Food and Drug Administration (U.S.)

The widening social impact of nanotechnology made itself felt on the U.S. Food and Drug Administration (FDA) in May 2006 when eight environmental and consumer activist groups petitioned the agency to remove sunscreen using nano-zinc oxide from the market. Sunscreen manufacturers maintained that there was no difference between regular zinc oxide, which had been used safely for years, and its smaller nano-sized counterpart. The only difference they maintained was that the optical properties of zinc oxide which, when rendered on the nanoscale, become transparent. To them, this property was a benefit since more consumers would be willing to wear a sunscreen if it went on the skin invisibly.

Consumer and environmental groups, however, were dismayed that this untested form of zinc oxide would be marketed to families and their children, when such little research was known about the safety and efficacy of nano-zinc oxide. They questioned not only whether it worked as safely and effectively as the original zinc oxide, but also whether the diminutive particle size could cross skin cell barriers and pose longer-term health risks. Moreover, they were concerned with the possible environmental consequences of the particles being dispersed through oceans, lakes, and waterways. Although the FDA maintains it knows of no health risks associated with nano-zinc or nano-titanium oxide, it participates in ongoing toxicology and phytotoxicity studies in collaboration with several other agencies. The difficulty in reaching an assessment of the basic safety and efficacy of a nanoparticle like nano-zinc oxide underscores the regulatory and scientific complexity of nanotechnology.

Largely in response to the public's demand for more FDA oversight, then commissioner Andrew von Eschenbach convened a Nanotechnology Task Force to assess the potential scientific and policy issues that nanotechnology presented the FDA. By July 2007, the FDA released its findings of its Nanotechnology Task Force. Noting the rapid growth in many sectors of nanotechnology and the potential impact upon almost all of the products and activities that come under FDA jurisdiction, the report recommended that the FDA develop its institutional capacity for handling nanotechnology.

To this end, the report recommended that the FDA begin to foster in-house expertise regarding nanotechnology, while simultaneously developing the techniques necessary to identify and assess the safety and effectiveness of nanotechnology. Indeed, the report noted that because safety and effectiveness may vary with changes in molecular size, the report suggested that nanotechnology might present specific challenges different from other emerging technologies. Moreover, because of this complexity, the report urged the FDA to develop transparent, consistent, and predictable regulatory tracks so that the FDA could ensure both private and public stakeholders that its practices were equitable, supporting both innovation and protecting public health.

The task force also surveyed the existing authorities for the FDA and noted that the FDA was best positioned to oversee the safety and efficacy of products requiring premarket approval (drugs, medical devices, biological products, food additives), whereas its ability to oversee and protect consumers from possible harm was not as comprehensive for products not requiring premarket approval (cosmetics, food ingredients that are generally recognized as safe [GRAS], dietary supplements). In turn, the report recommends that the FDA foster private-public relationships, data sharing, and provide guidance to manufacturers and researchers. Notably, the report also suggests that the addition of nanotechnology to already-existing products may require the submission of additional information, change its regulatory classification, even alter its regulatory pathway. Because of these possible contingencies, the report recommends that manufacturers establish communication with the agency early on in the research and development phase of a product.

...