Else Nutrition praises US bipartisan baby formula regulation modernization moves

Else Nutrition reveals that scientific, legislative, and executive developments in the US indicate a modernization of the infant formula sector. The clean label and plant-based childhood nutrition company hopes the developments will enable a regulatory pathway for commercializing plant-based baby formula, which currently faces challenges in commercialization.

It notes that the FDA recently commissioned a National Academy of Sciences (NAS) study to review the global regulatory standards for infant formula, with a focus on replacing the outdated Protein Efficiency Ratio (PER) test. 

Else Nutrition says this test has hindered plant-based infant formula options like its formula, which contains buckwheat and almonds. The PER test, used since 1996, examines protein quality based on weight gain in rats fed a specific amount of protein.

NAS says several experts criticize PER not capturing the biological and physiological relevance of protein in infant formula. It suggests that the FDA should not use PER as the method for establishing the biological quality of protein in new infant formulas and should create a draft guidance on PER.

“We are encouraged by the Academy’s findings and look forward to these recommendations informing forthcoming FDA guidance,” says Hamutal Yitzhak, CEO and co-founder of Else Nutrition.

Last month, the US Health and Human Services and the FDA opened a call for public comments on whether current infant formula nutrient requirements should be updated based on the latest scientific data. An update will mark the first comprehensive review since 2008.

Pressure to modernise plant-based infant formula

Else Nutrition notes that Congress has pressured the FDA to create a modernized regulatory pathway for plant-based infant formula.

The company says that this year, top Republican Appropriators sent a formal Congressional Oversight letter to urge the FDA to create a modernized regulatory pathway for plant-based infant formula to match international standards.

Else Nutrition believes that Congress’ response demonstrates a shared vision with the findings of the NAS study. 

Else Nutrition says PER has hindered plant-based infant formula options like its formula, which contains buckwheat and almonds.“Congressional Appropriators are sending a strong signal that US parents deserve safe, vetted plant-based alternatives, and that companies like Else Nutrition deserve a fair, science-aligned path to market, with regulatory guidance to match,” says Yitzhak.

Else Nutrition sees congressional interventional as a “rare” call for US policy updates to align with international standards, where plant-based formula options are welcomed.

Operation Stork Speed

The US administration also launched Operation Stork Speed to streamline regulatory processes and cut red tape. Else Nutrition sees this program as a fast-track FDA reforms backed by nutritional integrity.

“These reforms aren’t just good for Else Nutrition — they’re good for every parent seeking cleaner, safer, baby formula options beyond dairy,” says Yitzhak. 

“We continually get requests from so many families in real need of finding an alternative beyond dairy-based baby formula. We’re proud to be at the forefront of this movement for change and are ready to serve US families with the trusted nutrition they deserve.”

Nutrition Insight previously looked at gaps in infant formula safety with the Center for Food Safety and the Alliance for Natural Health. Experts warned of inaction on toxic contaminants, nano ingredients, and regulatory conflicts of interest. Meanwhile, the new FDA administrator for food safety, Kyle Diamantas, was critiqued on his role. During his time at Abbott Laboratories, he fought against parents of infants who were made ill from pathogens in Abbott’s formula.

“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,” comments Yitzhak

“Operation Stork Speed is an excellent initiative designed to expand access to these types of formulas…we look forward to continuing to collaborate with the White House, policymakers, and the FDA as we look to bring our unique solution to the market in a swift and responsible manner.”