ABT · 8-K · 20260820PR099247

Products and Technology

ABBOTT LABORATORIES · 2026-08-20 · Importance 10 · Surprise 6

Abbott’s preterm infant formulas are specialty nutrition products designed for premature and low-birth-weight infants requiring more calories and nutrients than full-term infants. The products include Similac Special Care 24 and are used primarily in neonatal intensive care units rather than sold directly to parents through retail channels. Abbott stated that it is one of only two companies in the U.S. providing preterm infant formulas. The products are FDA-regulated, and the FDA has not requested changes to their ingredients or labeling.

Key facts

• FDA regulates preterm infant formula, and has not asked for changes or additions to the ingredients or label. source
• For decades, Abbott has researched, developed and produced these specialized nutrition products, and today Abbott is one of only two companies in the U.S. providing these products. source
• The press release references a 100-page report authored by a Working Group organized by the Department of Health and Human Services that explained '[a]vailable evidence supports the hypothesis that it is the absence of human milk – rather than the exposure to formula – that is associated with an increase in the risk of NEC.' source
• The press release states that in October 2024, the FDA, CDC and NIH said 'There is no conclusive evidence that preterm infant formula causes NEC.' source
• Abbott stands by the safety of these products and the essential role they play in helping the medical community care for preterm infants. source
• Abbott complies with all applicable FDA regulations. source
• The press release says regulators and medical professionals recognize that these products are safe and necessary, and there is no reliable scientific evidence that they cause NEC. source
• The press release states that specialty preterm formulas are designed to meet the unique nutritional needs of preterm and low-birth-weight infants who need more calories and nutrients than full-term infants. source