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FDA Publishes Final Guidance on Nanotechology

June 27, 2014

The U.S. Food and Drug Administration's (FDA) reiterated in a final guidance, released June 24, 2014, that it will regulate nanotechnology products under existing statutory authorities. Guidance for Industry: Considering Whether an FDA-Regulated Product involves the Application of Nanotechnology is intended to help industry identify when it should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products, according to the agency.

Significantly, the guidance does not establish regulatory definitions for nano-products. Rather, the guidance lists two points that will be considered when determining if an FDA-regulated product involves the application of nanotechnology:

  1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm); and
  2. Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, which are attributable to its dimension(s), even if these dimensions fall outside of the nanoscale range, up to one micrometer (1,000 nm).

FDA elaborates in the guidance that technical assessments will be product-specific and will vary according to the statutory authorities and relevant regulatory frameworks. To date, FDA has issued three guidance documents (two final, one draft guidance) on the use of nanotechnology in specific FDA-regulated areas. These are:

Comments are due to FDA by September 10, 2014 on the draft guidance on the use of nanomaterials in food for animals.