Dear Friends:
    Judy wonders: "Why
obtain informed concent for an experimental product when it has already
been approved by the FDA? I have to present an accurate arguement. "
     The answer is that formula doesn't have to be approved by the FDA to be
sold.   The following is a direct quote from the FDA website, which can be
found at http://www.cfsan.fda.gov/~dms/qa-inf22.html
"The law does not require that FDA approve infant formulas but instead
requires companies to provide certain information to FDA before they market new
infant formulas. Manufacturers must provide assurances that they are following
good manufacturing practices and quality control procedures and that the formula
will allow infants to thrive. If such assurances are not provided, FDA will
object to the manufacturer's marketing of the formula; however, the manufacturer
may market the new infant formula over FDA's objection."
    I find this evidence that our government does not care about infant
health.
    warmly,
Nikki Lee RN, MS, Mother of 2, IBCLC, CIMI, CCE, craniosacral therapy
Adjunct faculty, Union Institute and University, Maternal and Child Health:
Lactation Consulting
Supporting the WHO Code and the Mother Friendly Childbirth Initiative

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