FDA suddenly sets "safe level" of melamine in infant formula

In perhaps one of the most astonishingly transparent acts of government caving to corporate pressure, the FDA has, within 48 hours, set a "safe limit" of melamine in infant formula. This, after conducting tests in secret on baby formula since September without informing the public. This information only became public when the Associated Press filed a Freedom of Information Act request to make the tests public.

This is astonishing because it typically takes a great deal of research to determine a safe level for infants of a previously untested chemical. I can only assume the FDA just cherrypicked Europe's established levels for melamine.

This is another egregious example of the FDA's complete and utter failure to do what it has been charged to do: protect the public. Perhaps it is underfunded. Perhaps it meets resistence from the Bush Administration. Perhaps it rolls over under pressure from industry. Or maybe, like the scientists in the EPA, its best efforts are thwarted at every turn. I tend to think the presence of people within the agency who have ties to industry is the biggest culprit. I prefer this scenario to one in which the agency scientists are this haphazard, unprofessional, unskilled, unbalanced, and, in the someone else's words, "tone deaf." Because that's too damn scary.

Read my original, less soapboxy, post on the FDA/Melamine situation here.

Melamine in Baby Formula: FDA says "Drink Up" again

"From a public health or infant health perspective, we consider those to be perfectly fine."
--Dr. Stephen Sundlof,
Food and Drug Administration

These words from a spokeman for the FDA, our fearless federal agency charged with protecting consumers from dangerous food and drug products. He was speaking about infant formula, sold in the United States, that have tested positive for trace amounts of melamine. The FDA gets on the horn to tell us that although melamine has been found in infant formula here in the States, it's safe! It's safe, even though no safe level of melamine in food products has been established by the FDA.

This story makes me sick. But I'll save my rant for later in the post. The important thing is the facts of the story as we currently understand it. The Associated Press had to file a Freedom of Information Act request to obtains secret tests the FDA has been conducting on baby formula, tests that would determine the level of melamine in these products if present. The agency found melamine present in one popular formula brand--Enfamil LIPIL with Iron, powder formula (UPDATE: I'm now hearing that the FDA may have incorrectly cited Enfamil LIPIL with Iron as containing melamine)--and cyanuric acid (melamine derivative) in another, Nestle's Good Start Supreme Infant Formula with Iron. A third was found by the FDA to be melamine-free, but the company itself corrected the FDA and said they had indeed found melamine in their formula: Similac.

In addition, the agency found that two nutritional supplements for ill children, particularly those who have trouble digesting food, contained melamine: Nestle's Peptamen Junior medical food and Nestle's Nutren Junior-Fiber.

It's important to point out that the FDA has known about this for at least a month, if not more. They have contacted the formula makers. They have not told consumers. Several legislators have stepped up and demanded the the FDA stop stalling, get its own story straight, and do something about this. From the AP Report:

Rep. Rosa DeLauro, D-Conn., who heads a panel that oversees the FDA budget, said the agency was taking a "marketplace first, science last" approach.

"The FDA should be insisting on a zero-tolerance policy for melamine in domestic infant formula until it is able to determine conclusively based on sound independent science that the trace levels would not pose a health risk to infants," DeLauro said.

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, said: "If no safe level of melamine has been established for consumption by children, then the FDA should immediately recall any formula that has tested positive for even trace amounts of the contaminant."

So what formulas are "melamine-free"?
What should parents do? There has been precious little practical advice, and the FDA's directive to keep using the formula, even the same brand, seems ridiculous even if the agency wasn't totally without credibility. We can't be sure of anything--this is a truism of living in today's "chemical culture." We do the best we can. Reuter's is reporting that Hain Celestial, which makes Earth's Best Organic Formula, has found no melamine or cyanuric acid in its tests. Another brand cited by Reuters as "melamine-free" is privately held PBM Nutritionals (store brand formulas--Vermont Organics and Bright Beginnings. Of course these were in-house tests, so we can't be sure they are accurate; however, Similac itself corrected the FDA by citing that its own in-house tests had detected melamine. I see no reason why a respected brand like Earth's Best, for example, would lie about its own tests, putting itself in serious legal danger.

One thing to anticipate are the countless "junk science" critics who will rail at those of us who breastfed, for example, that, well, you probably have as much melamine in your breastmilk as was found in these formulas! I don't know if this is true or not. Given the amount of chemicals we are exposed to unwittingly and without our permission every day, I wouldn't even be surprised. But this is not germane to the point. Melamine should not be in our breastmilk and it shouldn't be in our formula. Question closed. Another line of argument I've been seeing is that "melamine is already in lots of food." What's your point? We are talking about food that is served to infants, with much lower body weight and much higher body fat percentage (soluble), who rely on formula for every one of their meals. If just one food stuff should be melamine-free, it should be formula.

Below are some "lowlights" from this developing story.

From the "Wow, this makes the whole situation more palatable" Files: "The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally."
P>
From the "Let me Blatantly Contradict Myself" Files: "Sundlof told the AP the positive test results 'so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine." That's different from the impression of zero tolerance the agency left on Oct. 3, when it stated: "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns."

From the "I Don't Want to Have to Face the Pressure from U.S. Formula Makers So I'll Just Make Up an Arbitrary Rule on This" Files: It was not until the AP inquired about tests on domestic formula that the FDA articulated that while it couldn't set a safe exposure for infants, it would accept some melamine in formula - raising the question of whether the decision to accept very low concentrations was made only after traces were detected.

From the "There Are No Words for This Kind of Breathtaking Idiocy" Files: "On Sunday, Sundlof said the agency had never said, nor implied, that domestic infant formula was going to be entirely free of melamine."

From the "Don't You Know Even Trees Contain Formaldehyde" Files: "We're talking about trace amounts right here, and you know there's a lot of scientific bodies out there that say low levels of melamine are always present in certain types of foods," said McBean.

Thimerosal-free flu vaccine: press the issue and you'll get it

One of the only remaining vaccines that contains thimerosal, a mercury-containing preservative, is the flu shot. The amount may be neglible, and this is arguable when you take body weight rations into consideration, but it's important to avoid even small amounts of mercury given the fact that we have been exposed to small amounts over the course of our lives. I can't speak with authority about the rest of the country, but here in the Twin Cities my son's pediatrician only uses a thimerosal-free flu shot for children. (I should state for the record that based on overwhelming replicated scientific research, I do not believe vaccines "cause" autism. However, many people disagree with me. Regardless of your position on the issue, though, getting mercury-free vaccines is something we should all be fighting for.)

However, the adult vaccine does contain the preservative. I searched high and low in Twin Cities for a thimerosal-free shot, and learned that the only thimerosal-free offering is a nasal mist, which contains the live flu virus, albeit attenuated and highly unlikely to cause the flu. I told my husband to ask the nurses about it when he got his shot. He did. The conversation went something like this:
"Do you guys have thimerosal-free flu vaccines?"
"No."
"Really?"
"No. We don't. No one does."
"Oh."
"So which do you want, the shot or the nasal mist? The nasal mist contains the live virus. The shot doesn't."
"Oh. Well, the shot I guess."

Then, a few days ago, I finally went to see about my own flu shot. Although my toddler has been vaccinated, I didn't want to run any risk of getting him sick, nor did I want to fall helplessly ill myself because I am his primary caregiver. I walked into a SuperTarget Clinic, which have popped up in some Target stores here in Minnesota. They offer flu shots on the spot. So I walk up to the desk and after filling out paperwork, including a special survey section that determines whether I can take the live virus nasal spray vaccine--don't take if pregnant, for example--the following conversation takes place with the nurse.

"The nasal spray is thimerosal-free,right?"
[Nurse doesn't even look up from her paperwork] "No."
"I thought all nasal-spray vaccines were thimerosal-free."
"No."
"Oh."

I walk back to my seat. I begin flipping through the CDC paperwork on the vaccines she handed me as a matter of course. Under Live IntraNasal Flu Vaccine, it says in bold print: "Thimerosal-Free." I show this to the nurse. She acts surprised, takes it back to a doctor for confirmation, and then I go get my flu mist. As she's preparing the mist, she tells me it's confusing, that this is a new offering, etc., etc. She then looks at my son, who is sitting in a chair in the exam room and says: "Okay, but this contains the live virus, so if you get sick, he's going to get really, really sick."

Aside from the fact that my son has already been vaccinated, the nasal spray is no more likely to cause the flu than the shot is. This is blatantly false, and a way to scare people out of getting this safer vaccine. But beyond that, I was appalled not only by the complete lack of knowledge on the part of medical professionals regarding the nasal spray--this wonderful thimerosal-free offering--but I was shocked by the blithe disregard of questions about it, the automatic "no."

If any of you are still waiting on your flu shot or are on the fence about it, please look into the nasal mist vaccine. And if you happen upon a clinic that offers both the shot and the spray, know that the spray is thimersol-free. Press the issue. Look at the paperwork. Challenge these receptionists and nurses. Many if them clearly have not gotten the memo. And the more demand for this spray, the more likely it will be widely available each flu season. Also, this thimerosal-free vaccine is available for children 24 months and older, so for people who live in areas or go to pediatricians who don't offer a thimerosal-free shot, this would be an excellent option.

Below are some links regarding this year's flu vaccine:
Information from the CDC regarding flu shot and nasal mist vaccines

FluMist website (the commercial name of the spray): there is also a great location-finder that let's you identify clinics or providers within your zip code and beyond who are offering FluMist. I did notice the list was not complete--it didn't list Target Clinics for example. But it's a good starting place.

Just a quick aside. Writer Nancy Hokkanen drew my attention to the battle in Minnesota between people who want informed consent paperwork for mercury-containing vaccines and a patient right to have a vaccine with the lowest amount of mercury possible if such a choice is available and the Minnesota Department of Health. Apparently, the MDH believes that disclosing the fact that a vaccine contains mercury will dissuade parents from having their children vaccinated. I'm sure it would. But it would be an epidemiological disaster if people stopped vaccinating their children. There has to be a middle ground--and ironically, in this case, I think the "middle ground" is legislating mercury right out of all vaccines. Patients should have a right to know what is in the shots they are receiving, children deserve to be protected from vicious diseases, and I think it should be our right as human beings to have vaccines that do not contain mercury. It's possible. The CDC needs to step up and make it happen and stop making excuses like AstraZeneca (manufacturer of FluMist) won't make enough product. We hear from the company that they end up with so many unsold doses at the end of flu season that they have to destroy them.

Whew. Off my soapbox. For now.

The Friday Cool Product Post: Belli Products

Sheepishly, I post my Friday Cool Product Post, having gone a week without posting about anything science- or consumer-related. I can only plead endless editing assignments, toddler classes, and the culmination of a short story on which I've been working for five months.

That being said, I wanted to bring your attention to Belli's Pregnancy Skincare line. These products are for women who are pregnant, want to become pregnant, are of child-bearing years, or who simply don't want parabens, Sodium Lauryl Sulfate, and phthalates in their skincare products. Many women tend to break out when they become pregnant--I, on the other hand, reveled in crystal clear skin throughout my pregnancy. It was when the hormones actually went back to "normal" that my skin started acting up.

Belli's Acne Clearing Face Wash is free from salicylic acid (a standard in most acne fash washes), using lactic acid instead. At, and I can't resist point this out for any Sherlock Holmes fans out there, a seven per cent solution. It is free of parabens, phthalates, and "fragrance."

As for whether it works: well, for me it's a bit too soon to tell. I am on my second bottle and while I haven't seen a huge difference, my skin hasn't gotten worse. It does tend to dry out the skin, but I use it in the morning and the evening. What's cool about this product, for me, is that it is safe and that it is, at the very least, not ineffective.

I recommend buying Belli products at DermStore, as they ship free.

The Friday "Cool Product" Post

On a recent trip to Target, I came across CleanWell All-Natural Hand Sanitizer and thought I'd give it a shot. As the mother of a nineteen-month-old boy whose hands are perpetually in places they shouldn't be, I was forever hauling him up to our kitchen sink and washing his hands. Tricolosan-containing hand sanitizer is out for obvious reasons (endocrine-disruptor) and the alcohol-containing sanitizers contain such a high amount of alcohol that just a single drop makes me a little tipsy.

CleanWell is an excellent alternative. It is free of Tricolosan, alcohol, "fragrance" (which is a catch-all term used by cosmetic and personal product companies for a compound typically containing phthalates), Sodium Lauryl Sulfate (SLS), parabens, and so on. In fact, its active ingredient it thyme oil (thymus vulgaris). Even though its ingredient list is sans "fragrance," the product itself smells like freshly-picked thyme.

But more important: does it work? According to lab results from an EPA- and FDA-licensed lab in Eagan, Minnesota, CleanWell hand sanitizer is remarkably effective at killing staph, e.coli, MRSA, pneumonia, and so on. "Remarkably effective" translates into 99.9% after 15 seconds.

CleanWell's backstory is fascinating. The founder's son was born with an immune system disorder; standard cleaning products were toxic, so the family began searching for alternatives. You can read about the family's story here.

CleanWell also offers a number of other safe products based on their sanitizing formula, including hand wipes (yes!). Sold individually at Target, the sanitizers are comparably priced to Purell and other major brands; but you can get a real deal if you order their six pack online.

NBC picks up story on Carter's rashes--including class action lawsuit

The NBC affiliate out of Los Angeles has done a follow-up on an earlier investigation of the Carter's tag problem, and interviews Ava's mom, Janet Kunze. The law firm of Emerson Poynter has initiated a class action lawsuit against Carter's because the clothing company has refused to recall the Fall 2007 line, relying instead on a warning that appeared on its website and which was issued in conjunction with the CPSC.

Janet is not a party to this lawsuit (typically, settlements that arise out of such lawsuits require that the parties not talk publicly about the subject of the lawsuit, and Janet didn't want to be unable to discuss this issue with other potentially affected parents).

In other (good) news...

Getting away from the tired Dura Supreme/formaldehyde-in-cabinetry back and forth, I have some good news to report. The BPA advisory panel convened by the FDA has reported that the agency's scientific assessment of the dangers of BPA in regards to human consumption was flawed. The Science Board convened last week to discuss the panel's findings, which included a scathing 17-page review that called the FDA's conclusions on BPA "flawed"--singling out, in particular, the fact that the agency chose to consider only two industry-funded studies showing the chemical to be safe in current dosage guidelines and disregarding more than 200 independent research papers showing the opposite.

More, the FDA is likely going to open the floor to public comments about whether the compound should be taken out of food and beverage containers entirely. From Time Magazine:

But 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 Protection Agency scientist: "Unless the evidence is very compelling, you don't get such a strong statement from a group of scientists."

Be Your Own Attorney General, or: Long Live the "Irrational Consumer"!

For some reason, my old Dura Supreme postings have been making the rounds at Dura Supreme itself as well as other traditional cabinet companies (i.e. those who utilize formaldehyde-containing particleboard and plywood), and I've been receiving comments and e-mails from employees of those companies that are more and more vitriolic. I'm not worried about that--I've been through this kind of thing before, particularly after my reporting on Exxon. Dura Supreme is no Exxon, but the response has been similar. I continue to post these comments and respond to them, but I've noticed a common thread in them that I wanted to talk about. Blaming the consumer.

It was, apparently, my fault as a consumer for not knowing whether, despite claims to environmental responsibility--the KCMA label--Dura Supreme utilized formaldehyde-free plywood or particleboard. It was my fault that I didn't understand that the term "green" is "subjective", according to one industry commenter on the blog, and that a company may claim that mantle without doing anything to deserve it. It was my job to investigate, make calls, pin someone down and demand an honest answer about the parts per million in the adhesive (hard to do when Dura Supreme doesn't respond to formal inquiries, only sends its employees out in droves to post anonymous comments on blogs).

As I've mentioned before, I've only recently had the interest and, as a new mom, the time to research on topics like green construction. When I encountered this problem, I was like many consumers--I thought when a cabinetmaker touted an environmentally-friendly certification, like Dura Supreme did, that they wouldn't have the audacity to claim that while using formaldehyde-containing products. I was protecting my family from a known carcinogen that has been linked to a wide variety of maladies, including asthma and nasal cancer. I also relied on my contractor, who is currently taking courses in green construction, to vet these products for me, and even he was blindsided. Not a good sign for the cabinetmakers.

I think the comments on the Dura Supreme postings are instructive for any consumer, particularly those in the market for cabinets. There you'll find a sampling of the ethos under which many, but not all, of these companies operate under. They believe it is up to the consumer to weed through their claims and determine for themselves if a product can live up to those claims. If you don't "do your research", it's your fault. Don't go by the sales material. Don't go by the KCMA labels (see the comment someone left under Letter to Dura Supreme about the outrageous sham that is KCMA). Just assume the companies are lying. Be your own Attorney General. This is from the mouths of the company employees themselves.

I posted about this today because while this kind of reaction is par for the course for the kind of work I do, everyday consumers--the ones who visit my blog so they don't have to spend the time to do all the research--shouldn't have to deal with this. Even Carter's, which has, in my opinion, not done the right thing in not recalling the onesies causing rashes, has not attacked its customers for complaining and has even tried to make things right in some cases. The way a company and its employees react to dissatisfied customers is very telling, and it has been the way Dura Supreme has reacted--by refusing to acknowledge my letter but instead letting its employees post angry comments on my blog anonymously (my visitor counter allows me to see the domain/IP address under which commenters post). Is this the kind of company you want to do business with, even if you don't care about whether the product containins formaldehyde or not? Take my Dura Supreme experience as a cautionary tale, one that is representative of the experience of many normal consumers who don't have a blog about the toxicity of everyday products.

Oh, and I can't let this go uncommented upon. I was accused, too, of being a skilled writer whose ability to string words together obscured the lack of merit in my complaint. In addition, my complaints were "irrational." I couldn't help but laugh out loud when I read that accusation. Thanks for the first compliment; and as for the accusation of irrationality? Heard it before from other companies whose work I've questioned. I take it as a compliment, too. Coming from a company under attack, such an accusation means I'm doing my job.

In the meantime, here is a list of companies offered formaldehyde-free cabinetry (MDF, Plywood, or sustainably harvested hardwood). Long live the Irrational Consumer:

Charles R. Bailey Cabinetmakers
Breathe Easy Cabinetry
Neil Kelly Cabinets--ask about their melamine use, though.
Executive Kitchens

Kind of annoying

I visited Catalog Choice today to enter some new catalogs into my database of "refused catalogs." For those of you who don't know, Catalog Choice is an organization that works with retailers to reduce the amount of needless catalogs sent through the mail, thereby reducing waste, carbon emissions, etc. The other great thing about the organization is that it gives consumers an easy way to opt-out of catalogs they never wished to receive in the first place, and keep track of their requests.

I've been trying to get off Harry and David's mailing list for more than a year. Today I visited my choices on Catalog Choice and saw that the company has now officially refused to honor opt-out requests processed by Catalog Choice. I found this rather insulting. I previously had nothing against Harry and David, besides the ridiculous amount of catalogs I receive from them. But I find this idiotic. I e-mailed Harry and David's customer service to ask them to remove my name, and added a little "consumer note."

Hello,
I somehow got on your mailing list and through Catalog Choice, the organization devoted to reducing catalog waste and helping the environment, I requested that my name be removed. Today I learn that Harry and David refuses to work with Catalog Choice.

Please remove my name from your list at once. I would also like you to know that because you refuse to honor requests for name removal through Catalog Choice, I will never even consider ordering from your company again. In fact, I would hazard a guess that I will not be the only one, dismayed by your company's refusal to honor requests from people who do not want to be on your mailing list for environmental reasons, who will choose not to patronize your company ever again.

Ashley Shelby

I'm working on gathering a list of companies that refuse to honor opt-out requests from Catalog Choice. In the meantime, here is a short list of companies that have honored my requests through Catalog Choice--i.e. they told Catalog Choice they'd honor and I've actually stopped receiving catalogs. I am more likely to buy from them knowing that they honor consumer requests to opt-out:

Williams-Sonoma
Bliss
L.L. Bean
Land of Nod
Pottery Barn
Tiffany