Inositol
Inositol is GRAS for foods and infant formula under 21 CFR 184.1370 and 21 CFR 582.5370. NIH-cited clinical use up to 4 g/day is generally free of side effects, with mild GI symptoms only at very high doses (12 g/day).
What it is
Carbohydrate alcohol (cyclohexane-1,2,3,4,5,6-hexol); myo-inositol is the dominant form. Naturally present in many foods (cantaloupe, citrus, beans) and synthesized endogenously.
Nutrient/dietary supplement; lipotropic factor for cell membrane structure (phosphatidylinositol).
Why it's flagged
- GI upset at very high doses (>=10 g/day)
What regulators actually say
"Inositol (C6H12O6, CAS Reg. No. 87-89-8)... is generally recognized as safe for use in food and in infant formula in accordance with current good manufacturing practice."
Regulatory status
United States — FDA
GRAS for use in food and infant formula (21 CFR 184.1370, 21 CFR 582.5370).
European Union — EFSA
Authorized as a source of inositol in food supplements.
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