Else Nutrition Launches 'Formula for Change' Campaign, Building on Momentum from Operation Stork Speed to Deliver Real Choice for American Families

Rhea-AI Summary

Else Nutrition Holdings Inc. (TSX: BABY) (OTCQX: BABYF) has launched 'Formula for Change,' a campaign to accelerate U.S. regulatory support for clinical trials of its dairy-free, soy-free infant formula. The initiative builds on Operation Stork Speed, a federal effort to fast-track next-generation infant formula development.

The company has developed the world's first infant formula based on whole plant ingredients, including almonds and buckwheat, which mirrors human milk's nutritional profile and holds the Clean Label Project Purity Award. While available internationally, U.S. regulations currently prevent clinical trials required for approval.

Key campaign objectives include:

• Modernizing outdated U.S. regulatory pathways
• Addressing market concentration dominated by four companies
• Providing alternatives for babies intolerant to dairy/soy
• Creating solutions following the 2022-2023 formula shortage crisis

Positive

• Product already available and successful in international markets
• Received Clean Label Project Purity Award for safety
• First-mover advantage in plant-based infant formula category
• Product matches nutritional profile of human milk

Negative

• Unable to conduct clinical trials in the US due to regulatory barriers
• Requires significant regulatory changes before market entry
• Faces competition from four dominant market players
• Additional costs and time required for clinical trials and approval process

A Bold Step Toward Inclusion: Else Nutrition Aims to Deliver a Real Alternative for Millions of Babies Who Can't Tolerate Dairy-Based Formula

VANCOUVER, BC, April 23, 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, is launching a bold new advocacy campaign—'Formula for Change'—to accelerate U.S. regulatory support for clinical trials of its breakthrough dairy-free, soy-free infant formula.

This initiative builds on the positive momentum of Operation Stork Speed, a recent federal effort to fast-track next-generation infant formula development. Else Nutrition applauds this long-overdue modernization effort and urges the FDA to take the next step by opening innovative regulatory pathways for clinical trials of Else's infant formula. This will help ensure American families finally gain access to a safe, inclusive, and science-backed alternative to traditional dairy-based formulas.

"We're inspired by Operation Stork Speed," said Hamutal Yitzhak, CEO & Co-Founder of Else Nutrition. "It signals a shift toward innovation and inclusivity in infant nutrition. Now we're calling on the FDA and U.S. representatives to act on this progress and greenlight clinical trials that will allow us to bring our transformational option to families who've waited too long."

The First Real Innovation in a Generation

For decades, U.S. parents have had just two options: dairy or soy. But countless babies are unable to tolerate either. Families making plant-based lifestyle choices have similarly been left without viable options. Else Nutrition has developed the world's first infant formula based on whole plant ingredients, including almonds and buckwheat—free from dairy, soy, and ultra-processed ingredients. Already gaining international traction, the formula mirrors the nutritional benefits and profile of human milk and holds the Clean Label Project Purity Award for exceptional safety.

Pushing Forward with Progress - Not Hitting a Wall

While the product is already available abroad, outdated U.S. regulations currently prevent Else from initiating clinical trials required for infant formula approval. The Company sees Operation Stork Speed as a meaningful foundation to modernize these outdated systems and believes the time is ripe for inclusion of Plant-Based innovation in these efforts.

"We've already heard from thousands of U.S. families about how our toddler formula changed their children's lives," said Yitzhak. "Operation Stork Speed gives us hope—but hope needs action. Modernizing regulatory pathways is the crucial next step to enable innovation for the babies who need it most."

Why Else Nutrition Supports Operation Stork Speed

Else Nutrition is actively seeking inclusion in Operation Stork Speed to help close a dangerous gap in infant nutrition:

• U.S. regulations lag behind Europe, Canada, and Australia.
• Many U.S. formulas contain toxic metals or synthetic additives.
• Four companies control the market, creating vulnerability and limiting innovation.
• The 2022–2023 formula shortage crisis exposed deep systemic weaknesses.

Operation Stork Speed seeks to address these issues by encouraging innovation—and Else's formula represents exactly the kind of science-driven, next-generation product this program is designed to support.

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.
3. Pledge your support—$25, $50, or $100—to help Else advance clinical readiness.

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 is Else Nutrition's Formula for Change campaign seeking to achieve?

The campaign aims to accelerate FDA regulatory support for clinical trials of Else's dairy-free, soy-free infant formula in the U.S., building on Operation Stork Speed's momentum.

How is BABYF's plant-based infant formula different from existing options?

It's the first infant formula made from whole plant ingredients (almonds and buckwheat), free from dairy, soy, and ultra-processed ingredients, while matching human milk's nutritional profile.

Why can't Else Nutrition (BABYF) currently sell its infant formula in the US?

Current U.S. regulations prevent the company from initiating required clinical trials for infant formula approval, despite the product being available in other countries.

What are the main challenges BABYF is addressing in the US infant formula market?

The company aims to address market concentration (four companies control the market), provide alternatives for dairy/soy-intolerant babies, and prevent future shortages like the 2022-2023 crisis.