To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula

Inclusion Criteria:

• Infants who use a free amino acid based Infant formula during their first year of life including:

  • Those that are currently consuming the formula at the time of enrollment
  • Those for whom consumption of the formula is planned

• At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program

Exclusion Criteria:

- Infants <37 weeks of corrected gestation age (CGA) at time of enrollment

The intent of the program is to enroll infants consuming a free amino acid based infant formula identified in the US