A new study published online on August 7, 2013 in the peer-reviewed scientific journal JAMA Internal Medicine details conflicts of interest in the Generally Recognized as Safe (GRAS) determination process (Neltner et al. 2013). According to the authors from the non-profit organization The Pew Charitable Trusts, 22 percent of the 451 food additive GRAS determinations of which the U.S. Food and Drug Administration (FDA) was notified between 1997 and 2012, were made by an employee of the manufacturer, and 13 percent were made by an employee of a consulting firm selected by the manufacturer. None of the determinations were carried out by experts selected by an independent third party. One panel member served on 128 of the 290 panels that make GRAS determinations, indicating the small number of people part-taking GRAS decisions. However, the authors state that the study cannot elucidate whether the discovered financial conflicts of interest result indeed in a compromised GRAS decision process. The study used conflict of interest criteria developed by the Institute of Medicine. Neltner and colleagues conclude that a first step to manage conflicts of interest is for the “FDA to require that it be notified of all GRAS determinations and the financial conflicts of those who make these determinations”.
In an article published online on August 7, 2013 on the news website of CBS 3 Springfield, Michael Jacobson, executive director of the Center for Science in the Public Interest, commented that
under the current process “the FDA may not even have the chance to evaluate the safety of new ingredients”. FDA spokeswoman Theresea Eisenman responded that the agency encourages manufacturers to notify the U.S. FDA.
Neltner, T. et al. (2013). “Conflicts of interest in approvals of additives to food determined to be generally recognized as safe out of balance.” JAMA Internal Medicine (published online August 7, 2013).