Else Nutrition CEO Slams US FDA for ‘Unacceptable’ & ‘Outdated’ Regulation of Dairy-Free Baby Formula

In an op-ed published in the Washington Times, Else Nutrition CEO Hamutal Yitzhak urged the FDA to modernise its regulation of plant-based infant formula amid RFK Jr’s Operation Stork Speed.

The US Food and Drug Administration’s (FDA) regulatory guidance on infant formula must move with the times to address the needs of the millions of American children suffering from dairy or soy allergies, the head of a non-dairy formula company has said.

Writing in the Washington Times, a conservative newspaper with a substantial readership in the government, Else Nutrition CEO Hamutal Yitzhak criticised the FDA’s dated regulation of alternative baby formulas, which are treated the same way as conventional dairy or soy options.

“Put simply, the notoriously bureaucratic FDA never modernised 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,” wrote Yitzhak.

“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,” she added.

The op-ed comes weeks after the FDA and the Department of Health and Human Services announced Operation Stork Speed, which 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.

“The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” said health secretary Robert F Kennedy Jr.

Yitzhak called Operation Stork Speed “a life-saving initiative” that would make alternative formulas more accessible and streamline regulation, ensuring that “American families never face another infant formula shortage like the one in 2022”.

Regulatory barriers keep Else Nutrition’s clinical trials at bay

Else Nutrition is one of the leading players in the dairy-free formula market, having raised a reported $56.5M. It offers a range of infant nutrition products, and its formulas use ingredients like almond butter, buckwheat flour and tapioca maltodextrin.

Its toddler formula is Clean Label Certified, and made with over 90% organic, whole-food plant-based ingredients. Suitable for babies between 12 and 36 months, it contains all essential macronutrients like protein, healthy fats, carbohydrates and fibre, as well as over 20 vitamins and minerals.

The allergy-friendliness is a big part of the brand’s appeal. Its formula is free not just from dairy and soy, it contains no corn syrup or gluten either. It has been available in the US since 2020. However, its infant formula (for babies younger than 12 months) has not entered the country yet, despite being commercialised in markets like Australia.

In 2023, the company concluded the necessary pre-clinical studies and received Institutional Review Board approval for its infant growth clinical study protocol in the US. However, it is still awaiting final approval from the FDA to begin its clinical trial.

Yitzhak compared its predicament to a situation where a new safety feature for airplanes might be evaluated the same way as in cars, simply because the latter was invented first and the government “never got around to writing modernised regulatory guidance for new jets”. “If our government applied this rationale to aviation, modern flying would not exist,” she wrote.

Some 90% of formula products on the US market are dairy-based, and the rest usually contain soy or rice. Milk is amongst the most common food allergies in kids, affecting 1.9% of American children. Soy allergies, meanwhile, affect 0.4% of this demographic.

“Hundreds of thousands of America’s infants are currently unable to get the formulas they need for their unique medical or dietary challenges,” noted Yitzhak. “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.”

Could Operation Stork Speed be a boon for dairy-free baby formula?

The Else Nutrition CEO acknowledged the FDA’s previous efforts to modernise the regulatory guidance and meet international standards via a national study under Joe Biden’s presidency. But the study is still ongoing, and the guidance is yet to be revised.

Operation Stork Speed, she said, could help pick up the pace. “This initiative cuts the red tape and prioritises the FDA’s modernisation of formula guidance, which may be the linchpin needed for companies like ours to be able to confidently conduct clinical trials,” she explained.

Some Congress members called on the FDA to accelerate this effort in a letter to the agency’s commissioner, Robert M Califf, earlier this year, and have conducted oversight of its modernisation of formula.

Else Nutrition said it has been “actively engaged” in direct outreach to policymakers and bipartisan advocacy on Capitol Hill as it advocates for updated guidelines that validate the safety of non-soy, plant-based, allergen-friendly infant formulas.

“The FDA’s lack of modernisation 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,” Yitzhak wrote.

Her company, which suffered a 15% drop in revenue last year, launched a Formula for Change campaign to accelerate regulatory support for clinical trials. It is asking consumers to write to their local representatives to urge FDA action, sign a petition, and pledge monetary support to help it advance clinical readiness.

The plant-based baby formula market is set to expand by 7.8% annually until 2029. Else Nutrition’s op-ed comes just a month after Danone agreed to acquire fellow dairy-free formula maker Kate Farms. The French dairy giant previously also signed a letter of intent to license Canadian firm Else Nutrition’s vegan formula under its own branding, though there has been no public update since.

Others have also bemoaned the tight regulations surrounding infant formula. Getting approved 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

“It needs to have all the protein and formulation ready to go, but also undergo human clinical trials,” Amy Langfield, co-founder of UK startup Grow with Iris told Green Queen earlier this year. She is working to commercialise a non-dairy infant formula, which she says will take at least five years due to the intricacies of the regulatory framework.