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February 2017

Marketing Claims for Infant Formula: The Need for Evidence

Author Affiliations
  • 1Department of Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 2Retired former Director of the US Food and Drug Administration's Center for Food Safety and Applied Nutrition
  • 3Department of Health Policy and Management, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
JAMA Pediatr. 2017;171(2):105-106. doi:10.1001/jamapediatrics.2016.3837

The market for infant formulas has become increasingly competitive over the past decade. Ingredients that manufacturers once included only in specialized formulas are now added to nearly all formulas. These ingredients come with marketing claims, such as “fosters cognitive development” and “supports digestive health.”

It is time to ask whether there are data to support these claims. On September 9, 2016, the US Food and Drug Administration (FDA) issued its first draft guidance on this topic, which outlines the quality of evidence that formula manufacturers should have to substantiate these claims, including randomized trials.1 The evidence currently available to the public does not meet these standards. For many claims there is no evidence available to the public, and when the results of randomized trials are made public, we learn that they are limited by small sample sizes, poor follow-up, and provide unpersuasive results.2 It is also important to understand how these claims may affect breastfeeding and public health budgets, and to consider regulatory approaches that might produce better publicly available evidence.