EWG's Guide to Infant Formula and Baby Bottles

Summary & Findings

December 5, 2007

EWG's Guide to Infant Formula and Baby Bottles: BPA in formula--how harmful?

Each company we contacted was quick to point out that it complies with all relevant health guidelines regarding formula packaging. It’s true. Unfortunately, the standards and guidelines of the FDA and the Environmental Protection Agency are outdated and inadequate in light of growing scientific concerns about the potential harm to infants from BPA exposure.

This year, 2 separate panels from the National Institutes of Health (NIH) have expressed concerns about infant exposure to BPA. The Center for the Evaluation of Risks to Human Reproduction (CERHR) concluded that there was “some concern” that infant exposure could harm brain development and adversely affect behavior (CERHR 2007b). The chairman of the CERHR panel indicated that “it might be a time for application of the precautionary principle” for BPA, suggesting that parents would be wise to avoid all infant exposure to the chemical until serious outstanding questions about BPA’s potential harm are sorted out (Hileman 2007).

More grave concerns were expressed by a BPA expert committee convened by the National Institute of Environmental Health Sciences, a division of NIH. A consensus statement prepared by the committee concluded that the majority of current human exposures are at or above the levels that cause harm in repeated animal studies (vom Saal 2007).

Very little is known about BPA concentrations in infant formula. EWG and FDA have both tested liquid formulas. EWG tested 6 and FDA tested 14 samples (Biles 1997, EWG 2007a). Both studies found on average 5 parts per billion of BPA, and 4 samples with more than 10 ppb. At these concentrations, lighter and hungrier babies will exceed the daily doses of BPA that have been found harmful by the most sensitive laboratory studies. Most other children have an unacceptably low margin of safety between their daily exposures and the doses that are harmful in the laboratory. Because it is very likely that some people are more sensitive to BPA, or less efficient at eliminating it from their systems, it is vital that tougher regulations are put into place to reduce BPA exposures to levels many times below those found harmful in the lab.

Powdered formula samples in the U.S. have not been tested for BPA leaching. One study in Taiwan examined BPA in three powdered soy formula samples and four ‘follow-up’ formulas which are intended for older children (Kuo 2004). They detected BPA in every sample, at concentrations higher than those found in liquid formulas tested in the United States. Tests of U.S. powdered formulas are sorely needed.

Dozens of recent studies link very low concentrations of BPA with permanent alterations of the reproductive system, brain and behavior of laboratory animals (Maffini 2006). However, FDA regulations governing BPA leaching from food containers are completely out of touch with these findings of low dose toxicity. Regulations mandate that leaching of BPA into food must not exceed 0.05 milligrams of BPA from each square inch of the can surface (FDA 2006). At the maximum allowable BPA leaching, this would result in 0.5 to 5 parts per million of BPA in standard size formula cans, and lead an average 0 to 4 month old baby to exceed EPA’s outdated safe daily dose of BPA by up to 30 times (EPA 1998).

How much is safe?

Every manufacturer we contacted also assured us that there is no evidence that babies fed from BPA lined food cans and polycarbonate bottles are harmed. This also is true because no one has looked for these effects and because the potential health impacts of BPA exposure would occur later in life, and would not likely be traced back to BPA exposures during pregnancy and early life. BPA’s impacts include insulin resistance, brain and behavioral impacts, early puberty, altered hormone levels, and other reproductive problems--conditions that occur years or decades after babies are weaned from formula.

The very low concentrations of BPA found in formula put babies at unacceptable risks of harm to their brain and nervous system, and reproductive systems. Exposure to BPA in animal studies has been linked to a number of adverse health effects at incredibly low doses. The most sensitive studies find oral BPA exposures to lab animals of about 2 micrograms per kilogram of body weight per day caused increased prostate weight in animals exposed during pregnancy, (Nagel 1997), increased aggression at eight weeks of life (Kawai 2003), signs of early puberty (Howdeshell 1999), lower body weight (Honma 2002), decline in testicular testosterone (Akingbemi 2004), and cause breast cells to be predisposed to cancer in later life (Murray 2007).

Laboratory studies consistently show that the most sensitive periods of exposure to BPA are during pregnancy and early life (Maffini 2006). BPA has also been found in American mothers’ breast milk, amniotic fluid, and cord blood, indicating widespread exposure before birth (CERHR 2007b). A recent finding by the Centers for Disease Control found detectable BPA in more than 90% of 2,500 people sampled (Calafat 2007). The study didn’t include any children younger than 6, so much less is known about current exposures for newborns and babies.

EWG’s modeling, using real-life formula sampling and a survey of baby weight and formula intake, found that one of every 16 infants exclusively fed ready-to-eat canned formula would be exposed to BPA at doses exceeding those that altered testosterone levels, affected neurodevelopment, and caused other permanent harm to male and female reproductive systems (EWG 2007b). At the highest BPA levels found in formula, 17 parts per billion (ppb), nearly 2/3rds of all infants fed ready-to-eat formula would be exposed above doses that proved harmful in animal tests (EWG 2007b).

Earlier this year, the National Institutes of Health’s Center for the Evaluation of Risks to Human Reproduction (CERHR) program led an assessment of the safety of BPA. It was a highly contentious process. During the review NIH fired the CERHR contractor, Sciences International, for potential conflicts of interest including their contracts to work for companies who manufacture BPA (Bucher 2007). The draft scientific review document considered by the panel was riddled with hundreds of errors and omissions and received sharp criticism from BPA researchers (CERHR 2006). The CERHR panel dismissed evidence that BPA impacted breast and prostate development, and linking the chemical to infertility and early puberty. Nevertheless the panel did find that there was "some concern" for BPA's impact to brain and behavior for infants and children (CERHR 2007b). In the meantime, an alternative group of 38 BPA researchers and experts published a parallel review with conclusions that diverged sharply from CERHR, determining that that BPA presents a clear risk to human health (vom Saal 2007).

Much of the controversy arises over the interpretation of dozens of studies showing BPA affecting the reproductive problems and cancer at low doses. Several reviews have dismissed studies showing low-dose toxicity (EFSA 2006; CERHR 2007b). However the 38 BPA experts came to a different conclusion:

“Importantly, much evidence suggests that these adverse effects are occurring in animals within the range of exposure to BPA of the typical human living in a developed country, where virtually everyone is exposed to measurable blood, tissue and urine levels of BPA that exceed the levels produced by doses used in the low dose animal experiments" (vom Saal 2007).