Else Nutrition Holdings Inc., a company developing wholefood, plant-based nutrition products for infants, toddlers, children, and adults, announced that its CEO and co-founder, Hamutal Yitzhak, published an op-ed in The Washington Times on May 25 addressing the current regulatory challenges facing infant formula alternatives in the United States.
Operation Stork Speed
In her article, titled “Operation Stork Speed will ensure babies get the nutrition they need,” Yitzhak discusses the need to update the regulatory framework overseeing infant formula to accommodate novel nutrition products, particularly plant-based formulas designed for infants with dietary restrictions or allergen sensitivities. The Washington Times is widely read among US policymakers, providing a platform for influencing regulatory discussions.
Yitzhak noted, “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.”
She referenced Operation Stork Speed, an initiative recently launched by the US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), intended to improve regulatory review processes and encourage innovation in infant formula.
Else Nutrition is currently seeking FDA approval to initiate clinical trials for its plant-based infant formula, which uses ingredients such as almonds, buckwheat, and tapioca as alternatives to traditional dairy- and soy-based products.
The company completed pre-clinical studies in 2023 and received Institutional Review Board (IRB) approval for its infant growth clinical study protocol, marking progress toward regulatory compliance. However, final authorization to begin clinical trials in the US remains pending.
Lobbying for change on Capitol Hill
The company maintains a presence in Washington, D.C., engaging with a healthcare lobbying firm and participating in bipartisan meetings on Capitol Hill to advocate for updated infant formula guidelines. These efforts have contributed to Congressional oversight and calls for modernizing FDA regulations to include plant-based, non-soy, allergen-friendly infant formulas. A recent oversight letter from Congressional appropriators urged the FDA to expedite regulatory modernization efforts.
Clincal trails still pending
In January 2025, the FDA released its Long-Term National Strategy to Increase the Resiliency of the US Infant Formula Market, which aligns with Else Nutrition’s development timeline and regulatory approach.
Else Nutrition’s product is not yet approved or commercially available in the US market, and the company must complete clinical trials before full market entry. In addition to infant nutrition, Else Nutrition recently entered the adult food segment with plant-based nutritional shakes.