Conflicts of Interest and the FDA’s Determinations of Food Safety

By Leslie Francis

At last year’s Petrie-Flom conference on the FDA in the 21st Century, I had an experience that I’ve never really had before in my academic career.  I gave a paper (co-authored, actually) that was met with genuine ire.  The paper dealt with labeling GMO foods.  Several in the audience—including friends—heard me as going over to the dark side of anti-science, irrational skepticism, and downright immoral ignorance of important nutritional and commercial advantages.  I wasn’t buying into such bad science, however.  The written paper (concededly it’s always possible that a lengthy legal argument doesn’t come across in a nuanced way in a short presentation) argued three points:  (1) the FDA has not acted to the full extent of its statutory labeling authority; (2) the present processes for granting market clearance for particular GMO products is highly deferential to industry submissions with respect to safety (the safety of a particular GMO product is a different question from the general question of GMO safety—the FDA’s own example is the unknown allergenic effects of adding peanut genes to other agricultural products); and (3) in a context in which scrutiny of safety is so industry-dependent, there is a case to be made for labeling so that consumers can make their own choices.

In a nutshell, the current FDA process for allowing a particular GMO product to be marketed is a variant of the process for allowing marketing of additives Generally Recognized as Safe (GRAS).  Under the GRAS process, anyone can petition for a determination that an additive is GRAS; industry can also make its own GRAS determinations.  The procedure for clearing GMO foods is a consultative process that is also voluntary and entirely reliant on information from industry.  Unlike the GRAS process, however, it does not even require publication of the information relied on for consultations.

In an article published this week in JAMA Internal Medicine, Neitner et al. demonstrate the extent to which GRAS determinations are riddled with conflicts of interest.  The authors conclude, “The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.”  Given the parallels between the GRAS process and the process applied to GMO foods, one might hypothesize that conflicts of interest are similarly present in the latter.  The FDA should address these concerns, too.  This is not anti-science; it is respect for good science.

[Leslie Francis]
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About Leslie Francis

I'm Alfred C. Emery Distinguished Professor of Law and Distinguished Professor of Philosophy at the University of Utah. My chief interests these days are privacy and confidentiality, justice in health care, disability and anti-discrimination more generally. Most recently, John Francis and I have published Privacy: What Everyone Needs to Know (New York: Oxford).