To examine the trends in specialized formula use in children in the first year of life.

The study included national prescription data for specialized formulas in England (1991–2020), Norway (2009–2020), and Australia (1992–2020) for infants under one year of age.

This study was a cross sectional survey of comprehensive national prescription databases, publicly available from England, Norway, and Australia. The incidence of milk allergy of 1% was used to estimate the number of infants expected to use specialized formula. The total prescribed volume (TPV) of specialized formula expected for consumption was estimated using population-based formula feeding rates and daily formula consumption values. The volume and cost of specialized formula reimbursements were collected from the databases for analysis.

In England, a 2.8-fold increase in TPV was observed from 2007 to 2018; in 2020, the volume of reimbursed formula was 9.7 to 12.6-fold greater than the expected volume. In Norway, there has been a 2.2-fold increase in TPV from 2009 to 2020 with the volume of reimbursed formula being 8.3 to 15.6-fold greater than expected. The proportion of all infants in Norway being prescribed specialized formula increased from 2.2% in 2009 to 6.9% in 2020. In Australia from 2001 to 2012, TPV rose 3.2-fold. During the data collection period in England, Norway, and Australia, public expenditure on reimbursed specialized formula also increased to $117, $93, and $27 respectively per infant born in that year.

There has been an increase in specialized formula consumption in England, Norway, and Australia greater than what would be expected based on cow milk allergy prevalence. Increase in specialized formula consumption contains higher quantities of free sugar compared with standard formula and could have unintended consequences for children’s health.

This is the first study looking at comprehensive trends in specialized formula use and hypothesizes that this is secondary to milk allergy overdiagnosis. Further studies are needed to determine the reasons for discordance between milk allergy diagnoses and specialized formula prescriptions, as well as to examine the health implications of specialized formula consumption.