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Senior ex-official speaks on FDA's failure to get benzene out of soft drinks
BUSTED: former FDA head charged with conflict of interest and lying
Preschool puberty from cometics, drugs
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Please don't disrupt my endocrines!
Consumers to FDA: Be there or be square
Lead: Celebrate its ban, but don't cross it off your list
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BPA: What FDA doesn't know could hurt you
One of the unwritten rules of public relations is, if they’re running you out of town, get out front and say you’re leading the parade.
That’s one way to read the American Chemistry Council’s assertion that it “welcomes” the Sept. 3 National Toxicology Program’s assessment of bisphenol A (BPA), an artificial sex hormone used to manufacture a vast array of plastics. The Washington-based industry group said dismissively that the NTP “identified no serious human health concerns” from exposure to the chemical – which U.S. chemical manufacturers turn out at the rate of 2.3 billion pounds of BPA annually.
No question about it, the NTP, a Chapel Hill, N.C.-based interagency body that evaluates chemicals for risks to humans, has not found smoking-gun proof that BPA causes particular cancers or other illnesses in particular individuals. But after reviewing several hundred animal studies, the NTP spotted enough smoke to express, in a cautious but chilling statement, “some concern” that even low levels of BPA may affect “development of the prostate gland and brain and [cause] behavioral effects in fetuses, infants and children.” As top NTP scientist John Bucher put it, “We see developmental changes occurring in some animal studies at BPA exposure levels similar to those experienced by humans.”
That conclusion – that people, including children whose bodies and brains are still developing, are being exposed to a chemical in amounts that have caused irreversible changes in unborn and young lab animals -- directly contradicts the Federal Food and Drug Administration’s position, reiterated in mid-August, 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. “
The FDA statement was lawyerly, and it may have served those who want the BPA debate ended, now. But it didn’t have much traction among scientists who are at home in the world of unresolved questions and who don’t believe that what you don’t know won’t hurt you.
Nearly every day, as more research reports on BPA are published, the cloud over the chemical darkens. On Sept. 3, researchers at Yale School of Medicine made public one of the most disturbing findings yet. Yale scientists had given African green monkeys trace amounts of BPA, equivalent to the maximum dosage the U.S. Environmental Protection Agency says is safe for human consumption.
“Our goal was to more closely mimic the slow and continuous conditions under which humans would normally be exposed to BPA,” said study author Csaba Leranth, M.D., professor in the Department of Obstetrics, Gynecology & Reproductive Sciences and in Neurobiology at Yale. “As a result, this study is more indicative than past research of how BPA may actually affect humans.”
After just 28 days of trace BPA dosage, the Yale team documented what researcher Tibor Hajszan called “a devastating effect on synapses in the monkey brain.” Humans, the researchers said, would experience this subtle brain damage as memory loss, learning problems and depression.
On Sept. 16, an FDA science advisory panel is set to hear arguments over whether the agency should restrict the use of BPA in can linings, baby, water and drink bottles and other food packaging.
With stakes now reaching to the central nervous system, the reproductive system and behavior, it's a safe bet that many scientists will advise FDA that the benefits of BPA-laden food packaging are not worth the risk.
Photo by babydinosaur
5 things accomplished faster than sunscreen regulations
It's been nearly 30 years since the FDA acknowledged the need for sunscreen industry regulations, but it isn't because crafting regulations is too difficult a task for the U.S. government. It took the government less time to
- Craft and sign the Declaration of Independence
- Defeat Nazi Germany (granted, we had some help on that one)
- Figure out that prohibition was a bad plan
- Create the Medicare system
- Put a man on the moon (8 years from presidential imperative to lunar landing)
Getting sunscreen safety standards finalized should be a piece of cake compared to all that. We've seen the FDA bough to industry pressure on this issue
Maybe, just in case the industry still thinks they have something to hide, you should let the FDA know that you want them to finalize and implement their proposed standards. Go to the FDA's comment page to tell them you don't want to wait another 30 years for safe and effective sunscreens.
Coke settles benzene lawsuit
The Atlanta Journal-Constitution reports on Coca-Cola's settling of a benzene-in-soda lawsuit and the reformulation of two of its products.
Angry Toxicologist and Effect Measure were quick to pick this up. Their verdicts: Coke's baby steps are better than the inaction of Pepsi, Sunny Delight, Shasta, Rockstar, Polar and retailers Safeway and Publix. Still, there is no need for the combination of Vitamin C and preservatives that form benzene in children's drinks.
Banned pesticide still used in head lice treatment
A federal judge has dismissed a lawsuit brought against The Ecology Center and two Michigan pediatricians who stood up in support of banning the dangerous chemical lindane in anti-head-lice shampoos. The lawsuit, brought by Morton Grove Pharmaceuticals, failed to silence the debate in Michigan over why a chemical banned by EPA for use as a pesticide should be approved by FDA for use in an anti-lice shampoo for kids. Lindane, a suspected carcinogen and known cause of seizures is highly volatile and can easily penetrate food and water supplies. All uses of the chemical have been banned in 52 countries and in California. The bill proposed in Michigan (House Bill 4569)--backed by the Michigan chapter of American Academy of Pediatrics and the Michigan Department of Community Health among others--would phase out all pharmaceutical uses of lindane throughout the state.
Senior ex-official speaks on FDA's failure to get benzene out of soft drinks
In 1991 the FDA let the beverage industry decide what to do about benzene in its soft drinks, without offering any guidelines for eliminating the carcinogen. Fifteen years later, benzene was still forming in soft drinks containing the ingredients sodium benzoate and ascorbic acid.
In an article for Food Navigator, Chris Mercer interviews a former FDA enforcement official about the agency's permissive attitude toward carcinogens in soft drinks. Acknowledging he was “not proud” of the FDA’s inaction on benzene, the ex-official noted:
Big companies are very powerful. If you’re a regulator with a tight budget, it could have been one of those closets with skeletons in it that you don’t want to open.
Continue reading "Senior ex-official speaks on FDA's failure to get benzene out of soft drinks" »
Say NO to nano in cosmetics
While industry and government officials debate the safety of nanotech, 256 popular products have already been identified where nanomaterials are listed as ingredients. Products include eye liner, moisturizer, bronzer, lip balm and sunscreen.
Why should you care? Nanomaterials are super-tiny manmade chemicals that may pose unpredictable risks to public health. The FDA is concerned about these micro-sized ingredients because their toxicity may be very different, and potentially more severe than normal-sized chemical ingredients.
Take action now: Urge FDA to request that nanomaterials be clearly identified and assessed for safety before they are used in personal care products.
BUSTED: former FDA head charged with conflict of interest and lying
From Wonkette:
Ex-FDA chief Lester Crawford pled guilty today to being the latest administration scumbag caught owning shares of companies he regulated.[ link : AP ]Crawford was forced out last year, after a grand total of two months as Food and Drug Administration Commissioner. (He was acting director for three years before that, because the Senate didn’t want to confirm him.)
His official crimes are lying to the Justice Department, breaking conflict-of-interest laws and falsely reporting his stock ownership. For all this, he’ll pay a fine.
Preschool puberty from cometics, drugs
Today the New York Times reports some disturbing news about certain drugs and cosmetics causing preschoolers to go into puberty. In one case, a girl and her brother--whose father had been using a testosterone skin cream--started growing pubic hair just from skin contact with their father. Her brother also developed some aggressive behavior problems. The article cites some 1998 cases of early breast development in young girls brought on by a shampoo which contained estrogen and placental extract.
What does the FDA have to say about this? The FDA spokesperson told the Times that FDA was “aware of some reports describing premature sexual development” and that “there is no reason for consumers to be concerned.” And at this time “placental materials are neither prohibited by cosmetic regulations nor restricted” by the FDA.
Robert Cooper, chief of endocrinology at the reproductive toxicology division of the EPA suggests that conflicts of interest on advisory panels have hampered the development of adequate testing measures for these endocrine disruptors in consumer products:
In 1996, Congress directed the E.P.A. to develop a comprehensive screening program for possible endocrine disruptors within three years. Dr. Cooper says no such program has begun operation, a failure he attributed largely to stonewalling by chemical industry representatives who serve on an advisory committee for the program. Now the proposed rollout is December 2007, but Dr. Cooper said, “They may be dreaming.” Critics cite the program’s high potential costs and lack of reliable laboratory tests.
Full article
FDA is faulted for drug-safety process
The nation’s system for approving and monitoring the safety of medicines is inadequate and needs far-reaching reforms, and the Food and Drug Administration is plagued with poor management and persistent internal squabbling, according to a long-anticipated study of the agency. The study, requested by the FDA, was carried out by the Institute of Medicine, a nonprofit organization created by Congress to advise the federal government on health issues. The report is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the F.D.A.’s oversight. The debate began in earnest in September 2004 when Merck withdrew its popular arthritis drug, Vioxx.
[ Source : New York Times ]
Scientific integrity cartoon contest
Drug-review fees help industry shape FDA agenda
According to the Wall Street Journal, the Food and Drug Administration is bargaining with the pharmaceutical industry for an increase in fees used for reviewing new drug applications-- a move experts say will give the industry a greater role in shaping the priorities of its regulator. "There is no doubt that user fees give the industry leverage on setting the agency's priorities, because of the negotiating process," says Dr. Kessler, former head of the FDA, and now dean of the medical school at the University of California, San Francisco. "There are significant risks, especially when a growing percentage of the budget comes from user fees." For the next five-year agreement, which will begin Oct. 1, 2007, fees could cover 66 percent or more of the drug-review budget.
Just say yes to drugs
The Washington Post reported on a report by the National Research Center for Women & Families showing that expert panels assembled by the Food and Drug Administration (FDA) are often biased towards approving new drugs.
Officials can discuss what's a conflict of interest all day, but I have a simpler idea. How about if, for every panel member who's got any tie to a drug company (or a nonprofit or trade association they fund), we have TWO panelists that work only for public interest groups that have no tie to the drug industry?
... And just for fun, have a look at Mike Adams and Dan Berger's political cartoons about the FDA.
Where's the pudding?
The proof is in the pudding, as the saying goes, and obviously pudding is safe to eat. Just call me or Bill Cosby - we can talk tapioca all day.
Today's Salt Lake Tribune editorial insists that "Makers of dietary supplements should have to prove safety." Sounds obvious, but if it isn't food you eat or a drug you take, don't assume it's been proven safe.
Continue reading "Where's the pudding?" »
"Ok, Ok--So I Hid My Industry Ties,
But Everybody's Doin' It!"
 |
Recently there's been plenty of debate within scientific, regulatory, and public health circles about the role of industry funding in scientific research and on government advisory panels--with robust arguments from each side. But almost everyone--including the FDA, the American Chemistry Council, and the Society of Toxicology agree on one point: full disclosure of professional associations and financial interests is the bare minimum necessary to safeguard the public interest. Well, according to The Scientist magazine, there's one "expert" out there who won't be swayed by prevailing morality. That man is Dennis Paustenbach, CEO of the risk assessment firm ChemRisk, and repeat-participant on EPA and NAS advisory panels. On his secretive role ghostwriting a landmark study which sidelined efforts to raise cromium-6 drinking water standards The Scientist reports:
Paustenbach, however, told The Scientist that ChemRisk scientists are not the only contributors who have been less than forthcoming. "If the Journal [of Occupational and Environmental Medicine] was using those [full-disclosure] rules over the last 10 years, I think they'd find dozens of papers to have inadequacies in disclosure."
Dr. Paustenbach must've had his fingers crossed when he pledged to uphold these tenets in the Society of Toxicology Code of Ethics:
Conduct their work with objectivity and themselves with integrity. Being honest and truthful in reporting and communicating their research.Abstain from professional judgments influenced by undisclosed conflict of interest, disclose any material conflicts of interest and avoid situations that imply a conflict of interest.
Practice high standards of environmental and occupational health and safety for the benefit of themselves, their co-workers, their families, their communities, and society as a whole.
Past news coverage of ChemRisk misconduct.
FDA's 100th Birthday
Check out this FDA Centennial Anthem, written in honor of the big milestone:
One century past, a people’s hope fulfilled
By an act conceived for safe medicine and food
Protecting rights that our founding fathers willed
To life and liberty, to happiness pursued.[...]
Now in this proud hour, a vibrant vision thrives
True to our mission, whate’er the challenge be
With science our guide, we rededicate our lives
To help create a future healthy, safe, and free.
Hmm...so that's what they've been doing--writing songs.
Soda Ban in Schools Does Not Protect Students From Benzene
The beverage industry has conceded to remove high-calorie soft drinks from schools. They will, however, be continuing to sell diet sodas and fruit drinks, which contain fewer calories and less sugar. What many of these drinks do contain are the two ingredients which can form Benzene, a known human carcinogen.
Learn more about Benzene in sodas.
Tell FDA: Get benzene out of my soft drinks
Congress Blocks Ideologues From Health Agencies
FDA: We Don't Know What's in Tuna Cans
The heavy metal mercury gets into our bodies from seafood consumption and harms the brains of developing children and babies. Public health groups have long urged the FDA to provide clear warnings to women of childbearing age about how much seafood they can safely eat.
The Tribune reports: "We will definitely look at it through our office of seafood and determine whether there is something that requires further pursuit," Acheson said. He could not say exactly what the investigation would entail or whether the agency would conduct additional testing of canned tuna.
Environmental Working Group researchers exposed the FDA's coverup of their own focus group results in which Agency scientists warned women about mercury in tuna. To see how much tuna you can safely eat to keep your level of mercury at a safe level, use EWG's tuna calculator: http://www.ewg.org/issues/mercury/20031209/calculator.php
To read EWG's research, please visit http://www.ewg.org/issues/siteindex/issues.php?issueid=5010.
Newspaper Tests Fish for Mercury
Three points the authors make in today's installment:
> Officials with the Food and Drug Administration, which is responsible for the safety of commercial seafood, told the Tribune that the agency has neither the time nor the money to routinely test fish.
> The FDA, for instance, does not require exporting countries to maintain safety, sanitation and inspection programs comparable with the U.S. system, even though 80 percent of the seafood that Americans consume is imported. By contrast, the Department of Agriculture, which monitors meat and poultry, requires every exporter to meet such standards.
> The FDA has issued warnings for canned albacore tuna, which has averaged 0.35 parts per million in the agency's testing. Yet the agency has not issued warnings for orange roughy, which averaged 0.57 parts per million in the Tribune testing, or walleye, which was at 0.51.
EWG's research on mercury in seafood is viewable online at http://www.ewg.org/issues/siteindex/issues.php?issueid=5010.
Use EWG's tuna calculator to see how much tuna is safe for you: http://www.ewg.org/issues/mercury/20031209/calculator.php.