FDA issues BPA guidelines


The Food and Drug Administration said Friday that the safety of a controversial chemical found in some baby bottles, children’s drinking cups and other food containers merited further study but did not warrant immediate restrictions on its use.

The FDA, the Department of Health and Human Services and other health agencies have committed $30 million to studying the health effects of bisphenol A, or BPA, and expect results in 18 to 24 months.

“We have some concern, meaning in part that we need to know more,” FDA Commissioner Margaret Hamburg said in a conference call with reporters.


In the meantime, the agency has issued guidance for limiting the exposure of children and babies. FDA Deputy Commissioner Joshua Sharfstein said that for the present, “the FDA does support the use of baby bottles with BPA.”

The FDA action, which was praised by industry officials and criticized by some food safety and consumer watchdog groups, comes after more than a year of controversy.

Reacting to consumer pressure, the nation’s six largest plastic baby bottle makers, which control 90% of the market, have voluntarily removed BPA from baby bottles sold in the U.S. But millions of bottles and containers manufactured before the issue surfaced may still be in use, consumer groups said.

BPA is a plastic hardener and an ingredient in epoxy resin, which is used in can linings.

In the human body, it mimics the hormone estrogen. Some studies have tied the compound to reproductive abnormalities and increased risks of cancer and diabetes. Infants and children are thought to be particularly vulnerable to any adverse effects because their reproductive organs and ability to metabolize chemicals are not completely formed.

In a statement in 2008, the FDA said BPA was safe in materials that come into contact with food, but critics accused the agency of using outdated studies that had been sponsored by the chemical industry.

The FDA’s action Friday was not enough for Urvashi Rangan, director of technical policy at Consumers Union, a nonprofit organization that publishes Consumer Reports.


“It’s really disappointing. I’m surprised it was so soft,” Rangan said. “The least I expected was a ban on baby bottles and more guidance to pregnant women.”

The announcement is likely to sow confusion because it is at odds with bans on BPA in plastics already legislated by several state and local governments, said Dr. Sarah Janssen, a senior scientist at the Natural Resources Defense Council.

Connecticut and Minnesota and the city of Chicago, among others, have placed restrictions on BPA, and Canada has banned the substance in baby bottles. Sen. Dianne Feinstein (D-Calif.) has filed legislation that would ban the chemical from food and beverage containers.

The American Chemistry Council, an industry trade group, said the FDA announcement “confirms that exposure to BPA in food contact products has not been proven harmful to children or adults.”

But the council complained that “some of the recommendations are likely to worry consumers and are not well-founded.”

Also Friday, the FDA criticized McNeil Consumer Healthcare for a tardy investigation and recall of batches of Tylenol, Motrin and other over-the-counter products tainted by a chemical in wooden shipping pallets.


The FDA issued a warning letter to the company demanding improvements in its manufacturing processes.

“McNeil should have acted faster,” said Deborah Autor, the chief of compliance in the FDA’s drug office. “When something smells bad, literally and figuratively, companies must take all necessary actions” to fix the problem.

Autor said McNeil waited a year to notify the FDA after first learning that people were temporarily sickened by exposure to moldy smelling products and an additional two months before instituting a recall.