The question addressed in this paper is whether the Food and Drug Administration (FDA) has the tools it needs to regulate the products of nanotechnology.
The report analyzes the strength of current law as applied to nine categories of nanotechnology-based products that will come under the agency’s jurisdiction: cosmetic ingredients and products, whole foods, dietary supplements, generally recognized as safe (GRAS) food ingredients, food additives, food packaging, medical devices, over-the- counter (OTC) drugs and new drugs.
This report is an extremely important and thoughtful step in helping to ensure that FDA has the strategy, expertise and resources it needs in the area of nanotechnology to “get it right” now. To accomplish this task and to prepare more broadly for its oversight role. FDA needs better access to information about applications of nanotechnology that are in the development pipeline; this report suggests some targeted steps FDA could take to obtain such information.
There is a number of recommendations in this report. It does not have all the answers. It offers an evaluative framework and author’s analysis in this report as a starting point. The report can stimulate discussion and debate among FDA officials and FDA’s many stakeholders who aspire to effective and efficient regulation of nanotechnology products.
About the author
Nanotechnology and FDA
Potential Risks: What is New about Nanotechnology?
FDA’s Regulatory Role: Principles from Current Law
Evolution of the FDC Act
Key Features of the Current Law
Regulatory Principles from Current Law
Key Elements of a Regulatory Framework for Nanotechnology Products
Overview and Analysis of FDA’s legal Tools for Regulating Nanotechnology Products
Cosmetic Ingredients and Products
GRAS Food Ingredients
FDA Resources: Current Status and Importance for Safety
What FDA Needs To Do
FDA’s Growing Budget Gap
What FDA Is Doing
The Consequences of Scare Resources
Conclusion: Gaps in the Tool Kit
Long-Term Legal and Policy Actions
Table 1 Endnotes