FDA Jumps the Gun on Bisphenol A and Undermines Ongoing Safety Research


Guest post by Maricel V. Maffini, Ph.D., Senior Scientist, Natural Resources Defense Council

At low doses the FDA says bisphenol A, the substance used in cans, plastics and dental fillings, is safe. But, the agency is in the midst of a multimillion dollar study examining the safety of this synthetic estrogen. Haven’t they jumped the gun? 

FDA officials seem eager to put this discussion behind them and move on, but there is still a lot to be done in the quest to find answers to the question: does BPA adversely affect human health?

In 2009, Congress provided the National Institute of Environmental Health Sciences (NIEHS) with $30 million to invest in research that will lead to a better understanding of the public health consequences of exposures to bisphenol A. NIEHS’s National Toxicology Program partnered with the U.S. Food and Drug Administration (FDA) and created a consortium called CLARITY in which investigators from academic institutions, the FDA and the National Toxicology Program would work together to answer “important questions surrounding BPA and risks to human health” and “to support and perform the best science we can to inform the best possible decision making.”

The experiments were designed to be comprehensive and to cover 1) a wide variety of disorders and diseases including breast cancer and 2) exposures to everyday levels throughout the life of the animals. These experiments are still ongoing and it will take another three to four years to have all the data analyzed and published.That means it should take the FDA three to four years to make sense of the results and to draw conclusions about the safety of this widespread endocrine disruptor. 

For reasons only known to the FDA, its scientists published preliminary data in February that were limited in scope and duration and of questionable scientific value due to the contamination of the study’s control group. Animals that were not supposed to have been in contact with BPA were found to be contaminated. It’s bad enough that data of very limited significance got published, but FDA’s statement to Environmental Health News was worse:  “[t]he study reported no effects of BPA at any dose, except at the very highest levels, and is consistent with the FDA’s current position that BPA is safe at the very low amounts that occur in some foods.

Why would FDA declare BPA  safe at everyday exposure levels before the comprehensive study is finalized? What is the rush? Why would FDA jeopardize public health by making a premature decision?

Meanwhile, scientific evidence continues to pile up and other agencies have come up with opinions contrary to FDA’s current stance on BPA. In January 2014, the European Food Safety Authority (EFSA) (FDA’s counterpart across the pond) released its draft extensive Scientific Opinion on the risks to public health related to the presence of BPA in foodstuffs. EFSA’s opinion recommended to lower the current acceptable daily intake, in other words the amount of BPA one can safely consume without harm, from 50 micrograms/kg body weight to 5 micrograms/kg because of likely kidney, liver and mammary gland adverse effects. Also in Europe, the European Chemicals Agency (ECHA) last month has supported a proposal to strengthen the current classification of BPA as a reproductive toxicant from “suspected human reproductive toxicant” to “presumed human reproductive toxicant” based on evidence that it affects fertility.

The FDA seems unfazed by the hundreds of publications showing that 1) BPA causes numerous adverse effects and 2) free BPA can be measured in human blood. But FDA officials seem to be in a hurry to support their current stance using unreliable data. The best thing FDA should do is to let the study, and the data it will generate, run its course and then, only then, make a rigorous assessment of the safety of BPA considering ALL available information. 


Maricel V. Maffini, Ph.D.
Senior Scientist, Natural Resources Defense Council
Maricel Maffini is a member of the Breast Cancer Fund’s Science Advisory Panel. She is a senior scientist in the health and environment program at the Natural Resources Defense Council (NRDC) in Washington, DC. She joined NRDC in 2013 after completing a three-year research project evaluating the U.S. food additive regulatory system at The Pew Charitable Trusts. Dr. Maffini holds a Ph.D. in Biological Sciences from the National University of Litoral, Santa Fe, Argentina. 


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