- Updated FDA Framework Bolsters Scientific Validation Pathway for Else's Plant-Based Formula and Accelerates U.S. Commercialization Potential
VANCOUVER, BC, March 10, 2026 /PRNewswire/ - ELSE NUTRITION HOLDINGS INC. (TSX: BABY) (OTCQX: BABYF) (FSE: 0YL) ("Else" or the "Company"), a pioneer in whole-food plant-based, non-soy, non-dairy nutrition for early childhood nutrition, today announced that the U.S. Food and Drug Administration (FDA) has formally listed Protein Efficiency Ratio (PER) Rat Bioassay Study Guidance as an active topic within its Foods Program regulatory agenda.
For Else Nutrition, the FDA's advancement of PER guidance represents a meaningful step toward regulatory clarity for novel infant formulas, particularly plant-based formulations. Clearer scientific expectations for demonstrating protein quality are expected to reduce regulatory uncertainty and strengthen the pathway for potential FDA clearance of Else's plant-based infant formula in the United States.
FDA's PER Guidance Development: A Catalyst for Regulatory Clarity
The PER rat bioassay remains one of the FDA-recognized methodologies for demonstrating biological protein quality in infant formulas. However, existing standards are widely considered outdated and have historically created uncertainty for companies developing formulas based on novel or whole-food protein sources, including plant-based protein innovations like Else's.
By advancing PER guidance, the FDA signals an intention to clarify study design, endpoints, and expectations for protein quality validation. Greater transparency around these requirements provides companies with improved visibility into the scope, timeline, and cost of required preclinical studies.
For Else Nutrition, this development reduces a key regulatory risk factor associated with bringing its plant-based infant formula to the U.S. market.
Alignment with Federal Formula Modernization Efforts
The U.S. infant formula market-one of the world's largest-has persistently lacked diversified protein options. Congress and federal agencies have also publicly emphasized the need to expand consumer choice within the U.S. infant formula market with non-dairy, non-soy, plant-based options-a position Else highlighted in its June 2025 release.
The FDA's work on PER guidance aligns with broader federal initiatives to modernize infant formula oversight, including Operation Stork Speed, which aims to update regulatory frameworks and nutrient standards for the first time since 1998. Operation Stork Speed emphasizes formula modernization and regulatory streamlining, improving transparency and building predictable routes for new product approvals.
Strategic Implications for Else Nutrition
As most competitors rely on conventional dairy or soy proteins, the updated PER methodology explicitly benefits novel protein matrices by providing science-based standards tailored to modern formulations, enabling Else to demonstrate protein quality credibility on a level regulatory playing field.
As regulatory modernization progresses, Else believes it is well positioned to benefit from structural industry tailwinds, including:
- Increasing demand for clean-label and plant-based nutrition
- Federal efforts to expand competition and innovation in the U.S. formula market
- Greater regulatory transparency supporting new product approvals
A clearer regulatory pathway significantly enhances Else's ability to pursue entry into the multi-billion-dollar U.S. infant formula market.
The Company believes the alignment between its plant-based innovation strategy and evolving regulatory priorities further strengthens its positioning with long-only institutional investors, ESG-focused funds, and growth investors seeking companies with identifiable regulatory catalysts.
Hamutal Yitzhak, CEO & Co-Founder of Else Nutrition, commented, "The FDA's progress on PER guidance is a meaningful inflection point for Else Nutrition. As clarity increases around the scientific and procedural standards required for novel infant formulas, our regulatory roadmap becomes sharper, more predictable, and increasingly aligned with federal efforts to modernize the U.S. formula market. This development strengthens our confidence in the commercial potential of our infant formula program in the United States."
To delve deeper into Else Nutrition's offerings and its revolutionary approach to nutrition, visit www.elsenutrition.com
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
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SOURCE Else Nutrition Holdings Inc.
