FDA's Troubling Failures to Use Its Authority to Regulate Genetically Modified Foods

Authors

Leslie Francis
Robin Kundis Craig
Erika George, Boston University School of LawFollow

Document Type

Article

Publication Date

2016

ISSN

1064-590X

Publisher

Food and Drug Law Institute

Language

en-US

Abstract

This Article concerns the particular regulatory responsibilities only of FDA. It sets to one side the possible regulatory authority of agencies such as the Environmental Protection Agency ("EPA") or the U.S. Department of Agriculture ("USDA"). This approach risks replicating the regulatory fracture introduced during the Reagan Administration and criticized by some scholars,¹⁵ but there is a great deal to say about current FDA practices. Out of similar considerations of space and focus, this Article also sets to one side many other important issues that surround GM foods: intellectual property rights; rights to free speech or commercial speech; fair trade practice law and unfair competition law; warranty law; and the panoply of state and federal consumer product safety and consumer protection statutes, among others.

We should also note at the outset one further limit of the scope of this article. Our aim is to show that FDA has construed its authority too narrowly. As we discuss below, this includes FDA's understanding of its authority to prescribe the content of food labels. We do not propose a particular form that labels should take, including whether all GM foods should be labeled as such. Rather, our argument is that given the current state of FDA oversight and the importance of transparency to consumers, examination of the labeling issue is within FDA's purview.

In what follows, we argue that FDA is misconstruing the limits of its regulatory authority over GM foods in three important ways. First, it has been too deferential in the scientific scrutiny required for pre-market approval of new GM crops. Second, it delineates risks in an unjustifiably constricted manner in construing the extent of its regulatory authority. Finally, and relatedly, it construes its authority to require labeling of GM foods too narrowly, thus potentially depriving consumers of the opportunity to make choices that may be important to them. We begin with FDA's scientific scrutiny of GM crops.

Recommended Citation

Leslie Francis, Robin K. Craig & Erika George, FDA's Troubling Failures to Use Its Authority to Regulate Genetically Modified Foods , in 71 Food and Drug Law Journal 105 (2016).
Available at: https://scholarship.law.bu.edu/faculty_scholarship/3841