Recent research has detected potentially harmful nanoparticles in six out of six popular infant formulas tested. Not surprisingly, this has triggered yet more concern about the safety of these engineered particles, which are added to some of the foods we eat. The products tested were Gerber Good Start Gentle, Gerber Good Start Soothe, Enfamil, Similac Advance OptiGRO (liquid), Similac Advance OptiGRO (powder), and Well Beginnings Advantage. Some big players are involved. Gerber is owned by Nestlé, Enfamil is owned by Mead Johnson, Similac is owned by Abbott Laboratories, and Well Beginnings is owned by Walgreens. Friends of the Earth commissioned the independent laboratory studies with a nanotechnology research facility at Arizona State University. Researchers collected samples from retailers in the San Francisco Bay Area. The goal of the research was to learn more about the presence of engineered nanomaterials in popular baby formulas. On a broader level, the goal was “to inspire greater public scrutiny, industry accountability and government regulation of nanotechnology, particularly in the food sector,” according to a news release. What are nanoparticles anyway? Nanoparticles get their name from an infinitesimal unit of measurement, the nanometer, which is a billionth of a meter. That would be just one sliver if you were to slice the period at the end of this sentence into 50,000 slices. In other words, they’re not something you’d be able to see with the naked eye — or even with a regular microscope. The U.S. Food and Drug Administration (FDA) describes nanotechnology as an “emerging technology that allows scientists to create, explore and manipulate materials on a scale measured in nanometers, with a broad range of potential applications, such as improving the packaging of food and altering the look and feel of cosmetics.” Nanoparticles are used in foods as nutritional additives, flavorings, coloring, or anti-bacterial coatings for packaging. They are also used in hundreds of commercial products, among them transparent sunscreens and light-diffracting cosmetics, sporting equipment, and anti-bacterial house appliances such as vacuum cleaners, refrigerators and air conditioners. Concerns about nanoparticles are that they are small enough to penetrate the skin, lungs and digestive system, and perhaps pass through the vital blood-brain barrier. “Consumers should be concerned that these tiny chemicals may already be in foods and food contact materials, without being publicly disclosed,” said Jennifer Sass, senior scientist and nano authority for the Natural Resources Defense Council, in response to an earlier report on nanoparticles released in 2011 by the nonprofit As You Sow. The organization is a shareholder advocacy group that has engaged the food industry on safety issues for more than a decade. About the baby formula The organization’s report, “Nanoparticles in Baby Formula: Tiny new ingredients are a big concern,” details findings from the research done by the independent lab in Arizona and compiles data from health-impact studies on nanoparticles. “Unbeknownst to the general public, popular infant formulas sold throughout the United States contain infinitesimally small ingredients known as engineered nanoparticles or nanomaterials,” the first paragraph of the report’s executive summary states. “While some nanoscale ingredients may offer potential benefits, their safety remains poorly understood, and a growing body of scientific research is raising concerns about their use in food and many other consumer products.” According to the report, “a product fed to millions of infants should not be permitted to go to market if we are not certain that the ingredients it contains are safe for human consumption.” Referring to nanotechnology specifically, the report’s lead author, Ian Illuminato, warns that “this technology is moving from the lab to the marketplace without sufficient regulation, safety assessment and labeling.” “It’s of real concern that these tiny particles are used in hundreds of consumer products, and now in infant formula, with minimal to no oversight,” Illuminato said. “Companies must take extra care with a product fed to the most vulnerable among us.” Needle-like nanos Some nanoparticles are needle-like in structure, said Tracey Woodruff, PhD, MPH, of the Phillip R. Lee Institute for Health Policy Studies of California, San Francisco. “This is concerning,” he said. “We don’t know if they can possibly penetrate cell walls and migrate to other parts of the body, or cause harm when inhaled. The problem is, there hasn’t been enough research to suggest that using the types of nanoparticles found in this infant formula study is absolutely safe.” “Babies bodies are developing and can be especially vulnerable to exposures from hazardous materials,” said Mark Mitchell, chair of the National Medical Association’s Commission on Environmental Health. “As a physician working with low-income communities and communities of color, I am concerned that this new information on powdered baby formula may indicate disproportionate impacts on vulnerable populations.” This is also concern for working parents. “Like many parents and caregivers, I had to feed my child formula,” said Lisa Archer, director of the food and technology program at Friends of the Earth. “I am outraged that these poorly studied, virtually unregulated and unlabeled nanomaterials are present in infant formula when there are suitable non-nano ingredients that have been used for decades and don’t carry the same risks.” In an article, “Should Parents Worry About Nanoparticles in Baby Formula?” Andrew Maynard, director of the Risk Innovation Lab at Arizona State University, said it’s easy to see why people might be concerned. For example, when looking at the particles made of hydroxyapatite, a poorly soluble calcium-rich mineral, at super-high magnification, Maynard said, “It’s not hard to feel a little anxious about feeding them to a baby. They appear sharp and dangerous — not the sort of thing that has any place around infants.” Nanoparticles made of hydroxyapatite were found in three of the six baby formula tested. Even so, Maynard pointed out that, according to preliminary studies from Arizona State University researchers, hydroxyapatite needles don’t last long in the digestive system. Research on that question is still being reviewed for publication. “So maybe nanoscale hydroxyapatite needles in food are safer than they sound,” he said, adding that this doesn’t mean they’re completely off the hook since some of them may get past the stomach intact and reach more vulnerable parts of the gut. Still, he said, the findings do suggest that these ultra-small, needle-like particles could prove to be an effective source of dietary calcium — “possibly more so than larger or less needle-like particles that may not dissolve as quickly.” And Maynard offers this possibility: “Rapidly dissolving hydroxyapatite nano-needles are actually a boon, providing raw material for these natural and essential nanoparticles.” However, he concludes by coming out on the side of caution. “But given how high the stakes are, safety here should not, and indeed cannot, be taken for granted.” Health experts are also concerned about the possible toxicity of nanoparticles related to features such as shape, electrical charge, the ratio of surface area to volume, or other physical chemical properties. Detailed information about the specific nanoparticles found in the tested baby formulas and concerns about each of them is included in the report. Concerns range from the dangers of inhaling them to possible adverse effects on a fetus. What’s going on, or not going on? Michael Passoff, co-author of the 2011 “As You Sow” study about nanoparticles and now the CEO of Proxy Impact, said the same concerns about nanoparticles are still with us today. These include the complete lack of information about what products are in what foods and that FDA allows too much control over the nanoparticles to remain with food manufacturers. “This uncertainty and lack of transparency on the application of nanomaterials poses unnecessary risks for consumers, workers, companies and investors,” he said. He also said that given the fact that companies have been making more nano products, they’re probably in more foods. “There’s nothing to slow them down,” he said. “No regulations.” And though there’s concern about this, Passoff said it hasn’t been a consumer issue because most consumers don’t know about it. He also had this prediction to offer: “This (research) is the beginning of a larger consumer campaign.” In his work with large companies, Passoff said that nanoparticles in food is a concern he’s heard from companies such as McDonald’s, Kraft and Pepsi. “They’ve told me, ‘We don’t want to see this turn into another GMO battle,’ ” he said. GMOs, or genetically modified organisms, have remained controversial despite assurances from scores of scientists that they’re safe and with many consumers demanding that any foods containing GMOs be labeled as such. Passoff said that McDonald’s and Kraft even stated on their “corporate responsibility” websites that they wouldn’t use the nanotechnology until science says it’s OK. “The issue has always been that the science is not there to say it’s safe,” he noted. He’s surprised that this issue hasn’t gotten more attention. “It’s been flying under the radar,” he said. “But GMOs were like that in the first few years.” As for how other countries deal with nanoparticles in food, the European Parliament is working toward a moratorium on novel foods containing nanomaterials. France, Belgium and Denmark have implemented mandatory registries for nanomaterials, and the European Union has implemented a nanofood-labeling regime. In contrast, the U.S. has not developed any mandatory regulations or safety assessments for nanomaterials used in food or consumer products, according to the Friends of the Earth report. “It is important for U.S. consumers to know that manufacturers are not required to list nanomaterial ingredients on product packaging in the United States,” states the report. What about FDA? In explaining its approach to the regulation of nanotechnology products, FDA states that it “does not categorically judge all products containing nanomaterials, or otherwise involving the application of nanotechnology, as intrinsically benign or harmful.” Even so, the agency does note that nanomaterials can exhibit new or altered physiochemical properties at nanoscale dimensions. “The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting, also may merit examination to determine any effects on product safety, effectiveness, or other attributes,” FDA states. In other words, even though some ingredients — before they’re made into nanoparticles — are considered to be GRAS (generally recognized as safe), the question is whether they’re safe in their nanoparticle form. GRAS ingredients can be allowed in foods if a company notifies FDA, but without the agency exercising its usual oversight or regulation. According to FDA, its guidance documents encourage manufacturers to consult with the agency before taking their products to market. FDA guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the food substance, potentially warranting a regulatory submission to FDA. Passoff said FDA allows the food manufacturers to call the shots by giving them control over this. Maynard, the director of the Risk Innovation Lab at Arizona State University, sees things differently. He said that while there is some regulatory uncertainty in this area, FDA’s recommendations are quite strong. According to the agency’s specific language in an email to him, “Currently, we are not aware of any food substances intentionally engineered in the nanoscale range for which there are generally available safety data sufficient to serve as the foundation for a determination that the use of a food substance is GRAS.” In other words, nanoscale hydroxyapatite, for example, isn’t considered GRAS and has not been evaluated for safety under FDA regulations. Maynard said that a company could skirt this by claiming:
- The bulk of the material added was not nanoscale and the particles seen were just the tail end of a distribution;
- The particles were not added but were formed during manufacture; or
- The company had sufficient evidence to show that the additive was safe.
“But they would still be accountable to the FDA,” he said. What’s next? Recalls, moratoriums and labeling are among the actions Friends of the Earth wants FDA to take. The organization has joined with eight other organizations, among them the Center for Food Safety, the Center for International Environmental Law, Food and Water Watch, and the Institute for Agriculture and Trade Policy, in sending a letter to FDA urging it to take these measures:
- Assess the safety of and recall baby formulas with nanoparticle ingredients;
- Conduct a thorough review of the nanoparticle ingredients found in baby formulas. In the meantime, the agency must use its authority to enforce a manufacturer recall of baby formulas containing engineered nanoparticles as these ingredients may put human health at risk;
- Regulate nanomaterials as new substances;
- Subject all deliberately manufactured nanomaterials to rigorous nano-specific health and environmental impact assessments to demonstrate they’re safe prior to approval for commercial use in foods, food packaging, food contact materials, agricultural applications or other consumer products;
- Ensure transparency in safety assessment and product labeling;
- Place all relevant data related to safety assessments, and the methodologies used to obtain them, in the public domain;
- Require all manufactured nano-ingredients to be clearly indicated on product labels to allow the public to make an informed choice about product use;
- Require that the presence of nanomaterials to be disclosed to workers and other downstream users;
- Enact a moratorium on new commercial nanotech products, and,
- Deny products produced with nanomaterials access to the market until it’s determined how to properly assess and manage them to protect human health and the environment.
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