A Critical Review of the Marketing Claims of Infant Formula Products in the United States.

A highly competitive infant formula market has resulted in direct-to-consumer marketing intended to promote the sale of modified formulas that claim to ameliorate common infant feeding problems. The claims associated with these marketing campaigns are not evaluated with reference to clinical evidence by the Food and Drug Administration. We aimed to describe the language of claims made on formula labels and compare it with the evidence in systematic reviews. Of the 22 product labels we identified, 13 product labels included claims about colic and gastrointestinal symptoms. There is insufficient evidence to support the claims that removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula benefits infants with fussiness, gas, or colic yet claims like "soy for fussiness and gas" encourage parents who perceive their infants to be fussy to purchase modified formula. Increased regulation of infant formula claims is warranted.