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    NANOSCALE MATERIALS have the poten-tial to improve the taste, color, flavor, tex-ture, and consistency of food. Innovators in the food industry are using them to encap-sulate dietary supplements to increase the absorption and bioavailability of nutrients. And theyre adding these new materials to

    food packaging to create a stronger mechan-ical barrier, kill microbes, detect chemical and microbial contamination, and facilitate the traceability of foods.

    Despite the promises of nanotechnology for food applications, a growing number of people are beginning to question whether

    government over-sight and consumer awareness are suf-ficient to prevent the kind of public back-lash that occurred with genetically modified foods and food irradiation.

    At a daylong public meeting in September, the

    Food & Drug Administration called upon stakeholders to help the agency better understand concerns related to the safety and effectiveness of nanoscale materials in FDA-regulated products, including food, food packaging, and dietary supplements.

    In July 2007, FDA released its Nanotech-nology Task Force Report, which addressed the scientific and regulatory challenges asso-ciated with nanoscale materials (C&EN, July 30, 2007, page 44). The report recommended that FDA develop guidance for manufac-turers and researchers who are creating nanotech-based products that fall under FDAs jurisdiction. The September meeting was part of FDAs effort to get information to help the agency establish that guidance.

    Nanoscale materials present chal-lenges similar to those that weve come across with other emerging technologies in the past. But the fact that size influences efficacy and safety can complicate the chal-lenge, Richard A. Canady, senior science policy analyst in FDAs Office of Science & Health Coordination, noted at the meeting.


    in a wide range of food productsBRITT E. ERICKSON, C&EN WASHINGTON

    FULL SPEED AHEADNanotech-based foods and food packaging are now appearing on supermarket shelves, and some groups are calling for more government oversight.









    Among the concerns raised by FDA in the 2007 report and discussed at the Sep-tember meeting are the adequacy of current approaches for testing the safety, efficacy, and quality of nanotech products; the lack of standards for characterizing nanoscale materials; and the need for better detection and measurement tools to understand how nanoscale materials interact with biological systems. FDA is collaborating with other agencies such as the National Institute of Standards & Technology, the National Cancer Institutes Nanotechnology Char-acterization Laboratory, the National Toxi-cology Program, and the Organization for Economic Cooperation & Development to address these issues, Canady noted.

    THUS FAR, FDA has approached nano-technology on a case-by-case basis, Mitch-ell A. Cheeseman, deputy director of FDAs Office of Food Additive Safety, told the au-dience during a meeting breakout session focused on nanotech food additives and dietary supplements. The agency is looking for help in identifying which nanotech food ingredients or packaging components raise unique safety concerns, Cheeseman said. In addition, he said, FDA wants input relat-ed to circumstances under which a prod-ucts regulatory status might change due to the presence of nanoscale materials.

    For example, FDA is looking for feed-back on whether a substance that is designated by the agency as generally rec-ognized as safe (GRAS) at the macroscale should also be considered GRAS at the nanoscale and therefore be allowed to for-go safety testing and premarket approval. Several meeting participants stepped up to offer FDA input on this issue.

    What this really boils down to is ac-knowledging that a nanoscale particle that has novel properties should be deemed a new substance for purposes of safety evalu-ation, said Michael R. Taylor, a research professor at the George Washington Uni-versity School of Public Health & Health Services and a former FDA staff lawyer and assistant to the FDA commissioner. It is incumbent on FDA to provide guidance on this issue, he emphasized.

    Consumer advocacy groups pushed FDA

    to abandon GRAS status for all nanoscale materials. We urge FDA to recognize that nanoscale particles exhibit novel prop-erties and behaviors compared to their larger counterparts and raise unique safety concerns, said Michael Hansen, senior staff scientist at Consumers Union, the nonprofit organization most known for its publication Consumer Reports. Hansen recommended that FDA require separate safety assessments on all nanoscale ma-terials before they are used in any food or food packaging applications.

    Friends of the Earth (FoE), an envi-ronmental group, took it a step further and recommended that FDA establish a moratorium on nanoscale materials in all food products until specific safety laws are on the books. Major players in the food industry are investing in nanotech R&D, and many of them already have nanotech-based products on the market, warned Ian Illuminato, FoEs health and environment campaigner. Examples of such products include a nutritional supplement drink for children that contains iron nanoparticles, McDonalds hamburger containers, Cad-bury chocolate bar wrappers, and Miller Lite beer bottles, he noted. Illuminato estimated that the nanotech food industry would be worth $6 billion by 2010.

    The Project on Emerging Nanotech-nologies, a nonprofit partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts, keeps an inventory of consumer products that contain nanotechnology. To date, the database contains more than 800 products that were self-identified by the manufac-turers as containing nanotechnology.

    A search of this database finds four products that fall under the food and bev-erage category. They include a nanotea that claims to increase selenium supplement function by 10 times; a cooking oil with nanosized droplets, or micelles, that in-hibit cholesterol from entering the blood-stream; plastic beer bottles lined with a nanotech nylon material that scavenges oxygen to keep the beer fresher longer; and a chocolate shake with NanoClusters that offer enhanced flavor without the need for excess sugar.

    Despite the growing number of nanotech food products on the market,

    consumers arent aware of them.











































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    Despite the growing number of nanotech food products on the market, consumers arent aware of them. The public comment part of the food additives session at the FDA meeting was surprisingly silent; only a hand-ful of preregistered individuals spoke out.

    The lack of significant public input was not a surprise to social scientists who say that the public does not know that nano-tech food products already are on store shelves. Consumers have no information about nanotechnology in food, said Chris-tine M. Bruhn, an expert on consumer atti-tudes about food and director of the Center for Consumer Research at the University of California, Davis. They do not know about the benefits or the risks, she told C&EN.

    ONE REASON consumers dont have infor-mation on food-related nanotech is simple: Food and food packaging do not require labels to indicate that nanoscale materials have been added. Consumers, therefore, have no way of knowing which products contain nanotechnology. To remedy this sit-uation, FoE and other advocacy groups are pushing FDA to require labeling of nanotech products. Consumers want to make the choice. No labeling takes this freedom away from them, Illuminato emphasized.

    In addition to labeling, critics are calling for more public education about nanotech. After all, most observers say, the potential benefits of nanotechnology in food ap-plications are huge, but they also acknowl-edge that for the technology to be success-ful, the public has to be comfortable with it.

    To get a feel for what consumers are will-ing to accept, Michael Siegrist, professor of risk analysis at the Institute for Environmen-tal Decisions at the Swiss Federal Institute of Technology, Zurich, surveyed 337 randomly chosen people in Switzerland about the risks of nanotechnology in various food applica-tions. The results were published in July in the journal Appetite (2008, 51, 283).

    Siegrist found that acceptance for nano-technology in food packaging was relatively high. However, consumers were consider-ably more critical of nanotechnology-based ingredients in food. Even so, the potential for migration of nanoscale materials from food packaging did not emerge in the sur-vey as a big concern.

    Migration from food packaging was also discussed at the FDA meeting. According to Raymond David, manager of toxicology at BASF, the public has little to worry about. Exposure from food packaging can be controlled based on the size of the nanopar-

    ticles, he said, explaining that the larger the particle, the less likely it is to be released. Nanoparticles can also be impregnated into a matrix rather than just applied to a surface to make them less likely to migrate, he added.

    Many people at the meeting called for standard methods for testing the safety of nanoscale materials, similar to those under development by the newly formed Interna-tional Alliance for NanoEHS Harmoniza-tion (C&EN, Sept. 15, page 5). The EHS in the name stands for environment, health, and safety. FDA needs to provide guid-ance on testing methods. Divergent testing protocols will lead to limited comparability of tests and lower confidence in nanotech-nology, said Jo Anne Shatkin, managing director of CLF Ventures, a nonprofit affili-ate of the environmental advocacy group Conservation Law Foundation.

    Existing frameworks for assessing risks and establishing safety levels need to be updated to address nanoscale materials, Shatkin stressed. She recommended a life-cycle approachone that takes into ac-count cumulative exposuresto assess the risks of nanotechnology.

    Others, such as BASFs David, said that current risk assessment approaches should be adequate for nanoscale materials. What are needed, he said, are new in vitro tools for predicting how nanoparticles move in the body. The shelf life and stability of products that contain nanoscale materials should also be examined, he suggested.

    MEANWHILE, as U.S. manufacturers move forward with nanotechnology in food products, countries in Europe are taking a more cautious approach. For instance, the Food Safety Authority of Ireland recently reported that more research on the risks of nanotechnology is needed before nanotech food products should be allowed in the Irish market.

    A decade ago, industrys bravado in bringing genetically modified foods into the market elicited emotional public outcries with GM products derided as poorly tested frankenfoods that should not have a place in the diet. That is why those entering the nanotech food arena expect public attitudes to be mixed. Nearly everyone at the FDA meeting agreed that transparency and broad public engagement are needed to provide the knowledge that presumably will pre-empt consumer fear. Otherwise, they said, nanotech food products wont have much of a chance for success.


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