Ferrous Sulfate
Ferrous sulfate is FDA GRAS for food fortification (21 CFR 184.1315) and is one of the most studied and widely used iron fortificants globally. WHO and FAO endorse it for staple food fortification.
What it is
An iron(II) sulfate salt (FeSO4) used as an iron source for food fortification and dietary supplements.
Iron fortificant; used to enrich grains, cereals, infant formula and breads to prevent iron-deficiency anemia.
Why it's flagged
- GI upset at high supplement doses
- Contraindicated in hemochromatosis
- Iron overload risk if combined with high-dose supplements
What regulators actually say
"Ferrous sulfate (FeSO4·7H2O, CAS Reg. No. 7782-63-0)... is generally recognized as safe (GRAS) when used in food in accordance with current good manufacturing practice."
"The Tolerable Upper Intake Level (UL) for iron from food and supplements based on the amounts associated with gastrointestinal distress is 45 mg/day for all males and for females aged 14 years and older."
Regulatory status
United States — FDA
GRAS under 21 CFR 184.1315
European Union — EFSA
Authorized as a source of iron in food supplements and fortified foods
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