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The U.S Food and Drug Administration (FDA) has issued three final guidances and one draft guidance providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products. One final guidance addresses the agency's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics and food for animals, respectively.


The FDA does not make a categorical judgment that nanotechnology is inherently safe or harmful, and will continue to consider the specific characteristics of individual products. All four guidance documents encourage manufacturers to consult with the agency before taking their products to market. Consultations with the FDA early in the product development process help to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact and/or regulatory status of the product.


  • Guidance for Industry 01: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.
  • Guidance for Industry 02: Safety of Nanomaterials in Cosmetics.
  • Guidance for Industry 03: 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.
  • Draft Guidance for Industry: Use of Nanomaterials in Food for Animals.


Here the direct link to the press release, 24.06.2014.



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