The NanoBusiness Alliance Responds to New Report, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?

CHICAGO--(BUSINESS WIRE)--The NanoBusiness Alliance released its commentary today on The Project on Emerging Nanotechnologies (PEN) FDA Report authored by former Food and Drug Administration (FDA) Deputy Commissioner for Policy Michael R. Taylor. The report claims that gaps in legal authority and insufficient resources hinder the FDAs efforts to better understand and manage the potential risks from hundreds of new products incorporating nanotechnologies.

The NanoBusiness Alliance views the FDA as fully capable to carry out its mission to protect public health with regard to products produced using nanotechnologies. FDA is at the forefront of identifying problems which could conceivably surface as new applications of nanotechnology are considered, and the FDA has a well-established and robust regulatory framework in place to find answers and to address any such issues.

FDA implements and enforces legislation and regulations that provide for careful review prior to marketing of food additives, drugs, devices and diagnostic products, unless the proposed product meets pre-established criteria to excuse the filing of an application for clearance.

In the case of cosmetics, the cosmetics industry works closely with the FDA in a voluntary regulatory effort that has long maintained an excellent safety record. There is no evidence that the absence of a pre-clearance system for cosmetics has harmed the public, given the extensive voluntary effort to assure the safety of cosmetic ingredients.

The NanoBusiness Alliance believes the FDA has robust legal authority and significant discretion in setting the protocols for testing to regulate nanotechnologies. As the technology matures, new tests will be available and will be required or recommended for use, as appropriate. At this point, there is no basis to suggest that FDA cannot fulfill its mandate with the powers available to it, said Sean Murdock, Executive Director of the NanoBusiness Alliance. We believe FDA should be given all of the resources it needs, within the existing framework, to continue to ensure public safety and promote health through innovation. In the meantime, the NanoBusiness community takes its obligations seriously and will continue to work closely with the FDA to ensure that industry is doing its part to protect consumers while bringing new, beneficial products to market.

About The NanoBusiness Alliance

The NanoBusiness Alliance is the industry association for the emerging nanotechnology industry. Through its extensive network of leading startups, Fortune 500 companies, research institutions, non-governmental organizations and public-private partnerships, the Alliance shapes nanotechnology policy and helps accelerate the commercialization of nanotechnology innovations. The NanoBusiness Alliance has offices in New York, Chicago, Connecticut and Washington, D.C. For more information, visit


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