Else Nutrition Commends HHS & FDA's Operation Stork Speed on Expanding Infant Formula Options

Rhea-AI Summary

Else Nutrition Holdings (BABYF) welcomes the launch of Operation Stork Speed, a strategic initiative by the U.S. Department of Health and Human Services (HHS) and FDA aimed at expanding infant formula options. The company is actively pursuing the development of the first whole food, plant-based infant formula in the United States.

The company has established a presence in Washington D.C., engaging a healthcare lobbying firm and conducting bipartisan Congressional meetings. These efforts have led to Congressional oversight on modernized FDA guidance for plant-based, non-soy, non-dairy infant formula options.

This development follows the FDA's January 2025 release of their Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. Else Nutrition's formula focuses on using natural ingredients like almonds, buckwheat, and tapioca to create clean-label alternatives for early childhood nutrition.

Positive

• Regulatory progress with FDA guidance supporting plant-based infant formula development
• Strategic Washington D.C. presence established with healthcare lobbying support
• Alignment with new government initiatives for infant formula market expansion

Negative

• Product not yet approved or available in the US market
• Still requires completion of clinical trials
• Faces regulatory hurdles before market entry

HHS/FDA Announcement Bolsters Else Nutrition's Momentum in Bringing its Infant Formula to Market in the United States

VANCOUVER, BC, March 20, 2025 /PRNewswire/ - ELSE NUTRITION HOLDINGS INC. (BABY) (BABYF) (0YL.F) ("Else" or the "Company"), applauds the leadership of Secretary Robert F. Kennedy in launching Operation Stork Speed, a strategic initiative by the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) aimed at expanding infant formula options. This effort demonstrates the importance of nutritional adequacy and supply chain resilience while facilitating the development of new infant formulas within the United States.

As part of its commitment to bringing the first whole food, minimally processed, clean-label, plant-based infant formula to American families, Else Nutrition has been actively engaged in a robust Washington D.C. effort through its U.S. office. This includes hiring a leading healthcare lobbying firm, conducting bipartisan Congressional meetings across both chambers, and preparing to launch a grassroots lobbying program. To date, this effort has resulted in significant Congressional oversight on modernized FDA guidance on plant-based, non-soy, non-dairy infant formula options—an essential step for Else Nutrition to conduct key clinical trials in the U.S.

In January 2025, the FDA released their Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which followed the National Academies of Sciences, Engineering, and Medicine also recently convening a study on these issues. This week's announcement of Operation Stork Speed is another significant step from HHS in ensuring access to safe, high quality infant formulas.

"At Else Nutrition, we are dedicated to ensuring that families across America have access to safe, high-quality, minimally processed plant-based nutrition options," said Hamutal Yitzhak, CEO & Co-Founder of Else Nutrition. "Many infants with medical, dietary or dietary needs require such formulas. Congress has taken significant action to ensure access to these formulas and we are pleased to see the Administration continue this most important work. We applaud President Trump and Secretary Robert F. Kennedy for their leadership in launching Operation Stork Speed and look forward to collaborating with HHS and the FDA to create a modernized regulatory pathway for plant-based, non-soy, non-dairy infant formulas. By combining rigorous science with the power of natural ingredients like almonds, buckwheat, and tapioca, we are redefining early childhood nutrition to be healthier, more sustainable, and more accessible to parents seeking clean-label 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
• In May 2024 Else Nutrition's Ready-to-Drink Kids Vanilla Shake Named Among the Best in Family-Friendly Products by the Prestigious Mom's Choice Awards^®

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 an HHS/FDA initiative to expand infant formula options, which supports Else Nutrition's efforts to bring their plant-based infant formula to the US market.

What regulatory progress has BABYF made in March 2025?

BABYF has achieved Congressional oversight on modernized FDA guidance for plant-based, non-soy, non-dairy infant formula options, enabling them to conduct key clinical trials in the US.

What ingredients does Else Nutrition (BABYF) use in their infant formula?

Else Nutrition uses natural ingredients including almonds, buckwheat, and tapioca to create their clean-label, plant-based infant formula.

How is BABYF engaging with regulatory authorities in 2025?

BABYF has established a US office, hired a healthcare lobbying firm, conducted bipartisan Congressional meetings, and is preparing to launch a grassroots lobbying program.