Formula Regulations and Guidelines

INFANT FORMULA REGULATIONS AND GUIDELINES United States 

Food products that are designed and marketed for infants are regulated under the Federal Food, Drug and Cosmetic (FD C) Act of 1938 (21 U.S.C. 301) (Vanderveen, 1991). FDA, an agency in the U.S. Department of Health and Human Services (HHS), regulates infant formulas and evaluates the safety of food and color additives. 

Under Section 412 of the FD C Act, regulations have been promulgated and ultimately implemented that are intended to ensure proper formulation for infants to thrive. They include  

FDA (1996) has proposed to revise these regulations to establish quality factors, current good manufacturing practices, and revised quality control procedures. Table 1-1 lists some of the U.S., Canadian, and European Union laws and regulations related to adding new ingredients to infant formulas. 

The European Union also has regnlations in place for food additives, novel foods, and genetically modified organisms. However the Enropean regnlations are not specific for adding new ingredients to infant formnlas. 

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