Infant formula is loosely regulated in the USA as a food item, "generally
recognized as safe" or GRAS. It is the *food* part of the Food & Drug Admin
(FDA) that governs this, not the *drug* part.

"FDA does not approve infant formulas before they can be marketed. However,
all formulas marketed in the United States must meet federal nutrient
requirements. Infant formula manufacturers are required to register with
FDA and provide the agency with a notification prior to marketing a new
formula."
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048694.htm

So I call this the "Oops" form of oversight.  Formula manufacturers can
tinker with their product -- a LOT -- just so long as they let FDA know. No
pre-approvals needed.  If it turns out that the additive or whatever is
causing harm/adverse effects to babies, then FDA can say "Oops" and
institute a recall of the item.  Put another way: the guinea pigs for new
products are the bbies who are being given the product.

It is important for parents and healthcare providers to ALWAYS report an
adverse effect.  Smelly loud weird poops COUNT as an adverse effect.
http://www.fda.gov/Safety/MedWatch/default.htm
-- 
Liz Brooks, JD, IBCLC, FILCA
Wyndmoor, PA, USA
websites: LizBrooksIBCLC.com (and) www.LactSpeak/com/speaker/LizBrooks
Twitter: @LizBrooksIBCLC (and) Facebook: www.facebook.com/LizBrooksIBCLC
IBCLCs empower women and save babies' lives!  See how skilled IBCLC care
differs from
other breastfeeding help, at The Massachusetts Breastfeeding Coalition's
Landscape of Breastfeeding Support: http://massbreastfeeding.org/landscape/

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