Infant formula label review

The FDA review of infant formula labeling was conducted by a multi-disciplinary team composed of physicians, scientists, and experts in regulations and labeling. The review followed 2 tracks: the development of a general position of what would be necessary if we started with a blank label; and the purchase of many formulas and a critical review of information on the labels. An important part of the review was determining what information was available in the literature and using this information in assessing current practices and the effectiveness of present labeling. The review was divided into several major topics: introduction, definitions, historical perspectives, current regulatory situation, effectiveness of labeling, label review, other issues, and departmental initiatives. The labels review included product attributes, shelf life, retail and home storage instructions, and consumer preparation and use.