This is the Freedom of Information Act (FOIA) file with the U.S. Department of Health & Human Services (HHS), Health Resources and Services Administration (HRSA), for the Early Limited Formula for Treating Lactation Concerns (ELF-TLC) clinical trial. That is the later, larger of two ELF trials. It was a failed replication of the earlier trial; the first appeared to suggest early limited formula supplementation increased breastfeeding, but the second suggested it decreased it. According to published results, both trials resulted in preventable hospitalizations of exclusively breastfed newborns who had already been identified as having substantial weight loss. These documents show investigators failed to inform their IRB of associated risks — and their funder (HHS) of associated adverse events.
