Nanomaterials in Consumer Products:
It's a Small (and Unregulated) World After All

George A. Kimbrell, Staff Attorney
International Center for Technology Assessment

Consumer products composed of nanomaterials have arrived and represent the crest of a product wave spanning many sectors. Thousands of tons of nanomaterials are already being produced annually, with more than $32 billion in nano-enhanced products sold last year. Hundreds of nanomaterial products are on market shelves and are particularly prevalent in the personal care product sector. Moreover, product estimates are likely underestimates, as current laws do not require any specific labeling for products containing nanomaterials. The Food and Drug Administration (FDA) has regulatory authority over many of these products; however, as of yet, it has taken no oversight action to account for the fundamentally different properties and associated risks of the incorporation of nanomaterial ingredients into consumer products within its regulatory purview.

Why is this a "big" deal? "Nano" does not mean merely tiny; rather, what is distinctive about "nano" is that materials engineered or manufactured at the nanoscale can exhibit fundamentally different physical and chemical properties from their bulk-material counterparts. It is precisely because of this phenomenon that corporations have begun engineering and manufacturing nanomaterials, and inserting them into a wide variety of consumer goods.

Unfortunately for the public, U.S. regulators and businesses have neglected one crucial aspect of nanomaterials in their rush to hype and profit: the same features that make engineered nanomaterials unique ‹ small size, high-surface-area-to-volume ratio, increased reactivity, in effect, their very "nano-ness" ‹ also can create unique and unpredictable risks to human health and the environment. While studies have already begun to raise numerous red flags, much more research is urgently needed. That said, experts agree that the fundamentally different characteristics of nanoparticles, and their potential risks, cannot be safely extrapolated from the behavior of the same material at the bulk level. Thus, currently used toxicity testing parameters alone are insufficient, and new methodologies are needed.

Polls show that the majority of the public is still unaware of the concept of nanotechnology, not to mention the recent commercial explosion of nanomaterial-laced products. This rapid commercialization has seemingly caught federal agencies unaware, unprepared, and uncertain about how to proceed. But environmental and consumer advocacy groups have begun taking action. In May 2006, the International Center for Technology Assessment (CTA) and a coalition of consumer, health, and environmental groups filed the first legal action on the risks of nanotechnology, a legal petition with the FDA, demanding that the agency address the human health and environmental risks posed by nanomaterials in consumer products. The CTA petition calls for, among other things, comprehensive, nanomaterial-specific regulations, including: enacting formal definitions; requiring mandatory product labeling; formulating new paradigms of nano-specific toxicity testing; and treating nanomaterials as new substances, rather than inferring safety from bulk material counterparts.

FDA has not yet responded to the CTA petition in substance, but it did hold its first-ever public meeting on nanotechnology in October 2006. The meeting was a welcome acknowledgement of these issues, albeit overdue. During the meeting, CTA and other public interest advocates continued to press the agency to take action, in fulfilling of its mission of protecting public health and the environment. In addition, FDA received more than 10,000 public comments expressing concerns about nanomaterials in consumer products, and demanding agency action and adequate oversight. Let¹s hope FDA is listening.

George A. Kimbrell is a Staff Attorney at the International Center for Technology Assessment (CTA) in Washington, D.C., where he works on legal developments in biotechnology, nanotechnology, and climate change. The author recently had an article on the above topic published in Nanotechnology Law and Business (fall 2006), available at http://www.nanolabweb.com/. Much more information can be found at www.icta.org.