FDA criticised by its own experts over BPA

The US Food and Drug Administration (FDA)’s recent conclusion that controversial chemical bisphenol A (BPA) is safe at current levels is flawed, the agency’s own Science Board has warned.

In a report approved on 31 October, the committee - a group of outside experts that advises the FDA’s leadership on technical issues and scientific developments - criticised as ’inadequate’ the agency’s August preliminary findings on the compound.

The Board found ’sufficient scientific basis to conclude that the margins of safety defined by FDA as "adequate" in food contact products are, in fact, inadequate’. The panel also suggests that a ’more conservative margin of safety’ regarding BPA is required for infants and young children.

BPA is used to make polycarbonate - including for plastic baby bottles - and used in plastic coatings for food containers. But the compound can leach out of the plastic and into the bottle’s contents. Exposure to BPA, an oestrogenic compound, has been linked to developmental and neurological problems in infants and foetuses. More recently, high levels of exposure to the chemical were associated with increased risk of heart disease and diabetes.

Exposure

The Science Board forwarded its report to the FDA commissioner, Andrew von Eschenbach, just a week after the Canadian government announced it would develop regulation to prohibit the importation, sale and advertising of polycarbonate baby bottles containing BPA. 

The FDA responded to its Science Board report by noting that Canada’s assessment of BPA safety found that newborn and infant exposure levels were below the threshold that poses a health danger. ’Out of an abundance of caution, the government of Canada is taking steps to restrict the use of BPA,’ the agency stated.

The FDA adds that the consensus among regulatory agencies in the US, Canada, Europe, and Japan is that ’current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.’ However, the agency did acknowledge that, ’due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable’.

Board considers urging BPA ban 

At its meeting, the Science Board rejected a recommendation to urge FDA to temporarily limit BPA exposure in infants and young children. The proposal was deemed to overstep the board’s jurisdiction.

’The Science Board stuck to its charge,’ the committee’s consumer advocate, Larry Sasich from Lake Erie College of Medicine, Pennsylvania, told Chemistry World. ’Do I think we have a responsibility to go beyond our charge? Absolutely,’ he added. ’The science by itself doesn’t move public policy or public health issues forward.’

The FDA is unlikely to resolve the BPA safety issue quickly. The agency doesn’t have to officially respond to the Science Board report until February, by which time a new president will occupy the White House and a new Congress will be installed. The agency says its reply could include anything from a call for specific research proposals to the implementation of some type of BPA ban.

But the agency does appear to be feeling the pressure. ’We do understand all the issues here and the sense of urgency,’ Frank Torti, the FDA’s principal deputy commissioner and first chief scientist, told Sasich at the meeting. 

However, Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition, expressed some reservations. After the meeting, he told reporters that an FDA consumer recommendation to limit BPA in products like formula cans could put the health of infants at risk. ’There could be negative consequences in terms of infant nutrition,’ he said.

For its part, the American Chemistry Council (ACC) - the major trade group for US  chemical companies  - says industry will comply with the FDA’s final decision. But at the 31 October meeting, ACC official Steven Hentges cautioned that some of the Science Board report’s conclusions ’do not appear to be based on a sound and thorough scientific analysis,’ and are not supported by the ’limited and inconclusive evidence’ provided. 

Rebecca Trager, US correspondent for Research Day USA

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