As per the U.S. Food, Drug, and Cosmetic Act (FFDCA), infant formula is defined as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” Due to regulation and marketing purposes, infant formula is segmented into different stages to cater to different age groups. The types of infant formulas based on the age group include: stage-1 or standard infant formula, designed for infants below six months of age; stage-2 or follow-up formula designed for infants between 6 months and 1 year of age; and toddler or growing-up milk for children above 1 year of age.
Globally, stage-1 and stage 2/follow-up formulas are highly regulated, with most authorities advising against marketing of infant formulas to boost breastfeeding. With increasing food safety concerns, authorities are taking a more stringent stance on the regulatory framework to ensure infant safety. Changing regulatory standards, especially across China and Europe, are expected to have a significant mid-to-long term impact on the infant formula ingredients market.