1. The FDA in 30 seconds

2. What kind of body it is: the four types of influence

The institutions that appear in nanotechnology coverage do not make nanomaterials themselves, unlike companies. They can be grouped into four types by the route through which they influence the field.

3. What it does for nanotechnology

The FDA's nanotechnology page describes its activities as building regulatory-science knowledge, facilitating collaboration with stakeholders and establishing "a flexible, product-focused, science-based approach" to regulation. In July 2007 the FDA issued the report of its Nanotechnology Task Force, and it has issued the following guidance documents as part of implementing the report's recommendations Sourced.

* The list is the FDA's "Nanotechnology Guidance Documents" page. Its "Draft Guidance" entry reads "None". The page's own "content current as of" date is March 2018, although it also lists the 2022 guidance.

Two points to consider in deciding whether a product involves nanotechnology

According to the 2014 guidance, the FDA asks two questions when considering whether a product involves the application of nanotechnology Sourced.

• Is the material or end product engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm)?
• Is the material or end product engineered to exhibit properties or phenomena attributable to its dimensions, where those dimensions may fall outside the nanoscale range, up to one micrometre (1,000 nm)?

4. How far its influence reaches (powers and geography)

5. Premarket review by product class, and who else is involved

On the FDA's account, whether there is a premarket review depends on the product class, and where one exists, attention to nanomaterials is built into its standing procedures. For products without one, oversight rests on public information, voluntarily submitted information, adverse event reports and post-market surveillance, and the FDA encourages manufacturers to consult it before marketing a product that uses nanotechnology Sourced.

Organisations around it

* No company is named, because none could be confirmed from primary sources as having a relationship with the FDA.

6. Outlook

7. Glossary

8. References

1. FDA FDA at a Glance (January 2026: fiscal year 2025 budget of about US$7 billion, 20,593 FTEs, 276,206 registered facilities of which 164,403 are foreign, headquarters address). https://www.fda.gov/media/154548/download
2. FDA What We Do (the FDA's mission and the range of products it regulates). https://www.fda.gov/about-fda/what-we-do
3. FDA FDA Organization (a federal regulatory agency within the Department of Health and Human Services; its centers). https://www.fda.gov/about-fda/fda-organization
4. FDA FDA History (the 1906 Pure Food and Drugs Act; the present name from 1930). https://www.fda.gov/about-fda/fda-history
5. FDA Nanotechnology Programs at FDA (activities, NNI membership, participation in ISO, OECD and ASTM International). https://www.fda.gov/science-research/science-and-research-special-topics/nanotechnology-programs-fda
6. FDA FDA's Approach to Regulation of Nanotechnology Products (existing statutory authorities; premarket review by product class; post-market oversight). https://www.fda.gov/science-research/nanotechnology-programs-fda/fdas-approach-regulation-nanotechnology-products
7. FDA Nanotechnology Fact Sheet (the 2006 Task Force; the view that existing frameworks are adequate). https://www.fda.gov/science-research/nanotechnology-programs-fda/nanotechnology-fact-sheet
8. FDA Nanotechnology Guidance Documents (list of guidance documents; guidance is not binding). https://www.fda.gov/science-research/nanotechnology-programs-fda/nanotechnology-guidance-documents
9. FDA Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology (June 2014, final). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considering-whether-fda-regulated-product-involves-application-nanotechnology
10. FDA Guidance for Industry: Safety of Nanomaterials in Cosmetic Products (June 2014, final). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-safety-nanomaterials-cosmetic-products
11. FDA Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (April 2022, final). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-products-including-biological-products-contain-nanomaterials-guidance-industry
12. FDA 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 (June 2014, final). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-assessing-effects-significant-manufacturing-process-changes-including-emerging

9. Claim-to-source audit

Last updated 9 October 2026 / Troy Technical
Figures and document status come from the FDA's website as shown on 9 October 2026. Items marked "Inference" are this article's reading of the primary sources. This article does not give regulatory judgements or advice about any individual product.