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
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.
Else Nutrition (OTC: BABYF) il 18 nov 2025 ha dichiarato che il bilancio federale degli Stati Uniti per l’anno fiscale 2026, firmato dal presidente Trump, include una clausola nel rapporto congressuale (H. Rept. 119-172) che ordina alla FDA di snellire i percorsi normativi e di emettere linee guida formali per latte artificiale per neonati a base vegetale, non di soia e non lattiero.
L’azienda sostiene che la disposizione – collegata a Operation Stork Speed – sia stata avanzata grazie ai suoi sforzi di relazioni istituzionali e che i lavori sulle linee guida della FDA potrebbero iniziare non appena i dipendenti federali torneranno dopo la chiusura del governo. Else afferma di essere posizionata per accelerare l’coinvolgimento con i regolatori e per perseguire l’accesso al mercato statunitense delle formule infantili una volta implementate le linee guida.
Else Nutrition (OTC: BABYF) dijo el 18 de noviembre de 2025 que el presupuesto federal de EE. UU. para el año fiscal 2026, firmado por el presidente Trump, incluye una disposición de informe del Congreso (H. Rept. 119-172) que ordena a la FDA simplificar las vías regulatorias y emitir directrices formales para fórmulas infantiles a base de plantas, sin soja y sin lácteos.
La compañía afirma que la disposición – vinculada a Operation Stork Speed – fue impulsada a través de sus esfuerzos en asuntos gubernamentales y que el trabajo de orientación de la FDA podría comenzar cuando los empleados federales regresen tras el cierre del gobierno. Else señala que está posicionada para acelerar la interacción con reguladores y buscar el acceso al mercado estadounidense de fórmulas infantiles una vez que se implementen las directrices.
Else Nutrition (OTC: BABYF)는 2025년 11월 18일에 2026 회계연도 미국 연방 예산안이 트럼프 대통령이 서명했고 의회 보고서 문안(H. Rept. 119-172)이 FDA에 식물성, 대두 비포함, 유제품 비포함의 영아용 분유에 대한 규제 경로를 간소화하고 공식 지침을 발행하라고 지시한다고 밝혔다.
회사는 이 조항이 Operation Stork Speed와 연결되어 정부 업무 부문 노력을 통해 추진되었으며 연방 직원들이 셧다운 종료 후 복귀하면 FDA 지침 작업이 시작될 수 있다고 한다. Else는 지침이 구현되면 규제 당국과의 협력을 가속화하고 미국 영아용 분유 시장 진입을 추진할 위치에 있다고 설명했다.
Else Nutrition (OTC : BABYF) a déclaré le 18 novembre 2025 que le budget fédéral américain pour l’exercice 2026, signé par le président Trump, comprend une clause du rapport du Congrès (H. Rept. 119-172) qui enjoint à la FDA de rationaliser les voies réglementaires et de publier des directives officielles pour des formules pour nourrissons à base végétale, non à base de soja et sans produits laitiers.
La société affirme que la disposition était associée à Operation Stork Speed et a été avancée grâce à ses efforts de relations gouvernementales et que les travaux sur les directives de la FDA pourraient commencer lorsque les agents fédéraux reviendraient après la fermeture du gouvernement. Else indique qu’elle est positionnée pour accélérer les interactions avec les régulateurs et rechercher l’accès au marché américain des formules pour nourrissons une fois que les directives seront mises en œuvre.
Else Nutrition (OTC: BABYF) erklärte am 18. November 2025, dass der US-Bundeshaushalt für das Geschäftsjahr 2026, vom Präsidenten Trump unterzeichnet, eine Bestimmung im Kongressbericht (H. Rept. 119-172) enthält, die die FDA auffordert, regulatorische Wege zu straffen und formale Leitlinien für auf pflanzlicher Basis hergestellte, nicht-soja- und nicht-milchbasierte Säuglingsnahrung auszugeben.
Das Unternehmen sagt, dass die Bestimmung — verbunden mit Operation Stork Speed — durch seine Bemühungen im Bereich Government Affairs vorangetrieben wurde und dass die Arbeiten an den FDA-Leitlinien beginnen könnten, sobald die Bundesmitarbeiter nach der Stilllegung des Regierungsgeschäfts zurückkehren. Else erklärt, dass es positioniert sei, die Zusammenarbeit mit Regulierungsbehörden zu beschleunigen und den Zugang zum US-Markt für Säuglingsnahrung zu verfolgen, sobald die Leitlinien umgesetzt sind.
Else Nutrition (OTC: BABYF) في 18 نوفمبر 2025 قالت إن الميزانية الفيدرالية الأمريكية للسنة المالية 2026 والتي وقعها الرئيس ترامب تتضمن فقرة تقرير تشريعي (H. Rept. 119-172) توجه الـ FDA لتبسيط المسارات التنظيمية وإصدار إرشادات رسمية لـ صيغ حليب الأطفال النباتية، غير المعتمدة على الصويا، الخالية من منتجات الألبان.
وتقول الشركة أن الحكم — المرتبط بـ Operation Stork Speed — تم التقدم به من خلال جهودها في الشؤون الحكومية وأن عمل إرشادات FDA قد يبدأ عندما يعود الموظفون الفيدراليون بعد الإغلاق الحكومي. وتذكر Else أنها في وضع يسمح لها بتسريع التواصل مع الجهات التنظيمية والسعي للوصول إلى السوق الأمريكية لصيغ حليب الأطفال بمجرد تنفيذ الإرشادات.
- 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
- 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
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
"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:
"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
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
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
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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 did Else Nutrition announce about FDA regulatory changes on Nov 18, 2025 for BABYF?
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