BPA – Can you really trust the FDA?
FDA’s objectivity regarding BPA questioned
10/27/2008 4:29:38 PM
WASHINGTON — Federal lawmakers are investigating the relationship the US Food and Drug Administration (FDA) may have with the chemical industry regarding the FDA’s draft assessment that bisphenol A (BPA) is safe, an October 24 USA Today article reports.
The congressional action was launched in part after The Milwaukee Journal Sentinel reported that the FDA’s assessment of BPA was based on reports from the plastics industry and those with a financial stake in the chemical used to harden plastics, such as polycarbonate water bottles.
The findings of the FDA draft report are at odds with the conclusions of the FDA’s own advisers from the National Toxicology Program (NTP), who announced in September that the chemical is of “some concern” relating to the development of the brain, behavior and the prostate gland in fetuses, infants and children.
The Journal Sentinel reported that the FDA will not reveal who prepared its draft assessment on BPA, but FDA documents obtained by the newspaper show that the work was done primarily by those with ties to the chemical industry, including Stephen Hentges of the chemical manufacturer trade association American Chemistry Council’s group on bisphenol A.
The newspaper reported that Hentges commissioned a review of all studies of the neurotoxicity of the chemical and submitted it to the FDA. “The FDA then used that report as the foundation for its evaluation of the chemical on neural and behavioral development,” the Journal Sentinel reported.
The Journal Sentinel also reported that the congressional committee also is evaluating the role that an FDA-hired consulting group, Virginia-based ICF International, had in preparing the draft. Other ICF clients include the American Chemistry Council and the American Petroleum Institute.
Also being scrutinized is the fact that the chairman of the FDA subcommittee that is reviewing the FDA’s assessment of BPA heads a research center that has accepted a $5 million gift from a retired medical device manufacturer who says BPA is safe. BPA is used in the manufacture of some medical devices.
The Journal Sentinel reported that FDA subcommittee chairman Martin Philbert received $5 million from Charles Gelman, who told the Journal Sentinel that he had expressed his views that BPA is “perfectly safe” to Philbert in several conversations. “Philbert at first denied ever having been contacted by Gelman about bisphenol A. He now says that he is aware of Gelman’s views but is not influenced by them,” the newspaper reported.
The subcommittee’s review of the BPA report was expected to be released any day with a presentation in Washington on October 31. Consumer advocacy groups, including the Environmental Working Group (EWG), have said that many scientific studies suggest BPA may cause serious harm. The EWG issued a statement on October 23 saying that the Journal Sentinel’s investigative report “proves a glaring conflict of interest that should render the draft meaningless.”
The Canadian government on October 18 declared that BPA is a toxin and that it is banning its use in baby bottles, as WaterTech Online™ reported, and attorneys general from Connecticut, New Jersey and Delaware have asked 11 companies to stop using BPA in baby bottles and formula cans, USA Today reported.
To read the full USA Today article, click here.
To read the full Journal Sentinel report, click here.
For related information on this story, click here.
What is BPA or Bishenol A?
Bisphenol A, commonly abbreviated as BPA, is an organic compound with two phenol functional groups. It is a difunctional building block of several important polymers and polymer additives. With an annual production of 2–3 million tonnes, it is an important monomer in the production of polycarbonate.
Suspected of being hazardous to humans since the 1930s, concerns about the use of bisphenol A in consumer products grabbed headlines in 2008 when several governments issued reports questioning its safety, and some retailers pulled products made from it off their shelves.
Bisphenol A (BPA) is an industrial chemical used to make polycarbonate plastic resins, epoxy resins, and other products.
esearchers tested more than 2000 people between the ages of six and 85. And 93 percent of them tested positive for BPA, according to the U.S. Centers for Disease Control and Prevention.
Why should you care? Well, BPA is a component of the polycarbonate plastic in eyeglass lenses and DVDs among other things. And high levels of it have been linked to heart disease, diabetes and liver failure in humans, according to the Journal of the American Medical Association.
In fact, the National Toxicology Program warns that BPA may cause babies to develop abnormally. The Canadian government went so far as to ban it in baby bottles as well as listing it as a toxic substance. But the U.S. Food and Drug Administration and the Environmental Protection Agency maintain that BPA is perfectly safe.
Congress, for its part, is considering banning the substance in some products. In the meantime, note that items made from BPA are typically marked with a number seven. These plastics should never be microwaved or exposed to hot liquids—heat can dissolve BPA into what you’re drinking.
( does that sound like a good idea in your body?? reminds me of melamine)
The FDA says it is safe, but now new articles are saying maybe we should not trust them.
Congress questions FDA on safety of BPA in baby bottles and food containers.
Bisphenol A (BPA), the synthetic hormone used in baby bottles, toddler cups, water bottle and other recipients, has been a subject of controversy since “forever” or at least it seems so with so many scientific reports warning about its negative effects on babies’ health primarily and why not on adults’ health as well.
In August, the Food and Drug Administration issued a report in which it declared bisphenol –A safe at current levels found in baby bottles and canned foods. The report was highly criticized by lawmakers and scientists because it relied mostly on industry-funded studies and contradicted over 100 studies suggesting BPA is harmful.
Bisphenol-A has been under fire since April this year when a report by the National Toxicology Program said there was “some concern” about its risks in infants. Based on tests on animals the government-working group said bisphenol-A could cause changes in behaviour and the brain, and that it might reduce survival and birth weight in fetuses. The NTP’s report noted “some concern” for effects on the brain, prostate gland and on behaviour in fetuses, infants and children, “minimal concern” for reproductive effects in adults who work with bisphenol-A and “negligible concern” for fetal or neonatal death, birth defects, or reduced birth weight and growth in babies born to women exposed to bisphenol-A during pregnancy. The report concluded that “the possibility that BPA may affect human development cannot be dismissed.”
Studies linked higher urinary levels of bisphenol-A to an increased risk of diabetes and heart disease. Higher BPA levels are also associated with abnormal concentrations of three liver enzymes, a team of British and American scientists found, a study published in September in the Journal of the American Medical Association revealed.
Despite so many studies showing that bisphenol-A is harmful, the Food and Drug Administration in August concluded that the chemical is safe. But a panel of scientists. appointed by the agency’s Science Board to review its task force report, called the FDA’s conclusions on bisphenol-A inadequate and recommended that the agency abandon its earlier findings about the safety of the controversial chemical.
The 17-page report will be released today on the FDA Web site.
FDA spokeswoman Judy Leon said “FDA agrees that due to the uncertainties raised in some studies relating to the potential effects of low doses of bisphenol-A that additional research would be valuable.”
The report will be discussed at a meeting of the FDA’s science board Friday, but what exactly it will mean for consumers was not immediately clear.
“The panel was very clear, but we don’t know if the FDA is going to listen. If they do, it could be a couple of years before they do anything. The FDA’s assessment should have been done right the first time. Now it’s going to have to be redone,” said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families.
Is BPA (Bisphenol A) safe?
By RICARDO ALONSO-ZALDIVAR
WASHINGTON (AP) — BPA — a chemical used in food containers — is so widespread that most people have traces of it in their bodies.
But health officials can’t decide if that’s a problem, or something we all can live with.
Bisphenol A is useful for hardening plastics to make all sorts of consumer products, from CDs to baby bottles. And the canning industry uses it for coatings that prevent leaks and bacterial contamination in metal food containers.
Some scientists are concerned that BPA could be harmful, since it mimics some of the effects of a powerful hormone, estrogen. Infants may be particularly vulnerable because their bodies are developing and cannot eliminate the chemical as quickly.
Earlier this year, the Food and Drug Administration issued a scientific assessment that BPA is safe and asked independent scientists to review its conclusion. That report — made public Tuesday — found that the FDA's science was badly flawed. The FDA did not consider all the evidence and its margin of safety for human exposure to BPA could be off by a factor of ten times or more, the outside scientists said.
While the experts sort out the issue, what are the options for worried consumers? Here are some questions and answers:
Q: It sounds like BPA is everywhere, how can people avoid it?
A: "Get to know your plastics," says Urvashi Rangan, a senior scientist with Consumers Union, which publishes Consumer Reports. Avoid polycarbonate plastic containers, those imprinted with the recycling number "7" and the letters "PC." Don't microwave foods in these containers. Don't use polycarbonate plastic baby bottles. Consider powdered infant formula instead of liquid formula in cans. Cut down on canned foods.
"If you the consumer want to take matters into your own hands while the science is being sorted out here, those are the things you can do that will directly reduce your level of exposure to BPA," said Rangan.
One thing mothers should not do is stop giving their infants proper nutrition because of fears about BPA, says acting Surgeon General Steven Galson. "While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option," he said.
Q: Wait a minute, aren't some people overreacting here? Has anybody died from BPA?
A: No direct cause-and-effect relationship has been established to show that exposure to small amounts of BPA harms people.
But many scientific studies have raised that possibility, and some government scientists believe it should not be dismissed lightly. Chemical exposures that cause harm over a long time are hard to detect.
The National Toxicology Program conducted its own BPA assessment earlier this year, and differed with the FDA. The toxicology program found "some concern" for BPA effects on the brain, behavior and prostate gland in fetuses, infants and children at current exposure levels. "Some concern" is right in the middle of the toxicologists' five-level scale for ranking the possible harmful effects of chemicals.
The independent panel that reviewed the FDA's assessment said the agency needs to go back and take a second look at several studies it earlier dismissed.
Q: What's going to happen now?
A: On Friday, the FDA's Science Board will meet to discuss the controversy in public. It was a subcommittee of the Science Board that issued the report criticizing FDA's safety analysis. But FDA officials say it could take two to five years to complete additional research and reach a final conclusion.
If scientific evidence against BPA mounts and U.S. regulators don't act, Congress may try to restrict some uses for the chemical.
"If FDA continues to dismiss independent scientific evaluations of BPA, correcting the issue legislatively is an option," said Rep. Rosa DeLauro, D-Conn., chairwoman of a committee with jurisdiction over the FDA budget.
Q: What would be the downside of just banning BPA altogether?
A: The canning industry thinks there would be unintended consequences. The chemical is used to make epoxy resins that coat and seal the inside of cans. That prevents leaks and keeps bacteria from contaminating the foods inside.
"Although we are looking for alternatives, they are not readily available, and there is no 'drop-in' replacement for these uses," said John Rost, chairman of the North American Metal Packaging Alliance, a trade group. "Quick changes that have not been evaluated could impact the real safety issue: food poisoning."
Short of a ban on all BPA in food containers, Canada has banned it in baby bottles as a precaution.
On the Net:
* Scientific advisers report to the FDA: http://tinyurl.com/5mfmm7
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