The U.S. Food and Drug Administration (FDA) has issued draft guidance “intended to help industry and others identify when they should consider potential implications for regulatory status, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products.” The draft guidance applies to all FDA-regulated products, including food-contact materials, cosmetics and sunscreens, that can be made with nanotechnologies.

The draft guidance does not provide a regulatory definition of nanotechnology, but instead describes factors FDA will consider to determine whether a product “contains nanomaterials or otherwise involves the application of nanotechnology.” Those factors include (i) “Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm [nanometer] to 100 nm)”; or (ii) “Whether an engineered material or end product exhibits specific properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.” FDA will accept comments on the draft guidance for 60 days after publication in the Federal Register.