Last month, the FDA issued three final guidance documents and one draft guidance for the use of nanotechnology in the products it regulates. “Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” supplies a framework for regulation, listing two Points to Consider under either of which a product may be identified as requiring additional scrutiny. Determinations are based on product properties and not particle size. The final guidance on the safety of nanomaterials in cosmetic products states that current safety assessments are adequate but encourages evaluation of data needs and testing methods. “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” identifies factors that are to be considered when changing the manufacturing process for foods already on the market.

Source: FDA