To summarize the best available evidence regarding the short- and long-term health effects of cow’s milk intake in healthy, full-term infants up to 3 years of age.

We conducted a systematic review and meta-analysis.

We searched MEDLINE (via PubMed), EMBASE and the Cochrane Library between 1960 and July 2013 and manually reviewed reference lists of pertinent articles. Two researchers independently reviewed abstracts and full-text articles and extracted relevant data.

We included (randomized/non-randomized) controlled trials and observational studies.

We included data from twenty-three studies (one randomized controlled trial, four non-randomized controlled trials, eight case–control studies and ten cohort studies) for the evidence synthesis. Pooled results of four studies revealed a higher risk of Fe-deficiency anaemia for infants consuming cow’s milk compared with those consuming follow-on formula (relative risk=3·76; 95 % CI 2·73, 5·19). For type 1 diabetes mellitus, six out of seven case–control studies did not show a difference in the risk of developing this disease based on the age of introduction of cow’s milk. We did not find negative associations for other health effects.

Cow’s milk consumption in infancy is associated with an increased risk of developing Fe-deficiency anaemia. Limiting cow’s milk consumption may be important to ensure an adequate Fe intake for infants and toddlers. High-quality patient information for caregivers is needed on how infants’ Fe requirements can be met.