Else Nutrition Announces Major Breakthrough: President Trump Signs Pivotal FDA Funding Package that Includes Congressional Directive Streamlining Regulatory Pathway for Non-Dairy, Non-Soy Plant-Based Infant Formula

Rhea-AI Summary

Else Nutrition (OTC: BABYF) on Nov 18, 2025 said the Fiscal Year 2026 U.S. federal budget signed by President Trump includes Congressional report language (H. Rept. 119-172) that directs the FDA to streamline regulatory pathways and issue formal guidance for plant-based, non-soy, non-dairy infant formulas.

The company says the provision—linked to Operation Stork Speed—was advanced through its government affairs efforts and that FDA guidance work may begin as federal employees return following the government shutdown. Else states it is positioned to accelerate regulator engagement and pursue U.S. infant-formula market access once guidance is implemented.

Positive

• Congressional directive (H. Rept. 119-172) for FDA guidance on plant-based infant formula
• Federal budget signed on Nov 18, 2025 potentially accelerates regulatory pathway
• Else positioned to accelerate U.S. regulator engagement as FDA resumes work

Negative

• No FDA guidance yet; regulatory pathway remains pending and timing is uncertain

New Federal Budget Agreement Ends Government Shutdown and Expedites FDA Pathway for Innovative, Non-Soy, Plant-Based Infant Nutrition Under Operation Stork Speed

VANCOUVER, BC, Nov. 18, 2025 /PRNewswire/ - ELSE NUTRITION HOLDINGS INC. (BABY) (BABYF) (0YL.F) ("Else" or the "Company"), a global pioneer in whole-food, plant-based nutrition for babies, toddlers, children and adults, today recognizes the bicameral, bipartisan passage of the U.S. Government budget for Fiscal Year 2026 that officially ended the U.S. Government shutdown, marking a major milestone for the Company. The budget signed into law by President Donald Trump includes Report Language bolstering Operation Stork Speed and also directs the Food & Drug Administration (FDA) to streamline regulatory pathways for new infant formulas, specifically including plant-based, non-soy, non-dairy formula solutions, a report provision secured directly through the Company's Government Affairs initiatives.

This legislative milestone is incorporated into the Congressional Directives of the passed budget through H. Rept. 119-172 and is expected to streamline and accelerate regulatory pathways and guidance at the FDA for plant-based, non-soy, non-dairy formula. Else expects that, as FDA employees return to work now that the U.S. Government shutdown has ended, this guidance process may begin in earnest, marking a pivotal moment for American families seeking inclusive and safe nutritional alternatives.

"For too many parents, the absence of truly inclusive formula options has been a daily worry," said Hamutal Yitzhak, Co-Founder & CEO of Else Nutrition. "Congress has sent a clear directive: U.S. regulatory policy will soon catch up to the reality that babies' nutritional needs and families' values are evolving. We congratulate Congress on this momentum, and we stand ready to deliver on the promise."

"Furthermore, we are especially grateful to President Trump and Secretary Robert F. Kennedy for their leadership bringing new infant formulas to the American infants who need it most through Operation Stork Speed - a strong initiative that, in part through this legislative development, may soon include plant-based, non-soy, non-dairy formulas."

Key Highlights

• The report advanced by the U.S. House of Representatives includes language directing the FDA to establish clear approval pathways and provide formal regulatory guidance for plant-based, non-soy, non-dairy infant formulas, recognizing families with allergies, intolerances, sensitivities, or lifestyle/ethical preferences.
• With the government shutdown officially concluded, Else Nutrition is positioned to accelerate engagement with federal regulators to scale U.S. access and support families who have long waited for alternatives.
• Else's product pipeline, which includes its already-launched toddler nutrition line made from whole foods (almonds, buckwheat, tapioca) and ingredients with clean-label appeal, is now strategically suited for the U.S. infant-formula market when regulatory conditions allow.
• This moment is not only a major business milestone for Else that demonstrated its success in navigating complex U.S. Government regulatory dynamics, but a significant public-health and consumer-choice inflection point: expanding nutritional equity for infants regardless of dietary, allergy, or lifestyle constraints.

 Families across America face a narrowing field of formula choices, often limited to dairy- or soy-based products. For those whose infants cannot use these choices, or for families seeking plant-based, allergen-aware options, innovation has lagged. The U.S. Government's action, now signed into law, signals a regulatory paradigm shift may be coming in favour of innovation, choice, and accessibility.

Ms. Yitzhak added, "Else has long maintained that every child deserves safe, effective, and nutritionally complete baby formula options that reflect today's values and challenges. With this legislative accomplishment, we are entering the final phase of the U.S. policy transformation that will enable us to bring those options to market more rapidly and responsibly."

Else Nutrition will continue direct engagement with the FDA and federal representatives to ensure that implementation of the legislation fosters science-backed, verified product pathways. The Company remains committed to rigorous product standards, transparency, and the needs of families who cannot afford to wait.

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
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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/else-nutrition-announces-major-breakthrough-president-trump-signs-pivotal-fda-funding-package-that-includes-congressional-directive-streamlining-regulatory-pathway-for-non-dairy-non-soy-plant-based-infant-formula-302617738.html

SOURCE Else Nutrition Holdings Inc.

FAQ

What did Else Nutrition announce about FDA regulatory changes on Nov 18, 2025 for BABYF?

Else said the Fiscal Year 2026 federal budget includes report language directing the FDA to streamline pathways and issue guidance for plant-based, non-soy, non-dairy infant formulas.

How does H. Rept. 119-172 affect Else Nutrition (BABYF) regulatory prospects?

The report language directs the FDA to establish clear approval pathways and formal guidance for plant-based infant formulas, which Else says could accelerate regulatory progress.

Will Else Nutrition be able to sell infant formula in the U.S. immediately after the Nov 18, 2025 budget signing?

No; the budget directs the FDA to develop guidance, but Else notes that formal FDA guidance has not yet been issued and timing remains uncertain.

What is Operation Stork Speed and how does it relate to BABYF?

Else referenced Operation Stork Speed as an FDA-focused initiative cited in the budget that may include support for new infant formulas, including plant-based options.

Does Else have products ready for the U.S. infant-formula market after the Nov 18, 2025 announcement?

Else said its product pipeline, including a launched toddler line from whole foods, is strategically suited for the U.S. infant-formula market when regulatory conditions allow.