Another Reason the FDA Should Be Dismantled and Rebuilt from Scratch

Finally, something that is not about Carter's tagless onesies. Unfortunately, the news is not much better. There is some relatively new information to add to the BPA Files. Thank you to the reader who sent me information on this.

Earlier this month, the Milwaukee Journal-Sentinel broke news that only underscores the remarkable inefficiency of the FDA and bolsters the case that the people running the agency are caught up in hopeless conflicts of interests, which an eighth-grader would know are untenable.

Martin Philbert, chair of the FDA's panel that recently released preliminary findings that Bisphenol-A is perfectly safe, received an enormous donation to the University of Michigan Risk Science Center, Philbert's own research center. The donation was about twenty-five times the Center's annual budget. The donation came from a retired medical supply manufacturer who is a vocal proponent for the continued use of BPA, including the use of that chemical in baby products.

Philbert did not disclose the donation. He doesn't understand why anyone would want to know about it. He doesn't think it's relevant to the work he is doing on BPA. In fact, the FDA itself learned of the donation from Milwaukee Journal-Sentinel reporters who called the agency for comment.

The donor's name is Charles Gelman, "once labeled," the Journal-Sentinel reported, "the second worst polluter in Michigan by the state's Department of Natural Resources." Gelman went on to tell the paper that not only is BPA "safe", but also that "mother's groups and others who don't know the science" are responsible for the nationwide concern. Sexist and patronizing? Yes, but par for the course. One wouldn't expect anything less from Gelman. But what of the more than two hundred independent research papers finding the chemical harmful even at low levels?
He doesn't speak to that.

What is most concerning, is Philbert's response to this disclosure, which came about despite his best efforts. Although Gelman told the paper that he made his views on BPA very clear to Philbert in "several conversations," Philbert denies this. Incidentally, when Philbert was chosen for the panel, environmental groups criticized the pick. Maybe that was because Philbert has absolutely no background nor expertise in BPA.

Obviously the only appropriate action is for Philbert to remove himself from the panel. If he won't do it, he should be removed. Relying on a scientist who has no expertise on the chemical under consideration ought to be enough; but that he accepted a huge donation from a BPA-proponent, did not disclose it, and posed for pictures with the donor when the contribution was made is such a blatant conflict of interest that if the FDA does not move swiftly to correct it, its irrelevance will begin to look a lot like malfeasance.

CPSC issues "advisory" on Carter's tagless onesies

The Consumer Product Safety Commission, in conjunction with Carter's, issued an advisory regarding Carter's tagless onesies. The CPSC advisory can be found here, and I have reproduced it below.

This is a huge victory for parents whose children have suffered chemical burns from the large heat-transferred tags from some of Carter's onesies. This advisory came about because of the parents who contacted the CPSC, filed reports online, and blogged about their experiences.

However, the only acceptable solution at this point is a recall. Carter's claims that 400 reports have been filed about rashes and burns resulting from the heat-transferred tags on their Fall 2007 line. I firmly believe the number vastly underestimates the number of infants affected; the CPSC's complaint site is difficult to find (see below) and, as Ava's mom has pointed out in her blog, not every mother has the time for a long conversation with a Carter's customer service rep. I also believe many parents will not realize until they see this advisory what, exactly, has been causing their childrens' rashes or other injuries. Expect to hear about many, many more cases in the near future.

In addition to Ava's blog, I received a comment from a mother whose son also suffered a serious reaction to a Carter's onesie. The following entry on her blog contains photo of her son's back. And pictured here is a Minnesota infant who was affected by Carter's tagless onesies.

The one useful element of the advisory, besides its release to the public, is that it isolates at least one of the lines that is affecting infants: Fall 2007. You will recognize these onesies by the overly large heat-transferred "tag", which is mainly solid rather than stenciled. If my theory is correct, that the larger, solid tag contains a higher percentage of phthalates, then you should avoid any heat-transferred "tags" that are solid instead of stenciled, huge instead of small. In fact, Ava's mother says, and based on some e-mails I've received I agree with her, that this problem is not limited to the Carter's Fall 2007 line (and perhaps not even to the Carter's line at all).

For now, my advice is for parents to avoid tagless onesies or shirts that have a heat-transferred label that contains a lot of ink. Try for onesies that have one or two lines. Once you start getting into the paragraph-length script about origin, washing instructions, component ingredients, etc., then we're talking about more of the chemical (I believe it is phthalates) coming in contact with your infant's skin. Ideally, we'll all use "tagged" onesies until the industry ceases to use phthalate-containing ink.

For an extremely useful overview of this situation, please visit Z Recommends, which filed a Freedom of Information Act request to obtain records of parent complaints to the CPSC and plans to post analysis this coming week.

In the meantime, please read my posting regarding the letter CEO Michael Casey sent to Ava's mom--there you will find contact information for Carter's and a way to report an incident to the CPSC. An advisory is a good start, but a recall and the elimination of phthalates in these kind of tags is the only way Carter's will win back customers it has lost, not to mention those tens of thousands of people who are scouring the web right this minute for "Carter's tagless onesies rash."
Below please find the text of the CPSC advisory.

News from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207

--------------------------------------------------------------------------------
FOR IMMEDIATE RELEASE
October 24, 2008
Release #09-023 Firm’s Hotline: (888) 282-4674
CPSC Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908



CPSC and Carter’s Advise Parents of Rashes Associated with Heat Transferred, or “Tag-less,” Labels
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) and Carter’s, Inc., of Atlanta, Georgia, are advising parents and caregivers that they have received reports that a small percentage of babies and infants have developed rashes on the upper back after wearing Carter’s clothing with heat-transferred, or “tag-less,” labels.

This advisory applies to Carter’s Fall 2007 product line. The Fall 2007 line utilizes a label on the inside back of the garment that has a raised surface with a solid, rather than a stenciled, background. This advisory does not apply to previous and current product lines, which utilize labels with stenciled backgrounds.

The garments, which were made in various countries, were sold at Carter’s own retail stores and at department and national chain stores.

If your child develops a rash on the upper back after wearing garments that have a “tag-less” label with a solid background, you should stop using these garments. If the rash persists or worsens, you should contact your pediatrician. For additional information, visit Carter’s website at http://www.carters.com/corporate/tagless_message.aspx, contact Carter’s toll free at 1-888-282-4674 or by email at contactus@carters.com

Ava and Carter's: Part II

Ava's mother received a handwritten letter from Carter's CEO, Michael Casey. She's posted it on her blog, Ava's Tagless Horror with Carter's.

The letter is straight out of Corporate Central Casting: a handwritten note meant to convey sincerity and a kind of "we're taking this seriously" sensibility; an allusion to the CEO's own "six children", designed to make Ava's mom feel like she's dealing with a compassionate human being; and a request that she give Carter's a second chance to earn her trust, despite promising no action that would generate such trust in the first place. As I told Ava's mother, the hubris that infects many CEO's is so enormous that many of them, like Michael Casey, think that writing a handwritten note to a dissatisfied consumer, regardless of how insubstantial and disingeous that note is, will humble the consumer, pacify her, make her feel grateful that such an Important Person took the time to acknowledge her. Carter's, like many companies, underestimate their customers, at their own peril.

But Ava's mother's response was downright artful. She demanded a recall, corrected Mr. Casey's assertion that Ava's injury was a "rash" (she reminded him that it was, in fact, a chemical burn), and asked how, has the father of six children himself, he could let this problem continue to go unaddressed in any meaningful way.

Continue to report any reactions your children have had to Carter's onesies to the CPSC, as well as reactions your kids may have had to any tagless onesies (my son had issues with tagless onesies from The Gap). A mom-commenter on Z Recommends suggested writing to Consumer Reports about the issue with Carter's. You can e-mail them at ConsumerReports@ConsumerReports.org. And write to Carter's CEO at the following address:

Michael C. Casey, Chief Executive Officer
1170 Peachtree Street, Suite 900
Atlanta, Georgia 30309
Telephone 404-745-2802 Fax 404-892-3079
Email mike.casey@carters.com

Incidentally, Carter's has recalled clothing items before. From the CPSC's website:

FOR IMMEDIATE RELEASE
August 17, 2000
Release # 00-166a Company Phone Number: (888) 339-2129
CPSC Consumer Hotline: (800) 638-2772
CPSC Media Contacts: Ken Giles/Yolanda Fultz-Morris, (301) 504-7052/1219

Girl's Nightshirts Recalled by the William Carter Co.

PRODUCT: Girl's Nightshirts - The William Carter Co. (Carter's), of Morrow, Ga., is voluntarily recalling about 1,000 girl's nightshirts. The recalled nightshirts have long sleeves, and were sold in sizes small (4-5 year), medium (6-7 year), large (8-10 year) and, x-large (12-14 yr). They are made with 100 percent polyester fabric with a pattern of brown bears wearing pink pajamas and the words "p.j. bear" printed on a white background. Identification code "GPU CF79761" and "Carter's" are printed on a label sewn into the collar. Carter's, department and specialty stores sold these pajamas nationwide from May 2000 through August 2000 for between $10 and $13.

PROBLEM: The nightshirts, which fail to meet federal children's sleepwear flammability standards, could ignite easily and present a serious risk of burn injuries in violation of the Federal Flammable Fabrics Act.

I don't cite this to point out that Carter's is a "bad company"; I point this out because it demonstrates that Carter's has experience in the mechanism of recall and has the infrastructure and the tools to do it.

Just another appeal to Minnesota moms out there whose kids have had a reaction to any tagless onesie. Please e-mail me if you are willing to talk to an investigative reporter (not me) about your experiences. Photos are a big plus.

Carter's Tagless Burns: Updates

I recently received a comment on one of my earlier Carter's postings that I found deeply disturbing. This little girl has been suffering deep chemical burns after wearing Carter's tagless onesies. The burns have been on her back, in the shape of tagless "tag", since she was six weeks old. The story of her doctor's visits, the hospitalization due to a staph infection that developed because of one of these open, weeping chemical wounds, and so on, is almost Faulknerian in both its length and complexity.

Ava's burns are the worst I've seen. Her injuries only intensifies the urgency of this matter. It is Carter's responsibility to recall the Fall 2004 line, and any other line they find that contains the irritant, immediately. That the company has refused to do this despite hundreds, if not thousands, of complaints demonstrates its willingness to expose its customers to serious risk, and to expose itself to some costly lawsuits.

Back to little Ava. Her parents have tried to raise a response with Carter's for some time now, only to get the same useless response so many other parents have received. Send back all the onesies for a refund and a teddy bear. Some parents have been pleased by this. They shouldn't be. This isn't about the money. While none of us are rich, Carter's onesies cost about six bucks a pop; and I'm sure all of us would take the loss if Carter's would simply recall these items of clothing and protect other infants from burns like this.

An excerpt from Ava's parents' blog, Ava's Tagless Horror with Carters (which you should visit and pass along to any parents you know):

Then one day, the burn got worse and Ava was clearly in unbearable pain. We immediately took her to the pediatrician. The doctors in the practice saw Ava’s wound and agreed she should immediately be admitted to the children’s hospital emergency. Ava caught a staph infection from her open wound. As you may know, staph can be life threatening, especially to an infant; Ava was barely 3 months. She had to be in a strict sterile environment (medical masks, gloves and gowns were required by all who entered who room) and we waited for IV Antibiotics to mitigate further health risks. Ava and my wife were in the hospital overnight. We were alarmed by doctors who all claimed the issue to be very severe but none of whom could diagnose it. We were all horrified and traumatized by this, wondering if our daughter would recover. Ava was on antibiotics for at least a month, the burn subsided but never healed and continued to painfully affect her.

Ava's pediatrician confirmed Ava's injury was a chemical burn, not a rash. He agrees that the Carter's tag caused it, has filed a report with the Consumer Product Safety Commission (note: if you have had this problem with Carter's, please file an online complaint with the CSPC), and has notified the pediatric community in San Francisco of the Carter's problem. Incidentally, Ava's parents never suspected the tagless onesie as a culprit; in fact, they thought that the tagless clothes would be less irritating to Ava's wound. It wasn't until they checked online and learned of other parents' problems with Carters' onesies that they realized what had been causing the injuries all along.

I can only wonder at Carter's reluctance to do anything useful about this. Every day that passes, more parents learn of this problem and are, perhaps, more troubled by the company's inaction and refusal to acknowledge an obvious problem. Companies who believe that bad press will pass are foolish; in this day of blogging, consumer rating websites, and cached information, the stupid moves companies make are memorialized for years to come. And one demographic you don't play with are parents with internet access.

Finally--I could go on and on about this--I found this bit of information from Carter's, reproduced on Ava's blog, particularly idiotic. When speaking to a consumer affairs employee at Carter's, Ava's parents received this information: Mary had a group meeting with all of Carters Consumer Affairs Representatives and all agreed to “welcome” victims and to be more compassionate. Mary, no welcome and no compassion is needed. The only acceptable action at this point is a recall.

Immediately.

If not--and I don't say the following lightly--it might be time for Ava's parents, and the parents of other children who have suffered burns from these onesies, to get lawyers. Lawsuits are often the only language companies like Carter's understand.

NOTE: If you are a Minnesota mom and are dealing with this problem, please contact me, either by commenting below or by e-mailing me at bookofmoonsATgmail.com.

The "Fluffier" Side of Science

Finally, a post about "fluff", as my mother would say: make-up. So, roughly eighteen months after giving birth, I am finally getting enough sleep (and enough showers) that putting on make-up no longer seems like a futile exercise in It-Doesn't-Matter-Anyway. And in those eighteen months, a lot of cosmetic products that I used to use have been relegated to my "no way in hell" list: mercury-containing mascara, lead-containing lipstick, paraben-containing skin lotions, etc. Since my time for experimentation is rather limited, I only have a couple products to tell you about right now, but luckily for me they are really the only two items of makeup I wear: mascara and lipstick.

Jane Iredale Purelash Lengthening Mascara

Earlier this year, Minnesota became the first state to ban mercury-contaning mascara. I am unclear about the logistics of the switch, and how long companies have to reformulate their products, so I was looking for something to use in the meantime. After an admittedly haphazard search (it really wasn't at the top of my to-do list), I found Jane Iredale mascaras. They are mercury-free, dye-free, and they do not create clumps on the lash. The mascara actually contains algae extract, which serves to strengthen lashes instead of turning them into freakish, shellac-ed Bettie-Davis-in-Whatever Happened to Baby Jane-type lashes. Actually, as soon as I opened the container, I could tell the difference from other mascaras I've used in the past: it smelled like beeswax, not a chemical processing plant. (Iredale in fact uses beeswax). Anyway, bottom line, I love this mascara not only because it is free of mercury and other nasty things, but because it's actually the best one I've ever used.

You can learn more about Jane Iredale mascara on her website, Jane Iredale Mineral Cosmetics (though you can't buy it there). I buy mine from Dermstore because they ship free and because it offers the Purelash Lengthening Mascara for only $16.

Lead-Free Lipsticks

As a tomboy who was once so obsessed with basketball that I carried one around high school, I strategically used lipstick as my reminder to the world that I was, in fact, a girl. But even that once-indispensable tool had become utterly dispensable and unimportant. After clawing my way back from total subjugation-by-precocious-toddler, I have finally decided to pick it up again on the regular. The problem is that the vast majority of lipstick contain lead. It's a bit hard to believe, given that lead has been deemed unsuitable even for gas, but I digress. I'm in the hunt for a lead-free product. The Daily Green listed eleven lead-free offerings not so long ago, and I posted them on this blog. However, they tested specific colors for specific brands, all basically blood-red. I have a couple companies in mind, whose lead-free products I'll be trying in the next few months, so I will keep you updated. In the meantime, here are a few companies currently making lead-free lipstick.

Afterglow Mineral Cosmetics
Vashon Organic Cosmetics (note: be aware that just because a cosmetic product is labeled "organic" doesn't mean it is lead-free. Vashon's lipsticks are, however, lead-free.)
Gabriel Cosmetics

EPA won't regulate rocket fuel in tap water...but this time it's not their fault

I thought I'd share some news regarding perchlorate, the chemical found in rocket fuel that has been showing up in drinking water around the country. I wrote about this several months ago in a post, Rocket Fuel and Other Goodies." Just as a quick primer, perchlorate is basically a waste product from defense sites; found in rocket fuel, it poses significant health risks, particularly to thyroid functioning in, who else, infants, children, and pregnant women, at levels "five times lower than the current 'safe dose' deemed by the EPA," according to the Centers for Disease Control.

This chemical has showed up in the drinking water of 28 states. Consumer advocates and epidemiological organizations have been pushing for drinking water standards for perc, to great resistance from the current administration as well as the EPA. However, during the last week, the Washington Post has reported that the EPA might finally be willing to budge, and perhaps has been straining against the reins on this issue for some time. The paper reported that the EPA is set to "end a six-year-old battle between career EPA scientists" who actually want to regulate perc. It seems that EPA scientists have recognized the serious threat perc poses to a very vulnerable population, but have been stymied at every turn by both the White House and the defense contracting industry, who would be responsible for cleanup and mitigation. And yet, despite EPA scientists' concerns, the EPA's preliminary regulatory determination, which hasn't been released publicly yet but which was obtained by the Post, states that regulating perc would be a foolhardy endeavor because it wouldn't result in a "meaningful opportunity for health risk reduction for persons served by public water systems." (Do you see now why I keep my Orwell books stacked in a pile on my desk?)

What gives? It seems the EPA's report was extensively edited by the White House's Office of Management and Budget. One of the lowlights of the edited document was the White House's determination that there is no need to include detailed data that has already demonstrated that "infants would be exposed to perchlorate levels above" levels deemed safe by the National Academy of Sciences.

Finally, in a selection from the annals of inevitibility, defense companies have formed a front group to fight possible drinking water standards: Perchlorate Study Group. From their surely exhaustive and totally independent and objective research, they question whether percholorate poses any kind of health problem. Because they don't have a horse in this race or anything.

From the Washington Post: "EPA unlikely to limit Perchlorate in tap water"

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