Does FDA approve infant formulas before they are marketed?
 
No, FDA does not approve infant formulas before they can be marketed. 
However, all formulas marketed in the United States must meet federal nutrient 
requirements and infant formula manufacturers must notify the FDA prior to marketing 
a new formula. If an infant formula manufacturer does not provide the 
elements and assurances required in the notification for a new or reformulated infant 
formula, the formula is defined as adulterated under Section 412(a)(1) of the 
FFDCA and FDA has the authority to take compliance action if the new infant 
formula is marketed. 

Source: Excerpted from Guidance for Industry: Frequently Asked Questions 
about FDA's Regulation of Infant Formula March 1, 2006 



http://www.cfsan.fda.gov/~dms/qa-inf22.html

warmly,

Nikki Lee RN, MS, Mother of 2, IBCLC, CCE
Adjunct Faculty, Union Institute and University, Lactation Program
Film Reviews Editor, Journal of Human Lactation
www.breastfeedingalwaysbest.com

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