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Thread: New FDA comment on infant formulas




New FDA comment on infant formulas
user name
2006-11-04 16:42:03
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://ww
w.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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