Endocrine Society says FDA excludes critical research in decision-making on BPA use in food packaging
Chevy Chase, MD— The Endocrine Society, the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology, expressed disappointment today in the U.S. Food and Drug Administration (FDA) for neglecting key research and endocrine principles in deciding not to ban BPA in food packaging.
BPA is a known endocrine-disrupting chemical (EDC). EDCs are substances in the environment that interfere with hormone action resulting in adverse developmental, reproductive, neurological and immune effects in both humans and wildlife. Many of these chemicals are designed, produced and marketed largely for specific industrial purposes, but they are also found in some natural foods and may become further concentrated as foods are processed.
“The Society supports the FDA's continuing efforts to evaluate the safety of BPA, but it remains concerned that policy on BPA and other endocrine disrupting chemicals is ignoring the entirety of available scientific data,” said Janet E. Hall, MD, president of The Endocrine Society.
In its March 30, 2012 response to a Citizen Petition from 2008, the FDA denied the petitioners’ request to ban BPA from food and food packaging, stating that they had failed to provide sufficient data to persuade the FDA to begin a rulemaking. In its response, the FDA again called into question the relevance of small, academic studies on the effects of EDCs, despite the advice of its own scientific advisory board in November 2008 to include such studies in the assessment of BPA.
The FDA’s approach to discounting studies in the regulatory process does not allow for a thorough examination of the data and hinders the agency’s ability to ensure appropriate regulation of EDCs. A recent Endocrine Reviews article outlines a Weight-of-Evidence approach to evaluating low-dose studies from an endocrine perspective, focusing on criteria different from those used by the FDA.
“We encourage the FDA to consider low-dose studies examining important endocrinological endpoints when making policies regarding BPA or other endocrine-disrupting chemicals,” said Hall. “Many of the neglected studies of low-dose effects are well designed, heavily reviewed, NIH-funded work. The results of this research show significant health effects at exposures substantially lower than those deemed safe by the FDA."
Endocrinologists have a valuable and unique insight into the impact of EDCs, and modern endocrinology has greatly advanced the body of scientific knowledge in this field in the past decade. The Endocrine Society published its Scientific Statement on endocrine-disrupting chemicals in 2009. The Scientific Statement, available at www.endo-society.org/journals/scientificstatements, presents evidence on the health effects of endocrine-disrupting chemicals as well as recommendations for increasing understanding and raising awareness of these effects.
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Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 15,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md. To learn more about the Society, and the field of endocrinology, visit our web site atwww.endo-society.org.