EMBARGOED FOR RELEASE: 8 A.M. (CT), WEDNESDAY, AUGUST 7, 2013
Media Advisory: To contact study author Thomas G. Neltner, J.D., call Linda Paris at 202-540-6354 or 202-365-3343or email email@example.com. To contact commentary author Marion Nestle, Ph.D., M.P.H., call Courtney Bowe at 212-998-6797 or email Courtney.Bowe@nyu.edu.
Editor’s Note: The report is being released in conjunction with a workshop on potential conflicts of interest in “generally recognized as safe” (GRAS) food additive decisions held by The Pew Charitable Trusts.
CHICAGO – A study that examined conflicts of interest in approvals of additives to food suggests that the lack of an independent review in “generally recognized as safe” (GRAS) determinations raises concerns about the integrity of the process, according to a report published by JAMA Internal Medicine, a JAMA Network publication.
The Food Additives Amendment of 1958 allows manufacturers to determine when an additive is GRAS. After a GRAS determination is made, manufacturers are not required to notify the U.S. Food and Drug Administration (FDA), although in some instances the agency is notified, the authors write in the study background.
“The individuals that companies select to make these determinations may have financial conflicts of interest,” the authors comment in the study.
Thomas G. Neltner, J.D., of The Pew Charitable Trusts, Washington, D.C., and colleagues used conflict of interest criteria developed by a committee of the Institute of Medicine to analyze 451 GRAS notifications that were voluntarily submitted to the FDA between 1997 and 2012.
For the 451 GRAS notifications, 22.4 percent of the safety assessments were made by an employee of an additive manufacturer, 13.3 percent by an employee of a consulting firm selected by the manufacturer and 64.3 percent by an expert panel selected by either a consulting firm or the manufacturer, according to the results.
“Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. 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,” the study concludes.
(JAMA Intern Med. Published online August 7, 2013. doi:10.1001/jamainternmed.2013.10559. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: This work was supported by The Pew Charitable Trusts. Some authors are employees of Pew. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding andsupport, etc.
Commentary: Conflicts of Interest in the Regulation of Food Safety
In a related commentary, Marion Nestle, Ph.D., M.P.H., of New York University, writes: “The study by Neltner and colleagues provides an important addition to the growing body of evidence for undue food industry influence on food safety policy.”
“As Neltner et al argue, the lack of independent review in GRAS determinations raises serious questions about the public health implications of unregulated additives in the food supply, particularly the additives that the FDA does not even know about. It also raises questions about conflicts of interest in other regulatory matters,” Nestle continues.
“By focusing attention on one blatant example, this study performs a great public service,” Nestle concludes.
(JAMA Intern Med. Published online August 7, 2013. doi:10.1001/jamainternmed.2013.9158. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding andsupport, etc.
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