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FDA Releases Draft Guidance Toward Nanotech Regulation

The US Food and Drug Administration (FDA) has released a draft guidance to provide regulated industries with greater certainty over the use of nanotechnology, which generally involves materials consisting of particles at least one billionth of a meter in size. According to the agency, nanotechnology is an emerging technology with a broad range of potential applications, such as increasing the bioavailability of a drug and improving food packaging; it is also applied in cosmetics, most notably in sun care.

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” outlines the agency’s view on how to identify whether regulated products contain nanomaterials or involve such technologies. Specifically, the agency names certain characteristics such as the size of nanomaterials used and the exhibited properties of those materials, which may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs, in a press statement. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

According to the FDA, for products subject to premarket review, it intends to apply the points contained in the draft guidance, once finalized, to better understand the properties and behavior of engineered nanomaterials; for products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related can be adequately addressed.

The points outlined in the draft guidance that the FDA will consider include:

1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or

2. Whether an engineered material or end product exhibits 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.

The agency notes that these considerations apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. Additionally, they are subject to change in the future as new information becomes available, and to refinement in future product-specific guidance documents.

The agency adds that is will develop additional guidance documents related to specific products or product categories in the future, as needed. It is critical for the FDA to understand how changes in physical, chemical or biological properties seen in nanomaterials affect the safety, efficacy, performance or quality of a product that contains such materials.



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