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October 5, 2016

Nanoparticles: What the Eye Doesn’t See…

Contamination Control News

Baby Milk FormulaThere is little that’s more central to human health than the food that we eat. With each bite, we ingest the vitamins, minerals, fiber, starches, proteins, and fats that we need to fuel, re-build, and maintain our bodies. Each meal provides us with an opportunity to either nourish ourselves or to stress our systems with junk. Three times per day the choice is ours.

But there are individuals among us who do not have the luxury of autonomous choice. Here we’re talking about those most fragile of folks: babies. Reliant on the good choices of others, infants are at the mercy of those whose intentions may or may not be pure. Parents will always strive to provide the highest form of nutrition to their children but what happens if they are unaware of a potential threat lurking within a product that should be wholesome and nutrient-dense…baby formula.

…unaware of a potential threat lurking within a product that should be wholesome and nutrient-dense…baby formula…

Hydroxyapatite. It’s a simple substance with a complex name and is essentially an acidity regulator. A soluble calcium-rich mineral, it is also a dietary supplement that’s commonly found in off-the-shelf baby formula, both in liquid and in powder forms. And then there’s also nano titanium dioxide, a brightener for food products that is also used as an anti-caking agent. And finally nano silicon dioxide which, amongst other uses, is a food coating. This triumvirate of suspects was recently uncovered in samples of six leading baby formula compounds and the problem, as identified by a team of researchers at Arizona State University, is the form in which it appeared: engineered nanoparticles. Nano…what? Let’s back up a little…

Logo of DNA molecule on blue background. Pharmacology sign.

Nanoparticles are small. Very small. Infinitesimally minute structures that are utterly invisible to the human eye, so you’d be forgiven for not noticing them in your meal. On the nano scale (nm), for instance, a human hair is measured at 80,000 nm in width which, in comparison with a strand of DNA at 2.5nm wide, is positively immense. The nanoparticles of hydroxyapatite, silicon dioxide, and titanium dioxide were discovered only by scanning the brands of formula in an electron microscope, and looked to be between 150nm and 200nm in length.

Nanoparticles are small. Very small. Infinitesimally minute structures that are utterly invisible to the human eye…

And, in the case of the hydroxyapatite, they are needle-shaped.

Due to their very small size, all nanoparticles have an increased chance of successfully entering organs, tissues, cells, or even of crossing the blood-brain barrier. And the needle-shaped hydroxyapatite particles are of particular concern. According to Friends of the Earth, an environmental advocacy group, needle nano-hydroxyapatite has been found by the European Scientific Committee on Consumer Safety (SCCS) to be toxic and the group has recommended the prohibition of its use in oral preparations such as toothpaste, mouth rinses or dental whiteners. So how can it be that a compound considered unsafe for ‘cosmetics’ in the European Union is a legal additive to baby food in the U.S.?

The answer is simply one of mandates. The U.S. Food and Drug Administration (FDA) regulates baby formulas in terms only of the extent to which they meet nutritional guidelines and are pathogen-free, but there is no formal requirement to screen for nanoparticles or any other potentially toxic synthetic materials.(1) As Michael Passoff, co-author of a 2011 study by the advocacy group ‘As You Sow’ points out, the FDA lodges the burden of responsibility for nano-safety with the product manufacturer: “There’s nothing to slow them down. No regulations.” (2)

FDA lodges the burden of responsibility for nano-safety with the product manufacturer

And this is troubling on two distinct levels: firstly because the developing vital systems of infants (digestive, central nervous, immune, etc) are still vulnerable to damage; and secondly, because substances in nanoparticle form are more bioavailable and chemically reactive than the same substances in larger particle sizes. In fact, on the nanoscale the properties of a given substance change as it becomes subject to the laws of quantum physics. According to the National Nanotechnology Initiative, ‘when particle size is made to be nanoscale, properties such as melting point, fluorescence, electrical conductivity, magnetic permeability, and chemical reactivity change as a function of the size of the particle.’(3)

In an article published last month in the DairyReporter.com, the FDA is quoted as saying that it ‘does not categorically judge all products containing nanomaterials or otherwise involving the application of nanotechnology as intrinsically benign or harmful.’ But in addition, the agency also acknowledged that ‘while some ingredients may be safe or GRAS(4) in regular size and form, it has not been proven whether or not they can be considered safe in nanoparticle form.’(5)

And yet, on balance, the nanomaterial in infant formula is not considered a cause for concern.

Champions of this nascent technology point keenly to the results of a recent study on nanotoxicity undertaken by the German Hohenstein Institute.(6) Assessing the risk of nanomaterials to human health, researchers conducted a three-year test of silver nanoparticle enhanced (Ag-NP) fabrics, measuring inhalation, absorption, and ingestion of any released particles. The conclusion of the study showed that the Ag-NP fabric acted as a microbial agent in combatting bacteria produced by perspiration but did not damage the skin’s own natural protective bacteria. In addition, long-term exposure to the compounds did not cause skin irritation or any other negative impact upon the test subjects.(7)

What if they were produced in less than sanitary conditions before finding their way into the food supply

But this was one test, conducted with a wearable (rather than ingestible) material, involving adult test subjects with fully developed central nervous/immune/digestive systems. One would assume. And let’s go further. What if the nanoparticles were not merely inherently dangerous – as other experts such as Andrew Maynard of the Risk Innovation lab at ASU contend – but were also contaminated? What if they were produced in less than sanitary conditions before finding their way into the food supply of some of our most vulnerable citizens? Given how easily they can pass into lungs, liver, or kidneys or perhaps even penetrate the brain, a nightmare scenario is not hard to envisage.

And it is this scenario that groups like Friends of the Earth seek to prevent. Joining with organizations such as Food and Water Watch, the Center for Food Safety, and the Institute for Agriculture and Trade, FoE has urged the FDA to take strong and immediate action in assessing the safety of nanomaterials in baby formula. In addition to forcing a recall of all products containing nanoparticles, the consortium of concerned organizations is also pressing the agency to deny other products containing nanomaterials access to the market, to require explicit labeling of products and notification of workers, consumers, and any other ‘downstream users’ of the presence of nanomaterials, and to classify nanomaterials as ‘new products.’ These and a raft of other measures would essentially restrict the use of nanoparticles until they can be demonstrated to be safe in their uncontaminated form. And once that has been codified, we will only have to worry about contamination control and whether these almost invisible supplements are created in a clean and sterile manner.

…this problem is not going away any time soon..

Experts on both sides of the fence disagree strongly on the safety and future of nanomaterials in the food supply. For some – including Austin Wilson of ‘As You Sow’ – the risks outweigh the benefits. “Potentially harmful materials are not worth the risk, and engineered nanoparticles should be studied extensively before they are used.”(8) For others, such as the drug chain Walgreens whose Well Beginnings™ Advantage® formula was one of the brands found to contain needle nano-hydroxyapatite, engineering products such as vitamins and supplements on a nanoscale may be a way of increasing bioavailability and increasing potency for consumers with nutritional deficiencies. One thing, however, is certain: despite Walgreens’ SEC filing to block a shareholders’ inquiry into the issue, this problem is not going away any time soon. And it is incumbent upon the FDA to step in right now. With European studies demonstrating that ‘nano-HA can cause cell death and inflammation’ it is time for the FDA to climb down off the fence.(9) Calls have already begun to resound along those corridors of power for a securing of the stable door – the creation of a suite of guidelines for testing, labeling, and for the controlling these substances – before this particular horse gets the chance to bolt.

Do you have thoughts about nanoparticles in food? We’d love to hear them!

References:

  1. http://webiva-downton.s3.amazonaws.com/877/7b/0/8132/FOE_NanoBabyFormulaFACTsheet_4.pdf
  2. http://www.foodsafetynews.com/2016/05/researchers-find-potentially-harmful-nanoparticles-in-some-baby-formulas/#.V_Lf3YTiWaF
  3. http://www.nano.gov/nanotech-101/special
  4. GRAS means ‘Generally Recognized as Safe’ by the FDA
  5. http://www.dairyreporter.com/Regulation-Safety/Walgreens-denies-motion-to-investigate-nanoparticles-in-infant-formula/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=28-Sep-2016&c=KCrnyJKC8DdNTvj9cpeowuuoaeIkgRb9&p2=
  6. http://www.hohenstein.de/en/home/home.xhtml
  7. http://www.cleanroomtechnology.com/news/article_page/Nanoparticles_pose_little_or_no_risk_to_human_health_or_ecosystems_finds_research/95330
  8. http://www.dairyreporter.com/Regulation-Safety/Walgreens-denies-motion-to-investigate-nanoparticles-in-infant-formula/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=28-Sep-2016&c=KCrnyJKC8DdNTvj9cpeowuuoaeIkgRb9&p2=
  9. Ibid

Additional reading:

http://www.foe.org/projects/food-and-technology/nanotechnology

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