IOM Suggests New Guidelines for Infant Formula Makers

IOM Suggests New Guidelines for Infant Formula Makers

WASHINGTON--A new report from the Institute of Medicine (IOM)reported the current federal regulatory processes are not designed to addressthe unique needs and vulnerabilities of infants, and they are insufficient toensure the safety of new types of ingredients proposed for infant formula. Thereport lays out guidelines that clarify the types and extent of safety testingnecessary for new formula ingredients, particularly unconventional substancesderived from novel sources or technologies. It also calls on outside experts totake a more proactive role in determining how and when such tests should bedone.

Clarifying the steps needed for introducing new ingredients into an infantformula is crucial, according to IOM, given the increasing number of potentialingredients (e.g., bioactive peptides and enzymes) generated from unconventionalsources or produced through new technologies. Although the current regulatoryapproaches have worked well for ascertaining the safety of conventionalsubstances such as vitamins and minerals, they are not as well-suited toevaluating these new types of ingredients, the report stated.

"The current regulatory processes do not fully address the unique roleof formula as a food source," said committee chair Richard J. Deckelbaum,director of the Institute of Human Nutrition at Columbia University, New York."Formula is an infants only food if he is not being breast-fed."

IOM reported a key limitation concerning infant formulas is the lack ofexplicit guidelines to help formula manufacturers and their outside expertreviewers determine what safety data are needed on a proposed ingredient and howdata should be gathered. To help fill this gap, the report offers a set of"decision trees"--a hierarchical series of questions leading tospecific action steps--to help manufacturers determine the level and extent ofsafety testing needed at various stages of the manufacturing process.

In particular, these decision trees help simplify regulations such as theFood and Drug Administration's (FDA) GRAS (generally recognized as safe)notification process. While manufacturers typically generate or obtain safetydata through preclinical toxicity studies and clinical data, GRAS notificationdoes not provide guidelines for tests specifically designed to addressingredients for infant formula, leaving it up to manufacturers and their expertreviewers to determine what data are needed, according to IOM, which alsostrongly recommended that a physician--preferably a pediatrician--be includedamong the experts reviewing formula ingredients.

IOM has already tested out these trees on two novel ingredients recentlyadded to certain formulas: long-chain polyunsaturated fatty acids andprobiotics. While IOM was able to illustrate how the decision-making modelsworked, the committee was not asked to judge the safety of these substances.

In the meantime, FDA is proposing new regulations that would require formulaswith new ingredients to be evaluated for their ability to contribute to normalinfant growth and development through studies that follow participants for 120days--a process that some manufacturers already voluntarily undertake. Thereport also recommended proposed ingredients be judged by their tendency tocause allergic reactions; infants' tolerance to them; their impact on normalstomach and intestinal microbes; whether they interfere with infants' ability toget the benefits of other nutrients; and whether nutritional imbalances mightoccur if, for example, the particular ingredient's effects require the presenceof another substance.

The study the report was based on was sponsored by FDA and by Health Canada.The report, Infant Formula: Evaluating the Safety of New Ingredients, will beavailable later this summer from the National Academies Press (www.nap.edu).