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US regulatory considerations for infant formulas

The increasing involvement of parents in the formula they feed their infant provides opportunities for manufacturers to choose ingredients and differentiate their products in ways that are meaningful to parents.

Infant formulas provide a key source of nutrition during infancy, a vulnerable period of development. As a result, the infant formula category is highly regulated in the U.S. and most other markets. These regulations are more prescriptive than for other foods and stipulate the nutrients and concentrations that must be present in formulas, permitted ingredients, quality testing and substantiation of claims. Nevertheless, innovation and novel ingredients continue to be of interest to manufacturers and parents. This article reviews aspects where the regulations related to new ingredients or new claims differ from those for most other foods.

When infant formulas first became commercially available, they were promoted through physicians and were often designed for infants intolerant of cow milk or other conventional weaning foods. Physicians continue to have an influence on formula choice, especially for babies with diagnosed allergies and/or intolerance to ingredients such as lactose.  However, within the past 30 years, infant formulas in the U.S. are increasingly designed and promoted directly to parents. As a result, manufacturers have introduced features and promotional messages designed to appeal to mothers, as they most often choose the formula brand. Mothers want to provide the product they believe is the best for their baby, often regardless of price. For instance, she will often choose an organic formula for her infant, even when she doesn’t choose organic options for herself or others in the family. Other mothers are value shoppers and will choose a store brand over a more expensive option. Typically, parents are loyal to the brand they feel their baby best tolerates, but will switch brand if the baby shows symptoms of discomfort.

This increasing involvement of parents in the formula they feed their infant provides opportunities for manufacturers to choose ingredients and differentiate their products in ways that are meaningful to parents. These differentiations may have minimal impact with physicians and may not necessarily have the scientific justification physicians would typically require before recommending a specific formula. Many infant formula innovations involve the addition of formula features or ingredients to be "closer to human milk" or to deliver performance like that of a breastfed infant.           

Although human milk has hundreds of different compounds, the compounds and ingredients that can be added to infant formulas in the U.S. are strictly regulated. In addition, a new infant formula—one with a modified formulation or one made in a different manufacturing facility—cannot be marketed without approval by FDA. A formal New Infant Formula Notification (NIFN) must be prepared and provided to FDA at least 90 days before the first commercial manufacture of the product. If FDA has concerns or questions about any aspect of the notification, they must be addressed satisfactorily before production can proceed. The NIFN specifies the formulation, describes the processing facility, addresses quality factors (protein quality and infant growth and development) and demonstrates the formulation meets the label declaration for all nutrients and other substances throughout the intended shelf life of the product.

Infant formula ingredients must be adequate to provide all the nutrients specified in 21 CFR part 107.100. In addition, ingredients must fall into one of the following categories:

  • Approved food additive per the Code of Federal Regulations;
  • History of safe use, specifically in U.S. formulas; or
  • Be accepted as generally recognized as safe (GRAS).

The general safety recognition must be specific for infants. For instance, the exposure assessments must relate to infants using the formula as their exclusive source of nutrition and recognize the rapid growth rate during infancy, which result in infants consuming more energy on a body-weight basis than adults. 

If a manufacturer wants to use the GRAS route to add an ingredient, but it doesn’t have a GRAS notice for infants, a specific GRAS notice will need to be filed with FDA and a “No Comment” letter received ideally before submission of a NIFN. The filing of a GRAS notice must include documentation of ingredient safety at the planned usage level in rigorously conducted studies designed to critically assess safety. These studies can take years from design to completion, and are the critical factor in FDA’s consideration as to whether an ingredient can be considered GRAS and used in infant formula.

Infant formulas with novel ingredients usually need to demonstrate acceptable protein quality using a rat bioassay (AOAC Official Method 960.48). This test may be required even when the protein is the same as in another formula because other ingredients or processing could impact protein quality. Manufacturers also need to conduct a growth monitoring study in infants to show the formula supports normal growth and development over the first four months of life—a period when formula and/or human milk are usually the exclusive sources of nutrition. 

As is common for all food products, claims for infant formulas must be truthful, non-misleading and substantiated. In September 2016, FDA issued guidance on labeling infant formulas to help ensure the correct formulas are chosen for infants with specific dietary needs and to provide advice about the application of nutrient content and health claims. FDA also issued draft guidance for the substantiation of structure/function claims on infant formulas. Its recommendations include that substantiation for such claims on infant formulas consider the totality of the evidence and include randomized, controlled feeding trials in infants. As of this time, FDA has not addressed substantiation of structure/function claims in other conventional foods. 

Innovation in infant formula continues to be important for product differentiation and can help guide consumers in their product choices. However, the regulatory environment needs to be considered early in product development, during ingredient selection and well before formulations are finalized.

The infant formula industry is highly competitive, with novel formulations as well as ingredients introduced into the marketplace by manufacturers seeking to earn the trust of their highly discerning buyers. It is also highly regulated, ensuring FDA has confidence that product design and formulation meets the important criteria for a safe and reliable product, including truthful and substantiated claims. The development of infant formula products, particularly when the GRAS status for a novel ingredient needs to be demonstrated, is complicated, costly and time consuming. But, early consideration of all applicable regulations, consultation with FDA as appropriate, and careful planning can help ensure timely market access of new infant formulas.   

Robert “Robbie” Burns, Ph.D., is an independent consultant at EAS Consulting Group and an expert in infant formula. Burns works with EAS clients in the development of infant formula as part of EAS’ roster of food science experts. Burns was formerly the vice president of health and nutrition policy at Grocery Manufacturers Association (GMA). Prior to GMA, he held positions at Cadbury Schweppes and Mead Johnson Nutritionals. Burns has a doctorate in nutritional biochemistry from Queens University in Belfast, Ireland.

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