United States: FDA Issues Four Nanotechnology Guidance Documents

On June 27, 2014, FDA announced the availability of four guidance documents—three final and one draft—relating to nanotechnology:

The first guidance, Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives, outlines the factors industry should consider when determining whether changes in manufacturing processes of a marketed food affect the identity, safety, or regulatory status of the food substance. Such changes include the intentional reduction in particle size to the nanoscale.

The second guidance, Guidance for Industry: Considering Whether a Food and Drug Administration-Regulated Product Involves the Application of Nanotechnology, identifies particle dimensions and dimension-dependent properties or phenomena as two points to consider as initial screening tools.

The third guidance, Guidance for Industry: Safety of Nanomaterials in Cosmetic Products, represents FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. The guidance is intended to help industry identify potential safety issues and develop a framework for evaluating them.

The fourth guidance, Draft Guidance for Industry: Use of Nanomaterials in Food for Animals, applies to food ingredients that are intended for use in food for animals and either: (i) consist entirely of nanomaterials; (ii) contain nanomaterials as a component; or (iii) otherwise involve the application of nanotechnology. It is intended to assist industry in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. Comments on the nanomaterials in cosmetic products draft guidance are due September 10, 2014.

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