Tromethamine
Tromethamine is FDA-approved as an inactive ingredient in approved drug products and is used as a pH buffer. The Cosmetic Ingredient Review (CIR) Expert Panel evaluated tromethamine as safe in cosmetic use under current concentrations.
What it is
Tris(hydroxymethyl)aminomethane (TRIS), an organic amine used as a buffering agent and excipient.
Not a typical food ingredient; pH buffer in pharmaceuticals and cosmetics.
Why it's flagged
- Not commonly found in food
What regulators actually say
"The Cosmetic Ingredient Review Expert Panel concluded that Tromethamine ... is safe in the present practices of use and concentration in cosmetic formulations."
Regulatory status
United States — FDA
FDA-approved inactive pharmaceutical ingredient; approved API as injection (Tham)
European Union — EFSA
Not assessed as food additive; cosmetic ingredient
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