children and adults, is pleased to announce that its CEO and Co-Founder, Hamutal Yitzhak, authored a featured op-ed published in The Washington Times on May 25, 2025. Titled "Operation Stork Speed will ensure babies get the nutrition they need," the piece highlights the urgent need to modernize the infant formula regulatory environment and emphasizes the importance of increasing access to safe and innovative nutrition options—particularly for infants with dietary restrictions or allergen sensitivities. The Washington Times has a substantial readership in Washington, D.C., particularly among Congress and the Administration.

"Our mission has always been to deliver a safe, plant-based infant formula that supports healthy development and gives families—especially those with dietary or dairy/soy allergen concerns—greater access to trusted nutrition," said Hamutal Yitzhak, CEO and Co-Founder of Else Nutrition. "Operation Stork Speed is an excellent initiative designed to expand access to these types of formulas, and as noted in the Washington Times op-ed, we look forward to continuing to collaborate with the White House, policymakers, and the FDA as we look to bring our unique solution to market in a swift and responsible manner."

Regulatory Pathway and Status

Else Nutrition has developed a clean-label, whole plant-based infant formula intended as an alternative to dairy- and soy-based products. In 2023, the Company successfully concluded the pre-clinical studies required and received Institutional Review Board (IRB) approval for its infant growth clinical study protocol—marking a key step toward U.S. Food and Drug Administration (FDA) compliance. At present, the Company is awaiting final authorization from the FDA to initiate its clinical trial in the United States, pending regulatory modernization that the company believes may be accelerated through Operation Stork Speed. Several Congressional Appropriators recently called on the FDA to accelerate this effort, as directed through an oversight letter.

Policy Advocacy and Operation Stork Speed

The op-ed coincides with the recent launch of Operation Stork Speed, an initiative by the Trump administration and Health and Human Services Secretary Robert F. Kennedy Jr., aimed at improving the regulatory review and safety of infant formula in the United States as well as encouraging innovation and transparency in formula composition to serve unmet needs. Ms. Yitzhak's commentary lends industry perspective to this national conversation and urges regulatory authorities to accelerate the path to market for scientifically supported, non-traditional formula options.

Else Nutrition is actively engaged in this effort through direct outreach to policymakers, bipartisan advocacy on Capitol Hill, and consumer education. The Company continues to advocate for updated infant formula guidelines that recognize the validity and safety of plant-based, non-soy, allergen-friendly alternatives.

About Else Nutrition Holdings Inc.

Else Nutrition Holdings Inc. (TSX: BABY, OTCQX: BABYF, FSE: 0YL) is a food and nutrition company in the international expansion stage focused on developing innovative, clean, and Plant-Based food and nutrition products for infants, toddlers, children, and adults. Its revolutionary, Plant-Based, non-soy formula is a clean-ingredient alternative to dairy-based formulas. Since launching its Plant-Based Complete Nutrition for Toddlers, made of whole foods, almonds, buckwheat, and tapioca, the brand has received thousands of powerful testimonials and reviews from parents, gained national retailer support, and achieved rapid sales growth.

Awards and Recognition:

• "2017 Best Health and Diet Solutions" award at Milan's Global Food Innovation Summit
• #1 Best Seller on Amazon in the Fall of 2020 in the New Baby & Toddler Formula Category
• "Best Dairy Alternative" Award 2021 at World Plant-Based Expo
• Nexty Award Finalist at Expo West 2022 in the Plant-Based lifestyle category
• During September 2022, Else Super Cereal reached the #1 Best Seller in Baby Cereal across all brands on Amazon

To delve deeper into Else Nutrition's offerings and its revolutionary approach to nutrition, visit www.elsenutrition.com

TSX

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Caution Regarding Forward-Looking Statements

This press release contains statements that may constitute "forward-looking statements" within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as "will" or similar expressions. Forward-looking statements in this press release include statements with respect to the anticipated dates for filing the company's financial disclosure documents. Such forward-looking statements reflect current estimates, beliefs, and assumptions, which are based on management's perception of 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 expectation that there will be no interruptions or supply chain failures as a result of COVID-19 and that the manufacturing, broker, and supply logistic agreement with the company does not terminate. Actual results may differ from the estimates, beliefs, and assumptions expressed or implied in the forward-looking statements. 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.

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SOURCE Else Nutrition Holdings Inc.

FAQ

What is Operation Stork Speed and how does it affect Else Nutrition (BABYF)?

Operation Stork Speed is a Trump administration initiative aimed at improving infant formula regulatory review and safety while encouraging innovation. It could potentially accelerate Else Nutrition's FDA approval process for their plant-based infant formula.

What is the current regulatory status of Else Nutrition's (BABYF) infant formula?

Else Nutrition has completed pre-clinical studies and received IRB approval for its infant growth clinical study protocol. The company is currently awaiting FDA authorization to begin clinical trials in the United States.

What makes Else Nutrition's (BABYF) infant formula different from others?

Else Nutrition's formula is a clean-label, whole plant-based alternative to traditional dairy- and soy-based products, specifically designed for infants with dietary restrictions or allergen sensitivities.

How is Else Nutrition (BABYF) engaging with regulatory authorities?

The company is actively engaged through direct outreach to policymakers, bipartisan advocacy on Capitol Hill, consumer education, and promoting updated infant formula guidelines for plant-based, non-soy, allergen-friendly alternatives.