Conflicts of Interest Common in Defining Food Additive Safety

(HealthDay News) – Conflicts of interest are very common in the process of determining whether food additives are “generally recognized as safe” (GRAS), according to research published online Aug. 7 in JAMA Internal Medicine.

Using conflict of interest criteria developed by a committee from the Institute of Medicine, Thomas G. Neltner, JD, from the Pew Charitable Trusts in Washington, D.C., and colleagues analyzed 451 GRAS notifications that were voluntarily submitted to the FDA from 1997–2012.

The researchers found that none of the safety assessments were made by a standing expert panel. Most of the safety assessments (64.3%) were made by an expert panel selected by a consulting firm or the manufacturer; 22.4% were made by an employee of an additive manufacturer; and 13.3% were made by an employee of a consulting firm selected by the manufacturer. An average of 3.5 members and a maximum of seven members were on the 290 panels that made GRAS determinations. Ten members served on at least 27 panels, and one served on 128 panels. One or more of the 10 individuals with the most frequent service was a member of 225 panels.

“Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS,” the authors write. “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.”

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