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The Inverted Burden: Food Toxicology, Regulatory Capture, and the Case for Precautionary Food Safety

A. C. Applebee, L. N. Combe · 2026

Abstract

The modern food supply operates under an inverted burden of proof: substances are permitted in food until demonstrated harmful, rather than excluded until demonstrated safe. This paper argues that this inversion is ethically indefensible, scientifically unjustifiable, and causally linked to the epidemic-scale chronic disease burden of industrialised populations. We examine the regulatory frameworks governing food safety across four jurisdictions – the United States (FDA/GRAS), the European Union (EFSA), Australia and New Zealand (FSANZ), and international standards (Codex Alimentarius) – and demonstrate that each operates on a spectrum from near-total industry self-certification (US GRAS) to imperfect precaution (EU), with none approaching the evidentiary standard applied to pharmaceuticals. We document the GRAS (Generally Recognized As Safe) loophole, under which approximately 1,000 chemicals have been self-affirmed as safe by their manufacturers without any notification to the FDA, and under which 100% of GRAS expert panels between 1997 and 2012 had financial conflicts of interest (Neltner et al., 2013).

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