The FDA and BPA: What does the science say?

In the past few years, the FDA has made a concerted effort to review new research on BPA to provide evidence-based recommendations to the public, including answers to common questions, which can be found on “FDA Answers Key Questions about BPA Safety” or its “Questions and Answers on Bisphenol A (BPA) Use in Food Contact Applications” page. These recommendations include:

In September 2018, the U.S. National Toxicology Program (NTP) released the final report on the CLARITY Core Study. The scope and magnitude of this study are unprecedented for BPA and the results clearly show that BPA has little potential to cause health effects, even when people are exposed to BPA throughout their lives.

The CLARITY study results are consistent with the results of previous studies from U.S. federal government researchers, which collectively indicate that BPA is unlikely to cause health effects at the very low levels to which people are exposed. Based on these results, along with results from other relevant studies, the U.S. Food and Drug Administration (FDA) continues to reaffirm the answer to the question “Is BPA safe?” with a clear answer – “Yes.”


Past FDA Actions

Response to the Natural Resources Defense Council (NRDC)’s Citizen Petition in 2012: The FDA denied NRDC’s petition in its entirety, which asked the FDA to prohibit the use of BPA in human food and food packaging. This response included the statement that “the Food and Drug Administration’s assessment is that the scientific evidence at this time does not suggest that the very low levels of human exposure to BPA through the diet are unsafe.” FDA noted a variety of limitations in the studies cited by the NRDC petition.  Visit the FDA website for more information on this decision.

In its decision to reject the NRDC’s petition, the FDA reconfirmed its earlier conclusion that BPA is safe for use in food-contact applications. In an update coinciding with its response to the petition, FDA stated that “the scientific evidence at this time does not suggest that the very low levels of human exposure to BPA through the diet are unsafe.” This is consistent with both an August 2008 assessment and a January 2010 update that affirmed that BPA “is not proven to harm children or adults…” As noted by an FDA spokesperson, FDA objectively weighs all the evidence in an unbiased evaluation to reach its conclusion.

  • “Update on Bisphenol A for Use in Food Contact Applications” in 2010: HHS and the FDA released their recommendation to the public, which said that BPA “is not proven to harm children or adults…” This was consistent with a draft assessment issued by FDA in 2008 (see below). The update confirmed that studies using standardized toxicity tests continued to support the safety of BPA. FDA noted some studies, using novel approaches to testing for subtle effects, did raise questions and the agency would conduct additional scientific research to answer these key questions and clarify uncertainties. Although the agency noted “some concern,” meaning additional research is needed; it did not take regulatory action or impose restrictions on the use of BPA. To read the full report, please click here.
  • FDA releases docket of BPA information: On April 5, 2010, FDA released its docket of information pertinent to BPA. As a follow up to its January 2010 statement on BPA, FDA opened this docket to provide transparency of the scientific review process. To see FDA’s January statements supporting the continued safe use of BPA, and noting that the agency would open a docket, please click here. To visit the docket online, please click here.
  • FDA supports baby bottles with BPA: In January 2010, FDA Deputy Commissioner Joshua Sharfstein stated that “if [the Food and Drug Administration] thought it was unsafe, we would be taking strong regulatory action.” — The New York Times
  • Draft Assessment of Bisphenol A for Use in Food Contact Applications” in 2008: The FDA released a draft report on BPA in food-contact products such as water bottles, food containers and baby bottles. The FDA stated the following: “FDA concludes that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults.” More simply, this statement found that BPA is safe in food contact products. Please click here for the full report.

For more information on FDA research on BPA safety, please click here.