HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Thursday, April 17, 2008

Plastic Baby Bottles, BPA and the FDA

Reuters reports on the National Toxicology Program's findings of the potential danger posed to young children from the chemical bisphensol A, a chemical used in such items as baby bottles and also recently approved by the FDA as safe in products used by infants and children.  Will Dunham writes,

Based on draft findings by the National Toxicology Program, part of the U.S. National Institutes of Health, senior congressional Democrats asked the Food and Drug Administration to reconsider its view that the chemical bisphenol A is safe in products for use by infants and children.  The chemical, also called BPA, is used in many baby bottles and the plastic lining of cans of infant formula.The National Toxicology Program went further than previous U.S. government statements on possible health risks from BPA.

It said: "There is some concern for neural and behavioral effects in fetuses, infants and children at current human exposures." The findings expressed concern about exposure in these populations, "based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females." . . . .

The National Toxicology Program said laboratory rodents exposed to BPA levels similar to human exposures developed precancerous lesions in the prostate and mammary glands, among other things.  "The possibility that bisphenol A may impact human development cannot be dismissed. More research is needed," the agency said.  Bisphenol A is used in the production of polycarbonate plastics and epoxy resins and can be found in food and drink packaging as well as compact discs and some medical devices. Some dental sealants or composites contain it as well.

The National Toxicology Program expressed "negligible concern" that exposure of pregnant women to BPA causes fetal or neonatal death, birth defects or reduced birth weight and growth in babies. It also had "negligible concern" that exposure causes reproductive problems in adults. . . .

In Canada, the Globe and Mail newspaper said the Canadian health ministry was ready to declare BPA a dangerous substance, making it the first regulatory body in the world to reach such a determination. The newspaper said the ministry could announce the decision as soon as Wednesday. . . .

This follows yesterday's news from the New York Times that Senators from both parties believe the FDA is underfunded.

The Food and Drug Administration needs far more money than the White House has proposed for next year, senators of both parties said Tuesday.  “To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the agency’s spending.  The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely. . . .

The Senate passed a budget resolution last month that would make the F.D.A.’s allocated budget — that part of its spending that comes from taxpayer revenue, as opposed to user fees paid by drug and medical device manufacturers — $375 million greater in 2009 than this year. That would be a 20 percent increase, and Dr. von Eschenbach said he did not believe that the agency could absorb so large an addition in one year.

A report last year by a panel of outside advisers to the agency said American lives were in danger because the F.D.A. did not have the money, the staff or the scientific expertise to protect them. And in a speech last month, Dr. von Eschenbach acknowledged that the F.D.A. “may fail in its mission to protect and promote the health of every American” and that “peril exists.”  But he was far less pessimistic in his testimony on Tuesday.  “I believe we have been eminently successful up to this period of time,” Dr. von Eschenbach said. “We are the world’s gold standard.  “But if we want to continue that level of excellence,” he added, “we must change.”

The Bush administration has proposed increasing the agency’s allocated budget next year by 3 percent, to some $1.8 billion, not enough to pay even for increased costs. Dr. von Eschenbach spoke Tuesday about plans to hire up to 700 new employees for the F.D.A. staff, but he acknowledged that the agency would not have the money to do any hiring next year if the president’s budget was adopted without changes by Congress. . . .

Perhaps the FDA's problems go deeper than lack of funding . . .

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