Nanotechnology Guidance Documents

FDA has issued several guidance documents on topics relating to the application of nanotechnology in FDA-regulated products.   These guidance documents are being issued as part of FDA's ongoing implementation of recommendations from FDA's 2007 Nanotechnology Task Force Report.  While guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public, they do represent FDA's current thinking on a topic.  The following guidance documents discuss the use of nanotechnology or nanomaterials in FDA-regulated products:

Final Guidance

• 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
• Final Guidance for Industry - Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
• Final Guidance for Industry - Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
• Final Guidance for Industry - Safety of Nanomaterials in Cosmetic Products
• Final Guidance for Industry - Use of Nanomaterials in Food for Animals
• Final Guidance for Industry - Drug Products, Including Biological Products, that Contain Nanomaterials

Draft Guidance

• None

For more information about FDA guidance documents, click here.