Infant Formula Warning - Do Not Use Fluoridated Water

In November 2006 the The US Public Health Service's Centers for Disease Control and Prevention, and the American Dental Association, released a recommendation  that infant formula NOT be made with fluoridated water, following the NRC Review. The ADA states: "If liquid or powdered concentrate infant formula is the primary source of nutrition, mix with water that is fluoride free, including water that is labeled purified, demineralized, deionized, distilled or reverse osmosis filtered water."

Why is this important?

The ADA's warning is extremely important because:

• Fluoride exposure during the first year of life increases the risk of dental fluorosis far more than at any other age. The risk continues until 4 or 6 years of age.
• The risk is as much to the permanent teeth as it is to the "baby teeth".
• Fluorosis weakens the teeth and causes decay.
• Fluorosis can require ongoing expensive dental treatment - that you have to pay for.
• Fluorosis has psychological effects causing self-conscioussness resulting in reduced social interaction and employment success.
• It is internationally accepted that dental fluorosis is the first outward sign of fluoride poisoning. The NZ Ministry of Health is trying to deny the application of the ADA’s warning in NZ.

In NZ the risk from fluoride was raised in the Public Health Commission’s 1995 report on fluoridation, which mistakenly assumed that lowering the fluoride level of the powder would remove the risk. Subsequently, the NZ-Australian standard for fluoride levels in infant formula (2.9.1) was reviewed and reported on in 1999 (Proposal 93). The review (supplied by NZFSA) identified that the amount of fluoride in the water alone posed the risk, even with no fluoride in the powder, or if fluoridated water itself were given to a baby.

It found that even at the (lower) fluoride levels actually occurring in NZ formula, using fluoridated water created a risk of fluorosis. Interestingly, participants in the 3rd International Workshop on Fluorosis Prevention and Defluoridation of Drinking Water, 2000, run in conjunction with WHO, also considered 0.5 ppm to be the maximum safe level, and possibly less. That is the maximum level allowed in formula and considered safe in teh Report so lon gas fluoridatede water wasa not added.

The Ministry of Health's "justification" for not informing parents was based on three misleading claims:

1. That the Standard (2.9.1) was set on the assumption that fluoridated water would be used;
2. That fluoridated water alone was not the problem;
3. That baby formula in the US had much higher levels of fluoride than formula available in New Zealand.

The first point is misleading at best, and the other two are untrue:

1. The standard was set purely to ensure that, when mixed with water fluoridated at 1ppm, the made up formula would not exceed the legal Maximum Contaminant level of 1.5ppm - double the level actually used in NZ, and never recommendd even for adults in temperate climates. Possible adverse health effects were not considered in setting this standard. In fact it was known there was such a risk under this standard:

The report (ANZFA P93) behind the standard states:

"[The advisory] statement on infant formula labels [to consult a doctor about the risk of dental fluorosis if the set level (0.17mcg/100KJ) was exceeded] was proposed for infant formula powders containing levels above 0.5 mg/L when reconstituted with fluorine free water. At the levels given the formula may not cause dental fluorosis if prepared with water that has been distilled. However, if used with fluoridated water it may cause fluorosis" (emphasis added). 

"Sources of products that may contribute to excess fluoride ingestion in infants are fluoridated water, infant formula (reconstituted with optimally fluoridated water), …" and: "An Australian study (Silva & Reynolds, 1996) concluded that prolonged consumption (beyond 12 months) of infant formula with water fluoridated at 1ppm could contribute to dental fluorosis."

This essentially repeats the ADA's warning on not using fluoridated water for reconstituting infant formula and for precisely the same reason: risk of dental fluorosis.

Consequently, to be consistent with the health protection intent of Standard 2.9.1, parents should be warned not to feed their infants this level of fluoride; that is, not to make up formula with fluoridated water.

The report also states:

"The tolerable daily intake (TDI for adults) for contaminants [including fluoride] is not considered to be applicable to infants under 3 months of age [as the normal gastrointestinal and liver functions are not fully developed in infants]." and "It is unlikely that data will become available to establish safe levels of exposure for infants."

"The issue isn't the infant formula itself, but the [fluoridated] water it's reconstituted with"

It is therefore impossible to allow for fcluoridated water when setting the fluoride levels of infant formula. What was done was to allow fo a maximum of 1.5 ppm whene water fluoridated at 1ppm was aqdded to formula with fluoride equivalent to 0.5ppm.

3. Thirdly, the claim that USA infant formula has the lowest levels of fluoride in the world. The ADA's warning was based on the findings of the National Research Council, whose report was published in 2006. The true figures for US formula are quoted at page 30 of that report:

*The legal limit is 0.4 ppm, however the industry has adopted a tighter standard

#The maximum fluoride level for infant formula powder in NZ is 0.17 mcg per KJ (MoH press release). Infant formula typically contains 2900 KJ per litre when reconstituted (127 gm formula powder per litre). This equates to 0.49 mg fluoride per litre before considering the fluoride in the water. 900 ml water is required, adding another 0.9 mg fluoride, making a total of 1.39 mg per litre.

This demonstrates clearly the Ministry's deliberate deception. In fact the warning is even more relevant to NZ (and Australia, where that Ministry has made the same misleading statement) than the USA. As such the Ministry is in breach of its statutory duty under the Health Act. Any DHB trying to negate the ADA’s statement is also in breach of its statutory duty.

The recommended fluoride limit for children from 0 to 6 months is zero; the limit for 6 months to 3 years is 0.25 mg/day. The intake when fluoridated water alone is given to infants, let alone with the fluoride added from the formula, significantly exceeds this level.

The ADA is the leading promoter of water fluoridation, and referred to as a world authority by the Ministry when wanting support for its pro-fluoride position. Suddenly the Ministry wants to ignore its own "authority" when the ADA make a statement the Ministry doesn’t like!

The warning clearly states that it relates to water with 0.7 ppm or more, as in NZ. Although the US allows 4ppm of natural fluoride in water, it fluoridates at the same level as NZ, from 0.7ppm with a maximum of 1.5 ppm allowed. Also, the US Public Health Service advises that less than 1/2% of Americans drink water with more than 2 ppm. let alone 4ppm.

The Ministry also states:

"Labels on packages of infant formula product that contain the above levels of fluoride must indicate that consumption of the formula has the potential to cause dental fluorosis."

This confirms the position of the ADA!

Moreover, 1.5 mg/litre fluoride is twice the recommended concentration for adults (0.7 mg/l), and higher than the level of "optimally fluoridated" water the ADA warns should not be used (0.7 – 1ppm)! Clearly the limit set by the NZ MoH for liquid formula is unsafe and must be reduced immediately! This is no way contradicts the ADA’s recommendation. It simply establishes that the MoH is determined to bury its head in the sand rather than admit it has got fluoridation policy wrong!

This also establishes, in our view, legal liability of the MoH for fluorosis caused by consumption of formula made within their allowed limits. Recommending that parents "[discuss this] with a medical practitioner or other health professionals" is not only pointless, as health professionals will not know how the limit was set, but inappropriate: The warning should be uiversal - "Do not mix this with fluoridated water". Period!