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FDA Reaffirms the Safety of BPA; States Additional Research is Needed
For Immediate Release
January 15, 2010
January 15, 2010
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On January 15, the U.S. Food and Drug Administration (FDA) reaffirmed the safety of BPA for use in all food contact applications, noting studies employing standardized toxicology tests support safety at current low levels of human exposure. However, FDA agreed with the National Toxicology Program (NTP) that recent studies employing novel approaches designed to test for subtle effects have raised “some concern” about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children, and so is working with NTP to carry out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.
FDA reiterated BPA is safe in all of its current uses and noted that families should not change their infant feeding practices, including the use of infant formula. FDA added “the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.”
In the meantime, FDA is taking steps to help reduce human exposure to BPA, including facilitating the development for alternatives to the linings of metal cans for liquid infant formulas. To this end, the infant formula industry is working with the packaging industry as well as the FDA and Canadian government to minimize trace levels of BPA that may be contained in current packaging while aggressively researching to identify possible alternatives to current liquid infant formula packaging.
FDA is also supporting recommendations from HHS for infant feeding and food preparation to reduce potential BPA exposure (http://www.hhs.gov/safety/bpa/).
The infant formula industry takes all potential safety concerns very seriously, and we support science-based efforts to produce infant formula products of the highest possible quality. When new information becomes available on substances like BPA, we support bringing that information forward through the accepted process of scientific peer review and evaluation.
Parents and healthcare professionals can be assured infant formula is safe and nutritious.
Clarification of “some concern”
In 2008, the NTP concluded it had “some concern” for potential neural and behavioral effects in fetuses, infants, and children at current human exposures to BPA. NTP clarified its conclusion by stating: “There are insufficient data from studies in humans to reach a conclusion on reproductive or developmental hazards presented by current exposures to bisphenol A, but there is limited evidence of developmental changes occurring in some animal studies at doses that are experienced by humans. It is uncertain if similar changes would occur in humans, but the possibility of adverse health effects cannot be dismissed.” In other words, the current scientific literature on BPA cannot be interpreted for relevance to human health; FDA stated more research is needed for such a determination.
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The International Formula Council (IFC) is an association of manufacturers and marketers of formulated nutrition products, e.g., infant formulas and adult nutritionals, whose members are based predominantly in North America. IFC members are: Abbott Nutrition; Mead Johnson Nutrition; Nestlé Infant Nutrition; and Pfizer Nutrition.