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Beta-Sitosterol

Low concern

Plant sterols have an authorized FDA health claim for cholesterol reduction. EFSA has approved health claims at 1.5-3 g/day intake.

Found in
13 products

What it is

Plant sterol naturally found in vegetable oils, nuts, and seeds.

Cholesterol-lowering functional food ingredient.

Why it's flagged

What regulators actually say

"Plant sterol/stanol esters: Diets low in saturated fat and cholesterol that include 1.3 grams of plant sterol esters... may reduce the risk of heart disease."

21 CFR 101.83 - Health claims: plant sterol/stanol esters — ecfr.gov

Regulatory status

United States — FDA

Authorized health claim (21 CFR 101.83); GRAS for use in foods (multiple GRAS notices).

European Union — EFSA

Authorized health claim under Regulation 432/2012 at intake of 1.5-3 g/day.

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