The US government’s 2026 budget, signed into law by President Donald Trump, includes language directing the FDA to streamline regulatory pathways for non-dairy, non-soy infant formula.
Following the longest government shutdown in history, the US government’s budget for the next fiscal year marks a major step forward for the regulation of plant-based baby formula.
President Donald Trump signed the legislation after its narrow bipartisan passage in the Senate and House of Representatives. It includes report language bolstering health secretary Robert F Kennedy Jr’s Operation Stork Speed and directs the Food and Drug Administration (FDA) to streamline and accelerate the regulatory pathway for new dairy- and soy-free formula products.
Announced by the Department of Health and Human Services and the FDA in March, Operation Stork Speed aims to boost the quality, safety and nutritional adequacy of the domestic infant formula supply, while expanding options for families. It will involve the first comprehensive review and update of nutrients in these products since 1998.
“For too many parents, the absence of truly inclusive formula options has been a daily worry,” said Hamutal Yitzhak, co-founder and CEO of Else Nutrition, a non-dairy formula maker whose government affairs initiative secured the report provision.
Why Else Nutrition is fighting for dairy- and soy-free formula
Some 90% of formula products on the US market are dairy-based, and the rest usually contain soy or rice. The problem? Milk is one of the most common food allergies in kids, affecting 1.9% of American children. Soy allergies also impact 0.4% of this demographic.
Further, formula options without both dairy and soy are hard to come by in the US, and the way they’re regulated is a big reason why. To get approved for sale, these products have to undergo a complex, time-consuming process, which involves comprehensive testing based on strict standards, nutrient analysis, ingredient safety assessments, comparative studies with breast milk, and more.
Yitzhak criticised the FDA’s dated regulation of alternative baby formulas in an op-ed in June, calling on the “notoriously bureaucratic” agency to modernise its regulatory position to match international standards.
“Alternative formulas like ours, which are plant-based and made with minimally processed, whole-food ingredients, are regulated the same way as soy or dairy formulas. This bars products like ours from starting clinical trials, preventing access for families who need additional formula options,” she wrote.
Now, her effort has seemed to pay off. The report advanced by the House of Representatives includes language directing the FDA to establish clear approval pathways and provide formal regulatory guidance for such infant formulas, which Else Nutrition says recognises “families with allergies, intolerances, sensitivities, or lifestyle/ethical preferences”.
“Congress has sent a clear directive: US regulatory policy will soon catch up to the reality that babies’ nutritional needs and families’ values are evolving. We congratulate Congress on this momentum, and we stand ready to deliver on the promise,” said Yitzhak.
Else Nutrition ‘actively preparing’ for clinical trials
With FDA employees returning to work post-shutdown, the guidance process could begin in earnest, according to Else Nutrition, which outlined its aim to accelerate engagement with federal regulators to scale US access for vegan, soy-free baby formula.
One of the leading players in the dairy-free formula market, Else Nutrition has raised a reported $56.5M and offers a range of infant nutrition products using almond butter, buckwheat flour and tapioca maltodextrin. Its toddler formula has been selling in the US since 2020, made with 90% organic, whole-food plant-based ingredients and suitable for kids between 12 and 36 months of age.
Despite being available in markets like Australia, its infant formula (for babies younger than 12 months) has not made it to the US yet due to the regulatory complexity. In 2023, it concluded the necessary pre-clinical studies and received Institutional Review Board approval for its infant growth clinical study protocol in the US.
However, it’s still awaiting final approval from the FDA to begin its clinical trial. “Else is actively preparing for its next clinical phase to advance our plant-based infant formula toward market readiness,” Yitzhak said in the company’s Q3 earnings call last week, after boosting its profit margin and cutting operating costs significantly in the quarter.
“We are especially grateful to President Trump and Secretary Robert F Kennedy for their leadership bringing new infant formulas to the American infants who need it most through Operation Stork Speed – a strong initiative that, in part through this legislative development, may soon include plant-based, non-soy, non-dairy formulas,” she remarked on the government’s new budget.
“Else has long maintained that every child deserves safe, effective, and nutritionally complete baby formula options that reflect today’s values and challenges. With this legislative accomplishment, we are entering the final phase of the US policy transformation that will enable us to bring those options to market more rapidly and responsibly.”
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