October 31, 2008

GAITHERSBURG, Md., Oct. 31 -- The FDA erred when it determined that the use of the common chemical bisphenol A is safe, particularly for infants, the agency's full science board concluded today.

The full board, made up of independent advisers to the FDA, unanimously endorsed a highly critical report by a special board subcommittee on BPA. The subcommittee concluded that the agency employed faulty science when it determined the BPA is safe as currently used. (See: FDA Advisers Denounce Agency's Decision on BPA Safety)

The chemical is used in packaging of infant formula, and in molded plastic bottles and sippy cups. The current margin of safety is 5 mg/kg, but the subcommittee recommended lowering that level by one order of magnitude.

The full board, chaired by Barbara McNeil, M.D., Ph.D., of Harvard, accepted the subcommittee's report after inserting language to state that enough evidence exists to support a more conservative margin of safety for BPA exposure among infants.

In September, the FDA issued a draft assessment of BPA that said there was insufficient evidence to connect commonly used levels of BPA to some health issues, including those in infants. Canada, meanwhile, recently banned the use of BPA in baby bottles. (See: DA Gives Preliminary Okay to Bisphenol A in Food Packaging)

Some scientists and consumer groups have warned that the chemical might contribute to some cancers, early puberty, alterations of the prostate and urinary tracts, and behavioral problems.

The subcommittee released its assessment of the FDA's report earlier this week, which charged that the FDA was wrong to dismiss a number of government and academic studies in its assessment for not meeting the standard of "good laboratory practices."

Toxicologist Martin Philbert, Ph.D., of the University of Michigan School of Public Health, chairman of the science subcommittee, said he understands why the FDA assessment relied so heavily on two studies from a field of many BPA studies, because "good laboratory practice" studies tend to use more animals and readily submit raw data for independent analysis.

But he said the subcommittee disagrees that those two studies were the only "acceptable" studies to be used, and said more recent research must be considered, including a study published recently in the Journal of the American Medical Assocation that connected BPA to a number of health problems including cardiovascular disease. (See: Common Chemical Linked to Metabolic and Cardiovascular Disorders)

At today's science board meeting, Dr. Philbert reiterated the criticisms outlined in the subcommittee's report and criticized the limited scope of the FDA's assessment on the impact of BPA, because it examined the use of the chemical only in food applications.

He also criticized the FDA for not including demographic information to determine the likely number of people exposed at each BPA concentration and for relying on too few formula samples -- which were from the early 1990s and all from one city -- in making a determination about BPA in baby formula.

The board called for future, large-scale studies examining BPA exposure from a wider range of applications.

The report now goes to the FDA, which will likely respond in the next few months, said Stephen F. Sundlof, D.V.M., Ph.D., director of the agency's Center for Food Safety and Applied Nutrition.

If the FDA accepts the subcommittee's findings, such as a lower margin of safety for exposure for infants, the agency would likely issue new regulations. But, said Dr. Sundlof, the agency would not issue a public notice out of fear that mothers may stop buying infant formula and attempt to make their own, BPA-free, but less nutritious, formula.

According to Dr. Sundlof, the FDA is already working with manufacturing companies that use BPA in their products to develop alternatives or to figure out how to effectively lower levels of the chemical.