OPINION:
Hundreds of thousands of infants across America struggle with medical and dietary challenges that render traditional formulas unavailable for them. It is devastating for families, but there is a light at the end of the tunnel. Thanks to the work of President Trump and Health and Human Services Secretary Robert F. Kennedy Jr., who just launched Operation Stork Speed, these families can rest easy, knowing that more formula options may soon be available.
Operation Stork Speed is a lifesaving initiative seeking to expand infant formula options and make them more accessible, provide healthier and cleaner options, streamline regulatory pathways and ensure that American families never face another infant formula shortage like the one in 2022, which devastated so many.
As the CEO of an Israel-based infant formula company whose product helps meet the unmet medical needs of many such infants, a core aspect of my mission is to deliver our formula for families in the United States. Our toddler formula (for babies 12 months and older) has been on the market in the U.S. for almost five years and is trusted by more than 75,000 American families. Our plant-based infant formula (for babies younger than 12 months) is available in other regulatory comparable jurisdictions, such as Australia, but not in the United States, largely because of the Food and Drug Administration’s outdated regulatory guidance.
Put simply, the notoriously bureaucratic FDA never modernized its regulatory posture on infant formula to match the international standard. Instead, it continued to view all infant formula types as falling into just a few categories. This means that 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.
This situation is akin to the federal government regulating a new type of airplane safety feature in the same way it evaluates automobile safety features simply because cars were invented first and the agency never got around to writing modernized regulatory guidance for new jets. If our government applied this rationale to aviation, modern flying would not exist. Indeed, hundreds of thousands of America’s infants are currently unable to get the formulas they need for their unique medical or dietary challenges. This means that owing simply to a regulatory barrier, families in America whose children have unmet medical needs, such as a dairy or soy allergy, lack formula options that may work for them.
To its credit, the FDA has previously looked to modernize the regulatory guidance to meet the international standard. Under President Biden, it launched a national academy study to draw conclusions on this issue. Yet years later, it is still studying and has yet to revise the guidance to meet the international standard.
That’s why Mr. Trump and Mr. Kennedy’s Operation Stork Speed is so critical. This initiative cuts the red tape and prioritizes the FDA’s modernization of formula guidance, which may be the linchpin needed for companies like ours to be able to confidently conduct clinical trials under modernized guidance. Thankfully, Congress — including Reps. Mark Alford of Missouri and David Valadao of California, who earlier this year wrote a letter to FDA Commissioner Robert M. Califf on this very issue — has also recently conducted oversight of the FDA’s modernization of formulas. The combined commonsense oversight of Congress and the interests of Mr. Trump to resolve America’s infant formula crisis is laudable, and American families should be enormously grateful.
The FDA’s lack of modernization keeps families in the United States from accessing a formula that many of them need. That’s an unacceptable status quo that must change, and thanks to Operation Stork Speed, it very well might change soon.
• Hamutal Cohen Yitzhak is the co-founder and CEO of Else Nutrition, a publicly traded infant formula company based in Israel with operations in the U.S.
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