FDA to Update Public on BPA Later This MonthFeb 10, 2009 | Parker Waichman LLP
FDA Meets Manufacturers of Bisphenol A
The U.S. Food and Drug Administration (FDA) just announced that a regulatory meeting with manufacturers and users of Bisphenol A (BPA)-containing materials took place late last month.
On January 30, 2009, the FDA and Health Canada’s Health Products and Food branch hosted a meeting of representatives from United States and Canadian manufacturers and users of food packaging materials containing the toxic, plastic hardening chemical, BPA to discuss the activities underway and planned to minimize the levels of the ubiquitous, estrogen-mimicking chemical in food. The meeting was also part of FDA’s efforts to assist industry in its voluntary BPA reduction efforts.
According to the FDA, the joint U.S.-Canada meeting provided a forum for:
- Updating the industry on the FDA’s and Health Canada’s current activities as well as its planned research to further assess BPA exposure to BPA and manage any potential risks from the chemical.
- Describing manufacturers’ research activities and related work to refine packaging manufacturing practices to minimize migration of BPA into food as well as to describe recent marketplace developments.
- Dialoguing by the participants about further information from regulated industry stakeholders that would be helpful to the FDA and Health Canada in updating and refining their BPA risk assessments.
- Dialoguing about the different uses of BPA in food contact applications and the variation in availability of fully functional and evaluated alternative substances.
- Discussing the expectation that, because of availability of alternative products, polycarbonate baby bottles could cease to be a substantial component of the North American market in the future.
FDA Maintains Position On BPA
The FDA maintains its position that current BPA exposure levels through food packaging do not pose an immediate health risk to the general population, including infants and young children. Nevertheless, studies show that BPA seems to stay in the body longer than previously believed, reported WebMD, adding that the chemical is so ubiquitous, that it can be found virtually everywhere and is present in “detectable levels” in just about every human body.
BPA has also been linked to a variety of diseases including an increased risk of diseases or disorders of the brain, reproductive, and immune systems; recent studies have linked BPA exposure to problems with liver function testing, an increased risk of diabetes and heart disease, and interruptions in chemotherapy treatment; and BPA exposure has long been linked to hormonal disturbances. BPA was also linked to serious health problems based on 130 studies conducted in the past 10 years, The Washington Post reported late last year, and newer research found BPA to have negative effects at “very low doses,” lower than the FDA’s safety standards currently in place.
The FDA said it is currently preparing a detailed response to the October 2008 review by the FDA Science Board of the agency's draft assessment of the safety of BPA for use in food contact applications, which focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel. The FDA is also reviewing research about the potential low-dose effects of BPA and will carefully evaluate the findings of these studies. WaterTechOnline reported that the FDA is scheduled to provide the public with more BPA information later this month, on February 24.
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