Else Nutrition Expected to Benefit from FDA Regulatory Progress on Infant Formula Protein Standards

Rhea-AI Summary

Else Nutrition (OTCQX: BABYF) said the FDA has listed Protein Efficiency Ratio (PER) Rat Bioassay Study Guidance as an active topic in its Foods Program on March 10, 2026. Else states this advances scientific expectations for protein quality in novel infant formulas and may reduce regulatory uncertainty for plant‑based formulas.

The company highlights alignment with federal modernization efforts including Operation Stork Speed and says clearer guidance could accelerate U.S. commercialization potential for its plant‑based infant formula.

Positive

• FDA lists PER guidance as an active Foods Program topic
• Reduced regulatory uncertainty for plant‑based infant formulas
• Alignment with Operation Stork Speed regulatory modernization
• Improved visibility on study design, endpoints, and timelines

Negative

• Guidance listed as an active topic, not a finalized rule
• Timing and outcomes of PER guidance development remain uncertain
• No explicit FDA clearance or authorization for Else's formula yet

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• 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 However, existing standards are widely considered outdated and have historically created uncertainty for companies developing formulas based on novel or whole-food protein sources, including plant‑based protein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

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 PER guidance on March 10, 2026 (BABYF)?

Else announced the FDA listed PER Rat Bioassay Study Guidance as an active Foods Program topic. According to the company, this listing signals clearer scientific expectations for protein quality that may reduce regulatory uncertainty for plant‑based infant formulas.

How could FDA PER guidance affect Else Nutrition's U.S. commercialization prospects (BABYF)?

The guidance could narrow scientific requirements and reduce regulatory risk for Else's formula. According to the company, clearer study design, endpoints, and expectations may improve predictability for preclinical work and U.S. market entry timelines.

Does the FDA listing mean Else Nutrition has regulatory approval for its infant formula (BABYF)?

No, the FDA listing does not equal approval or clearance for Else's product. According to the company, it represents regulatory progress toward clearer standards but not a finalized approval or authorization for commercialization.

Why does Else say Operation Stork Speed matters for its plant‑based infant formula (BABYF)?

Operation Stork Speed aims to modernize formula oversight and update nutrient standards for the first time since 1998. According to the company, this federal focus increases the likelihood of streamlined pathways for novel, non‑dairy protein formulas.

What regulatory risks remain for Else Nutrition after the FDA PER guidance listing (BABYF)?

Significant risks remain because guidance development and timelines are uncertain and not binding. According to the company, while transparency improves, final study requirements and any FDA decisions on specific products are still pending.