Should the FDA ban BPA baby bottles?

December 1, 2008

The controversy over whether baby bottles containing BPA should be banned continues in an advisory assessment of an FDA draft report.

The Science Board advising the Food and Drug Administration (FDA) endorsed a review on October 31 that indicated FDA had done an inadequate job of gathering and weighing the evidence for a draft review of bisphenol A (BPA).

The board is made up of nine professionals from outside FDA. At the meeting, some board members indicated they wanted the agency to move quickly to take a stance on the issue, although the board's official role does not give it the authority to make that type of recommendation.

In the meantime, FDA has said that, "Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula."

FDA has been reviewing the issue since this spring. Its officials repeatedly noted that the agency itself had asked for the board's review of its draft report. Nevertheless, the variety of ways in which the review said the report was deficient raised questions about how science had been brought to bear on the issue.

Among other statements, the review, written by a subcommittee of the board, said:

Martin Philbert, PhD, a University of Michigan toxicology professor, and chair of the subcommittee that wrote the review, noted that focus on exposure in children's diet is appropriate, due to the metabolic state of development of the liver, the fact that children are more likely to have greater exposure, and the relative lack of activity in an infant.

He also noted that infants' food consumption patterns expose them to greater amounts of material. Moreover, "given some of the newer studies on development of the sexual systems and of the liver system, there may be vulnerability through a variety of mechanisms," noted Philbert.

However, Philbert said there is little information on what exposures from other routes are like, and whether food is the most important exposure. He said the review includes a call for studies to get those answers. Indeed, the review and discussion at the meeting indicated a range of new and different types of studies are needed.

On the other hand, the International Formula Council told the board that a number of regulatory agencies in other nations have looked at the issue and have not restricted BPA in food. It urged that, "Any new alternatives need to be carefully assessed to assure the highest possible standards of quality."

But board member Larry Sasich, PharmD, of the Lake Erie College of Medicine's School of Pharmacy, called on the panel to go beyond merely transmitting the report. Sasich indicated that both the FDA and the scientific system were "running the risk of losing any credibility with the public" unless they take more definitive actions that the public could understand. He also recommended a call for the FDA to "do a much better job in informing the public exactly about what is going on and what we know." Although the board members decided that kind of recommendation is not within their charge, they stated they could individually contact the agency about those concerns.

At the meeting's end, Frank Torti, MD, FDA chief scientist, assured Sasich the agency had heard his message. "We understand all of the issues here and the sense of urgency," Torti said.

Further tension had been brought to the BPA issue on October 17, when the Canadian government stated that it would prohibit the importation, sale, and advertising of polycarbonate baby bottles that contain BPA.

Canada's Food Directorate said that current levels of BPA exposure through food packaging is not expected to pose a risk for the population, including newborns and infants. But due to the uncertainty raised by some animal studies, it recommended that the principle of exposures "as low as reasonably achievable" be applied to food packaging for infants and newborns, specifically for prepackaged infant formula as a sole source of food.

Meanwhile, according to US news reports, consumers, manufacturers, and some businesses are taking their own steps to limit the use and sale of BPA in certain products.

Kathryn Foxhall is a contributing editor to Contemporary Pediatrics.