CFSAN Constituent Update
June 26, 2014
Today the U.S. Food and Drug Administration (FDA) issued a final guidance document addressing the use of nanotechnology in the area of foods, as well as a final guidance document addressing the use of nanotechnology in the area of cosmetics:
- Final 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 (the final foods guidance); and
- Final Guidance for Industry: Safety of Nanomaterials in Cosmetics (the final cosmetics guidance);
The two final guidance documents reflect FDA’s current thinking on these issues after taking into account public comment received on the corresponding draft guidance documents which were issued in 2012.
The final foods guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. This guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the use of the food substance, and potentially warrants a regulatory submission to FDA.
The final cosmetics guidance describes FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products and encourages manufacturers to consult with FDA on test methods and data needed to support the substantiation of a product’s safety.
Nanotechnology is an emerging technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they cannot be seen with a regular microscope. The technology has a broad range of potential applications, such as improving the packaging of food or altering the look and feel of cosmetics.
FDA will continue to pursue its ongoing scientific research and regulatory efforts and will consider new studies and data, as they become available, to determine future actions.
For more information:
- 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
- Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application Nantechnology
- Guidance for Industry: Safety of Nanomaterials in Cosmetic Products
- Draft Guidance for Industry: Use of Nanomaterials in Food for Animals
- Fact Sheet: Nanotechnology