Why the FDA Said No to a Ban of Bisphenol-A in Food Packaging June 13, 2012 San Francisco Medicine, SFMS Member FDA, Bisphenol A, Peter Curran 0 By Peter Curran, MD, President's Column originally printed in June 2012 issue of San Francisco Medicine The Food and Drug Administration (FDA) came out last month with a thumb-down on a ban of the chemical bisphenol-A (BPA) in food packaging, which came as a surprise to environmental groups such as the National Resources Defense Council (NRDC). Sarah Janssen, senior scientist at the NRDC, says, “The agency (FDA) has failed to protect our health and safety...” Other advocates went further, saying that the FDA is no longer meeting its obligation to protect the public health. Even the Obama administration was pulled into the debate; disappointed activists claiming that a perceived national climate of overregulation by government resulted in apparent apathy by the White House to side against industry in an election year. Why is BPA apparently being relegated to the trash heap of possible-but-not-scientifically-proven environmental toxins, along the lines of cell phones and microwaves? This is no thinly studied chemical. In fact, the government has spent an estimated $30 million studying BPA, first approving its use in the epoxy liners of plastic bottles and soup cans as a “food additive” in the 1960s. Lately BPA has been labeled an endocrine disrupter with serious potential harmful health effects, including cancer, heart disease, and infertility, particularly in children and the developing fetus. An estimated 90 percent of humans are thought to have trace amounts of BPA in their bodies, most likely from leaching of the chemical from food containers. Governor Jerry Brown signed into law the Toxin-Free Infants and Toddlers ACT last year, banning the use of BPA in baby products starting in 2013. Companies have already responded by creating BPA-free products; it has become fashionable to advertise BPA-free alternatives. Campbell’s company has decided to phase out BPA from its soup cans, following the lead of similar corporations. What happened with the latest negative ruling for the ban of BPA by the FDA? In 2008, the agency released a draft ruling that BPA is safe in food contact materials. Later in that same year, a subcommittee of the FDA reexamined the ruling after new information surfaced. An interim update was issued in 2010. The chemical industry argued that the potential exposure levels from BPA products are minimal and that the chemical is quickly eliminated from the human body and that, moreover, the food-safety benefits of epoxy liners greatly outweigh any risk from BPA. Meanwhile, in 2008 the NRDC submitted a citizen petition requesting that the Commissioner of the FDA prohibit the use of BPA in human food packaging and revoke all regulations permitting the use of any food additive that may result in BPA becoming a component of food. At one point, the chairman of the FDA committee studying BPA was accused of accepting a $5 million unreported research grant from a lobbyist in the chemical industry. Following a court order, the FDA was compelled to make a final ruling by the end of March 2012. The FDA met the deadline by one day and basically remained unpersuaded by the NRDC’s recommendations, and, probably less reported, its tactics. The FDA said after its ruling that there was not compelling scientific evidence to justify new restrictions. More research and monitoring will continue on one of the most studied chemicals of all time. Another report from the FDA on BPA is expected later this year. Was the FDA’s decision on BPA a failure to ensure the public health, or simply a failure of the NRDC to succeed in the art of negotiation? Dr. Janssen claims, "The FDA is out of step with scientific and medical research. This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals." Meanwhile, from the FDA camp, spokesman Douglas Karas emphasized in a statement that the agency's decision is not a "final safety determination on BPA” but rather a "decision on the NRDC petition." When two sides feel strongly about an issue, there is a need for consensus. If there is fundamental disagreement with an opponent’s position, it is time for compromise. That was the real failure on BPA. Comments are closed.
