Else Nutrition’s 'Formula for Change': Can Plant-Based Innovation Disrupt the Infant Formula Market?

The U.S. infant formula market has long been dominated by four major players, leaving families with limited options for babies with dietary intolerances or parents seeking cleaner, plant-based alternatives. Enter Else Nutrition, a disruptor aiming to redefine the industry with its dairy-free, soy-free infant formula made from whole plant ingredients like almonds, buckwheat, and tapioca. On April 23, 2025, the company launched its "Formula for Change" campaign, a strategic push to accelerate U.S. regulatory support for clinical trials of its groundbreaking product—a move that could shake up an industry in need of modernization.

The Campaign: Bridging Regulatory Gaps and Public Demand

Else’s campaign is rooted in addressing systemic flaws exposed by the 2022–2023 infant formula shortage crisis, which highlighted supply chain vulnerabilities, market dominance by legacy brands, and the prevalence of synthetic additives and toxic metals in existing formulas. The company’s formula, already approved in Europe, Canada, and Australia, has earned accolades like the Clean Label Project Purity Award—a stark contrast to U.S. regulations that currently bar clinical trials for non-dairy alternatives.

To push for change, Else is leveraging Operation Stork Speed, a federal initiative spearheaded by the FDA and HHS to modernize infant formula development and safety standards. The campaign mobilizes parents, pediatricians, and policymakers through petitions, grassroots lobbying, and direct engagement with Congress. CEO Hamutal Yitzhak frames the effort as urgent: “Hope needs action.”

The Regulatory Landscape: Momentum and Hurdles

The FDA’s Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, released in January 2025, aligns with Else’s goals by prioritizing diversity in formula options and strict contaminant testing. Under Operation Stork Speed, the FDA is expanding testing for heavy metals, PFAS, and BPA—issues that have plagued conventional formulas.

Else’s lobbying efforts, including bipartisan congressional meetings and the hiring of a top healthcare lobbying firm, have already spurred Congressional oversight to update FDA guidance for plant-based formulas. Yet hurdles remain:
- The FDA’s requirement for premarket notifications and rigorous nutrient testing could delay approval timelines.
- Else faces a Management Cease Trade Order (MCTO) due to delayed financial filings, though it aims to resolve this by May 2025.

Market Opportunity: A $50 Billion Prize with Growing Demand

The U.S. infant formula market is valued at $50 billion annually, with a rising consumer base seeking alternatives to dairy and soy. A 2024 survey by the Clean Label Project found that 68% of parents prioritize “clean” ingredients, yet only 12% of U.S. formulas meet that standard. Else’s product, designed to mirror human milk’s nutritional profile, directly targets this gap.

Else’s toddler formula, already a bestseller in global markets, offers a blueprint for success. Its Amazon #1 ranking and awards like the Nexty Award Finalist (2022) signal strong consumer demand for plant-based options. If the FDA approves its infant formula, Else could capture a significant share of a market desperate for innovation.

Risks and Considerations

• Regulatory Delays: The FDA’s process for approving novel formulas is notoriously slow. While Operation Stork Speed aims to fast-track approvals, no timeline guarantees exist.
• Competitor Pushback: Legacy brands may resist changes that threaten their dominance.
• Supply Chain Complexity: Scaling production of plant-based formulas could face challenges in sourcing ingredients and maintaining purity standards.

Conclusion: A High-Reward, High-Risk Play

Else Nutrition’s Formula for Change campaign is a bold bet on regulatory reform and consumer demand for transparency. With $50 billion at stake and the FDA’s renewed focus on safety and diversity, the company stands at a pivotal crossroads. If it secures FDA approval, it could redefine the infant formula landscape, leveraging its award-winning track record and grassroots momentum.

However, investors must weigh the risks: regulatory delays, operational hurdles like the MCTO, and the sheer difficulty of upending a concentrated market. Yet the data paints a compelling picture:
- Market Need: 68% of parents prioritize “clean” labels (Clean Label Project, 2024).
- FDA Priorities: Operation Stork Speed mandates modernization, with contaminant testing expanded by 40% in 2025 (FDA, 2025).
- Else’s Track Record: Its toddler formula has achieved Amazon’s #1 Best Seller status, proving consumer appetite for its approach.

For investors willing to take a calculated risk, Else Nutrition represents a chance to back a company poised to capitalize on a market ripe for disruption—if it can navigate the FDA’s labyrinth and outmaneuver entrenched competitors. The stakes are high, but the potential payoff—for families and shareholders—could be historic.