The Food and Drug Administration & Cosmetics

I’m speaking at The Divine Female, an event from yogitoes and The Yoga Beauty Bar for conscious beauty and breast cancer awareness, on Saturday at 11:30 a.m. about deciphering beauty ingredients.  I was talking to my mom about it, and she espoused a view held by many – that the Food & Drug Administration (FDA) makes sure the beauty products we use are safe.

But that assumption is false.  In fact, despite the fact that most of us believe the FDA looks out for  us, when it comes to cosmetics, it really doesn’t. So I thought I would discuss a bit of background about the FDA.

The FDA is responsible for over-the-counter and prescription drugs and medical devices, biologics, food (except for meat, poultry, egg products, and the labeling of alcoholic beverages and tobacco) and food additives, radiological products, and cosmetics.  How the FDA oversees personal care products is the most relevant generally to this blog.

The FDA’s authority over cosmetics is relatively limited.  As explained on the FDA’s website, “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices.”  FDA does not approve cosmetics ingredients before they are placed on the market, with the exception of certain color additives and a few substances are banned from cosmetics.  In fact, the FDA explains

“[i]n general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.”

The list of prohibited or restricted ingredients is amazingly short.  In comparison, the European Union list of prohibited or restricted chemicals is over 1,100 chemicals, although some of the chemicals would never be found in cosmetics.

Who determines whether a cosmetic is safe?  As explained on the FDA’s website, “[c]osmetic firms are responsible for substantiating the safety of their products and ingredients before marketing,” and not the FDA.  In other words, no independent agency determines whether a product is safe.  In fact, the FDA doesn’t even define the criteria.  While the regulations provide that each ingredient must be adequately substantiated for safety prior to marketing, the FDA doesn’t provide clear guidance as to the meaning of “adequately substantiated” or “safety” for cosmetics.  If cosmetic companies don’t adequately substance a cosmetic product’s safety before marketing it, they are required to include on the label the following statement:  “Warning – The safety of this product has not been determined.”  But if there are no definitions or guidance, how does a company even determine whether a product complies?  In fact, the Environmental Working Group (“EWG”) states that it reviewed more than 20,000 cosmetic product labels and did not find a single one with the statement.  I’ve never seen such a statement either.

Of course, this doesn’t mean that cosmetics are inherently unsafe.  But, at least one study concluded that approximately 89% of the ingredients routinely used in cosmetics have not been assessed by the FDA or the industry.  According to the EWG, 98% of all personal care products contain one or more ingredients never publicly assessed for safety.

Who does review cosmetics ingredients?  The companies manufacturing beauty products may privately conduct their own assessments.  The cosmetics industry also relies upon the Cosmetic Ingredient Review (“CIR”).  The CIR was created by the cosmetic industry trade group to police the industry.  The CIR is funded by the member companies of the Cosmetic, Toiletry and Fragrance Association and its recommendations regarding safety are just that, recommendations, not requirements, and can be ignored.  Also, the CIR’s focus is whether a cosmetic ingredient causes irritation or allergic reactions, not carcinogenicity or reproductive or developmental toxicity.  For an illuminating discussion of the CIR and the cosmetics industry, I highly recommend Stacy Malkan’s book, Not Just a Pretty Face: The Ugly Side of the Beauty Industry.

Not only does the FDA have no authority to approve cosmetics ingredients before products hit the market, the FDA is not authorized to require recalls of cosmetics.

The FDA is also responsible for food contact substances.  FDA’s regulation of food contact substances is also relevant to this blog (think BPA for example).  Food contact substances are those items that are not directly added to food, but are in contact with food, such as packaging materials.  If a new food contact substance is proposed, or a new use of an existing food contact substance is proposed, a manufacturer must give the FDA notice of it unless there are existing regulation related to the used or the substance or use is considered “Generally Recognized as Safe” (or “GRAS”).

This voluntary GRAS notification program was proposed in 1997.  In 1997, the FDA abolished its existing procedure by which it approved petitions to designate substances because the FDA did not have the resources to review and approve the petitions.  Under the GRAS notification process, a manufacturer informs the FDA that it has determined that a substance or use is GRAS, as opposed to petitioning the FDA to approve the use or a substance is GRAS.  As explained by the FDA, if the manufacturer’s determination is correct, the use or the substance is not subject to any legal requirement for FDA review and approval.  In fact, since the GRAS notification process is voluntary, a manufacturer may market the substance or use without informing FDA if the manufacturer determines it is GRAS or, if FDA is so informed, while FDA is reviewing that information.  Sounds crazy, doesn’t it?  As long as a manufacturer determines the food contact substance or use is GRAS, it can go ahead and market it.

What is “safe” for these regulations?  According to the implementing regulations, the term “safe” means “that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.  It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance.  Safety may be determined by scientific procedures or by general recognition of safety.”

So how does this voluntary GRAS notification process work?  Let’s look at one potentially relevant example.  If you’ve used or are using formula, you probably know  some manufacturers supplement their infant formula with DHA and ARA.  But, some manufacturers use DHA and ARA extracted from laboratory-grown fermented algae and fungus and processed with hexane, known as DHASCO and ARASCO, although not identified as such on the list of ingredients.  DHASCO and ARASCO are structurally different from the DHA and ARA found in breast milk.  The manufacturer of DHASCO and ARASCO submitted a notice to the FDA stating that DHASCO and ARASCO added to infant formula are GRAS.  The FDA responded to the notice that it had no further questions.  DHASCO and ARASCO are currently marketed in infant formula.  But, the FDA and the manufacturer recognize that some infants have adverse reactions from consuming infant formula with DHASCO and ARASCO such as diarrhea, bloating, vomiting, jaundice, apnea, flatulence, and other gastrointestinal problems.  Nevertheless, the manufacturer maintains they are GRAS, so the manufacturer is free to market them.  And these infant formula products are not labeled to indicate the presence of DHASCO and ARASCO (as opposed to DHA and ARA), so you can’t tell when buying formula.

So that is a bit about the FDA. More information to come on deciphering beauty ingredients.

 

FDA Changes Course – Now Believes Bisphenol A (BPA) Poses Safety Concern

Well, after years of contending that bisphenol A (BPA) is perfectly safe, the Food and Drug Administration has reversed course. On Friday, the FDA announced that it now considers BPA to be of some concern for effects on the brain, behavior and prostrate glands of fetuses, infants and young children (consistent with the National Toxicology Program’s findings). 

But, even though the FDA now has some concern about BPA’s safety, it claims it can’t do anything. The Milwaukee Wisconsin Journal Sentinel reports that top FDA officials say that while BPA’s safety is uncertain, they are powerless to regulate it. Why? Because it is listed among some 3,000 chemicals that are “generally regarded as safe” and that designation exempts those chemicals from scrutiny.

As the FDA explains:

Current BPA food contact uses were approved under food additive regulations issued more than 40 years ago.  This regulatory structure limits the oversight and flexibility of FDA.  Once a food additive is approved, any manufacturer of food or food packaging may use the food additive in accordance with the regulation.  There is no requirement to notify FDA of that use. For example, today there exist hundreds of different formulations for BPA-containing epoxy linings, which have varying characteristics.  As currently regulated, manufacturers are not required to disclose to FDA the existence or nature of these formulations.  Furthermore, if FDA were to decide to revoke one or more approved uses, FDA would need to undertake what could be a lengthy process of rulemaking to accomplish this goal.

So, FDA is going to study BPA some more. And it is looking for some legislative help so that it can regulate BPA, at least according to the officials quoted by the Milwaukee Sentinel. But that doesn’t help the rest of us very much if we are looking for ways to avoid BPA exposure, particularly if you are pregnant, or have young children.

And it isn’t very satisfying that at this late date, more than 10 years after leading scientists questioned BPA’s safety, that the FDA is reaching this decision but taking the position it can’t do anything. More stalling at the behest of the chemical industry?

The American Chemistry Council continues to proclaim that BPA is perfectly safe, because, as the ACC always says, BPA has not been proven harmful to children or adults. The FDA held a conference call on Friday for some media to discuss BPA. And while I was not invited, I avidly followed one of the journalists who was tweeting the call. And she kept tweeting statements of the ACC representative about how safe BPA was and how all the studies were flawed because they failed to account for human metabolization of BPA. When I tweeted at her to ask about the fact that infants under 3 months lack the full complement of enzymes necessary to metabolize BPA (and fetuses have none), the ACC representative completely dismissed the scientific studies. If you don’t know who the ACC is, it is an organization whose members include Monsanto, Bayer, Merck, DuPont and many others. And the FDA has been accused of being too cozy with the chemical industry lobbyists, including the chair of the FDA panel taking a $5 million donation.

And to be honest, the FDA’s reversal really annoys the heck out of me after FDA Acting Commissioner Andrew C. von Eschenbach, MD’s article, Andy’s Take on BPA from August of 2008. In his article, he stated that “with progress comes peril!” He then argued that “science creates these products and science must inform us of their risks.” So, he contended that until science showed us that BPA was unsafe, we should assume that it is safe. Which seemed like a bunch of bunk to me. If you believe that “with progress comes peril”, then it seems to me that you would take a cautious approach, and instead have science inform us that a chemical was safe before it was used.

So what can you do if you want to avoid BPA? Well, skip polycarbonate plastic and avoid canned foods and beverages. And you really might want to, particularly if you are pregnant. In a non-scientific CBS Early Show experiment, Kelly Wallace ate a sandwich made from canned tuna, and had her blood drawn. She then spent 2 days avoiding BPA, and had her blood drawn again. The first set of blood samples showed a BPA level five times higher than what is found in the average US woman. 

To avoid canned foods and beverages, go for fresh, frozen, dried or jarred in glass or a plastic other than polycarconate. Polycarbonate is in the #7 “other plastic” group. Not all #7 plastic is polycarbonate, however. If you need BPA free feeding gear for kids and babies, check out my dear friend’s website, The Soft Landing. If you need a guide, check out Z Recommends’ The ZRecs Guide for advice on BPA-free children’s products.

FDA, GRAS and what does algae, fungus & hexane have to do with baby formula

babyThe Food and Drug Administration (FDA) regulates infant formula. All infant formulas marketed in the United States must meet the FDA’s nutrient specifications (although some child health advocates contend that the nutrition requirements are out of date). In any event, what this means is that while infant formula manufacturers may have their own formulation, at a minimum, formula must contain at least the minimum levels of nutrients specified, without exceeding any maximum levels.  Although manufacturers must notify the FDA prior to marketing a new formula, the FDA does not approve infant formulas before they can be marketed.

So what does this have to do with algae and fungus?

To explain that, let me first explain how the FDA regulates food contact substances. Food contact substances are those items that are not directly added to food, but are in contact with food, such as packaging materials.  If a new food contact substance is proposed, or a new use of an existing food contact substance is proposed, a manufacturer must give the FDA notice of it unless there are existing regulation related to the used or the substance or use is considered “Generally Recognized as Safe” (or “GRAS”).

This voluntary GRAS notification program was proposed in 1997.  In 1997, the FDA abolished its existing procedure by which it approved petitions to designate substances because the FDA did not have the resources to review and approve the petitions.  Under the GRAS notification process, a manufacturer informs the FDA that it has determined that a substance or use is GRAS, as opposed to petitioning the FDA to approve the use or a substance is GRAS.  As explained by the FDA, if the manufacturer’s determination is correct, the use or the substance is not subject to any legal requirement for FDA review and approval.  In fact, since the GRAS notification process is voluntary, a manufacturer may market the substance or use without informing FDA if the manufacturer determines it is GRAS or, if FDA is so informed, while FDA is reviewing that information.  Sounds crazy, doesn’t it?  As long as a manufacturer determines the food contact substance or use is GRAS, it can go ahead and market it.

What is “safe” for these regulations?  According to the implementing regulations, the term “safe” means “that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.  It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance.  Safety may be determined by scientific procedures or by general recognition of safety.”

So how does this voluntary GRAS notification process work?  Well, this is where infant formula comes in.

If you’ve used or are using formula, you probably know some manufacturers supplement their infant formula with DHA and ARA.  But, some manufacturers use DHA and ARA extracted from laboratory-grown fermented algae and fungus and processed with hexane, known as DHASCO and ARASCO, although not identified as such on the list of ingredients.

DHASCO and ARASCO are structurally different from the DHA and ARA found in breast milk, which doesn’t necessarily mean that they cause problems. The manufacturer of DHASCO and ARASCO submitted a notice to the FDA stating that DHASCO and ARASCO added to infant formula are GRAS. The FDA responded to the notice that it had no further questions. But, the FDA and the manufacturer recognize that some infants have adverse reactions from consuming infant formula with DHASCO and ARASCO such as diarrhea, bloating, vomiting, jaundice, apnea, flatulence, and other gastrointestinal problems. Nevertheless, the manufacturer maintains they are GRAS, so the manufacturer is free to market them. And these infant formula products are not labeled to indicate the presence of DHASCO and ARASCO (as opposed to DHA and ARA), so you can’t tell when buying formula.

So, if your baby experiences problems with formula, it may not be an allergy but a reaction to the DHASCO and/or ARASCO, but you can’t even tell by looking at the formula label.

And the GRAS program doesn’t really seem to determine safety.

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Emails Show FDA Was Very Cozy With Lobbyists on Bisphenol A

bottle feeding babyIt is so disappointing to learn that yes, the US Food and Drug Administration (FDA) really has not done its job when it comes to bisphenol A (BPA). BPA is a hormone disruptor and has been linked to other health effects. We find it in polycarbonate plastic and the linings of canned foods and beverages. (Need more of a refresher on BPA – I’ve got one.)  

If you haven’t followed BPA over the last year or so, the FDA maintains that BPA is safe, even though an independent board, the FDA’s Science Advisory Board, soundly and completely renounced the FDA’s determination. Separately, the National Toxicology Program (NTP) found “some concern” (a 3 on its 5 point scale) for certain health endpoints for fetuses, infants and children at current BPA exposure levels. And, since those reports, additional research has been published reporting concerns with BPA, including male monkeys exposed to BPA prenatally acting more like females and that BPA slows the transition of tadpoles into frogs. 

Also, this week, researchers found that drinking cold liquids out of polycarbonate plastic bottles (the type of plastic that leaches BPA) increases BPA in the body.  Specifically, Harvard University researchers and the US Centers for Disease Control and Prevention found a 70% increase in the amount of BPA detected in the urine of college students who drank from plastic bottles made with BPA. The students drank from stainless for one week (to clean them out) and then out of polycarbonate plastic for a week. And in only one week, BPA concentrations rose dramaticallly.  

And yet, the FDA maintains BPA is safe. But FDA has apparently sold out completely. I previously questioned whether science was for sale in the context of FDA and BPA when the chair received a $5 million donation for his research foundation. But the level of coziness between the FDA and lobbyists reported by the Journal Sentinel indicates that the FDA has no interest whatsoever in protecting our most vulnerable population, our babies. 

The Milwaukee Journal Sentinel reviewed documents provided pursuant to a Freedom of Information Act (FOIA) request. It reports that those documents clearly demonstrate that the FDA relied on industry lobbyists to review scientific research. As an example, the Journal Sentinel:

 In one instance, the U.S. Food and Drug Administration’s deputy director sought information from the BPA industry’s chief lobbyist to discredit a Japanese study that found it caused miscarriages in workers who were exposed to it. This was before government scientists even had a chance to review the study.

 ‘I’d like to get information together that our chemists could look at to determine if there are problems with that data in advance of possibly reviewing the study,”‘Mitchell Cheeseman, deputy director of the FDA’s center for food safety and applied nutrition, said in an e-mail seeking advice from Steven Hentges, executive director of the trade association’s BPA group.”

 The reported communications are disturbing, especially since the review of scientific reports by governmental agencies should be free of this sort of coziness and influence. I recognize that politics, unfortunately, plays a role in our government agencies, but this amount of influence is disgusting. And it was just the industry lobbyists. The Journal Sentinel reports that non-industry lobbyists were not given the same sort of access, confirming this by reviewing the communications and talking to various individuals and groups.

 

The communications go on. The Journal Sentinel reports as follows: 

In other e-mails, trade lobbyists notified FDA officials about upcoming news reports on BPA and advised them how to respond. 

“Laura and Mitch,” Hentges wrote in an e-mail to FDA administrators. “I send this note to give you a head’s up on something we understand is coming next week.” 

The item was a report from the Environmental Working Group, an activist organization working to ban BPA. 

“At this time we have no information on what information they will report or how it will be publicized,” Hentges wrote. “However, we can anticipate that it will be widely publicized as a serious food safety issue. If correct, it might be appropriate for FDA to consider issuing a statement to reassure consumers about the safety of the food supply.” 

You may recall that yes, indeed, the FDA issued a statement concerning the safety of the food supply and BPA. 

So, what do you think? Do you think this is too cozy?

Oh, don’t worry, you’re just a mommy blogger & just a little bit of a carcinogen is okay

circle of kidsYes, I’m a “mommy blogger.” Yes, I try to practice a green lifestyle.  Yes, I choose to buy products without certain ingredients in an effort to provide a safer lifestyle for my kids.  I choose the alternatives.  I sort of think that it makes sense to be safe instead of sorry, especially when alternatives are available at pretty much the same price point.  And I’d rather give my money to a company doing the Earth some good.

That does not make me a hysterical mommy blogger.  That does not make me stupid. 

I understand the dose response relationship.  Yes, I’m well aware that traditional toxicology is founded on the principle the dose makes the poison, as I am also aware that the current school of toxicology thought is the dose and the timing make the poison.  Yes, I get it. 

A representative from the Formaldehyde Council has been making the rounds commenting on our various blog posts suggesting that we don’t know what we are talking about. There are also some twitterers who also respond to our tweets suggesting that we just don’t get the science. We are mommy bloggers. 

Hey, paid PR people (as we have discovered they are), do you get the science? And, by the way, do you understand that my children don’t use just one product?  That we have sources of formaldehyde and dioxane elsewhere in our lives?  That the cumulative exposure to certain chemicals, and how they may work together, might make the exposure and risk more significant?  

And, by the way, if you are bathing your child, and you have the option of a product with and one without 1,4 dioxane at the same price and the same effectiveness, are you really going to tell me you would pick the product with 1,4 dioxane in it? 

Or will you not drink the chromium tainted water either? (Reference to Erin Brokovich if you don’t get it.) 

What the heck am I talking about? 

green moms carnival logoThe Green Moms Carnival this month blogged about 1,4 dioxane, formaldehyde and other problemmatic ingredients in baby bath products.  You really should go check out Sommer at Green & Clean Mom who hosted this carnival. 

Why did we tackle this topic?  Because, a couple of weeks ago, the Environmental Working Group released a report (No More Toxic Tub) that looked at the concentrations of two carcinogens, 1,4-dioxane and formaldehyde, in baby bath products.  The information that these compounds are present in personal care products isn’t new (I’ve posted before about their presence in so called natural personal care products and litigation in California), but the focus on concentrations in baby bath products was new.  At the same time, in a case of bad timing, at least to the members of the Green Moms Carnival, Johnson & Johnson announced a new social media campaign using mommy bloggers to talk about its baby bath products and launched a video campaign using children bathing, with the top video being awarded $10,000. 

I called out the spokesperson, Angie Harmon, and Johnson & Johnson for purporting to be green yet continuing to use petroleum based ingredients containing carcinogens in non recycled content bottles.  And the other Green Moms were upset too, each with a different take on the issue.  Let me be clear – we understand that the EWG’s report does not purport to assess whether exposure actually occurs or whether that exposure would result in a health effect. 

Some of the commenters, particularly a representative of The Formaldehyde Council, keep saying that it is just a little bit, nothing to worry about.  Okay, that may be true – but I really don’t care.  I worry about the cumulative risk of exposure.  My kid will not just get 1,4 dioxane from one product, but from several products, plus other sources.  In fact, my kids get exposed to all sorts of chemicals, manmade & naturally occuring.  (Yes, I understand that carcinogens naturally occur in certain foods. You don’t need to tell me.)  So, if I can, I will use my money to support the company that can make the product without those potentially harmful ingredients. 

And. to be frank, everybody said that lead in paint was safe for YEARS.  Think about it – the first reported health effects linked to lead paint were in 1904.  Yet, in the 1940’s, after France and England and even Cuba had banned lead in residential paint, the US paint industry was still telling us lead in paint was safe.  We didn’t even get around to limiting lead in consumer paints and painted products until the 1970s. 

Alice Hamilton was called hysterical, yet her work helped protect countless workers.    

Everybody said that lead in gasoline didn’t really contribute to children’s blood lead levels.  Yet, banning lead as a gasoline additive has resulted in a dramatic drop in children’s blood lead levels (along with the limit on lead in certain consumer paints). 

DES was supposed to be safe.  So were PCBs.  As was DDT.  Now we have flame retardants, phthalates, triclosan and more that are being called into question. 

Do you see a pattern here?  We don’t always know what is safe or not, sometimes hazards pop up long after a compound is deemed safe.  (DES anybody?) We don’t always know what will harm our environment or not.  Unintended consequences often happen.  Synthetic chemicals persist in the environment, or react with other compounds, causing problems down the road.  (Yes, we still find PCBs and DDT in our homes and our bodies, including newborn cord blood, 30 years after they were banned.)  

So for me – I pick the products without those potentially harmful or questionable ingredients when I have a choice. 

And what do we use?  I love Earth Mama Angel Baby products.  California Baby is great too.  We use a lot of inexpensive plain liquid castile soap too – cheaper than almost every single conventional product on the market.  There are lots of wonderful products out there without phthalates, 1,4 dioxane or formaldehyde.  And most of those companies use less packaging, use recycled content packaging, steer clear of using any non renewable resource, etc.  I’d rather use my money for those products because, well, my children deserve it.  And so does the Earth.

FDA Changes Its Mind & Sets Limit for Melamine in Infant Formula After Found in Some Baby Formulas

baby drinking bottleDespite saying just over a month ago that it couldn’t set a safe level for melamine in infant formula, US Food and Drug Administration (FDA) has changed its mind.  And it seems like a rush to judgment.  I’m not trying to scare any parents – the melamine levels found in US infant formula are very, very low.  But, I’m concerned by an agency that doesn’t seem to use science for decision making (bisphenol A anyone?), although I’m hoping that this will soon change come January.


So why am I critical of the FDA’s decision?  In the FDA’s October 3, 2008 statement, the FDA stated that “the US FDA cannot establish a level of melamine and its analogues in [infant formula] that does not raise public health concerns.”  Yes, despite no new studies since its statement on October 3, 2008, the FDA has now issued a safe level for melamine in infant formula.  The FDA said it couldn’t establish a safe melamine level because of “several significant gaps” in its scientific knowlege about melamine, including the impact of the presence of more than one melamine analogue, the consequences of continuous use of infant formulas as the sole source of nutrition and the possibility that infant formulas can be the sole source of nutrition for premature infants with immature kidney function.


No new research studies have addressed these concerns.  But, suddenly, the FDA has figured it all out and set a safe level.  Why was the FDA compelled to do this?  What’s changed?  Well, the FDA has found low levels of melamine and cyanuric acid in some US infant formulas.  And it hasn’t completed its testing.  It has only tested 74 samples, yet the FDA is ready to assure us that the US infant formula supply is safe.  If you want to read the test results so far, check out the list.  The FDA has found, so far, melamine present at 0.137 ppm and 0.140 ppm in Good Start Supreme Infant Formula with Iron from Nestle and cyanuric acid present in Mead Johnson’s Infant Formula Powder, Enfamil Lipil with Iron, in the 12.9 oz can at 0.247, 0.245 and 0.249 ppm.  None of the 74 samples tested so far have both melamine and cyanuric acid present, which is when you get problems.  But, as Urvashi Rangan, a senior scientist with the Consumers Union in New York says, the FDA “just haven’t tested enough to know [the scope of the problem] yet.”


Also, the third major formula maker, Abbott Laboratories, announced that it found traces of melamine in its infant formulas, which include the Similac brand.


Now, these levels are not from melamine being added to the formula to fool quality control checks.  The melamine found in China milk products was intentionally added because, like protein, is rich in nitrogen.  So, if inspectors are checking to see if dilution has occurred, they will measure nitrogen content.  Adding melamine will fool this test.  That’s the basis of the problem in China, and the levels in the US are well below the levels found in Chinese milk products that sickened so many babies and killed at least 4.


With the US infant formula, the presence of melamine appears to be a result contact during processing, not intentional addition, which is prohibited in the US.  Melamine is used in the  manufacturing of dishes, plastic resins, flame-retardant fibers, components of paper and paperboard and industrial compounds.  So, melamine may come from rubbing off from these surfaces.  Also, trichloromelamine is approved as a sanitizer for food processing equipment and utensils, except for milk containers and equipment.  Trichloromelamine easily breaks down into melamine when it is used as a sanitizer.  This could also be a source.


Of course, needing to reassure us of the safety of the food supply, the FDA set a supposedly “safe” level of melamine in infant formulas.  FDA has concluded that melamine alone or cyanuric acid alone at or below 1 part per million (ppm) is safe.  The levels found in the US infant formula are below this safe level.  According to Dr. Stephen Sundlof, FDA’s Director of Food Safety, dangerous health effects occur only if both melamine and cyanuric acid are present. 


Taking a look at how the FDA established this new standard, it hasn’t addressed the questions that it raised.  Instead, it has applied some safety factors to derive the standard, using a 6.6 pound infant that eats 0.3 pounds infant formula per day.  The safety factor is suppose to take into account differences, but the analysis doesn’t really evaluate premature infants with immature kidney function.  It also doesn’t take into account other potential melamine exposure situations.  So, it seems just a bit odd that the FDA decided now to set a standard.  And Dr. Sundlof has no explanation for why the standard wasn’t set earlier.


John Dyer, FDA’s Deputy Commissioner for Operations and Chief Operating Officer believes that “FDA has worked hard to ensrue the safety of [our] food this Thanksgiving.”  I’m not sure I agree Mr. Dyer.  I’m not impressed by the FDA’s actions with respect to bisphenol A or melamine, because, well, it seems that the FDA doesn’t always follow the science.

But, again, for those parents using formula, the levels found in US formula so far are WELL BELOW those levels found in Chinese infant formula.  I’m not saying that there is a problem – there isn’t enough evidence as yet.  What I am critical of is FDA’s decision making that isn’t based on science, and its quick change from its October position of accepting no melamine in infant formula without new scientific support.

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FDA Subcommitee Harshly Critical of Draft Safety Report on Bisphenol A (BPA)

babyI recently expressed concern about whether the Food and Drug Administration’s (FDA) Subcommitee reviewing the FDA’s draft safety assessment of the use of bisphenol A (BPA) could provide a fair review.  I expressed concern because it had been revealed that Subcommittee Chairman Prof. Philbert had failed to disclose a significant donation from pro-plastics contributor Charles Gelman to the chairman’s research center at the Univ. of Michigan.  To resolve that question, the FDA Chair has issued a letter stating that he agrees with the findings of the review conducted by William McConagh a of FDA’s Office of Accountability and Integrity.  That review found that the $5,000,000 donation made by Charles Gelman and the unrestricted grant to the University of Michigan from Dow Chemical for a risk study of dioxin do not require Prof. Philbert to recuse himself but he nevertheless recommends that Prof. Philbert refrain from voting on the questions before the Board relating to BPA.


In any event, imagine my surprise to learn that the Subcommittee’s scientific peer-review report roundly criticizes the FDA’s draft BPA safety assessment.  So perhaps science isn’t for sale after all, at least with respect to the Subcommitee.


Okay, to catch you up, low level exposure to BPA has been linked to hormone disrupting effects in laboratory animals.  BPA is the key monomer of polycarbonate plastic, used for baby bottles.  BPA is also found in the epoxy resins used to line virtually all canned foods and beverages.  BPA can leach out of polycarbonate plastic and the epoxy resins and into your food.  Whether the effects seen in laboratory animals are likely to occur in humans based upon current levels of exposure is subject to much intense debate in the scientific community.  The National Toxicology Program (NTP) issued a report finding the risk a 3 on the NTP’s 5 point scale for 3 health endpoints.  The FDA has maintained that BPA is safe.


In August of this year, the FDA issued a draft report finding BPA safe.  Then, the FDA convenened a Subcommitee to review the draft report.  I thought that the Subcommitee would be, in essence a rubber stamp.


But surprise, surprise, the FDA’s Subcommitee does not agree with the draft safety assessment on BPA.  In fact, it is pretty critical of it.  It finds that the “draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment.  Specifically, the Subcommittee does not agree that the large number of non-GLP [good laboratory practice] studies should be excluded from use in the safety assessment.”  The report goes on to state “[c]oupling together the available qualitative and quantitative information (including the application of uncertainty factors) provides a sufficient scientific basis to conclude that the Margins of Sfatey defined by the FDA as ‘adequate’ are, in fact, inadequate.”


Okay, so what does that mean?


Well, what it means is that the peer reviewed assessment of the FDA’s draft report on BPA is telling the FDA that the draft report is inadequate.  The Subcommitee has particular criticisms – it finds that the FDA didn’t use enough infant formula samples and didn’t adequately account of variations among the samples.  It also finds that the FDA didn’t take into account multiple sources of BPA exposure.  But it also is particularly critical of the FDA’s wholesale discounting of studies found adequate by the NTP.  And, I think that this is most important.  The Subcommittee harshly criticizes the FDA for discounting or failing to consider scores of studies that have linked BPA to adverse health effects in animals.


Is the debate over?  No.  The Subcommitee’s report will be considered as part of a briefing on October 31, 2008.  What is likely is that more research will be approved.  And, in the interim, the FDA has issued a Statement on the release of the Subcommitee’s report, pointing out that “the present consensus among regulatory agenices in the United Sates, Canada, Europe and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.”


In light of the animal studies and the conclusion from the NTP finding “some” concern for effects on the prostate, brain and behavior, you may not want to take that risk.  So, if you want to try to avoid BPA, skip polycarbonate plastic.  Lots of alternatives exist – and don’t cost any more than polycarbonate plastic.  So you can play it safe.  Also, instead of canned foods and beverages, go for jarred, fresh, frozen or dried.

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The FDA and Bisphenol A in Baby Bottles – Science for Sale

Baby bottleAnd so the bisphenol A (BPA) debate goes on.  Is science for sale?  It seems more and more like it is.


The House Energy and Commerce Committee has sent a letter to the Food and Drug Administration questioning whether the FDA has been unduly influenced by the plastic industry in its continued assertion that BPA is safe.  The letter follows the news that the research center of the chairman of the FDA’s BPA advisory panel received a $5 million donation from a retired medical device manufacturer that believes BPA is “perfectly safe.”  The $5 million donation from Charles Gerlman occurred in July, the same month that chairman Martin Philbert was appointed to chair the FDA’s BPA subcommittee.  Philbert did not disclose to the FDA the donation to the institute that he founded and co-directs.  Prior to the donation, the institute’s annual budget was $210,000.  And who says that science isn’t for sale? 


The Oversight and Investigations Subcommittee of the House Energy and Commerce Committee sent the letter on October 15, 2008 and the response is due by October 29, 2008.  I’m curious how the FDA will respond, although I’m not holding my breath because the CPSC still hasn’t responded to the letter sent by the same committee on BPA in April.


The subcommittee that Philbert chairs will decide if the conclusions in the FDA’s draft report need to be amended.  That report found BPA safe, despite the report from the NTP finding “some concern” (a 3 on the 5 point scale) for certain health endpoints – effects on the prostate gland and brain, and for behavioral effects in fetuses, infants and children.  But the FDA’s draft report has been subject to much scrutiny.  And, the Milwaukee Journal Sentinel also reported yesterday that the draft FDA report finding BPA safe was largely written by those with a financial stake in the decision – the plastics industry and others.


According to the Milwaukee Journal Sentinel:



The newspaper reviewed the body of evidence that the task force considered. It found memos with entire sections blacked out, reviews commissioned by the American Plastics Council, an arm of the American Chemistry Council, and reviews completed by consulting firms with clients who havefinancial interests in the sale of bisphenol A.


Many of these reviews of individual studies are at odds with the NTP’s reviews of the same studies.


For example, one study funded by the National Institutes of Health and the Department of Defense looked at the effects of bisphenol A on prostate development in rats.


The FDA called it “severely limited,” in contrast to the NTP’s review, which labeled it of “high utility.”


Another government-funded study, which also looked at the effects of the chemical on the prostate, again was considered of “high utility” by the NTP for its evaluation, and it was deemed “very limited” by the FDA.


The FDA subcommittee’s statement is expected shortly.  It is due to be presented at a meeting on October 31, 2008.   Here’s hoping the FDA gets it right, but I’m not holding my breath.  In the meantime, Ill do what I can to avoid BPA, from not using polycarbonate plastic to skipping canned foods and beverages. 

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As FDA Debates BPA Safety Today, Study Finds Bisphenol A Exposure Linked to Heart Disease & Diabetes

Ironic, isn’t it?  As the US Food and Drug Administration (FDA) holds its hearing on the safety of bisphenol A (BPA) today, a major new study involving humans (not animals) finds exposure to BPA increases the risk of type 2 diabetes and heart disease.  So, finally, we have research suggesting that adverse health effects in humans occur as a result of exposure to BPA, the key monomer of polycarbonate plastic.  As the FDA debates whether BPA is safe.  I’m anxious to hear what happens at the FDA’s meeting.  Eager even.  I wish I could be there.  So, yes, I’m a green geek.


As you probably know, low level exposure to BPA has been linked to a host of health problems in laboratory animals, including disrupting hormones.  We are exposed to BPA from leaching of epoxy resin linings present in almost all canned food and beverages, and leaching from polycarbonate plastic, including baby bottles.  In fact, 93% of us have BPA in our systems, according to data from the Centers for Disease Control and Prevention (CDC).


The National Toxicology Program (NTP) recently issued its final report finding “some concern” (a 3 on the NTP’s 5 point scale) for current human exposures to BPA and effects on brain, behavior and the prostate.  Yet, the FDA continues to maintain that BPA is safe, having issued a draft reporting asserting such.  Today the FDA is holding a hearing to discuss its draft report, and many scientists and organizations critical of the FDA’s reliance on industry-supported, non peer reviewed studies are expected to comment.  It should be interesting, to say the least.  Well, at least if you are a green geek.  Being one, I really wish I could be there to hear the robust scientific debate.


At the same time, today a new study published in the Journal of the American Medical Association found that higher concentrations of BPA in urine were associated with higher rates of heart disease and diabetes.  Also, the survey of 1,455 US adults tested found a lnk between abnormal liver enzymes in people and BPA.  Basically, this major new study involving humans finds a significant relationship between BPA urine concentrations and cardiovascular disease, type 2 diabetes and liver-enzyme abnormalities. 


This major new study provides human data to support the animal studies which find evidence of harm to exposure to BPA.  However, already, the plastics industry has criticized this new study, contending that the study is flawed.


In any event, the outcome of the FDA’s hearing should be interesting.  In the interim, I’ll continue to be safe rather than sorry, and avoid BPA exposure.  How to do that?  Try these Simple Steps


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FDA Finds BPA Safe & Why Andy’s Take Pisses Me Off

Baby drinking from plastic bottleYou may have already read that last week, the Food and Drug Administration (FDA) issued its draft report finding that bisphenol A (BPA) is safe.   The draft report states “FDA has concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.”  If you are new to the BPA debate, you might want to review these summaries of the problem of BPA in baby bottles and canned foods and beverages, including infant formula


FDA’s position is not really a surprise.  The draft assessment was released in advance of a meeting of experts in September to discuss the issues.


The same day, Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, MD, published his Andy’s Take on BPA:  The Science, Evaluation and Safety.  And I find Andy’s Take extremely annoying, paternalistic and smug.  It starts off with a seemingly good statement that suggests that perhaps the FDA might consider caution is in order:



Since the splitting of the atom to now global warming, society has come to realize that, regarding science and technology, with progress comes peril!


With references to the atom bomb and global warming, you would think that the FDA would urge a cautious approach.  I mean, really, with global warming, weren’t we told it wasn’t a problem for years?


But then Andy’s Take goes on:



My Take on this is that science creates these products and science must inform us of their risks.  With regard to BPA thus far, the science FDA has reviewed does not justify recommending that anyone discontinue using these products . . .


And it just bothers me.  He seems to have it completely backwards.  If science creates these products, then science should inform us of their risks.  But not after the fact.  Science should inform us BEFORE we put the products on the shelves. 


And more importantly, it is interesting that he emphasizes “the science FDA has reviewed. . .”  I suppose that gives the FDA the out – if it hasn’t reviewed the science, then it can continue to say it is safe.  And the FDA has been criticized because its review of the BPA science conveniently ignores over a hundred peer reviewed studies involving low dose exposures to BPA in laboratory animals, while relying exclusively on industry-funded studies.  And these studies include those funded by the well-regarded National Toxicology Program.  If those studies are considered, then the margin of safety heavily relied on by the FDA does not exist.


Okay, so I understand that isn’t how it happens in the United States.  We don’t require safety to be demonstrated before an item is sold.  But it just galls me that Andy’s Take doesn’t include any recognition that a parent might be concerned . . . especially since that FDA’s assessment underestimates that amount of BPA ingested by babies.  The FDA’s own analyses of infant formula show that prepared liquid formula can contain BPA as high as 13 parts per billion (ppb) BPA, yet in this draft assessment, the FDA uses 2.5 ppb.


I think the September meeting of experts will be very interesting.  In the interim, don’t you want to ask “Andy” whether his 6 grandchildren used or use polycarbonate plastic bottles that may leach BPA? 


My own conclusion, as I’ve previously stated, I’d rather be safe than sorry.  With so many available alternates for polycarbonate plastic bottles and canned foods and beverages, why take the risk?  I’m not advocating elimination of polycarbonate plastic from all applications – I certainly don’t see a risk of exposure from polycarbonate plastic in helmets or DVDs – but when it comes to food contact items, I’ll take the alternatives. 


 

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