FDA, HHS announces plan to enhance quality, safety of domestic infant formula
The federal agencies are encouraging companies to develop new infant formulas and clarify opportunities to inform consumers about formula ingredients.
FDA, HHS announces plan to enhance quality, safety of domestic infant formula | Image Credit: © Africa Studio - © Africa Studio - stock.adobe.com.
The FDA and the US Department of Health and Human Services (HHS) has announced a plan titled "Operation Stork Speed" aimed at expanding options for safe, reliable, and nutritious infant formula, according to a press release from the federal agencies.1
Actions include beginning the nutrient review process and increased testing for heavy metals and other contaminants. The agencies are calling on companies to develop new infant formulas and "clarify opportunities to help inform consumers about formula ingredients," stated the agencies.
"The FDA is deeply committed to ensuring that moms and other caregivers of infants and young children and other individuals who rely on infant formula for their nutritional needs have confidence that these products are safe, consistently available, and contain the nutrients essential to promote health and wellbeing during critical stages of development and life,” said Sara Brenner, MD, MPH, acting commissioner of the FDA, in a statement.
"Whether breastfed, bottle fed or both, the rising generation must be nourished in a way that promotes health and longevity over the course of their lives, added Brenner.
According to a list provided by the FDA and HHS, the agencies stated they will use longstanding and newly granted authorities to uphold safety, nutritional adequacy, and resilience of infant formula and formula supply. The FDA is, according to the press release:
- Starting the nutrient review required by law by issuing a Request for Information in the coming months to start the first comprehensive update and review of infant formula nutrients by the FDA since 1998
- Increasing testing for heavy metals and other contaminants in infant formula and other foods children consume
- Extending the personal importation policy
- Encouraging companies to work with the FDA on any questions regarding increased transparency and clearer labeling
- Communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes
- Collaborating with the National Institutes of Health and other scientific bodies to address priority scientific research gaps regarding short- and long-term health outcomes associated with formula feeding in infancy and childhood across the lifespan
"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 Robert F. Kennedy, Jr., secretary of HHS, in a statement.
Recent formula news:
Bobbie launches first USDA organic whole milk infant formula in US
Bobbie Labs has announced the planned launch of Bobbie Organic Whole Milk Formula, which the company bills as the first and only USDA Organic Whole Milk infant formula on the US market.2
FDA approves Surgifort human milk-based fortifier for term infants after gastroschisis surgery
The FDA has approved the first human milk-based nutritional fortifier indicated for term infants, with the approval of Prolacta Bioscience's Surgifort, according to a press release from the company.3
The human, pasteurized fortifier is indicated for term infants at or older than 37 weeks, following corrective surgery for the gastrointestinal disorder gastroschisis.
References:
1. HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families. FDA. Press release. March 18, 2025. Accessed March 18, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3d78943
2. Campbell P. Bobbie launches first USDA organic whole milk infant formula in US. Contemporary Pediatrics. March 10, 2025. Accessed March 18, 2025. https://www.contemporarypediatrics.com/view/bobbie-launches-first-usda-organic-whole-milk-infant-formula-in-us
3. Fitch, J. FDA approves Surgifort human milk-based fortifier for term infants after gastroschisis surgery. Contemporary Pediatrics. February 25, 2025. Accessed March 15, 2025. https://www.contemporarypediatrics.com/view/fda-approves-surgifort-human-milk-based-fortifier-term-infants-gastroschisis-surgery
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