The debate regarding the polycarbonate substance called BPA and its use in plastic baby bottles continues. The following is a response to Fit Pregnancy's request for the Food and Drug Administration's most current position on BPA use. The statement comes from the FDA's Office of Food Additive Safety and was sent by biologist Julie N. Mayer, M.F.S. on July 31, 2007.
The FDA is unaware of any specific study in which humans exposed to BPA through any food containers experienced miscarriages, birth defects or cancer. Furthermore, human exposure levels to BPA from its use in food contact materials is in fact many orders of magnitude lower than the levels of BPA that showed no adverse effects in animal studies.
BPA is used in the manufacture of two types of polymers regulated in the U.S. Code of Federal Regulations for use in food-contact articles ... [These] polymers are, for the most part, intended for repeated contact with food. Typical uses include food processing equipment such as popcorn makers, and water and infant bottles intended for repeat use.
Both types are themselves high molecular weight long chain polymers that will not migrate to food, [but] they do contain small amounts of residual BPA that can migrate to food. Therefore, as part of FDA's pre-market safety review of all such substances, the agency evaluated the cumulative dietary exposure to BPA resulting from the intended use of these food contact polymers. FDA found that the small amounts of BPA that migrated into food from the use of polycarbonate-based polymers and BPA-based epoxy coatings resulted in a cumulative dietary concentration of 3.7 ppb, an extremely low level, and well below the levels that showed no adverse effects in animal studies.
Several debates currently exist in the scientific literature regarding potential reproductive and developmental effects of BPA and a possible low dose effect. References used in recent press reports cite studies showing extremely low "no observed adverse effect levels" (NOAELs) for BPA, and these studies are used as the basis for claiming that BPA is unsafe. However, further examination of the cited references indicates that the bases for these low values are studies for which significant debate exists regarding the animal model utilized, the statistical analysis of the data, the use of multiple/correctly spaced doses in the experimental protocol, the relationship of the observed finding to long term exposure, and the route of administration.
Although the debate continues regarding the methods used in these studies, additional reproductive studies that have been conducted in mice and rats, based on the use of well-established regulatory guidelines, a range of high and low dose exposures and good laboratory practices, do not indicate a safety concern at the current cumulative exposure.
In other words, the dietary exposure to BPA from all food contact materials is thousands of times lower than the levels that showed no adverse effects in animals. This margin is sufficiently large such that FDA has confidence that no safety concern exists for BPA in regulated food contact materials.
Furthermore, FDA has determined that the use of polycarbonate-based baby bottles and BPA-based epoxy coated cans used to hold infant formula is safe.
Therefore, FDA sees no reason at this time to ban or otherwise restrict the currently authorized food contact applications of polycarbonate polymers and BPA-based coatings. However, if new information becomes available to indicate that existing data no longer support the continued safe use of these materials, FDA will take appropriate regulatory action to remove these materials from the marketplace.
Julie N. Mayer, M.F.S.
Office of Food Additive Safety
Center for Food Safety and