Is Polysorbate 80 banned?
Polysorbate 80 is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Why Polysorbate 80 is flagged
Emerging research has raised concerns about polysorbate 80's effects on the gut. A landmark 2015 study in Nature (Chassaing et al.) found that dietary polysorbate 80 and polysorbate 60 at concentrations approaching food use levels promoted colitis and metabolic syndrome in genetically susceptible mice by disrupting the intestinal mucus layer and altering gut microbiome composition. The emulsifiers thinned the protective mucus layer, allowing bacteria to come into closer contact with gut epithelial cells and triggering inflammation. This study was a seminal contribution to gut health research, though it was conducted in mice and requires confirmation in humans. A 2020 follow-up study found that dietary emulsifiers including polysorbate 80 promoted gut inflammation and altered gut microbiome in human participants with Crohn's disease. People with inflammatory bowel disease may be most vulnerable to polysorbate 80's potential gut effects.
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