On January 21, 2010, Senators Mark Pryor (D-AR) and Benjamin Cardin (D-MD) introduced legislation aimed squarely at perceived uncertainties about the potential health implications of nanotechnology-based consumer products. If enacted, the so-called “Nanotechnology Safety Act of 2010” (“the Act,” S.2942) would substantially expand FDA’s capacity to regulate nanomaterial health and safety issues.

Background

Under the Food, Drug, and Cosmetics Act, FDA is generally responsible for ensuring the safety of biologics, cosmetics, drugs, foods, medical devices, and other products. By some estimates, products within the scope of FDA’s regulatory authority are valued at more than $1 trillion annually. Some observers even suggest that FDA-regulated products comprise roughly 25 percent of the nation’s GNP.

Numerous such products within FDA’s broad regulatory authority—including cosmetics, food additives, food packaging, and dietary supplements—already contain nanomaterials. Moreover, the use of nanomaterials in drug delivery systems is one of the most promising areas of ongoing research.

Despite the obvious potential implications for consumers, however, FDA has thus far undertaken no nano-specific regulatory activity to date. Instead, FDA generally approaches nanoparticle-containing products no differently than those containing “traditional” materials.

Critics frequently clamor that, in part, FDA lacks sufficient resources to address emerging nanotechnology health and safety issues. Although FDA is one of more than two dozen federal agencies collaborating on nanotechnology issues under the auspices of the National Nanotechnology Initiative (NNI), FDA currently receives no funding under NNI’s $1.6 billion annual budget. Indeed, even FDA itself has acknowledged that it needs an expanded research program and better in-house nanotech expertise to meet the challenges posed by nanomaterials in FDA-regulated products.

The Nanotechnology Safety Act of 2010

The newly-proposed Nanotechnology Safety Act appears to be a direct response. The Act expressly authorizes $25 million in annual spending from 2011 to 2015 on “scientific investigation of nanoscale materials included or intended for inclusion in products regulated by the FDA.” It broadly tasks FDA with addressing (i) the potential toxicology of such materials, (ii) the effects of such materials on biological systems, and (iii) the interaction of such materials with biological systems Activities under this research program would presumably include assessing existing literature and data on unspecified “nanomaterials of concern to FDA”; developing new models to predict the nanomaterial impacts on biological systems; new nanotechnology-related training within the FDA; and the overall expansion of FDA’s in-house nanotechnology expertise.

Potential Implications

First and foremost, the Act potentially sets the stage for nano-specific FDA action. As the number of nanomaterial products escalates in the coming years, FDA regulatory interest in nanomaterials could have far-reaching impacts.

More broadly, however, the bill confirms that nanotechnology-related issues are increasingly weighing on legislators’ minds, as well. As both legislative and regulatory interest continues to grow, businesses manufacturing, using, and selling nano-related products should actively monitor new legislative, regulatory, and litigation developments