Aluminum Hydroxide
Aluminum hydroxide is permitted as a substrate for FDA-listed color additives under 21 CFR Part 73 and 74 (e.g., 21 CFR 73.100 carmine). Direct dietary aluminum exposure from this use is small.
What it is
Aluminum oxide hydroxide (Al(OH)3); used as antacid, vaccine adjuvant, color-additive substrate.
In food, primarily a substrate for color-additive lakes (carmine, FD&C lakes); not used as a direct nutrient or flavoring.
Why it's flagged
- Cumulative dietary aluminum from multiple sources
- Renal impairment caution (antacid use)
What regulators actually say
"Color additive lakes including carmine are listed in 21 CFR Part 73 as the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles."
Regulatory status
United States — FDA
Permitted as color-additive substrate (21 CFR Part 73/74); OTC antacid (Monograph M001).
European Union — EFSA
Aluminum group ADI 1 mg/kg bw/week (EFSA 2008).
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