Exhibit 563 ยท Peer-reviewed study
Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance (JAMA Internal Medicine 173(22):2032-2036)
Between 1997 and 2012, we found that financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS.
Applied Institute of Medicine conflict-of-interest criteria to the 451 GRAS notices FDA received from 1997 to 2012. 22.4 percent were decided by a manufacturer's employee, 13.3 percent by a consultant firm's employee, and 64.3 percent by an expert panel chosen by the manufacturer or its consultant; none by a standing panel chosen by a third party. Ten people served on 27 or more of the 290 panels and one served on 128. The authors state the results do not prove the conflicts compromised any decision. Funded by Pew; three authors were Pew employees.
- Source
- Neltner TG, Alger HM, O'Reilly JT, Krimsky S, Bero LA, Maffini MV (Pew Charitable Trusts; University of Cincinnati; Tufts; UCSF)
- Date
- 9 December 2013 (online 7 August 2013)
- Quoted from
- Discussion, first sentence
- Grade
- Peer-reviewed
- Document
- https://doi.org/10.1001/jamainternmed.2013.10559
- Archived
- https://web.archive.org/web/2019/https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1725123
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- The publisher page is paywalled. Limitations stated by the authors: they lacked comparable data on determinations not submitted to FDA, did not evaluate the FEMA panel, and analyzed only employment relationships. Results, 'Assessment of GRAS Safety Determinations Not Submitted to the FDA': 'From 1997 to 2012, we found only 1 instance when the agency sought to obtain a GRAS safety determination that it had not received a notification for.' That instance was FDA's 2010 letters to four companies about caffeine in alcoholic beverages; none had made a GRAS determination.