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Polydextrose 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.
At doses above ~90 g/day, polydextrose can cause flatulence, bloating, and loose stools. At normal food use levels it is well tolerated. EFSA confirmed its safety in 2012. It functions as a soluble prebiotic fiber, feeding beneficial gut bacteria. No genotoxicity, carcinogenicity, or reproductive toxicity has been identified.
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