FDA Allows Bisphenol-A at 10 Times the Safe Level

Photo: Evangelos Patriarcheas / Istock

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The Food and Drug Administration relied on faulty industry studies, ignored independent science and concluded that Bisphenol-A is safe when it is not.

That's the conclusion of a panel appointed by the FDA to review its safety assessment of the chemical, found in many hard plastics, including water and baby bottles, and in the lining of cans, including baby formula. The panel said the FDA had set the safe limit of Bisphenol-A exposure 10 times too high.

The panel recommended that the FDA, which is in the midst of a larger safety review, ignore its earlier findings because they are fatally flawed.

Bisphenol-A mimics the hormone estrogen, and has been linked to a range of health problems, from diabetes to prostate cancer.

Earlier investigative reporting, led by the Milwaukee Journal Sentinel, found that the American Chemistry Council, an industry group, largely wrote the FDA's safety assessment. It also raised questions about the latest panel's objectivity, given that a prominent advocate for Bisphenol-A's safety donated $5 million to the institution directed by the panel's chairman — but it appears the panel ruled without letting that fact cloud its judgment.

Instead, the panel "took the FDA to task," as the Journal Sentinel reports:

• The FDA relied on a study "that looked at only 14 infant formula cans bought in the Washington, D.C., area as the basis for its estimate of what children across the country were being exposed to," in the words of the Journal Sentinel.

• The FDA used unrealistic assumptions about parenting. Among them, that parents no longer feed babies formula after 12 months, and that they stop sterilizing baby bottles at two months.

• The FDA failed to consider how microwaving baby bottles might affect how much Bisphenol-A is released into the milk or formula.

• The FDA based findings on two studies funded by the chemical industry, while dismissing studies that the National Toxicology Program used in its determination that the chemical is a potential health risk, and failed to justify why it ignored them.

Read the newspaper's full story.

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