Else Nutrition Applauds U.S. Government's Historic Shift in Infant Formula Rules, Unlocking Path to Commercialize the World's First Whole-Food, Dairy-Free Infant Formula

Rhea-AI Summary

Else Nutrition (BABYF) welcomes three major U.S. federal developments that could revolutionize the infant formula market, particularly for plant-based alternatives. The FDA-commissioned National Academy of Sciences study recommends replacing the outdated Protein Efficiency Ratio test with modern standards, aligning with Else's regulatory approach. Congressional Republican Appropriators have urged the FDA to create a modernized pathway for plant-based infant formula, while the Administration launched 'Operation Stork Speed' to streamline regulatory processes. These developments could pave the way for Else Nutrition to commercialize the world's first whole-food, dairy-free infant formula. The company is mobilizing stakeholders through a grassroots campaign to advocate for inclusive, evidence-based nutrition standards.

Positive

• National Academy of Sciences study supports modern testing standards that align with Else's regulatory strategy
• Congressional support through formal oversight letter urging FDA to create clear pathway for plant-based formula
• Launch of 'Operation Stork Speed' initiative to accelerate regulatory processes for infant formula
• Potential first-mover advantage in the dairy-free infant formula market

Negative

• Current regulatory barriers still in place until reforms are implemented
• Timeline for FDA regulatory changes remains uncertain
• Clinical trials yet to be launched
• Market entry depends on successful regulatory reform and FDA cooperation

Else Nutrition Welcomes 3 Major Federal Developments that Could Unlock Market Access & Open the Door to the First Major Breakthrough in Infant Formula in Decades

VANCOUVER, BC, June 10, 2025 /PRNewswire/ - ELSE NUTRITION HOLDINGS INC. (TSX: BABY) (OTCQX: BABYF) (FSE: 0YL.F)  ("Else" or the "Company"), a global leader in clean label, plant-based childhood nutrition, welcomes a recent trio of significant policy signals from the U.S. Government that could reshape the nation's infant formula landscape.

These developments - spanning FDA regulatory reform, Congressional oversight, and executive action - reflect growing national momentum to modernize outdated regulations and expand consumer choice in baby formula.

National Academy Report Supports Smarter Science, Aligns with Else's Regulatory Approach

In a move that could have broad implications for new formula entrants, the FDA commissioned a National Academy of Sciences study to examine global regulatory standards for infant formula - particularly focusing on the outdated Protein Efficiency Ratio (PER) study, which had long served as a barrier for plant-based options like Else's.

The newly released study recommends replacing the outdated PER test with modern, evidence-based alternatives that better reflect international norms and nutritional science. This marks a turning point for Else, whose regulatory strategy has been built around these same more progressive standards.

"We are encouraged by the Academy's findings and look forward to these recommendations informing forthcoming FDA guidance," said Hamutal Yitzhak, CEO & Co-Founder, Else Nutrition.

Congressional Pressure Grows for Modernized Plant-Based Infant Formula Pathway

In parallel, Else Nutrition welcomes mounting attention to infant formula policy from the United States Congress. Earlier this year, top Republican Appropriators - a Members of a powerful Committee in Congress that maintains the "Power of the Purse" - sent a formal Congressional Oversight letter to the agency, urging the FDA to create a clear, modernized regulatory pathway for plant-based infant formula that matches the international standard. Congress' intent reflects a shared perspective that the National Academy study unveiled.

This rare Congressional intervention emphasizes the urgency of reform and calls for U.S. policy to upgrade to international standards that already embrace plant-based options. It also signals the potential for future Congressional action to reinforce the need for change and hold the FDA accountable.

"Congressional Appropriators are sending a strong signal that American parents deserve safe, vetted plant-based alternatives, and that companies like Else deserve a fair, science-aligned path to market, with regulatory guidance to match," added Ms. Yitzhak.

Administration Launches 'Operation Stork Speed' to Cut Red Tape

Furthering the support is the Administration's new initiative, Operation Stork Speed, aimed at accelerating access to infant formula by streamlining regulatory processes and clearing bureaucratic roadblocks. The program is expected to fast-track FDA reforms while ensuring safety and nutritional integrity.

Else Nutrition looks forward to engaging directly with the Administration to help shape a smarter, more inclusive infant formula future.

A New Era of Opportunity for Infant Nutrition

Together, these three developments - scientific, legislative, and executive - signal a generational shift in how the U.S. regulates and supports infant nutrition. For Else Nutrition, they offer renewed confidence that the path forward is finally being cleared. This initiative is a direct complement to the Congressional attention and the National Academy study, and Else looks forward to collaborating with the Administration.

"These reforms aren't just good for Else - they're good for every parent seeking cleaner, safer, baby formula options beyond dairy," said Ms. Yitzhak. "We continually get requests from so many families in real need of finding an alternative beyond dairy-based baby formula. We're proud to be at the forefront of this movement for change and are ready to serve American families with the trusted nutrition they deserve."

Join the Movement: Demand Real Choice

Else Nutrition is mobilizing parents, pediatric professionals, and policymakers to advocate for inclusive, evidence-based nutrition. With public support and FDA cooperation, the Company can launch clinical trials and bring its formula to American shelves.

Here's how you can help drive the Formula for Change:

1. Email your Member of Congress to urge FDA action on modern regulatory pathways.
2. Sign the petition on Change.org to amplify the public voice.

Learn more and take action today: https://elsenutrition.com/pages/realchoice

DISCLAIMERS

This grassroots lobbying effort is a statement of issue advocacy and does not require disclosure under the Lobbying Disclosure Act. This is not an electioneering statement, and this message has not been coordinated with any political parties or candidates. This message is paid for by Else Nutrition and is intended for only a "restricted class" of stockholders and administrators of the company. Whereas this is an instance of grassroots lobbying, Else Nutrition's engaged lobbying principals file disclosures required under the Lobbying Disclosure Act for direct lobbying services on behalf of the company.

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

TSX

Neither the TSX nor its regulation services provider (as that term is defined in the policies of the TSX) accept responsibility for the adequacy or accuracy of this release.

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 are the three major federal developments affecting Else Nutrition (BABYF)?

The developments include: 1) FDA-commissioned National Academy study recommending modern formula testing standards, 2) Congressional pressure for plant-based formula pathways, and 3) Launch of Operation Stork Speed to streamline regulatory processes.

How could Operation Stork Speed benefit Else Nutrition's (BABYF) infant formula plans?

Operation Stork Speed aims to accelerate access to infant formula by streamlining regulatory processes and clearing bureaucratic roadblocks, potentially expediting Else Nutrition's path to market.

What regulatory changes is Else Nutrition (BABYF) seeking for its plant-based infant formula?

Else Nutrition seeks replacement of the outdated Protein Efficiency Ratio test with modern, evidence-based alternatives that align with international standards for plant-based formula approval.

What actions can supporters take to help Else Nutrition (BABYF) advance its formula approval?

Supporters can email their Congress members, sign a Change.org petition, and participate in the Formula for Change campaign at elsenutrition.com/pages/realchoice.

What is the significance of the National Academy of Sciences study for Else Nutrition (BABYF)?

The study recommends replacing outdated testing methods with modern standards that align with Else's regulatory strategy, potentially removing a major barrier for plant-based formula approval.