Allulose 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.
Generally considered safe with a favorable glycemic profile. Human studies show that allulose does not raise blood glucose or insulin. GI effects (bloating, abdominal cramping, diarrhea) have been reported in dose-response studies above 0.4 g/kg body weight; a 2016 study in the journal Food & Chemical Toxicology established a no-observed-adverse-effect level (NOAEL) in humans. Compared to erythritol, no cardiovascular concerns have been raised in the literature.
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