Powdered formula is not sterile and while it is appropriate for most babies you should discuss that with your doctor. Particularly for infants and preemies.
Also if you do use powdered or liquid concentrate you should only use non-fluoridated water to mix it. The occasional use of fluoridated water is not a concern. In most places this means buying bottled water, bottled water is not sterile -if your baby requires boiled water you must still boil the bottled water. Boiling fluoridated water does NOT remove the fluoride, nor do most in home-filtration systems.
As for formulas being FDA approved they are NOT. The FDA does not have the ability to prevent a company from marketing formula that does not meet the guidelines, they can only force a recall if there is a proven health risk.
"Powder infant formula is not sterile and in rare cases has made babies sick. If your baby is younger than 1 month old, premature, or ill, use powdered formula only under your doctor's instruction. Otherwise use liquid formula, which is sterile until the container is opened."
http://www.bchealthguide.org/healthfiles/hfile69b.stm
"Health Canada is drawing attention to the fact that powdered infant formulas are not commercially sterile products. Unlike liquid formulas, which are subjected to sufficient heat to render them commercially sterile, powdered infant formulas are not processed at high enough temperatures for sufficient time to achieve commercial sterility. Ready-to-use liquid infant formulas are available only in a commercially sterile form and indicated for premature or low-birth weight infants. However,"transition" infant formulas which are used for premature or low-birth weight infants after hospital discharge, may be either powdered or liquid. Human milk fortifiers which are added to pre-term breast milk are also available in powdered or liquid forms. A number of formulas, including formulas for infants with metabolic conditions are only available in powdered form. Powdered soy-based infant formulas may also become contaminated with E. sakazakii through improper cleaning of production lines and may, therefore, pose a safety hazard.
http://www.hc-sc.gc.ca/fn-an/securit/ill-intox/esakazakii/enterobacter_sakazakii_e.html
"There has been recent concern about the role of powdered formula preparations in the development of Enterobacter sakazakii infection in neonates. Previously known as "yellow pigmented" Enterobacter cloacae, it was renamed Enterobacter sakazakii in 1980. It has been known to cause meningitis, septicaemia, and necrotising enterocolitis in neonates, with reported mortality rates of up to 80%.
[...]
It is important to appreciate that powdered formulas and milk preparations are not sterile and can provide a medium for bacteria to proliferate. Appropriate preparation and handling of nutritional products is necessary to reduce the risk of milk becoming a source of nosocomial infection. 13 Breast feeding - apart from providing immunity through other means - reduces the risk of infection associated with formula preparation and storage, although care needs to be taken with breast milk which has been modified with additives."
http://www.adhb.co.nz/newborn/Guidelines/Nutrition/HandlingFeeds.htm
"Dear Health Care Professional:
The U.S. Food and Drug Administration (FDA) is writing to inform you about a growing body of information pertaining to Enterobacter sakazakii infections in neonates fed milk-based powdered infant formulas. Clusters of E. sakazakii infections have been reported in a variety of locations over the past several years among infants fed milk-based powdered infant formula products from various manufacturers. One study tested milk-based powdered infant formula products obtained from a number of different countries and found that E. sakazakii could be recovered from 20 (14%) of 141 samples (1).
Enterobacter sakazakii is a gram-negative rod-shaped bacterium within the family Enterobacteriaceae. The organism was called "yellow-pigmented Enterobacter cloacae" until 1980 when it was renamed Enterobacter sakazakii (2). The majority of cases of E. sakazakii infection reported in the peer-reviewed literature have described neonates with sepsis, meningitis, or necrotizing enterocolitis (3-5) as a consequence of the infection, and the case-fatality rate among infected neonates has been reported to be as high as 33%. The pathogen is also a rare cause of bacteremia and osteomyelitis in adults (2).
The literature suggests that premature infants and those with underlying medical conditions may be at highest risk for developing E. sakazakii infection. Several outbreaks have occurred in neonatal intensive care units worldwide. (See, for example, van Acker et al.(3).) However, an apparently healthy full term newborn infant in Iceland also became ill prior to hospital discharge and suffered permanent neurological sequelae (4). Although the reservoir of the organism is unknown, a growing number of outbreaks of infection among neonates has provided compelling evidence that milk-based powdered infant formulas have served as the source of infection (3-5). Significantly, the results of one investigation (the "Belgium outbreak" investigation (3)) suggest that even low levels of E. sakazakii in milk-based powdered infant formula (i.e., levels that are within what a 1994 Codex Alimentarius document (6) provides as a currently accepted limit for the presence of coliforms in milk-based powdered infant formula) can lead to development of infection."
http://www.cfsan.fda.gov/~dms/inf-ltr3.html
" The ADA offers these recommendations so parents, caregivers and health care professionals who are concerned have some simple and effective ways to reduce fluoride intake from reconstituted infant formula.
* Breast milk is widely acknowledged as the most complete form of nutrition for infants. The American Academy of Pediatrics recommends human milk for all infants (except for the few for whom breastfeeding is determined to be harmful).
* For infants who get most of their nutrition from formula during the first 12 months, ready-to-feed formula is preferred to help ensure that infants do not exceed the optimal amount of fluoride intake.
* If liquid concentrate or powdered infant formula is the primary source of nutrition, it can be mixed with water that is fluoride free or contains low levels of fluoride to reduce the risk of fluorosis. Examples are water that is labeled purified, demineralized, deionized, distilled or reverse osmosis filtered water. Many grocery stores sell these types of drinking water for less than $1 per gallon.
* The occasional use of water containing optimal levels of fluoride should not appreciably increase a child’s risk for fluorosis.
Parents and caregivers should consult with their pediatrician, family physician or dentist on the most appropriate water to use in their area to reconstitute infant formula. Ask your pediatrician or family physician whether water used in infant formula should be sterilized first (sterilization, however, will not remove fluoride)."
http://www.ada.org/prof/resources/positions/statements/fluoride_infants.asp
"Per the FDA, "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.""
http://www.kellymom.com/nutrition/milk/infant-formula.html
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