FDA Forced to Rule on Potential BPA Food Packaging Ban

Barbara Boughton

December 08, 2011

December 8, 2011 (San Francisco, California) — As part of a settlement in a lawsuit brought against the US Food and Drug Administration (FDA), the agency has agreed to rule on whether the controversial chemical bisphenol A (BPA) should be banned in food and beverage packaging.

The lawsuit was brought by the Natural Resources Defense Council, a national nonprofit environmental advocacy group, which filed a petition with the FDA in 2008 requesting that BPA be banned as a food additive.

When the FDA did not reply in the timeframe required by law — at most 180 days — the NRDC took its case to court. The new settlement announced on Wednesday requires the FDA to decide on BPA use by the end of March 2012.

"There have been hundreds of studies that show that bisphenol A causes harm in many different ways and in many different body systems, including the reproductive system, and it poses a risk for development of cancer. It hasn't been shown to be safe," Sarah Janssen, MD, PhD, senior scientist with the NRDC, told Medscape Medical News.

"We're happy that the FDA will be required to respond to our petition but at the same time we had to go to the courts to get them to do their job," Dr. Janssen added.

Dr. Janssen noted that the FDA could respond in a range of ways to the NRDC petition — by denying it in whole, by revoking approval for BPA in all food-related products, or by revoking approval in certain products named by the NRDC as a particular concern, such as baby food jars.

Because of the controversy surrounding the use of BPA, many baby bottle manufacturers and some plastic water bottle manufacturers have already stopped using BPA in their products.

BPA Ubiquitous

However, the chemical is ubiquitous in modern-day consumer products — it is found in polycarbonate plastic products, such as water bottles; resins used to line metal products, such as canned foods; as well as juice boxes, packaged foods, and even cash register receipts.

Animal studies as well as human epidemiologic studies have linked BPA to increased risk for precancerous growths in the mammary and prostate glands and to such health conditions as heart disease, liver disease, diabetes, and behavior conditions in children (eg, depression, anxiety, and hyperactivity).

Yet the link between BPA and health conditions in humans has been controversial, and in 2008 a report by the US National Toxicology Program expressed some concerns about the chemical's health effects on just fetuses, infants, and children. The report also concluded that the low levels of BPA most people are exposed to as adults were of "negligible concern."

The FDA declined a request by Medscape Medical News for an interview, but in its latest statement on BPA, released in January 2010, the agency noted that recent studies raise some concern about the potential effects of the chemical on the brain; behavior; and the prostate gland in fetuses, infants, and children.

Yet the agency's statement also noted that there are "substantial uncertainties with respect to the overall interpretations of these studies and their potential implications for human health."

New scientific studies on humans and animals now underway may provide at least some answers to the questions of how harmful BPA is to infants, children, and adults — if it is harmful at all.

Some Remain Unconvinced

The National Institute of Environmental Health Sciences has earmarked $30 million in funding to study BPA, and it's expected that results from some human and animal studies will be available within the next 6 to 12 months, according to Joe M. Braun, MSPH, PhD, from the Department of Environmental Health, Harvard School of Public Health, Boston, Massachusetts.

In a study published in Pediatrics in October and reported by Medscape Medical News at that time, Dr. Braun and colleagues found that prenatal exposure to BPA was associated with anxious, depressive, and hyperactive behaviors in female children at age 3 but not in male children of the same age.

"The new study results [of a soon-to-be-released paper] may help resolve some of the inconsistencies we've seen in both human and animal studies regarding BPA," Dr. Braun told Medscape Medical News. "Newer studies may help resolve questions about the potential harm of BPA, but then some people may even then remain unconvinced," he said.

Whatever the FDA ultimately decides, the agency's judgment will be welcomed by both industry and consumers alike, said Gilbert Ross, MD, medical and executive director of the American Council on Science and Health, a nonprofit that receives funding from industry as well as other sources.

"BPA use is widespread in consumer products, and its safety is well-studied," Dr. Ross said. "The consensus of the scientific data is that there is no serious threat to human health," he added. On the basis of the scientific evidence, concern about the health effects of BPA are unjustified, he added.

Canned Goods a Major Source

"If BPA were to be banned from consumer products such as canned goods, in which the chemical keeps metal from leaching into foods, substitutes would have to be found," Dr. Ross noted." And none of the possible substitutes are as well studied as BPA," he said.

Dr. Janssen acknowledged that it's likely that the FDA will revoke approval for use of BPA in baby bottles and sippy cups in response to an industry petition filed several months ago.

"But we know that the major source of exposure isn't baby bottles, but canned foods," Dr. Janssen wrote in the NRDC's blog, Switchboard, after the announcement of the settlement.

"Every day millions of American consumers are exposed to this dangerous chemical...The FDA has an obligation to use scientific evidence to assure us that food additives such as BPA are safe," Dr. Janssen writes.

Dr. Janssen, Dr. Braun, and Dr. Ross have disclosed no relevant financial relationships.

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