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News Alert: June 10, 2008 U.S Food and Drug Administration Says BPA is Safe. Read More
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  • Overview 4/14/2008

    During the week of April 14, 2008, upon the request of the Commissioner of Food and Drugs, FDA formed an agency-wide BPA (Bisphenol A) task force to facilitate cross-agency review of current research and new information on BPA for all FDA regulated products. As a result of this review, the task force will make recommendations to the Commissioner regarding next steps.

    As part of the evaluation, the FDA Task Force is reviewing the concerns presented in the National Toxicology Program (NTP) Draft Brief published on April 14, 2008 by the U.S. National Institutes of Health. We also are reviewing the concerns presented in the Canadian draft risk assessment released in April 2008 and are coordinating closely with Health Canada and the Canadian Ministry of the Environment and Minister of Health.
    FDA has been reviewing the emerging literature on BPA on a continuous basis.  For example, FDA has recently completed a review of the available biological fate data and two recently completed rodent multigeneration reproductive studies; these studies did not indicate a safety concern for BPA at current exposure levels.  In addition, FDA is conducting a review of the data on neural and behavioral effects of BPA exposure. 

    Based on our ongoing review, we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects.   However, we will continue to consider new research and information as they become available.

    This position is consistent with two risk assessments for BPA conducted by the European Food Safety Authority (EFSA) Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food and the Japanese National Institute of Advanced Industrial Science and Technology.  Each of these documents considered the question of a possible low-dose effect and concluded that no current health risk exists for BPA at the current exposure level. 

    Message for Consumers

    At this time, FDA is not recommending that anyone discontinue using products that contain BPA while we continue our risk assessment process. However, concerned consumers should know that several alternatives to polycarbonate baby bottles exist, including glass baby bottles.

  • FDA Statement on Polycarbonates. 1/29/2008
    Statement from the FDA, from a written communication dated January 29, 2008
    The Agency's current position on the presence of BPA impurities in food-contact polymers is as follows. BPA is used in the manufacture of two types of polymers used for food-contact articles (i.e., polycarbonate (PC) polymers and epoxy-based enamels and coatings) and is present at very low levels in the finished food contact materials. Typical uses of PC polymers include food processing equipment, such as popcorn makers, and water and infant baby bottles intended for repeated use. BPA-based epoxy coated cans are used in a variety of canned food and beverage applications, including cans used to hold infant formula. The Agency is aware of several reports stating that BPA has estrogen-like activity. However, there are other reports that appear to dispute any reason to expect harm at the low exposures that humans experience. A March 2007 report from a consumer group included studies showing the levels of BPA found in canned foods and migrating out of PC baby bottles and included claims that these levels are unsafe. FDA scientists have reviewed the available information from this report and have concluded that the BPA levels found in canned foods or migrating out of PC baby bottles are not significantly different than the very low levels previously found by FDA chemists and other laboratories, levels that result in a dietary exposure that is orders of magnitude below the levels known to not cause toxic effects in animals.
    The agency has been actively reviewing the safety of BPA and has completed a review of the available data obtained from animal studies, and migration studies. Based on the results of the migration studies conducted by FDA chemists, we have determined that the dietary exposure to BPA is low (3.7 ppb), the level that is orders of magnitude below the levels known to cause toxic effects in animals. Considering the low dietary exposure and the fact that BPA had not demonstrated adverse effects when consumed by animals in amounts of much higher (orders of magnitude) than humans would consume, FDA sees no reason at this time to ban or otherwise restrict the uses now authorized. Our conclusion is based on our ongoing review of all available data. We will continue to monitor data on BPA to determine if its use would raise a safety concern. If such a concern exists, FDA will take the appropriate post-market regulatory action.

     
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