1. Else Nutrition emphasizes need for safer infant formulas in op-ed. 2. Initiative 'Operation Stork Speed' aims to modernize formula regulations. 3. Company awaits FDA authorization for clinical trials on new formula. 4. Else advocates for plant-based formula to meet dietary needs. 5. Successful clinical study approval paves the way for market entry.
The op-ed and initiative may accelerate regulatory approvals, boosting growth potential for BABYF, similar to prior FDA approvals that benefited other health-focused companies.
The initiative and regulatory focus directly relate to Else's market strategy and approval processes, making this news significant for BABYF's performance.
Immediate regulatory changes could facilitate faster market entry for Else's products, impacting sales positively in the near term.
ELSE NUTRITION HOLDINGS INC. (TSX: BABY) (OTCQX: BABYF) (FSE: 0YL) ("Else" or the "Company"), a pioneer in wholefood, plant-based nutrition for babies, toddlers, children, and adults, is pleased to announce that its CEO and Co-Founder, Hamutal Yitzhak, authored a featured op-ed published in The Washington Times on May 25, 2025. Titled "Operation Stork Speed will ensure babies get the nutrition they need," the piece highlights the urgent need to modernize the infant formula regulatory environment and emphasizes the importance of increasing access to safe and innovative nutrition options— particularly for infants with dietary restrictions or allergen sensitivities. The Washington Times has a substantial readership in Washington, D.C., particularly among Congress and the Administration.
"Our mission has always been to deliver a safe, plant-based infant formula that supports healthy development and gives families—especially those with dietary or dairy/soy allergen concerns—greater access to trusted nutrition," said Hamutal Yitzhak, CEO and Co-Founder of Else Nutrition. "Operation Stork Speed is an excellent initiative designed to expand access to these types of formulas, and as noted in the Washington Times op-ed, we look forward to continuing to collaborate with the White House, policymakers, and the FDA as we look to bring our unique solution to market in a swift and responsible manner."
Else Nutrition has developed a clean-label, whole plant-based infant formula intended as an alternative to dairy- and soy-based products. In 2023, the Company successfully concluded the pre-clinical studies required and received Institutional Review Board (IRB) approval for its infant growth clinical study protocol—marking a key step toward U.S. Food and Drug Administration (FDA) compliance. At present, the Company is awaiting final authorization from the FDA to initiate its clinical trial in the United States, pending regulatory modernization that the company believes may be accelerated through Operation Stork Speed. Several Congressional Appropriators recently called on the FDA to accelerate this effort, as directed through an oversight letter.
The op-ed coincides with the recent launch of Operation Stork Speed, an initiative by the Trump administration and Health and Human Services Secretary Robert F. Kennedy Jr., aimed at improving the regulatory review and safety of infant formula in the United States as well as encouraging innovation and transparency in formula composition to serve unmet needs. Ms. Yitzhak's commentary lends industry perspective to this national conversation and urges regulatory authorities to accelerate the path to market for scientifically supported, non-traditional formula options.
Else Nutrition is actively engaged in this effort through direct outreach to policymakers, bipartisan advocacy on Capitol Hill, and consumer education. The Company continues to advocate for updated infant formula guidelines that recognize the validity and safety of plant-based, non-soy, allergen-friendly alternatives.
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.
To delve deeper into Else Nutrition's offerings and its revolutionary approach to nutrition, visit www.elsenutrition.com
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SOURCE Else Nutrition Holdings Inc.