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.

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BACKGROUND The accuracy of the risk criteria for brief resolved unexplained events (BRUEs) from the American Academy of Pediatrics (AAP) is unknown. We sought to evaluate if AAP risk criteria and event characteristics predict BRUE outcomes. METHODS This retrospective cohort included infants <1 year of age evaluated in the emergency departments (EDs) of 15 pediatric and community hospitals for a BRUE between October 1, 2015, and September 30, 2018. A multivariable regression model was used to evaluate the association of AAP risk factors and event characteristics with risk for event recurrence, revisits, and serious diagnoses explaining the BRUE. RESULTS Of 2036 patients presenting with a BRUE, 87% had at least 1 AAP higher-risk factor. Revisits occurred in 6.9% of ED and 10.7% of hospital discharges. A serious diagnosis was made in 4.0% (82) of cases; 45% (37) of these diagnoses were identified after the index visit. The most common serious diagnoses included seizures (1.1% [23]) and airway abnormalities (0.64% [13]). Risk is increased for a serious underlying diagnosis for patients discharged from the ED with a history of a similar event, an event duration >1 minute, an abnormal medical history, and an altered responsiveness (P < .05). AAP risk criteria for all outcomes had a negative predictive value of 90% and a positive predictive value of 23%. CONCLUSIONS AAP BRUE risk criteria are used to accurately identify patients at low risk for event recurrence, readmission, and a serious underlying diagnosis; however, their use results in the inaccurate identification of many patients as higher risk. This is likely because many AAP risk factors, such as age, are not associated with these outcomes.