Endocrine Society Expresses Concern on FDA’s BPA Safety Statement

The Endocrine Society today expressed disappointment with the U.S. Food and Drug Administration’s (FDA) statement asserting that the results of an interim report support previous determinations that bisphenol A (BPA) is safe for use in food containers and packaging.

“It is premature to draw conclusions based on the release of one component of a two-part report,” says Endocrine Society spokesperson Laura N. Vandenberg, PhD. “The National Toxicology Program draft report released Friday included the results of one government study with a partial data set and has yet to undergo peer review.”

The final Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) report will merge the results of research studies carried out in academic labs with those conducted by regulatory agencies. The draft released Friday only contained the studies conducted at the FDA’s National Center for Toxicological Research (NCTR).

The NCTR study did not examine some key areas of concern, such as BPA’s impact on brain development. NCTR researchers focused on how BPA affected growth, weight and tumor development.

“The endpoints studied here do not encompass the full effects of endocrine-disrupting chemicals, especially because the whole point of this study was to compare the NCTR’s endpoints with more sensitive effects evaluated by endocrinologists,” Vandenberg says. “Furthermore, the NCTR’s data does not provide assurance of BPA’s safety. They found certain BPA doses are linked to a higher rate of mammary gland tumors, which is concerning.”

The final CLARITY-BPA report is expected to include academic researchers’ studies of BPA’s effects on additional relevant endpoints. Policymakers and regulators should reserve judgment until the full report is released.

BPA and other endocrine-disrupting chemicals (EDCs) harm human health by mimicking, blocking or otherwise interfering with the body’s hormones. BPA mimics the hormone estrogen. Because tiny amounts of estrogen trigger the development of numerous tissues in unborn children, exposure to low doses of BPA during critical windows of development can have lifelong impacts on health.

As of 2014, nearly 100 epidemiological studies have been published tying BPA to health problems, according to the Introductory Guide to Endocrine-disrupting Chemicals published by the Society and IPEN, a global network that supports sound chemicals management. These include issues with reproductive health, behavior and metabolism.

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