WASHINGTON, May 26 — A new federal initiative, Operation Stork Speed, has been launched to help address a long-standing issue facing American families: limited access to specialized infant formula for babies with medical or dietary needs.
Announced by former President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr., the program seeks to prevent future formula shortages like the one in 2022, while expanding access to more diverse and cleaner formula options.
A Critical Need for More Options
Hundreds of thousands of infants in the U.S. cannot tolerate standard formulas due to allergies or other medical issues. Yet alternative products that meet these needs often remain unavailable, leaving families without essential nutrition solutions.
One such alternative is a plant-based formula developed by an Israel-based company. While the company’s toddler formula has been sold in the U.S. for nearly five years and is used by more than 75,000 families, its infant formula — available in countries like Australia — has yet to reach U.S. shelves. The main barrier: outdated Food and Drug Administration (FDA) regulations.
Regulatory Hurdles
Under current FDA rules, all infant formulas — whether dairy, soy, or plant-based — are categorized and regulated in the same way. This approach has made it difficult for newer types of formulas to begin clinical trials or reach the market, even if they meet international safety standards.
Critics argue that the FDA’s regulatory framework has not kept pace with innovation. “It’s like regulating airplane safety features using car standards,” said the formula company’s CEO. “Just because cars came first doesn’t mean the rules fit modern aviation — and the same goes for infant formula.”
Though the FDA began reviewing its regulations under President Biden, the agency has yet to implement changes. A national academy study was launched, but years later, results are still pending.
A Push for Reform
Operation Stork Speed intends to accelerate that process. By pushing the FDA to modernize its guidance and reduce red tape, the initiative could open the door for companies to conduct clinical trials and bring new formulas to market.
Congress has also shown interest in this issue. Lawmakers including Reps. Mark Alford (R-MO) and David Valadao (R-CA) recently called on the FDA to update its guidance to reflect global standards.
Supporters of the initiative hope that this combined effort will ensure American families have access to the full range of formula options they need — and prevent another crisis like the one that left store shelves empty just three years ago.
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