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FDA Cites Discredited Industry Science in Justifying High Levels of Contaminants in Infant Formula: Ignores Federally Funded Research Showing Serious Health Risks

WASHINGTON, DC – March 21 – In response to a congressional inquiry, the Food and Drug Administration (FDA) admitted that it based its determination that current levels of BPA exposure pose no health risks on two studies sponsored by the American Plastics Council (APC), the trade group that represents BPA manufacturers. One of these studies has been found to be deeply flawed by BPA experts and the other study has not been published nor has its results been made public. FDA chose to ignore data from almost 100 independent, peer-reviewed, and published animal studies that show that this chemical is toxic at very low levels of exposure. Many of these studies were funded by the National Institutes of Health. BPA is chemical component used in a number of different plastic products, including baby bottles and the lining in canned food.

“I’m not sure what’s worse — that FDA ignored almost 100 independent peer-reviewed studies expressing concerns over low-level BPA exposure or that they relied instead on 2 studies financed by the plastics lobby,” said Dr. Anila Jacob. ²This shows again how the industry works to influence regulators to water down the health risks posed by BPA.²

Here is an analysis by EWG Senior Scientists, Dr. Anila Jacob, MD, MPH of the FDA¹s findings:

Statements by the Food and Drug Administration (FDA) in response to a congressional inquiry reveal that the agency’s assertions that infant’s exposures to the toxic plastics chemical BPA in infant formula and baby bottles pose “no safety concern,” are based on two industry-funded studies, one unpublished and the other found to be deeply flawed by BPA experts. FDA’s calculations accompanying these assertions show that some infants are exposed to BPA at levels very close to those linked in lab studies to brain and reproductive system effects.

FDA’s methodology for assessing BPA health risks was made public in response to a request for information from the powerful House of Representatives Committee on Energy and Commerce that questioned the basis of the Agency’s public assurances about the safety of BPA, a chemical that contaminates the bodies of 93% of all Americans. BPA leaches into food and canned infant formula from the epoxy linings of metal food cans, and leaches into drinks held in polycarbonate plastic containers, like plastic baby bottles. The Agency’s response to the Committee reveals that FDA is relying exclusively on two studies funded by the plastics industry and disregarding nearly 100 studies confirming that BPA is toxic at low doses.

Below we provide EWG’s assessment of the gaping holes in FDA’s methods, from our analysis of their Committee submission. We find that FDA’s flawed analysis and biased consideration of the science puts public health at risk, especially for formula-fed infants and others who are highly exposed to BPA or highly vulnerable to its toxicity.

From FDA response to Committee on Energy and Commerce: “FDA believes that this level of exposure (11 ug/person/day and 7 ug/infant/day) is safe as defined in 21 CFRf170.3 (i). This conclusion is based on our most recently completed reviews of two pivotal multigenerational oral studies performed under applicable regulatory guidelines” (emphasis added).

Assessment: FDA is using flawed and unpublished studies funded by the plastics industry to make decisions that may impact the health of millions of people. Almost 100 peer-reviewed and published animal studies confirm that BPA is toxic at low doses. FDA based their analysis of BPA health risks on just two studies, both of which were funded by the American Plastics Council and one of which has not even been published in a peer-reviewed journal. One of these studies did not find evidence that BPA is toxic at low doses (Tyl et al 2002). BPA experts have widely questioned the validity of these findings, because the study did not include “positive controls.” Without these standard controls, it cannot be known if the study was capable of finding health effects from BPA, or if background contamination or other study design issues would have obscured health effects. The second study FDA has relied on is unpublished, not public, and funded by the plastics industry. Its use in developing critical public health policies for toxic chemicals is unconscionable.

From FDA response to Committee on Energy and Commerce: Estimated worst-case daily intake from the use of PC baby bottles and infant formula is 7 ug/infant/day.

Assessment: If a seven-pound newborn (3.1 kg) is fed with polycarbonate (BPA-leaching) baby bottles and given infant formula contaminated with BPA, they will be exposed to 2.2 ug/kg/day of BPA (micrograms of BPA per kilogram of body weight per day) based on FDA’s estimated daily intake. This is very close to the dose of 2.5 ug/kg/day, which has been shown in numerous animal studies to be toxic, leaving little or no margin of safety for young infants (EWG 2007).

From FDA response to Committee on Energy and Commerce: “FDA has completed a compact summary of the pharmacokinetic data on BPA in multiple species. FDA has determined that understanding the species differences and the differences in how metabolic systems handle BPA administered via various routes of exposure, such as oral versus subcutaneous, are pivotal to examining the safety of BPA” (emphasis added).

Assessment: FDA is suggesting that studies using non-oral routes of BPA administration have little relevance in human health assessments. However, it is well understood in the scientific community that it is actual serum levels of BPA that are relevant, regardless of the mode of administration. This was recently confirmed by a study published in the Journal Reproductive Toxicology that showed that non-oral routes of BPA administration are completely valid in assessing potential health effects (Taylor 2008). In this study, scientists administered BPA to neonatal mice by both oral and subcutaneous routes and found no significant difference in the plasma levels of unconjugated BPA, leading study authors to conclude “the large numbers of BPA studies that used non-oral administration at very low doses during the neonatal period should not be dismissed by scientists or the regulatory community based on route of administration.”

It should also be noted that there are numerous studies showing toxicity at daily BPA exposures ranging from 0.2 ug/kg body weight/day to 2 ug/kg body weight/day in which BPA is administered by the oral route (EWG 2007). FDA’s faulty decision to exclude studies based on the dosing route has resulted in a deeply skewed assessment of BPA health risks.

From FDA response to Committee on Energy and Commerce: “Intact bottles were held in boiling water for 5 minutes, filled with apple juice or formula, and refrigerated at 4 degrees Celsius for 24 hours. BPA was not detected in the juice or formula at a LOD [Limit of Detection] of 100 nanograms per milliliter (ng/ml) (100 ppb).”

Assessment: In this particular BPA migration study, the FDA uses a limit of detection (LOD) that is so high that it would not have detected BPA in any of the infant formula samples that have been tested by FDA and EWG (EWG 2007), and well above levels that would be a health concern. In fact, this LOD is 1000 fold higher than the LOD that FDA has used in other food testing (0.1 ppb).

In summary, FDA is basing important public health decisions on two industry-funded studies, one deeply flawed and one unpublished. FDA is disregarding the growing body of science that confirms the low dose toxicity of BPA in multiple, well conducted, peer-reviewed, and published studies. In addition, their own estimate of daily BPA intake shows that for formula-fed infants, there is little or no margin of safety from the harmful effects of BPA confirmed in lab studies. EWG has recommended that FDA set health standards for BPA that fully recognize the low-dose toxicity of this chemical, that are not biased in favor of industry lobbyists, and that fully protect the health of infants and others who are most vulnerable.

References:

1) Tyl RW, Myers CB, Marr MC, Thomas BF, Keimowitz AR, Brine DR, Veselica MM, Fail PA, Chang TY, Seely JC, Joiner RL, Butala JH, Dimond SS, Cagen SZ, Shiotsuka RN, Stropp GD, Waechter JM. 2002. Three generation reproductive toxicity study of dietary bisphenol A in CD Sprague-Dawley rats. Toxicological Sciences 68(1): 121-46.

2) Taylor JA, Welshons WV, vom Saal FS. 2008. No effect of route of exposure (oral; subcutaneous injection) on plasma bisphenol A throughout 24 h after administration in neonatal female mouse. Reproductive Toxicology 25(2): 169-76.

3) EWG. 2007. Bisphenol A: Toxic plastics chemical in canned food. Environmental Working Group, Washington, DC. Available at: http://www.ewg.org/reports/bisphenola.

EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.