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

30 Pages Posted: 4 Oct 2016 Last revised: 8 Nov 2016

See all articles by Leslie P. Francis

Leslie P. Francis

University of Utah - S.J. Quinney College of Law

Robin Kundis Craig

University of Utah S.J. Quinney College of Law

Erika R. George

University of Utah - S.J. Quinney College of Law

Date Written: 2016

Abstract

This Article has argued that FDA is construing its authority over GM foods too narrowly, in three respects. First, scientific scrutiny of these foods is not fully transparent and appears rife with conflicts of interest, effectively reversing the FDCA's requirement that manufacturers prove that food additives are safe. Second, FDA largely omits risks created in production processes from food safety analyses, despite authority to do so granted under FSMA and despite increasing consumer and scientific concern that at least some GM foods pose such risks. Finally, FDA's limited construction of what makes information "material" for food labeling purposes compounds the lack of transparency in the regulatory process and interferes with consumers' abilities to avoid allergens, respect religious requirements, and implement personal ethical and risk avoidance choices.

Arguments from the law governing the human right to food also support broader understanding of FDA's authority to regulate food safety and labeling. In light of growing scientific concerns about at least some GM foods, reconsideration of FDA's constricted interpretation of its authority to regulate food is imperative. Indeed, irony abounds in the current FDA approach: despite FDA's broad authority to "regulate through revelation" and label products, the consultative process that enables manufacturers to evade disclosing the genetic identity of food products remains opaque and potentially rife with conflicts of interest, while transparency to consumers is absent.

Suggested Citation

Francis, Leslie P. and Craig, Robin Kundis and George, Erika R., FDA's Troubling Failures to Use its Authority to Regulate Genetically Modified Foods (2016). 71 Food & Drug L.J. 105 2016; University of Utah College of Law Research Paper No.184. Available at SSRN: https://ssrn.com/abstract=2847303

Leslie P. Francis (Contact Author)

University of Utah - S.J. Quinney College of Law ( email )

383 S. University Street
Salt Lake City, UT 84112-0730
United States

Robin Kundis Craig

University of Utah S.J. Quinney College of Law ( email )

383 South University St.
Salt Lake City, UT 84112-0730
United States
801-585-5228 (Phone)

HOME PAGE: http://https://faculty.utah.edu/u0793211-ROBIN_KUNDIS_CRAIG/biography/index.hml

Erika R. George

University of Utah - S.J. Quinney College of Law ( email )

383 S. University Street
Salt Lake City, UT 84112-0730
United States

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