Comparison of Imported European and US Infant Formulas: Labeling, Nutrient and Safety Concerns

J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):480-486. doi: 10.1097/MPG.0000000000002395.


Objective: Infant formula in the United States is highly regulated. The American Academy of Pediatrics (AAP) has reported concerns over the use of non-Food and Drug Administration (FDA)-registered imported infant formulas. The purpose of this study is to identify Internet purchased and recommended imported European infant formulas and compare them with FDA labeling and nutrient requirements.

Study design: We searched "European infant formulas" in Google and DuckDuckGo to identify vendors of European formulas and blogs discussing these formulas to determine the most frequently purchased and recommended brands. We then compared the identified European formula's label and listed nutrients to FDA labeling and nutrient requirements.

Results: Thirteen of 18 vendors responded to our inquiry of their top selling formula and 17 blogs were reviewed. Sixteen formulas were identified. None met all FDA label requirements. Listed nutrients fell within FDA requirements in 15 of 16 formulas.

Conclusions: Non-FDA-registered imported European formulas do not meet all FDA-labeling requirements. Although linoleic acid, which was not listed on all of the European formulas, could not be evaluated, all formulas except one met the remaining FDA nutrient requirements. These European infant formulas are being imported into the United States via third party vendors and are not FDA-regulated, limiting the notable consumer protections set by the FDA that ensure infant formula safety. Pediatric gastroenterologists and healthcare providers need to understand the composition, labelling and lack of FDA regulation and safety concerns of these formulas in order to better counsel parents.

Publication types

  • Comparative Study

MeSH terms

  • Benchmarking
  • Europe
  • Female
  • Food Labeling / standards*
  • Humans
  • Infant Formula*
  • Infant, Newborn
  • Male
  • Nutritional Requirements
  • United States
  • United States Food and Drug Administration