FDA approves Fortini™ formula for term infants with failure to thrive


The US Food and Drug Administration (FDA) has cleared Fortini™, a formula meant for the nutritional needs of term infants with failure to thrive.

Following a review by the US Food and Drug Administration, the infant nutrition product Fortini™ by Nutricia is meant to be used under medical supervision and will be available to clinicians and registered dieticians by the end of September 2021.1 The formula is meant to support catch-up growth in term infants with growth failure or who are at risk of it as well as those who require more energy or have fluid restrictions.

The formula can be used in infants and toddlers up to age 18 months. The formula has 30 calories per fluid ounce and is the first created to feed infants with undernutrition or failure to thrive. The benefits of the Fortini™ have been supported by 7 clinical trials and a retrospective chart review. In those clinical trials, the formula was shown to be well tolerated by infants and toddlers. To achieve higher caloric density previously, clinicians have often had to recommend special recipes to parents that either involved increased amounts of powdered formula or liquid fats, which carried a risk of mixing errors, unbalanced nutrition, and poor tolerance of the over-concentration of formula.

Nutricia hopes to have the formula available for recommendation to families who qualify for either Medicaid or the Special Supplemental Nutrition Program for Women, Infants, and Children within the year following the product’s launch.


1. Nutricia. Fortini™ infant formula clears FDA review; energy- and nutrient-dense formula aims to set new standard in US to support growth in infants with, or at risk of, failure to thrive. Published September 23, 2021. Accessed September 29, 2021. https://www.prnewswire.com/news-releases/fortini-infant-formula-clears-fda-review-energy--and-nutrient-dense-formula-aims-to-set-new-standard-in-us-to-support-growth-in-infants-with-or-at-risk-of-failure-to-thrive-301381341.html

This article was originally posted on Contemporary Pediatrics®.

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