Word: fda
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Dates: during 2000-2009
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...Products Co.--to buy its crude heparin. Strunce has described them as meticulous in ensuring the quality of the crude heparin they buy for SPL. But several small suppliers told TIME they have sold directly to SPL or have been approached by the company, looking for product. And when FDA inspectors showed up in Hangzhou this year, after reports of a spike in deaths and illness, Ruihua Biomedical stiff-armed the investigators. It refused to let them inspect its processing lab and declined to provide a list of crude-heparin suppliers. Before last summer, SPL's China facility had never...
...last week, the reviewing panel disagreed, saying the FDA's analysis excluded several important studies on BPA in animals. The panel also questioned the quality of some of the included studies and found that the FDA did not incorporate enough infant-formula samples in its evaluation. According to the panel review, the FDA's safety report "creates a false sense of security" and the agency's margins of safety for BPA exposure are, in fact, "inadequate." Says Tracey Woodruff, director of the program on reproductive health and the environment at the University of California, San Francisco, and a former Environmental...
...Eschenbach to decide how to proceed. He may start from scratch and commission another report that includes the most recent findings on BPA; he may reject the panel's review and adhere to the FDA's original conclusion that BPA is harmless at current exposure levels; or he may ban the chemical from baby products, as the Canadian government did in April. Or he may draw no further conclusions about BPA until additional studies can be commissioned and completed to answer some unresolved questions...
...have some idea of how much BPA might leach from a baby bottle, there are intermediate steps between that and how much gets into an infant that we still need to model and establish mathematically," says John Bucher, associate director of the National Toxicology Program, which collaborates with the FDA, NIH and CDC. "And we don't have that yet." The FDA report maintains, for example, that a BPA exposure level of 5 mg/kg per day is acceptable. Health officials have determined that baby bottles can produce anywhere from 7 micrograms/g to 57.7 micrograms/g of BPA. The questions...
...FDA can't answer those questions yet, but some experts argue that the agency doesn't need to wait to take action. "The Federal Government entered into a voluntary recall of the Teflon chemicals [in pots and pans] on less evidence than we have for BPA," says Woodruff, "because there was concern that people were chronically exposed to a chemical linked to some evidence of potential human harm." Woodruff says the estimated range of exposure to BPA for formula-fed infants is within the range of doses that have led to adverse effects in animal studies...