🇺🇸 FDA
Authorized health claim (oat β-glucan + CHD · 21 CFR 101.81)
Beta-Glucan (β-glucan · cereal + yeast variants)
Also known as: β-1,3-glucan · (1,3/1,6)-β-D-glucan · Oat β-glucan · Yeast β-glucan
Mechanism of action
- Cereal: bile acid binding · cholesterol-lowering
- Yeast: Dectin-1 receptor immune training · AHCC pathway
Molecular + tissue targets
- LDL cholesterol (cereal)
- Innate immune training (yeast)
- Gut microbiome
Dosage range
Cereal: ≥ 3 g/day for cholesterol effect (FDA + EFSA dual-authorized · ANVISA Anexo I authorized constituent without alegação funcional); Yeast: 250-500 mg/day in emerging immune RCTs
Safety notes
Generally well tolerated; cereal β-glucan negative trial (Ibrügger 2013) disclosed; yeast β-glucan long-term data limited
Cross-market regulatory status
🇪🇺 EFSA
Authorized claim (oat + barley β-glucan + cholesterol maintenance)
🇧🇷 ANVISA
RDC 243/2018 dietary supplement framework · IN 28/2018 Anexo I authorized constituent (Beta-glucana de farelo de aveia · Beta-glucana de levedura) · NO Anexo V alegação funcional for beta-glucan (Anexo V fiber claims limited to psyllium ≥ 7 g/dia and quitosana ≥ 3 g/dia)
Authorized claims · verbatim (4)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇺🇸 FDA · 1 claim
21 CFR 101.81 Authorized Health Claim
Soluble fiber from oats, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the [necessary daily dietary intake of] beta-glucan soluble fiber from oats necessary per day to have this effect.
Conditions: ≥ 3 g/day β-glucan from whole oats or oat bran
Authorized 1997
🇪🇺 EFSA · 3 claims
Reg 432/2012
Oat beta-glucan has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.
Conditions: ≥ 3 g/day oat β-glucan
Authorized 2012
Reg 432/2012
Barley beta-glucan has been shown to lower/reduce blood cholesterol.
Conditions: ≥ 3 g/day barley β-glucan
Authorized 2012
Reg 432/2012
Beta-glucans contribute to the maintenance of normal blood cholesterol levels.
Conditions: ≥ 1 g/day β-glucan from oats/barley
Authorized 2012
Common use cases
- cholesterol management (cereal β-glucan)
- immune support (yeast β-glucan · emerging)
Cross-reference
Health goals: heart health gut digestion
Lifestyles: senior 60 plus
Full dossier: /ingredients/beta-glucan/
Machine-readable JSON: /api/nc/beta-glucan.json