The Lacuna Project

lacuna (n.) a gap in a record where something should be

Independent research. Not affiliated with any government, agency, or company.

Nonprofit

The Pew Charitable Trusts

Findings that rest on exhibits naming this entity

  • AGR-1.5: Of the 451 GRAS notices FDA received from 1997 to 2012, 22.4 percent were decided by an employee of the manufacturer, 13.3 percent by an employee of a consulting firm the manufacturer selected, and 64.3 percent by an expert panel selected by the manufacturer or its consultant. None used a standing panel selected by a third party; the study was funded by the Pew Charitable Trusts.
  • AGR-1.7: FDA's 2026 economic analysis states that the exact number of substances marketed under independent GRAS conclusions is unknown and assumes 1,000 to 3,000 (primary estimate 2,000), against 1,309 notices filed from February 1998 to March 2025. The proposed rule states that FDA "cannot verify the accuracy of these estimates."
  • AGR-1.8: FDA's regulation says general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as an additive approval. FDA removed cyclamate salts from the GRAS list in 1969, and in 2010 it sent warning letters to makers of caffeinated alcoholic beverages that had made no GRAS determination.

Exhibits naming this entity

  • Exhibit 563 9 December 2013 (online 7 August 2013). Neltner TG, Alger HM, O'Reilly JT, Krimsky S, Bero LA, Maffini MV (Pew Charitable Trusts; University of Cincinnati; Tufts; UCSF): 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)
  • Exhibit 564 25 October 2011. Neltner TG, Kulkarni NR, Alger HM, Maffini MV, Bongard ED, Fortin ND, Olson ED (Pew Health Group): Navigating the U.S. Food Additive Regulatory Program (Comprehensive Reviews in Food Science and Food Safety 10(6):342-368)