REGULATING THE PRODUCTIONS OF NANOTECHNOLOGY: Does FDA Have the Tools It Needs?

Publication Date : 2006
665 Visited Entry Date : 2015/01/14

International

English
Document type Report
Subject Regulatory & Legal Aspect
Application/Product Health Care & Cosmetics,Pharmaceutic & Medical Tools,Food
Summary
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.
Content
Foreword

Author’s Preface

Exective Summary

About the author

Introduction
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
Pre-Market Oversight
Post-Market Oversight

Overview and Analysis of FDA’s legal Tools for Regulating Nanotechnology Products
Cosmetic Ingredients and Products
Whole foods
Dietary Supplements
GRAS Food Ingredients
Food Additives
Food Packaging
Medical Devices
OTC Drugs
New Drugs

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

Recommendations
Near-Term Actions
Long-Term Legal and Policy Actions
Resource Needs
Concluding Observation

Table 1 Endnotes
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