According to a new article published in the Journal of the American Medical Association Internal Medicine, financial conflicts of interest are ubiquitous when food company employees, paid consultants or professional experts conclude that chemicals are "generally recognized as safe" and can be added to food. The article was co-authored by researchers from The Pew Charitable Trusts.
The article examines decisions about "generally recognized as safe," or GRAS determinations, which according to standard agency practice require no input from or even notification to the U.S. Food and Drug Administration. The co-authors find that out of 451 GRAS determinations made between 1997 and 2012, 22 percent were made by an employee of an additive manufacturer. More than 13 percent were made by an employee of a consulting firm selected by an additive manufacturer, and more than 64 percent by an expert panel selected by a consulting firm of an additive manufacturer.
In addition, the article finds that of the 290 panels convened, at least one of 10 individuals was selected to serve on 225 (78 percent) of them. Only 65 (22 percent) panels did not include one of the 10 individuals most frequently selected.
The authors used criteria developed by the Institute of Medicine in 2009 to identify conflicts of interest.
In 1958, Congress created the GRAS exemption to the more formal food additive petition process, but this exception was intended to be available for common food ingredients such as oil and vinegar. Since then, companies have expanded the use of the GRAS loophole to include a wide variety of chemicals whose safety is far from "generally accepted." Over the past 10 years, the loophole has effectively swallowed the law—thousands of chemicals have been cleared via GRAS determinations rather than the food additive petition process Congress set up.
The co-authors consist of three food additive experts from Pew—Maricel Maffini, Heather Alger and Tom Neltner—two widely-recognized ethics experts—Lisa Bero of University of California at San Francisco (and coauthor of the 2009 Institute of Medicine report) and Sheldon Krimsky of Tufts University—and a widely published expert on FDA law, James O'Reilly of the University of Cincinnati.
The co-authors call on the FDA to fulfill its responsibilities to the public under the law and minimize conflicts of interest in GRAS determinations. These recommendations mirror a 2010 report from the U.S. Governmental Accountability Office. Minimizing these conflicts is important because the food supply is so large and complicated that connecting a health problem back to a specific additive is often difficult, particularly when the illness takes time to develop.
Pew will present the article's findings at a "Potential Conflicts of Interest in GRAS Determinations" workshop on August 7, 2013 that will be webcast.
Pew is focused on conflicts of interest in the medical setting as well. Check out Pew's prescription project as it supports implementation of the Physician Payments Sunshine provisions in health care reform law, which requires drug and medical device manufacturers to publicly report gifts and payments made to physicians and teaching hospitals.