FDA takes a look at BPA
Ever since the National Toxicology Program (NTP) said two weeks ago that there is "some concern" for neural and behavioral effects in fetuses, infants, and children from bisphenol A (BPA), a widely used compound in hard plastic food containers, one retailer after another has pledged to pull BPA from baby products and consumers have been eyeing their water bottles, their kid's binky, and their Tupperware uneasily.
The Food and Drug Administration (FDA) regulates the use of BPA in products that come into contact with food, such as baby bottles and baby formula cans. When my colleague Lindsey Layton first reported on the NTP's latest conclusions, FDA was mum on the findings. (They have since given her an interview on a follow-up story.)
Inside the agency, however, BPA has been keeping FDA officials busy. Recently, the American Chemistry Council, the trade group for the nation's largest chemical companies, asked the FDA to update its position on BPA. FDA has also had to contend with House Energy and Commerce Committee Chairman Rep. John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak (D-Mich.) who have been looking into the government's position on BPA ever since environmental activists raised concerns last year that a contractor that was preparing a draft of the risks of BPA for the NTP also worked for the chemical industry.
Last week Dr. Michelle Twaroski, a supervisory toxicologist in the food packaging division of FDA, agreed to chat with us about where the agency's thinking on BPA is and where it's headed.
The Checkout: Given what NTP said recently, and the reaction of retailers such as Wal-Mart and Toys R Us, should consumers be freaking out? The science isn't totally conclusive. What are we supposed to think?
MT: Right now, FDA doesn't recommend that anyone stop using these products. However, concerned consumers should know that several alternatives to polycarbonate baby bottles exist, including glass baby bottles.
The Checkout: Is FDA going to take another look at its position on BPA?
MT: FDA has continuously monitored the data on BPA and has been actively evaluating BPA since 2007. Our review is in the process of evaluating the conclusions reached by the National Toxicology Programs expert advisory committee to the Center for the Evaluation of Risks to Human Reproduction (CERHR). That committee had reached a conclusion of "some concern" for neural and behavioral developmental toxicity. This concern was reiterated in the NTP draft brief released in April 2008; however, they also expressed "some concern" for developmental effects on the prostate gland, mammary gland, and an earlier age for puberty in females. We consider these conclusions very seriously and are actively reviewing the concerns they've raised. In fact, the Commissioner this month formed an agency task force on BPA. This task force will be developing recommendations for him with regard to FDA regulated products containing BPA.
The Checkout: Dingell and Stupak have called into question FDA's reliance on two chemical industry funded studies to support FDA's position on BPA. Can you respond to their concerns?
MT: We are aware of the questions raised regarding the two studies; However, FDA's on-going review of BPA has involved more than the two studies sponsored by industry. We have weighted the two industry studies as pivotal because they include regulatory protocols which were expanded to address the issues of concern at the time of their initiation, they included a large range of doses, including low doses, to allow for evaluation of a dose response, and all raw data was submitted to the agency for our independent evaluation. Though these studies were sponsored by industry, they were conducted by a well-known laboratory and were developed in consultation with our European counterparts and FDA was briefed on them. These studies were designed to answer questions that had risen about BPA at the time they were initiated. The new safety evaluations that have been published this April, the NTP draft Brief and Canada's, as well as that performed by NTP's expert panel, raised questions from newly evolving areas of research. As mentioned, we were already in the process of reviewing one set of endpoints and, with the new task force, we will be reviewing all the concerns raised in our new evaluation of BPA.
The Checkout: So FDA is going to reevaluate its position on BPA?
MT: Yes. The task force is performing a risk assessment on BPA and will submit its recommendations to the commissioner.
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