Independent Investigation Claims GRAS Determinations Rife with Conflicts of Interest
A recent study published in JAMA Internal Medicine has faulted the Food and Drug Administration’s (FDA’s) process for declaring food additives “generally recognized as safe” (GRAS), citing alleged financial conflicts of interest among those chosen by companies to verify the safety of new additives. Thomas Neltner, et al., “Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance,” JAMA Internal Medicine, August 2013. Led by Thomas Neltner, director of the Pew Health Group’s Food Additive Project, researchers used the Institute of Medicine’s conflict of interest criteria to analyze “451 GRAS notifications voluntarily submitted to FDA between 1997 and 2012.” In particular, they sought to determine (i) “the likelihood that a decision by an individual making a [GRAS] determination would be unduly influenced by the financial interests of a manufacturer of an additive,” and (ii) “the seriousness of possible harm if a GRAS determination was unduly influenced by the financial interests of a manufacturer of an additive, based on whether there was an FDA review and whether the notification to the agency was made public.”
This review of GRAS notifications apparently showed that “22.4% were made
by an employee of a manufacturer, 13.3% were made by an employee of
a consulting firm selected by a manufacturer, and 64.3% were made by an
expert panel selected by the manufacturer or a firm that was a consultant to
the manufacturer.” In addition, the study noted that the expert panels making
GRAS determinations often selected their members from a small number
of consultants, with 10 individuals serving on 27 or more panels and one
individual serving on 128 panels. “Over the 15-year period, at least 1 of these
10 individuals participated in 225 panels (77.6%), accounting for 43.1% (433
of 1,004) of the total number of seats on all 290 panels,” stated the researchers,
who questioned the financial ties of both employees and third-party panelists
as well as the reliance on a small pool of experts to provide scientific input.
“Between 1997 and 2012, we found that financial conflicts of interest were
ubiquitous in determinations that an additive to food was GRAS,” the study
concludes. “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 when the manufacturer does not
notify the FDA of the determination … To minimize and manage conflicts of
interest, an essential first step is for the FDA to require that it be notified of all
GRAS determinations and the financial conflicts of interest of those who make
these determinations.”
Additional details about Neltner’s work on food additive approvals appear in
Issue 415 of this Update.
